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1.
World J Gastrointest Oncol ; 16(8): 3368-3371, 2024 Aug 15.
Artículo en Inglés | MEDLINE | ID: mdl-39171186

RESUMEN

Laparoscopic surgery is the main treatment method for patients with gastrointestinal malignant tumors. Although laparoscopic surgery is minimally invasive, its tool stimulation and pneumoperitoneum pressure often cause strong stress reactions in patients. On the other hand, gastrointestinal surgery can cause stronger pain in patients, compared to other surgeries. Transversus abdominis plane block (TAPB) can effectively inhibit the transmission of nerve impulses caused by surgical stimulation, alleviate patient pain, and thus alleviate stress reactions. Remazolam is an acting, safe, and effective sedative, which has little effect on hemodynamics and is suitable for most patients. TAPB combined with remazolam can reduce the dosage of total anesthetic drugs, reduce adverse reactions, reduce stress reactions, and facilitate the rapid postoperative recovery of patients.

2.
Heliyon ; 10(15): e34321, 2024 Aug 15.
Artículo en Inglés | MEDLINE | ID: mdl-39144947

RESUMEN

Ultraviolet B (UVB) light exposure accelerates skin photoaging. Human adipose-derived stem cell exosomes (hADSC-Exos) and some antioxidants may have anti-photoaging effects. However, it is unknown whether the combination of hADSC-Exos and antioxidants plays a synergistic role in anti-photoaging. In cellular and 3D skin models, we showed that vitamin E (VE) and hADSC-Exos were optimal anti-photoaging combinations. In vivo, VE and hADSC-Exos increased skin tightening and elasticity in UVB-induced photoaging mice Combined treatment with VE and hADSC-Exos inhibited SIRT1/NF-κB pathway. These findings contribute to the understanding of hADSC-Exos in conjunction with other antioxidants, thereby providing valuable insights for the future pharmaceutical and cosmetic industries.

3.
Int J Nanomedicine ; 19: 8029-8042, 2024.
Artículo en Inglés | MEDLINE | ID: mdl-39130684

RESUMEN

Purpose: Heterologous immunization using different vaccine platforms has been demonstrated as an efficient strategy to enhance antigen-specific immune responses. In this study, we performed a head-to-head comparison of both humoral and cellular immune response induced by different prime-boost immunization regimens of mRNA vaccine and adjuvanted protein subunit vaccine against varicella-zoster virus (VZV) in middle-aged mice, aiming to get a better understanding of the influence of vaccination schedule on immune response. Methods: VZV glycoprotein (gE) mRNA was synthesized and encapsulated into SM-102-based lipid nanoparticles (LNPs). VZV-primed middle-aged C57BL/6 mice were then subjected to homologous and heterologous prime-boost immunization strategies using VZV gE mRNA vaccine (RNA-gE) and protein subunit vaccine (PS-gE). The antigen-specific antibodies were evaluated using enzyme-linked immunosorbent assay (ELISA) analysis. Additionally, cell-mediated immunity (CMI) was detected using ELISPOT assay and flow cytometry. Besides, in vivo safety profiles were also evaluated and compared. Results: The mRNA-loaded lipid nanoparticles had a hydrodynamic diameter of approximately 130 nm and a polydispersity index of 0.156. Total IgG antibody levels exhibited no significant differences among different immunization strategies. However, mice received 2×RNA-gE or RNA-gE>PS-gE showed a lower IgG1/IgG2c ratio than those received 2×PS-gE and PS-gE> RNA-gE. The CMI response induced by 2×RNA-gE or RNA-gE>PS-gE was significantly stronger than that induced by 2×PS-gE and PS-gE> RNA-gE. The safety evaluation indicated that both mRNA vaccine and protein vaccine induced a transient body weight loss in mice. Furthermore, the protein vaccine produced a notable inflammatory response at the injection sites, while the mRNA vaccine showed no observable inflammation. Conclusion: The heterologous prime-boost strategy has demonstrated that an mRNA-primed immunization regimen can induce a better cell-mediated immune response than a protein subunit-primed regimen in middle-aged mice. These findings provide valuable insights into the design and optimization of VZV vaccines with the potentials to broaden varicella vaccination strategies in the future.


