1.Influence of jiaweibugan decoction on VEGF expression of sciatic nerve in experimental diabetic rats
Jianyu FU ; Zeqi CHEN ; Juan HUANG ; Lili XIONG ; Xingping DAI
Journal of Chinese Physician 2008;10(8):1028-1031
Objective To observe the effect of jiaweibugan decoction on VEGF expression of sciatic nerve in experimental diabetic rat and explore the preventive and therapeutic effects of iiaweibugan decoction on peripheral neumpathy in~xperimental diabetic rats.Methotis The diabetic rat model was established by streptozotocin(STZ).The rats were killed on the 4th or 8th week from the beginning of treatment respectively,and VEGF mRNA of sciatic nerve was detected by reverse-transcriptase polymerase chain reaction(RT-PCR).Resuits The results of RT-PCR showed that VEGF expression ofthe model group and treated group on the4th or8th week WaS higherthan that of the normal control group(P<0.05).Compared with the model group,VEGF expression in the diabetic rats treated byjiaweibugan decoction increased markedly at the end of4th week(P<0.05),while decreaSed significantly at the end of8th week(P<0.05).Conclusion Jiaweibugan decoction has a proventive and therapeutic effect on peripheral neumpathy in experimental diabetic rats.
2.Research progress of acupuncture and moxibustion for endometrial receptivity in recent 10 years.
Zeqi DAI ; Weiwei SUN ; Ruihua ZHAO
Chinese Acupuncture & Moxibustion 2018;38(4):451-455
The research of acupuncture and moxibustion for endometrial receptivity in recent 10 years was reviewed. CNKI and PubMed databases were retrieved with "acupuncture" "moxibustion" and "endometrial receptivity" as key words. The retrieving time was from January of 2007 through December of 2016. As a result, 63 relevant papers were collected and 28 papers regarding clinical and experimental researches of acupuncture for endometrial receptivity were included into analysis. It was found that acupuncture and moxibustion could improve endometrial morphology (including the expression of pinopodes, endometrial thickness and the rate of endometrial type A), reduce the endometrial microcirculation (including endometrial pulsatility index, resistance index and hemodynamic index), increase the levels of estrogen and progesterone and the expressions of their receptors, and regulate the expression of molecular biological regulator (such as integrin, leukemia inhibitory factor, vascular endothelial growth factor and HOXA10). As a result, the endometrial receptivity was improved to provide good environment for embryo implantation and improve the pregnancy rate, which had significant advantage in the field of assisted reproductive technology. However, detections of pinopodes and integrin were invasive. Its application for clinical use had limitations. In addition, the evidence of acupuncture improving endometrial receptivity was still insufficient. By reviewing related research result, this paper further summarized and analyzed the action mechanism of acupuncture for endometrial receptivity to provide references for the clinical treatment.
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Embryo Implantation
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3.Oral Chinese Patent Medicines for Adult Functional Dyspepsia:A Scoping Review of Clinical Evidence and Drug Package Inserts
Miaomiao LI ; Hui ZHAO ; Yue WU ; Zeqi DAI ; Simin XU ; Xudong TANG ; Xing LIAO
World Science and Technology-Modernization of Traditional Chinese Medicine 2023;25(8):2840-2850
Objective To systematically review the present status of oral Chinese patent medicines(CPMs)for treating functional dyspepsia(FD),explore the formation rules of CPMs,and reveal the potential problems by referring to the methods and procedures of Scoping review.Methods First,we screened all CPMs from the domestic-related drug catalogs which are generally accepted and own the force of law,then we sorted the CPMs based on the drug instructions while carrying out Chinese and English database document retrieval to review the clinical studies.Descriptive analysis of the basic feature and clinical research evidence of CPMs was performed combined with visual charts.Results This study included 42 CPMs for treating FD.Among the formulas of CPMs,Tangerine peel,Radices saussureae,Poria cocos,Glycyrrhiza,Atractylodes macrocephala,and Six Divine Qu appeared frequently.In addition,96 studies involving 21 CPMs were included,among which Zhizhu Kuanzhong Capsule,Liuwei Anxiao capsule,and Dalitong granules had more clinical literature.By analyzing the included 96 clinical studies,we found that the combination of Chinese and Western medicine was the main intervention,and the effective rate,clinical symptom score,and adverse reactions were the main outcomes that were concerned.In addition,8 studies had off-label use of diseases,involving the Wuling capsule to treat the FD whether the disease was accompanied by depression and anxiety symptoms or not,and Zhizhu Kuanzhong Capsule to treat the FD with anxiety and depression.Although the Wuling capsule and Zhizhu Kuanzhong capsule were off-label used in clinical practice,there was no beyond the scope of the guideline.Conclusion The qi-regulating drug,spleen-strengthening drug and digestant drugs are the usual Chinese medicines used for treating adult FD.In recent years,research on CPMs for treating adult FD has increased rapidly.But there is insufficient reflection of CPMs treatment characteristics,ambiguous differences from the primary and secondary outcomes,multiple composite outcomes,and not explicit information on FD or its symptoms in drug package insert,which needs to be improved in the future.
