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Based on literature and questionnaire research, related evidence and related data on Shexiang Tongxin Dropping Pills were collected in terms of safety, effectiveness, economy, innovation, suitability, and accessibility. In addition, multi-criteria decision analysis(MCDA) model was used to comprehensively evaluate the clinical value of Shexiang Tongxin Dropping Pills. Quality control was carried out strictly based on evidence-based medicine evaluation. Shexiang Tongxin Dropping Pills were recommended for stable fatigue angina of coronary heart disease with Qi deficiency and blood stasis by guidelines and experts. The conventional treatment of western medicine adds Shexiang Tongxin Dropping Pills to reduce the frequency of angina attacks, shorten the duration, improve exercise tolerance, and improve the quality of life and Chinese symptoms, and the effectiveness is rated as grade A. Adverse reactions are mostly general adverse reactions, and no serious adverse reactions have been reported, consistent with the known risks listed in the instruction for adverse events, contraindications, and precautions. The safety is rated as grade A, and the daily cost is 7.74 yuan. The cost-effectiveness shows that it is a treatment regimen with pharmacoeconomic advantages, and the economic performance is rated as grade A. According to specialist research, Shexiang Tongxin Dropping Pills have good clinical innovation and service innovation, and innovation is rated as grade A. There are no special storage conditions, medicinal material ingredients, or other restrictions, and the clinical use meets the specifications of the medication guidelines. The suitability is rated as grade A. The price level, availability, and affordability of drugs are generally good, and the accessibility is rated as grade A. The clinical value of Shexiang Tongxin Dropping Pills is great.
Subject(s)
Coronary Disease , Drugs, Chinese Herbal , Humans , Quality of Life , Drugs, Chinese Herbal/adverse effects , Coronary Disease/drug therapy , Angina Pectoris/drug therapyABSTRACT
ObjectiveTo systematically review the existing evidence of Tongxiening（TXN） Granules in the treatment of diarrhea-predominant irritable bowel syndrome （IBS-D） with liver Qi invading spleen syndrome，and evaluate the clinical comprehensive value from the 6+1 dimension，providing references for national medical decision-making，drug clinical application promotion，pharmaceutical services，etc. MethodFollowing the relevant standards of the "Guidelines for the Management of Clinical Evidence and Value Evaluation of Drugs"， a combination of qualitative and quantitative approaches based on evidence-based medicine，questionnaire surveys，pharmacoeconomic evaluation，etc.，was employed. Multi-criteria decision analysis （MCDA） model was employed to comprehensively evaluate the clinical evidence and value of TXN Granules in the treatment of IBS-D with liver Qi invading spleen syndrome from the "6+1" dimensions of effectiveness，safety，economy，innovation，suitability，accessibility， and traditional Chinese medicine （TCM） characteristics Result① Safety： Based on the evaluation of known risks and adequacy of safety evidence， TXN granules were considered to have controllable risks with sufficient safety evidence. ② Effectiveness： Meta-analysis showed that TXN granules combined with probiotics could reduce the intestinal symptom score level of IBS-D patients ［mean difference （MD）=-2.29， 95% confidence interval （CI） （-3.20， -1.38）， P<0.01］， and TXN granules combined with conventional treatments （such as Bifidobacterium triple viable capsules，pinaverium bromide tablets，or trimebutine maleate tablets）effectively improved the comprehensive improvement rate of IBS-D patients ［relative risk （RR）=1.19， 95%CI （1.14，1.25）， P<0.01］. TXN granules significantly improved abdominal pain ［RR=1.99， 95%CI （1.62，2.44）， P < 0.01］ and diarrhea efficacy rate ［RR = 1.56， 95% CI （1.07，2.25）， P<0.05］ in IBS-D patients. TXN granules were comparable to pinaverium bromide tablets in reducing HAMA score ［MD = 0.29， 95% CI （-0.30， 0.88）， P=0.34］， HAMD score ［MD=0.35， 95%CI （-0.31，1.00），P=0.30］， and improving IBS-QOL score ［MD = 0.28， 95%CI （-1.70，2.26）， P=0.78］. Based on the quality of evidence and evidence value assessment of effectiveness， it was considered that there was sufficient evidence of effectiveness for this product. ③ Economy： TXN granules are a national medical insurance category B product. After 5 years of simulation with three kinds of Markov models， it was considered that TXN granules were the advantageous treatment option with stable results and good economy. ④ Innovation： TXN granules adhered to original innovation， conducting research and development from clinical application， product components， and production processes. They have obtained national TCM new drug certificates， first prizes from the China Association of Chinese Medicine for Science and Technology， and excellent awards for Chinese patents， providing sufficient innovative evidence in clinical， corporate， and industrial aspects. ⑤ Suitability： The information service of this drug is comprehensive. The questionnaire survey results showed that this drug was suitable for clinical doctors， nurses， pharmacists， and patients in terms of individual compliance， system， and management across multiple dimensions. The