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1.
Chinese Journal of Experimental Traditional Medical Formulae ; (24): 154-162, 2024.
Article in Chinese | WPRIM | ID: wpr-1011454

ABSTRACT

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.

2.
Chinese Journal of Experimental Traditional Medical Formulae ; (24): 134-143, 2024.
Article in Chinese | WPRIM | ID: wpr-1006564

ABSTRACT

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.

3.
Chinese Journal of Experimental Traditional Medical Formulae ; (24): 111-117, 2024.
Article in Chinese | WPRIM | ID: wpr-1006275

ABSTRACT

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.

4.
Chinese Journal of Experimental Traditional Medical Formulae ; (24): 190-197, 2024.
Article in Chinese | WPRIM | ID: wpr-1005269

ABSTRACT

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.

5.
Chinese Journal of Experimental Traditional Medical Formulae ; (24): 99-108, 2023.
Article in Chinese | WPRIM | ID: wpr-988185

ABSTRACT

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.

6.
China Journal of Chinese Materia Medica ; (24): 3965-3976, 2023.
Article in Chinese | WPRIM | ID: wpr-981528

ABSTRACT

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.


Subject(s)
Humans , Child , Drugs, Chinese Herbal/therapeutic use , Nonprescription Drugs/therapeutic use , Technology Assessment, Biomedical , Tiapride Hydrochloride/therapeutic use , Tics/drug therapy , Tic Disorders/drug therapy , Medicine, Chinese Traditional
7.
China Journal of Chinese Materia Medica ; (24): 1951-1961, 2023.
Article in Chinese | WPRIM | ID: wpr-981415

ABSTRACT

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.


Subject(s)
Humans , Drugs, Chinese Herbal/adverse effects , Treatment Outcome , Gastroenteritis/drug therapy , Prescriptions
8.
China Journal of Chinese Materia Medica ; (24): 2249-2259, 2023.
Article in Chinese | WPRIM | ID: wpr-981356

ABSTRACT

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.


Subject(s)
Humans , Dyspepsia , Abdominal Pain , Stomach Diseases
9.
Chinese Journal of Experimental Traditional Medical Formulae ; (24): 155-162, 2023.
Article in Chinese | WPRIM | ID: wpr-998174

ABSTRACT

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.

10.
China Pharmacy ; (12): 2378-2384, 2023.
Article in Chinese | WPRIM | ID: wpr-996395

ABSTRACT

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.

11.
Chinese Journal of Experimental Traditional Medical Formulae ; (24): 109-116, 2023.
Article in Chinese | WPRIM | ID: wpr-980180

ABSTRACT

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.

12.
Chinese Journal of Experimental Traditional Medical Formulae ; (24): 160-167, 2023.
Article in Chinese | WPRIM | ID: wpr-984594

ABSTRACT

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.

13.
China Journal of Chinese Materia Medica ; (24): 6285-6293, 2023.
Article in Chinese | WPRIM | ID: wpr-1008827

ABSTRACT

According to the Guidelines for clinical comprehensive evaluation of Chinese patent medicine(2022 version), this study comprehensively compared the clinical value of Jinsang Liyan Pills/Capsules with that of another commonly used Chinese patent medicine(drug A).(1)Effectiveness: Jinsang Liyan Pills/Capsules had antimicrobial, anti-inflammatory, and pain-relieving effects and can improve the total response rate in the treatment of chronic pharyngitis. Moreover, they took effect faster than the control group.(2)Safety: Jinsang Liyan Pills/Capsules did not cause acute toxicity and long-term toxicity, with low incidence of adverse reactions, which were mild and alleviated after drug withdrawal. Therefore, the risk of Jinsang Liyan Pills/Capsules was under control.(3)Economy: Jinsang Liyan Pills/Capsules had lower cost per course of treatment than drug A. The incremental cost-effectiveness ratio(ICER) of Jinsang Liyan Pills combined with Jinsang Qingyin Pills was-39.97 yuan compared with conventional treatment. The ICER of Jinsang Liyan Pills compared with amoxicilin was 0.01 yuan. The results meant that Jinsang Liyan Pills/Capsules had a cost-effectiveness advantage.(4)Innovation: Jinsang Liyan Pills/Capsules had reasonably formula and wide indications, meeting the clinical needs. Moreover, they had been authorized four patents of advanced manufacturing technology.(5)Suitability: the storage and administration of Jinsang Liyan Pills/Capsules were convenient, with clear instruction of medication.(6) Accessibility: Jinsang Liyan Pills/Capsules had sufficient drug reserve, caused low economic burden of patients, and presented environmental bearing capacity. Finally, Jinsang Liyan Pills/Capsules were scored 79.10 points, and drug A 67.93 points. The experts reached the consensus of grade A for Jinsang Liyan Pills/Capsules, which can be directly converted into decision making. The result of this comprehensive evaluation of Jinsang Liyan Pills/Capsules highlight the clinical advantages in the treatment of chronic pharyngitis and lay a foundation for the standardized research on the clinical basic research of the drug in the future.


