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贝尼地平治疗冠心病心绞痛临床有效性和安全性的系统评价
Efficacy and Safety of Benitepin in the Treatment of Coronary Heart Disease Angina Pectoris: a Systematic Review
  
DOI:
中文关键词:  贝尼地平  冠心病心绞痛  有效性  安全性  系统评价  随机对照试验
英文关键词:Bendipine  Angina pectoris  Efficacy  Safety  Systematic review  Randomized controlled trial
基金项目:北京市卫生和计划生育委员会老年重大疾病关键技术研究项目(编号:PXM2017_026283_000002)
作者单位
刘泽辉1,2 刘桦1 高扬1 1.航天中心医院药剂科 北京 100049 2.首都医科大学宣武医院药学部 
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中文摘要:
      摘 要 目的:系统评价贝尼地平治疗冠心病心绞痛患者的疗效与安全性,为临床提供循证依据。 方法:计算机检索CNKI、CDDBFT、WanFang Data、VIP、the Cochrane Library、Medline(EBSCO)和PubMed数据库,搜集关于贝尼地平治疗冠心病心绞痛的随机对照试验(randomized controlled trials,RCTs),检索时限均从建库至2018年10 月,由 两名研究者独立筛选文献、提取资料并评价纳入研究的偏倚风险后,采用 RevMan 5.3软件进行 Meta 分析。 结果:共纳入 12个 RCTs ,包含 1 460 例冠心病心绞痛患者。Meta分析结果显示,与常规疗法联用其他钙通道阻滞药(CCB)或常规疗法的对照组相比,贝尼地平治疗组可明显提高冠心病心绞痛患者的治疗有效率[OR=2.56,95%CI(1.93,3.40),P<0.000 01] 、抑制治疗后心电图S T段下降 [MD=-0.34,95%CI(-0.50,-0.19),P<0.000 1] 、抑制治疗后舒张压下降[MD=3.78,95%CI(0.60,6.95),P=0.02];两组患者治疗后收缩压降低值的差异无统计学意义[MD=3.78,95%CI(-0.75,8.30),P>0.05];安全性方面,贝尼地平治疗冠心病心绞痛患者的不良反应发生率低于照组[OR=0.52,95%CI(0.32,0.83),P=0.006]、且能抑制心率增加[MD=-6.19,95%CI(-8.65,-3.72),P<0.000 01]。〖HTH〗结论:〖HTK〗基于当前证据,使用贝尼地平治疗冠心病心绞痛的疗效显著,且安全性较好。受纳入研究数量和质量的限制,上述结论尚待更多高质量研究予以验证。
英文摘要:
      ABSTRACT Objective: To evaluate the safety and efficiency of bendipine for coronary heart disease angina pectoris, in order to provide evidence based reference for clinical use. Methods:CNKI, CDDBFT, WanFang Data, VIP, the Cochrane Library, Medline (EBSCO) and PubMed were electronically searched to collect randomized controlled trials (RCTs) of bendipine for coronary heart disease angina pectoris from inception to October, 2018. Two researchers independently screened literature, extracted data and assessed the risk of bias of included studies, then, Meta analysis was performed by RevMan 5.3 software. Results: A total of 12 RCTs involving 1 460 angina pectoris patients were included. The results of Meta analysis showed that: compared with routine treatment or routine treatment combined with calcium channel blocker, benitepine treatment group could significantly improve the treatment efficiency of patients with angina pectoris (OR=2.56, 95%CI 1.93 to 3.40, P<0.000 01), prevent ECG S T segment reduced value (MD=-0.34, 95%CI -0.50 to -0.19, P<0.000 1), reduce diastolic pressure declined after treatment (MD=3.78, 95%CI 0.60 to 6.95, P=0.02). There was no statistically significant difference in reduce systolic pressure declined after treatment between two groups (MD=3.78, 95%CI -0.75 to 8.30, P>0.05). The incidence of adverse reaction in benitepine treatment group was lower than control group (OR=0.52, 95%CI 0.32 to 0.83, P=0.006). The benitepine treatment group could delayed heart rate increasing (MD=-6.19, 95%CI -8.65 to -3.72, P<0.000 01). Conclusion:Bendipine demonstrated curative effect on coronary heart disease angina pectoris, and no obvious side effects. Due to limited quality and quantity of the included studies, more high quality studies are needed to verify above conclusion.
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