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ObjectiveTo review the drug information and clinical researches on Chinese patent drug in Pharmacopoeia of the People's Republic of China，National Essential Drugs List and Medicine List for National Basic Medical Insurance，Employment Injury Insurance and Maternity Insurance. MethodSearch Chinese patent medicine，which can reduce blood sugar in the three major catalogues above. CNKI，VIP，Wanfang，Embase and PubMed were searched from their inception dates to August 14th，2021 for the clinical researches on Chinese patent drug. A database was established based on the collected Chinese patent drug for the treatment of diabetes. And then，descriptive analysis was performed to analyze the general condition of clinical researches． ResultFrom the three catalogues above，28 kinds of Chinese patent drugs were retrieved， and Supplementing Qi and Nourishing Yin was the basic effect of 22 kinds of Chinese patent drugs. A total of 1 069 clinical researches published and peaked in 2017 before August 14th，2021 were included. Clinical studies have been carried out and published in all 30 provinces and autonomous regions，and the province with the largest number of published literature was Henan.What's more，16.65% of the projects were supported by government funding. The number of research to Shenqi Jiangtang tablets/granules/capsules was the largest，among the 28 kinds of Chinese patent drugs.Besides，the most frequent type of interventions in the 958 two-arm trials was the load test，accounting for 78.91%.Most types of diabetes，including type 1 diabetes，type 2 diabetes and its complications，gestational diabetes，other types of diabetes and pre-diabetes，were covered in in this study. And the results showed that different drugs with different suitable crowd. ConclusionA summary of the current status of clinical research on Chinese patent drug by means of scoping review can provide direction for the next research.
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Health research priority setting， based on the existing disease burden or healthcare needs， screens out specific areas or topics with relatively high research priority by scientific and systematic methods， and optimizes the allocation of health resources by influencing healthcare decision-making， so as to alleviate the imbalance between regional or global health and development. Many developed countries have carried out related research and practical work on different scales， and the World Health Organization （WHO） attaches great importance to the transformation and application of relevant achievements in developing countries. As the largest developing country in the world， China's research in this field started relatively late， and only a small number of scholars have carried out part of the localization methodology research and practice according to the specific national conditions. However， health research priority setting has not yet attracted the attention of large-scale research institutions or government organizations in China. Although the priority setting is rarely mentioned in the research on traditional Chinese medicine （TCM）， the research and decision-making on the diseases responding specifically to TCM can also be regarded as the practical work of exploring the priority of TCM. Policymakers have a sense of priority support in the "priority of TCM research"， but the decisions from the top design are mainly based on the consensus reached by high-level think tanks. There is a lack of extensive research， and moreover， the data of multiple stakeholders are not included. Therefore， it is urgent to introduce appropriate priority setting methods to solve the problem of transparency and scientificity in the decision-making process. Given the perspective of the specific implementation， the present study introduced three international priority setting methods， i.e.， the James Lind Alliance and Priority Setting Partnerships（JLAPSP，）the Child Health and Nutrition Research Initiative（CHNRI）， and the Council on Health Research and Development （COHRED）， and presented relevant recommendations on how to apply them in the research of TCM， which is expected to provide references for the local research.
