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1.
China Pharmacy ; (12): 129-135, 2022.
Article in Chinese | WPRIM | ID: wpr-913100

ABSTRACT

Chinese patent medicine is an important part of pharmaceutical products in China. In order to speed up the establishment of an effective evaluation index system for the variety selection and clinical application of Chinese patent medicine in line with the characteristics of traditional Chinese medicine ,so as to scientifically select drugs and carry out the clinical application evaluation of Chinese patent medicine in a standardized and reasonable manner ,Jiangsu Society of Traditional Chinese Medicine and Traditional Chinese Medicine Special Committee of Nanjing Pharmaceutical Society have organized the formulation of this expert consensus. Consensus experts have used literature research method ,brainstorming method ,analytic hierarchy process , Delphi method ,etc. to build an evaluation index system for the selection and clinical application of Chinese patent medicine , including 24 secondary indicators and 102 tertiary indicators ,from the seven dimensions of safety ,effectiveness,economy, innovation,suitability,accessibility and clinical application (primary indicators ). It is expected to provide decision-making basis for the variety selection and evaluation of Chinese patent medicine by the pharmaceutical management and pharmacotherapeutics committee(group)of medical institutions ,promote medical institutions at all levels to continuously optimize the medication catalogue and medication structure ,and accelerate the formation of the “1 + X ”(“1”for the essential medicine ,“X”for non-essential medicine ) medication model dominated by essential drugs ,promote medical institutions to use Chinese patent medicines scientifically ,reasonably and safely ,so as to improve the quality of pharmaceutical care ,control the irrational drug use and cost ,and better meet the drug use needs of the people.

2.
China Pharmacy ; (12): 1382-1385, 2021.
Article in Chinese | WPRIM | ID: wpr-877262

ABSTRACT

OBJECTIVE:To conduct the prescri ption comment of Chinese patent medicine based on self-developed rational drug use system and evaluate its effect ,and to promote rational use of Chinese patent medicine. METHODS :The self-developed rational drug use system was used to evaluate the complete prescriptions and classified special prescriptions of Chinese patent medicines in our hospital from Jan. to Jun. 2019(before implementation )and from Jan. to Jun. 2020(after implementation ); combined with pharmacists ’manual comments ,the situation of irrational drug use in the two periods was compared ,and the effect of prescription comment by rational drug use system was evaluated. RESULTS :Results of full prescription comment of Chinese patent medicine in our hospital showed that the unqualified rate of Chinese patent medicine prescriptions was 1.5%,which was significantly lower than 5.6% before the implementation (P<0.05). Results of special prescription comment of Chinese patent medicine showed that the unqualified rates of TCM injection ,toxic Chinese patent medicines and emergency Chinese patent medicines were 11.8%,10.7%,11.0% before implementation ;while after implementation ,they were 3.6%,4.2% and 6.6%, which were significantly lower than before implementation (P<0.05). CONCLUSIONS :Self-developed rational drug use system of Chinese patent medicine shows remarkable effect on full prescription comment and special comment ,which greatly improves the level of rational drug use of Chinese patent medicines in our hospital.

