复方芪麻胶囊治疗高血压病中医临床疗效及不良反应Meta分析
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摘要
目的运用Meta分析法评价中药新药复方芪麻胶囊(QM)治疗高血压病的临床疗效和安全性,为QM新药临床试验提供依据。方法检索2018年7月31日前中国知网(CNKI)、万方数据和维普资讯全文数据库(会议、期刊、学位论文)中QM单独或合用西药干预(西药为对照组)高血压病患者中医证候评分、临床疗效和不良反应的全文文献,根据纳入与剔除标准筛选随机对照试验(RCT)文献。评价文献质量并提取数据,采用RevMan 5.3进行Meta分析,计量与计数数据分别以加权均数差(WMD)和比值比(OR)及其95%置信区间(95%CI)表示,同时χ~2和Z检验分别用于异质性和效应比较的检验。结果纳入24篇文献中收治1 917例(治疗组997例,对照组920例)高血压病患者,其中14、12、17篇文献分别报道有证候积分(治疗组522例,对照组519例,证候疗效(治疗组556例,对照组541例)和不良反应(17篇文献中10篇进行Meta分析,治疗组556例,对照组539例)。与对照组比较,治疗组治疗后证候积分[WMD=-3.58(-5.20,-1.96)]和不良反应发生率[OR=0.39(0.20,0.75)]均有显著性减少(Z=4.34,2.84,P<0.01),证候疗效[OR=2.67(1.41,5.06)]有显著性改善(Z=3.01,P=0.003<0.05);与治疗前比较,QM治疗后患者症状积分[WMD=-10.85(-14.17,-7.53)]有显著性减少(Z=6.41,P<0.01)。结论与单独应用降压西药相比,QM单独或合用降压西药可改善高血压病患者症侯、减少不良反应发生率;但上述结论尚需进一步按中药新药标准开展大样本、多中心、随机双肓对照试验研究的验证。
Objective To evaluate the safety and TCM curative efficacy of compound Qi Ma capsule(QM) for hypertension,and to provide references for clinical trial of QM. Methods CNKI,Wanfang Data and VIP,the three largest national full-text database(conferences,periodicals,dissertations)were searched for randomized controlled trials(RCT)of QM in treating hypertension(updated to July 31,2016). According to the inclusive criteria,the included studies contained at least the following indicators:TCM syndromes scores,TCM syndromes curative effect and adverse effects rates. Literature quality and research data were assessed and extracted, and then Review Manager 5.3 software was used for data analysis. Measurement data and counting data were described as weighted mean difference(WMD),odds ratio(OR)respectively,and their 95 % confidence interval(95% CI);Chi2 test(χ~2)and Z test were used for heterogeneity test and effect comparison test. Results A total of 24 RCTs with 1 917 patients(997 vs 920:treatment group vs control group)were included,among them,14,12 and 17 literatures reported scores of syndromes(522 vs 519 cases,all of the 14 literatures were designed by RCT+self-control);syndromes efficacy(556 vs 541 cases),and adverse effects rate(10 of which were meta-analyzed,556 vs 539 cases). Compared with the control group,TCM syndromes score [WMD=-3.58(-5.20,-1.96) ] and adverse effects rate [OR =0.39(0.20,0.75)] in treatment group were significantly reduced(Z = 4.34,2.84,P<0.01),and TCM syndromes curative effect [OR = 2.67(1.41,5.06)] was significantly improved(Z = 3.01,P = 0.003<0.05);TCM syndromes score [WMD=-10.85(-14.17,-7.53)] was significantly lowered after QM treatment than that before QM treatment(Z = 6.41,P<0.01). Conclusion Compared with antihypertensive western medicine alone,QM or QM combined with antihypertensive western medicine can improve hypertension patients' TCM syndromes,and reduce adverse effects rate. The conclusions mentioned above still need to be further verified by larger sample with multicenter,double-blind RCTs in accordance with the clinical trial standards of new TCM.