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ObjectiveTo review the drug information and research progress on oral Chinese patent medicines in the treatment of cardiac arrhythmia to identify existing problems and provide references for follow-up research. MethodChinese patent medicines against cardiac arrhythmia were retrieved from the three major drug catalogues，Yaozh.com，and relevant guidelines with arrhythmia as the retrieval term. The instructions for included Chinese patent medicines were retrieved through Yaozh.com and specific information was extracted. The research articles on Chinese patent medicines included were retrieved from the five databases，and the information meeting the inclusion and exclusion criteria was extracted and displayed in the form of text description and graphs after statistical analysis. ResultSixty-five oral Chinese patent medicines were included in this study，with the main functions of activating the blood and resolving stasis. The average daily cost of medicines was 8.17 yuan，and there were 42 medicines with an average daily cost of less than 10 yuan，showing a moderate medicine cost. A total of 351 research articles on Chinese patent medicines were screened out，including 259 randomized controlled trials （RCTs），16 non-RCTs，eight non-controlled trials，62 systematic reviews，two guidelines，and two expert consensuses. Eighteen types of Chinese patent medicines were involved，whose clinical trials had been conducted in 28 provinces，cities，autonomous regions，and municipalities in China. Wenxin granules and Shensong Yangxin capsules were the top medicines under investigation，accounting for 75.21% of all research articles. Among the included studies，the most common comparison design was Chinese patent medicine combined with western medicine vs western medicine （64.25%）. The outcome evaluation was mainly based on clinical efficacy，symptom efficacy，arrhythmia efficacy，adverse reactions，and heart rate changes. ConclusionThe number of clinical studies of oral Chinese patent medicines against cardiac arrhythmia varies greatly，but traditional Chinese medicine （TCM） syndrome differentiation thinking is less considered in practical application. Due to unstandardized clinical research and low-quality literature，further advancement is required in the future.
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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.
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ObjectiveTo re-evaluate the systematic reviews/Meta-analyses （SRs/MAs） of tonic traditional Chinese medicine （TCM） injections against cerebral ischemic stroke （CIS） and provide evidence support for clinical practice and decision-making. MethodTCM injections of different varieties were obtained after searching the three major drug catalogues. Seven Chinese and English databases were searched from database inception to March 13，2022，for the relevant SRs/MAs. The methodological quality，risk of bias，reporting quality，and quality of evidence were assessed by Assessment of Multiple Systematic Reviews-2 （AMSTAR-2），the Risk of Bias in Systematic Review （ROBIS），the Preferred Reporting Items for Systematic Reviews and Meta-analyses 2020 （PRISMA 2020），and the Grading of Recommendations Assessment，Development，and Evaluation （GRADE）. In addition，the literature overlap matrix was established to calculate the corrected covered area （CCA） and evaluate the rate of overlaps of the original literature. ResultFive types of TCM injections and 18 SRs/MAs were included. AMSTAR 2 evaluation showed that the methodological quality of 18 SRs/MAs was extremely low，and 14 SRs/MAs had a high risk of bias assessed by ROBIS. The quality evaluation results reported by the PRISMA 2020 showed that the scores of the studies included ranged from 19.5 to 28.5，with 10 being of medium quality and eight of low quality. The evaluation with the GRADE system demonstrated that one outcome was moderate-quality evidence，15 outcomes were low-quality evidence，and 41 outcomes were very low-quality evidence. The CCA of the included SRs/MAs was 0.263，indicating a low rate of overlaps of the original literature. ConclusionTonic TCM injections are effective and safe in the treatment of CIS，but this conclusion should be treated with caution because of the low quality of methodology，reports，and evidence in published SRs/MAs. It is recommended to improve the study design，obtain clinical evidence of higher quality，and conduct systematic evaluations in strict accordance with procedures to standardize the reporting of research results.
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Based on the community research experience of heat-sensitive moxibustion, this study explained technical recommendations for pragmatic randomized controlled trials (pRCTs) of heat-sensitive moxibustion in community from 7 aspects: selection of community research sites, ethical approval and registration, patient recruitment, training of standard operating procedures, ensuring patient compliance, quality control of follow-up visits and patient safety, which aimed to reduce the difficulty of research execution and improve the quality of pRCTs implementation and follow-up visits of heat-sensitive moxibustion.
