Meta-analysis of Distribution Frequency of Traditional Chinese Medicine Syndrome in Primary Osteoporosis / 中国实验方剂学杂志

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.

Current Situation of Health Technology Assessment in Traditional Chinese Medicine Hospitals / 中国实验方剂学杂志

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.

Clinical Evidence of Oral Chinese Patent Medicines in Treatment of Chronic Kidney Disease： A Scoping Review / 中国实验方剂学杂志

ObjectiveTo review the information and clinical studies of oral Chinese patent medicines （CPMs） for chronic kidney disease （CKD）. MethodThe CPMs for treating CKD were retrieved from the 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. China National Knowledge Infrastructure（CNKI）， VIP， Wanfang Data， SinoMed， PubMed， Embase， Cochrane， and Web of Science were searched for the clinical trials of the treatment of CKD by CPMs from their inception dates to September 25， 2022. A database was established with the collected CPMs， and then the general conditions of the clinical trials were analyzed and presented visually. ResultA total of 16 CPMs for CKD were included in this study， including 5 classical traditional Chinese medicine （TCM） prescriptions involving Rehmanniae Radix and 11 new CPMs. The indications of the TCM prescriptions did not mention the corresponding western disease names， and those of the new CPMs mainly included chronic renal insufficiency， chronic renal failure， and chronic nephritis. Four CPMs were prepared with single Chinese medicine or active components. Specifically， Bailing Preparation and Jinshuibao Preparation were mainly prepared with the powder of Cordyceps， and the main components of Haikun Shenxi capsules and Huangkui capsules were fucoidan sulfate and the flower extract of Abelmoschi Corolla， respectively. The CPMs mainly exerted tonifying and eliminating effects on the lung， spleen， and kidney. A total of 892 clinical trials were screened out， covering all the areas in China and presented an increasing trend. Bailing Preparation was the most studied， followed by Niaoduqing Preparation. Among the 892 studies， 475 focused on single CPMs without combination with other CPMs or therapies. These studies mainly compared between conventional intervention and conventional intervention + CPM， which accounted for 75.58%. The 475 studies covered different kidney diseases， such as chronic kidney disease， chronic renal failure， nephrotic syndrome， diabetic kidney disease， IgA nephropathy， and membranous nephropathy， and involved a variety of populations including the elderly and children. Thirty-six studies evaluated TCM syndromes， reflecting the characteristics and advantages of TCM treatment. ConclusionThere are abundant oral CPMs for CKD， with varied efficacy and characteristics for different kidney diseases. However， the instruction manuals of the oral CPMs are not detailed or standard. According to the clinical research evidence in this field， the research on oral CPMs for CKD is characterized by a wide scope， rich study types， and wide disease coverage， while the sample size and quality remain to be improved.

Clinical Researches on Chinese Patent Drug for Diabetes： A Scoping Review / 中国实验方剂学杂志

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.

Introduction to Health Research Priority Setting Methods and Application Recommendations of Methods in Field of Traditional Chinese Medicine / 中国实验方剂学杂志

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.

Clinical Evidence of Oral Chinese Patent Medicines in Treatment of Cardiac Arrhythmia： A Scoping Review / 中国实验方剂学杂志

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.

Clinical Evidence of Chinese Patent Medicines in Treatment of Respiratory Diseases in Children： A Scoping Review / 中国实验方剂学杂志

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.

Tonic Traditional Chinese Medicine Injections Against Cerebral Ischemic Stroke： An Overview of Systematic Reviews/Meta-analyses / 中国实验方剂学杂志

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.

Systematic review and Meta-analysis of Biling Weitong Granules in treatment of stomach ache disorder / 中国中药杂志

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.

