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.
Humans ; Medicine, Chinese Traditional ; Reference Standards ; Nonprescription Drugs ; Drugs, Essential ; Osteoarthritis/drug therapy* ; Drugs, Chinese Herbal/adverse effects*

This study took the 2020 edition of Chinese Pharmacopoeia(ChP) and the 2018 edition of National Essential Drug List(NEDL) for children as research carriers to systematically analyze the current situation of and problems in the use of Chinese patent medicine for children(CPMC) in China. In view of the problems of imprecise dosage, incomplete safety information, and lack of sui-table varieties, dosage form and specification of CPMC in China, development strategy of CPMC in the future was proposed. It is reco-mmended to carry out systematic post-marketing revaluation studies of CPMC, encourage the development of new varieties or new dosa-ge forms suitable for children, advocate the continuous promotion of real-world studies on children, and expand the information on the use of CPMC with real-world data, so as to lay the foundation for post-marketing revaluation of CPMC and guide the rational use of clini-cal medicines. This study was expected to build a positive policy ecosystem to ensure the supply of CPMC, and promote the high-quality development of CPMC.
Child ; Humans ; Nonprescription Drugs ; Medicine, Chinese Traditional ; Ecosystem ; Drugs, Essential ; China ; Drugs, Chinese Herbal

In this study, the evidence mapping was employed to systematically analyze the clinical research literature and learn the distribution of evidence on the prevention and treatment of essential hypertension with Chinese patent medicines in recent six years. CNKI, Wanfang, VIP, SinoMed, PubMed, and Cochrane Library were searched for the relevant literature published from January 2016 to December 2021. The distribution characteristics of evidence were analyzed and presented in charts combined with words. A total of 263 studies were selected, including 238 intervention studies, 17 systematic reviews/Meta-analysis, and 8 observation studies. A total of 72 Chinese patent medicines were involved, among which Songling Xuemaikang Capsules had the highest frequency. In China, the attention to the treatment of essential hypertension with Chinese patent medicines was insufficient, as manifested by the declining number of published literature and the low quality of studies. There were cases of off-label use and medication without syndrome differentiation in clinical practice. Some outcome indicators failed to embody the characteristics of traditional Chinese medicine and there were cases ignoring the end-point outcome indicators. The overall quality of systematic reviews/Meta-analysis was low, and a variety of studies failed to draw valid conclusions. In the future, it is necessary to standardize the clinical medication and improve the quality of randomized controlled trial(RCT), so as to produce high-quality evidence-based medical evidence and provide strong support for the efficacy and safety of Chinese patent medicines in the prevention and treatment of essential hypertension.
Humans ; Asian People ; Drugs, Chinese Herbal/therapeutic use* ; Essential Hypertension/drug therapy* ; Medicine, Chinese Traditional ; Nonprescription Drugs/therapeutic use* ; Systematic Reviews as Topic ; Meta-Analysis as Topic

To evaluate the efficacy and safety of Songling Xuemaikang Capsules combined with conventional Western medicine in the treatment of essential hypertension. PubMed, VIP, CNKI, Wanfang and other databases were retrieved from the establishment of the database to February 2020 for clinical randomized controlled trial(RCT) about Songling Xuemaikang Capsules combined with conventional Western medicine in the treatment of essential hypertension. The literatures were screened out according to the inclusion criteria, and RevMan 5.3 software was used for Meta-analysis. A total of 3 100 patients in 27 RCTs were enrolled. According to Meta-analysis, Songling Xuemaikang Capsules combined with conventional Western medicine could effectively reduce systolic blood pressure(MD=-7.88,95%CI[-9.68,-6.08],P<0.000 01) and diastolic blood pressure(MD=-7.85, 95%CI[-9.07,-6.62], P<0.000 01), triglyceride(MD=-0.46, 95%CI[-0.66,-0.26], P<0.000 01) and total cholesterol(MD=-0.92, 95%CI[-1.49,-0.35], P=0.001), but increase HDL cholesterol(MD=0.51, 95%CI[0.28, 0.73], P<0.000 01), with a better effect than the Western medicine group alone. The results of LDL-C analysis showed that there was no significant difference between the two groups(MD=-0.91, 95%CI[-1.82, 0.01], P=0.05). The subgroup analysis suggested that reduced systolic blood pressure may be related to the use of ARB. There was a close correlation between CCB drugs and the decrease of diastolic blood pressure. In addition, there was no significant difference in the compliance and the incidence of adverse reactions. Clinical application of Songling Xuemaikang Capsules combined with Western medicine in the treatment of patients with essential hypertension has clear efficacy and certain safety. More clinical randomized controlled trials are needed for verification in the future.
Angiotensin Receptor Antagonists ; Angiotensin-Converting Enzyme Inhibitors ; Capsules ; Drugs, Chinese Herbal ; Essential Hypertension/drug therapy* ; Humans