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Humans , Follow-Up Studies , Hot Temperature , Moxibustion/methods , Randomized Controlled Trials as TopicABSTRACT
Objective@#To evaluate the effect of high-intensity interval somatosensory training combined with neuromuscular acupoint electrical stimulation on blood glucose and motor function among patients with type 2 diabetes mellitus (T2DM), so as to provide insights into prevention of daily life disability among T2DM patients.@*Methods@#T2DM patients treated in Zhejiang Hospital during the period from January 2019 to October 2021 were enrolled and randomly assigned into four groups. Patients in the K group received Kinect somatosensory interaction technology-assisted high-intensity interval training, patients in the N group received neuromuscular acupoint electrical stimulation, and patients in the KN group received high-intensity interval somatosensory training combined with neuromuscular acupoint electrical stimulation, while patients in the C group were given no interventions. The 2 h postprandial plasma glucose and glycated haemoglobin (HbA1c) levels were measured prior to interventions and 4 and 12 weeks post-interventions, and seven physical fitness tests were performed. The blood glucose levels and motor activity were compared among four groups using generalized estimating equations to evaluate the effectiveness of interventions.@*Results@#Totally 199 T2DM patients were enrolled, including 51 patients in the KN group, 49 patients in the K group, 52 patients in the N group and 47 patients in the C group. There were no significant differences in gender, age, course of disease, duration of daily exercises, waist-to-hip ratio, vital capacity or maximal oxygen uptake among the four groups prior to interventions (all P>0.05). There were time-group interaction effects in blood glucose and exercise parameters among the four groups post-interventions (all P>0.05), with the largest changes seen in the KN group. The HbA1c, 2 h postprandial plasma glucose, 2.4 m standing and detour test and back scratch test results reduced by 17.06%, 27.01%, 36.52% and 20.94% 12 weeks post-interventions as compared to those prior to interventions, while 2 min stepping test, 30 s sit-ups, 30 s loading and elbow flexion test, 6 min walking test and sit and reach test results increased by 18.85%, 34.69%, 15.41%, 7.22% and 112.37%, respectively.@*Conclusion@#High-intensity interval somatosensory training combined with neuromuscular acupoint electrical stimulation may improve the blood glucose and motor activity among patients with T2DM.
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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.
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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.
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ObjectiveTo evaluate the safety， efficacy， and economy of the four Chinese patent medicines （CPMs）， including Simotang oral liquid， Liuwei Anxiao capsule， Baohe pill， and Jianwei Xiaoshi oral liquid in the treatment of functional dyspepsia （FD） by a rapid health technology assessment （RHTA）， thus providing evidence support for clinical decision making. MethodChina National Knowledge Infrastructure （CNKI）， WanFang Database， VIP Chinese Technology Periodical Database （VIP）， China Biology Medicine disc （CBMdisc）， PubMed， EMBASE， Cochrane Library， and Web of Science were searched by computer from inception to March 2022. After literature screening， data extraction， and quality evaluation， the descriptive analysis of the results combined with visual charts was performed. Nineteen studies were included， involving 18 randomized controlled trials （RCTs） and 1 Meta-analysis. Neither economic studies nor health technology assessment （HTA） reports were retrieved. ResultThe four CPMs were safe and effective in the treatment of FD， but economic research was lacking. Among them， Simotang oral liquid could be used for children with FD and FD caused by qi and food stagnation， liver and spleen disharmony， and liver and spleen stagnation. Liuwei Anxiao capsule could be used for adult patients with FD caused by food stagnation. Baohe pill could be used for the elderly with FD. Jianwei Xiaoshi oral liquid could be used for children with FD caused by spleen and stomach weakness. ConclusionThe four CPMs have their advantages in the treatment of FD. Among them， the clinical universality of Simotang oral liquid is higher. However， the quality of clinical evidence is generally low， and comparative analysis among drug dosage forms is lacking. In the future， it is necessary to improve， apply， and promote RHTA for rapid evidence production while carrying out a more standardized and scientific evidence-based demonstration of the comprehensive clinical efficacy of CPMs.