Asunto(s)
Adyuvantes Inmunológicos , Inmunidad Celular , Ratones Endogámicos C57BL , Nanopartículas , Vacunas de Subunidad , Animales , Vacunas de Subunidad/inmunología , Vacunas de Subunidad/administración & dosificación , Nanopartículas/química , Adyuvantes Inmunológicos/administración & dosificación , Femenino , Vacunas de ARNm , Ratones , Herpesvirus Humano 3/inmunología , Anticuerpos Antivirales/sangre , Inmunización Secundaria/métodos , Proteínas del Envoltorio Viral/inmunología , Proteínas del Envoltorio Viral/administración & dosificación , Vacuna contra el Herpes Zóster/inmunología , Vacuna contra el Herpes Zóster/administración & dosificación , Liposomas
4.
J Tradit Chin Med ; 44(3): 609-619, 2024 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-38767646

RESUMEN

OBJECTIVE: To assess the quality of Clinical practice guidelines (CPGs) in the context of diabetic kidney disease (DKD) and determine whether any factors affect the quality. METHODS: We searched eight databases along with five international and national organizations to develop or archive guidelines from their inception to July 2023, with an additional search of medlive.cn. And the authoritative organizations related to nephrology. CPGs and consensus statements created using direct differential diagnosis or therapy for DKD were included without language restrictions. Their quality was evaluated by four reviewers using the Appraisal of Guidelines for Research and Evaluation Ⅱ (AGREE Ⅱ) instrument. Along with the item and domain scores, the guideline was also allocated an overall quality score, which ranged from 1 (lowest possible quality) to 7 (highest possible quality). Moreover, an overall recommendation for use was also assigned ("recommended", "recommended with modifications" or "not recommended"). RESULTS: A total of 16 CPGs were included, of which 14 were from Asia and the remaining two from Europe. These two CPGs were updated in the third version. Six CPGs were recommended for use because their primary domains scored in the medium or high category. Furthermore, five CPGs were recommended with modifications as the stakeholder involvement, applicability, and editorial independence domains were evaluated as low categories. In all domains, the lowest average score was for rigour of development (33%), followed by application (36%), and stakeholder involvement (51%). The highest average score was for scope and purpose (79%), followed by clarity of presentation (75%). None of the CPGs considered the patient's viewpoint, and six of 16 CPGs did not use any grading system to translate the evidence into recommendations. Additionally, only three of 16 CPGs shared search strategy, and eight of 16 CPGs did not declare a funding source. CONCLUSIONS: According to the AGREE II evaluation, more than one in four CPGs for DKD had poor methodological quality. Enhanced efforts are needed to advance the rigour of development, application, and editorial independence of DKD guideline panels for most guidelines. Stakeholders, CPG developers, and CPG users should consider methodological quality while choosing CPGs, and interpret and implement their issued suggestions.


Asunto(s)
Nefropatías Diabéticas , Guías de Práctica Clínica como Asunto , Humanos , Nefropatías Diabéticas/terapia , Nefropatías Diabéticas/diagnóstico
5.
J Nanobiotechnology ; 22(1): 66, 2024 Feb 17.
Artículo en Inglés | MEDLINE | ID: mdl-38368393

RESUMEN

BACKGROUND: The transplantation of exosomes derived from human adipose-derived mesenchymal stem cells (hADSCs) has emerged as a prospective cellular-free therapeutic intervention for the treatment of neurodevelopmental disorders (NDDs), as well as autism spectrum disorder (ASD). Nevertheless, the efficacy of hADSC exosome transplantation for ASD treatment remains to be verified, and the underlying mechanism of action remains unclear. RESULTS: The exosomal long non-coding RNAs (lncRNAs) from hADSC and human umbilical cord mesenchymal stem cells (hUCMSC) were sequenced and 13,915 and 729 lncRNAs were obtained, respectively. The lncRNAs present in hADSC-Exos encompass those found in hUCMSC-Exos and are associated with neurogenesis. The biodistribution of hADSC-Exos in mouse brain ventricles and organoids was tracked, and the cellular uptake of hADSC-Exos was evaluated both in vivo and in vitro. hADSC-Exos promote neurogenesis in brain organoid and ameliorate social deficits in ASD mouse model BTBR T + tf/J (BTBR). Fluorescence in situ hybridization (FISH) confirmed lncRNA Ifngas1 significantly increased in the prefrontal cortex (PFC) of adult mice after hADSC-Exos intraventricular injection. The lncRNA Ifngas1 can act as a molecular sponge for miR-21a-3p to play a regulatory role and promote neurogenesis through the miR-21a-3p/PI3K/AKT axis. CONCLUSION: We demonstrated hADSC-Exos have the ability to confer neuroprotection through functional restoration, attenuation of neuroinflammation, inhibition of neuronal apoptosis, and promotion of neurogenesis both in vitro and in vivo. The hADSC-Exos-derived lncRNA IFNG-AS1 acts as a molecular sponge and facilitates neurogenesis via the miR-21a-3p/PI3K/AKT signaling pathway, thereby exerting a regulatory effect. Our findings suggest a potential therapeutic avenue for individuals with ASD.