4.Drug Selection and Evaluation in Medical Institutions: A Scoping Review
Simin XU ; Zeqi DAI ; Junling CAO ; Xing LIAO
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(7):154-162
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.
5.Construction and Interpretation of Clinical Comprehensive Evaluation Index System for Chinese Patent Medicine Based on EVIDEM Framework
Zeqi DAI ; Chengyang JING ; Xue WU ; Le ZHANG ; Xing LIAO
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(6):134-143
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.
6.Health Technology Assessment Institutions and Organizations: A Scoping Review
Xue WU ; Simin XU ; Zeqi DAI ; Xing LIAO
Chinese Journal of Experimental Traditional Medical Formulae 2022;28(20):178-185
To understand the development status and provide the basis for the construction and development of health technology assessment (HTA) institutions/organizations in China, this paper systematically reviewed the status of international HTA institutions/organizations and the HTA institutions/organizations in western developed countries and some Asian countries. This study was based on the results of the second round of global survey on HTA conducted by the World Health Organization (WHO) in 2020/2021. The websites of WHO, International HTA Database (INAHTA), international HTA institutions/organizations, and the HTA institutions/organizations in different countries were searched. After data extraction and classification, we summarized the status of 9 international HTA institutions/organizations (including Decide: Health Decision Hub, Health Technology Assessment International, HTAsiaLink, International Network of Agencies for Health Technology Assessment, European Network for Health Technology Assessment, Health Technology Assessment Network of the Americas, International Society for Pharmacoeconomics and Outcomes Research, Southern African Health Technology Assessment Society, International Information Network on New and Emerging Health Technologies), 11 HTA institutions/organizations in western developed countries and Asian countries (including Canada, France, Germany, the United Kingdom, Australia, the United States, Japan, Malaysia, South Korea, Singapore, and Thailand), and 6 HTA organizations/teams in China. The use of HTA varies greatly because of different medical and health systems among different countries, and thus the role of HTA in health decision-making varies among different countries. The international HTA institutions/organizations have greatly strengthened the communication between HTA institutions/organizations and the pharmaceutical industry and facilitated the promotion and practice of evidence-based health decision-making.
7.Current Situation on Clinical Comprehensive Evaluation of Chinese Patent Medicines in China
Wenshuang LI ; Zeqi DAI ; Qingran SUN ; Chuchuan WAN ; Xing LIAO ; Xiaoyu XI
Chinese Journal of Experimental Traditional Medical Formulae 2023;29(24):155-162
ObjectiveTo clarify the development and methodological research status of clinical comprehensive evaluation of Chinese patent medicines in China and identify the problems and difficulties in the evaluation, so as to provide a reference for promoting the subsequent evaluation. MethodFirstly, we analyzed the current situation of clinical comprehensive evaluation in China by reviewing the articles about the process of clinical comprehensive evaluation of drugs and the process of clinical comprehensive evaluation of Chinese patent medicines. Secondly, we comprehensively summarized the formulation background and key points of policies related to clinical comprehensive evaluation of Chinese patent medicines and then show the development status in this field at the national and provincial levels. ResultThe comprehensive clinical evaluation of Chinese patent medicines is still in its infancy in China, and 32 articles of specific evaluation of Chinese patent medicines were included in the study. The dosage forms were mainly capsules (15 articles, 46.88%) and injections (28.13%). The evaluation mainly involved diseases such as the nervous system (10 articles, 31.25%), digestive system (5 articles, 15.63%), and respiratory system (5 articles, 15.63%). The research results of clinical comprehensive evaluation of Chinese patent medicines were mainly from relevant societies and research institutions. Different research teams have developed technical guidelines or specifications for the evaluation, while the government-leading evaluation guidelines remained to be formulated at the national and provincial levels. In addition, the research articles in this field mainly concentrated on the application of evaluation methods, the building of evaluation index systems, and completed evaluation reports. ConclusionTo reflect the unique value and advantages of Chinese patent medicines, the government needs to build technical guidelines for the clinical comprehensive evaluation of Chinese patent medicines on the basis of the clinical comprehensive evaluation of drugs and create a favorable policy environment for the evaluation work.
