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1.
China Journal of Chinese Materia Medica ; (24): 234-246, 2023.
Article in Chinese | WPRIM | ID: wpr-970519

ABSTRACT

This study aimed to evaluate the efficacy and safety of Chinese patent medicines containing Hirudo in the treatment of atherosclerosis(AS) by network Meta-analysis, and to provide evidence-based reference for clinical treatment of AS. The clinical randomized controlled trial(RCT) on the treatment of atherosclerosis with Chinese patent medicines containing Hirudo were searched in CNKI, Wanfang, VIP, SinoMed, PubMed and EMbase from the establishment of the databases to July 1, 2022. And data extraction and quality assessment of the included RCT was performed according to the Cochrane standards. Stata 17 and ADDIS 1.16.5 were then used for Bayesian model network Meta-analysis. Finally, 67 RCTs with a total sample size of 6 826 cases were included, 3 569 cases in the experimental group and 3 257 cases in the control group, involving three oral Chinese patent medicines. Network Meta-analysis showed that in terms of reducing intima-media thickness(IMT), the top three Chinese patent medicines were Tongxinluo Capsules+sta-tins>Maixuekang Capsules+statins>Maixuekang Capsules. In terms of reducing plaque area, the top one was Maixuekang Capsules+sta-tins, and the other Chinese patent medicines had similar efficacy. For lowering AS Crouse scores, the top three were Maixuekang Capsules>Tongxinluo Capsules+statins>Naoxintong Capsules. For decreasing plaque number, the top three were Naoxintong Capsules+sta-tins>Tongxinluo Capsules+statins>Tongxinluo Capsules. With regard to adverse reactions/events, Naoxintong Capsules+statins had the lo-west incidence. In conclusion, in Chinese patent medicines containing Hirudo for the treatment of AS, Tongxinluo Capsules+statins, Maixuekang Capsules, Maixuekang Capsules+statins, and Naoxintong Capsules+statins were the primary choices to reduce IMT, AS Crouse scores, plaque area, and plaque number, respectively. The efficacy of Chinese patent medicines containing Hirudo with or without statins was more significant than that of statins alone in the four outcome indexes. Additionally, the treatment of AS should be evaluated comprehensively, and attention should be paid to Chinese patent medicines or their combination with western medicine, to optimize the treatment effect and minimize adverse reactions as the benchmark.


Subject(s)
Humans , Network Meta-Analysis , Nonprescription Drugs/therapeutic use , Capsules , Hydroxymethylglutaryl-CoA Reductase Inhibitors , Bayes Theorem , Carotid Intima-Media Thickness , Drugs, Chinese Herbal/therapeutic use , Atherosclerosis/drug therapy , Medicine, Chinese Traditional
2.
China Journal of Chinese Materia Medica ; (24): 3965-3976, 2023.
Article in Chinese | WPRIM | ID: wpr-981528

ABSTRACT

This study aims to comprehensively evaluate the clinical value of Shaoma Zhijing Granules(SZG), Changma Xifeng Tablets(CXT), and Jiuwei Xifeng Granules(JXG) in the treatment of children with tic disorder with the method of rapid health technology assessment(RHTA), which is expected to serve as a reference for medical and health decision-making and clinical rational use of drugs in children. To be specific, relevant articles were retrieved from eight databases and three clinical trial registry platforms. After the quality evaluation, rapid assessment was carried out from the dimensions of disease burden and unmet needs, technical characteristics, safety, efficacy and economy, and the results were analyzed and presented descriptively. A total of 22 articles(1 in English, 21 in Chinese) were screened out: 18 randomized controlled trials(RCTs) and 4 clinical controlled trials(CCTs). Among them, 5 were about the SZG(all RCTs) and 9 were on CXT(6 RCTs and 3 CCTs). The rest 8 focused on JXG(7 RCTs and 1 CCT). Moreover, the overall risk of bias for 94.40% RCTs was evaluated as "some concerns" and only one(5.60%) had high risk of bias. In terms of quality, the 4 CCTs scored 5-6 points(<7 points), suggesting low quality. SZG alone or in combination with tiapride has obvious advantages in improving traditional Chinese medicine syndromes and tic symptoms compared with tiapride alone, with the average daily cost of CNY 79.44-119.16. Compared with conventional western medicine or placebo, CXT alone or in combination with conventional western medicine can improve the total effective rate and alleviate tic symptoms, and the average daily cost is CNY 22.50-67.50. JXG alone or in combination with conventional western medicine can effectively relieve tic symptoms compared with conventio-nal western medicine or placebo, with the average daily cost of CNY 82.42-164.85. The adverse events related to the three Chinese patent medicines mainly occurred in the digestive, respiratory, and nervous systems, all of which were mild. In general, SZG, CXT, and JXG are effective for children with tic disorder. They have been approved to be used in this field, of which SZG was approved in 2019, with the most up-to-date research evidence and high-quality RCT in Q1 journals. However, the comparative analysis of the three was affected by many factors, which should be further clarified. Based on the large sample data available in multiple dimensions, a comprehensive comparative evaluation of the three Chinese patent medicines should be carried out, thereby highlighting the advantages and disadvantages of them and serving a reference for rational clinical use and drug supervision.