3.
China Pharmacy ; (12): 750-757, 2021.
Article in Chinese | WPRIM | ID: wpr-875659

ABSTRACT

OBJECTIVE:To systematically evaluate the therapeutic efficacy and safety of Chinese patent medicine compound preparation combined with conventional therapy for psoriasis vulgaris ,and to provide evidence-based reference for clinical drug use. METHODS :Retrieved from CNKI ,Wanfang database ,VIP,CBM,PubMed,the Cochrane Library and Web of Science , RCTs about Chinese patent medicine compound preparation combined with conventional therapy versus conventional therapy in the treatment of psoriasis vulgaris were collected during the inception to Feb. 2020. After literature retrieval and data extraction ,the quality of the included studies was evaluated with risk bias assessment tool recommended by the Cochrane evaluation manual handbook 5.1. Bayesian network Meta-analysis was perfor med by using Stata 15.0 software,Addis 1.16.6 software and Markov Chain Monte Carlo method. RESULTS :A total of 41 RCTs were included ,involving 4 122 patients. 5 kinds of interven- tion measures included Compound qingdai capsule ,Xiaoyin SF-010) granule, Keyin pill ,Yujin yinxie tablet and conventional therapy. Results of network Meta-analysis showed that in terms of improving the total effective rate , compared with conventional therapy ,4 kinds of Chinese patent medicine compound preparations combined with conventional therapy could significantly improve the total effective rate (P<0.05);the results of network Meta-analysis were as follows :Keyin pill combined with conventional therapy >Compound qingdai capsule combined with conventional therapy >Xiaoyin granule combined with conventional therapy >Yujin yinxie tablet combined with conventional therapy >conventional therapy. In terms of reducing psoriasis area and severity index (PASI)score after treatment ,compared with conventional therapy ,Keyin pill and Xiaoyin granule combined with conventional therapy could significantly reduce the PASI score (P<0.05),while Compound qingdai capsule and Yujin yinxie tablet combined with conventional treatment had no significant difference (P>0.05);the results of network Meta-analysis showed that Xiaoyin granule combined with conventional therapy >Keyin pill combined with conventional therapy > Compound qingdai capsule combined with conventional therapy >Yujin yinxie tablet combined with conventional therapy > conventional therapy. In terms of reducing serum inflammatory factor level ,compared with conventional therapy ,Compound qingdai capsule and Xiaoyin granule combined with conventional therapy could significantly reduce the level of IL- 17(P<0.05), but Keyin pill and Yujin yinxie tablet combined with conventional therapy had no significant difference (P>0.05);the results of network Meta-analysis showed that Xiaoyin granule combined with conventional therapy >Compound qingdai capsule combined with conventional therapy >Yujin yinxie tablet combined with conventional therapy >Keyin pill combined with conventional therapy>conventional therapy. In terms of safety ,there was no statistical significance in the incidence of ADR between 4 kinds of Chinese patent medicine combined with conventional therapy and conventional therapy (P>0.05);the results of network Meta-analysis showed that Compound qingdai capsule combined with conventional therapy >Xiaoyin granule combined with conventional therapy >Keyin pill combined with conventional therapy >conventional therapy >Yujin yinxie tablet combined with conventional therapy . CONCLUSIONS :Compared with conventional therapy ,additional use of 4 kinds of Chinese patent medicine compound preparations can improve the curative effect of psoriasis vulgaris patients with blood heat syndrome ,and Keyin pill is the best ;Xiaoyin granule is the best in reducing the degree of skin lesions and serum inflammatory factors ;additional use of 4 kinds of Chinese patent medicine compound preparations show good safety ,and Compound qingdai capsule is the best.

4.
Article in Chinese | WPRIM | ID: wpr-887970

ABSTRACT

The present study analyzed the current Chinese medicinal health products and Chinese patent medicines effective in boosting memory,aiming at providing references for the formulation and development of memory-boosting health products. The information on memory-boosting health products published by the Department of Special Food Safety Supervision and Management,the State Administration for Market Regulation( SAMR) was collected and the Chinese patent medicines on DRUGDATAEXPY were searched. Microsoft Excel and the TCMISS were used to statistically analyze the characteristics of formulations. A total of 212 memory-boosting health products were obtained from SAMR,including 83 ones containing Chinese medicinal materials. Twelve Chinese herbal medicines showed a usage frequency ≥ 8,with 151 times in use. In DRUGDATAEXPY,258 similar Chinese patent medicines were collected.Twelve Chinese herbal medicines showed a usage frequency ≥ 58,with 907 times in use. Through unsupervised hierarchical entropybased clustering of the above-mentioned Chinese medicinal health products and Chinese patent medicines separately,5 and 12 new formulas were obtained. The selection of Chinese herbal medicines for the new formulas was consistent with the principles of traditional Chinese medicine( TCM) theories,i. e.,tonifying kidney and marrow,benefiting Qi,nourishing Yin,resolving phlegm,and eliminating stasis. According to TCM theories,syndrome differentiation of the users was conducted,and the formulas were designed following the correspondence of syndromes with formulas and Chinese herbal medicines. This study is expected to provide new ideas and methods for the development of Chinese medicinal health products and accurately guide practical applications to exert the advantages of TCM in health care based on syndrome differentiation and improve the effect of Chinese medicinal health products.


Subject(s)
China , Drugs, Chinese Herbal , Humans , Medicine, Chinese Traditional , Nonprescription Drugs , Syndrome
5.
China Pharmacy ; (12): 1616-1622, 2021.
Article in Chinese | WPRIM | ID: wpr-881465