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The method of scoping review was used to systematically search and sort out the clinical research of oral Chinese patent medicines for ischemic stroke，to understand the scope of relevant research and the distribution of evidence. Three medical catalogs were manually searched to obtain the oral Chinese patent medicines used for ischemic stroke，and 7 databases were retrieved to obtain the clinical research including these oral Chinese patent medicines. Then the clinical evidence results were visualized by description combined with chart analysis. A total of 68 oral Chinese patent medicines were retrieved，and 1 392 articles were included，with 367 published in core journals， involving 35 oral Chinese patent medicines. The research types included randomized controlled trials，cohort studies，case series，case reports，secondary studies，adverse drug reaction reports，pharmacoeconomic evaluations，drug interactions，consensus or guidelines，non-randomized intervention studies and cross-sectional studies，of which randomized controlled trials had the largest number （283， 77.1%），followed by secondary studies and case series （25， 6.7% for each）. Among the 283 randomized controlled trials，there were 159 clinical studies in the acute phase of ischemic stroke，65 in the non-acute phase，and 59 in the unclear phase. Ten intervention control types and 20 outcome index types were summarized. Among them， the composite outcome index and surrogate outcome index were used 217 times （76.7%） and 245 times （86.6%）， respectively，followed by the degree of neurological impairment （three scales）. Future clinical research of oral Chinese patent medicines for ischemic stroke should clarify the stage of the disease，and the research design should specify the advantages of oral Chinese patent medicines intervening in ischemic stroke. Furthermore， publicly-recognized positive controls should be employed，and important clinical outcome indexes should be selected.
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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.
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ObjectiveTo evaluate the methodological quality of traditional Chinese medicine （TCM） diagnosis and treatment guidelines/consensus of constipation with Appraisal of Guidelines for Research and Evaluation Ⅱ （AGREE Ⅱ）tool， and to study the attention situation of the included Chinese patent medicines in China's National Reimbursement Drug List in the guidelines/consensus. MethodThe data of CNKI，VIP，Wanfang Data，SinoMed，PubMed and Cochrane from the inception of the databases to October 2021 were searched to collect the TCM diagnosis and treatment guidelines/consensus of constipation. Then，the diagnosis and treatment standards and recommended Chinese patent medicines were extracted. Two researchers assessed the methodological quality of the guidelines/consensus with AGREE Ⅱ tool independently. The quality of reports was evaluated by Reporting Items for practice Guidelines in HealThcare （RIGHT） Statement. The recommended Chinese patent medicines in the guidelines/consensus were compared with those in the National Reimbursement Drug List. ResultEleven consensus and 2 guidelines were included，involving 794 experts. The scores of AGREE II were clarity of presentation（59.0%），scope and purpose（44.0%），stakeholder involvement（23.1%），rigor of development （12.1%），applicability （11.1%），and editorial independence （8.3%） from high to low. Five articles were recommended at B level（recommended after revision） and 8 articles were at C level （not recommended）. The average scores of RIGHT Statement were as follows：basic information （93.59%），background （57.69%），evidence （18.46%），recommendations （20.88%），review and quality assurance （19.23%），funding，declaration and management of interests （0.00%）， and other information （0.00%）. The included guidelines/consensus recommended a total of 27 Chinese patent medicines，among which 20 were included in the National Reimbursement Drug List，with 4 species of Class A and 16 species of Class B， accounting for 74.1% of all recommended Chinese patent medicines. Ten purgative Chinese patent medicines in the National Reimbursement Drug List were recommended by the guidelines/consensus，accounting for 50% of all purgative drugs， and 8 were not recommended. There were prescriptions for purgation， for promoting digestion and removing food stagnation， for clearing heat and purging fire，and for warming the middle and dissipating cold，Tibetan medicine and Mongolian medicine. ConclusionBy the AGREE Ⅱ assessment，the methodological quality of the TCM diagnosis and treatment guidelines/consensus of constipation included in this study needed to be improved in the future. The report quality evaluated with RIGHT Statement was low. Most drugs included in the National Reimbursement Drug List were paid attention in the TCM diagnosis and treatment guidelines/consensus of constipation. Moreover，the drugs included in the National Reimbursement Drug List could basically fulfill the clinical needs reflexed from the guidelines/consensus recommendations. However， the reasons of some drugs failing to be included in the National Reimbursement Drug List needed to be studied in the future.