Subject(s)
Humans , Child , Drugs, Chinese Herbal/therapeutic use , Nonprescription Drugs/therapeutic use , Technology Assessment, Biomedical , Tiapride Hydrochloride/therapeutic use , Tics/drug therapy , Tic Disorders/drug therapy , Medicine, Chinese Traditional
3.
China Journal of Chinese Materia Medica ; (24): 3949-3964, 2023.
Article in Chinese | WPRIM | ID: wpr-981527

ABSTRACT

This study aimed to evaluate the efficacy of Qi-supplementing and Yin-nourishing Chinese patent medicine in the treatment of early diabetic nephropathy(DN) by network Meta-analysis to explore the Chinese patent medicine with optimal efficacy and provide references for preventing renal deterioration and delaying the progression of early DN. Eight databases, including CNKI, Wanfang, VIP, SinoMed, PubMed, EMbase, Cochrane Library, and Web of Science, were searched for clinical randomized controlled trial(RCT) of Qi-supplementing and Yin-nourishing Chinese patent medicines in the treatment of early DN. After the literature mee-ting the inclusion criteria was screened, the quality of the literature was evaluated using the Cochrane risk-of-bias tool, and network Meta-analysis was performed using the BUGSnet package in R 4.2.1. Seventy-two research articles with a sample size of 6 344 cases were included, involving eight Chinese patent medicines and seven outcome indicators. The results of the network Meta-analysis showed that(1)in terms of improving urinary albumin excretion rate(UAER), Chinese patent medicines combined with conventional treatment were superior to conventional treatment, and Qiyao Xiaoke Capsules + conventional treatment was optimal.(2)In terms of reducing serum crea-tinine(Scr), Bailing Capsules + conventional treatment had superior efficacy.(3)In terms of reducing 24-hour urine total protein(24hUTP), Shenyan Kangfu Tablets + conventional treatment and Jinshuibao Capsules + conventional treatment had equivalent efficacy, and Shenyan Kangfu Tablets + conventional treatment was superior.(4)In terms of improving fasting blood glucose(FBG), Shenyan Kangfu Tablets + conventional treatment had superior efficacy.(5)In terms of improving total cholesterol(TC), Qiyao Xiaoke Capsules +conventional treatment had superior efficacy.(6)In terms of reducing triglyceride(TG), Bailing Capsules + conventional treatment had superior efficacy.(7)In terms of safety, the occurrence of adverse reactions was reported in seven interventions, but due to the large clinical heterogeneity, the quantitative analysis could not be performed. Overall, Qi-supplementing and Yin-nourishing Chinese patent medicines combined with conventional treatment were superior to conventional treatment alone in the treatment of early DN. The results showed that Qi-supplementing and Yin-nourishing Chinese patent medicines combined with conventional treatment had good clinical efficacy, and they could significantly reduce renal function indicators such as UAER, Scr, and 24hUTP, and reduce blood sugar and blood lipid, which can provide evidence-based support for the treatment of early DN. However, due to the differences in the quantity and quality of the included research articles, large-sample, multi-center, high-quality studies are still needed for further verification.


Subject(s)
Humans , Diabetic Nephropathies/drug therapy , Nonprescription Drugs/therapeutic use , Qi , Network Meta-Analysis , Capsules , Drugs, Chinese Herbal/therapeutic use , Tablets , Diabetes Mellitus/drug therapy
4.
China Journal of Chinese Materia Medica ; (24): 3934-3948, 2023.
Article in Chinese | WPRIM | ID: wpr-981526

ABSTRACT

This study aimed to evaluate the efficacy and safety of various oral Chinese patent medicines in the adjuvant treatment of rotavirus gastroenteritis(RVGE) in children based on network Meta-analysis. Randomized controlled trial(RCT) of oral Chinese patent medicine in the adjuvant treatment of RVGE in children was retrieved from the databases such as CNKI, Wanfang, VIP, SinoMed, PubMed, Cochrane Library, EMbase, and Web of Science from database inception to October 22, 2022. The quality of the included RCT was evaluated according to the Cochrane risk-of-bias tool, and the data were analyzed by RevMan 5.4 and Stata 16 software. Sixty-three RCTs were included, with 11 oral Chinese patent medicines involved, including Xingpi Yanger Granules, Weichang'an Pills, Qiuxieling Mixture, Erxieting Granules, and Changyanning Granules/Syrup. The results of the network Meta-analysis showed that in terms of clinical total effective rate, the top 3 optimal interventions were Changyanning Granules/Syrup, Xiaoer Guangpo Zhixie Oral Liquid, and Xiaoer Shuangjie Zhixie Granules combined with conventional western medicine. In terms of the anti-diarrheal time, the top 3 optimal interventions were Shenling Baizhu Granules, Qiuxieling Mixture, and Shuangling Zhixie Oral Liquid combined with conventional western medicine. In terms of the antiemetic time, the top 3 optimal interventions were Changyanning Granules/Syrup, Xingpi Yanger Granules, and Xiaoer Shuangjie Zhixie Granules combined with conventional western medicine. In terms of the antipyretic time, the top 3 optimal interventions were Shenling Baizhu Granules, Xiaoer Shuangjie Zhixie Granules, and Qiuxieling Mixture combined with conventional western medicine. In terms of the negative conversion rate of rotavirus, the top 3 optimal interventions were Xingpi Yanger Granules, Erxieting Granules, and Cangling Zhixie Oral Liquid combined with conventional western medicine. In terms of reducing creatine kinase isoenzyme MB(CK-MB) level, the top 3 optimal interventions were Weichang'an Pills, Xingpi Yanger Granules, and Xiaoer Shuangjie Zhixie Granules combined with conventional western medicine. In terms of adverse reactions, no se-rious adverse reactions were reported in all studies. Oral Chinese patent medicines in the adjuvant treatment of children with RVGE have their own advantages, Specifically, Changyanning Granules/Syrup + conventional western medicine focuses on improving the clinical total effective rate and shortening the antiemetic time, Shenling Baizhu Granules + conventional western medicine on shortening the anti-diarrheal time and antipyretic time, Xingpi Yanger Granules + conventional western medicine on improving the negative conversion rate of rotavirus, and Weichang'an Pills + conventional western medicine on reducing the CK-MB level. Limited by the quantity and quality of literature included in this study, the results need to be verified by high-quality RCT with a larger sample size.