overall assessment showed sufficient evidence of suitability for this product. ⑥ Accessibility： The daily cost of TXN granules accounts for 2.43% of the median disposable daily income of urban residents and 9.26% of rural residents， which is moderate and reasonable compared to similar drugs. There is sufficient evidence of affordability， and it is sold nationwide covering all 31 provinces， municipalities， and autonomous regions， with full accessibility evidence and clear results. TCM characteristics： TXN granules originate from the prescription for treating diarrhea in Danxi's Experiential Therapy. They are derived from classical formulas and have undergone multiple clinical trials involving 5 000 cases since their launch， accumulating a certain amount of human use experience. Based on the principles of evaluating TCM characteristics， TXN granules highlight TCM characteristics. The comprehensive value measured using CSC V2.0 software is 0.83 points based on the results of “6+1” dimensions. ConclusionBased on the evaluation results of TXN granules in various dimensions and the comprehensive evaluation score， it is considered that there is sufficient clinical value evidence for TXN granules in treating IBS-D with liver Qi invading spleen syndrome， which can provide references for clinical decision-making and pharmaceutical management. It is suggested for future research to conduct network Meta-analysis， conduct horizontal comparisons of similar TCM treatments for IBS-D， improve the quality of evidence-based evidence， and fully leverage the clinical value advantages of TXN granules.
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Through analyzing the current situation of clinical comprehensive evaluation researches of domestic medical products from 2013 to 2023， it is found that there is a phenomenon of “four more， four less”. Specifically， there is a greater emphasis on conducting research on drug clinical comprehensive evaluation， but fewer comprehensive evaluation opinions provided； more research data come from publicly available information， but fewer derived from real world； more options for similar reference drugs， but less pre-defined research on reference drugs； the research process involves more steps， yet there are fewer studies strictly implementing quality control. Based on this， suggestions are proposed in three aspects： improving the quality of clinical comprehensive evaluation of medical products， enhancing the transformation and dissemination of results， and improving the standardization of clinical comprehensive evaluation of medical products. Regarding the current state of clinical comprehensive evaluation research on Chinese patent medicine， reflections are presented on elevating original research evidence and highlighting the characteristics and advantages of Chinese patent medicine， so as to promote better transformation and application of the results of clinical comprehensive evaluation of medical products.
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OBJECTIVE To design the implementation path around the key links of the management in the clinical comprehensive evaluation of drug in China， and to provide suggestions for optimizing and perfecting the management in the clinical comprehensive evaluation of drug. METHODS Based on the relevant experience of drug evaluation management in typical countries regions at home and abroad， the discussion was performed and the management mechanism was designed from seven aspects， such as funding source， selection of topics， staff management， information management， data management， evaluation process and quality assessment. RESULTS & CONCLUSIONS In terms of funding sources， the financial department can provide funding guarantees or other alternative forms such as performance evaluations to encourage all parties to undertake the clinical comprehensive evaluation of drug projects. In terms of the selection of topics， a “top-down” or “bottom-up” selection mode can be determined according to the project’s nature and actual situation， and a selection process of “forming alternatives-setting up theme selection list-demonstrating and publishing theme selection list” can be formed. In terms of staff management， the specialty of team members should be specified， and the expert team should be established to provide clinical comprehensive evaluation of drug. In terms of information management， the national/provincial basic informational platform should be established， and the registration system should be established. In terms of data management， a regional health data-sharing platform should be formed and the “application-checking-utilization” mechanism should be conducted. In terms of the evaluation process， the evaluation procedures that concern on project implementation plan demonstration system and project closing review system should be constructed. In terms of quality assessment， quality assessment and reward and punishment mechanism for project completion，that consider the quality of management first while focusing on the technical quality， can be established. The management mechanism based on the standardized implementation of the seven key links will standardize the development of clinical comprehensive evaluation of drugs in China to some extent， and help improve the quality of clinical comprehensive evaluation projects for drugs.