ABSTRACT

OBJECTIVE:To investigate and study the problems in the items labeling of Chinese patent medicine instructions in National Essential Medicines List ,and to provide reference for rational drug use and instruction revision. METHODS :Totally 268 Chinese patent medicines contained in the 2018 edition of National Essential Medicines List ,including 465 instructions of different . An dard docetaxel as first-line therapy in patients with meta - economic evaluation of docetaxel and paclitaxel regimens in metastatic breast cancer in the UK[J]. Pharmacoeco - dosage forms ,were collected ,and the labeling rate and content problems of drug instructions were counted. RESULTS :Of the 465 instructions,86.88% were labeled with cautions. The labeling rates of ADR ,pharmacokinetics,contraindications,drug interactions , clinical trials ,pharmacological toxicology and pharmacological action were low ,being 20.64%,0.21%,30.1%,1.07%,2.36%, 8.81%,1.93%. All other items were labeled. Incomplete description of ingredients ,incomplete information of decoction pieces and excipients accounted for 2.15% and 48.81%,respectively;the expression of functional indications was varied ,and there were 12 expression methods ,among which 16.5% of indications lacked TCM indications ;specifications were not uniform ,and there were 5 expression methods ;usage and dosage were not clearly marked ,and 465 instructions did not mention the usage and dosage for the elderly or pregnant and lactating women. Drug interactions ,ADR,matters needing attention and contraindications were not fully described with no substantive content ;only 0.64% marked interaction with chemical medicine and 12.68% marked contraindication content. CONCLUSIONS :There are some problems in the description of Chinese patent medicine instructions in 2018 edition of National Essential Medicine List ,such as non-standard and incomplete. It is suggested to strengthen efforts to establish and improve the information collection and feedback mechanism of Chinese patent medicine ,and introduce policies to support enterprises to carry out basic and clinical research after listing ;and through actively carrying out basic and clinical research in line with the characteristics of traditional Chinese medicine ,guided by the theory of traditional Chinese medicine ,combined with the latest research results ,so as to further improve the contents of Chinese patent medicine instructions.

6.
Article in Chinese | WPRIM | ID: wpr-879196

ABSTRACT

Chinese patent medicine prescriptions containing Jujubea Fructus in 2015 edition of Chinese Pharmacopoeia and the Composition Principles of Chinese Patent Drug were collected, and the characteristics of Chinese patent medicine containing Jujubea Fructus were analyzed by using data mining technology. Statistical software Excel 2019, Clementine 12.0 and SPSS 21.0 were used to conduct statistical analysis of conforming Chinese patent medicine prescriptions by means of frequency statistics, association rule analysis and cluster analysis. Finally, a total of 185 Chinese patent medicine prescriptions containing Jujubea Fructus were included in this study, involving 402 Chinese medicines and 28 kinds of high frequency Chinese medicines, with Jujubea Fructus, Poria, Zingiberis Rhizoma Recens, Glycyrrhizae Radix et Rhizoma, and Codonopsis Radix as the top five. The deficiency-nourishing drugs were in the most common efficacy classification, mainly sweet, bitter and pungent, with most medicine properties of warm and gentle, main meridians of spleen lung and stomach, dosage forms of pills, granules and tablets, and main indications of splenic diseases. Fifteen drug combinations were obtained in association rule analysis. Eleven drug combinations were obtained by association rule analysis of Chinese patent medicine containing Jujubea Fructus in the treatment of splenic diseases, and the drugs were divided into two categories by cluster analysis. According to the above analysis, it is found that the Chinese patent medicine prescriptions containing Jujubea Fructus are mainly composed of deficiency-nourishing drugs, mostly compatible with drugs of sweet, bitter and pungent flavors, warm and gentle properties, and spleen, lung, and stomach meridians in the treatment of splenic diseases, with Sijunzi Decoction as the main drug. This study provides guidance for modern clinical application and development of Jujubea Fructus.


Subject(s)
China , Data Mining , Drugs, Chinese Herbal , Medicine, Chinese Traditional , Nonprescription Drugs
7.
Article in Chinese | WPRIM | ID: wpr-879195

ABSTRACT

Network Meta-analysis was used to evaluate the efficacy and safety of different oral Chinese patent medicines combined with transcatheter arterial chemoembolization(TACE) in the treatment of primary liver cancer. Randomized controlled trials of oral Chinese patent medicines for primary liver cancer were retrieved from CNKI, Wanfang, VIP, SinoMed, PubMed, Cochrane Library and EMbase databases from inception to May 2020. According to the Cochrane recommendation standard, the quality of the included articles was evaluated, and the data were analyzed by RevMan, R software and GeMTC software. A total of 10 kinds of oral Chinese patent medicines and 68 RCTs were included. Network Meta-analysis results showed that: as compared with TACE alone, 10 kinds of oral Chinese patent medicines combined with TACE showed advantages in effective rate, 1-year survival rate, 2-year survival rate, KPS score improvement rate and reduced adverse reaction incidence. In the pairwise comparison of oral Chinese patent medicines, the results showed that Cidan Capsules were superior to Jinlong Capsules and Xihuang Pills in 1-year survival rate. According to the probabi-lity ranking results: Shenyi Capsules and Ganfule were more obvious in improving the effective rate; Cidan Capsules and Shenyi Capsules were more effective in improving the 1-year survival rate; Pingxiao Capsules and Shenyi Capsules had better efficacy in improving 2-year survival rate; Huaier Granules and Shenyi Capsules had better efficacy in improving the quality of life; Huisheng Oral Liquid and Ganfule were more effective in reducing the incidence of adverse reactions(such as nausea, vomiting and leukocytosis). The current evidence showed that oral Chinese patent medicine combined with TACE was superior to TACE alone in efficacy and safety. In terms of the effective rate, 1-year survival rate, 2-year survival rate, KPS score improvement rate and reduced adverse reaction incidence, the optimal treatment measures were Shenyi Capsules, Cidan Capsules, Pingxiao Capsules, Huaier Granules and Huisheng Oral Liquid in turn. However, due to the limitations of the research, the current level of evidence is not high, and clear conclusions and evi-dence strength still need to be further verified and improved by high-quality researches.