Subject(s)
Child , Humans , Adjuvants, Pharmaceutic , Antiemetics , Antipyretics , Drugs, Chinese Herbal/therapeutic use , Enteritis/drug therapy , Network Meta-Analysis , Nonprescription Drugs/therapeutic use , Rotavirus , Randomized Controlled Trials as Topic
5.
China Journal of Chinese Materia Medica ; (24): 3650-3663, 2023.
Article in Chinese | WPRIM | ID: wpr-981495

ABSTRACT

This study aimed to systematically evaluate the efficacy and safety of different Chinese patent medicines in the treatment of idiopathic membranous nephropathy. The relevant randomized controlled trial(RCT) was retrieved from PubMed, EMbase, Cochrane Library, CNKI, SinoMed, Wanfang, and VIP with the time interval from database inception to December 2022. The Cochrane risk of bias assessment tool was employed to evaluate the quality of the included RCT, and Stata 15.0 and GEMTC to perform the Bayesian network Meta-analysis. Finally, 51 RCTs were included, involving 9 Chinese patent medicines and 3 591 patients. The results of network Meta-analysis showed that in terms of the total effective rate and the increase in plasma albumin, the top three interventions were Zhengqing Fengtongning Sustained Release Tablets + conventional western medicine, Bailing Capsules + conventional western medicine, and Tripterygium Glycosides Tablets + conventional western medicine. In terms of reducing 24-hour urine total protein, the top three interventions were Zhengqing Fengtongning Sustained Release Tablets + conventional western medicine, Shenfukang Capsules +conventional western medicine, and Huangkui Capsules + conventional western medicine. In terms of reducing serum creatinine, the top three interventions were Shenfukang Capsules + conventional western medicine, Bailing Capsules + conventional western medicine, and Zhengqing Fengtongning Sustained Release Tablets + conventional western medicine. In terms of safety, Chinese patent medicines combined with conventional western medicine had fewer adverse reactions than the control group. The results suggest that Chinese patent medicines combined with conventional western medicine can improve the therapeutic effect on idiopathic membranous nephropathy, and differentiated medications can be adopted according to the specific symptoms of patients in clinical treatment. Further validation needs to be carried out in the future with multi-center, large-sample, and high-quality RCT.


Subject(s)
Humans , Nonprescription Drugs/therapeutic use , Network Meta-Analysis , Glomerulonephritis, Membranous/drug therapy , Bayes Theorem , Capsules , Delayed-Action Preparations , Drugs, Chinese Herbal/adverse effects , Tablets
6.
China Journal of Chinese Materia Medica ; (24): 2237-2243, 2022.
Article in Chinese | WPRIM | ID: wpr-928164

ABSTRACT

Clinical expertise, patient preference, and the best evidence are the three elements of evidence-based medicine. Based on high-level and high-quality evidence, qualitative and quantitative analysis of the prescribing decisions of physicians is beneficial to improving clinical efficacy. A mature methodological system is available for the retrieval, analysis, summary, evaluation, and recommendation of the evidence, but there are still few studies on physicians' prescribing decisions. How to analyze the trend of physicians' prescribing decisions based on the priority ranking in addition and subtraction of prescriptions? Analytic hierarchy process(AHP) is a method for decision making, which arranges the elements of the decision problem into overall goal, criteria, and operational sub-criteria, and uses the matrix eigenvector method to solve the problem. This study aims to analyze the priority of physicians' prescribing decisions for diabetes mellitus with deficiency of both Qi and Yin based on AHP. To be specific, a database of diabetes mellitus cases with deficiency of both Qi and Yin was established and AHP was used to yield the priority ranking of Chinese patent medicine prescriptions in specific clinical scenarios. In the selected cases of diabetes mellitus with deficiency of both Qi and Yin, Xiaoke Pills was the best prescription for the treatment of type 2 diabetes mellitus(deficiency of both Qi and Yin)(normalized=0.388), followed by Liuwei Dihuang Pills(normalized=0.269), Qishen Capsules(normalized=0.230), and Shengmai Injection(normalized=0.113). According to the analysis the available data, for type 2 diabetes mellitus(deficiency of both Qi and Yin), Xiaoke Pills was the most effective prescription in specific scenarios. When the physicians' prescribing decisions are consistent with the evidence, quantitative analysis of physicians' cognition will boost the evidence-based medical decision-making. However, the research results are also affected by the quality of literature, evidence level and priority, which are thus have some limitations. It is recommended that further small data research based on individual cases be carried out to lay a evidence-based basis for the clinical decision-making of type 2 diabetes mellitus.


Subject(s)
Humans , Analytic Hierarchy Process , China , Diabetes Mellitus, Type 2/drug therapy , Drug Prescriptions , Medicine, Chinese Traditional , Nonprescription Drugs/therapeutic use , Qi , Syndrome , Yin Deficiency/drug therapy
7.
China Journal of Chinese Materia Medica ; (24): 2211-2227, 2022.
Article in Chinese | WPRIM | ID: wpr-928162

ABSTRACT

To evaluate the efficacy and safety of Chinese patent medicines in the treatment of ankylosing spondylitis(AS) by frequency network Meta-analysis. Randomized controlled trials(RCTs)of Chinese patent medicines for AS were retrieved from CNKI, Wanfang, VIP, CBM, PubMed, EMbase and Cochrane Library databases from the time of database establishment to January 2021. The quality of the included RCTs was evaluated according to the Cochrane bias risk standard, and the data was analyzed by RevMan 5.3 and Stata/MP 15.1. A total of 12 kinds of Chinese patent medicines in 55 RCTs were included. According to Meta-analysis, in term of the effectiveness, the top three optimal medication regimens were Biqi Capsules, Yishen Juanbi Pills and Yaobitong Capsules combined with western medicine. The top three interventions to reduce the erythrocyte sedimentation rate(ESR)were Yishen Juanbi Pills, Xianling Gubao Capsules and Fufang Xuanju Capsules combined with western medicine. The top three interventions to reduce the C-reactive protein(CRP)were Biqi Capsules, Xianling Gubao Capsules and Fufang Xuanju Capsules combined with western medicine. In terms of the safety, top three optimal medication regimens were Total Glucosides of Paeony Capsules, Yishen Juanbi Pills, and Wangbi Tablets combined with western medicine. This network Meta-analysis suggests that Chinese patent medicines combined with conventional western medicine can effectively improve the joint pain symptoms of AS patients and reduce the acute inflammatory indicators, with high safety. However, the literature included in this study is generally of low methodological quality, and the conclusion needs to be verified by high-quality research.