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ObjectiveTo comprehensively evaluate the clinical value of Feilike mixture and provide a basis for the allocation of medical resources， rational drug use， and hospital procurement and supply of Chinese patent medicines. MethodWith the data from available studies and provided by drug manufacturers， the methods of evidence-based medicine， pharmacoeconomics， and health technology assessment were employed to construct a multi-criteria decision-making analysis framework from the "6+1" dimensions of safety， effectiveness， economy， innovation， suitability， accessibility， and characteristics of traditional Chinese medicine （TCM）. The clinical evidence and value evaluation software of Chinese patent medicine， CSCv2.0， was used to comprehensively evaluate the clinical value of Feilike mixture. ResultBased on the existing clinical evidence， the following results were obtained. ① Safety： Multi-sources of evidence showed that Feilike mixture had little known risk and sufficient evidence， with the safety rated as grade A， which indicated good safety. ② Effectiveness： The systematic review and Meta-analysis showed that Feilike mixture combined with conventional Western medicine in the treatment of bronchitis shortened the time to disappearance of cough compared with conventional Western medicine alone， with the evidence rated as grade B by the Grading of Recommendations Assessment， Development， and Evaluations （GRADE） system， which indicated high effectiveness. ③ Economy： From the perspective of health system， Feilike mixture combined with conventional Western medicine was more economical than conventional Western medicine alone， and the quality evaluation of pharmacoeconomics rated the economy as grade B. ④ Innovation： Feilike mixture combined with conventional Western medicine improved the clinical treatment effect and had innovation advantages compared with similar drugs. From the aspects of cultivation， identification of medicinal materials， and production， the sufficient supply and safety of medicinal materials can be ensured for Feilike mixture. This medicine was rated as grade B in terms of the medicinal material quality， preparation technology， and patents， which indicated good innovation. ⑤ Suitability： According to the results of the questionnaire survey， the usage of Feilike mixture was easy to be mastered and accepted by doctors and nurses， without special administration time， complex personalized treatment， and special technical and management requirements. It is convenient for patients to use， with convenient supply and storage， and weak influences of policy， publicity， and drug information. Therefore， the suitability of Feilike mixture was rated as grade B. ⑥ Accessibility： Among the similar Chinese patent medicines， Feilike mixture had a moderate price， high production capacity， wide sales coverage， wide coverage of hospitals， sustainable supply of medicinal materials， and low costs of treatment for acute bronchitis， with the accessibility rated as grade A. ⑦ TCM characteristics： Feilike mixture is composed of Scutellariae Radix， Peucedani Radix， Stemonae Radix， Gentianae Rhodanthae Herba， Scleromitrion diffusum， Firmiana platanifolia Radix， and Aster ageratoides， with reasonable compatibility. This formula is derived from the medical experience of Miao ethnic group， with rich experience in human use and the TCM characteristics rated as grade B. According to the evaluation results in the "6+1" dimensions， Feilike mixture was evaluated as class B， with a high clinical value. ConclusionAccording to the existing clinical evidence， compared with conventional Western medicine alone， Feilike mixture combined with conventional Western medicine demonstrates a high clinical value and prominent TCM characteristics in the treatment of acute bronchitis with phlegm-heat invading lung. It is suggested that it should be translated into the basic clinical drug management policy results according to the conditions.