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Ultra-high performance liquid chromatography coupled with quadrupole/time-of-flight tandem mass spectrometry (UPLC-Q/TOF-MS/MS) has been used to detect the metabolites of schaftoside in plasma, bile, urine and feces of mice after oral administration. The study was approved by the Experimental Animal Ethics Committee from Xuzhou Medical University (No. XZMULL201612024). Compounds were identified by analyzing their high-resolution mass spectrometry data, mass spectra, and comparison with reference substances and the literatures. The parent compound and 29 metabolites were detected in the plasma, bile, urine and feces samples of mice. The main metabolic pathways of schaftoside in mice include deglycosylation/glycosylation, hydroxylation/dehydroxylation, hydrogenation, methylation, acetylation, sulfation, and glucuronidation. This study provides references for the material basis of schaftoside in vivo.
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The present study explored the effective approaches to realize the leading role of traditional Chinese medicine （TCM） in preventing diseases， the synergistic role in treating serious diseases， the core role in the rehabilitation of diseases and summarized the experience to provide feasible plans for the evaluation of other dominant diseases of TCM. To evaluate the effectiveness， safety， and economy of TCM in the treatment of ischemic stroke， encephalopathy project team of the China Center for Evidence-based Traditional Chinese Medicine（CCEBTCM） established an evaluation group to determine the work plan and complete the evaluation work. The concepts of the evaluation involved high-quality evidence， expert opinion survey， expert interview， and drug catalog. Under the guidance of clinical experts and methodologists， the evaluation work was completed in accordance with four steps， i.e.， plan making， data collection and data extraction， evidence synthesis and evaluation， and report writing with the rapid review method. Through the review of TCM and western medicine experts， the advantage of TCM in the treatment of ischemic stroke was positioned in the convalescence period with the predominant effects of improving the neurological function defect and improving the daily living ability. In the convalescence period of stroke， TCM treatment could improve post-stroke motor dysfunction， post-stroke cognitive impairment， consciousness disorder， swallowing disorder， aphasia， constipation， urinary function， diplopia， etc.， and the advantages of acupuncture， Chinese medicine， and traditional exercise were more prominent. In terms of safety， TCM treatment of ischemic stroke showed lower incidence of adverse reactions， fewer adverse events， and a milder degree of related symptoms. In terms of economic performance， the combined treatment of TCM and western medicine played a synergistic role and made the treatment cost more reasonable. Compared with conventional intervention， the integrated TCM and western medicine rehabilitation program showed more economic and social benefits.
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Evidence and value：impact on DEcisionMaking （EVIDEM） framework was developed by EVIDEM collaboration. Its core is the combination of multiple criteria decision analysis （MCDA） model and standardized health technology assessment （HTA） report， which aims to evaluate the overall value of medical interventions. It has been tested and implemented in the real-world evaluation environments. After more than 10 years of development， EVIDEM framework has been updated to version 10， and the relevant operation manuals have been published. More than 40 countries have joined the collaboration and more than 20 countries have carried out relevant studies. The framework is constructed with patients， population and sustainability as the overall goals， combing the evidence and value， forming a relatively complete decision-making framework system composed of 2 levels， 7 dimensions and 20 criteria. The two levels include normative universal criteria and contextual criteria. The normative universal criteria， namely EVIDEM core model， is the quantitative evaluation， consisting of 5 dimensions and 13 criteria. Contextual criteria， namely contextual tools， are qualitative evaluation， consisting of 2 dimensions and 7 criteria. The specific operation steps of EVIDEM framework include selecting and constructing criteria， assigning weights， integrating and evaluating evidence， quantitative and qualitative evaluation of value， comprehensive value estimation and ranking based on value estimation. EVIDEM framework is applicable to disease diagnosis， treatment， management and other fields. Its application scope includes medical insurance reimbursement， clinical practice decision-making， drug selection and so on， which can provide a method for more systematic， transparent and scientific healthcare decision-making. At present， the framework has been introduced into the field of traditional Chinese medicine and can provide a scientific and feasible evaluation tool and methodology system for the clinical comprehensive evaluation of Chinese patent medicine.