Subject(s)
Humans , Capsules , China , Drugs, Chinese Herbal/adverse effects , Network Meta-Analysis , Nonprescription Drugs/therapeutic use , Spondylitis, Ankylosing/drug therapy
8.
China Journal of Chinese Materia Medica ; (24): 2351-2357, 2022.
Article in Chinese | WPRIM | ID: wpr-928115

ABSTRACT

The clinical randomized controlled trials(RCTs) of Chinese patent medicine in the treatment of chronic obstructive pulmonary disease(COPD) were reviewed and analyzed to provide references for clinical research, guideline development, policy formulation, and quality improvement of clinical evidence. On the basis of the collection in the Traditional Chinese Medicine(TCM) Clinical Evidence Database System(EVDS), CNKI, Wanfang, SinoMed, Cochrane Library, PubMed, EMbase were searched for RCTs of Chinese patent medicine for COPD as a source of clinical evidence from database inception to December 31, 2019. The publication time, sample size, intervention and control measures, course of treatment, outcome indicators, and methodological quality of the trials were analyzed and evaluated. A total of 733 RCTs of Chinese patent medicine for COPD were included, among which 228 RCTs had a sample size higher than 100, accounting for 31.1% of total RCTs. Eighty-eight Chinese patent medicines were involved, including 40 oral medicines and 48 injections. A total of 327 RCTs mentioned intervention and control measures(Chinese patent medicine + conventional treatment vs conventional treatment), accounting for 43.0%. In addition, 94.40% of the RCTs reported the course of treatment, and 53.20% of the RCTs determined 8-14 d as the intervention course. The evaluation indicators adopted were numerous, among which physicochemical indicators(70.57%) and symptoms/signs(24.35%) were the most frequently employed. The operation of allocation concealment and blinding was not standard. Registration and the procedure related to ethics were mostly missing. The results indicate that there are prominent methodological problems in the clinical trials of Chinese patent medicine in the treatment of COPD, affecting the reliability and practicability of the trials. It is necessary to further standardize the design, implementation, and quality control of clinical trials of Chinese patent medicine in the treatment of COPD, highlight the clinical value of Chinese patent medicine for COPD, and improve the quality of evidence.


Subject(s)
Humans , China , Clinical Trials as Topic , Drugs, Chinese Herbal/therapeutic use , Medicine, Chinese Traditional , Nonprescription Drugs/therapeutic use , Pulmonary Disease, Chronic Obstructive/drug therapy , Reproducibility of Results
9.
China Journal of Chinese Materia Medica ; (24): 2338-2342, 2022.
Article in Chinese | WPRIM | ID: wpr-928113

ABSTRACT

The clinical randomized controlled trial(RCT) of Chinese patent medicine in the treatment of influenza were reviewed and analyzed to provide basic information for clinical decision and related research. On the basis of the collection in the Traditional Chinese Medicine(TCM) Clinical Evidence Database System(EVDS), CNKI, Wanfang, VIP, SinoMed, EMbase, PubMed, and Cochrane Library were searched for RCTs of Chinese patent medicine for influenza published from database inception to July 25, 2021. The publication time, sample size, intervention and control measures, course of treatment, outcome indicators, and methodological quality of the trials were analyzed and evaluated. Ninety-two RCTs of Chinese patent medicine for influenza published between 2005 and 2021, were included, among which 17 RCTs(18.48%) had a sample size higher than 200 and the average sample size was about 145. Twenty-seven Chinese patent medicines were involved, including twenty-one oral medicines and six injections. The Chinese patent medicines in trials reported in more than five papers included Lianhua Qingwen Capsules/Gra-nules, Tanreqing Injection, and Reduning Injection. Fourteen intervention protocols were reported, of which Chinese patent medicine+western medicine+conventional treatment vs western medicine+conventional treatment(20.65%) was the most frequently employed. Additionally, 85.87% of the RCTs reported the course of treatment, and 80.43% of the RCTs determined 3-7 d as the intervention course. Forty-five outcome indicators were extracted, which were used 434 times, including symptoms/signs, physicochemical detection, safety events, TCM symptoms/syndromes, quality of life, long-term prognosis, and economic evaluation. Symptoms/signs(61.52%) exhibited the highest frequency. Methodological problems were prevalent in the included trials. The findings reveal that there are few clinical trials on influenza treatment by Chinese patent medicine, and the methodological problems are prominent, affec-ting the reliability and practicability of the trials. In the future research, the value characteristics of Chinese patent medicine should be highlighted and the quality control in the whole process should be strengthened based on the scientific and rigorous design.


Subject(s)
Humans , China , Clinical Trials as Topic , Drugs, Chinese Herbal/therapeutic use , Influenza, Human/drug therapy , Medicine, Chinese Traditional , Nonprescription Drugs/therapeutic use , Quality of Life , Reproducibility of Results
10.
China Journal of Chinese Materia Medica ; (24): 2330-2337, 2022.
Article in Chinese | WPRIM | ID: wpr-928112

ABSTRACT

To systematically collect and analyze clinical randomized controlled trial(RCT) of Chinese patent medicine treatment for stroke in 2020, in order to provide basic information for clinical decision-making and related research. On the basis of the collection in the Traditional Chinese Medicine(TCM) Clinical Evidence Database System(EVDS), CNKI, Wanfang, SinoMed, Cochrane Library, PubMed, EMbase were searched for RCTs of Chinese patent medicine for stroke in 2020. The publication, sample size, intervention and control measures, course of treatment, outcome indicators, methodological quality and other contents were statistically analyzed.A total of 68 RCTs studies on Chinese patent medicine for stroke were included in 2020, of which 29(42.60%) were RCTs with sample size>100 cases. A total of 41 kinds of proprietary Chinese medicines were involved, including 23 kinds of oral proprietary Chinese medicines and 18 kinds of injections. A total of 18 intervention/control cases were included in RCTs, and 19 cases(Chinese patent medicine+Western medicine vs Western medicine) were applied in RCTs, accounting for 27.90%. The duration of treatment was reported in 91.18% of the studies, and the intervention duration was 8-14 days in 50.00% of the studies. Evaluation indexes were widely used, among which physical and chemical testing indexes(49.36%) were the most widely used. According to the methodological quality evaluation, the overall methodological quality of the study is not high, especially the implementation of the allocation hidden, blind method is not accurate, and the registration, ethics and other links are often missing. In conclusion, 2020 implementation of proprietary Chinese medicine in the treatment of stroke research methodology problems is outstanding, the similar function scale large range of optional, no specification selection criteria, reliability and practicability of the impact study, need to further standardize the proprietary Chinese medicine in the treatment of stroke study design, implementation and quality control, and highlight the value of proprietary Chinese medicine in the treatment of stroke and improve the quality of the evidence.