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ObjectiveTo systematically review the studies about Yiqing Capsules in the treatment of pharyngitis， tonsillitis， gingivitis， and oral ulcers with heat-toxin syndrome and clarify the advantages and therapeutic characteristics of Yiqing capsules， thus providing reference for the decision-making by relevant departments and clues for the clinical and basic research. MethodThe multi-criteria decision analysis （MCDA） model and CSC v2.0 were employed to comprehensively evaluate Yiqing capsules from multiple aspects. ResultThe serious adverse reactions in the spontaneous reporting system （SRS） monitoring data of Yiqing capsules included pruritus， rash， an ddiarrhea， all of which were relieved or cured， without aggravation or interhospital transfer for treatment. Literature data showed that the main clinical adverse reactions were abdominal pain， diarrhea， etc. Both acute toxicity and long-term toxicity tests showed good safety， and thus the safety of Yiqing capsules was rated as grade B. The results of Meta-analysis showed that Yiqing capsules used alone or in combination with other medicines outperformed Niuhuang Jiedu capsules or Western medicine in the treatment of pharyngitis， tonsillitis， gingivitis， and oral ulcers with heat toxin in terms of symptom alleviation， disappearance rate of main symptoms， and recurrence rate of aphtha. Pharmacological and pharmacodynamic studies showed that Yiqing capsules had antimicrobial， antiviral， and anti-inflammatory effects， with the effectiveness rated as grade B. The decision tree model was adopted to analyze the incremental cost-effectiveness ratio. With the threshold of 1 fold per capita GDP and the disappearing rate of pain in gingivitis as the indicator， Yiqing capsules had an economic advantage in the treatment of gingivitis due to heat-toxin compared with Niuhuang Jiedu capsules， and the incremental cost-effectiveness ratio was 0.39 yuan/%， which indicated acceptable cost， with the economy rated as grade B. Yiqing capsules can not only clear heat from Qi aspect but also purge blood fire， serving as the representative prescription of clearing and purging for heat-toxin syndrome. Considering the industrial service system and enterprise innovation， the comprehensive innovation of Yiqing capsules was rated as grade B. Generally， this product does not require personalized treatment plans and features convenient supply， storage， transportation， policy publicity， drug information standards， and easy operation for medical care and patients. The Chinese patent medicine information was complete and in line with national standards， and thus the suitability of Yiqing capsules was rated as grade A. With a low price and good availability and affordability， the accessibility of Yiqing capsules was rated as grade A. The Yiqing capsules prescription， Sanhuang Xiexin decoction， originated from ancient medical books， with rich real-world studies， and thus the traditional Chinese medicine characteristics of Yiqing capsules was rated as grade C. ConclusionThe clinical value of Yiqing capsules was rated as grade B from the "6+1" dimensions， suggesting that it could be conditionally converted into the relevant policy results of basic clinical drug management according to the procedure.
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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.
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This study evaluated the clinical effectiveness of Ruyi Zhenbao Pills in the treatment of osteoarthritis, aiming to clarify its clinical advantages and promote rational drug use and related policy transformation. Following the relevant standards in Guidelines for the Comprehensive Evaluation of Drugs in Clinical Practice and Technical Specifications for the Clinical Comprehensive Evaluation of Chinese Patent Medicine, comprehensive research and related data on Ruyi Zhenbao Pills in the treatment of osteoarthritis were collected in the dimensions of safety, effectiveness, economy, innovation, suitability, accessibility, and traditional Chinese medicine(TCM) cha-racteristics(referred to as the "6+1" dimensions). Through evidence-based medicine, questionnaire surveys, health technology assessment, pharmacoeconomic evaluation, and other methods, a multi-criteria decision analysis(MCDA) model and CSC v2.0 software were used to comprehensively evaluate the clinical value of Ruyi Zhenbao Pills. Spontaneous reporting system data on adverse reactions and literature data indicate that the adverse reactions of Ruyi Zhenbao Pills are mostly general adverse reactions, with no reports of se-rious adverse reactions. The known risks are small, and its safety is rated as class A. It has been shown to effectively relieve joint pain and restore joint function in the treatment of osteoarthritis. However, more high-quality, large-sample randomized controlled trials are needed to further validate its effectiveness, which is rated as class B. There is evidence supporting its economic viability, and its economic is rated as class B. It demonstrates good clinical innovation, innovative enterprise service system, and industrial innovation, and innovation is rated as class A. Medical professionals and patients have a favorable perception of the suitability of Ruyi Zhenbao Pills, and further improvement can be made in terms of convenience of administration and promotion to facilitate rational drug use by healthcare professionals and patients. Suitability is rated as class B. The drug has a favorable price level, availability, and affordability, and accessibility is rated as class A. Ruyi Zhenbao Pills are a classic Tibetan medicinal prescription with excellent TCM theoretical characteristics. However, further research is needed on its use in human studies. TCM characteristics are rated as class B. Based on the evaluation results of the "6+1" dimensions, the comprehensive clinical evaluation is rated as grade B. Ruyi Zhenbao Pills have good clinical value in the treatment of osteoarthritis, and it is recommended to undergo the necessary procedures for conditional transformation into a policy for the management of essential clinical drugs.