8.Clinical Evidence of Treatment of Constipation with Oral Chinese Patent Medicine: A Scoping Review
Simin XU ; Zeqi DAI ; Miaomiao LI ; Xue WU ; Xudong TANG ; Xing LIAO
Chinese Journal of Experimental Traditional Medical Formulae 2022;28(20):144-153
This study systematically and comprehensively sorted out the application status of Chinese patent medicines for the treatment of constipation in the clinic, to provide scientific evidence for future research directions and clinical drug use in this field. Based on the method of scoping review, the Chinese patent medicines for the treatment of constipation were retrieved from three drug lists to obtain the medicines that needed to be evaluated. A comprehensive and systematic search was carried out on the included studies on the treatment of constipation by Chinese patent medicines through eight Chinese and English databases, and the included studies were integrated and analyzed. The results were displayed in combination with charts. Thirty-four Chinese patent medicines and 118 studies were included in this study. According to the efficacies, Chinese patent medicines were divided into 4 categories, namely eliminating accumulation, purging fire, promoting Qi, and moistening bowels, involving 125 Chinese medicines. The overall attention of constipation research is on the rise. Marenwan (granules or soft capsules) gained the highest attention, with 42 studies, followed by Qirong Runchang oral liquid, with 21 studies, and Biantong tablets (capsules), with 19 studies. There are 10 studies on Congrong Tongbian oral liquid. Seventeen Chinese patent medicines had no corresponding clinical research. There were 8 study design types, and all drugs were mainly randomized controlled trials except Danggui Longhui pill. Among the intervention types, the comparison between Chinese patent medicines and western medicines was the most. The highest outcome indicators were efficacy, safety evaluation, and main symptoms or scores, and there was a lack of a unified core outcome indicator set. There were few studies on adverse reactions and the economy. Only 11.86% of the studies were funded. Clinically, Chinese patent medicines are widely used in the treatment of constipation, and the amount of related research shows an increasing trend. However, some Chinese patent medicines lack corresponding clinical evidence, and the published research has problems such as unrigorous design, ununified criteria for efficacy evaluation, lack of comprehensive evidence studies, and insufficient funds. It is hoped that more investment will be made in this field in the future, and more attention will be paid to drugs with relatively blank research and constipation syndromes with few treatments. Comprehensive evidence studies such as systematic reviews should be carried out actively. And the study design should be standardized to provide reliable evidence for the treatment of constipation with Chinese patent medicines.