Three oral Chinese patent medicines for children with tic disorder: a rapid health technology assessment / 中国中药杂志

This study aims to comprehensively evaluate the clinical value of Shaoma Zhijing Granules(SZG), Changma Xifeng Tablets(CXT), and Jiuwei Xifeng Granules(JXG) in the treatment of children with tic disorder with the method of rapid health technology assessment(RHTA), which is expected to serve as a reference for medical and health decision-making and clinical rational use of drugs in children. To be specific, relevant articles were retrieved from eight databases and three clinical trial registry platforms. After the quality evaluation, rapid assessment was carried out from the dimensions of disease burden and unmet needs, technical characteristics, safety, efficacy and economy, and the results were analyzed and presented descriptively. A total of 22 articles(1 in English, 21 in Chinese) were screened out: 18 randomized controlled trials(RCTs) and 4 clinical controlled trials(CCTs). Among them, 5 were about the SZG(all RCTs) and 9 were on CXT(6 RCTs and 3 CCTs). The rest 8 focused on JXG(7 RCTs and 1 CCT). Moreover, the overall risk of bias for 94.40% RCTs was evaluated as "some concerns" and only one(5.60%) had high risk of bias. In terms of quality, the 4 CCTs scored 5-6 points(<7 points), suggesting low quality. SZG alone or in combination with tiapride has obvious advantages in improving traditional Chinese medicine syndromes and tic symptoms compared with tiapride alone, with the average daily cost of CNY 79.44-119.16. Compared with conventional western medicine or placebo, CXT alone or in combination with conventional western medicine can improve the total effective rate and alleviate tic symptoms, and the average daily cost is CNY 22.50-67.50. JXG alone or in combination with conventional western medicine can effectively relieve tic symptoms compared with conventio-nal western medicine or placebo, with the average daily cost of CNY 82.42-164.85. The adverse events related to the three Chinese patent medicines mainly occurred in the digestive, respiratory, and nervous systems, all of which were mild. In general, SZG, CXT, and JXG are effective for children with tic disorder. They have been approved to be used in this field, of which SZG was approved in 2019, with the most up-to-date research evidence and high-quality RCT in Q1 journals. However, the comparative analysis of the three was affected by many factors, which should be further clarified. Based on the large sample data available in multiple dimensions, a comprehensive comparative evaluation of the three Chinese patent medicines should be carried out, thereby highlighting the advantages and disadvantages of them and serving a reference for rational clinical use and drug supervision.

Systematic review and Meta-analysis of efficacy and safety of Fengliao Changweikang prescription in treatment of acute gastroenteritis / 中国中药杂志

This study systematically evaluated the clinical efficacy and safety of Fengliao Changweikang prescription for treating acute gastroenteritis(AGE). The databases of CNKI, Wanfang, VIP, SinoMed, Medline, Cochrane Library and two clinical trial registration platforms were retrieved from inception to August 30, 2022, to collect randomized controlled trial(RCT) on Fengliao Changweikang prescription treating AGE. Two researchers independently conducted literature screening, data extraction, and risk of bias assessment according to pre-established inclusion and exclusion criteria. RevMan 5.4.1 was used for data analysis. Finally, 18 RCTs were included, involving 3 489 patients. Meta-analysis showed that compared with conventional western medicine, Fengliao Changweikang prescription improved the relief rate of abdominal pain(RR=1.27, 95%CI[1.17, 1.38],P<0.000 01); Fengliao Changweikang prescription + conventional western medicine increased the cure rate(RR=1.43, 95%CI[1.12, 1.82], P=0.004), shortened the duration of diarrhoea(RR=-1.65, 95%CI[-2.44,-0.86], P<0.000 1), abdominal pain(RR=-1.46, 95%CI[-2.00,-0.92], P<0.000 01), vomiting(RR=-2.16, 95%CI[-2.51,-1.81], P<0.000 01) and fever(RR=-2.61, 95%CI[-4.00,-1.23], P=0.000 2), down-regulated the level of interleukin-8(IL-8)(RR=-1.07, 95%CI[-1.26,-0.88], P<0.000 01), IL-6(RR=-8.24, 95%CI[-8.99,-7.49], P<0.000 01) and hypersensitive C-reactive protein(hs-CRP)(RR=-3.04, 95%CI[-3.40,-2.69], P<0.000 01) and recurrence of AGE(RR=0.20, 95%CI[0.05, 0.90], P<0.04). In conclusion, Fengliao Changweikang prescription was safe in clinical application. It was beneficial to alleviate the clinical symptoms of diarrhea, abdominal pain, vomiting, and fever, and down-regulate the levels of some serum inflammatory factors in AGE patients. However, considering that few high-quality studies have evaluated the efficacy and safety of Fengliao Changweikang prescription in treatment of AGE, further evidence is needed in the future.