Subject(s)
Drugs, Chinese Herbal , Drugs, Essential , Osteoarthritis , Humans , Medicine, Chinese Traditional , Reference Standards , Nonprescription Drugs , Osteoarthritis/drug therapy , Drugs, Chinese Herbal/adverse effectsABSTRACT
The articles involving Xiangju Capsules were retrieved, and qualitative research and quantitative research methods were combined to evaluate the evidence of the safety, effectiveness, economy, innovation, suitability, accessibility, and characteristics of traditional Chinese medicine( "6+1" dimensions) of this drug. Multi-criteria decision analysis(MCDA) model and CSC v2.0 software were used to comprehensively evaluate the clinical value of Xiangju Capsules in the treatment of rhinosinusitis and clarify the precise clinical positioning. The dimensions are graded A, B, C, or D. Multi-source safety evidence showed that the main adverse reactions were gastrointestinal reactions, rash, itching, dizziness, and headache. Based on the available studies, the risk is controllable and the safety is grade A. Meta-analysis showed that Xiangju Capsules + conventional western medicine could recover the Lund-Kennedy score, Lund-Mackay score, and CT score, relieve headache, nasal congestion, olfactory disturbance, and facial pain, with the effectiveness is grade B. The incremental cost-effectiveness ratio of Xiangju Capsules + conventional western medicine compared with conventional western medicine alone in the treatment of chronic rhinosinusitis was 263.71 yuan, about 0.82% of the per capita disposable income. The results of sensitivity analysis showed that the research results were relatively robust. Based on the assumption that the per capita disposable income in 2020 will be the threshold of patients' willingness to pay, it is more economical to use Xiangju Capsules + conventional western medicine. The drug belongs to grade A of the national medical insurance, with an average daily cost of 3.06 yuan, and the economy is grade B. This formula is modified from classic formulas and characteristic empirical formulas, be capable of improving immunity and preventing repeated attacks. It can be used for acute and chronic rhinitis-rhinosinusitis. It had a wide range of applicability, especially for the patients with head and face tenderness. Service innovation was reflected in the measures to guarantee supply, capacity, scalability, and coverage of grass-roots sales channels. The industrial innovation was improved through the management of medicinal resources, pharmaceutical industry, production technology, quality control, scientific research and development, and this formula won three national invention patents. Comprehensively, the innovation of Xiangju Capsules is grade B. According to the survey of 188 medical practitioners and 196 patients in 20 provinces, municipalities, and autonomous regions of China, the drug was characterized by easy preparation and administration, individualized medication, simple technology and management, convenient use, storage, and transport, and controllable adverse reactions, with the suitability is grade B. Xiangju Capsules showed the cost of 45.9 and 275.4 yuan for treatment of acute and chronic rhinitis-rhinosinusitis, respectively, being well affordable. It was sold in 35 000 medical institutions in China. The dosage form was suitable for transportation, storage, and grass-root application. With rich, sustainable, and available medicinal resources, the accessibility of Xiangju Capsules is grade A. This drug can be used for both acute and chronic rhinitis-rhinosinusitis, clearing heat and expelling pus, and strengthening the exterior to prevent relapse. After this drug was available on the market, over 4 000 cases were studied, with rich experience in human use accumulated, and characteristics of traditional Chinese medicine is grade B. Overall, the clinical value of Xiangju Capsules is class B. It is suggested that Xiangju Capsules should be used in accordance with the relevant policies of basic clinical drug administration to play its role.
Subject(s)
Rhinitis , Sinusitis , Humans , Rhinitis/drug therapy , Sinusitis/drug therapy , Medicine, Chinese Traditional , Headache , China , CapsulesABSTRACT
Objective: To analyze the safety, effectiveness, economics, innovation, suitability and accessibility of tetrandrine in the treatment of pneumoconiosis, and provide evidence-based basis for health policy decision-making and clinical practice. Methods: In July 2022, the system searched PubMed, Embase, the Cochrane Library, CNKI, Wanfang, SinoMed databases (the retrieval time was from the establishment of the database to June 30, 2022), screened the documents that meet the standards, extracted and evaluated the data, and used the "HTA checklist" developed by the International Network of Agencies for Health Technology Assessment (INAHTA) to evaluate the HTA report. AMSTAR-2 Scale was used to evaluate the quality of systematic evaluation/Meta analysis. CHEERS Scale was used to evaluate the quality of pharmacoeconomics research. The included cohort study or case-control study was evaluated with the Newcastle-Ottawa Scale. The included randomized controlled trial (RCT) studies were evaluated using the Cochrane Risk Bias Assessment Tool (Cochrane RCT) quality evaluation criteria. Comprehensive comparison and analysis based on the characteristics of the data included in the study. Results: A total of 882 related literatures were detected from the initial screening. According to relevant standards, 8 RCT studies were finally selected for analysis. Statistical results showed that basic treatment with tetrandrine could better improve FEV(1) (MD=0.13, 95%CI: 0.06-0.20, P<0.001), FEV(1)/FVC (MD=4.48, 95%CI: 0.61-8.35, P=0.02) and clinical treatment efficiency. Tetrandrine had a low incidence of adverse reactions. The affordability coefficient of tetrandrine tablets was 0.295-0.492. Conclusion: Tetrandrine can improve the clinical symptoms and pulmonary ventilation function of pneumoconiosis patients, most of the adverse reactions are mild, and the clinical application is safe.
