Qiao Li-Jie, Li Bin, Wang Yong-Xia, Zhu Ming-Jun
Henan University of Chinese Medicine Zhengzhou 450000, China.
the First Affiliated Hospital of Henan University of Chinese Medicine Zhengzhou 450000, China.
Zhongguo Zhong Yao Za Zhi. 2022 Oct;47(19):5375-5382. doi: 10.19540/j.cnki.cjcmm.202206024.501.
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.
本研究采用证据图谱法，系统分析临床研究文献，了解近六年中成药防治原发性高血压的证据分布情况。检索中国知网、万方、维普、中国生物医学文献数据库、PubMed及考克兰图书馆中2016年1月至2021年12月发表的相关文献。分析证据的分布特征，并结合文字以图表形式呈现。共纳入263项研究，其中干预性研究238项、系统评价/Meta分析17项、观察性研究8项。共涉及72种中成药，其中松龄血脉康胶囊的使用频次最高。国内对中成药治疗原发性高血压的重视程度不足，表现为发表文献数量呈下降趋势且研究质量较低。临床实践中存在超说明书用药及辨证用药不足的情况。部分结局指标未体现中医药特色，存在忽视终点结局指标的情况。系统评价/Meta分析的整体质量较低，多种研究未能得出有效结论。未来，有必要规范临床用药，提高随机对照试验（RCT）质量，以产生高质量的循证医学证据，为中成药防治原发性高血压的疗效和安全性提供有力支持。
