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ObjectiveTo review the drug information and clinical researches on Chinese patent drug in Pharmacopoeia of the People's Republic of China，National Essential Drugs List and Medicine List for National Basic Medical Insurance，Employment Injury Insurance and Maternity Insurance. MethodSearch Chinese patent medicine，which can reduce blood sugar in the three major catalogues above. CNKI，VIP，Wanfang，Embase and PubMed were searched from their inception dates to August 14th，2021 for the clinical researches on Chinese patent drug. A database was established based on the collected Chinese patent drug for the treatment of diabetes. And then，descriptive analysis was performed to analyze the general condition of clinical researches． ResultFrom the three catalogues above，28 kinds of Chinese patent drugs were retrieved， and Supplementing Qi and Nourishing Yin was the basic effect of 22 kinds of Chinese patent drugs. A total of 1 069 clinical researches published and peaked in 2017 before August 14th，2021 were included. Clinical studies have been carried out and published in all 30 provinces and autonomous regions，and the province with the largest number of published literature was Henan.What's more，16.65% of the projects were supported by government funding. The number of research to Shenqi Jiangtang tablets/granules/capsules was the largest，among the 28 kinds of Chinese patent drugs.Besides，the most frequent type of interventions in the 958 two-arm trials was the load test，accounting for 78.91%.Most types of diabetes，including type 1 diabetes，type 2 diabetes and its complications，gestational diabetes，other types of diabetes and pre-diabetes，were covered in in this study. And the results showed that different drugs with different suitable crowd. ConclusionA summary of the current status of clinical research on Chinese patent drug by means of scoping review can provide direction for the next research.
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Shujin Jianyao Pills is a kind of concentrated honey pills made of 13 Chinese herbal medicines, such as Cibotii Rhizoma, Rosae Laevigatae Fructus, and Spatholobi Caulis. It has the effects in tonifying liver and kidney, strengthening muscles and bones, removing wind and dampness, activating collaterals and relieving pain. Under the leadership of the Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences and Wangjing Hospital of China Academy of Chinese Medical Sciences, the Expert consensus on clinical application of Shujin Jianyao Pills was developed by 22 universities, scientific research institutes and hospitals. This consensus formed 1 recommendation and 9 consensus suggestions, which were based on evidence and oriented to clinical practice. The expert consensus had a new understanding of the indications of Shujin Jianyao Pills, especially the applicable Western medicine diseases, the advantages and characteristics of treatment, the time of intervention, the applicable syndromes, the precautions and contraindications of medication. The indications were detailed and expressed as the combination of disease, symptom and syndrome. And it filled in the gaps of package inserts in applicable syndrome and special population medication in the process of drug use. The expert consensus showed the optimization of precautions and contraindications, and more detailed description of drug safety. Therefore, it provides guidance and reference for clinicians to use Shujin Jianyao Pills rationally.
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China , Consensus , Drugs, Chinese Herbal , Medicine, Chinese TraditionalABSTRACT
To evaluate the economy and applicability of Jinye Baidu Granules in the treatment of acute upper respiratory tract infection, a randomized, double-blind, positive drug parallel control clinical trial was conducted in this study. Stratified block random, double-blind and double simulation test was used. The experimental group took Jinye Baidu Granules, 10 g/time, three times a day, and Compound Shuanghua Granules placebo, 6 g/time, four times a day. The control group took Compound Shuanghua Granules, 6 g/time, 4 times a day, and Jinye Baidu Granules placebo, 10 g/time, 3 times a day. The course of treatment was 5 days. The total cost of this study included direct medical cost and indirect medical cost. The incremental cost-effect analysis method was used for evaluation. Treeage Pro software was used to build a pharmaco-economics model and make statistical analysis. Patients from 10 hospitals were divided into experimental group(304 cases) and control group(302 cases). The baseline values of age, sex ratio, clinical symptoms and signs scores, and important physical examination indexes of the two groups were compared. After 5 days of treatment, the cost per capita of the experimental group was(388.06±94.17) Yuan, and that of the control group was(378.47±95.46) Yuan. The cost of direct medical treatment per capita was(271.24±54.11) Yuan for the experimental group and(264.88±112.71) Yuan for the control group. The average cost of indirect medical treatment was(116.82±82.75) Yuan in the experimental group and(113.59±87.77) Yuan in the control group, with no significant difference in the cost of medical treatment per capita, the cost of direct medical treatment per capita and the cost of indirect medical treatment per capita between both groups. The results of incremental cost-effect analysis based on the total score difference in symptoms and signs after 5 days of treatment showed that ICER=23.39 Yuan/score, which was less than the willingness to pay 100 Yuan/score determined through expert interviews. The experimental group had economic advantages over the experimental group, with the economic probability of 53%. Sensitivity analysis supported the robustness of the results. The results of incremental cost-effect analysis based on the total recovery rate of symptoms and signs showed that compared with the experimental group, the control group had lower cost, better effect and absolute economic advantage, with a corresponding probability of 55%. Based on the above results, it is concluded that there is no significant difference in economic outcome between Jinye Baidu Gra-nules and Compound Shuanghua Granules in the treatment of acute upper respiratory tract infection.