Subject(s)
Benzylisoquinolines , Drugs, Chinese Herbal , Pneumoconiosis , Humans , Pneumoconiosis/drug therapy , Benzylisoquinolines/therapeutic use , Case-Control StudiesABSTRACT
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.
Subject(s)
Drugs, Chinese Herbal , Medicine, Chinese Traditional , Nonprescription Drugs , Consensus , China , Reference StandardsABSTRACT
OBJECTIVE To compare the clinical comprehensive value of 15 Chinese patent medicines for the treatment of chronic hepatitis B， in order to provide reference for clinical rational drug use. METHODS According to the Management Guidelines for Clinical Comprehensive Evaluation of Pharmaceuticals （2021 Version for Trial Implementation）， systematic literature review， meta-analysis and other related data analysis methods were used to perform qualitative and quantitative analysis for the safety， efficacy， economy， suitability， accessibility and innovation of 15 Chinese patent medicines. RESULTS In terms of safety， most of the adverse drug reactions of chronic hepatitis B Chinese patent medicines before the market were unobserved or unclear； post-marketing safety took nucleoside analogs as the intermediate bridge for meta-analysis， there was no significant difference in the incidence of adverse drug reactions among the combined regimens of Chinese patent medicines （P＞0.05）， except that the combination regimen of Fuzheng huayu capsule， Compound yiganling capsules versus combination regimen of Jiuwei gantai capsules showed statistically significant differences （P＜0.05）. In terms of effectiveness， the results of network meta-analysis showed that most Chinese patent medicines， such as Fuzheng huayu capsules combined regimens， had no significant differences in effective rate， HBeAg negative conversion rate and HBV-DNA negative conversion rate （P＞0.05）； however， in reducing the liver elastic hardness value， the combined regimen of Dangfei liganning tablet （capsule） was better than the other combined regimens （P＜0.05）. In terms of economy， the highest cost was the Shuganning injection， and the lowest was Hepatitis B qingre jiedu granules. In terms of suitability， most of the medicines were capsules， tablets and granules， which only needed to be sealed to store and taken orally or taken with boiling water. Compared with injections and some similar products that required strict control of storage temperature， its suitability was better. In terms of accessibility， from the perspective of drug price and affordability， Shuganning injection had the highest average daily cost， the number of days that needed to be borne by the average daily wage was the highest； the average daily cost of Compound yiganling tablets was the lowest， and the number of days required to be borne by the average daily wage was the lowest. From the perspective of availability， Compound biejia ruangan tablets， Dangfei liganning capsules and Wuzhi granules were easier to obtain. In terms of innovation， the 15 Chinese patent medicines included in the study were all domestically produced medicines with a relatively long-term theoretical basis of traditional Chinese medicine and experience in human medicine， and had good industrial innovation. Among them， Compound huayu tablets （capsules） and Anluo huaxian pills were protected varieties of traditional Chinese medicine； Fuzheng huayu tablets （capsules） with more patents had 6 valid patents， all of which were patents for invention. CONCLUSIONS Wuzhi capsule， Sedum sarmentosum granules， Compound yiganling tablets， Rhubarb buchong pills and Dangfei liganning capsules have high clinical comprehensive value.
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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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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.
