中药治疗原发性高血压随机对照试验的Meta分析
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摘要
目的:评价近十年中药治疗原发性高血压随机对照试验的有效性及安全性。方法:计算机检索电子数据中关于中药治疗原发性高血压的随机对照试验(RCTs)。由两位研究者独立筛选文献、资料提取和质量评价,采用RevMan 5.3软件进行Meta分析。结果纳入24篇文献,共4 502例患者,但其方法学质量偏低。Meta分析结果显示:与西药组比较,中药联合西药组能提高降压疗效(RR=1.20,95%CI=[1.13,1.27],P<0.00001)、中医证候疗效(RR=1.37,95%CI=[1.26,1.49],P<0.00001)。但"倒漏斗"图左右不对称,表明所纳入研究存在一定的发表偏倚。所有纳入RCTs均未报告严重不良反应。结论:现有证据表明中药治疗原发性高血压具有一定的优势,在一定程度上能起补充治疗的作用。但大部分纳入研究方法学质量偏低,可能影响Meta分析结果的真实性,仍需更多高质量的临床研究以增加证据强度。
Objective: To evaluate the efficacy and safety of Chinese herbal medicine in the treatment of essential hypertension in resent 10 years. Methods: The computer searched databases to collected all randomized controlled trials of Chinese herbal medicine in the treatment of essential hypertension. Two reviewers independently screened literature, extracted data and assessed the quality. Revman 5.3 software was used to do data analysis. Results: Twenty-four RCTs involving 4 502 patients with primary hypertension, were included in the study. The overall quality of clinical research was not high. The results of Meta-analysis showed: The Chinese herbal medicine combined with western medicine group had advantages over western medicine group in the aspects of antihypertensive effect(RR=1.20, 95%CI=[1.13,1.27], P<0.00001) and effect of TCM syndrome and(RR=1.37, 95%CI=[1.26,1.49], P<0.00001). However, the ‘Inverted funnel' pattern was asymmetric, indicating that there were some published bias in the study. No severe adverse effects was reported in the included studies. Conclusion: The current evidence shows that traditional Chinese medicine in the treatment of EH has certain advantages and complement the treatment effect to a certain extent. Most research had low methodological quality which affected the authenticity of the results of Meta-analysis and conclusion. More high quality clinical research is still expected to increase the strength of evidence.
Objective: To evaluate the efficacy and safety of Chinese herbal medicine in the treatment of essential hypertension in resent 10 years. Methods: The computer searched databases to collected all randomized controlled trials of Chinese herbal medicine in the treatment of essential hypertension. Two reviewers independently screened literature, extracted data and assessed the quality. Revman 5.3 software was used to do data analysis. Results: Twenty-four RCTs involving 4 502 patients with primary hypertension, were included in the study. The overall quality of clinical research was not high. The results of Meta-analysis showed: The Chinese herbal medicine combined with western medicine group had advantages over western medicine group in the aspects of antihypertensive effect(RR=1.20, 95%CI=[1.13,1.27], P<0.00001) and effect of TCM syndrome and(RR=1.37, 95%CI=[1.26,1.49], P<0.00001). However, the ‘Inverted funnel' pattern was asymmetric, indicating that there were some published bias in the study. No severe adverse effects was reported in the included studies. Conclusion: The current evidence shows that traditional Chinese medicine in the treatment of EH has certain advantages and complement the treatment effect to a certain extent. Most research had low methodological quality which affected the authenticity of the results of Meta-analysis and conclusion. More high quality clinical research is still expected to increase the strength of evidence.
