生脉注射液治疗病毒性心肌炎有效性与安全性的Meta分析
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摘要
目的评价生脉注射液联合西药治疗病毒性心肌炎的临床疗效和安全性。方法计算机检索Pub Med、Embase、Cochrane library、CNKI、VIP、万方数据库和CBM,收集关于生脉注射液联合西药治疗病毒性心肌炎的随机对照试验(RCT),2名研究者独立严格进行纳入研究的质量评价和资料提取,采用Rev Man5.3软件进行Meta分析,采用TSA v0.9软件进行试验序贯分析(TSA),并采用GRADEpro软件进行证据质量分级评价。结果最终纳入14个RCT,共1492例患者。Meta分析结果显示:(1)生脉+支持治疗的总有效率优于支持治疗(RR=1.11,95%CI:1.02~1.20,P<0.05);(2)生脉+对症治疗的总有效率优于对症治疗(RR=1.23,95%CI:1.17~1.30,P<0.00001);(3)治疗后试验组患者的CK含量(MD=-66.31,95%CI:-110.38~-22.23,P=0.003)、CK-MB含量(MD=-12.91,95%CI:-14.91~-10.90,P<0.00001)、LDH含量(MD=-64.11,95%CI:-107.07~-21.15,P=0.003)、AST含量(MD=-11.85,95%CI:-14.15~-9.55,P<0.00001)均低于对照组,且差异均有统计学意义。试验序贯分析提示生脉+支持治疗与生脉+对症治疗的总有效率优于单用西药、生脉联合西药更能降低肌酸磷酸激酶(CK)、天门冬氨酸氨基转移酶(AST)、肌酸激酶同工酶(CK-MB)的含量证据确切,而对于乳酸脱氢酶(LDH)含量尚需进一步证实。证据分级提示,当前等级从"低级"到"极低"质量。结论生脉注射液联合西药治疗病毒性心肌炎具有一定的疗效。但现有研究质量偏低,且数量偏少,需要更多高质量、多中心的随机双盲临床试验的进一步验证。
Objective To systematically review the clinical effect and safety of Shengmai Injection combined with western medicine in the treatment of viral myocarditis(VMC). Method Databases as Pub Med, Embase, Cochrane library, CNKI, VIP, Wanfang data and CBM were searched in order to collect randomized clinical trials(RCTs) on the effectiveness and safety of Shengmai Injection combined with western medicine in the treatment of VMC. Two researchers independently screened literatures according to the inclusion and exclusion criteria, and evaluated the methodological quality of included studies. We carried out meta-analysis and TSA analysis by using Rev Man 5.3 version and TSA v0.9 respectively, and GRADEpro was used to evaluate the quality of evidence. Result 14 RCTs including 1492 cases were included eventually. The analysis shows that:(1)the total effective rate of Shengmai Injection(SMI) + supportive therapy was superior to those of pure supportive therapy(RR=1.11, 95%CI: 1.02 to 1.20, P<0.05);(2)the same as the total effective rate of SMI + symptomatic treatment versus pure symptomatic treatment(RR=1.23, 95%CI: 1.17 to 1.30, P<0.00001);(3)the levels of Creatine phosphokinase(CK, MD=-66.31, 95%CI:-110.38 to-22.23, P=0.003), creatine kinase isoenzyme(CK-MB, MD=-12.91, 95%CI:-14.91 to-10.90, P<0.00001), lactate dehydrogenase(LDH, MD=-64.11, 95%CI:-107.07 to-21.15, P=0.003), and aspartate aminotransferase(AST, MD=-11.85, 95%CI:-14.15 to-9.55, P<0.00001) were lower with SMI combined with western medicine than with western medicine controls. Result of TSA analysis showed that SMI combined with western medicine were effectively for VMC treatment, and could lower CK, CK-MB and AST, but the effecton LDH was unclear. Conclusion Shengmai injection combined with Western medicine in the treatment of viral myocarditis has a certain effect. However, the quality of existing research is low and the number is too small, which required more high-quality, multi-center randomized double-blind clinical trials for further validation.
