头痛宁联合氟桂利嗪治疗偏头痛的Meta分析及序贯分析
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摘要
目的:系统评价头痛宁联合氟桂利嗪治疗偏头痛的疗效及安全性。方法:电子检索PubMed、Cochrane library、Embase、CNKI、VIP、万方和CBM,检索时间限定为自建库至2017年7月6日,检出所有头痛宁联合氟桂利嗪治疗偏头痛的有关文献,2名研究员独立严格进行纳入研究的质量评价和资料提取,用Stata 14.0软件进行Meta分析,用TSA v 0.9软件进行试验序贯分析。采用Harbord方法或Egger检验及剪补法进行发表偏倚的检验。结果:共纳入16个RCT包括1 746例患者。Meta分析结果显示总有疗效(RR=1.21,95%CI[1.16,1.26])、CGRP(WMD=-0.25,95%CI[-0.39,-0.12])、VAS评分(WMD=-1.04,95%CI[-1.42,-0.66])、血钾浓度(WMD=-2.05,95%CI[-0.32,-0.18])、血镁浓度(WMD=0.09,95%CI[0.04,0.14])、血管血流速度等比较差异均有统计学意义(P<0.05),治疗组优于对照组。治疗组不良反应发生率为2.27%,对照组为2.89%。试验序贯分析提示头痛宁联合氟桂利嗪治疗偏头痛总有效率证据确切。结论:头痛宁联合氟桂利嗪能显著提高总有疗效,改善VAS评分、CGRP、血钾及血镁浓度、血管血流速度,且不良反应较少,值得临床推广。
OBJECTIVE To systematically review the efficacy and safety of Toutongning capsules combined with flunarizine against migraine.METHODS Such databases as PubMed,Cochrane library,Embase,CNKI,VIP,Wanfang data and CBM were searched in order to collect literatures about Toutongning capsules combined with flunarizine against migraine on the deadline to July 6,2017.Two researchers independently screened literatures according to the inclusion and exclusion criteria,and evaluated the methodological quality of included studies.Meta-analysis and TSA analysis were carried out by using Stata 14 version and TSA v 0.9 respectively.The publication bias was utilized to evaluate by Harbord or Egger test and Trim and Filled method.RESULTS Totally 16 RCT including 1 746 cases were included eventually.The analysis showed that the curative effect of Toutongning capsules combined with flunarizine against migraine in the improvement of total efficiency(RR=1.21,95% CI[1.16,1.26]),CGRP(WMD=-0.25,95% CI [-0.39,-0.12]),VAS score(WMD=-1.04,95%CI[-1.42,-0.66]),serum potassium concentration(WMD=-2.05,95%CI[-0.32,-0.18]),blood magnesium concentration(WMD=0.09,95%CI[0.04,0.14])and blood vessel velocity were better than those of flunarizine alone.The incidence of adverse reactions was 2.27%in the treatment group and 2.89%in the control group.Subgroup analysis showed that the total effective rate was increased in all subgroups(P<0.05).The TSA analysis showed that the evidence of the total effective rate was definite.CONCLUSION Toutongning capsules combined with flunarizine can increase efficacy in the treatment of migraine,and improve VAS score,CGRP,serum potassium and blood magnesium concentration and blood vessel velocity,which is worthy of clinical promotion.
OBJECTIVE To systematically review the efficacy and safety of Toutongning capsules combined with flunarizine against migraine.METHODS Such databases as PubMed,Cochrane library,Embase,CNKI,VIP,Wanfang data and CBM were searched in order to collect literatures about Toutongning capsules combined with flunarizine against migraine on the deadline to July 6,2017.Two researchers independently screened literatures according to the inclusion and exclusion criteria,and evaluated the methodological quality of included studies.Meta-analysis and TSA analysis were carried out by using Stata 14 version and TSA v 0.9 respectively.The publication bias was utilized to evaluate by Harbord or Egger test and Trim and Filled method.RESULTS Totally 16 RCT including 1 746 cases were included eventually.The analysis showed that the curative effect of Toutongning capsules combined with flunarizine against migraine in the improvement of total efficiency(RR=1.21,95% CI[1.16,1.26]),CGRP(WMD=-0.25,95% CI [-0.39,-0.12]),VAS score(WMD=-1.04,95%CI[-1.42,-0.66]),serum potassium concentration(WMD=-2.05,95%CI[-0.32,-0.18]),blood magnesium concentration(WMD=0.09,95%CI[0.04,0.14])and blood vessel velocity were better than those of flunarizine alone.The incidence of adverse reactions was 2.27%in the treatment group and 2.89%in the control group.Subgroup analysis showed that the total effective rate was increased in all subgroups(P<0.05).The TSA analysis showed that the evidence of the total effective rate was definite.CONCLUSION Toutongning capsules combined with flunarizine can increase efficacy in the treatment of migraine,and improve VAS score,CGRP,serum potassium and blood magnesium concentration and blood vessel velocity,which is worthy of clinical promotion.