Asunto(s)
Trastorno del Espectro Autista , Exosomas , Células Madre Mesenquimatosas , MicroARNs , ARN Largo no Codificante , Humanos , Ratones , Animales , ARN Largo no Codificante/genética , ARN Largo no Codificante/metabolismo , Proteínas Proto-Oncogénicas c-akt/metabolismo , Exosomas/metabolismo , Trastorno del Espectro Autista/genética , Trastorno del Espectro Autista/terapia , Trastorno del Espectro Autista/metabolismo , Hibridación Fluorescente in Situ , Fosfatidilinositol 3-Quinasas/metabolismo , Estudios Prospectivos , Distribución Tisular , Neurogénesis , MicroARNs/genética , MicroARNs/metabolismo , Células Madre Mesenquimatosas/metabolismo , Interferón gamma/metabolismo
6.
Artículo en Chino | WPRIM (Pacífico Occidental) | ID: wpr-1006275

RESUMEN

ObjectiveTo systematically evaluate the distribution of traditional Chinese medicine(TCM) syndromes of primary osteoporosis(POP) in China by using evidence-based medicine methods, and to understand the distribution law of the syndromes. MethodChina National Knowledge Infrastructure(CNKI), VIP Chinese Science and Technology Journal Database(VIP), WanFang Data Knowledge Service Platform(WanFang) and China Biology Medicine(CBM) were searched to obtain representative literature, and each database was searched from the 1994 World Health Organization defined diagnostic criteria for osteoporosis until May 1, 2023. Two researchers independently screened literature according to the criteria, extracted data, and cross-checked them. Meta analysis was conducted using R4.1.3, and subgroup analysis was performed. ResultA total of 56 Chinese papers were included, involving 14 415 patients. After standardized classification of syndromes, 11 articles were excluded, and Meta analysis results of the ultimately included 45 Chinese articles showed that the distribution frequencies of liver-kidney Yin deficiency syndrome, spleen-kidney Yang deficiency syndrome and kidney deficiency and blood stasis syndrome in 12 723 patients were 27%[95% confidence interval(CI) 0.24-0.31], 32%(95% CI 0.29-0.36), 36%(95% CI 0.30-0.42). Subgroup analysis showed that there was a statistically significant difference in the distribution of the three TCM syndromes in the north and south(P<0.05). In addition, the incidence of TCM syndrome fractures in different types of POP was 15%(95% CI 0.09-0.24) for liver-kidney Yin deficiency syndrome, 20%(95% CI 0.12-0.30) for spleen-kidney Yang deficiency syndrome, and 31%(95% CI 0.25-0.39) for kidney deficiency and blood stasis syndrome. ConclusionThe distribution of syndromes in POP patients is mainly kidney deficiency, accompanied by liver and spleen dysfunction. Liver-kidney Yin deficiency syndrome, spleen-kidney Yang deficiency syndrome and kidney deficiency and blood stasis syndrome are all the main syndromes of POP and osteoporotic fractures, and kidney deficiency and blood stasis syndrome is most closely related to the development of osteoporotic fractures. The reference standards for syndrome determination among the included studies are inconsistent, and in the future, it is necessary to focus on their determination standards to obtain consensus research results, at the same time, conduct large-scale syndrome research to obtain representative research results, providing a basis for clinical practice and research.

7.
Artículo en Chino | WPRIM (Pacífico Occidental) | ID: wpr-1006564

RESUMEN

ObjectiveTo establish the clinical comprehensive evaluation index system for Chinese patent medicine(CPM) based on Evidence and Value:Impact on DEcisionMaking(EVIDEM) framework, so as to promote the scientific, systematic and standardized implementation of clinical comprehensive evaluation of CPM. MethodThe clinical comprehensive evaluation index system was determined through literature review, semi-structured interview and Delphi method, and the weights of each index were clarified by analytic hierarchy process(AHP). ResultThe recovery rates of both rounds of expert consultation were 100%, and the authority coefficient of experts was 0.90 and 0.905, respectively. Kendall's coordination coefficients(W) of the second- and third-level indicators in the first-round consultation were 0.320 and 0.283(P<0.001), and in the second round were 0.411 and 0.351, respectively(P<0.001). The finally constructed clinical comprehensive evaluation index system for CPM included 6 first-level indicators, 13 second-level indicators and 28 third-level indicators. Among the first-level indicators, the weights of effectiveness, safety, economy, innovation, suitability and accessibility were 37.34%, 32.68%, 11.85%, 5.87%, 5.79% and 6.47%, respectively. ConclusionThis study has constructed a universal clinical comprehensive evaluation index system for CPM, and the domain and criteria are introduced and interpreted in detail, which can provide reference and information for carrying out the clinical comprehensive evaluation of CPM, but it needs to be refined and improved in combination with the clinical practice of CPM for specialized diseases.

