口服硝苯地平与静脉注射拉贝洛尔治疗妊娠期高血压急症有效性及安全性比较的系统评价

摘要

目的:系统评价口服硝苯地平与静脉注射拉贝洛尔分别治疗妊娠期高血压急症的有效性及安全性.方法:通过检索数据库,搜集口服硝苯地平与静脉注射拉贝洛尔分别治疗妊娠期高血压急症的相关随机对照试验,根据Cochrane系统评价方法对纳入的研究进行质量评价,采用RevMan 5.3软件进行文献荟萃(Meta)分析.结果:纳入7个随机对照试验,共480例患者.Meta分析结果显示,与静脉注射拉贝洛尔组患者比较,口服硝苯地平组患者达到目标血压所需时间明显更短,差异有统计学意义(MD=-12.12,95％CI=-20.25～-3.99,P=0.003);2组患者达到目标血压所用治疗剂量与初始剂量比值的差异无统计学意义(MD=-0.51,95％CI=-1.08～0.05,P=0.07).安全性方面,两组围产期妇女不良反应发生率(OR=0.98,95％CI=0.27～3.50,P=0.97)、5 min Apgar评分<7分的新生儿数(OR=0.42,95％CI=0.14～1.25,P=0.12)及重症监护住院新生儿数(OR=0.74,95％CI=0.43～1.29,P=0.29)比较,差异均无统计学意义.结论:口服硝苯地平与静脉注射拉贝洛尔都可以用于治疗妊娠期高血压急症,口服硝苯地平达到目标血压需要的时间更少,但仍需要更多设计严格的大样本随机对照研究为临床提供更可靠的证据.%OBJECTIVE: To systematically evaluate the efficacy and safety of oral nifedipine and labetalol for intravenous injection in respective treatment of acute gestational hypertension . METHODS: After retrieving the database , randomized controlled trials on oral nifedipine and labetalol for intravenous injection in respective treatment of acute gestational hypertension were collected and involved in quality evaluation in accordance with Cochrane systematic review , RevMan 5.3 was then adopted to conduct Meta analysis .RESULTS: 7 RCTs were involved , including 480 patients .Results of Meta analysis indicated that it took significantly shorter time to achieve target blood pressure among patients received oral nifedipine than given labetalol for intravenous injection , the difference was statistically significant (MD=-12.12, 95％CI=-20.25--3.99, P=0.03); there was no statistical significance in the differences of ratios of target blood pressure required therapeutic dose to initial dose between two groups ( MD=-0.51 , 95％CI =-1.08-0.05 , P =0.07 ) . About the safety , there were no statistical significances in the differences of incidences of adverse drug reactions in perinatal women ( OR=0.98, 95％CI=0.27-3.50, P=0.97) , the number of newborns scored <7 in 5 min Apgar scores (OR=0.42, 95％CI=0.14-1.25, P=0.12) and number of hospitalized newborns in ICU (OR=0.74, 95％CI=0.43-1.29, P=0.29) between two groups.CONCLUSIONS:Both oral nifedipine and labetalol for intravenous injection can be used in treatment of acute gestational hypertension , and it takes significantly shorter time to achieve target blood pressure among patients received oral nifedipine , however , RCTs with strict design and large sample size are needed to provide more reliable clinical evidence .