Subject(s)
Carcinoma, Hepatocellular/drug therapy , Chemoembolization, Therapeutic , China , Drugs, Chinese Herbal , Humans , Liver Neoplasms/drug therapy , Network Meta-Analysis , Nonprescription Drugs , Quality of Life
8.
Article in Chinese | WPRIM | ID: wpr-879119

ABSTRACT

Classical Chinese patent medicines(CPMs) are a kind of modern preparation developed from the experience of compatibility and application about ancient prescriptions. Its rich history of human use and reliable clinical efficacy imply the unique theoretical essence and precious value of traditional Chinese medicine(TCM). With the development of evidence-based medicine and the improvement of medical policy, it is particularly urgent to evaluate the clinical values of post-marketing classical CPMs. In this paper, some problems on the clinical value evaluation of CPMs would be described, and it is considered that the simplified evaluation procedures can lead to the lack of evidence for evaluating clinical value of CPMs, causing the difficulty in evaluating the quality of CPM, lack of R&D motivation of enterprises, low content of science and technology, and poor international development. Based on this background, it points out that the clinical value evaluation is the core of the post-marketing evaluation of the classical CPMs, and the eva-luation should be based on the direction of literature research and the latest practice. We should adhere to the research mode of combination disease with syndrome, and select the appropriate type of trials, with clinical efficacy, health economic benefits and safety eva-luation as the main content of the studies, in order to refine the indications and standardize the clinical positioning. Clinical value eva-luation is the basis and main content of post-marketing comprehensive researches on classic and famous CPMs to clarify their clinical value, obtain the conditions for continued marketingand standardize their clinical application, so as to optimize the evidence and quality service of classic and famous CPMs and inherit the core value concept of Chinese medicine.


Subject(s)
China , Drugs, Chinese Herbal , Humans , Marketing , Medicine, Chinese Traditional , Nonprescription Drugs
9.
Article in Chinese | WPRIM | ID: wpr-879118

ABSTRACT

Traditional Chinese medicine(TCM) is an important feature of cancer treatment in China. The methods to tap the advantages of TCM, reasonably evaluate and accurately apply Chinese patent medicines have become current research hotspots and difficulties. TCM takes syndrome differentiation and treatment as the core, with the characteristics of overall regulation and multi-targets efficacy. Therefore, the post-marketing survival benefit evaluation of Chinese patent medicines for cancer is different from that in modern medicine. The primary treatment goals in cancer patients include to improve the disease control rate and prolong their survival time. At present, Chinese patent medicines for cancer patients are lacking indepth studies on survival benefit at the post-marketing stage. In addition, the characteristics of individualized treatment with TCM have also increased the complexity of clinical research on TCM. Therefore, it is of certain practical significance and necessity to evaluate the survival benefit of Chinese patent medicines for cancer after marketing. Based on this, in this paper, we first summarized the technical methodological means of survival benefit evaluation at this stage, and then explored the post-marketing survival benefit evaluation of Chinese patent medicines for cancer from three aspects: the evaluation of cancer treatment effect based on survival time and quality of life, treatment-related toxicity and the auxiliary effect of TCM, and the improvement effect for tumor-related symptoms. Based on the practices of early clinical researches, and according to the insufficient efficacy evaluation of current clinical research on Chinese patent medicines, this paper proposed to improve the evaluation system for clinical researches on Chinese patent medicines, establish the evaluation method with TCM characteristics, clarify the dominant population, lay a theoretical foundation for the evaluation of post-marketing survival benefits of Chinese patent medicines for cancer in the future, and promote the modernization process of TCM.


