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1.
Lima; Instituto Nacional de Salud; feb. 2022.
Non-conventional in Spanish | LILACS, BRISA | ID: biblio-1369710

ABSTRACT

ANTECEDENTES: Este informe se efectúa en atención a la solicitud la jefatura del Instituto Nacional de Salud (INS). El 8 de diciembre de 2021, la FDA emitió la autorización de uso de emergencia de la combinación de anticuerpos monoclonales tixagevimab y cilgavimab (Evusheld) como profilaxis pre exposición (prevención) en cierta población de adultos y niños (personas inmunocomprometidas y antecedentes de reacciones adversas severas a las vacunas contra COVID-19) (1). La EMA continua con el proceso de revisión de la eficacia y seguridad (2). El objetivo es sintetizar la evidencia científica publicada respecto a la eficacia y seguridad de la combinación de tixagevimab y cilgavimab (EvusheldTM) contra la COVID-19. MÉTODOS: Pregunta PICO: ¿En población con COVID-19, cuál es la eficacia y seguridad de la combinación de de tixagevimab y cilgavimab (Evusheld)? Criterios de elegibilidad: Los criterios de selección de los estudios fueron los siguientes: Ensayos clínicos aleatorizados o revisiones sistemáticas que reporten resultados para al menos uno de los desenlaces. En ausencia de resultados de eficacia para alguno de los desenlaces, se considerará los resultados de efectividad a partir de estudios de cohorte o test negativo. Estudios publicados en idioma inglés y español. Se excluyeron cartas al editor, revisiones narrativas, estudios preclínicos (estudios in vitro o en modelos animales), artículos de opinión y manuscritos no revisados por pares. Métodos para la búsqueda e identificación de la evidencia: Los ensayos clínicos fueron identificados desde las siguientes fuentes (búsqueda realizada el 3 de febrero de 2022): Plataforma Living Overview of the Evidence (L·OVE) de la Fundación Epistemonikos (https://www.epistemonikos.org/en/). Bases de datos electrónicas: MEDLINE/Pubmed, Embase y Cochrane Library. Registro de Ensayos Clínicos de Estados Unidos (https://clinicaltrials.gov/ct2/home) y la Plataforma Internacional de Registro de Ensayos Clínicos de la OMS (https://trialsearch.who.int/). Páginas institucionales de la Food and Drug Administration (FDA) de Estados Unidos (https://www.fda.gov/) y la European Medicines Agency (EMA) (https://www.ema.europa.eu/en). RESULTADOS: No se encontraron ECA o RS en las bases de datos seleccionadas que muestren resultados de eficacia o seguridad de la combinación de tixagevimab y cilgavimab (Evusheld). En cambio, se encontraron 8 protocolos de ECA que están en progreso. CONCLUSIONES: La presente nota técnica tiene como objetivo sintetizar la evidencia disponible sobre la eficacia y seguridad de la combinación de tixagevimab y cilgavimab (Evusheld) para la prevención de la infección por SARS-CoV-2. En la búsqueda de información, no se encontraron ECA o RS publicados en revistas científicas que mostraran información sobre la eficacia y seguridad de la combinación de tixagevimab y cilgavimab (Evusheld). En cambio, se encontró una revisión de la FDA de la ECA PROVENT que evaluó la eficacia y seguridad de la combinación de tixagevimab y cilgavimab (Evusheld). La combinación de tixagevimab y cilgavimab (Evusheld) fue evaluada en población que fue candidata a inmunización pasiva con anticuerpos, en este grupo se incluyeron las personas que tuvieron una respuesta deficiente a vacunas o personas con riesgo incrementado a infección por SARS-CoV-2. Según el informe, combinación de tixagevimab y cilgavimab (Evusheld) mostró una reducción del riesgo relativo en la infección sintomática por SARS-CoV-2 (confirmado por RT-PCR) de 76.7%. La combinación de tixagevimab y cilgavimab (Evusheld) mostró una reducción del riesgo relativo de muerte por cualquier causa de 68.8%. Se ha reportado eventos adversos asociados a tratamiento en el grupo intervención (8%) y en el grupo placebo (7%). Se ha reportado eventos adversos con desenlace de muerte en el grupo AZD7442 (0.12%) y placebo (0.23%), los detalles de estos desenlaces no están disponibles en el reporte. Los eventos adversos de especial interés fueron reportados en el grupo AZD7442 (3%) y en el grupo placebo (2%).


Subject(s)
Humans , SARS-CoV-2/drug effects , COVID-19/drug therapy , Antibodies, Monoclonal/therapeutic use , Drug Combinations
2.
Lima; Instituto Nacional de Salud; ene. 2022.
Non-conventional in Spanish | LILACS, BRISA | ID: biblio-1369728