Subject(s)
Humans , Drugs, Chinese Herbal/therapeutic use , Pharyngitis/drug therapy , Medicine, East Asian Traditional , Nonprescription Drugs/therapeutic use , Capsules
14.
China Journal of Chinese Materia Medica ; (24): 6278-6284, 2023.
Article in Chinese | WPRIM | ID: wpr-1008826

ABSTRACT

This study used health technology assessment methods and multi-criteria decision analysis(MCDA) model, according to the guideline for clinical comprehensive evaluation of Chinese patent medicine, we developed this assessment tool. The comprehensive evaluation score of Jinsang Sanjie Pills/Capsules is calculated based on the additive model. This score is calculated by "quantitative evaluation software v1.0 for clinical comprehensive evaluation of Chinese patent medicines" which developed by the project team. The evaluation yielded the following results.(1)Effectiveness: compared with the control group, Jinsang Sanjie Pills/Capsules can improve the total effectiveness rate of vocal nodule/polyp of vocal cord, and improve the symptoms and signs.(2)Safety: Jinsang Sanjie Pills/Capsules did not show acute toxicity and long-term toxicity. The most common adverse reaction was gastrointestinal system damage, all of the adverse reactions were either improved or cured.(3)Economy: from the perspective of the health system, evaluating the single use or combination of Jinsang Sanjie Pills/Capsules with conventional medication in the treatment of vocal nodule/polyp of vocal cord is relatively effective and cost-effective compared to conventional medication, with a stable cost-effectiveness advantage.(4) Innovation: Jinsang Sanjie Pills/Capsules are used for the treatment of slow throat paralysis(vocal nodules, polyp of vocal cord, thickening of vocal mucosa) caused by heat toxin accumulation, Qi stagnation and blood stasis, and the resulting hoarseness. Jinsang Sanjie Pills/Capsules have good innovation and targeted indications.(5) Suitability: the investigated doctors, pharmacists and patients all believed that Jinsang Sanjie Pills/Capsules have good suitability.(6)Accessibility: Jinsang Sanjie Pills/Capsules are included in the category B of the National Basic Medical Insurance, Work Injury Insurance, and Maternity Insurance Drug Catalogue(2021 edition), which have good cost-effectiveness and affordability for medical insurance and self-paid patients. Jinsang Sanjie Pills/Capsules do not contain endangered animals and plants. The supply of raw materials can meet the demand of production at present. The comprehensive evaluation score is 76.06 points. Based on all dimensions of evidence, 71.4% experts consensus on Jinsang Sanjie Pills/Capsules is class A, which can be directly converted into decision making. This study comprehensively evaluated the clinical application value of Jinsang Sanjie Pills/Capsules in the treatment of vocal nodule/polyp of vocal cord, so as to provide evidence for their rational clinical use and regulatory decision-making.


Subject(s)
Pregnancy , Humans , Female , Drugs, Chinese Herbal/therapeutic use , Vocal Cords , Capsules , Medicine, East Asian Traditional , Nonprescription Drugs/therapeutic use , Medicine, Chinese Traditional
15.
China Journal of Chinese Materia Medica ; (24): 6269-6277, 2023.
Article in Chinese | WPRIM | ID: wpr-1008825

ABSTRACT

The Guidelines for prevention and treatment of colorectal adenoma with integrated Chinese and western medicine are put forward by Nanjing University of Chinese Medicine and approved by China Association of Chinese Medicine. According to the formulation processes and methods of relevant clinical practice guidelines, the experts in clinical medicine and methodology were organized to discuss the key problems to be addressed in the clinical prevention and treatment of colorectal adenoma(CRA) and provided answers following the evidence-based medicine method, so as to provide guidance for clinical decision-making. CRA is the major precancerous disease of colorectal cancer. Although the prevention and treatment with integrated Chinese and western medicine have been applied to the clinical practice of CRA, there is still a lack of high-quality guidelines. Four basic questions, 15 clinical questions, and 10 outcome indicators were determined by literature research and Delphi questionnaire. The relevant randomized controlled trial(RCT) was retrieved from CNKI, Wanfang, VIP, SinoMed, PubMed, EMbase, Cochrane Library, Web of Science, and 2 clinical trial registries, and finally several RCTs meeting the inclusion criteria were included. The data extracted from the RCT was imported into RevMan 5.3 for evidence synthesis, and the evidence was evaluated based on the Grading of Recommendations, Assessment, Development, and Evaluations(GRADE). The final recommendations were formed by the nominal group method based on the evidence summary table. The guidelines involve the diagnosis, screening, treatment with integrated Chinese and western medicine, prevention, and follow-up of colorectal adenoma, providing options for the clinical prevention and treatment of CRA.