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Humans , Cost-Benefit Analysis , Double-Blind Method , Marketing , Respiratory Tract InfectionsABSTRACT
Calculus Bovis is the dry gall-stone of Bos taurus domesticus Gmelin, which is the most precious traditional Chinese medicine for its incomparable therapeutic effects. In vitro cultured Calculus Bovis,cultured Calculus Bovis and artificial Calculus Bovis are developed as the substitutes of Calculus Bovis. The Chinese Pharmacopoeia 2015 edition includes 89 Chinese patent drugs containing cow-bezoar and its substitutes. In this paper, the standards of Calculus Bovis and its substitutes in 89 Chinese patent drugs were reviewed to provide suggestions and reference for improving the relative standards. The qualities of Calculus Bovis and its substitutes of several Chinese patent drugs were summarized and analyzed based on the quality research of these drugs in recent years to offer suggestions for the revision of quality standards of relevant drugs and regulatory policy.
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Hugan Tablets is a Chinese patent medicine,it has the function of anti-inflammation and reducing transaminase. Based on questionnaire investigation of doctors and a systematic review of research literature on Hugan Tablets,using international clinical practice guidelines' developing methods,with the best available evidence and fully combining expert experience,and following the principle of " evidence-based,consensus-based and experience-based",Expert consensus statement on Hugan Tablets in clinical practice was developed by more than 30 multidisciplinary experts from the nationwide,aimed at guiding and standardizing the rational use of Hugan Tablets by clinicians and to improve clinical efficacy and safety. The expert consensus adopts internationally recognized recommendation criteria for classification of evidence: GRADE. The formation of expert consensus adopts the nominal group technique. Six main considerations are quality of evidence,curative effect,safety,economical efficiency,patient acceptability and other factors. If there is sufficient evidence,a " recommendation" is formed,using GRADE grid voting rule. If there isn' t sufficient evidence,a " consensus opinion" is formed,using majority counting rule. Focus on the indication,usage and dosage,drug use in special population and safety of Hugan Tablets,two recommendations and eight consensus opinions were put forward. Through expert meetings and correspondence,a nationwide consultation and peer review was conducted. This consensus applies to clinicians in hospitals and grass-roots health services,to provide guidance and reference for the rational use of Hugan Tablets.
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Humans , Consensus , Drugs, Chinese Herbal , Therapeutic Uses , Inflammation , Drug Therapy , Nonprescription Drugs , TabletsABSTRACT
OBJECTIVE@#To analyze the composition rules of oral prescriptions in the treatment of headache, stomachache and dysmenorrhea recorded in National Standard for Chinese Patent Drugs (NSCPD) enacted by Ministry of Public Health of China and then make comparison between them to better understand pain treatment in different regions of human body.@*METHODS@#Constructed NSCPD database had been constructed in 2014. Prescriptions treating the three pain-related diseases were searched and screened from the database. Then data mining method such as association rules analysis and complex system entropy method integrated in the data mining software Traditional Chinese Medicine Inheritance Support System (TCMISS) were applied to process the data.@*RESULTS@#Top 25 drugs with high frequency in the treatment of each disease were selected, and 51, 33 and 22 core combinations treating headache, stomachache and dysmenorrhea respectively were mined out as well.@*CONCLUSIONS@#The composition rules of the oral prescriptions for treating headache, stomachache and dysmenorrhea recorded in NSCPD has been summarized. Although there were similarities between them, formula varied according to different locations of pain. It can serve as an evidence and reference for clinical treatment and new drug development.
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It is of great importance to bring proprietary Chinese medicines to EU as its herbal medicinal product is world-leading, yet the current status for registrations from China is full of challenges. The routes for registration of herbal medicinal products are introduced at first and then the current registration status on the overall assessment of the products, the characteristics of combinations, the utilization of EU monograph and main indications are analyzed. Suggestions on registering proprietary Chinese medicines are made in the end.
