正天丸治疗偏头痛的有效性与安全性的系统评价  

Systematic Evaluation of Effectiveness and Safety of Zhengtian Pill for Migraine

作　　者：陈倢[1] 梁伟雄[1,2] 秦劭晨[1] 黑赏艳[1] 刘琼[3] 

机构地区：[1]广州中医药大学,广州510405 [2]广州中医药大学第二附属医院,广州510120 [3]广东医学院,广东湛江524023

出　　处：《中国实验方剂学杂志》2015年第19期194-200,共7页Chinese Journal of Experimental Traditional Medical Formulae

基　　金：国家"重大新药创制"科技重大专项(2012ZX09303009-003)

摘　　要：目的:系统评价正天丸治疗偏头痛的有效性和安全性。方法:计算机检索国内外数据库(从创建到2014年12月),查找正天丸与常规西药或安慰剂对照治疗偏头痛的随机对照试验(RCT)的文献。由2位评价员按纳入和排除标准独立筛选文献、提取资料和评价纳入研究的方法学质量后,采用Rev Man 5.3.0进行Meta分析。结果:纳入15个RCT,共956例患者。Meta分析显示:1正天丸联合尼莫地平治疗的总有效率优于对照组[RR=1.44,95%CI(1.2,1.74),P=0.000 1];2正天丸联合西比灵治疗在总有效率[RR=1.21,95%CI(1.08,1.35),P=0.000 9],偏头痛持续时间[MD=-0.84,95%CI(-12.03,-4.88),P<0.000 01]方面优于对照组;3正天丸与阿司匹林对照的总有效率差异无统计学意义[RR=1.21,95%CI(0.99,1.49),P=0.06];4正天丸与模拟剂对照,在总有效率[RR=2.5,95%CI(1.83,3.41),P=0.000 01],偏头痛持续时间[MD=-1.31,95%CI(-1.60,-1.02),P<0.000 01],发作次数[MD=-1.42,95%CI(-1.81,-1.03),P=0.000 01],发作天数[MD=-1.25,95%CI(-1.91,-0.60),P<0.000 01],发作程度[MD=-1.11,95%CI(-1.43,-0.79),P<0.000 01],改善伴随症状(恶心[MD=-1.11,95%CI(-1.27,-0.95),P<0.000 01],畏光[MD=-0.43,95%CI(-0.81,-0.28),P<0.000 01],流泪[MD=-0.54,95%CI(-0.7,-0.38),P<0.000 01]}等方面,均优于对照组。但从已有证据尚无法判断正天丸与所报告不良事件的关系。结论:目前证据提示正天丸治疗偏头痛疗效确切,在改善偏头痛发作程度、减少发作时间、减轻部分伴随症状等方面优于安慰剂,治疗偏头痛总有效率与阿司匹林相当,正天丸联合西药(尼莫地平或西比灵)治疗的效果优于纯西药治疗。但由于纳入研究的文献质量较低,本结论的可靠性和外推性有待更多高质量的随机对照试验的验证。Objective： To systematically evaluate the effectiveness and safety of Zhengtian pill for migraine. Method： The randomized controlled trails （RCTs） of Zhengtian pill and conventional western medicine or placebo in treating migraine were searched in domestic and overseas databases through computer. Literature screening, information extracting and literature quality assessment were completed by 2 reviewers independently. And Revman 5.3.0 software was adopted for the meta analysis. Result： Totally 15 RCTs involving 956 patients were included. The results showed that when compared with the control group, Zhengtian pill combined with Nimodipine group was superior in the total effective rate [ RR = 1.44, 95% CI （ 1.2, 1.74）, P = 0. 000 1 ] , Zhengtian pill combined with Flunarizine group had a better effective rate [ RR = 1.21, 95% CI （ 1.08, 1. 35） , P=0.0009] and a shorter headache duration [MD=-0.84, 95%CI （-12.03, -4.88）, P〈0.00001]; when compared with the aspirin group, Zhentian pill group bad no statistical difference in the total effective rate[RR=1.21, 95%CI （0.99, 1.49）, P=0.06]; when compared with the placebo group, Zhentian pill had a better effective rate [ RR = 2.5, 95% CI （1.83, 3.41）, P = 0.000 01 ], shorter headache duration [MD= -1.31,95%CI （ -1.60, -1.02）, P〈0.00001], lower frequency of headache [MD= -1.42,95% CI（-1.81,-1.03）, P=0.000 01], less episode days [MD = -1.25, 95%CI （ -1.91, -0.60）,P〈 0.000 01], decreased headache degree [MD = - 1.11, 95% CI （ - 1.43, -0.79）, P 〈0.000 01] and better conditions for the accompanied symptoms such as nausea [MD = -1.11, 95%CI （ -1.27, -0.95）, P 〈 0.000 01], photophobia [MD = - 0.43, 95% CI （ - 0.81, - 0.28）, P 〈 0.000 01] and less tears [ MD = - 0. 54,95% CI （ -0. 7, - 0. 38）, P 〈 0. 00001 ]. But the existing evidences cannot verify the relations between Zhengtian pill and reported adverse events. Conclusion： The current evidences showed that Zhengtian pill is effective in treating migraine

关 键 词：正天丸 偏头痛 系统评价 随机对照试验 

分 类 号：R287.6[医药卫生—中药学]