To systematically evaluate the efficacy and safety of Tianma Gouteng Granules combined with conventional anti-hypertensive drugs in the treatment of essential hypertension. The clinical randomized controlled trials(RCTs) on the treatment of essential hypertension with Tianma Gouteng Granules combined with conventional anti-hypertensive drugs were searched in PubMed, EMbase, Cochrane Library, VIP, CNKI, Wanfang, SinoMed since the establishment of the databases to April 2020 based on inclusion and exclusion criteria, and Meta-analysis was conducted by using RevMan 5.3 software. A total of 15 RCTs were included, involving a total of 1 508 patients. Meta-analysis results showed that Tianma Gouteng Granules combined with conventional Western medicine were supe-rior to the control group in reducing systolic blood pressure(MD=-10.24, 95%CI[-13.54,-6.95], P<0.000 01), diastolic blood pressure(MD=-5.33, 95%CI[-7.21,-3.45], P<0.000 01), improving the clinical efficacy of patients(RR=1.22, 95%CI[1.15, 1.28], P<0.000 01) and curative effect of traditional Chinese medicine syndrome(RR=1.26, 95%CI[1.02, 1.57], P=0.04), increasing nitric oxide content(MD=9.59, 95%CI[7.23, 11.96], P<0.000 01), reducing endothelin-1(MD=-10.74, 95%CI[-15.74,-5.75], P<0.000 1), tumor necrosis factor(MD=-0.28, 95%CI[-0.36,-0.19], P<0.000 01), and interleukin-6(MD=-39.71, 95%CI[-43.40,-36.03], P<0.000 01). There was no statistically significant difference between the test group and the control group in the incidence of adverse reactions. No liver and kidney dysfunction occurred. The results of the subgroup analysis showed that the effect of Tianma Gouteng Granules combined with ARB drugs was more obvious in reducing the systolic and diastolic pressure. Trial sequential analysis showed that the studies accumulatively included for clinical efficacy crossed the traditional threshold and the TSA threshold, further affirming its clinical efficacy. The clinical application of Tianma Gouteng Granules combined with conventional Western medicine in the treatment of primary hypertension and accompanying symptoms has clear efficacy and certain safety, so it is recommended for clinical application.
Angiotensin Receptor Antagonists ; Angiotensin-Converting Enzyme Inhibitors ; Antihypertensive Agents/therapeutic use* ; Drugs, Chinese Herbal ; Essential Hypertension/drug therapy* ; Humans