Objective To evaluate the safety and TCM curative efficacy of compound Qi Ma capsule(QM) for hypertension,and to provide references for clinical trial of QM. Methods CNKI,Wanfang Data and VIP,the three largest national full-text database(conferences,periodicals,dissertations)were searched for randomized controlled trials(RCT)of QM in treating hypertension(updated to July 31,2016). According to the inclusive criteria,the included studies contained at least the following indicators:TCM syndromes scores,TCM syndromes curative effect and adverse effects rates. Literature quality and research data were assessed and extracted, and then Review Manager 5.3 software was used for data analysis. Measurement data and counting data were described as weighted mean difference(WMD),odds ratio(OR)respectively,and their 95 % confidence interval(95% CI);Chi2 test(χ~2)and Z test were used for heterogeneity test and effect comparison test. Results A total of 24 RCTs with 1 917 patients(997 vs 920:treatment group vs control group)were included,among them,14,12 and 17 literatures reported scores of syndromes(522 vs 519 cases,all of the 14 literatures were designed by RCT+self-control);syndromes efficacy(556 vs 541 cases),and adverse effects rate(10 of which were meta-analyzed,556 vs 539 cases). Compared with the control group,TCM syndromes score [WMD=-3.58(-5.20,-1.96) ] and adverse effects rate [OR =0.39(0.20,0.75)] in treatment group were significantly reduced(Z = 4.34,2.84,P<0.01),and TCM syndromes curative effect [OR = 2.67(1.41,5.06)] was significantly improved(Z = 3.01,P = 0.003<0.05);TCM syndromes score [WMD=-10.85(-14.17,-7.53)] was significantly lowered after QM treatment than that before QM treatment(Z = 6.41,P<0.01). Conclusion Compared with antihypertensive western medicine alone,QM or QM combined with antihypertensive western medicine can improve hypertension patients' TCM syndromes,and reduce adverse effects rate. The conclusions mentioned above still need to be further verified by larger sample with multicenter,double-blind RCTs in accordance with the clinical trial standards of new TCM.
引文
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[8]王清海,卢桂梅,李爱华.血压健胶囊治疗原发性高血压(气虚痰浊型)105例临床观察[J].中药新药与临床药理,1997,8(4):204-206.
[9]黄琳,王清海,丁大珍,等.动态脉压与高血压肾损害的关系及中药干预的作用[J].中国中医药信息杂志,2010,17(9):13-16.
[10]黄琳,王清海,丁大珍,等.复方芪麻胶囊对高血压病早期肾损害的影响[J].中国实验方剂学杂志,2010,16(7):192-194.
[11]王清海,卢桂梅,李爱华.中药血压健治疗高血压病(气虚痰浊型)65例观察[J].国医论坛,1997,12(6):25-26.
[12]王清海,卢桂海.血压健胶囊对高血压患者左心重构逆转作用的临床研究[J].河南中医,1998,18(2):34,38.
[13]陈宁,王清海,李爱华,等.血压健4号治疗气虚痰浊型高血压临床观察[J].中西医结合心脑血管病杂志,2004,2(5):255-256.
[14]梁文坚.气虚痰瘀型高血压病流行特点及临床研究[D].广州:广州中医药大学,2008.
[15]刘秋江.复方芪麻胶囊对高血压左室肥厚患者BNP影响的临床研究[D].广州:广州中医药大学,2009.
[16]丁大珍.复方芪麻胶囊对高血压病早期肾损害的作用研究[D].广州:广州中医药大学,2009.
[17]靳利利,丁达,郭英普,等.复方芪麻胶囊治疗气虚痰浊型单纯收缩期高血压病60例临床观察[J].广州中医药大学学报,2010,27(3):217-221.
[18]郭英普.高血压病五脏相关性及中药干预的研究[D].广州:广州中医药大学,2010.
[19]李典鸿,靳利利,刘秋江.复方芪麻胶囊对高血压左室肥厚患者血浆脑钠尿肽的影响[J].陕西中医,2010,31(10):1307-1309.
[20]黄培红,靳利利,李典鸿,等.复方芪麻胶囊对气虚痰浊型单纯收缩期高血压患者血压及炎症因子的影响[J].河南中医,2011,31(6):618-620.
[21]刘秋江,靳利利,苏慧,等.复方芪麻胶囊对气虚痰浊型高血压患者左心室质量指数的影响[J].广州中医药大学学报,2011,28(5):465-467.
