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1.
Trials ; 21(1): 766, 2020 Sep 05.
Artigo em Inglês | MEDLINE | ID: mdl-32891160

RESUMO

OBJECTIVES: To investigate the potential efficacy of Acacia Senegal extract Gum Arabic (GA) supplementation as immunomodulatory and anti-inflammatory dietary intervention among newly diagnosed COVID 19 Sudanese patients. To study the effect of GA on the level of cytokines, TNFα, IL8, IL6 IL10, CRP and the viral load. Secondary outcomes will be the effect of GA oral intake on mortality rate and days of hospital admission. TRIAL DESIGN: Quadruple blind, randomized placebo-controlled clinical trial Phase II & III. Prospective, two-arm, parallel-group, randomised (1:1 allocation ratio) superiority trial of oral GA among seropositive COVID-19 patients. PARTICIPANTS: Inclusion criteria: COVID-19 infected (newly diagnosed) as proved by real-time PCR within 72 hours of PCR. Age 8-90 years Both genders Exclusion criteria: Intubated patients on parenteral treatment Allergy to Gum Arabic The study will be conducted in COVID Isolation Centres and Soba University Hospital Khartoum State Sudan. INTERVENTION AND COMPARATOR: Experimental: Intervention Group This arm will receive 100% natural Gum Arabic provided in a powder form in 30-grams-dose once daily for four weeks Placebo Comparator: Control group: This group will be provided with pectin powder provided as one-gram-dose once daily for four weeks Both GA and placebo will be in addition to standard care treatment based on local clinical guidelines. MAIN OUTCOMES: Mean change from baseline score of Immune Response to end of the trial. Changes of the level of Tumor Necrosis Factor (TNFα), interleukin IL8, IL6, and IL10 from the baseline values (Four weeks from the start of randomization). Mortality rate: The percentage of deaths among COVID 19 patients received Gum Arabic compared to placebo (Four weeks from the start of randomization]). RANDOMISATION: Randomization (1:1 allocation ratio) and will be conducted using a sequence of computer-generated random numbers by an independent individual. Each participating centre will be assigned a special code generated by the computer. The randomization will be kept by the PI and a research assistant. BLINDING (MASKING): Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) NUMBERS TO BE RANDOMISED (SAMPLE SIZE): 110 eligible patients will be randomly assigned to either GA (n=55) or placebo (n=55) groups. TRIAL STATUS: Protocol Version no 2, 30th June 2020. Recruitment will start on 15th September 2020. The intended completion date is 15th January 2021. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04381871 . Date of trial registration: 11 May 2020. FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.


Assuntos
Betacoronavirus/efeitos dos fármacos , Infecções por Coronavirus/tratamento farmacológico , Goma Arábica/uso terapêutico , Fatores Imunológicos/uso terapêutico , Pneumonia Viral/tratamento farmacológico , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Betacoronavirus/imunologia , Betacoronavirus/patogenicidade , Criança , Ensaios Clínicos Fase II como Assunto , Ensaios Clínicos Fase III como Assunto , Infecções por Coronavirus/diagnóstico , Infecções por Coronavirus/imunologia , Infecções por Coronavirus/virologia , Feminino , Goma Arábica/efeitos adversos , Interações entre Hospedeiro e Microrganismos , Humanos , Fatores Imunológicos/efeitos adversos , Masculino , Pessoa de Meia-Idade , Pandemias , Pneumonia Viral/diagnóstico , Pneumonia Viral/imunologia , Pneumonia Viral/virologia , Estudos Prospectivos , Ensaios Clínicos Controlados Aleatórios como Assunto , Fatores de Tempo , Resultado do Tratamento , Adulto Jovem
2.
Trials ; 21(1): 769, 2020 Sep 07.
Artigo em Inglês | MEDLINE | ID: mdl-32895056

RESUMO

OBJECTIVES: To assess the effect of anticoagulation with bivalirudin administered intravenously on gas-exchange in patients with COVID-19 and respiratory failure using invasive mechanical ventilation. TRIAL DESIGN: This is a single centre parallel group, superiority, randomized (1:1 allocation ratio) controlled trial. PARTICIPANTS: All patients admitted to the Hamad Medical Corporation -ICU in Qatar for COVID-19 associated respiratory distress and in need of mechanical ventilation are screened for eligibility. INCLUSION CRITERIA: all adult patients admitted to the ICU who test positive for COVID-19 by PCR-test and in need for mechanical ventilation are eligible for inclusion. Upon crossing the limit of D-dimers (1.2 mg/L) these patients are routinely treated with an increased dose of anticoagulant according to our local protocol. This will be the start of randomization. EXCLUSION CRITERIA: pregnancy, allergic to the drug, inherited coagulation abnormalities, no informed consent. INTERVENTION AND COMPARATOR: The intervention group will receive the anticoagulant bivalirudin intravenously with a target aPTT of 45-70 sec for three days while the control group will stay on the standard treatment with low-molecular-weight heparins /unfractionated heparin subcutaneously (see scheme in Additional file 1). All other treatment will be unchanged and left to the attending physicians. MAIN OUTCOMES: As a surrogate parameter for clinical improvement and primary outcome we will use the PaO2/FiO2 (P/F) ratio. RANDOMISATION: After inclusion, the patients will be randomized using a closed envelope method into the conventional treatment group, which uses the standard strategy and the experimental group which receives anticoagulation treatment with bivalirudin using an allocation ratio of 1:1. BLINDING (MASKING): Due to logistical and safety reasons (assessment of aPTT to titrate the study drug) only the data-analyst will be blinded to the groups. NUMBERS TO BE RANDOMISED (SAMPLE SIZE): We performed a sample size calculation and assumed the data for P/F ratio (according to literature) is normally distributed and used the mean which would be: 160 and SD is 80. We expect the treatment will improve this by 30%. In order to reach a power of 80% we would need 44 patients per group (in total 88 patients). Taking approximately 10% of dropout into account we will include 100 patients (50 in each group). TRIAL STATUS: The local registration number is MRC-05-082 with the protocol version number 2. The date of approval is 18th June 2020. Recruitment started on 28th June and is expected to end in November 2020. TRIAL REGISTRATION: The protocol is registered before starting subject recruitment under the title: "Anticoagulation in patients suffering from COVID-19 disease. The ANTI-CO Trial" in ClinicalTrials.org with the registration number: NCT04445935 . Registered on 24 June 2020. FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 2). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.