Subject(s)
Humans , China , Clinical Trials as Topic , Drugs, Chinese Herbal/therapeutic use , Medicine, Chinese Traditional , Nonprescription Drugs/therapeutic use , Reproducibility of Results , Stroke/drug therapy
11.
China Journal of Chinese Materia Medica ; (24): 2322-2329, 2022.
Article in Chinese | WPRIM | ID: wpr-928111

ABSTRACT

The present study systematically collected, analyzed, and evaluated randomized controlled trial(RCT) of Chinese patent medicine in the treatment of heart failure to provide references for follow-up clinical research design, guideline update, and policy formulation, and promote the improvement of clinical evidence quality. On the basis of the collection in the Traditional Chinese Medicine(TCM) Clinical Evidence Database System(EVDS), CNKI, VIP, Wanfang, SinoMed, PubMed, and Web of Science were searched for RCTs of Chinese patent medicine in the treatment of heart failure from database inception to December 31, 2020. The di-sease type, publication time, sample size, intervention/control setting, course of treatment, evaluation indexes, and methodological quality were analyzed and evaluated. A total of 1 631 RCTs were included, including 1 622 in Chinese and 9 in English. It was first published in 1995, with the largest number of publications in 2016. There were only 56 RCTs(3.43%) with a sample size≥200. Seventy-eight types of Chinese patent medicines were involved, including 49 types of oral drugs and 29 types of injections. There were 34 intervention/control protocols, which were dominated by Chinese patent medicine+conventional treatment vs conventional treatment, accounting for 28.51%(n=465). About 94.0% of RCTs reported the course of treatment, mainly 14-56 days. The evaluation indexes were mainly physical and chemical tests and symptoms/signs, and left ventricular ejection fraction(LVEF) was the most frequently used measurement index. In enumeration indexes, clinical efficacy(response rate) was used the most frequently. Methodologically, 92.0% of the research subjects were rated as high risk of blindness. There were only 13 RCTs(0.80%) reporting registered information. It is necessary to further standardize the design, implementation, and quality control of clinical studies in order to improve the quality of evidence and avoid research waste.


Subject(s)
Humans , China , Drugs, Chinese Herbal/therapeutic use , Heart Failure/drug therapy , Medicine, Chinese Traditional , Nonprescription Drugs/therapeutic use , Randomized Controlled Trials as Topic , Stroke Volume , Ventricular Function, Left
12.
China Journal of Chinese Materia Medica ; (24): 1980-1987, 2021.
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)
Humans , China , Drugs, Chinese Herbal/therapeutic use , Marketing , Medicine, Chinese Traditional , Neoplasms/drug therapy , Nonprescription Drugs/therapeutic use , Quality of Life
14.
Rev. bras. epidemiol ; 21(supl.2): e180007, 2018. tab, graf
Article in Portuguese | LILACS | ID: biblio-985273

ABSTRACT

RESUMO: Introdução: Automedicação retrata o princípio do próprio indivíduo buscar espontaneamente por algum medicamento que considere adequado para resolver um problema de saúde. Essa prática é ainda pouco explorada entre idosos de acordo com outros estudos baseados em dados populacionais. Objetivo: Examinar as tendências da prática de automedicação dos idosos do Estudo SABE entre 2006 e 2010. Método: Estudode base populacional cujos dados foram obtidos do Estudo Saúde, Bem-Estar e Envelhecimento (SABE). Aamostra de 2006 foi constituída de 1.258 idosos e a de 2010, de 865 idosos que utilizaram medicamentos. Resultados: Observou-se redução da automedicação de 42,3% em 2006 para 18,2% em 2010. Em ambos os períodos, as classes terapêuticas predominantes foram as dos medicamentos com ação no sistema nervoso (27,9% em 2006 e 29,6% em 2010) e trato alimentar e metabolismo (25,5% em 2006 e 35,9% em 2010). Entreos medicamentos mais usados nos anos de 2006 e 2010 estão os analgésicos/anti-inflamatórios e vitaminas. Houve tendência a declínio da utilização de medicamentos potencialmente inapropriados entre 2006 (26,4%) e 2010 (18,1%). Oidoso foi o principal responsável pela indicação da automedicação em 2006 (65,2%) e 2010 (66,5%). Conclusão: A extensão da prática de automedicação nos idosos do SABE apresentou redução entre 2006 e 2010, porém o emprego de medicamentos que oferecem risco à saúde ainda foi relatado. Desse modo, os achados reforçam a importância de monitorar, avaliar e educar continuamente os idosos acerca dos riscos e benefícios do consumo de medicamentos, sobretudo daqueles isentos de prescrição.