[22]袁利梅.复方芪麻胶囊治疗单纯收缩期高血压机制与临床研究[D].广州:广州中医药大学,2011.
[23]袁利梅,刘磊,朱培罡,等.益气化浊法治疗气虚痰浊型单纯收缩期高血压临床研究[J].河南中医,2012,32(11):1459-1460.
[24]谭炜.复方芪麻胶囊在高血压动脉保护中的作用机制研究[D].广州:广州中医药大学,2012.
[25]梁宏宇,袁丁,许杰红,等.益气化痰法治疗气虚痰浊型单纯收缩期高血压临床研究[J].新中医,2013,45(7):10-12.
[26]史振羽.复方芪麻胶囊对老年ISH患者动脉弹性的影响[D].广州:广州中医药大学,2014.
[27]苏慧,靳利利,史振羽,等.复方芪麻胶囊对老年单纯收缩期高血压患者动脉弹性及功能的影响[J].按摩与康复医学,2014,5(5):23-24.
[28]李莹鸿.复方芪麻胶囊对H型髙血压患者临床疗效及瘦素的影响[D].广州:广州中医药大学,2015.
[29]梁文坚,徐玉莲,杨跃娜.复方芪麻胶囊治疗气虚痰瘀型高血压病35例临床观察[J].湖南中医杂志,2015,31(8):35-36.
[30]张珍珍.基于PVAT/Adiponectin探索复方芪麻胶囊对高血压血管损伤的影响[D].广州:广州中医药大学,2015.
[31]吴永刚,王清海,靳利利,等.复方芪麻胶囊对气虚痰浊型高血压患者血管内皮损伤相关因子的影响[J].辽宁中医杂志,2016,43(1):86-88.
[32]李莹鸿,靳利利,黄培红,等.复方芪麻胶囊干预治疗对H型高血压患者同型半胱氨酸、瘦素水平的影响[J].中国中西医结合杂志,2017,37(6):676-679.
[33]林志强.复方芪麻胶囊治疗高血压病合并高尿酸血症临床研究[D].广州:广州中医药大学,2017.
[34]叶明花,蒋力生,曹征.高血压病的中医养生保健[J].江西中医学院学报,2008,20(3):36-41.
[35]姜波.浅谈中医治疗高血压的现状[J].基层医学论坛,2018,22(1):101-102.
[36]汪磊,尤可.从虚、痰、瘀论治老年高血压病[J].中医药临床杂志,2017,29(10):1647-1649.
[37]邓铁涛.邓铁涛医集[M].北京:人民卫生出版社,1995:1-2.
[38]张贺,于美丽,徐浩.中医特色疗法即时降压效应的临床研究进展[J].中西医结合心脑血管病杂志,2017,15(24):3125-3127.
[2]王河宝,孙悦,曹征,等.高血压病中医证候规范化思路[J].中华中医药杂志,2018,33(2):603-605.
[3]刘福明,陈晓虎,杜午奇,等.高血压病中医证型分布规律的临床研究[J].江苏中医药,2009,41(10):33-34.
[4]中华人民共和国卫生部.中药新药临床研究指导原则:第1辑[S].1993:28.
[5]张伯臾.中医内科学[M].北京:人民卫生出版社,1988:34.
[6]田德禄.中医内科学[M].北京:人民卫生出版社,2003.
[7]郑筱萸.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,2002:74,77-85.
[8]王清海,卢桂梅,李爱华.血压健胶囊治疗原发性高血压(气虚痰浊型)105例临床观察[J].中药新药与临床药理,1997,8(4):204-206.
[9]黄琳,王清海,丁大珍,等.动态脉压与高血压肾损害的关系及中药干预的作用[J].中国中医药信息杂志,2010,17(9):13-16.
[10]黄琳,王清海,丁大珍,等.复方芪麻胶囊对高血压病早期肾损害的影响[J].中国实验方剂学杂志,2010,16(7):192-194.
[11]王清海,卢桂梅,李爱华.中药血压健治疗高血压病(气虚痰浊型)65例观察[J].国医论坛,1997,12(6):25-26.
[12]王清海,卢桂海.血压健胶囊对高血压患者左心重构逆转作用的临床研究[J].河南中医,1998,18(2):34,38.