Subject(s)
Humans , Adenoma/prevention & control , Colorectal Neoplasms/prevention & control , Drugs, Chinese Herbal/therapeutic use , Evidence-Based Medicine , Medicine, Chinese Traditional
16.
China Journal of Chinese Materia Medica ; (24): 6257-6268, 2023.
Article in Chinese | WPRIM | ID: wpr-1008824

ABSTRACT

According to the systematic review of text and opinion(SrTO) developed by the Joanna Briggs Institute(JBI), this study integrated the evidence of the medical cases, papers, medical experience, and other related research of famous experts and schools on the treatment of chronic renal failure in the field of traditional Chinese medicine(TCM) nephropathy, analyzed the academic characteristics and influencing factors from the aspects of the principle, method, recipe, and medicines, and explored the internal logic and law of inheritance and innovation in TCM nephropathy. A total of 36 famous TCM experts and 4 schools were included. The work areas are concentrated in North and South China. 94.0% of the famous TCM experts have experienced master-disciple teaching. 27.8% have studied TCM through family succession. 38.9% have been taught by multiple famous teachers. And 5.6% have not experienced master-disciple teaching. In terms of principle, method, recipe, and medicines, many innovations have been made, with 30.6% of famous TCM experts proposing new theories, 11.1% advocating staged treatment of chronic renal failure, and 47.2% summarizing the treatment methods. The formation of the academic thoughts of contemporary famous TCM experts and schools on the treatment of chronic renal failure is closely related to the learning mode, era, and work area. Contemporary famous TCM experts and schools have the academic characteristics of combining classical and clinical theories and paying more attention to TCM with western medicine supplemented. The field of TCM nephropathy has the characteristics of simultaneous inheritance and innovation. On the basis of inheriting the classical theories of TCM, it absorbs modern medical theories, combines clinical diagnosis with the syndrome and treatment law of contemporary diseases, and makes innovations in principle, method, recipe, and medicines, which has significant clinical efficacy in the treatment of chronic renal failure.


Subject(s)
Humans , Medicine, Chinese Traditional , Schools , China , Kidney Failure, Chronic/drug therapy , Drugs, Chinese Herbal/therapeutic use
17.
China Journal of Chinese Materia Medica ; (24): 6249-6256, 2023.
Article in Chinese | WPRIM | ID: wpr-1008823

ABSTRACT

This study systematically searched and sorted out randomized controlled trial(RCT) of acupuncture-moxibustion treatment for non-specific low back pain by scoping review, so as to demonstrate the current state of the research evidence and provide a reference point for future clinical research and healthcare decision-making. Eight commonly used Chinese and English databases were searched, and the search time was from the establishment of the databases to July 7, 2023, so as to analyze the characteristics of the current status of the current research through visualization methods. A total of 50 studies were included, including 23 studies in Chinese and 27 studies in English. The overall number of studies showed an increasing trend. The percentage of studies published in Chinese non-core journals was 42.0%. The disease subtypes of interest were mainly chronic non-specific low back pain, accounting for 68.0% of the studies. The sample sizes of the studies were mainly concentrated in the range of 50-100 cases. A total of 15 types of interventions were categorized, with acupuncture interventions being the most studied. Duration of treatment did not exceed one month in 80.0% of the studies. Only 8.0% of the studies used minimal clinical important difference(MCID) as a basis for judgment. The follow-up period was set within 3 months in 28.0% of the studies, and 82.0% of the studies concluded that acupuncture-moxibustion was effective in the treatment of non-specific lower back pain. Adverse events were reported in 20.0% of the studies. The risk of bias in the included studies was dominated by low risk of bias and uncertain risk of bias, with fewer studies focusing on high risks of bias. In most of the studies, acupuncture-moxibustion was significantly more effective than the control group. The research on acupuncture-moxibustion treatment for non-specific low back pain is developing rapidly, but there are still insufficient studies on psychological state, safety, and other indicators, and there are still some studies with uncertain risks of bias, which is not conducive to the generalization and application of the findings. Therefore, future studies should improve and refine these shortcomings.


