马尼地平治疗高血压有效性与安全性的Meta分析

A Meta-analysis on efficacy and safety of manidipine on hypertension

目的研究马尼地平与氨氯地平相比治疗高血压的有效性与安全性。方法计算机检索Pub Med、EMbase、Cochrane图书馆临床对照试验资料库、中国知网(CNKI)、中国生物医学文献数据库(CBM)、万方数据库,检索时间均从建库至2014年2月28日。由2名评价员根据纳入与排除标准独立进行文献筛选、资料提取和质量评价并交叉核对后,采用Rev Man 5.2进行Meta分析。结果共纳入10项随机对照研究,共1625例患者。Meta分析结果显示:马尼地平在降低诊室坐位收缩压(MD=-0.81,95%CI:-1.88~0.26)、舒张压(MD=-0.31,95%CI:-0.96~0.34)及需要增加剂量的患者数量(RR=1.08,95%CI:0.97~1.20)与氨氯地平比较,无统计学差异。然而在总不良反应发生率(RR=0.73,95%CI:0.58~0.90)、水肿发生率(RR=0.35,95%CI:0.23~0.53)方面,显著优于氨氯地平组。与氨氯地平相比,马尼地平可轻微的降低心率(WMD=-0.21,95%CI:-0.40^-0.02)。结论目前证据显示,马尼地平降低诊室坐位收缩压、舒张压的程度与氨氯地平类似;其耐受性较好,总不良反应发生率和水肿发生率显著低于氨氯地平。但仍需进一步设计良好的大型临床研究予以证实。

Objective To compare the efficacy and safety of manidipine and amlodipine in hypertension treatment.Methods The databases of PubMed, EMbase, Cochrane Controlled Trials Register, CNKI, CBM and WanFang Database were retrieved with computer from database establish time to Feb. 28, 2014. The data was screened, extracted and reviewed by 2 researchers independently according to inclusion and exclusion criteria, and after cross-checking, was given a Meta-analysis by using RevMan 5.2 software.Results There were totally 10 RCT included involving 1625 cases, and the results of Meta-analysis showed that there was no statistical difference between manidipine and amlodipine in sitting systolic blood pressure （MD=-0.81, 95%CI： -1.88-0.26）, sitting diastolic blood pressure （MD=-0.31, 95%CI： -0.96-0.34） and number of patients needed to increase drug dose （RR=1.08, 95%CI： 0.97-1.20）. Manidipine was significantly superior to amlodipine in the total incidence of adverse reactions （RR=0.73, 95%CI： 0.58-0.90） and edema incidence （RR=0.35, 95%CI： 0.23-0.53）. Manidipine could mildly reduce heart rate （WMD=-0.21, 95%CI： -0.40--0.02） compared with amlodipine.Conclusion The current evidence shows that manidipine and amlodipine are similar to each other in reducing sitting systolic blood pressure and sitting diastolic blood pressure, and manidipine has higher tolerance. The total incidence of adverse reactions and edema incidence induced by manidipine are significantly lower than those induced by amlodipine. More well-designed large-scale clinical studies are required for further verifying the results.