8.
Artículo en Chino | WPRIM (Pacífico Occidental) | ID: wpr-1030956

RESUMEN

The education concepts of four famous traditional Chinese medicine(TCM) doctors(XIAO Longyou, SHI Jinmo, KONG Bohua and WANG Fengchun) in Beijing during the Republic of China were compared, the commonalities in their education concepts of TCM were sorted out, and the root system of the cultivation and growth of talents in TCM, as well as the direction and way of further development were searched, so as to improve the quality of the inheritance and development of TCM. Based on the systematic review of text and opinion method(SrTO) developed by the centre for evidence-based health care at the Joanna Briggs Institute(JBI) in Australia, this study was conducted to collate and analyze the relevant information, including 14 books, 115 journal papers and 7 documents. Related theory construction and practice of early tutor and academic education have been summarized from college, continuing and tutor education, academic research, examination, and so on. And then the connections and commonalities between the different forms of education in the period were summarized to form a SrTO-based narrative, opinion, text assessment and review instrument(NOTARI) summary table. The findings revealed that these four esteemed TCM doctors and educators, through their substantial influence on TCM education in Beijing, emphasized the importance of classics in teaching and clinical practice, underscored the cultivation of virtue, preserved the traditional teaching model, and championed the establishment of TCM schools. They also put forward novel requisites for the compilation of curricula, teaching materials, and books. Moreover, they advocated for a unified perspective on TCM and western medicine, fostering talent capable of bridging the gap between the two. They encouraged the standardization of TCM teaching examination system, and actively participated in scientific research and book writing. The four TCM doctors transcended the traditional boundaries of TCM practice, fostering a new TCM model of education-clinical-research, and profoundly influencing the contemporary TCM colleges and teacher education.

9.
Artículo en Chino | WPRIM (Pacífico Occidental) | ID: wpr-1031470

RESUMEN

ObjectiveTo explore the research status and trends of cohort studies on traditional Chinese medicine (TCM) efficacy evaluation from 2017 to 2022 and provide ideas and references for research in this field. MethodsSix databases including Pubmed, Web of Science, Embase, Scopus, Cochrane Library and CNKI were searched from January 1st, 2017 to December 31st, 2022. The total number of annual publications, journals, highly cited literatures, and keywords were quantitatively and visually analyzed by Bibliometrix. ResultsA total of 328 articles were included, which were published in 141 journals. The number of articles published in this field showed an overall upward trend, and retrospective cohort studies (282 papers, 85.98%) accounted for the largest proportion. A total of 151 cohort studies (46.04%) were conducted based on the database and showed an overall upward trend. The subjects were mainly patients with tumors (77 papers, 23.48%), and cardiovascular and cerebrovascular diseases (64 papers, 19.51%). The top 3 highly cited literatures mainly explore the association between TCM and survival outcome and quality of life in patients with malignant tumors. Fourteen and twenty-five high-frequency keywords were included in Chinese and English literature respectively, which formed 3 clusters such as research methods, statistical analysis and diseases. ConclusionIt was the current status to focus on retrospective cohort studies and focus on patients with tumors or cardiovascular and cerebrovascular diseases. Using observational database to conduct cohort studies of TCM efficacy evaluation could be the future research direction.

10.
Artículo en Chino | WPRIM (Pacífico Occidental) | ID: wpr-1031889

RESUMEN

ObjectiveBased on knowledge mapping, the studies on prediction models in the field of traditional Chinese medicine (TCM) were visually analyzed, which provided a reference basis for the excavation and evolution of the future research direction by combing the development process and summarizing the research hotspots and dynamic trends. MethodChina National Knowledge Infrastructure and Web of Science Core Collection databases were searched to obtain studies on prediction models in the field of TCM from inception to February 28, 2023. Endnote X20 software was used for document management. Knowledge mapping generated by CiteSpace software and VOSviewer software was used to visually analyze the characteristics of publication, institutional cooperation relationship, author cooperation network, co-citation, and keywords. ResultA total of 264 pieces of Chinese literature and 266 pieces of English literature were included, and the overall number of research publications showed an increasing trend year by year. The cooperation relationship between the issuing institutions showed obvious regional characteristics, with the closest cooperation relationship between the universities of TCM and their affiliated hospitals, as well as secondary units subordinate to scientific research institutions. The number of research teams and team members publishing papers in English was higher, and cooperation between different teams was more frequent. Groundbreaking and/or referential studies were widely cited and referred to. The highly cited literature was mainly published in complementary and alternative medicine journals and pharmaceutical journals. Research hotspots mainly focused on clinical prediction models of TCM, quantitative models of TCM, and specific modeling methods. The application of artificial intelligence technologies such as machine learning and deep learning in the field of TCM will be the most cutting-edge research direction in the future. ConclusionThe field of TCM is paying more and more attention to the studies on prediction models, while the research cooperation mode involving multiple organizations and teams has increasingly become the mainstream. With the continuous development of multi-disciplinary integration, studies on prediction models are closely related to the development and rise of innovative techniques and methods, and any breakthrough in theory or application will induce and guide a new round of research upsurge. Systematic reviews of topic-specific prediction models should be carried out in the future to provide evidence-based evidence.

