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作 者:庞国勋[1] 马银玲[1] 邱志宏[1] 高瑾[1] 董占军[1] PANG Guo-xun;MA Yin-ling;QIU Zhi-hong;GAO Jin;DONG Zhan-Jun(Heibei General hospital,Hebei Shijiazhuang 050051,China)
出 处:《中国药物评价》2018年第5期384-390,共7页Chinese Journal of Drug Evaluation
基 金:河北省医学适用技术跟踪项目(GL201607)
摘 要:目的:系统评价口服硝苯地平与静脉注射拉贝洛尔治疗重度妊娠期高血压的有效性及安全性。方法:检索Cochrane library、Pub Med、EMBASE、Sino Med、CNKI、VIP、万方,均从建库日期检索至2017年12月,纳入口服硝苯地平与静脉注射拉贝洛尔治疗重度妊娠期高血压的随机对照试验(RCT),由2名评价员独立提取资料,并对其方法学质量进行评价。对符合纳入标准的研究采用Rev Man 5. 3软件进行Meta分析。结果:纳入9个研究,共737名孕妇,根据给药剂量的不同进行亚组分析,Meta分析结果显示:口服硝苯地平较静脉注射拉贝洛尔达到目标血压所需时间(WMD=-10. 45,95%CI:-10. 45~-4. 06,P=0. 001)更短,但二者达到目标血压所用最大剂量与初始剂量的比值(WMD=-0. 57,95%CI:-1. 16~0. 03,P=0. 06)无统计学意义。安全性方面,孕妇不良反应的发生率(RR=0. 92,95%CI:0. 54~1. 58,P=0. 77)及5 min新生儿Apgar评分<7(RR=0. 67,95%CI:0. 39~1. 17,P=0. 16)比较,差异均无统计学意义(P> 0. 05)。结论:现有研究显示口服硝苯地平与静脉注射拉贝洛尔治疗重度妊娠期高血压作用显著,且安全性较好。硝苯地平组达到目标血压的时间更少,但仍需要更多高质量、多中心的随机对照研究,提供更真实、可靠的证据。Objective:To determine the efficacy and safety of oral nifedipine for treatment of severe hypertension of pregnancy compared with intravenous labetalol. Methods : Retrieval with computer from the Cochrane Library, PubMed, EMBASE, SinoMed, CNKI, VIP, Wanfang databases were performed to collect randomized controlled trials(RCTs) on the treatment of severe hypertension during pregnancy using oral nifedipine or intravenous labetalol from their establishments up to December, 2017. Two reviewers analyzed these data independently. The included studies were evaluated according to the Cochrane systematic review. The results of RCTs were analyzed by Rev Man 5.3 software. Results : According to the initial dosing scheme and maximum doses of different subgroup analysis, the pooled analysis of nine trials consisting of 737 woman-infant pairs showed that oral nifedipine was associated with less time to target blood pressure( MD = - 11.48, 95% CI: - 13.72 - -9.24, P =0. 000 2) , however, the ratio of the maximum close and initial close ( MD = -0. 57, 95% CI: - 1.16 - 0. 03 P 〈0. 000 01 ) was no significant difference. In terms of safely, there was reported maternal side effects( OR = 0.94,95% CI:0.43 - 2.04,P =0.008) and the 5 mins APGAR score less than 7(OR = 0.64,95% CI: 0. 35 - 1.19,P = 0. 93) not reach statistical signi? cance. Conclusion: Current evidence demonstrates that oral nifedipine is as efficacious and safe as intravenous labetalol, oral nifedipine was associated with less time to target blood pressure but it needs further studies to provide more sufficient evidence.
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