Subject(s)
Medicine, Chinese Traditional , Nonprescription Drugs , Consensus , China , Reference Standards , Drugs, Chinese HerbalABSTRACT
Objective: To analyze the safety, effectiveness, economics, innovation, suitability and accessibility of tetrandrine in the treatment of pneumoconiosis, and provide evidence-based basis for health policy decision-making and clinical practice. Methods: In July 2022, the system searched PubMed, Embase, the Cochrane Library, CNKI, Wanfang, SinoMed databases (the retrieval time was from the establishment of the database to June 30, 2022), screened the documents that meet the standards, extracted and evaluated the data, and used the "HTA checklist" developed by the International Network of Agencies for Health Technology Assessment (INAHTA) to evaluate the HTA report. AMSTAR-2 Scale was used to evaluate the quality of systematic evaluation/Meta analysis. CHEERS Scale was used to evaluate the quality of pharmacoeconomics research. The included cohort study or case-control study was evaluated with the Newcastle-Ottawa Scale. The included randomized controlled trial (RCT) studies were evaluated using the Cochrane Risk Bias Assessment Tool (Cochrane RCT) quality evaluation criteria. Comprehensive comparison and analysis based on the characteristics of the data included in the study. Results: A total of 882 related literatures were detected from the initial screening. According to relevant standards, 8 RCT studies were finally selected for analysis. Statistical results showed that basic treatment with tetrandrine could better improve FEV(1) (MD=0.13, 95%CI: 0.06-0.20, P<0.001), FEV(1)/FVC (MD=4.48, 95%CI: 0.61-8.35, P=0.02) and clinical treatment efficiency. Tetrandrine had a low incidence of adverse reactions. The affordability coefficient of tetrandrine tablets was 0.295-0.492. Conclusion: Tetrandrine can improve the clinical symptoms and pulmonary ventilation function of pneumoconiosis patients, most of the adverse reactions are mild, and the clinical application is safe.
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Humans , Pneumoconiosis/drug therapy , Benzylisoquinolines/therapeutic use , Drugs, Chinese Herbal , Case-Control StudiesABSTRACT
OBJECTIVE To explore standardized evaluation process for clinical comprehensive evaluation of blood lipid- regulating drugs and perform rapid assessment of clinical comprehensive evaluation of blood lipid-regulating drugs with different mechanisms so as to provide reference for the drug catalogue selection and rational drug use of medical institutions. METHODS Referring to guidelines and consensus such as the guideline for the management of comprehensive clinical evaluation of drugs， the methods such as literature research， expert interviews， and Delphi expert consultation were used to establish a multi-dimensional and multi-criteria clinical comprehensive evaluation index system and quantitative scoring table for blood lipid-regulating drugs around the two main lines of technical evaluation and policy evaluation. Then 13 blood lipid-regulating drugs with different mechanisms in 21 third-grade class-A medical institutions from five provinces and regions of Northwest China were scored from both technical and policy dimensions to form a comprehensive evaluation result. RESULTS The clinical comprehensive evaluation index system and corresponding rapid evaluation quantitative scoring table were constructed for blood lipid-regulating drugs in the five northwest provinces and regions. The technicalevaluation section included 6 primary indicators， 13 secondary indicators， and 34 tertiary indicators， totaling 110 points. The policy evaluation section included 4 primary indicators and 6 secondary indicators， with a total score of 40 points （30 points for some drugs） and a total score of 150 points （or 140 points）. The scoring results showed that the highest score was atorvastatin， followed by rosuvastatin and simvastatin. CONCLUSIONS Statins are still the cornerstone of drug therapy for patients with dyslipidemia； the rapid evaluation quantitative scoring table constructed in this study is comprehensive， systematic and operable. The evaluation process in this study can provide empirical references for other groups to exploring the standardized path and quality control mechanism of clinical comprehensive evaluation of drugs.
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OBJECTIVE To construct the drug clinical comprehensive evaluation index system and quantitative grading in China， and to provide a reference for scientifically carrying out comprehensive clinical evaluation of drugs. METHODS The analytic hierarchy model was used to establish the drug clinical comprehensive evaluation index system， the weight of the evaluation index and the quantitative grading of each index were determined through expert consultation and model calculation. RESULTS The results of expert consultation were integrated by using the analytic hierarchy model， and the drug clinical comprehensive evaluation index system was obtained： including six first-level indicators of effectiveness， safety， economy， suitability， accessibility and innovation， as well as twenty-three second-level indicators of recommended status， medication for special populations， and drug treatment costs； the weight of each indicator was calculated through estimation-matrix method. CONCLUSIONS The analytic hierarchy model can construct the drug clinical comprehensive evaluation index system and quantitative grading in China， which can provide methodological references for comprehensive analysis and decision-making， thus making the clinical comprehensive evaluation of drugs completer and more scientific.