ABSTRACT

ANTECEDENTES: Este informe se efectúa en atención a la solicitud la jefatura del Instituto Nacional de Salud (INS). En un comunicado de prensa (publicado el 5 de noviembre de 2021), Pfizer indicó que, a través de un análisis provisional de su ECA fase 2/3, su nuevo antiviral candidato a tratamiento contra la COVID-19 (Paxlovid™) reduce el riesgo de hospitalización o muerte en un 89%, en comparación de las personas que recibieron placebo, en adultos no hospitalizados con COVID-19 (1). El comunicado menciona también que Pfizer planea enviar los datos a la FDA para su uso de emergencia, tan pronto como sea posible. El 16 de diciembre de 2021, la EMA emite recomendaciones sobre el uso de Paxlovid™ para el tratamiento de la COVID-19 (2) y el 19 de noviembre la EMA solicitó una opinión científica sobre los datos preclínicos, clínicos y de calidad disponibles sobre el potencial uso de Paxlovid™ para el manejo de pacientes con COVID-19 (el reporte se publicó el 10 de enero) (3). El 22 de diciembre de 2021, la FDA comunicó que autorizó el uso de emergencia de la combinación de nirmatrelvir y ritonavir (Paxlovid™) contra los casos leves y moderados de COVID-19 en adultos y población pediátrica de 12 a más años (que pesen de 40 Kg a más) (4). El 28 de enero del 2022, la EMA otorgó autorización comercial condicional a Paxlovid™ (5). El objetivo es sintetizar la evidencia científica publicada respecto a la eficacia y seguridad de la combinación de nirmatrelvir y ritonavir (Paxlovid™) contra la COVID-19. MÉTODOS: Pregunta PICO: ¿En población con COVID-19, cuál es la eficacia y seguridad de la combinación de nirmatrelvir y ritonavir (Paxlovid™)? Criterios de elegibilidade: Los criterios de selección de los estudios fueron los siguientes: Ensayos clínicos aleatorizados o revisiones sistemáticas que reporten resultados para al menos uno de los desenlaces. En ausencia de resultados de eficacia para alguno de los desenlaces, se considerará los resultados de efectividad a partir de estudios de cohorte o test negativo. Estudios publicados en idioma inglés y español. Se excluyeron cartas al editor, revisiones narrativas, estudios preclínicos (estudios in vitro o en modelos animales), artículos de opinión y manuscritos no revisados por pares. Métodos para la búsqueda e identificación de la evidencia: Los ensayos clínicos fueron identificados desde las siguientes fuentes (búsqueda realizada en 26 de enero de 2022): Plataforma Living Overview of the Evidence (L·OVE) de la Fundación Epistemonikos (https://www.epistemonikos.org/en/). Bases de datos electrónicas: MEDLINE/Pubmed, Embase y Cochrane Library. Registro de Ensayos Clínicos de Estados Unidos (https://clinicaltrials.gov/ct2/home) y la Plataforma Internacional de Registro de Ensayos Clínicos de la OMS (https://trialsearch.who.int/). Páginas institucionales de la Food and Drug Administration (FDA) de Estados Unidos (https://www.fda.gov/) y la European Medicines Agency (EMA) (https://www.ema.europa.eu/en). RESULTADOS: En la búsqueda bibliográfica no se encontraron ECA o estudios observacionales publicados o en proceso de publicación (in press) o sin revisión por partes (preprint) que hayan evaluado la eficacia y seguridad de la combinación de nirmatrelvir y ritonavir (Paxlovid™) contra la COVID-19. En cambio, se encontraron 3 ECA en proceso, sin resultados preliminares publicados en Clinical Trials (Tabla 1). Se encontró 1 evaluación realizada por la EMA de los datos del ECA de Paxlovid™ (NCT04960202) (3). El ensayo clínico es de tipo aleatorizado, en fase 2/3, doble ciego, controlado con placebo en adultos con COVID-19 sintomáticos y no hospitalizados que se encuentran en riesgo incrementado de progresar a enfermedad severa. El objetivo del ECA fue determinar la eficacia, seguridad y tolerabilidad de la combinación de nirmatrelvir (PF-07321332) y ritonavir (Paxlovid™) comparado con placebo en pareamiento 1:1. Las características del ECA se resumen en la Tabla 2. Con un análisis provisional de datos, con 45% de los participantes que completaron el seguimiento al día 28, se reportó una reducción absoluta del 6.317% (CI95%: -9.041%, -3.593%; p<0.0001). La EMA mencionó que no está completamente claro en qué medida los subgrupos de pacientes con COVID-19 leve y moderado están representados y adecuadamente balanceados en ambos grupos. Asimismo, hay una pobre representación de los pacientes con factores de riesgo (enfermedad pulmonar crónica, enfermedades cardiovasculares, enfermedades inmunosupresivas, etc.). Además, la EMA indicó que la falta de información de la actividad de nirmatrelvir (FP-07321332) contra la variante Omicron in vitro puede ser una advertencia crítica. CONCLUSIONES: El objetivo de la nota técnica fue sintetizar la evidencia científica publicada respecto a la eficacia y seguridad de la combinación de nirmatrelvir y ritonavir (Paxlovid™) contra la COVID-19. No se encontraron ECA o estudios observacionales publicados o en proceso de publicación (in press) o sin revisión por partes (preprint) que hayan evaluado la eficacia y seguridad de la combinación de nirmatrelvir y ritonavir (Paxlovid™) contra la COVID-19. Se encontraron 3 ECA en proceso, sin resultados preliminares publicados en Clinical Trials. Se encontró una evaluación de la EMA a un ECA de Pfizer (NCT04960202) que tuvo como objetivo evaluar la eficacia y seguridad de la combinación de nirmatrelvir y ritonavir (Paxlovid™) contra la COVID-19. Con un análisis provisional de datos, con 45% de los participantes que completaron el seguimiento al día 28, se reportó una reducción absoluta de la proporción de hospitalizaciones relacionadas a COVID-19 o muertes por cualquier causa en 6.317% (CI95%: -9.041%, -3.593%; p<0.0001) respecto de placebo. Según la ficha técnica de la FDA de Paxlovid™ y la información de la EMA, las reacciones adversas más frecuentes son disgeusia, diarrea, hipertensión y mialgias. No se reportaron muertes en el grupo Paxlovid™. Los datos sobre la eficacia de la combinación de nirmatrelvir y ritonavir (Paxlovid™) deben tomarse con precaución. La EMA señaló que no está completamente claro la representatividad de los grupos según grado de severidad y presencia de factores de riesgo. Además, existe falta de información sobre la actividad del Paxlovid contra la variante Omicron in vitro.


Subject(s)
Humans , Ritonavir/therapeutic use , Coronavirus 3C Proteases/therapeutic use , SARS-CoV-2/drug effects , COVID-19/drug therapy , Efficacy , Cost-Benefit Analysis , Drug Combinations
3.
Article in Chinese | WPRIM | ID: wpr-936121

ABSTRACT

OBJECTIVE@#To evaluate the clinical characteristics and effectiveness of pulpotomy in mature permanent teeth with bioceramic putty repairmen iRoot and mineral trioxide aggregate (MTA).@*METHODS@#Pulpotomy was performed on mature permanent premolars and molars with carious exposures at the Department of General Dentistry of Peking University School and Hospital of Stomatology, from November 2017 to September 2019. The patients were randomly divided into 2 groups, Group iRoot (n=22) and Group MTA (n=21). In Group iRoot, bioceramic putty repairmen iRoot was used as pulp capping agent, while in Group MTA, mineral trioxide aggregate was used as pulp capping agent. All the patients had signed informed consent forms. The clinical efficacy was evaluated by clinical examinations (temperature and electrical activity test) and imaging examinations 3, 6, and 12 months after surgery. Blinding was used for the patients and evaluators, but due to the obvious differences in the properties of the two pulp capping agents, the blinding method was not used for the treatment provider (the attending physician).@*RESULTS@#There was no significant difference in gender, average age, dentition and tooth position distribution between the two groups (P>0.05). In the study, 7 cases were lost to follow-up 12 months after operation (4 cases in Group iRoot, and 3 cases in Group MTA). One case in each of the two groups had transient sensitivity at the end of the 3-month follow-up, and the pulp vitality was normal at the end of the 6-month follow-up. One case in Group iRoot showed sensitivity at the end of the 12-month follow-up. The success rates of the two groups at the end of 12-month follow-up were 100%, and the cure rates were 94.4% (Group iRoot) and 100% (Group MTA), respectively, and the difference was not statistically significant (P>0.05). No cases in Group iRoot had obvious crown discoloration, while 3 cases in Group MTA had.@*CONCLUSION@#The clinical characteristics and effectiveness of pulpotomy in mature permanent teeth with bioceramic putty repairmen iRoot were similar with MTA. Bioceramic putty repairmen iRoot is an acceptable material when used in pulpotomy of mature permanent teeth. Because it is not easy to cause tooth discoloration after treatment and is convenient to operate, bioceramic putty repairmen iRoot has a better clinical application prospect.