To systematically evaluate the efficacy and safety of Yangxue Qingnao Granules combined with conventional Western medicine in the treatment of essential hypertension and its accompanying symptoms. PubMed, EMbase, Cochrane Library, VIP, CNKI, Wanfang, and China biomedical database(CBD) were searched to screen out from the establishment of the database to April 2020 about the clinical randomized controlled trials of Yangxue Qingnao Granules combined with conventional Western medicine in the treatment of essential hypertension and accompanying symptoms. The articles were selected according to the inclusion and exclusion criteria. RevMan 5.3 software was used for Meta-analysis. TSA 0.9.5.10 Beta software was used for sequential analysis, and GRADE 3.6 was used for evidence quality evaluation. A total of 4 532 patients were included in 34 randomized controlled trials. Meta-analysis results showed that: Yangxue Qingnao Granules combined with conventional anti-hypertensive agents reduced systolic blood pressure(MD=-10.56, 95%CI[-13.63,-7.50], P<0.000 01) and diastolic blood pressure(MD=-8.21, 95%CI[-10.84,-5.59], P<0.000 01), improved total effective rate(RR=1.21, 95%CI[1.14, 1.29], P<0.000 01), improved patients dizziness(RR=1.29, 95%CI[1.21, 1.37], P<0.000 01), insomnia(RR=1.66, 95%CI[1.44, 1.91], P<0.000 01), headache(RR=1.32, 95%CI[1.21, 1.43], P<0.000 01), chest distress(RR=1.26, 95%CI[1.12, 1.42], P=0.000 1), memory loss(RR=1.24, 95%CI[1.10, 1.40], P=0.000 4), palpitation(RR=1.28, 95%CI[1.17, 1.41], P<0.000 01), and improved traditional Chinese medicine symptom scores(MD=-4.24, 95%CI[-5.25,-3.23], P<0.000 01) and headache symptom improvement scores(MD=-2.02, 95%CI[-2.51,-1.53], P<0.000 01) as compared with Western medicine group alone. Subgroup analysis results showed that Yang-xue Qingnao Granules combined with ACEI drug had more obvious effects in lowering systolic blood pressure and diastolic blood pressure. There was no statistically significant difference in the incidence of adverse reactions, and no abnormal liver and kidney function was observed in each study. Trial sequential analysis showed that the total effective rate was cumulative across the traditional and TSA thresholds, further confirming its clinical efficacy. The evidence level was mostly low or extremely low in GRADE evaluation. The clinical application of Yangxue Qingnao Granules combined with conventional Western medicine in the treatment of essential hypertension and its accompanying symptoms is clear and safe, so it is recommended for clinical application.
Antihypertensive Agents/adverse effects* ; China ; Drugs, Chinese Herbal/adverse effects* ; Essential Hypertension ; Humans ; Medicine, Chinese Traditional ; Randomized Controlled Trials as Topic

At present, most of Chinese patent medicines have problems, such as weak scientific basis, unclear clinical value evaluation, etc., which lead to the lack of sufficient evidence for the entry into the essential medicine list, medical insurance catalog and other important health resource allocation tools. This has a negative impact on the development of traditional Chinese medicine. It is urgent to establish a comprehensive evaluation methodology system of Chinese patent medicine in China. There are at least three reasons including producing evidence for clinical rational use scientifically, developing an objective and transparent selecting strategy, eventuating and highlighting its clinical value. The process and method of health technology assessment(HTA) can provide reference for the establishment of comprehensive evaluation method of Chinese patent medicine. However, HTA is rarely carried out in the field of traditional Chinese medicine. The latest domestic and international research showed that HTA combined with multi-criteria decision analysis(MCDA) can increase the transparency of decision-making and improve the quality of decision-making. The combined two formed the EVIDEM framework, which is conducive to drug selection and its clinical use. In this paper, the EVIDEM framework was introduced to establish the methodology framework of the comprehensive clinical evaluation system of Chinese patent medicine. A preliminary research idea has been put forward. In the future, we can establish a set of comprehensive clinical evaluation methods for Chinese patent medicine in cooperation with relevant national drug decision-making departments and management departments. It is believed that such cooperation could promote the full implementation of the re-evaluation for Chinese patent medicine.
China ; Drugs, Essential ; Medicine, Chinese Traditional ; Nonprescription Drugs ; Technology Assessment, Biomedical

BACKGROUNDAt the present time, the government is considering to establish the independent financing system for essential medicines (EMs). However, it is still in the exploration phase. The objectives of this study were to calculate and estimate financing amount of EMs in China in 2014 and to provide data evidence for establishing financing mechanism of EMs.

METHODSTwo approaches were adopted in this study. First, we used a retrospective research to estimate the cost of EMs in China in 2014. We identified all the 520 drugs listed in the latest national EMs list (2012) and calculated the total sales amount of these drugs in 2014. The other approach included the steps that first selecting the 109 most common diseases in China, then identifying the EMs used to treat them, and finally estimating the total cost of these drugs.