Subject(s)
China , Drugs, Chinese Herbal/therapeutic use , Humans , Marketing , Medicine, Chinese Traditional , Neoplasms/drug therapy , Nonprescription Drugs/therapeutic use , Quality of Life
10.
Article in Chinese | WPRIM | ID: wpr-879117

ABSTRACT

At present, the value evaluation of Chinese patent medicines is in the exploratory stage, and a clinical value evaluation system that can reflect the characteristics of traditional Chinese medicine has not been established. This article investigates four universal drug value tools from abroad, namely, evidence rating matrix, cancer value label, patient-perspective value framework and multiple criteria decision analysis advance value framework. The evidence rating matrix is used to measure the benefits and risks of different treatment measures, and the net health benefit is used as the best estimate point to evaluate the value of treatment; the cancer value label is mainly used to weigh the economic value and innovative value of drug treatment programs of different anti-tumor drugs by matrix composed the ratio between the expected result and the cost; the patient-perspective value framework emphasizes the evaluation of the value of different healthcare intervention methods from the patient's perspective; multiple criteria decision analysis advance value framework measures the value of drugs or measures from multiple dimensions. Combined with the characteristics of the above universal drug value evaluation tools and the correlation research of domestic drug value evaluation, the paper proposes to analyze the characteristics of Chinese patent medicine value evaluation from the six dimensions of effectiveness, safety, innovation, economy, suitability and accessibility of Chinese patent medicine, and expounds the strategy of constructing Chinese patent medicine value evaluation tool, so as to provide reference for the drug value evaluation and decision-making application of Chinese patent medicine.


Subject(s)
China , Drugs, Chinese Herbal , Humans , Medicine, Chinese Traditional , Nonprescription Drugs
11.
Article in Chinese | WPRIM | ID: wpr-879031

ABSTRACT

It is the core of the development for Chinese patent medicine enterprises to cultivate large varieties of Chinese patent medicine, and the selection of potential "seed" products is the prerequisite for the cultivation strategy. By constructing the evaluation model from multiple dimensions of value and risk, we can conduct specialized evaluation of Chinese patent medicines to effectively, professionally and objectively select the "seed" products with large variety cultivation potential. In this paper, the establishment of a multidimensional evaluation system would be discussed from the aspects of drug naming and prescription composition, safety risk and supply guarantee of raw materials and medicinal materials, competition situation, access to policy catalogue, scientific and technological support, clinical evidence and recognition, systematical and standardized collection of information on product instructions, quality standards, policy catalogue, scientific and technological literature, market competition and clinical application of Chinese patent medicines. Through the objective evaluation index and the range of objective index, the multi-dimensional evaluation model on values and risks of Chinese patent medicine products was discussed. Based on this model, a batch of Chinese patent medicine products can be quickly and comprehensively analyzed, and quantitative comparison can be formed among different types and fields of products. According to the evaluation results of the model and the comprehensive evaluation of experts, high-quality "seed" products can be selec-ted, laying a solid foundation for the next step of large variety cultivation. With use of this model, we can further clarify the external competitive advantages and internal priority levels of each product, and provide support for enterprises to optimize product structure and improve product strategic layout.


Subject(s)
China , Drugs, Chinese Herbal/adverse effects , Medicine, Chinese Traditional , Nonprescription Drugs/adverse effects , Quality Control
12.
Article in Chinese | WPRIM | ID: wpr-879004

ABSTRACT

Rhei Radix et Rhizoma is a kind of commonly used Chinese medicinal materials. Due to the overharvesting, the wild resource is endangering. Large market demand caused severely adulterant of commercial Rhei Radix et Rhizoma medicinal materials and decoction pieces. This manuscript reviewed the advances of the original species authentication in the industrial chain of Rhei Radix et Rhizoma during the latest decade, including characteristics and microscopic features, phytochemical analysis on anthraquinones, and molecular authentication based on DNA barcoding. Accordingly, an original species authentication route for the industrial chain of Rhei Radix et Rhizoma was summarized:(1)the identification of seeds and seedlings by DNA barcoding;(2) the selection of high variable sites based on the chloroplast genome;(3)biomonitoring of the Rhei Radix et Rhizoma medicinal materials and decoction pieces by two-dimensional DNA barcode;(4)traceability of Chinese patent medicines by third-generation sequencing. In conclusion, the combination of molecular identification and traditional identification methods provides a new idea for the identification of the original species of Rhei Radix et Rhizoma in the industrial chain and a essential guidance for the research of drug safety and efficacy of Rhei Radix et Rhizoma.


Subject(s)
Animals , Anthraquinones , Drugs, Chinese Herbal , Plant Roots , Rheum , Rhizome
13.
Article in Chinese | WPRIM | ID: wpr-878978

ABSTRACT

Single herbs and Chinese patent medicine preparations often have bad taste, such as bitterness and astringency, which is one of the key factors affecting patients' medication compliance, and would affect the therapeutic effect and restrict the extensive application in clinical practice. Therefore, how to make use of taste masking techniques to improve the bad taste of traditional Chinese medicines has become an important project. Through the collection and summarization of Chinese and foreign journals and papers in recent years, this paper discussed the generation mechanism of bitter taste, the new methods of masking bitter taste and the evaluation me-thods of bitter taste, in order to provide references for the taste masking of Chinese patent medicines preparations.