Assuntos
Antitrombinas/uso terapêutico , Infecções por Coronavirus/tratamento farmacológico , Fragmentos de Peptídeos/uso terapêutico , Pneumonia Viral/tratamento farmacológico , Respiração Artificial , Síndrome do Desconforto Respiratório do Adulto/terapia , Anticoagulantes/uso terapêutico , Betacoronavirus , Infecções por Coronavirus/sangue , Estado Terminal , Produtos de Degradação da Fibrina e do Fibrinogênio/metabolismo , Heparina/uso terapêutico , Heparina de Baixo Peso Molecular/uso terapêutico , Hirudinas , Humanos , Pandemias , Tempo de Tromboplastina Parcial , Pneumonia Viral/sangue , Catar , Proteínas Recombinantes/uso terapêutico
3.
Nan Fang Yi Ke Da Xue Xue Bao ; 40(4): 586-594, 2020 Apr 30.
Artigo em Chinês | MEDLINE | ID: mdl-32895128

RESUMO

Since the outbreak of coronavirus disease 2019 (COVID-19) in the late 2019, a variety of antiviral drugs have been used in the first-line clinical trial. The Diagnostic and Treatment Protocol for COVID-19 (Trial Version 6) in China recommends chloroquine phosphate for the first time as an anti-coronavirus trial drug. As a classic drug for treatment of malaria and rheumatism, chloroquine phosphate has been used clinically for more than 80 years, and has also shown good results in the treatment of various viral infections. As the plasma drug concentration varies greatly among different races and individuals and due to its narrow treatment window, chloroquine in likely to accumulate in the body to cause toxicity. Among the treatment regimens recommended for COVID-19, reports concerning the safety of a short-term high-dose chloroquine regimen remain scarce. In this review, the authors summarize the current research findings of chloroquine phosphate in the treatment of COVID-19, and examine the pharmacokinetic characteristics, antiviral therapy, the therapeutic mechanism and safety of chloroquine.


Assuntos
Betacoronavirus/efeitos dos fármacos , Cloroquina/análogos & derivados , Infecções por Coronavirus , Pandemias , Pneumonia Viral , Antivirais , China , Cloroquina/uso terapêutico , Infecções por Coronavirus/tratamento farmacológico , Humanos , Pneumonia Viral/tratamento farmacológico
4.
Nan Fang Yi Ke Da Xue Xue Bao ; 40(8): 1072-1080, 2020 Aug 30.
Artigo em Chinês | MEDLINE | ID: mdl-32895172

RESUMO

OBJECTIVE: To explore the pharmacologically active ingredients in Toujie Quwen granules (TJQW) for treatment of coronavirus disease 2019 (COVID-19) in light of systemic pharmacology. METHODS: We performed database search, literature mining and drug-like index screening to identify the bioactive components in TJQW, the positive drugs for disease treatment and their therapeutic targets. The core disease target was investigated based on the cross-linking interaction of the bioactive components, positive drug and potential disease target, and the target proteins at the key nodes were analyzed by GO and KEGG analyses. Based on the therapeutic targets for COVID-19, virtual screening was conducted to screen the compounds in TJQW and construct the network cross-linking the key bioactive molecules in TJQW, key node targets of the disease, and the related biological pathways. RESULTS: We identified 159 compounds in TJQW and obtained 18 core proteins based on the cross-linking of the bioactive components, positive drugs and disease targets. The key node targets consisted of 22 targets including the latest 4 COVID-19 proteins. Virtual screening results showed that at least 14 compounds could bind with the core disease target proteins. The material basis of TJQW for COVID-19 treatment was explained in multi-pathway, multi-component and multi-target perspectives. In terms of the structural characteristics of the compounds, we screened the top 30 molecules with strong binding with the target proteins, among which flavonoids were the predominant components. CONCLUSIONS: This investigation reveals the therapeutic mechanism of TJQW for COVID-19 involving multiple components, targets and pathways from the perspective of key bioactive molecules, disease key node targets and related biological pathways. We screened 30 active precursors from TJQW, which provides reference for the clinical application and further development of TJQW.


Assuntos
Betacoronavirus , Infecções por Coronavirus , Medicamentos de Ervas Chinesas , Pandemias , Pneumonia Viral , Infecções por Coronavirus/tratamento farmacológico , Humanos , Medicina Tradicional Chinesa , Pneumonia Viral/tratamento farmacológico
6.
Theranostics ; 10(21): 9591-9600, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32863947

RESUMO

Cytokine storms, defined by the dysregulated and excessive production of multiple pro-inflammatory cytokines, are closely associated with the pathology and mortality of several infectious diseases, including coronavirus disease 2019 (COVID-19). Effective therapies are urgently needed to block the development of cytokine storms to improve patient outcomes, but approaches that target individual cytokines may have limited effect due to the number of cytokines involved in this process. Dysfunctional macrophages appear to play an essential role in cytokine storm development, and therapeutic interventions that target these cells may be a more feasible approach than targeting specific cytokines. Nanomedicine-based therapeutics that target macrophages have recently been shown to reduce cytokine production in animal models of diseases that are associated with excessive proinflammatory responses. In this mini-review, we summarize important studies and discuss how macrophage-targeted nanomedicines can be employed to attenuate cytokine storms and their associated pathological effects to improve outcomes in patients with severe infections or other conditions associated with excessive pro-inflammatory responses. We also discuss engineering approaches that can improve nanocarriers targeting efficiency to macrophages, and key issues should be considered before initiating such studies.