ABSTRACT: Introduction: Self-medication involves the concept of the spontaneous search by the individual for some drug that he or she considers appropriate to solve a health problem. Self-medication practice is little explored by the elderly according to other studies based in population data. Objective: To examine the trends in self-medication practice among the Brazilian elderly between 2006 and 2010. Methods: This is a population-based study whose data were obtained from the Health, Well-being and Ageing Study (SABE Study). Thesample consisted of 1,257 elderly people in 2006 and 865 in 2010, who used drugs. Results: The findings showed self-medication reduction from 42.3% in 2006 to 18.2% in 2010. In both periods, predominant utilized therapeutic classes were those acting on the nervous system (27.9% in 2006, and 29.6% in 2010) and on the alimentary tract and metabolism (25.5% in 2006, and 35.9% in 2010). The most commonly used medicines in 2006 and 2010 were analgesics, anti-inflammatories, and vitamins. There was a tendency to decrease the use of potentially inappropriate medicines between 2006 (26.4%) and 2010 (18.1%). The elderly themselves were the main responsible for the decision about the drug use in 2006 (62.5%) and 2010 (66.5%). Conclusion: Theextent of self-medication practice among the elderly who participated in the study decreased between 2006 and 2010, but the use of medicines that offer risks to health was still reported. Thus, the findings reinforce the importance of monitoring, evaluating, and continuously educating the elderly about risks and benefits of drug consumption, particularly over-the-counter medicines.


Subject(s)
Humans , Male , Female , Self Medication/trends , Self Medication/statistics & numerical data , Aged/statistics & numerical data , Reference Values , Socioeconomic Factors , Time Factors , Brazil/epidemiology , Health Status , Risk Factors , Age Factors , Sex Distribution , Age Distribution , Polypharmacy , Nonprescription Drugs/therapeutic use , Middle Aged
15.
J. appl. oral sci ; 25(5): 575-584, Sept.-Oct. 2017. tab, graf
Article in English | LILACS, BBO | ID: biblio-893651

ABSTRACT

Abstract Tooth whitening represents perhaps the most common aesthetic procedure in dentistry worldwide. The efficacy of bleaching depends on three aspects: bleaching agent, bleaching method, and tooth color. Objective: This in vivo study aimed to examine whitening effects on frontal teeth of the upper and lower jaws using an over-the-counter (OTC) non-hydrogen peroxide bleaching agent in comparison to a placebo after one single use. Material and methods: Forty subjects (25 female; 15 male) participated in this double-blind randomized placebo-controlled trial. The subjects were randomly allocated to two groups (n=20). The test group received the OTC product (iWhite Instant) and the placebo group received an identically composed product except for the active agents. Each subject was treated with a prefilled tray containing iWhite Instant or the placebo for 20 minutes. The tooth shade of the front teeth (upper and lower jaws) was assessed before (E_0), immediately after (E_1) and 24 h after treatment (E_2), using a shade guide (VITA classical). Statistical testing was accomplished using the Mann-Whitney U test (p<0.001). The dropout rate was 0%. Results: There were no significant differences at E_0 between placebo and test groups regarding the tooth color. Differences in tooth color changes immediately after (ΔE1_0) and 24 h after treatment (ΔE2_0) were calculated for both groups. The mean values (standard deviations) of tooth color changes for ΔE1_0 were 2.26 (0.92) in the test group and 0.01 (0.21) in the placebo group. The color changes for ΔE2_0 showed mean values of 2.15 (1.10) in the test group and 0.07 (0.35) in the placebo group. For ΔE1_0 and ΔE2_0 significant differences were found between the groups. Conclusion: In this short-term study, the results showed that a non-hydrogen peroxide bleaching agent has significant whitening effects immediately and 24 h after a single-use treatment.


Subject(s)
Humans , Male , Female , Adolescent , Adult , Middle Aged , Young Adult , Phthalimides/therapeutic use , Tooth Bleaching/methods , Caproates/therapeutic use , Calcium Compounds/therapeutic use , Tooth Bleaching Agents/therapeutic use , Gluconates/therapeutic use , Lactates/therapeutic use , Time Factors , Observer Variation , Placebo Effect , Double-Blind Method , Reproducibility of Results , Treatment Outcome , Colorimetry , Statistics, Nonparametric , Dentin Sensitivity/chemically induced , Nonprescription Drugs/therapeutic use
16.
Rev. gaúch. enferm ; 38(1): e65111, 2017. tab, graf
Article in Portuguese | LILACS, BDENF | ID: biblio-845223

ABSTRACT

RESUMO Objetivo Determinar a prevalência e os fatores associados à automedicação entre estudantes de enfermagem. Método Estudo transversal realizado com 116 estudantes de enfermagem de uma universidade pública do Estado do Amazonas – Brasil, no período de março a abril de 2014. Utilizou-se questionário constituído por variáveis socioeconômicas e de consumo de medicamentos. Foi realizada a análise bivariada e a regressão logística – nível de significância de 5%. Resultados A prevalência de automedicação foi de 76,0%, motivada especialmente pela percepção de que o problema de saúde não requeria visita ao médico (46,6%). Metade dos estudantes relataram queixas álgicas. Os grupos farmacológicos mais consumidos foram anti-inflamatórios não esteroides (63,2%) e antibióticos (11,1%). O desconhecimento das implicações negativas da prática da automedicação foi associado à automedicação (OR=6,0). Conclusão A alta prevalência de automedicação, além de poder levar a reações adversas retrata também o uso irracional de medicamentos pelos estudantes, especialmente, quando considerado o papel destes futuros profissionais na segurança do paciente.


RESUMEN Objetivo Determinar la prevalencia y los factores asociados con la automedicación entre estudiantes de enfermería. Métodos Estudio transversal con 116 estudiantes de enfermería de una universidad pública en Amazonas - Brasil, en el período de marzo y abril del 2014. Se utilizó un cuestionario que consta de los niveles socioeconómicos y el consumo de drogas. Se realizó un análisis bivariante y regresión logística -nivel de significación del 5%. Resultados La prevalencia de la automedicación fue de un 76,0%, motivada especialmente por la constatación de que el problema de salud requiere no visitar al médico (46,6%). La mitad de los estudiantes reportaron quejas de dolor. Los grupos de fármacos más consumidos fueron los antiinflamatorios no esteroide (63,2%) y antibióticos (11,1%). Ignorar las implicaciones negativas de la práctica de la automedicación se asoció con la automedicación (OR = 6,0). Conclusión La alta prevalencia de la automedicación, pueden dar lugar a reacciones adversas, retrata el uso irracional de los medicamentos por los estudiantes, especialmente teniendo en cuenta el papel de estos futuros profesionales de la seguridad del paciente.