11.
Artículo en Chino | WPRIM (Pacífico Occidental) | ID: wpr-1005269

RESUMEN

ObjectiveThis study aims to understand the recognition of practitioners in traditional Chinese medicine (TCM) hospitals on hospital-based health technology assessment (HB-HTA), assessment needs, challenges, and suggestions, so as to provide references for the future work. MethodThe convenient sampling method was adopted to survey the relevant practitioners in TCM hospitals. The questionnaire included 39 questions in 4 dimensions and was distributed through the online platform Weijuanxing. ResultA total of 244 questionnaires were recovered, and the obtained data were analyzed in SPSS. The results showed that 137 practitioners were very familiar with HB-HTA and there was no significant difference in the recognition of practitioners in different occupations (F=0.251; P=0.778). The practitioners in Hong Kong, Macao, and Taiwan had lower recognition than those in other regions. In terms of the assessment needs, 127 practitioners believed that it was very necessary to carry out HB-HTA in TCM hospitals in the future. Chinese patent medicines/Chinese herbal medicine decoction pieces (5.91) and TCM appropriate technology (5.57) had higher assessment priority scores. The assessment needs were high for the effectiveness (235 practitioners) and safety (224 practitioners) of health technology. The lack of specialized organization and standardized evaluation process system and the shortage of talents were considered to be the major challenges for the future development in this field. ConclusionThe stakeholders carrying out the health technology assessment in TCM hospitals had certain awareness of HB-HTA. Most practitioners believed that it was necessary to carry out HB-HTA in TCM hospitals in the future, while the work might face challenges such as the lack of organizations and system and the shortage of talents, which requires policy support.

12.
Artículo en Chino | WPRIM (Pacífico Occidental) | ID: wpr-1011454

RESUMEN

ObjectiveBy analyzing the current situation of drug selection and evaluation in medical institutions in the world,we aim to understand the development of relevant selection methods and tools,provide reference basis for drug selection in traditional Chinese medicine (TCM) medical institutions,and promote the optimization of drug catalogs in TCM medical institutions. MethodBased on the method of scoping review,the eight databases were systematically searched,the included documents were screened,extracted and analyzed,and the research results were graphically displayed. ResultA total of 23 articles were included in this study,including 13 in Chinese and 10 in English,involving 23 methods or tools related to drug selection. Of the 14 methods or tools from Chinese medical institutions,the earliest one was published in 2012,and five were published in 2022. The published methods or tools involved different levels of hospitals,different drug varieties,different evaluation angles,etc.,such as the drug selection methods of one county hospital and one township hospital, methods and tools for different types of drugs such as antibacterial drugs,ibuprofen preparations,proton pump inhibitors and hypoglycemic drugs used in pediatric intensive care units, Chinese patent medicine selection tools, tools for evaluation from the perspective of pharmacoeconomics, and universal tools for selecting domestic medical institutions. The nine drug selection tools of foreign medical institutions were from the European,American,Asian and African countries. It was first published in 1955. The contents included the formulation standards that medical institutions should follow for drug prescription sets,the management formulation and update of hospital prescription sets,and drug evaluation tools. ConclusionOn the whole,the drug selection methods and institutional methods of foreign medical institutions developed earlier than those in China. In recent years,Chinese medical institutions have paid high attention to drug selection and released various types of drug selection tools. However,the standardization should be further improved in the future.

13.
Artículo en Chino | WPRIM (Pacífico Occidental) | ID: wpr-1026903

RESUMEN

Objective To introduce a partially nested design based on the characteristics of TCM in treating the same disease with different treatments and syndrome differentiation and treatment.Methods Partially nested design was used for standardized treatment of complex interventions.The TCM group was divided into multiple subsets according to"syndrome type-treatment method-prescription"(with nested structure),while the control group was treated with standardized Western medicine(without nested structure);taking a case study of"different treatments for the same disease"data for ulcerative colitis,this design type was applied and analyzed using a multi-level model.Results The partially nested design was consistent with the feature of TCM of"different treatments for the same disease"and met the methodological requirements for evidence-based evaluation.Multilevel models allowed analyses with this type of data.Conclusion The use of partially nested design enables the evaluation of the comprehensive effectiveness of"different treatments for the same disease",which can provide a methodological reference for the assessment of clinical effectiveness of TCM.