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OBJECTIVE To construct a comprehensive evaluation index system for anti-lung cancer drugs， and to provide a basis for drug selection and rational clinical use. METHODS Based on the Guidelines for the Management of Comprehensive Clinical Evaluation of Drugs （2021 edition for trial use）， a preliminary evaluation index system framework and an index preselection pool were initially formulated through literature analysis. The evaluation indices were then selected and modified by using the Delphi method. The weights of each index were determined through expert scoring and relevant calculations， thereby establishing a comprehensive evaluation index system for anti-lung cancer drugs. Referred to Quick Guideline for Drug Evaluation and Selection in Chinese Medical Institutions， scoring detailed rules for clinical comprehensive evaluation indexes of anti-lung cancer drugs were formulated. The constructed comprehensive evaluation index system and scoring detailed rules were applied to conduct empirical evaluation of the anti-lung cancer drug pembrolizumab. RESULTS The constructed comprehensive evaluation index system for anti-lung cancer drugs included 6 primary indicators and 15 secondary indicators. The weights of the primary indicators were as follows： safety （18）， efficacy （38）， economy （15）， innovation （9）， suitability （10）， and accessibility （10）. The scoring detailed rules for the comprehensive evaluation index system for anti-lung cancer drugs had been preliminarily established. The results of empirical evaluation showed that the comprehensive evaluation score （61 points） of pembrolizumab combined with chemotherapy regimen was higher than that of the monotherapy chemotherapy regimen （56 points）. The former demonstrated superior efficacy， innovation and suitability compared to the latter， while the latter exhibited better safety and economy. CONCLUSIONS The constructed comprehensive evaluation index system for anti-lung cancer drugs has the potential for generalizability and practical application， providing a reference basis for rational clinical drug use.
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Objective To analyze the research status and predict the development trend of clinical comprehensive evaluation of drugs in China, and to provide reference for clinical comprehensive evaluation. Methods CNKI, Wanfang and VIP database were used to search the published articles of clinical comprehensive evaluation. Literature searching was set from the building time of the database to 2022, the basic information about the published articles was obtained for the evaluation of the literature quality. Bibliometrics and CiteSpace 6.1.R3 software were used to visualize the research authors, research institutions, and key words. Results After data screening, a total of 126 Chinese published articles were selected. The analysis showed that the numbers of published articles were rising continuously, and China Academy of Chinese Medical Sciences and Xie Yanming were the institute and the author with the maximum number of literatures, respectively. Conclusion The clinical comprehensive evaluation of drugs was conducted based on the clinical value of drugs, guided by the policy requirements. It is suggested that researchers should conduct the comprehensive evaluation according to the focus and requirements of government agencies, the pharmaceutical industry and the clinical applications.
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Objective:To explore the contents and methods of clinical comprehensive evaluation of microecologics, with the example of Bifidobacterium quadruple viable tablet, in order to provide evidence for clinical rational use of microecologics, and microecologics research, development and related decision-making, and to promote rational use of medications. Methods:Based on the research data collected from systematic literature search, health technology assessment methods such as evidence-based medicine and pharmacoeconomics evaluation were used to estimate the safety, efficacy, economics, suitability, accessibility and innovation of Bifidobacterium quadruple viable tablet. Results:In terms of efficacy, Bifidobacterium quadruple viable tablet showed significant therapeutic effects in the treatment of pediatric diarrhea, antibiotic-related diarrhea, diarrhea-predominant irritable bowel syndrome, and secondary diarrhea caused by diseases such as ulcerative colitis, as well as constipation and functional dyspepsia. It can also be used in the treatment of various diseases such as Helicobacter pylori related gastritis, liver cirrhosis, non-alcoholic fatty liver disease. In terms of safety, the incidence of adverse effects of this medication was low, and most were mild to moderate and transient symptoms. In terms of economics, compared with mesalazine alone in the treatment of ulcerative colitis, the incremental cost-effectiveness ratio of combination of Bifidobacterium quadruple viable tablet and mesalazine was 1 743.2. Besides, the daily treatment cost of Bifidobacterium quadruple viable tablet was lower than that of combination of Bifidobacterium triple viable and Bacillus licheniformis (1.87 to 2.80 yuan vs. 2.08 to 5.78 yuan). In terms of innovation, this medication had multiple patents and had been identified as a high-tech product in Zhejiang Province. In terms of suitability, the overall suitability of use and technical characteristics of medication were good. It could be further improved in the aspects of dosage form and system. In terms of accessibility, the price of the medication was stable, affordable and accessible to the general public. Conclusions:Based on the existing evidence, Bifidobacterium quadruple viable tablet presented effective with supported evidences, good safety, accessibility and innovation. The suitability can be further optimized. However, more in-depth and targeted research is needed in terms of economics and innovation in different clinical applications, and there is space for optimization in medication suitability.