Assuntos
Anti-Infecciosos/uso terapêutico , Citocinas/imunologia , Infecções/imunologia , Macrófagos/imunologia , Nanomedicina/tendências , Animais , Infecções por Coronavirus/tratamento farmacológico , Infecções por Coronavirus/imunologia , Humanos , Infecções/tratamento farmacológico , Macrófagos/efeitos dos fármacos , Pandemias , Pneumonia Viral/tratamento farmacológico , Pneumonia Viral/imunologia
7.
Medicine (Baltimore) ; 99(35): e20841, 2020 Aug 28.
Artigo em Inglês | MEDLINE | ID: mdl-32871858

RESUMO

BACKGROUND: This study aimed to provide reliable estimates for dietary antioxidant vitamin (vitamins A, C, and E) intake and their effect on fracture risk at various sites. METHODS: The PubMed, EMBASE, and Cochrane Library databases were searched to identify prospective cohort studies published throughout October 2019. The pooled relative risk (RR) with its 95% confidence interval (CI) was calculated using a random-effects model. RESULTS: In total, 13 prospective cohort studies involving 384,464 individuals were selected for this meta-analysis. The summary RR indicated that increased antioxidant vitamin intake was associated with a reduced fracture risk (RR: 0.92; 95% CI: 0.86-0.98; P = .015). When stratified by the vitamin types, increased vitamin E intake was found to be associated with a reduced fracture risk (RR: 0.66; 95% CI: 0.46-0.95; P = .025), whereas increased vitamin A and C intake did not affect this risk. Increased antioxidant vitamin intake was associated with a reduced fracture risk, irrespective of fracture sites (HR: 0.90; 95% CI: 0.86-0.94; P < .001); however, it did not affect hip fracture risk. Furthermore, increased antioxidant vitamin intake was associated with a reduced fracture risk in men (RR: 0.81; 95% CI: 0.68-0.96; P = .017) and combined men and women (RR: 0.83; 95%CI: 0.73-0.93; P = .002); however, it did not affect fracture risk in women. CONCLUSION: Fracture risk at any site is significantly reduced with increased antioxidant vitamin intake, especially vitamin E intake and in men.


Assuntos
Suplementos Nutricionais/efeitos adversos , Fraturas Ósseas/epidemiologia , Osteoporose/tratamento farmacológico , Vitaminas/administração & dosagem , Adulto , Idoso , Idoso de 80 Anos ou mais , Antioxidantes/efeitos adversos , Ácido Ascórbico/administração & dosagem , Ácido Ascórbico/uso terapêutico , Feminino , Fraturas Ósseas/prevenção & controle , Fraturas do Quadril/epidemiologia , Fraturas do Quadril/prevenção & controle , Humanos , Masculino , Pessoa de Meia-Idade , Osteoporose/complicações , Osteoporose/epidemiologia , Osteoporose/prevenção & controle , Prevalência , Estudos Prospectivos , Fatores de Risco , Vitamina A/administração & dosagem , Vitamina A/uso terapêutico , Vitamina E/administração & dosagem , Vitamina E/uso terapêutico , Vitaminas/uso terapêutico
8.
Medicine (Baltimore) ; 99(35): e21449, 2020 Aug 28.
Artigo em Inglês | MEDLINE | ID: mdl-32871867

RESUMO

BACKGROUND: Pulsed electromagnetic fields shows some potential in alleviating pain after mammaplasty. This systematic review and meta-analysis is conducted to investigate the analgesic efficacy of pulsed electromagnetic fields for pain control after mammaplasty. METHODS: The databases including PubMed, EMbase, Web of science, EBSCO, and Cochrane library databases are systematically searched for collecting the randomized controlled trials regarding the impact of pulsed electromagnetic fields on pain intensity after mammaplasty. RESULTS: This meta-analysis has included 4 randomized controlled trials. Compared with control group after mammaplasty, pulsed electromagnetic fields results in remarkably reduced pain scores on 1 day (MD = -1.34; 95% confidence interval [CI] = -2.23 to -0.45; P = .003) and 3 days (MD = -1.86; 95% CI = -3.23 to -0.49; P = .008), as well as analgesic consumption (Std. MD = -5.64; 95% CI = -7.26 to -4.02; P < .00001). CONCLUSIONS: Pulsed electromagnetic fields is associated with substantially reduced pain intensity after mammaplasty.


