苯磺酸左旋氨氯地平治疗原发性高血压有效性和安全性的系统评价

Efficacy and Safety of Levoamlodipine Besylate for Essential Hypertension:A Systematic Review

目的评价苯磺酸左旋氨氯地平治疗原发性高血压的有效性及安全性。方法计算机检索PubMed(1999～2007.10)、EMbase(1999～2007.10)、Cochrane图书馆(2007年第3期)、中国期刊全文数据库(1999～2007)、万方数据库(1999～2007)、维普(1999～2007)、中国生物医学文献数据库(CBM,1999～2007.10)。在严格质量评价的基础上,使用RevMan4.2软件进行系统评价。结果共初检出345篇文献,经筛选最终纳入17篇RCT进行分析。Meta分析结果显示:①有效率:苯磺酸左旋氨氯地平与吲达帕胺相比,差异有统计学意义[RD=0.14,95%CI(0.06,0.22),P=0.0004],其有效率更高;其余各亚组差异均无统计学意义,但大多显示出苯磺酸左旋氨氯地平组优于对照组的趋势。②不良反应发生率:苯磺酸左旋氨氯地平与吲达帕胺[RD=–0.12,95%CI(–0.21,–0.03),P=0.01]、氨氯地平[RD=–0.06,95%CI(–0.11,–0.01),P=0.02]、尼群地平[RD=–0.27,95%CI(–0.46,–0.08),P=0.006]相比差异有统计学意义,其不良反应发生率更低;其余各亚组差异均无统计学意义,但大多显示出苯磺酸左旋氨氯地平组不良反应发生率低于对照组的趋势。结论本系统评价结果显示,苯磺酸左旋氨氯地平治疗原发性高血压与其他降压药相比,具有疗效更好,不良反应更少的趋势。但由于本系统评价纳入研究大多质量较低,有必要开展更多设计严谨,大样本、多中心的随机对照试验来确证这种趋势。

Objective To assess the efficacy and safety of levoamlodipine besylate for essential hypertension. Methods We searched MEDLINE （1999 to October 2007）, EMBASE （1999 to October 2007）, The Cochrane Library （Issue 3, 2007）, CNKI （1999 to 2007）, Wanfang （1999 to 2007）, VIP （1999 to 2007） and CBM （1999 to October 2007）. The quality of included studies was critically evaluated. Data analyses were performed with The Cochrane Collaboration＇ s RevMan 4.2 software. Results A total of 345 articles were retrieved, but only 17 were finally included. Meta-analyses showed that the effective rate in patients receiving levoamlodipine besylate was significantly higher than that in patients receiving indapamide （RD 0.14, 95%CI 0.06 to 0.22, P=0.0004）, while no significant differences were noted between the levoamlodipine besylate group and other control groups. The incidence of adverse effects was significantly lower in the levoamlodipine besylate group compared to the indapamide group （RD -0.12, 95%C[ -0.21 to -0.03, P=0.01）, the amlodipine group （RD -0.06, 95%CI -0.11 to -0.01, P=0.02） and the nitrendipine group （RD -0.27, 95%CI -0.46 to -0.08, P=0.006）. No significant differences were observed between the levoamlodipine besylate group and other control groups. Conclusion Levoamlodipine besylate tends to have better efficacy and safety profiles compared with other antihypertensive drugs. However, most trials included in the review were of poor quality and, so, multi-center large-scale randomized controlled trials of higher quality are needed to confirm this.