左旋氨氯地平与氨氯地平治疗原发性高血压有效性和安全性的Meta分析

目的:系统评价左旋氨氯地平与氨氯地平治疗原发性高血压的有效性和安全性。方法:计算机检索Medline、EMbase、Cochrane图书馆临床对照试验资料库、中国生物医学文献光盘数据库(CBM)及中国期刊全文数据库(CNKI),纳入比较左旋氨氯地平与氨氯地平治疗原发性高血压的随机对照试验(RCT),对纳入研究的方法学质量进行评价,并应用RevMan5.1软件进行统计分析。结果:共纳入20项RCT,合计3127例患者。Meta分析结果表明,左旋氨氯地平和氨氯地平均能有效降低血压,总有效率[RR=1.04,95%CI(1.00,1.08),P=0.08]、诊室收缩压下降值[SMD=-0.40,95%CI(-0.84,0.05),P=0.08]、24小时平均收缩压下降值[WMD=-0.18,95%CI(-1.05,0.68),P=0.68]、剂量增加的人数[RR=0.82,95%CI(0.64,1.05),P=0.11]比较,差异均无统计学意义;左旋氨氯地平降低诊室舒张压[SMD=-0.43,95%C(I-0.81,-0.06),P=0.02]及24小时平均舒张压的效果优于氨氯地平[WMD=-0.86,95%CI(-1.65,-0.07),P=0.03]。左旋氨氯地平组的不良反应发生率少于氨氯地平组[RR=0.43,95%C(I0.33,0.57),P<0.00001]。结论:左旋氨氯地平治疗原发性高血压的疗效与氨氯地平相当,降低舒张压的效果更好,不良反应较少。但由于纳入研究质量所限,降低了本系统评价结论的可靠性,要进一步验证其疗效和安全性,尚需进行设计合理、执行严格、多中心大样本且随访时间足够的RCT。

Meta-analysis of Effectiveness and Safety of Levoamlodipine and Amlodipine for Essential Hypertension

OBJECTIVE:To systematically evaluate the effectiveness and security of levoamlodipine and amlodipine in the treatment of essential hypertension.METHODS:We searched Medline,Embase,Cochrane Library,CBM and CNKI,randomized controlled trials(RCT) on levoamlodipine and amlodipine in the treatment of essential hypertension were included and compared.The methodological quality of included studies was evaluated and meta-analysis was performed by RevMan 5.1 software.RESULTS:20 RCT invdving 3 127 patieuts were included.Meta-analysis showed that both levamlodipine and amlodipine were effective in lowering blood pressure.There were no statistical differences in total efficiency[RR=1.04,95%CI(1.00,1.08),P=0.08],decreased value of systolic blood pressure[SMD=-0.40,95%CI(-0.84,0.05),P=0.08],decreased value of 24 h average systolic blood pressure[WMD=-0.18,95%CI(-1.05,0.68),P=0.68],the number of doses increase[RR=0.82,95%CI(0.64,1.05),P=0.11].Levoamlodipine was better than amlodipine in the effect of reducing the clinic diastolic blood pressure[SMD=-0.43,95%CI(-0.81,-0.06),P=0.02] and 24 h average diastolic blood pressure[WMD=-0.86,95%CI(-1.65,-0.07),P=0.03].Safety analysis showed the incidence of adverse drug reaction in levoamlodipine group was less than in amlodipine group[RR=0.43,95%CI(0.33,0.57),P<0.000 01].CONCLUSIONS:According to the result of Meta-analysis,levoamlodipine is similar to amlodipine in the treatment of essential hypertension,and levoamlodipine is better than amlodipine in the effect of reducing the diastolic blood pressure with less adverse drug reaction.The reliability of systematic review is affected by low quality of included study.Further reasonable designed,multi-center and large-scale randomized controlled trials with enough following-up should be carried out to validate the therapeutic efficacy and safety.