Subject(s)
Humans , Acupuncture Therapy/methods , Low Back Pain/etiology , Moxibustion/methods , Randomized Controlled Trials as Topic
18.
China Journal of Chinese Materia Medica ; (24): 5668-5674, 2023.
Article in Chinese | WPRIM | ID: wpr-1008764

ABSTRACT

Lixuwang~® Xuesaitong Soft Capsules(referred to as "Xuesaitong Soft Capsules") have the effects of promoting blood circulation, resolving blood stasis, and dredging meridians and collaterals. They are widely used in the prevention and treatment of cardiovascular and cerebrovascular diseases in clinical practice. Through years of clinical observation, they have shown significant efficacy in ischemic stroke, coronary heart disease, and other diseases, and have been recommended by multiple guidelines, consensus statements, and monographs. Based on the summary of clinical application experience by doctors and existing evidence-based research, following the Technical Specifications for Consensus Development of Chinese Patent Medicine by Clinical Experts issued by Standardization Office of the Chinese Association of Traditional Chinese Medicine, a nominal group method was used to reach 19 recommended opinions/consensus suggestions. This document proposes the timing of medication, syndrome differentiation for medication, therapeutic effects, dosage and administration, treatment duration, economic considerations, and safety considerations in the use of Xuesaitong Soft Capsules for the treatment of ischemic stroke and angina pectoris in coronary heart disease. It is intended for doctors in internal medicine, encephalopathy(neurology), cardiovascular medicine, geriatrics, emergency medicine, general practice, and traditional Chinese medicine departments of various medical institutions, as well as pharmacists in hospitals and pharmacies, as a medication reference when using Xuesaitong Soft Capsules. It is hoped that the widespread application of this consensus can improve the clinical efficacy of Xuesaitong Soft Capsules in the treatment of ischemic stroke and coronary heart disease, promote rational drug use, and reduce medication risks. This consensus has been reviewed and published by the China Association of Traditional Chinese Medicine, with the identification number GS/CACM 323-2023.


Subject(s)
Humans , Consensus , Drugs, Chinese Herbal/therapeutic use , Medicine, Chinese Traditional , Coronary Disease/drug therapy , Ischemic Stroke/drug therapy , Capsules
19.
China Journal of Chinese Materia Medica ; (24): 4521-4528, 2023.
Article in Chinese | WPRIM | ID: wpr-1008706

ABSTRACT

This study aims to analyze the outcomes and measurements of randomized controlled trial(RCT) for traditional Chinese medicine(TCM) treatment of endometriosis(EM) and provide a basis for the building of the core outcome set(COS) of EM. The RCT for TCM treatment of EM was retrieved from medical literature databases with the time interval from inception to February 3, 2022. The Cochrane risk of bias assessment tool was employed to evaluate the risk of bias of the included RCT, and descriptive analyses of the extracted information were carried out. A total of 519 RCTs were included, with the sample sizes ranging from 28-582 patients and 239 outcome indicators(8 outcome indicators per RCT on average). According to the functional properties, the reported outcome indicators were classified into 7 indicators: clinical efficacy assessment, indicators of clinical symptoms and signs, TCM symptom efficacy indicators, physical and chemical examinations, quality of life, long-term prognosis, and safety events. All the 519 RCTs had problems, such as the lack of differentiation between primary and secondary outcome indicators(1.73% RCTs reported such differen-tiation), poor quality, confused criteria for composite outcome indicators and arbitrary combination of indicators(45 criteria for the single outcome indicator of efficiency), and messy measurements(as many as 18 measurements for TCM symptom score). In addition, as a chronic disease, EM requires long-term management. The outcome indicators vary for the patients in different disease stages, such as EM pain, EM infertility, and post-operative EM, while the specific outcome indicator sets for different EM populations remain to be developed. In addition, the time point of measurement for EM long-term outcomes remains unclear, and the definition of TCM syndromes lacks standards. The RCT for TCM treatment had a variety of problems, such as the lack of differentiation of outcome indicators, confusion in criteria and measurements, lack of specific outcome indicator sets for different EM populations, and unclear time points for long-term outcomes. Therefore, the studies about COS need to be carried out urgently.


Subject(s)
Female , Humans , Medicine, Chinese Traditional , Endometriosis/complications , Quality of Life , Syndrome , Drugs, Chinese Herbal/adverse effects
20.
Chinese Journal of Experimental Traditional Medical Formulae ; (24): 96-104, 2023.
Article in Chinese | WPRIM | ID: wpr-975161

ABSTRACT

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.

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