高血压患者使用左旋氨氯地平的安全性系统评价

摘要

Objective To review systematically the safety of levamlodipine (LA) in treatment of hypertension, and provide evidence for safe medication in clinical practice. Methods The databases of Ovid EMBase, PubMed, Cochrane Library, CNKI, CBM, VIP and WanFang Data were retrieved with computer from establishing time to Dec. 2017. The literature was screened, data was extracted and bias risks of included studies were reviewed by 2 researchers independently, and then a Meta-analysis was conducted by using Rev Man 5.3 software. Results There were totally 342 studies included involving 193 RCT, 42 non-RCT, 5 cohort studies and 102 case reports. The study results showed that: ①the clinical symptoms of LA-induced adverse reactions were mainly ankle edema, palpitation, flushing, headache and dizzy; ②the results of Meta-analysis for RCT, non-RCT and cohort studies showed that the incidence of cardiovascular and neural adverse reactions induced by LA were lower than that induced by other calcium channel blocker (CCB); the results of Meta-analysis for RCT and non-RCT showed that the incidence of digestive adverse reactions induced by LA were lower than that induced by other CCB; the results of Meta-analysis for RCT showed that the incidence of cardiovascular adverse reactions induced by LA were higher than that induced by ACEI/ARB; and the results of Meta-analysis for RCT showed that the incidence of cardiovascular and neural adverse reactions and systemic damage induced by LA was lower than that induced by diuretics. Conclusion LA can reduce adverse reactions with higher safety in hypertensive patients according to current clinical evidence. But the above results should be further verified by high-quality studies because of limited quality of included studies.%目的 系统评价左旋氨氯地平治疗高血压的安全性,为临床安全用药提供参考依据.方法计算机检索Ovid EMBase、PubMed、Cochrane Library、CNKI、CBM、VIP和WanFang Data,均从建库检索至2017年12月,由两位研究员独立筛选文献、提取资料和评价纳入研究的偏倚风险后,采用Rev Man 5.3软件进行Meta分析.结果 共纳入342篇研究,包括193个RCT,42个非RCT,5个队列研究,102个病例报告.研究结果显示:①左旋氨氯地平所致不良反应主要临床表现为踝部水肿、心悸、潮红、头痛和头晕等;②RCT,非RCT和队列研究的Meta分析结果提示左旋氨氯地平心血管系统和神经系统不良反应发生率低于其他钙通道阻滞剂(CCB);对于消化系统不良反应发生率,RCT和非RCT研究结果表明左旋氨氯地平低于其他CCB;但与ACEI/ARB相比,RCT研究结果显示左旋氨氯地平心血管系统不良反应发生率较高;此外,RCT研究结果显示在心血管系统、神经系统和全身性损害方面,左旋氨氯地平不良反应发生率低于利尿剂.结论 基于当前临床证据,左旋氨氯地平可减少高血压患者的不良反应,安全性较好.受纳入研究质量限制,上述结论尚期待高质量研究进一步验证.