中成药治疗原发性高血压的系统评价再评价

Overviews of systematic reviews of listed Chinese patent medicine in the treatment of essential hypertension

  • 摘要: 目的 对降压中成药治疗原发性高血压的系统评价进行再评价。方法 计算机检索中国知网、中国生物医学文献数据库、万方、维普及PubMed、Embase、Web of Science、Cochrane图书馆等数据库,搜集2020年国家医保目录中收载的中成药治疗原发性高血压的系统评价/荟萃分析,检索时限从建库初始至2020年7月底。对纳入研究的基本特征和荟萃分析结果进行定性综合,对部分纳入研究数量较少且分散的荟萃分析进行定量合成;并利用系统综述和荟萃分析优先报告的条目(PRISMA)声明、系统评价质量评价工具2(AMSTAR-2)和等级推荐、判定、发展和评价(GRADE)评级软件分别评价所纳入系统评价的报告质量、方法学质量和证据质量。结果 最终纳入28个系统分析,包含21种中成药,22个结局指标;发表系统评价最多的中成药是松龄血脉康和养血清脑颗粒;纳入原始研究均为随机对照试验,试验方法包括补充疗法(试验组采用中成药联合对照组措施)和替代疗法(试验组单用中成药),二者比例4∶1;对照措施采用常规抗高血压化学药物。采用替代疗法的22个荟萃分析(6个中成药品种)中,19个显示中成药和化学药物的降压疗效差异无统计学意义;采用补充疗法的78个荟萃分析(17个品种)中,70个结果显示联合中成药的降压疗效优于单用化学药物;36个结果显示中成药补充疗法可使收缩压平均降低6.17~15.21 mm Hg; 34个结果显示可使舒张压平均降低2.28~14.16 mm Hg。不良反应的结果显示,中成药与化学药物之间比较差异无统计学意义或中成药组不良反应低于化学药物组。总体上看,近几年发表的系统评价报告质量和方法学质量优于早年;系统评价结局指标的证据等级多为“低”和“极低”级,共性问题多体现在方法学内容上。结论 中成药作为替代疗法的降压证据不足,而作为补充疗法积累的证据较多,但由于系统评价纳入研究的方法学质量普遍偏低,证据水平总体偏低。中医整体观和辨证论治这两大特色在试验设计中体现不足。临床医生在使用这些证据进行临床决策时需注意甄别。

     

    Abstract: Objective To overview the systematic review(SR) of antihypertensive Chinese patent medicines in the treatment of essential hypertension. Methods Firstly, the databases of CNKI(China national knowledge infrastructure), Chinese biomedical literature, Wanfang, VIP, PubMed, EMBASE, web of science, Cochrane Library were searched to identify the SR/meta-analysis of antihypertensive Chinese patent medicine on the medical insurance catalog of 2020. The retrieval period was from the establishment of the database to July 2020. Secondly, the basic characteristics and meta-analysis results of included studies were qualitatively synthesized, and the scattered meta-analyses with a small number of included studies were also quantitatively synthesized. PRISMA(preferred reporting items for systematic reviews and meta-analyses) statement, AMSTAR-2(a measurement tool to assess systematic reviews-2) tool and GRADE(grading of recommendations, assessment, development, and evaluation) rating software were used to evaluate the reporting quality, methodological quality and evidence quality of included SR.Results A total of 28 SR, with 21 Chinese patent medicines and 22 outcome indicators were included. The Chinese patent medicines with the most SR were Songling Xuemaikang and Yangxueqingnao Granules. The original studies included in the SR were all randomized controlled trials. The experimental methods included supplementary therapy(the test group adopted Chinese patent medicine combined with the control drugs) and the alternative therapy(the test group used Chinese patent medicines alone), the ratio of the two studies was 4∶1. The controls were conventional antihypertensive chemical drugs. There was no significant difference in the antihypertensive effect between Chinese patent medicine replacement therapy and chemical medicine therapy in 19 out of 22 meta-analyses(6 Chinese patent medicines). The antihypertensive effect of supplementary therapy was better than that of chemical medicine therapy in 70 out of 78 meta-analyses(17 Chinese patent medicines). The results of 36 meta-analyses showed that systolic blood pressure decreased by 6.17-15.21 mm Hg on average, and 34 meta-analyses showed diastolic blood pressure decreased by 2.28-14.16 mm Hg. There were no significant differences in adverse effects between the chemical medicine and Chinese patent medicine, or the Chinese patent medicine had fewer adverse reactions. Overall, the quality of SR reports and methodology published in recent years were better than those in earlier years, and the common problems were mostly reflected in the content of methodology. The level of evidence of SR outcome indicators was "low" and "very low". Conclusions There is insufficient evidence for Chinese patent medicine as an alternative therapy to reduce blood pressure, while there is more evidence as a complementary therapy. Due to the poor methodological quality of studies included in SR, the overall level of evidence is low. The holistic view of traditional Chinese medicines and the treatment based on syndrome differentiation are not fully reflected in the experimental design. Clinicians should carefully screen these evidence when making clinical decision.

     

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