Subject(s)
Aluminum Compounds/therapeutic use , Calcium Compounds/therapeutic use , Drug Combinations , Humans , Oxides/therapeutic use , Pulpotomy , Silicates/therapeutic use , Treatment Outcome
4.
Article in English | WPRIM | ID: wpr-928966

ABSTRACT

OBJECTIVE@#To systematically evaluate the efficacy of Shengmai San in patients with cardiotoxicity of anthracyclines.@*METHODS@#Randomized controlled trials (RCTs) were identified by searching China National Knowledge Infrastructure (CNKI), Wanfang Database, Chinese Biomedical Literature Database (CBM), PubMed, Cochrane Library, and Embase Databases from the inceptions until December 2020. The Cochrane Handbook was used to evaluate the risk of bias in the included studies. Data analysis was conducted using RevMan 5.3 software.@*RESULTS@#Totally 19 RCTs with 2,331 participants were included in this review. Results showed that in improving arrhythmia (13 RCTs, n=1,877, RR=0.37, 95%CI 0.25 to 0.52, P<0.00001), the treatment group was superior to the control group. In terms of reducing left ventricular end-diastolic diameter (LVEDD, 2 RCTs, n=128, MD=-0.79, 95%CI -0.93 to -0.65, P<0.00001) and left ventricular end systolic diameter (LVESD, 2 RCTs, n=128, MD=-0.58, 95%CI -0.82 to -0.35, P<0.00001), the treatment group was also better than the control group. In reducing myocardial enzymes such as creatine kinase (CK) [(3 RCTs, n=256, SMD=-0.80, 95%CI -1.16 to -0.44, P<0.0001), (2 RCTs, n=126, SMD=-0.62, 95%CI -0.98 to -0.26, P=0.0007)], the treatment group was superior to the control group.@*CONCLUSION@#Shengmai San has a positive effect on the treatment of cardiotoxicity from anthracyclines. However, in the future, it is still necessary to conduct high-quality RCTs to verify its efficacy.


Subject(s)
Anthracyclines/adverse effects , Cardiotoxicity/etiology , Drug Combinations , Drugs, Chinese Herbal/adverse effects , Humans
5.
Article in English | WPRIM | ID: wpr-928948

ABSTRACT

OBJECTIVE@#To explore the effect of Shenmai Injection (SMI) on the long-term prognosis of patients with chronic heart failure (CHF).@*METHODS@#The Hospital Information System was used to extract data of CHF patients, and the retrospective cohort study was conducted for analysis. In non-exposed group, standardized Western medicine treatment and Chinese patent medicine or decoction were applied without combination of SMI while in the exposed group, SMI were applied for more than 7 days. Evaluation indicators are followed with New York Heart Association functional classification (NYHA classification), left ventricular ejection fraction (LVEF), N-terminal brain natriuretic peptide precursor (NT-ProBNP), cardiogenic death and heart failure (HF) readmission. Statistical analysis includes Kaplan-Meier analysis and Cox regression which are used to explore the relationship between SMI and outcome events.@*RESULTS@#A total of 1,211 eligible CHF patients were involved and finally 1,047 patients were followed up successfully. After treatment, the cases of NYHA classification decline in the exposed and non-exposed groups accounted for 64.30% and 43.45%, respectively; the improvement values of LVEF were 8.89% and 7.91%, respectively; the improvement values of NT-ProBNP were 909 pg/mL and 735 pg/mL, respectively. After exposure on SMI, the rates of cardiogenic death and HF readmission reduced from 15.43% to 10.18% and 38.93% to 32.37%. According to Kaplan-Meier analysis, the log-rank P value of SMI and cardiogenic death was 0.014, while the counterpart of SMI and HF readmission was 0.025. Cox regression analysis indicated that for cardiogenic death, age, cardiomyopathy, diabetes, and NYHA classification were risk factors while β-blockers, aldosterone receptor antagonists, Chinese patent medicine/decoction and SMI were protective factors. Likewise, for HF readmission, age, cardiomyopathy, and NYHA classification were risk factors while SMI was a protective factor.@*CONCLUSION@#Combination with SMI on the standardized Western medicine treatment can effectively reduce cardiogenic mortality and readmission rate in CHF patients, and thereby improve the long-term prognosis.


Subject(s)
Biomarkers , Drug Combinations , Drugs, Chinese Herbal , Follow-Up Studies , Heart Failure/drug therapy , Humans , Natriuretic Peptide, Brain , Peptide Fragments , Prognosis , Retrospective Studies , Stroke Volume , Ventricular Function, Left
6.
Article in Portuguese | LILACS, ColecionaSUS, CONASS, SES-GO | ID: biblio-1391794

ABSTRACT

Selexipague e outros medicamentos de controle da Hipertensão Arterial Pulmonar grupo 1. Indicação: Tratamento de Hipertensão Arterial Pulmonar grupo 1. Pergunta: Há superioridade em eficácia e segurança da tripla terapia com selexipague, comparado a dupla terapia, disponível no SUS, no tratamento de Hipertensão Arterial Pulmonar grupo 1? Métodos: Revisão rápida de evidências (overview) de ensaios clínicos randomizados e revisões sistemáticas, com levantamento bibliográfico realizado na base de dados PUBMED, utilizando estratégia estruturada de busca. A qualidade metodológica das revisões sistemáticas foi avaliada pela ferramenta risco de viés da Cochrane. Resultados: Foi selecionado um ensaio clínico randomizado, especificamente um artigo contendo análise de subgrupo de dados desse estudo. Conclusão: As evidências demonstraram redução do número de hospitalizações relacionadas à HAP e de eventos de progressão da doença no tratamento de selexipague em tripla terapia em pacientes na classe funcional II, quando comparada à dupla terapia sem selexipague. A tripla terapia é tão segura quanto a dupla terapia, pois tem riscos similares de eventos adversos e eventos adversos sérios. A tripla terapia não é diferente da dupla terapia no risco da mortalidade geral


Selexipag and other drugs for the control of Pulmonary Arterial Hypertension group 1. Indication: Treatment of Pulmonary Arterial Hypertension group 1. Question: Is there superiority in efficacy and safety of triple therapy with selexipag, compared to dual therapy, available in the SUS, in the treatment of ulmonary Arterial Hypertension group 1? Methods: Rapid review of evidence (overview) of randomized clinical trials and systematic reviews, with a bibliographic survey carried out in the PUBMED database, using a structured search strategy. Results: A randomized clinical trial was selected, specifically an article showing a subgroup analysis of data from this study. Conclusion: Evidence showed a reduction in the number of Pulmonary Arterial Hypertension related hospitalizations and disease progression events in the treatment of selexipag in triple therapy in patients in functional class II, when compared to dual therapy without selexipag. Triple therapy is as safe as dual therapy, as it has similar risks of adverse events and serious adverse events. Triple therapy is no different from dual therapy in the risk of overall mortality