Subject(s)
Astringents , China , Humans , Medicine, Chinese Traditional , Nonprescription Drugs/pharmacology , Taste
14.
Article in Chinese | WPRIM | ID: wpr-878964

ABSTRACT

To evaluate the efficacy and safety of Chinese patent medicine in the treatment of knee osteoarthritis(KOA) with network Meta-analysis, and provide evidence-based medicine evidences for clinical practice. PubMed, Cochrane Library, EMbase, CNKI, Wanfang, VIP and CBM were used to search for clinical randomized controlled trials(RCTs) on Chinese patent medicines for treatment of knee osteoarthritis, with a time limit from the establishment of each database to March 2020. The bias risk assessment tool recommended by Cochrane was used to evaluate the quality of the included RCTs. The network Meta-analysis was performed by Stata 14.0 software. A total of 5 788 patients in 58 RCTs were included, involving 9 kinds of Chinese patent medicines. The results of the network Meta-analysis indicated that in terms of total effective rate, the top three optimal medication regimens were Jinwu Gutong Capsules + Amino Acid Glucose(AAG), Xianling Gubao + AAG and Biqi Capsules; the top three interventions to reduce the VAS score were Panlongqi Tablets > Xianling Gubao + AAG > Xianling Gubao + non steroidal anti-inflammatory drugs(NSAIDs); the top three interventions to reduce the total score of WOMAC were Jintiange Capsules+NSAIDs> Jinwu Gutong Capsules + AAG > Biqi Capsules + NSAIDs; the top three medication schemes with better curative effect to reduce Lequesnse index were Xianling Gubao + NSAIDs > Biqi Capsules + NSAIDs > Jintiange Capsules + NSAIDs; the top three interventions to reduce TNF-α level Xianling Gubao + AAG > Jintiange Capsules > Jintiange Capsules + AAG=Jinwu Gutong Capsules + AAG. In terms of safety, the top five interventions with the least adverse reactions were Biqi Capsules > Jinwu Gutong Capsules > Biqi Capsules + NSAIDs > Xianling Gubao + NSAIDs > Jintiange Capsules. The combined application of Chinese patent medicine and NSADIs or AAG can improve the clinical treatment effect and reduce adverse reactions in KOA patients.


Subject(s)
Biological Products , China , Drugs, Chinese Herbal , Humans , Network Meta-Analysis , Nonprescription Drugs , Osteoarthritis, Knee/drug therapy
15.
Article in Chinese | WPRIM | ID: wpr-878897

ABSTRACT

Network Meta-analysis was used to compare the efficacy and safety of Chinese patent medicines in the treatment of unstable angina pectoris. PubMed, Cochrane Library, CNKI, Wanfang, VIP and other databases were retrieved by computers from the establishment of the databases to June 2020. Randomized controlled trials(RCTs) of Chinese patent medicines for the treatment of unstable angina pectoris were collected. Two investigators independently screened out the literatures, and extracted data according to the inclusion and exclusion criteria. The quality of the included RCTs was evaluated according to the bias risk assessment tool recommended by the Cochrane System Reviewer Manual, and the Stata 13.0 software was used for data analysis and mapping. Through screening, 28 eligible studies were finally included, with the sample size of 2 885 cases, involving 8 Chinese patent medicines. The results of the network Meta-analysis showed that in terms of total effective rate for angina symptom improvement, the order was as follows: Shenshao Capsules > Naoxintong Capsules > Ginkgo Ketone Ester Dripping Pills > Compound Danshen Dripping Pills > Ginkgo Leaf Tablets > Shexiang Baoxin Pills > Tongxinluo Capsules > Yindan Xinnaotong Soft Capsules; in terms of total effective rate for ECG curative effect, the order was as follows: Ginkgo Ketone Ester Dripping Pills>Compound Danshen Dripping Pills > Tongxinluo Capsules > Shenshao Capsules > Shexiang Baoxin Pills > Yindan Xinnaotong Soft Capsules; in terms of hypersensitivity-C-reactive protein curative effect, the order was as follows: Tongxinluo Capsules > Shenshao Capsules > Ginkgo Leaf Tablets>Compound Danshen Dropping Pills> Shexiang Baoxin Pills > Naoxintong Capsules > Yindan Xinnaotong Soft Capsules > Ginkgo Ketone Ester Dropping Pills. Chinese patent medicine combined with conventional therapy can improve the clinical efficacy of unstable angina pectoris. Due to the differences in the quantity and quality of the included studies, the order results of Chinese patent medicines need to be further verified.