引文
[1]Yu SY,Chen M.The strategy of drug therapy for migraine in adults[J].Chin J New Drug(中国新药杂志),2014,23(14):1631-1636.
[2]Nie XZ,Du X,Zhang RR,et al.Study on regulation mechanism of Toutongning capsule through TNF signaling pathway in treatment of migraine based on systems pharmacology method[J].Chin J Chin Materia Med(中国中药杂志),2017,42(3):548-554.
[3]Ma J,Liu N,Chen J,et al.Clinical effect of Toutongning Capsules combined with Flunarizine Capsules in treatment of migraine[J].Chin Tradit Patent Med(中成药),2013,35(4):677-680.
[4]Lu QH,Liu HY.Clinical Study on Toutongning capsule in treatment of omigraine[J].J Emerg Tradit Chin Med(中国中医急症),2011,20(12):1908-1909.
[5]Cochrane Handbook for Systematic Reviews of Interventions Version 5.0.1[updated September 2008].The Cochrane Collaboration,2008.
[6]Weng H,Li S,Zeng XT,et al.Application of the Trial Sequential Analysis Soft ware for Meta-analysis[J].Chin J Evid Based Med(中国循证医学杂志),2016,16(5):604-611.
[7]Gao P.Effect of Flunarizine combined with headache Ning Capsule on migraine patients and its effect on serum MMP-9,TNF-αand LPA[J].J Clin Exper Med(临床和实验医学杂志),2017,16(4):379-382.
[8]Li CS.Clinical effect of Toutongning Capsules combined with Flunarizine in treatment of migraine[J].Henan Med Res(河南医学研究),2017,26(3):516-517.
[9]Li SF.50cases of Toutongning Capsules combined with Flunarizine Capsules in treating migraine[J].Chin Naturopathy(中国民间疗法),2015,23(3):61-62.
[10]Lin WH.A clinical observation of Toutongning Capsules combined with Flunarizine in treatment of migraine[J].Strait Pharmaceut J(海峡药学),2017,29(2):133-134.
[11]Liu XJ,Liu Y,Cao AB,et al.A clinical observation of Toutongning Capsules combined with Flunarizine in treatment and prevention of migraine[J].J Pract Tradit Chin Med(实用中医药杂志),2013,29(12):1006-1007.
[12]Lu XL.Effect observation of Toutongning Capsules combined with Flunarizine in treatment of migraine in 30cases[J].Guangxi Med J(广西医学),2013,35(7):960-961.
[13]Peng Y.Clinical effect observation of Toutongning Capsules combined with Flunarizine in treatment of migraine[J].Chin Health Indust(中国卫生产业),2014,11(5):91,93.
[14]Shi HZ.Clinical effect observation of Toutongning Capsules combined with Flunarizine in treating migraine[J].Med J Chin People’s Health(中国民康医学),2011,23(6):690,699.
[15]Sun DB,Li WY,Li XY.The Effect observation of Flunarizine combined with Toutongning capsules in treatment of patients with migraine[J].People’s Milit Surg(人民军医),2011,54(8):705-706.
[16]Tan XW,Wang XL,Jin MX,et al.Clinical analysis of 30cases of migraine treated with integrated traditional Chinese and Western Medicine[J].Chin Pract Med(中国实用医药),2014,9(31):186-187.
[17]Tang K.Headache Ning Tong Ning combined with flunarizine capsules in the tratment of patients with migraine Clinical observation of curative effect and biochemical indexes[D].Lanzhou University(兰州大学),2011.
[18]Tian L.The Effect observation ofToutongning capsules combined with Flunarizine in treatment of patients with migraine[J].Chin J Pract Nervous Dis(中国实用神经疾病杂志),2010,13(17):84-85.
[19]Wang CL.The Clinical Effect observation of Flunarizine combined with Toutongning capsules in treatment of migraine[J].Chin Pract Med(中国实用医药),2011,6(22):143-144.
[20]Xiao YJ.The Clinical Effect observation of Flunarizine capsules combined with traditional Chinese medicine in treatment of migraine[J].Jiangxi Med J(江西医药),2016,51(7):645-647.
[21]Zuo XH,Wang JZ.Toutongning capsules combined with Flunarizine in treatment of patients with migraine[J].Clin Med(临床医学),2009,29(2):69-70.
[22]Zhang ZX,Cao KG,Fan JP.Migraine of Traditional Chinese Medicine Diagnosis and Treatment Rule[J].Chin Arch Tradit Chin Med(中华中医药学刊),2011,29(4):717-719.