引文
[1]张晓红,元新华,孙履东.针灸、天麻钩藤饮联合治疗高血压(肝阳上亢型)疗效观察.中西医结合心血管病杂志,2016,30(4):152-153
[2]郝秀珍,肖延龄,王兴.安宫降压丸治疗肝阳上亢证原发性高血压的临床观察.中华中医药杂志,2016,31(8):3362-3364
[3]王雪冰,李晓.补中益气汤加味治疗高血压病Meta分析.山西中医,2016,32(9):46-48
[4]刘泽萍.针灸、天麻钩藤饮联合治疗肝阳上亢型高血压的疗效观察.内蒙古中医药,2017,36(2):111
[5]CFDA.中药新药临床研究指导原则(试行).北京:中国医药科技出版社,2002:73-77
[6]朱芹英,任永学,黄学莲.夏枯草汤治疗老年高血压的疗效及对ET-1的影响.中药材,2016,39(3):669-671
[7]滕英华,谢睿,史先知.补肾活血汤对老年肾虚血瘀型高血压患者血压变异性和生活质量的影响.中国实验方剂学杂志,2016,22(20):173-177
[8]郑艳,林莘,郑平,等.松龄血脉康胶囊联合杞菊地黄丸对肝肾亏虚兼血瘀证老年高血压患者血管内皮功能的影响.中国实验方剂学杂志,2016,22(18):164-168
[9]丁康,赵菁,马诺莎,等.潜阳育阴颗粒治疗高血压病(阴虚阳亢证)的临床研究.时珍国医国药,2015,26(5):1149-1150
[10]吴琼,刘永明,高俊杰,等.四逆汤加减联合西药对阳虚型高血压病患者血压变异性的影响.中医杂志,2015,56(17):1483-1486
[11]陈曦,程广书,范军铭.中西医结合诊疗方案治疗中青年2级高血压病的多中心随机对照试验.中国中西医结合杂志,2015,35(7):801-805
[12]白雪,杨思进,江云东,等.蛭龙活血通瘀胶囊对老年高血压患者踝臂指数及高敏C反应蛋白、同型半胱氨酸的影响.辽宁中医杂志,2014,41(1):97-99
[13]丁自娟,葛巧,钱荣江,等.平肝降浊方治疗中老年高血压的临床研究.中华中医药学刊,2014,32(1):88-89
[14]沈嫱.中医利水法配合治疗高血压的临床探究.中国地方病防治杂志,2014,29(S2):63
[15]杨大赋,杨颖,沈元良,等.中西医结合治疗对原发性高血压患者血压及生存质量改善的临床观察.辽宁中医杂志,2014,41(4):753-755
[16]李芳,李霞.半夏白术天麻汤联合血府逐瘀汤佐治高血压病的疗效及对内皮功能的影响.广东医学,2014,35(6):936-937
[17]陆新,张瑶光.健脾益气降浊方配合西药治疗痰湿壅盛型原发性高血压病84例疗效观察.中医杂志,2014,55(5):404-407
[18]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.中国实验方剂学杂志,2013,19(4):292-294
[19]付强.中西医结合治疗原发性高血压的临床研究.中华中医药杂志,2013,28(9):2802-2803
[20]王明乐.双丹滴丸对原发性高血压患者血压及血浆血管紧张素Ⅱ表达的影响.中国实验方剂学杂志,2013,19(5):338-340
[21]吴琼,邵春林,刘永明,等.四逆汤加减治疗阳虚型原发性高血压病的临床研究.辽宁中医杂志,2013,40(12):2480-2482
[22]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.中国实验方剂学杂志,2012,18(24):327-330
[23]董守金,熊晓玲.天钩潜阳胶囊治疗阴虚阳亢型高血压病120例.中医杂志,2011,52(20):1779-1781
[24]邱泽安.天麻钩藤饮治疗社区高血压病.中国实验方剂学杂志,2011,17(15):252-253
[25]钟广伟,罗艳红,相玲丽,等.平肝潜阳方治疗早、中期原发性高血压病患者的临床疗效研究.中国中药杂志,2010,35(6):776-781
[26]谢富明,肖玉玲,王化中,等.降压散治疗高血压病300例临床研究.中医杂志,2009,50(3):215-217
[27]王勉,秦扬,李冰.加味大补地黄汤治疗肝肾阴虚型高血压病103例临床分析.中国中药杂志,2008,33(18):2144-2146
[28]王宏献.天麻钩藤饮治疗高血压病的临床研究.中华中医药学刊,2008,26(2):338-340
[29]吕放光.中西医结合治疗原发性高血压:65例临床疗效比较.中国组织工程研究与临床康复,2007,11(52):10480-10482
[30]Xiong X,Wang P,Zhang Y,et al.Effects of traditional Chinese patent medicine on essential hypertension:A systematic review.Medicine(Baltimore),2015,94(5):e442
[31]王琼,冼绍祥.中医药治疗高血压临床疗效的Meta分析.中国实验方剂学杂志,2013,19(9):345-349