Assuntos
Mama/cirurgia , Campos Eletromagnéticos/efeitos adversos , Mamoplastia/efeitos adversos , Dor Pós-Operatória/tratamento farmacológico , Adolescente , Adulto , Idoso , Analgésicos/farmacologia , Estudos de Casos e Controles , Feminino , Humanos , Pessoa de Meia-Idade , Manejo da Dor/métodos , Dor Pós-Operatória/prevenção & controle , Ensaios Clínicos Controlados Aleatórios como Assunto , Adulto Jovem
9.
Medicine (Baltimore) ; 99(35): e21468, 2020 Aug 28.
Artigo em Inglês | MEDLINE | ID: mdl-32871869

RESUMO

Saline is a commonly used intravenous solvent, however, its excessive infusion may increase drug-induced sodium intake. To investigate the effects of saline infusion on blood pressure variability (BPV) in patients with hypertension, a retrospective study was performed in 1010 patients with hypertension. The patients who received saline infusion before surgery for continuous 3 to 5 days were divided into 2 groups according to the saline infusion volume during the hospitalization, which are >500 mL per day group and <500 mL per day group. The overall incidence of abnormal BPV was 11.58%. As for the incidence of abnormal BPV in the <500 mL per day group with 698 patients was 9.17%, while that in the >500 mL per day group with 312 patients was as high as 16.99%. Additionally, >500 mL of daily saline infusion for continuous 3 to 5 days (P for trend = .004, odds ratio [OR] = 1.911, 95% confidence interval [CI] for OR 1.226-2.977), medical history of diabetes mellitus (P < .001, OR = 4.856, 95% CI for OR 3.118-7.563) and cardiovascular diseases (P < .001, OR = 2.498, 95% CI for OR 1.549-4.029) may be risk factors of abnormal BPV; while anti-hypertensive therapy with diuretics (P < .001, OR = 0.055, 95% CI for OR 0.024-0.125) may be the protective factor. Our study suggests that >500 mL of daily saline infusion for continuous 3 to 5 days may have disadvantages in the blood pressure control for hypertensive patients, especially for the patients with diabetes mellitus and cardiovascular diseases.


Assuntos
Variação Biológica da População/fisiologia , Pressão Sanguínea/efeitos dos fármacos , Hipertensão/epidemiologia , Solução Salina/efeitos adversos , Adulto , Idoso , Idoso de 80 Anos ou mais , Pressão Sanguínea/fisiologia , Determinação da Pressão Arterial/tendências , Doenças Cardiovasculares/epidemiologia , Estudos de Casos e Controles , China/epidemiologia , Diabetes Mellitus/epidemiologia , Feminino , Humanos , Hipertensão/tratamento farmacológico , Incidência , Infusões Intravenosas , Masculino , Pessoa de Meia-Idade , Procedimentos Ortopédicos/métodos , Procedimentos Ortopédicos/estatística & dados numéricos , Estudos Retrospectivos , Fatores de Risco , Solução Salina/administração & dosagem
10.
Medicine (Baltimore) ; 99(35): e21576, 2020 Aug 28.
Artigo em Inglês | MEDLINE | ID: mdl-32871874

RESUMO

BACKGROUND: Cellular energetics play an important role in Parkinsons disease etiology, but no treatments directly address this deficiency. Our past research showed that treatment with febuxostat and inosine increased blood hypoxanthine and ATP in healthy adults, and a preliminary trial in 3 Parkinson's disease patients suggested some symptomatic improvements with no adverse effects. METHODS: To examine the efficacy on symptoms and safety in a larger group of Parkinsons disease patients, we conducted a single-arm, open-label trial at 5 Japanese neurology clinics and enrolled thirty patients (nmales = 11; nfemales = 19); 26 patients completed the study (nmales = 10; nfemales = 16). Each patient was administered febuxostat 20 mg and inosine 500 mg twice-per-day (after breakfast and dinner) for 8 weeks. The primary endpoint was the difference of MDS-UPDRS Part III score immediately before and after 57 days of treatment. RESULTS: Serum hypoxanthine concentrations were raised significantly after treatment (Pre = 11.4 µM; Post = 38.1 µM; P < .0001). MDS-UPDRS Part III score was significantly lower after treatment (Pre = 28.1 ±â€Š9.3; Post = 24.7 ±â€Š10.8; mean ±â€ŠSD; P = .0146). Sixteen adverse events occurred in 13/29 (44.8%) patients, including 1 serious adverse event (fracture of the second lumbar vertebra) that was considered not related to the treatment. CONCLUSIONS: The results of this study suggest that co-administration of febuxostat and inosine is relatively safe and effective for improving symptoms of Parkinsons disease patients. Further controlled trials need to be performed to confirm the symptomatic improvement and to examine the disease-modifying effect in long-term trials.


Assuntos
Febuxostat/uso terapêutico , Supressores da Gota/uso terapêutico , Inosina/uso terapêutico , Doença de Parkinson/tratamento farmacológico , Trifosfato de Adenosina/sangue , Administração Oral , Idoso , Estudos de Casos e Controles , Quimioterapia Combinada , Febuxostat/administração & dosagem , Febuxostat/efeitos adversos , Feminino , Supressores da Gota/administração & dosagem , Supressores da Gota/efeitos adversos , Humanos , Hipoxantina/sangue , Inosina/administração & dosagem , Inosina/efeitos adversos , Japão/epidemiologia , Masculino , Pessoa de Meia-Idade , Doenças do Sistema Nervoso/epidemiologia , Doença de Parkinson/metabolismo , Doença de Parkinson/fisiopatologia , Segurança , Resultado do Tratamento , Xantina Desidrogenase/antagonistas & inibidores
11.
Medicine (Baltimore) ; 99(35): e21606, 2020 Aug 28.
Artigo em Inglês | MEDLINE | ID: mdl-32871876