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Traditional Chinese medicine （TCM） health technology assessment （HTA） provides scientific information and decision-making basis for decision-makers at all levels to choose TCM health technology reasonably. However， it is still in its infancy. In the future， it is necessary to strengthen top-level design， improve cognition and attention， enhance talent training and cooperation， and speed up the development of evaluation criteria in line with the characteristics of TCM， so as to promote the development of HTA in TCM. Therefore， it is imperative to create a method system and tools suitable for TCM HTA. Evidence and value impact on decisionmaking （EVIDEM） framework is developed by EVIDEM collaboration. It combines evidence and value to form a relatively complete decision-making framework system， which can provide methodological support for medical insurance reimbursement， clinical practice decision-making， drug selection and so on. The introduction of EVIDEM framework into the field of TCM has methodological feasibility and practical operability， but it is still necessary to further integrate and optimize the TCM characteristics. On the basis of theoretical research， pilot studies are carried out with Chinese patent medicine as the breakthrough point， forming a preliminary framework and implementation path for the research of TCM HTA， in order to promote healthcare decision-making and achievement transformation.
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This study systematically evaluated the effectiveness and safety of Dingkundan combined with conventional western medicine in the treatment of female infertility. Four Chinese databases，three English databases， and two clinical trial registration platforms were retrieved from inception to April 2021. Two researchers independently carried out literature screening，data extraction，risk assessment of bias，and grading of evidence quality. RevMan 5.4.1 was used for data analysis. A total of 216 research articles were retrieved and 21 randomized controlled trials （RCTs） were included，involving 2 172 cases. The risks of bias in the included RCTs were high. As unraveled by Meta-analysis results， Dingkundan combined with western medicine for ovulation stimulation was superior to western medicine for ovulation stimulation alone in improving pregnancy rate and progesterone level ［relative risk（RR）pregnancy rate=1.67，95% confidence interval（CI）（1.44，1.93）；standardized mean difference （SMD）progesterone=1.21，95% CI（0.82，1.60）］. Dingkundan combined with western medicine for improving the endometrium was superior to western medicine for improving the endometrium alone in improving the pregnancy rate ［RRpregnancy rate=1.35，95% CI（1.23，1.48）］. Dingkundan combined with clomiphene was more effective than clomiphene alone in regulating endometrial thickness and reducing follicle-stimulating hormone and estradiol levels ［MDendometrial thickness=3.34，95% CI（3.27，3.41）， MDfollicle-stimulating hormone=-0.42，95% CI（-0.65，-0.19）， MDestradiol=-4.33，95% CI （-8.18，-0.48）］. Dingkundan combined with letrozole was superior to letrozole alone in increasing the follicle-stimulating hormone level and reducing the estradiol level ［MD follicle-stimulating hormone=1.14，95% CI（0.49，1.78）， MDestradiol =-33.65，95% CI（-59.13，-8.17）］. The single-study results showed that Dingkundan combined with conventional western medicine had certain advantages in regulating endometrial thickness，reducing follicle-stimulating hormone，luteinizing hormone，and estradiol levels，and increasing progesterone levels. The Grading of Recommendations， Assessment， Development， and Evaluation（GRADE）system was used for the evaluation of outcome indicators. The results showed that the quality of the evidence was graded moderate or low. Based on the existing evidence，Dingkundan combined with western medicine for infertility treatment had certain advantages in increasing the pregnancy rate， improving endometrial thickness， regulating hormone levels， and reducing adverse reactions. However，affected by the quality of the included trials，the results may have limitations，and high-quality RCTs are needed for verification in the future.