Subject(s)
Humans , Male , Female , Adult , Middle Aged , Aged , Receptors, Epoprostenol/agonists , Pulmonary Arterial Hypertension/drug therapy , Drug Combinations
7.
Frontiers of Medicine ; (4): 83-92, 2022.
Article in English | WPRIM | ID: wpr-929204

ABSTRACT

The dihydrofolate reductase (dhfr) and dihydropteroate synthetase (dhps) genes of Plasmodium vivax, as antifolate resistance-associated genes were used for drug resistance surveillance. A total of 375 P. vivax isolates collected from different geographical locations in China in 2009-2019 were used to sequence Pvdhfr and Pvdhps. The majority of the isolates harbored a mutant type allele for Pvdhfr (94.5%) and Pvdhps (68.2%). The most predominant point mutations were S117T/N (77.7%) in Pvdhfr and A383G (66.8%) in Pvdhps. Amino acid changes were identified at nine residues in Pvdhfr. A quadruple-mutant haplotype at 57, 58, 61, and 117 was the most frequent (57.4%) among 16 distinct Pvdhfr haplotypes. Mutations in Pvdhps were detected at six codons, and the double-mutant A383G/A553G was the most prevalent (39.3%). Pvdhfr exhibited a higher mutation prevalence and greater diversity than Pvdhps in China. Most isolates from Yunnan carried multiple mutant haplotypes, while the majority of samples from temperate regions and Hainan Island harbored the wild type or single mutant type. This study indicated that the antifolate resistance levels of P. vivax parasites were different across China and molecular markers could be used to rapidly monitor drug resistance. Results provided evidence for updating national drug policy and treatment guidelines.


Subject(s)
Antimalarials/pharmacology , China/epidemiology , Drug Combinations , Drug Resistance/genetics , Folic Acid Antagonists/pharmacology , Humans , Mutation , Plasmodium vivax/genetics , Prevalence
8.
Article in Chinese | WPRIM | ID: wpr-927940

ABSTRACT

A content determination method based on ~1H-qNMR was developed for the determination of total ginsenosides in Shenmai Injection. The parameters were optimized with CD_3OD as the solvent, dimethyl terephthalate as the internal standard, the peak at δ 8.11 as the internal standard peak, and the peaks at δ 1.68 and δ 0.79 as quantitative peaks of total ginsenosides. The developed ~1H-qNMR-based method was validated methodologically. The results showed that the method could achieve accurate measurement of total ginsenosides in Shenmai Injection in the range of 0.167 6-3.091 1 mmol·L~(-1). The developed ~1H-qNMR-based method for total ginsenosides is simple in operation, short in analysis time, strong in specificity, independent of accompanying standard curve, and small in sample volume, which can serve as a reliable mean for the quality control of Shenmai Injection. This study is expected to provide new ideas for the development of quantification methods of total ginsenosides.


Subject(s)
Drug Combinations , Drugs, Chinese Herbal , Ginsenosides/analysis , Quality Control
9.
Article in Chinese | WPRIM | ID: wpr-927939

ABSTRACT

Shenmai Injection is a Chinese medicinal injection prepared from Ginseng Radix et Rhizoma Rubra and Ophiopogonis Radix, which is widely used in clinical practice for the treatment and adjuvant therapy of cardiovascular diseases with significant pharmacological effects. Proton nuclear magnetic resonance spectroscopy(~1H-NMR) has the advantages of simple and nondestructive sample pretreatment, fast analysis, abundant chemical information, quantification and no need to follow the standard curve. It is widely used in the analysis and research of complex mixtures of traditional Chinese medicine, clinical blood and urine samples. In this study, the ~1H-NMR fingerprint of Shenmai Injection was established. Thirty-two chemical components were identified, including seven amino acids, eight small molecular organic acids, one alkaloid, four sugars, two nucleosides, seven saponins, and three other components. Pearson's correlation coefficient and multivariate analysis of variance(principal component analysis combined with hierarchical cluster analysis) were applied based on the ~1H-NMR fingerprint to evaluate the quality consistency. The results showed high-quality consistency of 82 batches of Shenmai Injection. This study confirms that the ~1H-NMR fingerprint has great potential in the application of quality control of Chinese medicinal injection.


Subject(s)
Chromatography, High Pressure Liquid , Drug Combinations , Drugs, Chinese Herbal/chemistry , Proton Magnetic Resonance Spectroscopy , Rhizome/chemistry
11.
Prensa méd. argent ; 107(8): 412-417, 20210000. tab
Article in Spanish | LILACS, BINACIS | ID: biblio-1358664

ABSTRACT

El dolor lumbar bajo y el dolor cervical con o sin irradiación son causas muy comunes de consulta a los médicos generalistas en los países desarrollados. La discopatía aguda y el dolor por estenosis del canal espinal son los diagnósticos más frecuentes. La postura tradicional ha sido la de administrar antiinflamatorios no esteroideos (AINES) para estas lumbalgias o cervicalgias agudas. Cuando existe irradiación neural por compresión radicular es usual asociar al AINE un corticoide a baja dosis, así como un antineurítico, para lograr un mejor resultado. Con el objeto de documentar la utilidad de esta práctica habitual, efectuamos en 142 pacientes ambulatorios un estudio multicéntrico randomizado que compara la efectividad y la tolerancia de una asociación a dosis fija de diclofenac, betametasona y cianocobalamina administrada por vía oral versus la administración de diclofenac como monofármaco en el tratamiento de la patología dolorosa de la columna lumbar y cervical asociada a compresión neural. La asociación demostró ser más eficaz en controlar el dolor y mejorar la funcionalidad de los pacientes que la administración de diclofenac en forma aislada y se asoció a escasos efectos colaterales, principalmente digestivos


Low back pain and neck pain with or without radiation are very common causes of consultation with general practitioners in developed countries. Acute discopathy and pain due to spinal canal stenosis are the most frequent diagnoses. The traditional approach has been to administer non-steroidal antiinflammatory drugs (NSAIDs) for these acute low back or cervical pain. When there is neural radiation due to root compression, it is usual to associate a low-dose corticosteroid with the NSAID, as well as an antineuritic, to achieve a better result. In order to document the usefulness of this routine practice, we conducted a randomized multicenter study in 142 outpatients that compared the effectiveness and tolerance of a fixed-dose combination of diclofenac, betamethasone, and cyanocobalamin administered orally versus the administration of diclofenac as Monopharmaceutical in the treatment of painful pathology of the lumbar and cervical spine associated with neural compression. The association proved to be more effective in controlling pain and improving the functionality of patients than the administration of diclofenac in isolation and was associated with few side effects, mainly digestive


Subject(s)
Humans , Adult , Middle Aged , Cats , Spinal Stenosis/therapy , Vitamin B 12/administration & dosage , Randomized Controlled Trials as Topic , Diclofenac/administration & dosage , Administration, Oral , Treatment Outcome , Low Back Pain/drug therapy , Neck Pain/drug therapy , Drug Combinations , Drug Evaluation
12.
Lima; Instituto Nacional de Salud; sept. 2021.
Non-conventional in Spanish | LILACS, BRISA | ID: biblio-1354733