RESUMO

The increasing availability of antiretroviral therapy (ART) worldwide is yet to result in decreasing HIV-related mortality among adolescents (10-19 years old) living with HIV (ALHIV) in part because of poor adherence. the poor adherence might itself be due to high level of depression. We assess the prevalence of depressive symptomatology and it's associated with adherence among ALHIV receiving ART care in Brazzaville and Pointe Noire, Republic of Congo (RoC).Adolescents aged 10 to 19 years, on antiretroviral therapy (ART), followed in the two Ambulatory Treatment Centers (ATC) in Brazzaville and Pointe Noire, RoC were included in this cross-sectional study. From April 19 to July 9, 2018, participants were administered face to face interviews using a standardized questionnaire that included the nine-item Patient Health Questionnaire (PHQ-9). Participants who reported failing to take their ART more than twice in the 7 days preceding the interview were classified as non-adherent. Bivariate and multivariable log-binomial models were used to estimate the prevalence ratio (PR) and 95% confidence interval (95%CI) assessing the strength of association between predictors and presence of depressive symptoms (PHQ-9 score ≥9).Overall, 135 adolescents represented 50% of ALHIV in active care at the 2 clinics were interviewed. Of those, 67 (50%) were male, 81 (60%) were 15 to 19 years old, 124 (95%) had been perinatally infected, and 71 (53%) knew their HIV status. Depressive symptoms were present in 52 (39%) participants and 78 (58%) were adherent. In univariate analyses, the prevalence of depressive symptoms was relative higher among participants who were not adherent compared to those who were (73% vs 33%; PR: 2.20 [95%CI: 1.42-3.41]). In multivariate analysis, after adjustment for report of been sexually active, alcohol drinking, age category (10-14 and 15-19), not in school, loss of both parents, the association between depression and adherence was strengthened (PR: 2.06 [95%CI: 1.23-3.45]).The prevalence of depressive symptoms in adolescents living with HIV is high and was strongly associated with poor adherence even after adjustment of potential confounders. Efforts to scale-up access to screening and management of depression among ALHIV in sub-Saharan is needed for them to realize the full of ART.


Assuntos
Antirretrovirais/uso terapêutico , Depressão/epidemiologia , Infecções por HIV/psicologia , Adesão à Medicação/psicologia , Adolescente , Instituições de Assistência Ambulatorial , Estudos de Casos e Controles , Criança , Congo/epidemiologia , Estudos Transversais , Depressão/psicologia , Feminino , Infecções por HIV/tratamento farmacológico , Humanos , Masculino , Programas de Rastreamento/métodos , Programas de Rastreamento/psicologia , Adesão à Medicação/estatística & dados numéricos , Assistência Perinatal/estatística & dados numéricos , Assistência Perinatal/tendências , Prevalência , Inquéritos e Questionários , Adulto Jovem
12.
Medicine (Baltimore) ; 99(35): e21808, 2020 Aug 28.
Artigo em Inglês | MEDLINE | ID: mdl-32871901

RESUMO

BACKGROUND: Viral pneumonia is a common respiratory disease that leads to high mortality around the world. Tanreqing (TRQ) injection has been widely used to treat viral pneumonia in China. However, the efficiency and safety of TRQ injection for viral pneumonia have not been scientifically and methodically evaluated up to now. Thus, this protocol describes a plan of performing a systematic review and meta-analysis to evaluate the efficacy and safety of TRQ injection on patients with viral pneumonia. METHODS: Only randomized controlled trials will be enrolled in our study, and we will search eligible studies in the following electronic databases: PubMed, Embase, Cochrane Central Register of Controlled Trials, Clinical Trials, China National Knowledge Infrastructure, the Wanfang database, the Chinese Scientific Journal Database, and the Sinomed. The total effective rate of clinical efficacy will be used as primary outcome. Time to relieve symptoms, incidence of adverse reactions, and the laboratory parameters will be used as secondary outcomes. Any side effects and adverse events will be recorded and assessed as safety outcomes. Study inclusion, data extraction, and quality assessment will be performed independently by 2 reviewers, and any disagreement will be resolved by a third reviewer. After that, data synthesis and subgroup analysis will be conducted with the Review Manager V.5.3.3 software. RESULTS: This review will provide a high-quality synthesis to assess the effectiveness and safety of TRQ injection for viral pneumonia patients. CONCLUSION: Our study will provide comprehensive evidence to decide whether TRQ injection is effective and safe for viral pneumonia patients. PROSPERO REGISTRATION NUMBER: PROSPERO CRD42020164164.


Assuntos
Medicamentos de Ervas Chinesas/uso terapêutico , Metanálise como Assunto , Pneumonia Viral/tratamento farmacológico , Revisões Sistemáticas como Assunto , Humanos , Injeções , Medicina Tradicional Chinesa , Projetos de Pesquisa
13.
Medicine (Baltimore) ; 99(35): e21825, 2020 Aug 28.
Artigo em Inglês | MEDLINE | ID: mdl-32871904

RESUMO

OBJECTIVE: To conduct a meta-analysis evaluating the effect of combining traditional Chinese medicine (TCM) with Western medicine in treating hepatitis C, and to provide an evidence-based medical strategy. METHODS: Randomized controlled trials (RCTs) comparing the effect of pegylated interferon (Peginterferon) combined with ribavirin (PR) alone and its combination with TCM were manually retrieved from the Weipu Information Resources System (VIP), Wan Fang Database, PubMed, and the Chinese Journal Full Text Database (CNKI). Studies meeting the inclusion criteria were selected and analyzed using the Review Manager 5.3 software. Suitable tests were also performed to determine the quality, heterogeneity, and sensitivity of the studies included in the meta-analysis. RESULTS: Twenty-eight RCTs met the inclusion criteria. The combination therapy or intervention group showed significantly greater HCV-RNA negative rate post-treatment compared to the monotherapy or the control group (P < .05). In addition, the serum levels of the liver function indicators alanine aminotransferase (ALT), aspartate aminotransferase (AST), and albumin (ALB) were significantly improved after the combination therapy compared to PR alone (P < .05), while total bilirubin (TB) and r-glutamyltransferase (GGT) levels were not affected by TCM (P > .05). Finally, the parameters of liver fibrosis were also reduced by the combination therapy more effectively than the monotherapy. CONCLUSION: The combination of TCM and PR can improve the Comprehensive Clinical Efficacy of hepatitis C and have a better negative rate of HCV-RNA with a better benefit in the liver function. The effect of TCM + PR is better than that of PR alone in treating hepatitis C.