Rapid health technology assessment of four oral Chinese patent medicines in treatment of functional gastrointestinal disorders / 中国中药杂志

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.

Guideline for clinical comprehensive evaluation of Chinese patent medicine (2022 version) / 中国中药杂志

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.

Clinical Comprehensive Evaluation of Biantong Capsules and Biantong Tablets in Treatment of Constipation / 中国实验方剂学杂志

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.

Systematic Review and Meta-analysis of Hexue Mingmu Tablets in Treatment of Diabetic Retinopathy and Retinal Vein Obstruction / 中国实验方剂学杂志

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.

Clinical Comprehensive Evaluation of Jinsang Kaiyin Preparation in Treatment of Acute Pharyngitis/Laryngitis / 中国实验方剂学杂志

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.

Current Situation on Clinical Comprehensive Evaluation of Chinese Patent Medicines in China / 中国实验方剂学杂志

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.

Quality evaluation of the research literature on the pharmacoeconomics of traditional Chinese medicines in China from 2018 to 2022 / 中国药房

OBJECTIVE To evaluate the quality of research literature on pharmacoeconomics of traditional Chinese medicine （TCM） in China from 2018 to 2022， to understand the development status and problems of TCM pharmacoeconomic research in China， and to provide a reference for future standardized research on this field. METHODS The systematic search of relevant databases at home and abroad was conducted to obtain the published literature on TCM pharmacoeconomic research in China from January 1， 2018 to November 21， 2022 to summarize the basic information of the literature， the research profile， the method and content of pharmacoeconomic evaluation and to evaluate the quality of the literature by using the CHEERS 2022 checklist； calculate the total literature score by counting the scores of the specific entries of each piece of literature and classifying the quality of the literature as excellent， good， qualified， and unqualified. RESULTS A total of 71 studies were included， involving 60 in Chinese and 11 in English， and 53.52% of the literature was supported by grants； the most studied TCM dosage form was injection （31.03%）； less than half （46.48%） of the literature reported the study angle； short-term economic evaluation was predominantly used （69.01%）； the Chinese studies were dominated by cost-effectiveness analyses （70.00%）， and the English studies were dominated by cost-utility analysis （54.55%）. The average score of literature quality evaluation was 11.02， with two （2.82%） of the literature being of good quality， nine （12.68%） of the literature being of qualified quality， and the majority of the literature （84.51%） being of unqualified quality. The average score of Chinese literature was 9.98， and the average score of English literature was 16.73， with the quality of the latter being significantly better than that of the former. CONCLUSIONS At present， the pharmacoeconomic researches of TCM mainly has problems such as lack of scientific selection of intervention in the control group， nonstandard cost measurement， unreasonable selection of research time limit， quality of evidence for health output indicators to be improved， selection of evaluation methods to be improved， and lack of scientific basis for threshold selection. In order to support the implementation and development of high-level pharmacoeconomics research on TCM， policymakers need to create a favorable policy environment and formulate pharmacoeconomic evaluation guidelines that meet the characteristics of TCM， so as to promote the application and transformation of evaluation results.

Health Technology Assessment Institutions and Organizations： A Scoping Review / 中国实验方剂学杂志

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.

Clinical Evidence on Treatment of Otorhinolaryngologic Diseases with Oral Chinese Patent Medicine： A Scoping Review / 中国实验方剂学杂志

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.