14.
J Tradit Chin Med ; 43(6): 1259-1267, 2023 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-37946489

RESUMEN

This study is to investigate the effectiveness and safety of bloodletting puncture (BP) for acute ischemic stroke (AIS) when used in combination with standard treatment, as well as the patients' feelings and attitudes toward the treatment. This is a mixed method research which includes a multi-center, superiority, randomized controlled clinical trial, and focus group interview. A total of 360 AIS participants will be enrolled. They will be randomized into one of the following two groups for 7 d: (a) BP with standard treatment group (n = 180); (b) standard treatment group (n = 180). The primary outcome will be National Institute of Health stroke scale (NIHSS) score at day 7 after treatment. Secondary outcomes will be changes of Glasgow Coma Scale score, NIHSS score, mRS and Traditional Chinese Medicine syndrome score from baseline to 7, 14, and 30 d after treatment, recurrence rate and all-cause mortality rate within 30 d, and the safety assessments. The focus group will be conducted with a purposive sample of 1-2 acupuncturists and 1-2 patients respectively at each center at 7 and 30 d after treatment. We designed a mixed method study to evaluate the effect of BP, an acupuncture therapy for patients with AIS. If the findings of this study confirm the effectiveness of BP to reduce the NIHSS score and other related outcomes and patients are willing to accept the therapy, we believe this study will help the implementation of this therapy in clinical practice, and provide new evidence for the treatment of AIS.


Asunto(s)
Isquemia Encefálica , Accidente Cerebrovascular Isquémico , Accidente Cerebrovascular , Humanos , Accidente Cerebrovascular/tratamiento farmacológico , Accidente Cerebrovascular Isquémico/complicaciones , Isquemia Encefálica/tratamiento farmacológico , Venodisección/efectos adversos , Grupos Focales , Resultado del Tratamiento , Punciones/efectos adversos , Ensayos Clínicos Controlados Aleatorios como Asunto , Estudios Multicéntricos como Asunto
15.
Artículo en Chino | WPRIM (Pacífico Occidental) | ID: wpr-975161

RESUMEN

ObjectiveTo comprehensively evaluate the clinical application value of four types of Jinsang Kaiyin preparation(JSKYs) and the other two Chinese patent medicines(CPMs) in the treatment of acute pharyngitis/laryngitis,so as to provide evidence for their rational clinical use and regulatory decision-making. MethodAccording to the guideline for clinical comprehensive evaluation of CPM,the effectiveness,safety,economy,innovation,suitability and accessibility of four JSKYs and the other two CPM in the treatment of acute pharyngitis/laryngitis were comprehensively evaluated,which were ranked based on the quantitative scoring tool. Result① Effectiveness:Compared with the control group,JSKYs can improve the total effectiveness rate of acute pharyngitis/laryngitis and improve the symptoms. Network meta-analysis showed that the probability of JSKY ranked the first in terms of total effectiveness rate.② Safety:JSKYs did not show acute toxicity and long-term toxicity. The main adverse reactions were skin rash,abdominal pain,diarrhea,nausea and vomiting,etc,which were similar with the other two CPM.③ Economy:For patients with acute laryngitis(wind heat syndrome),compared with drug A,JinsangKaiyin capsule has the comparable cost-effectiveness. For patients with acute pharyngitis(wind heat syndrome),compared with drug B,JinsangKaiyin capsul has low cost and better effectiveness.④ Innovation:Compared with the other two CPM,the indications of JSKYs have their own unique population. JSKYs have six patent approval certifications and has been approved for sale in the Philippines.⑤ Suitability:Compared with the other two CPM,the investigated doctors,pharmacists and patients all believed that the instruction of JSKY was clearer and easier to understand,the use and storage conditions were more convenient,etc.⑥ Accessibility:JSKYs are included in the category B of the National Basic Medical Insurance(2022 edition),which has good cost-effectiveness and affordability for medical insurance and self paid patients. JSKYs do not contain endangered animals and plants. The supply of raw materials can meet the demand of production at present. ConclusionAs for the drug value calculation,JSKY obtained the highest score. Based on all dimensions of evidence,expert consensus on JSKY is class A,which can be directly converted into decision making.

