清脑降压中成药治疗原发性高血压疗效与安全性的系统评价
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摘要
目的评价清脑降压中成药治疗原发性高血压的疗效与安全性。方法通过检索Cochrane Library、Pubmed、EMbase、中国生物医学文献数据库(CBM)、中国知网(CNKI)、维普数据库(VIP)、万方等数据库(时间为建库至2018年11月4日),全面搜集有关清脑降压中成药治疗原发性高血压的随机对照试验,并对文献进行筛选、资料提取和质量评价,质量评价参照Cochrane handbook 5.1.0标准,数据分析采用Revman 5.3。结果有7篇文献纳入评价,清脑降压联合用药组(试验组)与西药组(对照组)对比,在收缩压[MD=-9.85,95%CI(-18.29,-1.41),P=0.02]、舒张压[MD=-7.84,95%CI(-11.50,-4.18),P<0.000 1]、降压有效率[RR=1.13,95%CI(1.06,1.20),P<0.000 1]方面比较差异均有统计学意义。其中有3项研究对药物的不良反应进行了报道,随机效应模型分析结果:RR=1.44,95%CI(0.21,9.65),P=0.71;敏感性分析提示结果稳定。清脑降压单独与西药、安慰剂对比的研究均仅有1例,无法进行亚组分析。结论清脑降压中成药可在单纯降压西药的基础上,进一步提高降压疗效,而安全性方面未见明显差异。
Objective To assess the efficacy and safety of Qingnao Jiangya patent medicine(QJPM) for treating primary hypertension.Methods The literatures were retrieved from Cochrane Library,PubMed,EMbase,China Biology Medicine(CBM) database,China National Knowledge Infrastructure(CNKI) database, VIP database,and Wangfang database with the deadline on Nov 4, 2018.The randomized controlled trials(RCTs) about QJPM for primary hypertension were collected.After literature screening,data extraction,the quality of each trial was assessed according to the Cochrane handbook 5.1.0.Data analysis was performed using RevMan 5.3.Results Seven RCTs were included in this review.There were differences in systolic blood pressure(SBP) [MD=-9.85,95% CI(-18.29,-1.41),P=0.02] and diastolic blood pressure(DBP) [MD=-7.84,95% CI(-11.50,-4.18),P<0.000 1],effective rate of lowering pressure [RR=1.13,95% CI(1.06,1.20),P<0.000 1] between combined group and control group.Three studies reported adverse reactions.There was no significant difference in the adverse reactions [RR=1.44,95% CI(0.21,9.65),P=0.71] between combined group and control group.The sensitivity analysis indicated that the Results were stable.There was only one trial about QJPM compared with western medicine and placebo,and subgroup analysis could not be performed.Conclusion QJPM can further improve the antihypertensive effect on the basis of western medicine.There is no obvious difference in safety.However,due to the small number of studies included,no definite conclusion can be drawn.
Objective To assess the efficacy and safety of Qingnao Jiangya patent medicine(QJPM) for treating primary hypertension.Methods The literatures were retrieved from Cochrane Library,PubMed,EMbase,China Biology Medicine(CBM) database,China National Knowledge Infrastructure(CNKI) database, VIP database,and Wangfang database with the deadline on Nov 4, 2018.The randomized controlled trials(RCTs) about QJPM for primary hypertension were collected.After literature screening,data extraction,the quality of each trial was assessed according to the Cochrane handbook 5.1.0.Data analysis was performed using RevMan 5.3.Results Seven RCTs were included in this review.There were differences in systolic blood pressure(SBP) [MD=-9.85,95% CI(-18.29,-1.41),P=0.02] and diastolic blood pressure(DBP) [MD=-7.84,95% CI(-11.50,-4.18),P<0.000 1],effective rate of lowering pressure [RR=1.13,95% CI(1.06,1.20),P<0.000 1] between combined group and control group.Three studies reported adverse reactions.There was no significant difference in the adverse reactions [RR=1.44,95% CI(0.21,9.65),P=0.71] between combined group and control group.The sensitivity analysis indicated that the Results were stable.There was only one trial about QJPM compared with western medicine and placebo,and subgroup analysis could not be performed.Conclusion QJPM can further improve the antihypertensive effect on the basis of western medicine.There is no obvious difference in safety.However,due to the small number of studies included,no definite conclusion can be drawn.
引文
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[13] 索志荣,管振孝.清脑降压片联合氨氯地平治疗老年单纯收缩期高血压[J].中西医结合心脑血管病杂志,2009,7(10):1246-1247.
[2] WANG Z,CHEN Z,ZHANG L,et al.China hypertension survey investigators[J].Circulation,2018,29,137(22):2344-2356.
[3] LU J,LU Y,WANG X,et al.Prevalence,awareness,treatment,and control of hypertension in China:data from 1.7 million adults in a population-based screening study(China PEACE Million Persons Project)[J].Lancet,2017,390(10112):2549.
[4] 梅俊,张颖,徐凤芹.中医药治疗老年高血压研究进展[J].中西医结合心脑血管病杂志,2018,16(16):2324-2328.
[5] CFDA.中药新药临床研究指导原则(试行)[M].北京:中国医药科技出版社,2002:73-77.
[6] HIGGINS J.P T,Green S.Cochrane handbook for systematic reviews of interventions,Version 5.1.0,the Cochrane Collaboration 2015[EB/OL ].Available at:www.Cochrane handbook.org.
[7] 温勇坚.硝苯地平对老年高血压患者内皮分泌及依赖性舒张功能的影响[J].北方药学,2016,13(5):68-69.
[8] 张骞,张敏,朱思敏,等.调压方治疗老年单纯收缩期高血压阳亢络阻证疗效观察[J].宁夏医科大学学报,2014,36(4):461-463.
[9] 朱梅,臧永发,马彩虹.加用清脑降压片治疗原发性高血压(阴虚阳亢)62例[J].中国实验方剂学杂志,2013,19(4):292-294.
[10] 黄建生,胡勇光,吴锡炜.替米沙坦联合清脑降压颗粒治疗原发性高血压疗效观察[J].现代医院,2018,18(2):278-280.
[11] 任江华.清脑降压片治疗高血压(肝阳上亢证)的临床疗效及对血管内皮功能的影响[J].中国实验方剂学杂志,2012,18(24):327-330.
[12] 徐志浩.缬沙坦联合清脑降压颗粒治疗老年原发性高血压并糖尿病42例疗效观察[J].中国药业,2018,27(5):71-73.
[13] 索志荣,管振孝.清脑降压片联合氨氯地平治疗老年单纯收缩期高血压[J].中西医结合心脑血管病杂志,2009,7(10):1246-1247.