Assuntos
Antivirais/uso terapêutico , Hepatite C/terapia , Medicina Tradicional Chinesa , Alanina Transaminase/sangue , Aspartato Aminotransferases/sangue , Bilirrubina/sangue , Terapia Combinada , Quimioterapia Combinada , Hepacivirus/genética , Humanos , Interferon-alfa/uso terapêutico , Cirrose Hepática/tratamento farmacológico , Polietilenoglicóis/uso terapêutico , RNA Viral/sangue , Proteínas Recombinantes/uso terapêutico , Ribavirina/uso terapêutico , Albumina Sérica , gama-Glutamiltransferase/sangue
14.
Medicine (Baltimore) ; 99(35): e21827, 2020 Aug 28.
Artigo em Inglês | MEDLINE | ID: mdl-32871905

RESUMO

To retrospectively evaluate initial tumor necrosis factor inhibitor (TNFi) failure patients for clinical predictors of response to a 2nd TNFi in our 4282 rheumatoid arthritis (RA) patient database.A cross-sectional retrospective manual chart review of the electronic health record (EHR) was performed on 322 "real world" RA patients who were prescribed 2 TNFis. Response to TNFi was determined by the treating provider who had real time Clinical Disease Activity Index (CDAI) scores to inform treatment decisions. Age, gender, body mass index (BMI), insurance provider, duration of disease, cyclic citrullinated peptide antibody (CCP) and rheumatoid factor (RF) positivity, concomitant disease modifying anti-rheumatic drug therapy, length of time between diagnosis and start of 1st and 2nd TNFi, transient efficacy of 1st TNFi (defined as response to TNFi at 3 months but later lost response), and reason for discontinuation of 1st TNFi were analyzed. A multivariable logistic regression model was used to model response to a 2nd TNFi.Response proportions to the 2nd TNFi were greater in females (161/223, 72.2% response female vs 41/75, 54.7% male, P < .01), those who began their 1st TNFi within 3 months of their RA diagnosis, and in RF+ patients (123/170, 72.4% response seropositive vs 66/110, 60.0% seronegative, P < .03). The higher female response rate was independent of age, BMI, and seropositivity.In RA patients who failed an initial TNFi, female patients and patients with RF+ were more likely to have a clinical response to a 2nd TNFi. In the absence of these predictors, stronger consideration for choosing a biologic with an alternative mechanism of action might be given when the 1st TNFi fails.


Assuntos
Antirreumáticos/uso terapêutico , Artrite Reumatoide/tratamento farmacológico , Inibidores do Fator de Necrose Tumoral/uso terapêutico , Anticorpos Anti-Proteína Citrulinada/sangue , Artrite Reumatoide/sangue , Estudos Transversais , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Fator Reumatoide/sangue , Fatores Sexuais , Tempo para o Tratamento
15.
Medicine (Baltimore) ; 99(35): e21848, 2020 Aug 28.
Artigo em Inglês | MEDLINE | ID: mdl-32871908

RESUMO

RATIONALE: Drug-induced pancreatitis (DIP) is a kind of acute pancreatitis with a relatively low incidence. There are many cases of acute pancreatitis (AP) caused by chemotherapeutic agents that have been reported. However, few reports focus on the combination of chemotherapeutic agents that induce acute pancreatitis. This article aims to retrospectively analyze a case of DIP and to explore the relationship between chemotherapeutic agents and acute pancreatitis. PATIENT CONCERNS: Here, we report a 35-year-old Chinese female patient who was diagnosed as acute myeloid leukemia with BCR/ABL expression. After induction chemotherapy of daunorubicin and cytarabine, bone marrow aspiration showed: Acute myeloid leukemia-not relieved (AML-NR). Then the regimen of homoharringtonine, cytarabine and dasatinib was started. The patient developed abdominal pain on the 14th day of chemotherapy. Laboratory tests showed elevated serum amylase (AMY) and lipase (LIPA). Computed tomography (CT) of the abdomen revealed a swollen pancreas with blurred edges and thickened left prerenal fascia. DIAGNOSIS: The patient was diagnosed as DIP by the symptoms of upper abdominal pain and the change of CT images. Other common causes of AP were excluded meanwhile. INTERVENTIONS: The chemotherapy was stopped immediately. And after fasting, fluid infusion and inhibiting the secretion of the pancreas, the symptoms were relieved. OUTCOMES: DIP relapsed when the regimen of aclacinomycin + cytarabine + G-CSF + dasatinib regimen (G-CSF (400ug/day, day 1 to 15), cytarabine (30 mg/day, day 2 to 15), aclacinomycin (20 mg/day, day 2 to 5)and dasatinib (140 mg/day, continuously)) was given, and was recovered after treatment for AP was performed. LESSONS: To choose the best treatment plan for patients, clinicians should raise awareness of DIP, and should know that chemotherapeutic agents can induce pancreatitis and the combination of chemotherapeutic agents may increase the risk of drug-induced pancreatitis.