9.Clinical Evidence on Treatment of Otorhinolaryngologic Diseases with Oral Chinese Patent Medicine: A Scoping Review
Zeqi DAI ; Xue WU ; Le ZHANG ; Miaomiao LI ; Xing LIAO
Chinese Journal of Experimental Traditional Medical Formulae 2022;28(20):170-177
This paper aims to systematically retrieve and summarize the clinical evidence on oral Chinese patent medicine in otorhinolaryngology by scoping review and analyze the distribution of the evidence, which is expected to serve as a reference for clinical practice and healthcare decision-making. Seven databases were searched (from inception to March 2022) for the clinical evidence of oral Chinese patent medicine in the prevention and treatment of otorhinolaryngologic diseases, and the distribution of the evidence was discussed. A total of 248 papers from core journals/SCI were included: 238 clinical studies (185 randomized controlled trials, 46 semi-/non-randomized controlled trials, 7 case series studies), 5 systematic reviews, 4 guidelines/expert consensuses, and 1 pharmacoeconomic study. The papers covered 26 oral Chinese patent medicines and 40 otorhinolaryngological diseases (5 ear diseases, 22 nose diseases, and 13 throat diseases). The majority of the clinical studies included 100-300 cases. The combination of Chinese patent medicine and western medicine is the common intervention in the experimental group. The outcomes were mainly “cure rate” and improvement of clinical symptoms. Common adverse events were nausea, vomiting, rash, headache, gastrointestinal discomfort, fatigue, etc. In summary, there is a lack of high-quality clinical evidence on oral Chinese patent medicine in otorhinolaryngology. In addition, the available studies have such problems as seldom use of recognized outcomes, low quality of clinical studies, and lack of pharmacoeconomic study. In future, efforts should be made to carry out more rigorous primary and secondary research and enhance the pharmacoeconomic evaluation, in a bid to explore the advantages of Chinese patent medicine in the treatment of otorhinolaryngologic diseases and promote the more rational allocation and application of health resources.
10.Clinical Evidence of Chinese Patent Medicines in Treatment of Respiratory Diseases in Children: A Scoping Review
Xue WU ; Zeqi DAI ; Miaomiao LI ; Le ZHANG ; Xing LIAO
Chinese Journal of Experimental Traditional Medical Formulae 2023;29(6):147-156
ObjectiveThis study performed a scoping review to comprehensively analyze and report the information on the instructions of Chinese patent medicines and clinical research evidence for the treatment of respiratory diseases in children. MethodChinese patent medicines against respiratory diseases in children were obtained by searching the three major drug catalogues. The Chinese and English databases were searched for relevant literature,followed by data statistics and visualized analysis. ResultAfter screening and analysis,52 Chinese patent medicines were included,involving nine dosage forms. The main drugs were Scutellariae Radix,Armeniacae Semen Amarum,Forsythiae Fructus,etc. The main functions included clearing heat and releasing exterior syndrome,and relieving cough and dissipating phlegm. The indications mainly included common cold with wind-heat syndrome and cough in children. Adverse drug reactions and contraindications were only specified in 19.23% (10/52) of Chinese patent medicines,and the rest only displayed "unclear". A total of 279 articles were included,including 277 articles from Chinese Core Periodicals and two articles from SCIE. In terms of research type,those articles included 253 randomized controlled trials (RCTs,with six dosage form/dose comparisons involved),11 retrospective analyses based on Hospital Information System (HIS) data,one case series,13 systematic reviews/Meta-analyses (with two network Meta-analyses involved),and one economic evaluation article. Among them,72.76% (203/279) of the articles were published in the Core Journals of Chinese Science and Technology. Only 33 Chinese patent medicines were involved,and Xiaoer Feire Kechuan Oral Liquid was the top 1 under investigation,accounting for 15.71% (44/280). The indicated diseases were mainly infantile pneumonia,bronchitis,respiratory tract infection,cough,asthma,and other western medicine diseases. Xiaoer Chiqiao Qingre Granules and Xiaoer Dingchuan Oral Liquid were used off-label. The sample size was concentrated in 51-150 cases,accounting for 67.17% (178/265). The interventions in the experimental group were mainly Chinese patent medicine + western medicine + basic treatment or Chinese patent medicine + western medicine. The main outcomes were the effective rate and the improvement of clinical symptoms. The adverse reactions were mainly gastrointestinal reactions,drug-induced skin symptoms,etc.,and two studies have shown that drug doses were associated with adverse reactions. ConclusionIn research years,the research on Chinese patent medicines in the treatment of respiratory diseases in children has advanced rapidly. However,there are still some problems that need to be resolved in the future,such as incomplete information on drug content in the instruction,concentrated drugs to be studied,limited indications,failure to highlight the characteristics of traditional Chinese medicine (TCM) syndromes,unstandardized research design,and an incomplete reflection of Chinese patent medicine.