1. 北京中医药大学中医学院
2. 北京中医药大学东方医院
3. 国家中医药管理局中医医师认证中心
纸质出版:2021
移动端阅览
[1]韩梅,夏芸,李雪梅,于宁,刘建平.中药配方颗粒临床研究现状、疗效与安全性的概况性评价——以华润三九配方颗粒为例[J].中医杂志,2021,62(10):861-867.
HAN Mei, XIA Yun, LI Xuemei, et al. A Scoping Review of Clinical Researches on Chinese Herbal Dispersing Granules and Its Effectiveness and Safety: Taking Dispersing Granules Manufactured by China Resources Sanjiu as an Example[J]. Journal of Traditional Chinese Medicine2021, 62(10): 861-867.
[1]韩梅,夏芸,李雪梅,于宁,刘建平.中药配方颗粒临床研究现状、疗效与安全性的概况性评价——以华润三九配方颗粒为例[J].中医杂志,2021,62(10):861-867. DOI: 10.13288/j.11-2166/r.2021.10.008.
HAN Mei, XIA Yun, LI Xuemei, et al. A Scoping Review of Clinical Researches on Chinese Herbal Dispersing Granules and Its Effectiveness and Safety: Taking Dispersing Granules Manufactured by China Resources Sanjiu as an Example[J]. Journal of Traditional Chinese Medicine2021, 62(10): 861-867. DOI: 10.13288/j.11-2166/r.2021.10.008.
目的以华润三九配方颗粒为例
对中药配方颗粒的临床研究现状、疗效、安全性、依从性和便捷性等方面进行概况性评价。方法检索中国知网、重庆维普、万方数据知识服务平台、中国生物医学文献服务系统以及PubMed数据库中关于华润三九配方颗粒的临床研究
检索时间从建库至2018年4月30日。对临床研究概况进行描述性分析。采用Cochrane协作网偏倚风险评估方法对随机对照试验(RCT)进行质量评价
采用RevMan 5.3对RCT的临床痊愈率和临床总有效率进行Meta分析。结果截止2018年4月30日
共纳入临床研究692项
涉及研究对象共计68218例
治疗的疾病以消化系统疾病最多(116项)
占所有研究的16.8%
单个疾病最多的研究是抑郁症(27项
3.9%)。对561项RCT的Meta分析结果显示
中药配方颗粒不论是治愈率[RR=1.59
95%CI(1.52
1.66)]还是有效率[RR=1.19
95%CI(1.16
1.22)]均高于西医常规治疗;在西医常规治疗的基础上使用中药配方颗粒的治愈率[RR=1.51
95%CI(1.39
1.64)]及有效率[RR=1.23
95%CI(1.21
1.25)]疗效更佳;与中成药比较
中药配方颗粒的治愈率[RR=1.80
95%CI(1.64
1.98)]及有效率[RR=1.22
95%CI(1.17
1.28)]更优;与汤药比较
中药配方颗粒的治愈率[RR=1.08
95%CI(1.01
1.15)]及有效率[RR=1.05
95%CI(1.02
1.07)]疗效基本相当;与安慰剂比较
中药配方颗粒的治愈率[RR=1.53
95%CI(1.10
2.13)]及有效率[RR=1.54
95%CI(1.19
1.98)]约为安慰剂的1.5倍。227项研究表明
中药配方颗粒组没有任何严重的不良事件发生
不良事件在停药后均能缓解和恢复正常。部分研究显示中药配方颗粒可以缩短治疗周期
使用上具有便利性且患者依从性较好。结论中药配方颗粒单独使用或联合西医常规治疗一起使用
在治疗疾病的痊愈率和有效率两个结局上均显示出优于对照组的疗效
并且不良事件的发生率较低
部分研究显示出较好的依从性和便捷性。
Objective To review the clinical researches on Chinese herbal dispersing granules and to explore its effectiveness
safety
compliance and convenience
by taking Chinese herbal dispersing granules manufactured by China Resources Sanjiu Medical&Pharmaceutical Co.
Ltd.(CR Sanjiu) as an example. Methods CNKI
VIP
Wanfang
Sinomed and PubMed were searched from their inception dates to April 30 th
2018 for the clinical researches on Chinese herbal dispersing granules manufactured by CR Sanjiu. Descriptive analysis was performed to analyze the general condition of clinical researches. Cochrane risk of bias tool was used to assess the methodological quality of randomized controlled trials(RCTs). RevMan 5.3 was used to perform meta-analyses of clinical cure rate and clinical effectiveness rate based on RCTs. Results A total of 692 clinical researches published before April 30 th
2018 were included
and 68218 patients were involved. Digestive system diseases were mostly explored(116 trials
16.8%)
and depression was the most common disease among single-disease studies(27 trials
3.9%). There were 561 RCTs
and the meta-analyses showed that Chinese herbal dispersing granules had higher cure rate [risk ratio(RR) 1.59
95% confidence interval(CI) 1.52 to 1.66] and effectiveness rate(RR=1.19
95%CI 1.16 to 1.22) than routine treatment with western medicine; Chinese herbal dispersing granules in addition to routine treatment also had higher cure rate(RR=1.51
95% CI 1.39 to 1.64) and effectiveness rate(RR=1.23
95%CI 1.21 to 1.25) than routine treatment alone. Compared to Chinese patent medicine
dispersing granules had higher cure rate(RR=1.80
95% CI 1.64 to 1.98) and effectiveness rate(RR=1.22
95% CI 1.17 to 1.28). The dispersing granules were similar to herbal decoctions on cure rate(RR=1.08
95% CI 1.01 to 1.15) and effectiveness rate(RR=1.05
95% CI 1.02 to 1.07). The cure rate(RR=1.53
95% CI 1.10 to 2.13) and effectiveness rate(RR=1.54
95% CI 1.19 to 1.98) of dispersing granules were about 1.5 times those of placebo. Two hundred and twenty seven researches showed that there were no serious adverse events in dispersing granules group
and certain adverse events were relieved and recovered after discontinuing the medication. Certain researches demonstrated that dispersing granules can shorten the treatment duratio and is convenient with good patient compliance. Conclusion Chinese herbal dispersing granules used alone or in combination with western medicine has better effects than control group on cure rate and effectiveness rate
and less adverse events have been reported. Some studies have shown that treatment with Chinese herbal dispersing granules indicated sound compliance and convenience.
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