ABSTRACT Objective To determine the prevalence of self-medication and associated factors among nursing students. Method This is a cross-sectional study with 116 nursing students from the public university in the state of Amazonas, Brazil, from March to April 2014. Data were collected using a questionnaire with socioeconomic and medicine use variables. The data were subjected to bivariate analysis and logistic regression at a significance level of 5%. Results The prevalence of self-medication was 76.0%, chiefly motivated by the belief that the health condition did not require a medical appointment (46.6%). Half of the students reported pain-related complaints. The most commonly used pharmacological groups were non-steroidal anti-inflammatory drugs (63.2%) and antibiotics (11.1%). Lack of awareness of the negative implications of self-medication was associated with self-medication (OR = 6.0). Conclusion The high prevalence of self-medication that may lead to adverse reactions reveals the students’ irrational use of medicines, especially considering the role of these future professionals in patient safety.


Subject(s)
Humans , Male , Female , Self Medication/statistics & numerical data , Self Medication/adverse effects , Socioeconomic Factors , Students, Nursing/statistics & numerical data , Vitamins/therapeutic use , Biological Products/therapeutic use , Brazil , Anti-Inflammatory Agents, Non-Steroidal/therapeutic use , Cross-Sectional Studies , Surveys and Questionnaires , Contraceptive Agents/therapeutic use , Drug Utilization , Nonprescription Drugs/therapeutic use , Histamine Antagonists/therapeutic use , Anti-Bacterial Agents/therapeutic use
17.
Braz. J. Psychiatry (São Paulo, 1999, Impr.) ; 36(1): 16-23, Jan-Mar. 2014. tab, graf
Article in English | LILACS | ID: lil-702645

ABSTRACT

Objectives: To describe patterns of nonprescribed use of tranquilizers by students aged 10 to 18 years and assess the sociodemographic characteristics of these adolescents and their use of other substances. Methods: A randomized and stratified sample of 47,979 students from state and private schools of the 27 Brazilian state capitals completed a self-report questionnaire. Poisson regression was used to estimate the associations between tranquilizer use and sociodemographic factors, as well as the use of other psychotropic substances. Results: The lifetime prevalence of nonprescribed use of tranquilizers was 3.9%. Use was most common among girls, wealthier adolescents, and those from private schools. An association was found between use of tranquilizers and lifetime use of alcohol (prevalence ratio [PR] = 3.15; 95% confidence intervals [95%CI] 2.58-3.85), tobacco (PR = 2.61; 95%CI 2.31-2.95), illicit drugs (PR = 3.70; 95%CI 3.19-4.29), and other prescription drugs (PR = 7.03; 95%CI 6.18-7.99). As the number of substances adolescents reported having used increased, so did the nonprescribed use of tranquilizers. Conclusions: Nonprescribed use of tranquilizers by adolescents might indicate the use of other substances, including high-risk combinations such as tranquilizers and alcohol. The risks of this association should be addressed during the early stages of drug prevention programs. .


Subject(s)
Adolescent , Child , Female , Humans , Male , Nonprescription Drugs/therapeutic use , Students/statistics & numerical data , Tranquilizing Agents/therapeutic use , Adolescent Behavior , Age Distribution , Alcohol Drinking/epidemiology , Benzodiazepines/therapeutic use , Brazil/epidemiology , Cross-Sectional Studies , Prevalence , Surveys and Questionnaires , Risk Factors , Sex Distribution , Sex Factors , Socioeconomic Factors , Substance-Related Disorders/epidemiology , Time Factors
18.
Rev. saúde pública ; 47(4): 759-768, ago. 2013. tab
Article in Portuguese | LILACS | ID: lil-695417

ABSTRACT

OBJETIVO Analisar o uso de medicamentos entre idosos e os fatores associados. MÉTODOS Estudo transversal com 400 indivíduos maiores de 60 anos residentes na área de abrangência da Estratégia Saúde da Família, em Recife, PE, em 2009. Os indivíduos foram selecionados por amostra probabilística sistemática, com coleta de dados de base domiciliar. Foram avaliadas variáveis socioeconômicas e demográficas, estilo de vida, condições de saúde e nutricionais. A variável independente foi uso de medicamentos. O diagrama analítico envolveu análises estatísticas uni e multivariadas. RESULTADOS A prevalência de uso de medicamentos foi de 85,5%. A polifarmácia (> 5 medicamentos) ocorreu em 11% dos casos. Dos 951 medicamentos relatados, 98,2% foram por prescrição médica e 21,6% foram considerados inseguros para idosos. Os medicamentos de uso nos sistemas cardiovascular (42,9%), nervoso central (20,2%), digestório e no metabolismo orgânico (17,3%) foram os mais utilizados. O uso de polifarmácia associou-se à escolaridade (p = 0,008), à saúde autorreferida (p = 0,012), à doença crônica autorreferida (p = 0,000) e ao número de consultas médicas ao ano (0,000). CONCLUSÕES A proporção de uso de medicamentos é elevada entre idosos, inclusive daqueles considerados inadequados, e há desigualdades entre grupos de idosos quando se considera escolaridade, quantidade de consultas médicas e saúde autorreferida. .