ABSTRACT

INTRODUCCIÓN: La enfermedad por coronavirus 2019 (COVID-19), causada por el coronavirus 2 del Síndrome respiratorio agudo grave (SARS-CoV-2) fue inicialmente reportada en Wuhan, China en diciembre de 2019 (2). El espectro de la enfermedad es amplio e incluye desde cuadros leves y autolimitados hasta neumonía atípica severa y progresiva, falla multiorgánica y muerte (3,4). La Organización Mundial de la Salud (OMS) al 29 de junio de 2021 reportó 2.6 millones de casos nuevos en la última semana, con más de 57 mil nuevas muertes reportadas (5). Desde la identificación inicial del SARS-CoV-2, hasta el momento de este reporte, la OMS ha identificado cuatro como variantes cuya patogenicidad es preocupante (Alpha: B.1.1.7, Beta: B.1.351, Gamma: P.1 y Delta: B.1.617.2) y que podrían modificar el curso de la pandemia (6). Casirivimab e Imdevimab son anticuerpos monoclonales tipo inmunoglobulina G1 (IgG1) humana, ambos se administran en conjunto y que se dirigen contra el virus SARS-CoV-2 que causa la COVID-19, ya que se unen a los epítopos no competitivos del dominio de unión al receptor (RBD) de la proteína espiga (S) del SARS-CoV-2. La combinación de estos anticuerpos monoclonales, denominada REGEN COV, ha recibido la Autorización de uso de emergencia (EUA) por la Administración de Alimentos y Medicamentos de los Estados Unidos (FDA) (7). La presente nota técnica tiene como objetivo describir la evidencia científica publicada respecto a la eficacia y efectividad de la combinación de los anticuerpos monoclonales Casirivimab e Imdevimab (REGEN COV) en la prevención de COVID-19. MÉTODOS: Se realizó una búsqueda sistemática hasta el 10 de setiembre de 2021 en las bases de datos científicas MEDLINE/PubMed, LILACS/Biblioteca virtual en salud (BVS) y L.OVE/Epistemonikos, incluyendo términos en lenguaje natural y lenguaje estructurado (Tesauros) según cada base de datos para el fármaco de interés: "REGEN-COV", "casirivimab", "imdevimab", "REGN10933" y "REGN10987"; "SARS-CoV-2", "COVID-19". Se incluyeron publicaciones de ensayos clínicos o en etapa de pre-impresión (manuscritos no certificados por una revisión por pares) que reporten resultados para al menos uno de los desenlaces. Se consideraron publicaciones en idioma: inglés, español o portugués. Adicionalmente, se incluyeron estudios de ensayos de neutralización que trataban de la efectividad del fármaco de interés frente a las variantes del SARS-CoV-2. Se excluyeron estudios realizados en animales. La selección de los estudios y extracción de los datos no fue pareada. No se hizo evaluación de riesgo de sesgo de las publicaciones incluidas. RESULTADOS: En la Revisión Rápida N° 04-2021 de UNAGESP, se realizó una búsqueda sistematizada hasta el 28 de junio de 2021 (1); en esta búsqueda se recuperaron 02 reportes correspondientes a las 02 partes de un ensayo clínico aleatorizado del fármaco de interés (Casirivimab e Imdevimab) para la prevención de infección sintomática por SARS-CoV-2. Adicionalmente, se realizó una búsqueda sistematizada hasta el 10 de setiembre en la que se recuperaron 04 documentos sobre la efectividad de este fármaco sobre las variantes de preocupación (VOC) del SARS-CoV-2. CONCLUSIONES: El objetivo de esta nota técnica fue describir la evidencia científica publicada respecto a la eficacia y efectividad de la combinación de los anticuerpos monoclonales Casirivimab e Imdevimab (REGEN COV) en la prevención de COVID-19. La intervención evaluada para la prevención de COVID-19 fue la combinación de anticuerpos monoclonales REGEN-COV (Casirivimab (REGN 10933) 600mg e Indevimab (REGN 10987) 60mg) que es administrada por vía subcutánea. Se identificó un ensayos clínicos aleatorizados (ECA) realizado en partes (parte A y B) que evaluaron la eficacia de la combinación REGEN COV (Casirivimab/Imdevimab) para prevenir infección sintomática por SARS-CoV-2 (COVID-19); no se identificó ningún estudio que evaluara la efectividad de este fármaco para la prevención de COVID-19. Se identificaron 4 estudios que evaluaron la capacidad de neutralización de estos anticuerpos frente a las variantes Alpha, Beta, Gamma y Delta del SARS-CoV-2 en estudios in vitro. La combinación REGEN COV (Casirivimab 600mg/Imdevimab 600mg) administrada por vía subcutánea, en pacientes con PCR negativo y exposición a un contacto intradomiciliario con infección por SARS-CoV-2, redujo el riesgo de desarrollar COVID-19 en un 81.4% en relación al riesgo de los que recibieron placebo (1.5% vs 7.8%, RR: 0.186, IC 95% 0.09 ­ 0.35). En relación a los eventos adversos, en la parte A del ECA revisado se reportaron 265/1311 (20.2%) eventos adversos en el grupo de intervención y 379/1306 (29%) en el grupo placebo. Los eventos adversos más frecuentes fueron cefalea y reacción en el lugar de inyección. La frecuencia de eventos adversos serios (EAS) fue de 10/1311 (0.8%) en el grupo intervención y de 15/1306 (1.1%) en el grupo placebo. Ninguno de los EAS fueron atribuidos a la vacuna. En el grupo de intervención no se reportó ningún evento de especial interés. Se reportaron 4 fallecimiento después del término del seguimiento, 2 en cada brazo, de los cuales ninguno fue atribuido a la vacunación. En cuanto a la capacidad de neutralización frente a las variantes de preocupación (VOC) del SARS-CoV-2, los estudios revisados informaron que la combinación REGEN COV (Casirivimab/Imdevimab) mantuvo la capacidad de neutralización contra la variante Alpha (B.1.1.7) y Delta (B.1.617.1 y B.1.617.2), y mantuvo parcialmente la capacidad de neutralización contra la variante Beta (B.1.351) y Gamma (P.1), probablemente debido a mutaciones K417N y E484K resistentes a Casirivimab.