[13]陈宁,王清海,李爱华,等.血压健4号治疗气虚痰浊型高血压临床观察[J].中西医结合心脑血管病杂志,2004,2(5):255-256.
[14]梁文坚.气虚痰瘀型高血压病流行特点及临床研究[D].广州:广州中医药大学,2008.
[15]刘秋江.复方芪麻胶囊对高血压左室肥厚患者BNP影响的临床研究[D].广州:广州中医药大学,2009.
[16]丁大珍.复方芪麻胶囊对高血压病早期肾损害的作用研究[D].广州:广州中医药大学,2009.
[17]靳利利,丁达,郭英普,等.复方芪麻胶囊治疗气虚痰浊型单纯收缩期高血压病60例临床观察[J].广州中医药大学学报,2010,27(3):217-221.
[18]郭英普.高血压病五脏相关性及中药干预的研究[D].广州:广州中医药大学,2010.
[19]李典鸿,靳利利,刘秋江.复方芪麻胶囊对高血压左室肥厚患者血浆脑钠尿肽的影响[J].陕西中医,2010,31(10):1307-1309.
[20]黄培红,靳利利,李典鸿,等.复方芪麻胶囊对气虚痰浊型单纯收缩期高血压患者血压及炎症因子的影响[J].河南中医,2011,31(6):618-620.
[21]刘秋江,靳利利,苏慧,等.复方芪麻胶囊对气虚痰浊型高血压患者左心室质量指数的影响[J].广州中医药大学学报,2011,28(5):465-467.
[22]袁利梅.复方芪麻胶囊治疗单纯收缩期高血压机制与临床研究[D].广州:广州中医药大学,2011.
[23]袁利梅,刘磊,朱培罡,等.益气化浊法治疗气虚痰浊型单纯收缩期高血压临床研究[J].河南中医,2012,32(11):1459-1460.
[24]谭炜.复方芪麻胶囊在高血压动脉保护中的作用机制研究[D].广州:广州中医药大学,2012.
[25]梁宏宇,袁丁,许杰红,等.益气化痰法治疗气虚痰浊型单纯收缩期高血压临床研究[J].新中医,2013,45(7):10-12.
[26]史振羽.复方芪麻胶囊对老年ISH患者动脉弹性的影响[D].广州:广州中医药大学,2014.
[27]苏慧,靳利利,史振羽,等.复方芪麻胶囊对老年单纯收缩期高血压患者动脉弹性及功能的影响[J].按摩与康复医学,2014,5(5):23-24.
[28]李莹鸿.复方芪麻胶囊对H型髙血压患者临床疗效及瘦素的影响[D].广州:广州中医药大学,2015.
[29]梁文坚,徐玉莲,杨跃娜.复方芪麻胶囊治疗气虚痰瘀型高血压病35例临床观察[J].湖南中医杂志,2015,31(8):35-36.
[30]张珍珍.基于PVAT/Adiponectin探索复方芪麻胶囊对高血压血管损伤的影响[D].广州:广州中医药大学,2015.
[31]吴永刚,王清海,靳利利,等.复方芪麻胶囊对气虚痰浊型高血压患者血管内皮损伤相关因子的影响[J].辽宁中医杂志,2016,43(1):86-88.
[32]李莹鸿,靳利利,黄培红,等.复方芪麻胶囊干预治疗对H型高血压患者同型半胱氨酸、瘦素水平的影响[J].中国中西医结合杂志,2017,37(6):676-679.
[33]林志强.复方芪麻胶囊治疗高血压病合并高尿酸血症临床研究[D].广州:广州中医药大学,2017.
[34]叶明花,蒋力生,曹征.高血压病的中医养生保健[J].江西中医学院学报,2008,20(3):36-41.
[35]姜波.浅谈中医治疗高血压的现状[J].基层医学论坛,2018,22(1):101-102.
[36]汪磊,尤可.从虚、痰、瘀论治老年高血压病[J].中医药临床杂志,2017,29(10):1647-1649.
[37]邓铁涛.邓铁涛医集[M].北京:人民卫生出版社,1995:1-2.
[38]张贺,于美丽,徐浩.中医特色疗法即时降压效应的临床研究进展[J].中西医结合心脑血管病杂志,2017,15(24):3125-3127.
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