16.
Artículo en Chino | WPRIM (Pacífico Occidental) | ID: wpr-980180

RESUMEN

In order to evaluate the efficacy and safety of Hexue Mingmu tablets in the treatment of diabetic retinopathy(DR) and retinal vein obstruction(RVO), and to provide a basis for the clinical treatment of ophthalmic diseases, this paper obtained randomized controlled trials(RCTs) of Hexue Mingmu tablets in the treatment of DR and RVO by searching Chinese and English electronic databases and trial registration platforms(up to September 13, 2022). The risk of bias in the included studies was assessed using RoB2.0, and Meta-analysis was performed using RevMan5.4. A total of 35 RCTs involving a total sample size of 3 261 patients were included. Meta-analysis results showed that compared with conventional western medical treatment alone, the combination of Hexue Mingmu tablets with conventional western medical treatment improved patients' macular thickness{mean difference(MD) =-39.83, 95% confidence interval(CI) [-51.60, -28.06], P<0.000 01}, improved corrected visual acuity{risk ratio(RR)dichotomous=1.09, 95% CI [1.00, 1.18], P=0.04; MDcontinuous variable=0.15, 95% CI [0.13, 0.17], P<0.000 01}, increased effective rate of fundus symptom improvement(RR=1.26, 95% CI [1.22, 1.30], P<0.000 01), improved hemorheology index{standard mean difference(SMD)=-1.53, 95% CI [-2.04, -1.01], P<0.000 01}, shortened improvement time of fundus symptoms(MD=-5.53, 95% CI [-5.96, -5.09], P<0.000 01), and there was no significant difference on adverse events between the two groups. The results show that treatment of DR and RVO with Hexue Mingmu tablets may improve the macular thickness and hemorheology index of patients, which can significantly enhance the effect of corrected visual acuity and clinical efficiency, and shorten the time to symptom improvement. However, the original literature is of low quality and the pooled results have some limitations. Subsequent studies should try to use uniform standard assessment criteria and testing methods, focus on the rigor of study design and implementation, and pay attention to the key outcomes of this disease and the clinical safety of medication, so as to provide more reliable evidence to support this kind of clinical problems.

17.
Artículo en Chino | WPRIM (Pacífico Occidental) | ID: wpr-981356

RESUMEN

This study aimed to evaluate the efficacy and safety of Biling Weitong Granules in the treatment of stomach ache disorder. Randomized controlled trial(RCT) of Biling Weitong Granules in the treatment of digestive diseases with stomach ache disorder as the primary symptom was retrieved from Chinese and English electronic databases and trial registration platforms from database inception to June 10, 2022. Two investigators conducted literature screening and data extraction according to the screening criteria. The Cochrane risk-of-bias tool(v 2.0) was used to assess the risk of bias in the included studies. Analyses were performed using RevMan 5.4 and R 4.2.2, with summary estimates measured using fixed or random effects models. The primary outcome indicators were the visual analogue scale(VAS) scores and stomach ache disorder symptom scores. The secondary outcome indicators were clinical recovery rate, Helicobacter pylori(Hp) eradication rate, and adverse reaction/events. Twenty-seven RCTs were included with a sample size of 2 902 cases. Meta-analysis showed that compared with conventional western medicine treatments or placebo, Biling Weitong Granules could improve VAS scores(SMD=-1.90, 95%CI[-2.18,-1.61], P<0.000 01), stomach ache disorder symptom scores(SMD=-1.26, 95%CI[-1.71,-0.82], P<0.000 01), the clinical recovery rate(RR=1.85, 95%CI[1.66, 2.08], P<0.000 01), and Hp eradication rate(RR=1.28, 95%CI[1.20, 1.37], P<0.000 01). Safety evaluation revealed that the main adverse events in the Biling Weitong Granules included nausea and vomiting, rash, diarrhea, loss of appetite, and bitter mouth, and no serious adverse events were reported. Egger's test showed no statistical significance, indicating no publication bias. The results showed that Biling Weitong Granules in the treatment of digestive system diseases with stomach ache disorder as the primary symptom could improve the VAS scores and stomach ache disorder symptom scores of patients, relieve stomach ache disorder, and improve the clinical recovery rate and Hp eradication rate, with good safety and no serious adverse reactions. However, the quality of the original studies was low with certain limitations. Future studies should use unified and standardized detection methods and evaluation criteria of outcome indicators, pay attention to the rigor of study design and implementation, and highlight the clinical safety of the medicine to provide more reliable clinical evidence support for clinical application.