Subject(s)
Humans , SARS-CoV-2/drug effects , COVID-19/prevention & control , Antibodies, Monoclonal/administration & dosage , Efficacy , Cost-Benefit Analysis , Drug Combinations
13.
Braz. dent. j ; 32(3): 21-31, May-June 2021. tab, graf
Article in English | LILACS, BBO | ID: biblio-1345507

ABSTRACT

Abstract This study assessed the fracture resistance of simulated immature teeth reinforced with calcium aluminate cement (CAC) or mineral trioxide aggregate (MTA) containing calcium carbonate nanoparticles (nano-CaCO3). The microstructural arrangement of the cements and their chemical constitution were also evaluated. Forty-eight canines simulating immature teeth were distributed into 6 groups (n=8): Negative control - no apical plug or root canal filling; CAC - apical plug with CAC; CAC/nano-CaCO3 - apical plug with CAC+5% nano-CaCO3; MTA - apical plug with MTA; MTA/nano-CaCO3 - apical plug with MTA+5% nano-CaCO3; and Positive control - root canal filling with MTA. The fracture resistance was evaluated in a universal testing machine. Samples of the cements were analyzed under Scanning Electron Microscope (SEM) to determine their microstructural arrangement. Chemical analysis of the cements was performed by Energy Dispersive X-ray Spectroscopy (EDS). The fracture resistance of CAC/nano-CaCO3 was significantly higher than the negative control (p<0.05). There was no significant difference among the other groups (p>0.05). Both cements had a more regular microstructure with the addition of nano-CaCO3. MTA samples had more calcium available in soluble forms than CAC. The addition of nano-CaCO3 to CAC increased the fracture resistance of teeth in comparison with the non-reinforced teeth. The microstructure of both cements containing nano-CaCO3 was similar, with a more homogeneous distribution of lamellar- and prismatic-shaped crystals. MTA had more calcium available in soluble forms than CAC.


Resumo Este estudo avaliou a resistência à fratura de dentes imaturos simulados reforçados com cimento de aluminato de cálcio (CAC) ou trióxido agregado mineral (MTA) contendo nanopartículas de carbonato de cálcio (nano-CaCO3). O arranjo microestrutural dos cimentos e sua constituição química também foram avaliados. Quarenta e oito caninos simulando dentes imaturos foram distribuídos em 6 grupos (n=8): Controle negativo - sem plug apical ou obturação do canal radicular; CAC - plug apical com CAC; CAC/nano-CaCO3 - plug apical com CAC + 5% nano-CaCO3; MTA - plug apical com MTA; MTA/nano-CaCO3 - plug apical com MTA + 5% nano-CaCO3; e Controle positivo - obturação dos canais radiculares com MTA. A resistência à fratura foi avaliada em máquina universal de ensaios. Amostras dos cimentos foram analisadas em Microscópio Eletrônico de Varredura (MEV) para determinar seu arranjo microestrutural. A análise química dos cimentos foi realizada por Espectroscopia de Energia Dispersiva de Raio-X (EDS). A resistência à fratura de CAC/nano-CaCO3 foi significativamente maior do que o controle negativo (p<0,05). Não houve diferença significativa entre os outros grupos (p>0,05). Ambos os cimentos apresentaram microestrutura mais regular com a adição de nano-CaCO3. As amostras de MTA apresentaram mais cálcio disponível em formas solúveis do que CAC. A adição de nano-CaCO3 ao CAC aumentou a resistência à fratura dos dentes em comparação aos dentes não reforçados. A microestrutura de ambos os cimentos contendo nano-CaCO3 foi semelhante, com uma distribuição mais homogênea de cristais de formato lamelar e prismático. MTA apresentou mais cálcio disponível nas formas solúveis do que CAC.


Subject(s)
Humans , Root Canal Filling Materials , Tooth Fractures , Oxides , Root Canal Obturation , Silicates , Calcium Compounds , Aluminum Compounds , Tooth Apex , Dental Cements , Drug Combinations
14.
Braz. dent. j ; 32(1): 53-58, Jan.-Feb. 2021. tab, graf
Article in English | LILACS, BBO | ID: biblio-1180728

ABSTRACT

Abstract The endodontic revascularization may be an alternative treatment for necrotic immature teeth, however, several treatment steps may cause tooth discoloration. This study evaluated the use of three calcium silicate-based cements with different radiopacifying agents on the color alteration (∆E) of extracted premolars after simulation of revascularization. Forty single rooted extracted premolars were shaped with #1-6 gates Glidden drills, rinsed with sodium hypochlorite, and filled with fresh human blood. Three calcium silicate-based cements with different radiopacifying agents (bismuth oxide - CSBi, calcium tungstate - CSW, and zirconium oxide - CSZr) were applied over the blood clot (n=10). The control group received the application of a temporary zinc oxide-based cement (TFZn) (n=10). ∆E was measured with a spectrophotometer, using the L*a*b* color system of the International Commission on Illumination (CIELab), in different times: prior to the preparation of the access cavity (t0); right after treatment (t1); and after one (t2), two (t3), three (t4) and four (t5) months. The tooth site for color evaluation was standardized by silicon matrix, the color reading was performed 3 times per tooth, and the teeth were stored in 37º water between evaluations. ∆E, whiteness (WID index) and yellowness (b*) were evaluated. Data were subjected to one-way ANOVA and repeated measures ANOVA, followed by Tukey's post hoc test (α=0.05). All groups were similar in ∆E1 (t0-t1). The ∆E was the lowest and constant in the control group. In all evaluation times, CSBi presented the highest ∆E (p<0.01). CSW and CSZr were similar in all evaluated times and presented intermediate ∆E values. WID index from CSBi and CSW presented more distancing from 'white' reference. CSBi presented the greatest decrease in yellowness (b* value). The cement containing bismuth oxide presented the highest color alteration values. All tested calcium silicate-based cements presented clinically perceptible discoloration. Calcium tungstate and zirconium oxide may be used as alternative radiopacifiers to decrease tooth discoloration after endodontic tooth revascularization.


Resumo A revascularização endodôntica pode ser um tratamento alternativo para dentes imaturos necrosados, porém, várias etapas do tratamento podem causar alteração de cor dental. Este estudo avaliou o uso de três cimentos a base de silicato de cálcio com diferentes agentes radiopacificadores na alteração de cor (∆E) de pré-molares extraídos após a simulação de revascularização. Quarenta pré-molares unirradiculares extraídos foram conformados com brocas gates glidden #1-6, irrigados com hipoclorito de sódio, e preenchidos com sangue humano fresco. Três cimentos a base de silicato de cálcio com diferentes agentes radiopacificadores (óxido de bismuto - CSBi, tungstato de cálcio - CSW, e óxido de zircônio - CSZr) foram aplicados sobre o coágulo sanguíneo (n=10). O grupo controle recebeu a aplicação de um cimento temporário a base de óxido de zinco (TFZn) (n=10). ∆E foi medida com um espectrofotômetro, utilizando o sistema de cor L*a*b* da International Commission on Illumination (CIELab), em tempos diferentes: previamente ao preparo da cavidade de acesso (t0); logo após o tratamento (t1); e após um (t2), dois (t3), três (t4) e quatro (t5) meses. O local do dente para a avaliação de cor foi padronizado por uma matriz de silicone, a leitura da cor foi realizada 3 vezes por dente, e os dentes foram armazenados em água a 37ºC entre as avaliações. ∆E, 'clareamento' (índice WID) e tom amarelado (b*) foram avaliados. Os dados foram submetidos ao teste de ANOVA um fator e teste ANOVA de medidas repetidas, seguidos pelo teste post hoc de Tukey (α=0,05). Todos os grupos foram semelhantes em ∆E1 (t0-t1). A ∆E foi menor e constante no grupo controle. Em todos os tempos de avaliação, CSBi apresentou os maiores valores de ∆E (p<0.01). CSW e CSZr foram semelhantes em todos os tempos avaliados e apresentaram valores intermediários de ∆E. O índice WID de CSBi e CSW se distanciaram mais da referência 'branco'. CSBi apresentou maior diminuição no tom amarelado (valor de b*) os outros grupos. O cimento contendo óxido de bismuto apresentou os maiores valores de alteração de cor. Todos os cimentos testados apresentaram alteração de cor clinicamente perceptível. O tungstato de cálcio e óxido de zircônio podem ser usados como radiopacificares alternativos para a diminuição da alteração de cor dental após o processo de revascularização endodontica.


