目的 系统评价中药辨证联合降压药治疗高血压早期肾损害（hypertensive early renal damage，HT-ERD）的疗效及安全性。方法 计算机检索中国知网（CNKI）、万方数据库（Wanfang）、中文科技期刊数据库（VIP）、中国生物医学文献服务系统（SinoMed）、Web of Science、PubMed、Embase与Cochrane Library等数据库（检索时间为建库至2020年12月），收集中药辨证联合降压药治疗HT-ERD的随机对照试验（randomized controlled trial，RCT）研究；由2名研究者独立进行文献筛选、数据提取及偏倚风险评估，通过Jadad评分与Risk of Bias工具进行方法学质量评估；采用RevMan 5.4软件进行Meta分析。结果 共纳入Jadad评分≥ 4的文献24篇，共2268例患者，其中治疗组1129例，对照组1139例。Meta分析结果显示，与单纯降压药治疗相比，中药辨证联合降压药可显著降低HT-ERD患者的尿微量白蛋白（micro-albumin，mALB）[MD=-4.59，95% CI（-5.51，-3.68），P<0.000 01]、β₂微球蛋白（β₂-microglobulin，β₂-MG）[血β₂-MG，MD=-0.75，95% CI（-0.95，-0.55），P<0.000 01；尿β₂-MG，MD=-0.06，95% CI（-0.09，-0.02），P=0.000 8]、血肌酐（serum creatinine，Scr）[MD=-6.05，95% CI（-8.69，-3.41），P<0.000 01]、尿素氮（blood urea nitrogen，BUN）[MD=-1.77，95% CI（-2.88，-0.65），P=0.002<0.01]与血清胱抑素C（cystatin-C，Cys-C）[MD=-0.30，95% CI（-0.44，-0.17），P<0.000 1]水平；但在诊室血压方面，中药辨证联合降压药治疗HT-ERD的疗效并不优于单纯降压药治疗[收缩压，MD=-0.95，95% CI（-2.69，0.80），P=0.29>0.05；舒张压，MD=-0.55，95% CI（-1.85，0.76），P=0.41>0.05]。纳入17篇研究报告的安全性指标或不良反应未见明显异常。结论 现有的有限证据表明，中药辨证联合降压药对HT-ERD患者的肾功能相关指标的异常有明确的改善作用；但上述结论仍需更多大样本、高质量研究进一步验证。

Objective To systematically evaluate the efficacy and safety of traditional Chinese medicine (TCM) syndrome differentiation combined with anti-hypertensive drugs in the treatment of hypertensive early renal damage patients. Methods The databases of China National Knowledge Infrastructure (CNKI), Wanfang Database, Chinese Science and Technology Journal Database (VIP), Chinese Biomedical Literature Service System (SinoMed), Web of Science, PubMed, Embase and Cochrane Library (retrieved from the time of database establishment to December 2020) were searched by computer to collect randomized controlled trial (RCT) studies of TCM syndrome differentiation combined with anti-hypertensive drugs in the treatment of hypertensive early renal damage patients. Two investigators independently performed literature screening, data extraction, and bias risk assessment. The methodological quality assessment was evaluated according to Jadad scores and Risk of Bias tool. RevMan 5.4 software was used for Meta-analysis. Results A total of 24 articles with Jadad scores ≥ 4 were included in this study, with a total of 2268 patients, including 1129 patients in the treatment group and 1139 patients in the control group. Meta-analysis showed that compared with anti-hypertensive drugs treatment, TCM syndrome differentiation combined with anti-hypertensive drugs could significantly reduce urinary micro-albumin (mALB)[MD=-4.59, 95% CI (-5.51, -3.68), P<0.000 01], β₂-microglobulin (β₂-MG)[serum β₂-MG, MD=-0.75, 95% CI (-0.95, -0.55), P<0.000 01; urinary β₂-MG, MD=-0.06, 95% CI (-0.09, -0.02), P=0.000 8], serum creatinine (Scr)[MD=-6.05, 95% CI (-8.69, -3.41), P<0.000 01], blood urea nitrogen (BUN)[MD=-1.77, 95% CI (-2.88, -0.65), P=0.002 < 0.01], and serum cystatin-C (Cys-C)[MD=-0.30, 95% CI (-0.44, -0.17), P<0.000 1]. In terms of clinical blood pressure, the efficacy of TCM syndrome differentiation combined with anti-hypertensive drugs in the treatment of hypertensive early renal damage patients was not superior to anti-hypertensive drugs treatment alone (P>0.05)[systolic blood pressure, MD=-0.95, 95% CI (-2.69, 0.80), P=0.29 > 0.05, diastolic blood pressure, MD=-0.55, 95% CI (-1.85, 0.76), P=0.41 > 0.05]. Seventeen studies reported no significant abnormalities in safety parameters or adverse reactions. Conclusion The limited evidence shows that TCM syndrome differentiation combined with anti-hypertensive drugs has a clear improvement on abnormal renal function-related parameters in hypertensive early renal damage patients. However, the above conclusions still need to be further verified by more large-sample and high-quality studies.

R285.64

国家重点研发计划“中医药现代化研究”重点专项（2018YFC1704904）；湖南省教育厅优秀青年项目（20B436）；湖南省卫健委一般指导课题（202103102090）；杭州市科技发展计划重大项目（20180417A03）