Subject(s)
Angina, Unstable/drug therapy , China , Drugs, Chinese Herbal , Humans , Medicine, East Asian Traditional , Network Meta-Analysis , Nonprescription Drugs
16.
Article in Chinese | WPRIM | ID: wpr-888158

ABSTRACT

In order to solve the problems of confusion in clinical medication and imperfect instructions in Chinese patent medicines(CPMs), the Standardization Department of the China Association of Chinese Medicine and Center for Pharmacovigilance and Rational use of Chinese Medicine in Beijing University of Chinese Medicine jointly compiled the Instructions for Clinical Application of Chinese Patent Medicines(CPMs). As the interpretation and supplement of drug instruction information, it aims to guide clinical safety and rational use of CPMs. In addition, the technical specification for clinical application description of CPMs has been formulated, which covers the seven processes of "carding instructions, clinical investigation, data retrieval, data screening, evidence classification, path transformation and writing format". It will enable readers of Instructions for Clinical Application of Chinese Patent Medicines to understand the work behind the compilation.


Subject(s)
Beijing , China , Drugs, Chinese Herbal , Medicine, Chinese Traditional , Nonprescription Drugs , Pharmacovigilance
17.
Article in Chinese | WPRIM | ID: wpr-888156

ABSTRACT

To systematically evaluate the efficacy of oral Chinese patent medicines of Ziziphi Spinosae Semen in the treatment of primary insomnia by using network Meta-analysis. Nine databases(CNKI, Wanfang, VIP, CBM, PubMed, EMbase, Web of Science, Medline and Cochrane Library) were systematically and comprehensively undertaken to identify the literatures published from the establishment of each database to August, 2020. Randomized controlled trials(RCTs) on oral Chinese patent medicine of Ziziphi Spinosae Semen in the treatment of primary insomnia, either alone or in combination with conventional sedative hypnotics, were screened out according to inclusion criteria and exclusion criteria. Literature screening, data extraction and the evaluation of the risk of bias for the included studies were conducted independently by 2 researchers. Traditional Meta-analysis and Bayesian network Meta-analysis were then conducted with use of Stata 15.0 and R software. Finally, a total of 42 RCTs were included, involving 9 kinds of oral Chinese patent medicines and 4 196 patients. The results of Meta-analysis showed that(1) in terms of improving Pittsburgh sleep quality index scale score, the efficacy of the combination of drugs was significantly superior to that of sedative-hypnotics or most of Chinese patent medicines used alone, and Bailemian Capsules combined with sedative-hypnotics had the best effect; both the efficacy of Shenqi Wuweizi Tablets and Compound Zaoren Anshen Capsules alone were significantly superior to that of conventional sedative-hypnotics treatment, and Shenqi Wuweizi Tablets had the best effect.(2)In terms of safety, single use or combined use of Chinese patent medicine had a certain improvement as compared with conventional sedative-hypnotics treatment. Due to the large clinical heterogeneity, the studies could not be combined quantitatively, and no serious adverse reactions occurred in all patients enrolled in the study. The results showed that Chinese patent medicine of Ziziphi Spinosae Semen combined with conventional sedative-hypnotics could significantly improve the short-term sleep quality of patients with primary insomnia. In the comparison among single use of drugs, Shenqi Wuweizi Tablets had the largest possibility for best effect. However, the lack of evidences for international promotion, the influence of different types of sedative-hypnotics treatment and intervention time on the curative effect, and the patients' different acceptance of combined treatment should be considered before clinical application. Limited by the number and quality of the included studies, the above conclusions need to be further verified by more large sample-size and high-quality studies.


Subject(s)
Bayes Theorem , China , Drugs, Chinese Herbal/therapeutic use , Humans , Network Meta-Analysis , Nonprescription Drugs , Semen , Sleep Initiation and Maintenance Disorders/drug therapy
18.
Article in Chinese | WPRIM | ID: wpr-888091

ABSTRACT

The formulation of expert consensus on clinical application of Chinese patent medicines, in means of exploring the effective combination of experience and evidence to form a research method in line with the characteristics of Chinese patent medicines, is an important transitional stage for clinical researches on Chinese patent medicines. Pre-searching is a new step in the formulation of expert consensus on clinical application of Chinese patent medicines. Before steps of interview and investigation on clinical application, pre-searching is conducted to collect publications and literature on certain variety and similar Chinese patent medicines; the publications on related medical classics and formulas of this variety; the recommendation condition of this variety in clinical practice guidelines and expert consensus; and the medication regimens recommended in disease-specific guidelines. Pre-searching is designed to know about the advantages of certain variety of Chinese patent medicine as well as its potential problems recorded in the literature, which is helpful to find out the clinical positioning of Chinese patent medicines, develop reasonable clinical questions and provide ideas for formal literature searching. However, it is not the direct basis for developing clinical questions. Moreover, interviews and investigations are still needed to further clarify the clinical positioning of Chinese patent medicines and develop reasonable questions. This paper took expert consensus on clinical application of Yanshen Jianwei Capsules as an example to introduce the pre-searching process and methods used during formulation of expert consensus on clinical application of Chinese patent medicines, and to further discuss the role of pre-searching to facilitate the formulation of clinical questions on selection of participants, interventions, controls and outcomes.