Subject(s)
Humans , Root Canal Filling Materials , Tooth Discoloration , Oxides , Silicates , Calcium Compounds , Aluminum Compounds , Dental Cements , Drug Combinations
15.
Braz. dent. j ; 32(1): 42-47, Jan.-Feb. 2021. tab, graf
Article in English | LILACS, BBO | ID: biblio-1180727

ABSTRACT

Abstract New methodologies using micro-CT to evaluate solubility besides dimensional and morphological changes of endodontic materials are proposed. However, there is no standardization in the methods. The aim of this study was to assess the effect of different dimensions of test samples on volumetric change evaluation of different endodontic materials. AH Plus, FillCanal and Sealapex root canal sealers, Biodentine, IRM and MTA root-end filling cements were used in the tests. Samples of each material with a thickness of 1.5 mm and different diameters were manufactured: 6.3, 7.75, and 9.0 mm. The samples were scanned in micro-computed tomography (micro-CT) after setting and after 7 days of immersion in distilled water. The volumetric change was evaluated by means of the difference in the total volume of the specimens before and after immersion. Data were submitted to ANOVA and Tukey tests (p<0.05). The size of the samples did not affect the percentage of volumetric change of the materials (p>0.05). All sample sizes had greater volume loss for Sealapex among the sealers and Biodentine for the cements (p<0.05). In conclusion, Biodentine and Sealapex had the highest volume loss after immersion. Samples with 1.5 mm thickness, and diameters ranging between 6.3 and 9.0 mm can be used to assess the stability of endodontic materials using micro-CT without affecting the percentage of volumetric change.


Resumo Novas metodologias utilizando micro-CT são propostas para avaliar a solubilidade além de alterações dimensionais e morfológicas em materiais endodônticos. No entanto, não há padronização nos métodos. O objetivo deste estudo foi avaliar o efeito de diferentes dimensões de corpos de prova na avaliação da alteração volumétrica de diferentes materiais endodônticos. Os cimentos obturadores AH Plus, FillCanal e Sealapex e os cimentos retrobturadores Biodentine, IRM e MTA foram utilizados nos testes. Foram confeccionadas amostras de cada material com espessura de 1.5 mm e diâmetros diferentes: 6.3, 7.75 e 9.0 mm. As amostras foram escaneadas em microtomografia computadorizada (micro-CT) após a presa e após 7 dias de imersão em água destilada. A alteração volumétrica foi avaliada por meio da diferença no volume total dos corpos de prova antes e após a imersão. Os dados foram submetidos aos testes ANOVA e Tukey (p<0,05). A dimensão das amostras não afetou o percentual de alteração volumétrica dos materiais (p>0,05). Todos os diâmetros de amostra mostraram maior perda de volume para Sealapex entre os cimentos obturadores e Biodentine entre os cimentos retrobturadores (p<0,05). Como conclusão, Biodentine e Sealapex mostraram a maior perda volumétrica após a imersão. Amostras com 1.5 mm de espessura e diâmetros variando entre 6.3 e 9.0 mm podem ser usadas para avaliação da estabilidade de materiais endodônticos utilizando micro-CT, sem influenciar no percentual de alteração volumétrica.


Subject(s)
Root Canal Filling Materials , Oxides , Root Canal Obturation , Materials Testing , Calcium Compounds , Drug Combinations , Epoxy Resins , X-Ray Microtomography
16.
Article in Chinese | WPRIM | ID: wpr-879198

ABSTRACT

Drug combination is a common clinical phenomenon. However, the scientific implementation of drug combination is li-mited by the weak rational evaluation that reflects its clinical characteristics. In order to break through the limitations of existing evaluation tools, examining drug-to-drug and drug-to-target action characteristics is proposed from the physical, chemical and biological perspectives, combining clinical multicenter case resources, domestic and international drug interaction public facilities with the aim of discovering the common rules of drug combination. Machine learning technology is employed to build a system for evaluating and predicting the rationality of clinical drug combinations based on "drug characteristics-repository information-artificial intelligence" strategy, which will be debugged and validated in multi-center clinical practice, with a view to providing new ideas and technical references for the safety and efficacy of clinical drug use.


Subject(s)
Artificial Intelligence , Drug Combinations , Machine Learning , Technology
17.
Chinese Medical Journal ; (24): 2850-2856, 2021.
Article in English | WPRIM | ID: wpr-921172

ABSTRACT

BACKGROUND@#Central nervous system (CNS) symptoms after efavirenz (EFV) treatment in people living with human immunodeficiency virus (HIV) could persist and impact their quality of life. We assessed the impact of EFV-based regimen replacement with elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF), which is considered an alternative option for subjects who do not tolerate EFV. Most specifically, we assessed the safety and the efficacy of E/C/F/TAF and its effects on the participants' neuropsychiatric toxicity symptoms in a real-life setting.@*METHODS@#A prospective cohort study was conducted among virologic suppressed HIV-positive participants receiving EFV-based regimens with ongoing CNS toxicity ≥ grade 2. The participants were switched to single-pill combination regimens E/C/F/TAF and followed up for 48 weeks. The neuropsychiatric toxicity symptoms were measured using a CNS side effects questionnaire, as well as the Hospital Anxiety and Depression Scale and the Pittsburgh Sleep Quality Index. The primary outcome measure was the proportion of participants experiencing grade 2 or higher CNS toxicity after EFV switch off at weeks 12, 24, and 48. Secondary endpoints included virologic and immunological responses and the effect on fasting lipids at week 48 after switch.@*RESULTS@#One hundred ninety-six participants (96.9% men, median age: 37.5 years, median: 3.7 years on prior EFV-containing regimens) were included in the study. Significant improvements in anxiety and sleep disturbance symptoms were observed at 12, 24, and 48 weeks after switching to E/C/F/TAF (P < 0.05). No significant change in depression symptom scores was observed. At 48 weeks after switch, HIV viral load <50 copies/mL was maintained in all of the participants, median fasting lipid levels were moderately increased (total cholesterol [TC]: 8.2 mg/dL, low-density lipoprotein cholesterol [LDL-C]: 8.5 mg/dL, high-density lipoprotein cholesterol [HDL-C]: 2.9 mg/dL, and triglyceride (TG): 1.6 mg/dL, and the TC:HDL-C ratio remained stable.@*CONCLUSIONS@#The single-pill combination regimens E/C/F/TAF is safe and well tolerated. This study reveals that switching from EFV to E/C/F/TAF significantly reduces neuropsychiatric toxicity symptoms in people living with HIV with grade 2 or higher CNS complaints.