[23]Yang HX,Zhang YQ,Liu B.Therapeutic Effect of Toutongning Capsule in Treatment of Patients with Migraine and its Effects on Blood Platelet and Hemorrheological Parameters[J].Chin J Exp Tradit Med Form(中国实验方剂学杂志),2012,18(5):230-232.
[2]Nie XZ,Du X,Zhang RR,et al.Study on regulation mechanism of Toutongning capsule through TNF signaling pathway in treatment of migraine based on systems pharmacology method[J].Chin J Chin Materia Med(中国中药杂志),2017,42(3):548-554.
[3]Ma J,Liu N,Chen J,et al.Clinical effect of Toutongning Capsules combined with Flunarizine Capsules in treatment of migraine[J].Chin Tradit Patent Med(中成药),2013,35(4):677-680.
[4]Lu QH,Liu HY.Clinical Study on Toutongning capsule in treatment of omigraine[J].J Emerg Tradit Chin Med(中国中医急症),2011,20(12):1908-1909.
[5]Cochrane Handbook for Systematic Reviews of Interventions Version 5.0.1[updated September 2008].The Cochrane Collaboration,2008.
[6]Weng H,Li S,Zeng XT,et al.Application of the Trial Sequential Analysis Soft ware for Meta-analysis[J].Chin J Evid Based Med(中国循证医学杂志),2016,16(5):604-611.
[7]Gao P.Effect of Flunarizine combined with headache Ning Capsule on migraine patients and its effect on serum MMP-9,TNF-αand LPA[J].J Clin Exper Med(临床和实验医学杂志),2017,16(4):379-382.
[8]Li CS.Clinical effect of Toutongning Capsules combined with Flunarizine in treatment of migraine[J].Henan Med Res(河南医学研究),2017,26(3):516-517.
[9]Li SF.50cases of Toutongning Capsules combined with Flunarizine Capsules in treating migraine[J].Chin Naturopathy(中国民间疗法),2015,23(3):61-62.
[10]Lin WH.A clinical observation of Toutongning Capsules combined with Flunarizine in treatment of migraine[J].Strait Pharmaceut J(海峡药学),2017,29(2):133-134.
[11]Liu XJ,Liu Y,Cao AB,et al.A clinical observation of Toutongning Capsules combined with Flunarizine in treatment and prevention of migraine[J].J Pract Tradit Chin Med(实用中医药杂志),2013,29(12):1006-1007.
[12]Lu XL.Effect observation of Toutongning Capsules combined with Flunarizine in treatment of migraine in 30cases[J].Guangxi Med J(广西医学),2013,35(7):960-961.
[13]Peng Y.Clinical effect observation of Toutongning Capsules combined with Flunarizine in treatment of migraine[J].Chin Health Indust(中国卫生产业),2014,11(5):91,93.
[14]Shi HZ.Clinical effect observation of Toutongning Capsules combined with Flunarizine in treating migraine[J].Med J Chin People’s Health(中国民康医学),2011,23(6):690,699.
[15]Sun DB,Li WY,Li XY.The Effect observation of Flunarizine combined with Toutongning capsules in treatment of patients with migraine[J].People’s Milit Surg(人民军医),2011,54(8):705-706.
[16]Tan XW,Wang XL,Jin MX,et al.Clinical analysis of 30cases of migraine treated with integrated traditional Chinese and Western Medicine[J].Chin Pract Med(中国实用医药),2014,9(31):186-187.
[17]Tang K.Headache Ning Tong Ning combined with flunarizine capsules in the tratment of patients with migraine Clinical observation of curative effect and biochemical indexes[D].Lanzhou University(兰州大学),2011.
[18]Tian L.The Effect observation ofToutongning capsules combined with Flunarizine in treatment of patients with migraine[J].Chin J Pract Nervous Dis(中国实用神经疾病杂志),2010,13(17):84-85.
[19]Wang CL.The Clinical Effect observation of Flunarizine combined with Toutongning capsules in treatment of migraine[J].Chin Pract Med(中国实用医药),2011,6(22):143-144.
[20]Xiao YJ.The Clinical Effect observation of Flunarizine capsules combined with traditional Chinese medicine in treatment of migraine[J].Jiangxi Med J(江西医药),2016,51(7):645-647.
[21]Zuo XH,Wang JZ.Toutongning capsules combined with Flunarizine in treatment of patients with migraine[J].Clin Med(临床医学),2009,29(2):69-70.
[22]Zhang ZX,Cao KG,Fan JP.Migraine of Traditional Chinese Medicine Diagnosis and Treatment Rule[J].Chin Arch Tradit Chin Med(中华中医药学刊),2011,29(4):717-719.
[23]Yang HX,Zhang YQ,Liu B.Therapeutic Effect of Toutongning Capsule in Treatment of Patients with Migraine and its Effects on Blood Platelet and Hemorrheological Parameters[J].Chin J Exp Tradit Med Form(中国实验方剂学杂志),2012,18(5):230-232.