RESULTSThe results of the two methods, which showed the estimated financing amounts of EMs in China in 2014, were 17,776.44 million USD and 19,094.09 million USD, respectively.

CONCLUSIONSComparing these two results, we concluded that the annual budget needed to provide for the EMs in China would be about 20 billion USD. Our study also indicated that the irrational drug use continued to plague the health system with intravenous fluids and antibiotics being the typical examples, as observed in other studies.

China ; Drugs, Essential ; economics ; Humans ; Retrospective Studies ; Time Factors

OBJECTIVE: To evaluate the prescription behavior for outpatients in primary health care institutions of Yiyang and to provide scientific basis for promoting the rational use of drugs.
 METHODS: A multi-stage random sampling method was conducted in 21 primary health care institutions from Yiyang. Fifteen prescriptions were randomly selected in every month from each institution and a total of 3780 prescriptions were eventually collected in a year.
 RESULTS: Both the number of drugs and percentage of injection in a prescription were greater than the international standards. Children were more likely to be prescribed by multiple prescriptions, antibiotics prescriptions, hormones and injections prescriptions. The utilization of essential drug was more frequent in female. Antibiotics and hormones were more frequently used in summer and autumn season. Polypharmacy, antibiotics, injections and essential drugs were more frequently used in hospitals of small town. The skin and subcutaneous tissue diseases were often treated with multiple prescriptions, while the respiratory diseases were often treated with antibiotics, hormones and injections. Most primary health care institutions were at the upper limit of rational drug use.
 CONCLUSION The usage of prescription drug in most primary health care is rational, but some still surpass international standards. Thus, primary health care physicians should strictly control their prescriptions behavior.
Anti-Bacterial Agents ; Drug Prescriptions ; statistics & numerical data ; Drug Utilization Review ; Drugs, Essential ; Hormones ; Humans ; Injections ; Outpatients ; Practice Patterns, Physicians' ; Primary Health Care

OBJECTIVETo evaluate the effectiveness and safety of Songling Xuemaikang Capsule (, SXC) for the treatment of primary hypertension.

METHODSAn extensive search including Cochrane Library, PubMed, Cochrane Central Register of Controlled Trials (CENTRAL), Chinese Biomedical Literature Database (CBM), Chinese National Knowledge Infrastructure (CNKI), Chinese Scientific Journal Database (VIP), KoreaMed, Japanese database, and online clinical trial registry websites was performed up to February 2013. Randomized controlled trials (RCTs) regarding SXC for the treatment of primary hypertension were searched without no language restrictions. The quality of each trial was assessed according to the Cochrane Reviewers' Handbook 5.0, and RevMan 5.0 provided by the Cochrane Collaboration.

RESULTA total of 17 RCTs involving 1,778 patients were included. Meta-analysis showed that there was no significant difference between SXC and antihypertensive agents on systolic blood pressure [mean difference (MD): -0.10 [-4.83, 4.63]; P=0.97] and diastolic blood pressure (MD: 1.00 [-1.16, 3.16]; P=0.36), but SXC combined with antihypertensive drugs was more effective in lowering systolic blood pressure (MD: -6.17 [-7.86, -4.49]; P<0.00001) and diastolic blood pressure (MD: -7.24 [-8.62, -5.85]; P<0.00001) compared with the antihypertensive drugs alone.

CONCLUSIONSSXC used alone or combined with antihypertensive drugs appear to be an effective treatment for lowering elevated blood pressure and improving symptoms in patients with primary hypertension. However, the conclusion cannot be drawn definitely due to the poor quality of the included studies. There is still an urgent need for well-designed, long-term studies to address the benefits of SXC for treating primary hypertension.

Adult ; Aged ; Aged, 80 and over ; Antihypertensive Agents ; administration & dosage ; therapeutic use ; Capsules ; Drugs, Chinese Herbal ; administration & dosage ; therapeutic use ; Essential Hypertension ; Female ; Humans ; Hypertension ; drug therapy ; epidemiology ; Male ; Middle Aged ; Randomized Controlled Trials as Topic ; statistics & numerical data ; Treatment Outcome