Subject(s)
Capsules , China , Consensus , Drugs, Chinese Herbal , Humans , Medicine, Chinese Traditional , Nonprescription Drugs
19.
Article in Chinese | WPRIM | ID: wpr-888037

ABSTRACT

The effect of oral or nasal feeding with Chinese patent medicine on hypertensive intracerebral hemorrhage was systematically evaluated by using the method of network Meta-analysis. Four Chinese databases(CNKI, VIP, Wanfang, CBM), three English databases(Medline, EMbase, Cochrane Library) and ClinicalTrials.gov were retrieved through computers. According to the inclusion criteria and exclusion criteria, randomized controlled trials(RCTs) of Chinese patent medicine combined with Western medicine in the treatment of hypertensive intracerebral hemorrhage were screened out according to the inclusion criteria and exclusion criteria. The Cochrane bias risk assessment tool was used to evaluate the quality of the included studies, and Stata 16.0 software was used to analyze the outcome indicators. A total of 3 888 literatures were retrieved, and 30 studies involving 6 kinds of Chinese patent medicines were finally included. The total sample size was 2 758 cases, including 1 401 cases in the treatment group and 1 357 cases in the control group. According to the results of network Meta-analysis,(1)in terms of improving the degree of nerve function defect, the order of Chinese patent medicines was conventional Western medicine combined with Xiaoyukang Capsules>combined with Tongxinluo Capsules>combined with Naoxuekang Oral Liquid>combined with Naoxueshu Oral Liquid>combined with Angong Niuhuang Pills>conventional Western medicine;(2)in terms of reducing the amount of residual cerebral hematoma, the order of Chinese patent medicines was conventional Western medicine combined with Naoxueshu Oral Liquid>combined Xiaoyukang Capsules>combined Naoxuekang Oral Liquid>conventional Western medicine;(3)in terms of improving ability of daily living, the order of Chinese patent medicines was conventional Western medicine combined with Shenzhi Huoxue Capsules>combined with Angong Niuhuang Pills>combined with Naoxueshu Oral Liquid>conventional Western medicine;(4)in terms of improving total effective rate, the order of Chinese patent medicines was conventional Western medicine combined with Naoxueshu Oral Liquid>combined with Xiaoyukang Capsules>combined with Angong Niuhuang Pills=combined with Naoxuekang Oral Liquid>combined Tongxinluo Capsules>conventional Western medicine treatment. The results showed that in addition to conventional Western medicine therapy, the combined use with Chinese patent medicine can improve the clinical efficacy in the treatment of hypertensive intracerebral hemorrhage. However, due to the differences in the number and quality of various Chinese patent medicines included in the studies, and the lack of direct comparison of Chinese patent medicines, the ranking results still need to be verified by multi center, large-sample-size randomized double-blind trials in the future, so as to provide more reliable evidence support for clinical drug use.


Subject(s)
China , Humans , Intracranial Hemorrhage, Hypertensive , Medicine, East Asian Traditional , Network Meta-Analysis , Nonprescription Drugs , Randomized Controlled Trials as Topic
20.
Article in Chinese | WPRIM | ID: wpr-906499

ABSTRACT

In this paper, a comparative analysis is carried out on the policy of listed drugs in Australia, the policy of over-the-counter drugs in Japan, the policy related to the conversion of Chinese patent medicines to over-the-counter drugs, and the policy related to health food. The focus is on one of the possible situations for the registration of over-the-counter traditional Chinese medicines (TCMs), namely new prescription-composed over-the-counter TCMs. This paper discussed separately from the three parts of the scope of Chinese medicinal materials in the prescription medicines, the scope of indications, and the technical requirements, in order to provide references for the technical requirements related to the registration of over-the-counter TCMs. Recommendations on the marketing and registration of new prescription-composed over-the-counter TCMs:①It is recommended to formulate a list of medicinal materials for the use of Chinese herbal medicines, and consider including raw materials of health food. On this basis, a batch of safe Chinese medicinal materials/decoction pieces was added. And consider dynamic supervision, such as allowing the addition or recall of Chinese medicinal materials/decoction pieces in the list of medicinal materials. ②The scope of indications is recommended to consider the scope of indications for the conversion of Chinese patent medicines to over-the-counter TCMs in China, and the selection of medium-risk indications can reflect the characteristics and advantages of TCM treatment. ③Efficacy evaluation needs to provide high-quality scientific evidence, including clinical research data, and consider relaxing the requirements for non-clinical pharmacodynamic trials.

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