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To clarify the research progress and existing problems in the clinical research on oral Chinese patent medicine in the treatment of breast cancer. National drug catalogs and databases were searched for oral Chinese patent medicines against breast cancer. Chinese and English databases were searched for clinical trials on oral Chinese patent medicines in the treatment of breast cancer. The main functions，drug composition，literature basic characteristics，intervention measures， and outcome indicators of Chinese patent medicines were comprehensively analyzed and evaluated by a scoping review based on visual charts. In 68 Chinese patent medicines included，53% of them were potent in activating blood， resolving stasis， tonifying the kidney， and strengthening the spleen. In terms of frequency， the top drugs were Ligustri Lucidi Fructus， Astragali Radix， Moutan Cortex， Poria， and Olibanum，indicating the importance of the therapeutic principles of activating blood， resolving stasis， tonifying the kidney， and strengthening the spleen for breast cancer treatment. In 161 included clinical trials，70.71% of the intervention measures were Chinese patent medicine combined with chemotherapy. Literature studies mainly reported Xihuang pills and Huaier granules，which may be related to the combination of chemotherapy and the inclusion in the medical insurance. The outcome evaluation was mainly based on immune indexes，tumor markers，Karnofsky score，safety report and objective response rate，while the survival time and characteristic outcome indicators of traditional Chinese medicine （TCM） were insufficient. The application and research on oral Chinese patent medicine in the treatment of breast cancer have advanced in recent years，but most of the clinical research evidence is not robust，and the evaluation of outcome indicators is not standardized，which needs to be improved.
ABSTRACT
This study aims to summarize the clinical research evidence on oral Chinese patent medicines for the treatment of influenza with the method of scoping review， and thus clarify the status quo and problems. Specifically， the target medicines were selected from related drug catalogues and diagnosis and treatment protocols， and the basic information of the medicines on the specifications was collected. Articles on these medicines were retrieved from Chinese and English databases for statistical analysis and visualization. Finally， 36 medicines and 87 articles were included. The main efficacy of the medicines is clearing heat and removing toxin， and the main components of the medicines are Lonicerae Japonicae Flos， Forsythiae Fructus， and Isatidis Radix. A total of 12 medicines can be used for the treatment of mumps and acute bronchitis in addition to influenza. Only 6 medicines have contraindications and adverse reactions labeled on the specifications. Papers on oral Chinese patent medicines in the treatment of influenza show an increasing trend， and the authors are from 25 provinces and cities in China. Among them， papers on Lianhuaqingwen preparations take up the largest proportion. The studies were mostly randomized controlled trials， non-randomized controlled trials， and retrospective research. A total of 13 studies were supported by national funding， and only 9 studies included more than 200 cases. The most frequently used method was the comparison of the intervention effect of Chinese patent medicines with western medicine， and the treatment course was generally 3-14 days. A total of 7 outcome indicators were used in the studies and the frequency was in the order of ① composite effective rate，② antipyretic effect， ③ symptom improvement， ④ safety indicator， ⑤ virological examination， ⑥ serum inflammatory factor， and ⑦ traditional Chinese medicine （TCM） syndrome score. The conclusions in the clinical studies show difference from the information in drug catalogues. The drug specifications are generally not standard. The available clinical studies have the limitations of small quantity， low in quality， and no demonstration of TCM advantages. In the future， it is necessary to optimize the specifications of Chinese patent medicines， enhance clinical research， further standardize the design of clinical research， and highlight the characteristics of Chinese patent medicines， thereby providing evidence to support the comprehensive clinical evaluation of oral Chinese patent medicines for influenza.