Assuntos
Protocolos de Quimioterapia Combinada Antineoplásica/efeitos adversos , Leucemia Mieloide Aguda/tratamento farmacológico , Pancreatite/induzido quimicamente , Adulto , Citarabina/administração & dosagem , Citarabina/efeitos adversos , Dasatinibe/administração & dosagem , Dasatinibe/efeitos adversos , Daunorrubicina/administração & dosagem , Daunorrubicina/efeitos adversos , Feminino , Mepesuccinato de Omacetaxina/administração & dosagem , Mepesuccinato de Omacetaxina/efeitos adversos , Humanos , Pancreatite/diagnóstico por imagem , Tomografia Computadorizada por Raios X
16.
Medicine (Baltimore) ; 99(35): e21858, 2020 Aug 28.
Artigo em Inglês | MEDLINE | ID: mdl-32871910

RESUMO

INTRODUCTION: These years, due to dissatisfaction with western medicine treatments, traditional Chinese medicine (TCM) becomes a main treatment for bronchial asthma patients. Lung and kidney yang deficiency syndrome is a common type of asthma and the Chinese herbal medicine formula modified Mahuang-Fuzi-Xixin (MFX) decoction is prescribed for mild bronchial asthma patients with acute exacerbation syndrome. However, there is not obvious evidence to support the efficacy and safety of modified MFX decoction the efficacy and safety to treat mild bronchial asthma and the mechanism of this disease is still unclear. METHODS: A double-blind, placebo-controlled, randomized clinical trial was proposed by us. After a 10-day run-in period, 180 eligible objects will be recruited in this study. These subjects will be allocated to the experimental group or control group in a 1:1 ratio. Patients in the experimental group will take modified MFX decoction. At the same time, patients in the control group will receive a matched placebo. The budesonide inhalation powder will be used as a western medicine treatment for both groups. All subjects will receive 14 days of treatment and another 6 months of follow-up. The primary outcome is the mean change in peak expiratory flow rate from the baseline to 14 days in this research. The secondary outcome includes forced expiratory volume in one second, asthma control test score, Asthma Quality of Life Questionnaire score, curative effect of TCM syndrome, and salbutamol dosage. This trial will also explore the association between the change of immunoglobulin E and modified MFX decoction treatment. Any side effects of the treatment will be recorded. DISCUSSION: The results of this trial will provide the evidence for the effect of modified MFX decoction in patients with mild bronchial asthma during acute exacerbation. It also will explore the mechanism of this formula in the treatment of bronchial asthma, which will provide another treatment option for patients with mild bronchial asthma.


Assuntos
Antiasmáticos/uso terapêutico , Asma/tratamento farmacológico , Medicamentos de Ervas Chinesas/uso terapêutico , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos , Humanos , Pico do Fluxo Expiratório
17.
Medicine (Baltimore) ; 99(35): e21881, 2020 Aug 28.
Artigo em Inglês | MEDLINE | ID: mdl-32871917

RESUMO

BACKGROUND: Pain control after total knee arthroplasty has shown many advances; however, the optimal method remains controversial. The purpose of this present study is to assess the efficacy and safety of the addition of local infiltration analgesia to adductor canal block for pain control after primary total knee arthroplasty. METHODS: This prospective randomized controlled research was conducted from January 2018 to June 2019. All the patients and their family members signed the informed consent forms, and this work was authorized via the ethics committee of Jinxiang Hospital Affiliated to Jining Medical College (JXHP0024578). Inclusion criteria were 55 years old or older, who possess the physical status I-III of American Society of Anesthesiologists, and the body mass index in the range of 18 to 30 kg/m. Exclusion criteria were regional and/or neuroaxial anesthesia contraindications, the history of drug allergy involved in the research, neuropathic pain, as well as the chronic pain requiring opioid therapy. Seventy-two patients were divided into 2 groups randomly. Study group (n = 36) received both adductor canal block and local infiltration analgesia. Control group (n = 36) received adductor canal block alone. Primary outcome included postoperative pain score (visual analog scale 0 to 10 cm, in which 0 represents no pain and 10 represents the most severe imaginable pain). The measures of secondary outcome included the knee range of motion, opioid consumption, the hospital stay length as well as the postoperative complications (for instance, pulmonary embolism, deep vein thrombosis, and the wound infection). All the analyses were conducted through utilizing the SPSS for Windows Version 20.0. RESULTS: The results will be shown in .(Table is included in full-text article.) CONCLUSION:: The study will provide more evidence on the combination use of adductor canal block and local infiltration analgesia in the treatment of pain after the total knee arthroplasty. TRIAL REGISTRATION: This study protocol was registered in Research Registry (researchregistry5832).


Assuntos
Anestésicos Locais/administração & dosagem , Artroplastia do Joelho , Bloqueio Nervoso , Dor Pós-Operatória/tratamento farmacológico , Analgésicos Opioides/uso terapêutico , Bupivacaína/administração & dosagem , Humanos , Injeções Intra-Articulares , Articulação do Joelho , Tempo de Internação , Ensaios Clínicos Controlados Aleatórios como Assunto , Amplitude de Movimento Articular , Ropivacaina/administração & dosagem , Escala Visual Analógica
18.
Medicine (Baltimore) ; 99(35): e21939, 2020 Aug 28.
Artigo em Inglês | MEDLINE | ID: mdl-32871938