[32]武月萍,张建刚.中医药治疗原发性高血压病降压疗效的Meta分析.时珍国医国药,2012,23(9):2360-2361
[2]郝秀珍,肖延龄,王兴.安宫降压丸治疗肝阳上亢证原发性高血压的临床观察.中华中医药杂志,2016,31(8):3362-3364
[3]王雪冰,李晓.补中益气汤加味治疗高血压病Meta分析.山西中医,2016,32(9):46-48
[4]刘泽萍.针灸、天麻钩藤饮联合治疗肝阳上亢型高血压的疗效观察.内蒙古中医药,2017,36(2):111
[5]CFDA.中药新药临床研究指导原则(试行).北京:中国医药科技出版社,2002:73-77
[6]朱芹英,任永学,黄学莲.夏枯草汤治疗老年高血压的疗效及对ET-1的影响.中药材,2016,39(3):669-671
[7]滕英华,谢睿,史先知.补肾活血汤对老年肾虚血瘀型高血压患者血压变异性和生活质量的影响.中国实验方剂学杂志,2016,22(20):173-177
[8]郑艳,林莘,郑平,等.松龄血脉康胶囊联合杞菊地黄丸对肝肾亏虚兼血瘀证老年高血压患者血管内皮功能的影响.中国实验方剂学杂志,2016,22(18):164-168
[9]丁康,赵菁,马诺莎,等.潜阳育阴颗粒治疗高血压病(阴虚阳亢证)的临床研究.时珍国医国药,2015,26(5):1149-1150
[10]吴琼,刘永明,高俊杰,等.四逆汤加减联合西药对阳虚型高血压病患者血压变异性的影响.中医杂志,2015,56(17):1483-1486
[11]陈曦,程广书,范军铭.中西医结合诊疗方案治疗中青年2级高血压病的多中心随机对照试验.中国中西医结合杂志,2015,35(7):801-805
[12]白雪,杨思进,江云东,等.蛭龙活血通瘀胶囊对老年高血压患者踝臂指数及高敏C反应蛋白、同型半胱氨酸的影响.辽宁中医杂志,2014,41(1):97-99
[13]丁自娟,葛巧,钱荣江,等.平肝降浊方治疗中老年高血压的临床研究.中华中医药学刊,2014,32(1):88-89
[14]沈嫱.中医利水法配合治疗高血压的临床探究.中国地方病防治杂志,2014,29(S2):63
[15]杨大赋,杨颖,沈元良,等.中西医结合治疗对原发性高血压患者血压及生存质量改善的临床观察.辽宁中医杂志,2014,41(4):753-755
[16]李芳,李霞.半夏白术天麻汤联合血府逐瘀汤佐治高血压病的疗效及对内皮功能的影响.广东医学,2014,35(6):936-937
[17]陆新,张瑶光.健脾益气降浊方配合西药治疗痰湿壅盛型原发性高血压病84例疗效观察.中医杂志,2014,55(5):404-407
[18]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.中国实验方剂学杂志,2013,19(4):292-294
[19]付强.中西医结合治疗原发性高血压的临床研究.中华中医药杂志,2013,28(9):2802-2803
[20]王明乐.双丹滴丸对原发性高血压患者血压及血浆血管紧张素Ⅱ表达的影响.中国实验方剂学杂志,2013,19(5):338-340
[21]吴琼,邵春林,刘永明,等.四逆汤加减治疗阳虚型原发性高血压病的临床研究.辽宁中医杂志,2013,40(12):2480-2482
[22]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.中国实验方剂学杂志,2012,18(24):327-330
[23]董守金,熊晓玲.天钩潜阳胶囊治疗阴虚阳亢型高血压病120例.中医杂志,2011,52(20):1779-1781
[24]邱泽安.天麻钩藤饮治疗社区高血压病.中国实验方剂学杂志,2011,17(15):252-253
[25]钟广伟,罗艳红,相玲丽,等.平肝潜阳方治疗早、中期原发性高血压病患者的临床疗效研究.中国中药杂志,2010,35(6):776-781
[26]谢富明,肖玉玲,王化中,等.降压散治疗高血压病300例临床研究.中医杂志,2009,50(3):215-217
[27]王勉,秦扬,李冰.加味大补地黄汤治疗肝肾阴虚型高血压病103例临床分析.中国中药杂志,2008,33(18):2144-2146
[28]王宏献.天麻钩藤饮治疗高血压病的临床研究.中华中医药学刊,2008,26(2):338-340
[29]吕放光.中西医结合治疗原发性高血压:65例临床疗效比较.中国组织工程研究与临床康复,2007,11(52):10480-10482
[30]Xiong X,Wang P,Zhang Y,et al.Effects of traditional Chinese patent medicine on essential hypertension:A systematic review.Medicine(Baltimore),2015,94(5):e442
[31]王琼,冼绍祥.中医药治疗高血压临床疗效的Meta分析.中国实验方剂学杂志,2013,19(9):345-349
[32]武月萍,张建刚.中医药治疗原发性高血压病降压疗效的Meta分析.时珍国医国药,2012,23(9):2360-2361