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非洛地平对比硝苯地平治疗中国人原发性高血压的Meta分析及其GRADE证据质量评价
Felodipine vs. Nifedipine for Chinese Patients with Essential Hypertension: a Meta-analysis and Quality of Evidence Evaluation based on GRADE System
  
DOI:
中文关键词:  非洛地平  硝苯地平  原发性高血压  Meta分析  GRADE系统
英文关键词:Felodipine  Nifedipine  Essential hypertension  Meta-analysis  GRADE system
基金项目:
作者单位
刘利勤 李青 ①山西医科大学药学院(太原 030001)②山西医科大学第一医院药学部 
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中文摘要:
      摘 要 目的:采用Meta分析方法评价非洛地平对比硝苯地平治疗中国人原发性高血压的疗效和安全性。方法:计算机检索the Cochrane Library(2016年第11期)、PubMed、MEDLINE、Embase、CNKI、WanFang Data、VIP、SinoMed,检索时限均为建库至2016年11月15日,全面收集非洛地平对比硝苯地平治疗中国人原发性高血压的随机对照试验(RCTs)。采用Cochrane系统评价手册进行严格质量评价,经RevMan 5.3统计软件对符合标准的RCTs进行Meta分析,并用GRADE profiler 3.6软件进行证据质量评价。结果:共纳入14个RCTs,包括1 909例患者。Meta分析结果显示,与硝苯地平相比,非洛地平能提高原发性高血压患者的总有效率(OR=3.58,95%CI:2.08~6.18,P<0.05)和显效率(OR=2.24,95%CI:1.52~3.31,P<0.05),增加收缩压降低值(ΔSBP,MD=5.83,95%CI:0.70~10.97,P<0.05)和舒张压降低值(ΔDBP,MD=3.63,95%CI:-0.02~7.29,P=0.05),降低药品不良反应发生率(RR=0.41,95%CI:0.31~0.55,P<0.05)。证据等级显示,总有效率、ΔSBP和ΔDBP为极低级,显效率和ADR发生率为低级,推荐强度均为弱推荐。结论:基于现有临床证据,与硝苯地平比较,非洛地平疗效和安全性均更好,值得临床推广。由于纳入研究的质量不高,该结论有待高质量的RCTs进一步验证。
英文摘要:
      ABSTRACT Objective:To make a Meta-analysis on the efficacy and safety of felodipine vs. nifedipine for the treatment of Chinese patients with essential hypertension by Meta-analysis. Methods: The Cochrane Library (Issue11,Nov.2016), PubMed, MEDLINE, Embase, CNKI, WanFang Data, VIP, SinoMed were electronically searched up to 15st November 2016. Randomized controlled trials (RCTs) that reported felodipine vs. nifedipine in treating Chinese patients with essential hypertension were included. Meta-analysis was performed by RevMan 5.3 statistical software on the basis of critically evaluated the quality of the included studies with the Cochrane systematic evaluated manual. The evidence quality was assessed with GRADE profiler 3.6 software. Results:14 RCTs with 1 909 patients were included. Meta-analysis indicated that the total effective rate in patients receiving felodipine was significantly higher than that in patients receiving nifedipine (OR=3.58, 95%CI: 2.08 6.18, P<0.05), and the excellent rate (OR=2.24, 95%CI: 1.52 3.31, P<0.05), and ΔSBP (MD=5.83, 95%CI: 0.70 10.97,P<0.05), and ΔDBP (MD=3.63, 95%CI:-0.02 7.29,P=0.05). While the adverse drug reaction(ADR) rate was significantly lower in the felodipine group compared to the nifedipine group (RR=0.41, 95%CI: 0.31 0.55, P<0.05). The evidence quality was very low in total effective rate, ΔSBP and ΔDBP; low in excellent rate and ADR rate. And the strength of recommendation was 2. Conclusion:The result indicated that felodipine was better than nifedipine on efficacy and safety, which is thus worthy of clinical application. Due to the poor quality of included studies, high quality RCT were required to further validate above conclusions.
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