RESUMO

RATIONALE: Maturity-onset diabetes of the young type 5 (MODY 5) is a form of monogenic diabetes that is often accompanied by pancreatic dysfunction. To date, no cases of MODY 5 treated with glucagon-like peptide-1 receptor agonist (GLP-1RA) have been reported. We present the first case of MODY 5 treated with GLP-1RA. PATIENT CONCERNS: A 17-year-old woman, with a history of being operated for congenital ileal atresia at birth, was admitted to our hospital due to hyperglycemia. She had been clinically diagnosed with type 1 diabetes 1 month prior, and administered 14 units of insulin glargine 300 U/mL per day. DIAGNOSIS: She had hypopotassemia, hypomagnesaemia, pancreatic body, and tail defects, multiple renal cysts, and a family history of diabetes, and urogenital anomaly. Genetic testing revealed heterozygous deletion of hepatocyte nuclear transcription factor-1 beta, leading to the diagnosis of MODY 5. INTERVENTIONS: The patient was treated with multiple daily insulin injections for 9 days (22 units/d) before administration of GLP-1RA, and then liraglutide was initiated. OUTCOMES: Liraglutide treatment (0.6 mg/d) alone maintained the patient's glycated hemoglobin level below 7.0% for at least 12 months after discharge. A higher dose, 0.9 mg/d, of liraglutide was not tolerated by the patient due to nausea. Serum levels of C-peptide immunoreactivity were 1.15 ng/mL and 1.91 ng/mL, respectively, after 6 and 12 months of liraglutide therapy. LESSONS: GLP-1RA might be effective at regulating glucose metabolism by utilizing residual pancreatic endocrine function in patients with MODY 5. Imaging and genetic screening were helpful in the diagnosis of MODY 5.


Assuntos
Doenças do Sistema Nervoso Central/tratamento farmacológico , Esmalte Dentário/anormalidades , Diabetes Mellitus Tipo 2/tratamento farmacológico , Receptor do Peptídeo Semelhante ao Glucagon 1/agonistas , Hipoglicemiantes/uso terapêutico , Doenças Renais Císticas/tratamento farmacológico , Liraglutida/uso terapêutico , Adolescente , Doenças do Sistema Nervoso Central/diagnóstico por imagem , Esmalte Dentário/diagnóstico por imagem , Diabetes Mellitus Tipo 2/diagnóstico por imagem , Feminino , Humanos , Hipoglicemiantes/farmacologia , Doenças Renais Císticas/diagnóstico por imagem , Liraglutida/farmacologia , Pâncreas/diagnóstico por imagem
19.
Medicine (Baltimore) ; 99(35): e21959, 2020 Aug 28.
Artigo em Inglês | MEDLINE | ID: mdl-32871945

RESUMO

BACKGROUND: Diabetic nephropathy (DN) is not only an important microvascular complication of diabetes but also the main cause of end-stage renal disease. Ginkgo biloba has a variety of biological activities and has been widely used in China to treat kidney diseases such as DN. This article aimed to evaluate the efficacy and safety of G biloba in patients affected with DN in the early stage. METHODS: This protocol follows the preferred reporting items for systematic review and meta-analysis protocols and the recommendations of the Cochrane Collaboration Handbook. Seven electronic databases will be searched from inception to July 31, 2020. Two investigators will independently identify relevant randomized controlled trials, fetch data, and assess the risk of bias with tools provided by Cochrane. A comprehensive meta-analysis will be conducted with the Cochrane Collaboration software (Review Manager 5.3) for eligible and appropriate studies. Further, the evidence will be assessed with the Grading of Recommendations Assessment, Development, and Evaluation approach. RESULTS: The results will be published in academic peer-reviewed journals, and the evidence gathered by this project will be dedicated to assessing the efficacy and safety of G biloba for DN patients in the early stage. CONCLUSION: This systematic review and meta-analysis will synthesize the available evidence to demonstrate the efficacy of G biloba in delaying the progression of patients with early DN. TRIAL REGISTRATION NUMBER: PROSPERO CRD42020166805.


Assuntos
Nefropatias Diabéticas/tratamento farmacológico , Ginkgo biloba , Fitoterapia , Extratos Vegetais/uso terapêutico , Humanos , Metanálise como Assunto , Revisões Sistemáticas como Assunto
20.
Medicine (Baltimore) ; 99(35): e21992, 2020 Aug 28.
Artigo em Inglês | MEDLINE | ID: mdl-32871950

RESUMO

BACKGROUND: Diabetic macular edema (DME) can cause severe vision impairments for patients with diabetes. Recently, Conbercept has shown efficacy on DME with 3-monthly loading dose injection and pro re nata (PRN, 3+PRN) thereafter in retrospectivetrials. Furthermore, there are some other approaches have been recommended such as 2mg bimonthly (2q8) after 5 initial doses, or Conbercept 0.5mg treat-and-extend, however, some patients still have recurrence of the disease after treatment. Therefore, in order to identify more efficacy and safety approach on Conbercept inpatients with DME, a randomized controlled trial will be performed with 6-monthly loading dose injection and PRN (6+PRN) compared with 3+PRN treatments. METHODS: This study is a multicenter, randomized control trial of Conbecept treating DME in China. Patients with type 2 diabetes suffered from DEM who already planned to receive Conbercept treatment will be recruited. All subjects will be randomized divided into either a study agent treatment group (6+PRN) or a control group (3+PRN), and observes the subjects for 48 weeks after initiation of treatment. RESULTS: This study will provide a new powerful evidence of the efficacy and safety of Conbecept treating DME. DISCUSSION: This RTC study will determine whether multiple treatments of Conbercept provide better effectiveness in patients with DME. TRIAL REGISTRATION NUMBER: ChiCTR2000032728.


Assuntos
Retinopatia Diabética/tratamento farmacológico , Edema Macular/tratamento farmacológico , Proteínas Recombinantes de Fusão/uso terapêutico , Angiografia , Estudos de Equivalência como Asunto , Humanos , Estudos Multicêntricos como Assunto , Tomografia de Coerência Óptica
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