Asunto(s)
Humanos , Dispepsia , Dolor Abdominal , Gastropatías
18.
Artículo en Chino | WPRIM (Pacífico Occidental) | ID: wpr-970521

RESUMEN

Currently,the research or publications related to the clinical comprehensive evaluation of Chinese patent medicine are increasing,which attracts the broad attention of all circles. According to the completed clinical evaluation report on Chinese patent medicine,there are still practical problems and technical difficulties such as unclear responsibility of the evaluation organization,unclear evaluation subject,miscellaneous evaluation objects,and incomplete and nonstandard evaluation process. In terms of evaluation standards and specifications,there are different types of specifications or guidelines with different emphases issued by different academic groups or relevant institutions. The professional guideline is required to guide the standardized and efficient clinical comprehensive evaluation of Chinese patent medicine and further improve the authority and quality of evaluation. In combination with the characteristics of Chinese patent medicine and the latest research achievement at home and abroad,the detailed specifications were formulated from six aspects including design,theme selection,content and index,outcome,application and appraisal,and quality control. The guideline was developed based on the guideline development requirements of China Assoication of Chinese medicine. After several rounds of expert consensus and public consultation,the current version of the guideline has been developed.


Asunto(s)
Medicina Tradicional China , Medicamentos sin Prescripción , Consenso , China , Estándares de Referencia , Medicamentos Herbarios Chinos
19.
Artículo en Chino | WPRIM (Pacífico Occidental) | ID: wpr-970583

RESUMEN

To provide proof of the evidence-based medicine and decision-making information for the clinical decision of functional gastrointestinal disorders(FGIDs), this study evaluated and compared the efficacy, safety, and economy of four oral Chinese patent medicines(CPMs) in the treatment of FGIDs using the method of rapid health technology assessment. The literature was systematically retrieved from CNKI, Wanfang, VIP, SinoMed, EMbase, PubMed, Cochrane Library and ClinicalTrials.gov from the establishment of the databases to May 1, 2022. Two evaluators screened out the literature, extracted data, evaluated the quality of the literature, and descriptively analyzed the results according to the prepared standard. Eventually, 16 studies were included, all of which was rando-mized controlled trial(RCT). The results showed that Renshen Jianpi Tablets, Renshen Jianpi Pills, Shenling Baizhu Granules, and Buzhong Yiqi Granules all had certain effects on the treatment of FGIDs. Renshen Jianpi Tablets treated FGIDs and persistent diarrhea. Shenling Baizhu Granules treated diarrhea with irritable bowel syndrome and FGIDs. Buzhong Yiqi Granules treated diarrhea with irritable bowel syndrome, FGIDs, and chronic diarrhea in children. Renshen Jianpi Pills treated chronic diarrhea. The four oral CPMs all have certain effects on the treatment of FGIDs and have specific advantages for specific patients. Compared with other CPMs, Renshen Jianpi Tablets have higher clinical universality. However, there are problems such as insufficient clinical research evidence, generally low quality of evidence, lack of comparative analysis among medicines, and lack of academic evaluation. More high-quality clinical research and the economic research should be carried out in the future, so as to provide more evidence for the evaluation of the four CPMs.


Asunto(s)
Niño , Humanos , Síndrome del Colon Irritable , Evaluación de la Tecnología Biomédica , Enfermedades Gastrointestinales , Diarrea
20.
Artículo en Chino | WPRIM (Pacífico Occidental) | ID: wpr-984594

RESUMEN

ObjectiveTo carry out the clinical comprehensive evaluation of Biantong capsules and Biantong tablets in the treatment of constipation guided by the clinical value of drugs, and to provide a scientific basis for the rational pricing, rational use, and cataloging of Biantong capsules/tablets. MethodThe available evidence and survey data were used for the clinical comprehensive evaluation of Biantong capsules/tablets and three control drugs in the treatment of constipation in terms of the six dimensions including effectiveness, safety, economics, innovation, suitability, and accessibility. ResultIn terms of effectiveness, Biantong capsules/tablets can improve the response rate, with clear pharmacological mechanism. In terms of safety, the absence of toxic reaction, the mild adverse reactions, and the favorable prognosis indicate high safety. In terms of economics, the average daily cost of Biantong capsules/tablets is the lowest among the tested drugs, which indicates a cost-effectiveness advantage. In terms of innovation, Biantong capsules/tablets have been authorized patents in China and listed as members in the third category of new drugs of traditional Chinese medicine/ninth new drugs of traditional Chinese medicine. In terms of suitability, Biantong capsules/tablets are convenient to store and take and have good suitability in terms of drug technical characteristics and drug usage. In terms of accessibility, Biantong capsules/tablets have a wide coverage in hospitals, sufficient capacity, low patient burden, extensive drug catalogue coverage, and no major environmental risk for long-term application. The comprehensive values of the tested drugs follow a descending order of control drug B (84.27 score), Biantong capsules/tablets (82.47 score), control drug A (70.47 score), and control drug C (59.46 score). The recommendations of the expert panel are Class A (18/18), which can be directly converted into decision-making. ConclusionBiantong capsules/tablets demonstrate a high clinical comprehensive value in the treatment of constipation, providing a reference for the rational pricing, rational use, and cataloging of drugs.

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