OBJETIVO Analizar el uso de medicamentos entre ancianos y los factores asociados MÉTODOS Estudio transversal con 400 individuos mayores de 60 años residentes en área abarcada por la Estrategia Salud de la Familia, en Recife, PE, Brasil, 2009. Los individuos fueron seleccionados por muestreo probabilístico sistemático, con colecta de datos de tipo domiciliar. Se evaluaron variables socioeconómicas y demográficas, estilo de vida, condiciones de salud y nutricionales. La variable independiente fue el uso de medicamentos. El diagrama analítico involucró análisis estadísticos uni y multivariados. RESULTADOS La prevalencia del uso de medicamentos fue de 85,5%. La polifarmacia (> 5 medicamentos) ocurrió en 11% de los casos. De los 951 medicamentos relatados, 98,2% fueron por prescripción médica y 21,6% fueron considerados inseguros para ancianos. Los medicamentos de uso en los sistemas cardiovascular (42,9%), nervioso central (20,2%), digestivo y en el metabolismo orgánico (17,3%) fueron los más utilizados. El uso de polifarmacia se asoció con la escolaridad (p=0,008), la salud auto-referida (p=0,012), la enfermedad crónica auto-referida (p=0,000) y el número de consultas médicas por año (p=0,000). CONCLUSIONES La proporción de uso de medicamentos es elevada entre ancianos, inclusive en aquellos considerados inadecuados, y desigualdades entre grupos de ancianos al considerarse la escolaridad, cantidad de consultas médicas y la salud auto-referida. .


OBJECTIVE To analyze medication use and associated factors among the elderly. METHODS A population-based cross-sectional study was carried out with a sample of 400 elderly people aged over 60 living in the urban area covered by the Family Health Strategy program in Recife, Northeastern Brazil in 2009. Individuals were selected by systematic random sampling and household data were collected. Demographic, socio-economic, lifestyle factors including nutrition practices and health variables were evaluated. Medication use was the independent variable. Univariate and multivariate statistical analysis were performed. RESULTS : The prevalence of medication use was 85.5%. Polypharmacy (> 5 drugs) occurred in 11% of cases. Of the 951 drugs reported, 98.2% were prescribed by doctors and 21.6% were considered unsafe for the elderly. The most commonly prescribed groups were: cardiovascular drugs (42.9%), central nervous system agents (20.2%) and drugs with an effect on the digestive tract and metabolism (17.3%). The use of polypharmacy was associated with education (p = 0.008), self-reported health (p = 0.012), self-reported chronic disease (p = 0.000) and the number of doctor appointments per year (0.000). CONCLUSIONS The results of this study indicate a high proportion of medication use among the elderly, including of those considered unsuitable, and inequality among groups of elderly individuals regarding the use ofmedication, when education, number of doctor appointments and self-reported health are considered. .


Subject(s)
Aged , Aged, 80 and over , Female , Humans , Male , Middle Aged , Pharmaceutical Preparations/administration & dosage , Polypharmacy , Brazil , Cross-Sectional Studies , Nonprescription Drugs/therapeutic use , Self Medication , Socioeconomic Factors , Urban Population/statistics & numerical data
19.
Article in English | IMSEAR | ID: sea-163230

ABSTRACT

Aims: To investigate the consumers’ attitudes and intentions to exhibit brand loyal behavior of Bangladeshi consumer on over the counter (OTC) drugs. Study Design: A cross- sectional survey. Place and Duration of Study: Consumers from the five major hospitals (Dhaka, Bangladesh) had been surveyed between January 2012 and June 2012. Methodology: The study was conducted among 100 OTC consumers in Bangladesh. Data were collected through questionnaire surveys and personal interviews. Results: The experimental data suggest that direct experience with the product, price range and brand reliance are important determinants of repetitive purchase behavior on OTC drugs. Cost sensitivity had a vital effect on intention to further purchase (r = .02, p =0.05). Moreover, earlier experience with the brand was critical in determining trustworthiness, beliefs, price sensitivity and purchase behavior. The behaviors of OTC consumers are influenced by a different set of factors. Previous experience and price sensitivity is dependent (Chi square = 31.603; p = 0.01. Furthermore, medical experience and buying an OTC product is dependent and the result were also found significant (Chi square = 32.292; p = 0.01). Conclusion: Present study shows that branding and prior experience remains the major influences to buy an OTC drug in Bangladesh.


Subject(s)
Bangladesh , Chi-Square Distribution , Consumer Advocacy , Consumer Behavior , Humans , Nonprescription Drugs/analysis , Nonprescription Drugs/economics , Nonprescription Drugs/standards , Nonprescription Drugs/supply & distribution , Nonprescription Drugs/therapeutic use
20.
Article in Portuguese | LILACS | ID: lil-658500

ABSTRACT

O presente artigo apresenta uma análise da qualidade das propagandas de medicamentos isentos de prescrição destinadas à classe médica, baseado na nova RDC no 96, de 17 de dezembro de 2008. Para análise coletou-se 16 fascículos da Revista Brasileira de Medicina (RBM) a partir de agosto 2009 a dezembro de 2010. Para averiguação da qualidade, elaborou-se um questionário dividido em três partes. Ao todo 160 peças publicitárias foram encontradas, em que 27 delas eram referentes aos medicamentos isentos de prescrição, contemplando nove indústrias farmacêuticas. Observou-se que nenhuma das peças publicitárias cumpriu na íntegra as novas regras exigidas na legislação vigente (RDC 96/08), apresentando infrações desde identificação da mesma até as proibições de figuras humanas e mensagens subjetivas. Portanto, concluiu-se que: há necessidade de implantação de um instrumento mais efetivo de fiscalização, a fim de melhorar à qualidade das propagandas para poderem ser usadas como fonte fidedigna de informação e atualização aos prescritores.


This article presents an analysis of the quality of advertisements for over-the-counter (OTC) drugs addressed to the medical profession, based on the new Anvisa resolution RDC 96 (17/12/2008). For this analysis, 16 volumes of the Brazilian Journal of Medicine (RBM) were collected, from August 2009 to December 2010. To investigate the quality of the adverts, we prepared a questionnaire divided into three parts. In total, 160 advertisements were found, of which 27 were related to drugs exempt from prescription, from 9 laboratories. It was observed that none of the advertisements complied fully with the new rules, as required by legislation (RDC 96/08), with violations ranging from identification of the advert to prohibitions of human figures and subjective messages. Therefore, it was concluded that there is a need to implement more effective monitoring, so as to improve the quality of the adverts, so they can be used as a reliable source of information and update by prescribers.


Subject(s)
Drug Publicity , Legislation, Drug , Nonprescription Drugs/therapeutic use , Propaganda
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