Subject(s)
Adenine/therapeutic use , Adult , Alanine , Alkynes , Anti-HIV Agents/adverse effects , Benzoxazines , Central Nervous System , Cobicistat/therapeutic use , Cyclopropanes , Drug Combinations , Emtricitabine/therapeutic use , Female , HIV Infections/drug therapy , Humans , Male , Prospective Studies , Quality of Life , Quinolones , Sleep Quality , Tenofovir/analogs & derivatives
18.
Article in Chinese | WPRIM | ID: wpr-888153

ABSTRACT

This study aims to explore the active components and molecular mechanism of Shenmai Injection in the treatment of atrial fibrillation(AF) based on the application of network pharmacology and molecular docking technology. The chemical components of single herbs of Shenmai Injection were collected from TCMSP and TCMID, with the standard chemical name and PubChem CID(referred to as CID) obtained from PubChem database. The active components were screened using SwissADME, and their targets were predicted using SwissTargetPrediction. Targets related to AF treatment were identified using GeneCards, OMIM, and other databases. Venn diagram was constructed using Venny 2.1 to obtain the intersection targets. The single herb-active component-potential target network was constructed using Cytoscape, and the clusterProfiler R function package was used to perform the gene ontology(GO) and Kyoto encyclopedia of genes and genomes(KEGG) pathway enrichment. The protein-protein interaction(PPI) network of intersection targets was generated based on the STRING database. The hub target protein was identified by visualization using Cytoscape, and then docked to its reverse-selected active components. The analysis showed that there were 65 active components with 681 corresponding targets in Shenmai Injection, 2 798 targets related to AF treatment, and 235 intersection targets involving 2 549 GO functions and 153 KEGG pathways. Finally, hub target proteins, including RAC-alpha serine/threonine-protein kinase(AKT1), phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha(PIK3 CA), and estrogen receptor 1(ESR1), were screened out by PPI network visualization. The molecular docking was performed for 39 active components screened out in reverse, among which 30 active components de-monstrated high affinity. Among them, homoisoflavanoids CID 10871974, CID 5319742, and CID 10361149 had stronger affinity docking with AKT1. This study preliminarily indicates that Shenmai Injection treats AF through multiple components, multiple targets, and multiple pathways. Homoisoflavonoids of Ophiopogon japonicus are its important active components, which target AKT1 to regulate metabolism, inflammation, and apoptosis in AF treatment.


Subject(s)
Atrial Fibrillation/drug therapy , Drug Combinations , Drugs, Chinese Herbal , Humans , Medicine, Chinese Traditional , Molecular Docking Simulation
19.
Article in Chinese | WPRIM | ID: wpr-888126

ABSTRACT

To summarize and evaluate the efficacy and safety of Shenmai Injection in the treatment of viral myocarditis, shock, pulmonary heart disease, coronary heart disease, neutropenia and tumor chemotherapy, so as to provide supportive evidences for clinical rational use of Shenmai Injection. By searching literatures about studies on the systematic reviews on Shenmai Injection in treatment of viral myocarditis, shock, pulmonary heart disease, coronary heart disease, neutropenia and tumor chemotherapy from the main Chinese and English databases. Primary efficacy and safety outcome measures were selected for comparative analysis and summary, and the appraisal tool of AMSTAR 2 was used to evaluate the included studies.A total of 36 systematic reviews(published from 2005 to 2020) were included, involving viral myocarditis, shock, pulmonary heart disease, malignant tumor and coronary heart disease. The number of cases included in each type of the above diseases was 3 840, 2 484, 12 702, 28 036 and 27 082, respectively. The comparison results showed that, Shenmai Injection combined with conventional/western medicine treatment groups had better efficacy than conventional/western medicine groups alone in the prevention and treatment of the above five diseases. The main adverse reactions of Shenmai Injection reported in the included studies were facial flushing, rash, palpitation, etc., but the incidence was low and the general symptoms were mild, so no special treatment was needed. Therefore, the application of Shenmai Injection on the basis of conventional treatment or western medicine treatment had better prevention and treatment efficacy of the diseases. It was suggested that more multi-center and larger sample-size randomized controlled trials should be carried out in the future, and the relevant reporting standards should be strictly followed in systematic reviews, so as to improve the scientificity and transparency of the study.


Subject(s)
Drug Combinations , Drugs, Chinese Herbal , Humans , Pulmonary Heart Disease , Systematic Reviews as Topic
20.
Article in Chinese | WPRIM | ID: wpr-888080

ABSTRACT

As a dangerous disease with rapid progression, endotoxemia is easy to induce the damage to multiple organs. However, its specific and efficient treatment methods are still lacking at present. Both Qingkailing Injection(QKLI) and Shengmai Injection(SMI) have been proved effective in anti-inflammation, anti-endotoxin and organ protection. In this study, carrageenan and endotoxin were injected successively into rats to establish an endotoxemia model. Different doses of QKLI and SMI were administered to the endotoxemia rats by intraperitoneal injection separately or in combination. Then the count of white blood cells, the number of platelets, the content of cytokines, biochemical indexes, organ coefficient and pathological changes of main organs in the rats were detected. The results showed that the rats in the model group had obvious symptoms of endotoxemia, i.e., leucopenia, thrombocytopenia, increase in cytokines(IL-6 and TNF-α) and biochemical indexes of liver and kidney function as well as pathological damage to liver, kidney and lung. QKLI alone can alleviate the above symptoms of endotoxemia and the organ injury. SMI alone is less effective in improving disseminated intravascular coagulation(DIC) and cytokine secretion complicated with endotoxemia, but capable of reducing the inflammation degree of the lung, liver and kidney. The combination of QKLI and SMI remarkably increased the number of platelets in the peripheral blood, improved the liver and kidney function and reduced inflammatory factors, with lung, liver, kidney and other organ structures protected well. Moreover, the improvement effect of the combination of QKLI and SMI was stronger than those of the two injections alone at fixed doses, indicative of a synergistic effect.


Subject(s)
Animals , Drug Combinations , Drugs, Chinese Herbal , Endotoxemia/drug therapy , Rats
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