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To analyze the prescription rules of preparations containing Crataegi Fructus in the drug standards of the People's Republic of China Ministry of Public Health-Chinese Patent Drug(hereinafter referred to as Chinese patent drug), and provide some references for clinical application and the research and development of new medicines. Based on TCMISS(V2.5), the prescriptions containing Crataegi Fructus in Chinese patent drug were collected to build the database; association rules, frequency statistics and other data mining methods were used to analyze the disease syndrome, common drug compatibility and prescription rules. There were a total of 308 prescriptions containing Crataegi Fructus, involving 499 kinds of Chinese medicines, 34 commonly used drug combinations, and mainly for 18 kinds of diseases. Drug combination analysis was done with "Crataegi Fructus-Citri Reticulatae Pericarpium" and "Crataegi Fructus-Poria" as the high-frequency herb pairs and with "stagnation" and "diarrhea" as the high-frequency diseases. The results indicated that the Crataegi Fructus in different herb pairs had a roughly same function, and its therapy effect was different in different diseases. The prescriptions containing Crataegi Fructus in Chinese patent drug had the effect of digestion, and they were widely used in clinical application, often used together with spleen-strengthening medicines to achieve different treatment effects; the prescription rules reflected the prescription characteristics of Crataegi Fructus for different diseases, providing a basis for its clinically scientific application and the research and development of new medicines.
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Objective To put forward suggestions for improving the writing standards of package inserts of Chinese patent drug in China. Methods Totally 84 package inserts of Chinese patent drug were chosen randomly. The labeled items in them would be investigated and analyzed according to legal documents in China. Results The rate of complete labeled items was 0%. Meanwhile, many problems existed in the items which affected medication safety seriously. In addition, there were defects in expression of the content, revision of package inserts of Chinese patent drug and so on. Conclusion It is urgent to improve the writing standards and the completeness of the labeled items as well as the scientificalness on the expressions of package inserts of Chinese patent drug.
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To analyze the problems in the essential medicine of Chinese materia medica (CMM) in China and make the corresponding suggestions to provide a reference for the improvement of our characterized essential medicine list of CMM. By reviewing literatures, we learnt from foreign experience and analyzed the current situation of the essential medicine of CMM, stated the five primary problems existing in the part of the national essential medicine list of CMM, and proposed the suggestions. The problems are as follows: selection of the list in CMM is more based on the expertise with subjective factors; The proportion of the list in Chinese patent drug (CPD) is not clear; The access to the essential medicines of CMM is poor; There are many security risks with the quality of CMM injections and the prominent phenomenon of irrational use in CMM. The suggestions are as follows: to strengthen the evidence-based decision-making, improve the scientificity of the evidence in selecting the essential medicine of CMM, definite the proportion of the CPD in the list as soon as possible, strengthen the equipment and use of essential medicines of CMM, strengthen the ADR's monitoring and reevaluation of CMM injections, strengthen the guidance and advocacy of CMM, and reduce irrational drug use as well.
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OBJECTIVE:To promote the rational use of Chinese patent drugs(CPD).METHODS:The efficacy of several groups of CPD which share the similar formulation were compared and the components in each formulation were further analyzed in detail.RESULTS:The origins and pathogenesis of diseases treated with different CPD of the similar formulation varied,so did their indications.CONCLUSION:Only by following the principle of"Syndrome Differentiation Treatment"can the efficacy of CPD be maximized.
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OBJECTIVE:To offer references for clinical rational use of Chinese patent drugs. METHODS:The basic theory of Chinese medicine was applied to analyze the current common problems encountered by western medicine physicians in the use of Chinese patent drugs. RESULTS & CONCLUSION:In the clinical use of Chinese patent drugs, the western medicine physicians should give consideration of the specific condition and get a detailed knowledge of drug constituents and the related clinical data as well as strictly follow the specification of drug package inserts.
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The physicochemical environment and action are similar between the traditional decoction and the extract technics with water or alcohol in the production of Chinese patent drug. Different heating time inevitably differs Chinese patent drug from its decoction; and the alteration of extracting dissolvent make great changes in the chemical constitution. All these lead to the change in the nature of a Chinese patent drug. The authors hold that it is difficult to embody exactly the aim of the prescription of Chinese drug in the existing production technology of Chinese patent drug. It is necessary to advance innovative thoughts of adopting modern technology to extract effective ingredients from single Chinese drug and in the reference of traditional decoction, recombining the composition and dosage of Chinese patent drug.
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OBJECTIVE: To analyze the uncertainty of determination of western medicine composition illegally added into Chinese patent drug and find out the effect factors of uncertainty in order to provide scientific basis for evaluating test report. METHODS: Antler tablets were tool as example. Qualitative analysis of additive composition was carried out using HPLC-MS method and the content of sildenafil citrate in each tablet was determined. Uncertainty of test was evaluated according to the regulation specified in Evaluation and Expression of Measurement of Uncertainty (JJF1059-1999). RESULTS: The uncertainty of the test is 0.10 mg in each tablet. CONCLUSION: The uncertainty of the experiment is mainly caused by non homogeneity of sample.