Objective To systematically review the clinical effect and safety of Shengmai Injection combined with western medicine in the treatment of viral myocarditis(VMC). Method Databases as Pub Med, Embase, Cochrane library, CNKI, VIP, Wanfang data and CBM were searched in order to collect randomized clinical trials(RCTs) on the effectiveness and safety of Shengmai Injection combined with western medicine in the treatment of VMC. Two researchers independently screened literatures according to the inclusion and exclusion criteria, and evaluated the methodological quality of included studies. We carried out meta-analysis and TSA analysis by using Rev Man 5.3 version and TSA v0.9 respectively, and GRADEpro was used to evaluate the quality of evidence. Result 14 RCTs including 1492 cases were included eventually. The analysis shows that:(1)the total effective rate of Shengmai Injection(SMI) + supportive therapy was superior to those of pure supportive therapy(RR=1.11, 95%CI: 1.02 to 1.20, P<0.05);(2)the same as the total effective rate of SMI + symptomatic treatment versus pure symptomatic treatment(RR=1.23, 95%CI: 1.17 to 1.30, P<0.00001);(3)the levels of Creatine phosphokinase(CK, MD=-66.31, 95%CI:-110.38 to-22.23, P=0.003), creatine kinase isoenzyme(CK-MB, MD=-12.91, 95%CI:-14.91 to-10.90, P<0.00001), lactate dehydrogenase(LDH, MD=-64.11, 95%CI:-107.07 to-21.15, P=0.003), and aspartate aminotransferase(AST, MD=-11.85, 95%CI:-14.15 to-9.55, P<0.00001) were lower with SMI combined with western medicine than with western medicine controls. Result of TSA analysis showed that SMI combined with western medicine were effectively for VMC treatment, and could lower CK, CK-MB and AST, but the effecton LDH was unclear. Conclusion Shengmai injection combined with Western medicine in the treatment of viral myocarditis has a certain effect. However, the quality of existing research is low and the number is too small, which required more high-quality, multi-center randomized double-blind clinical trials for further validation.
引文
[1]汪朝晖,廖玉华.病毒性心肌炎[J].中国实用内科杂志,2012,32(7):511-3.
[2]Shauer A,Gotsman I,Keren A,et al.Acute viral myocarditis:current concepts in diagnosis and treatment[J].Isr Med Assoc J,2013,15(3):180-5.
[3]周亚滨,王毅然,陈会君.病毒性心肌炎中医药研究进展[J].辽宁中医药大学学报,2016,18(12):1-2.
[4]王艳玲,李康康,张曾譻.急性病毒性心肌炎的中医药研究概况[J].中西医结合心脑血管病杂志,2016,14(18):2118-21.
[5]全国心肌炎、心肌病专题研讨会.成人急性心肌炎诊断参考标准[S].临床心血管疾病杂志,1995,11(6):325.
[6]中华医学会儿科学分会心血管学组.病毒性心肌炎诊断标准(修订草案)[J].中华儿科杂志,2000,38(2):75-81.
[7]吴瑞萍,胡亚美,江载芳.实用儿科学[M].第6版.北京:人民卫生出版社,1997:1495-6.
[8]翁鸿,李胜,曾宪涛,等.试验序贯分析软件在Meta分析中的应用[J].中国循证医学杂志,2016,16(5):604-11.
[9]曾宪涛,冷卫东,李胜,等.如何正确理解及使用GRADE系统[J].中国循证医学杂志,2011,15(9):985-90.
[10]吕靖怡.生脉注射液辅助治疗病毒性心肌炎临床疗效分析[J].中国现代药物应用,2007,1(4):16-7.
[11]张俊彪.生脉辅助治疗病毒性心肌炎临床疗效分析[J].中国医疗前沿,2010,5(16):35.
[12]张秀萍.生脉注射液治疗小儿病毒性心肌炎70例[J].中国中医急症,2011,20(2):307-8.
[13]张育彬.生脉注射液治疗病毒性心肌炎40例疗效观察[J].山西中医学院学报,2007,8(5):20-1.
[14]李加.生脉注射液治疗病毒性心肌炎的临床观察[J].西南军医,2010,12(5):851-2.
[15]林勤劼.生脉注射液用于治疗病毒性心肌炎疗效评价[J].医学信息,2014,27(3):365-6.
[16]樊小平.中西医结合治疗病毒性心肌炎临床观察[J].实用中医药杂志,2006,22(5):295.
[17]罗志英,卿国忠.生脉注射液联合果糖二磷酸钠治疗小儿病毒性心肌炎疗效观察[J].儿科药学杂志,2006,12(2):12-4.
[18]赵亚佩.生脉注射液治疗小儿病毒性心肌炎疗效观察[J].现代保健:医学创新研究,2006,3(3):102.
[19]金丽杰,谢敬东.生脉注射液治疗病毒性心肌炎188例临床观察[J].中国当代医药,2012,19(7):80-1.
[20]高应红.应用生脉注射液治疗病毒性心肌炎的疗效分析[J].当代医药论丛,2015,13(7):250-1.
[21]魏洪伟,赵序云.生脉注射液治疗病毒性心肌炎临床疗效分析[J].世界中西医结合杂志,2010,5(1):64-5.
[22]鲍国颂.生脉注射液治疗病毒性心肌炎的效果分析[J].世界临床医学,2016,10(10):173-5.
[23]齐斌.生脉注射液治疗小儿病毒性心肌炎疗效观察与护理[J].中国医学创新,2010,7(20):153-4.
[24]郑纪宁,张凤英,高玉峰,等.生黄合剂对病毒性心肌炎小鼠心肌细胞的保护作用[J].辽宁中医杂志,2012,33(9):1195-6.
[25]赵述强,李翔宇.病毒性心肌炎中西医防治的研究进展[J].中西医结合心脑血管病杂志,2016,14(18):2115-8.
[26]范增光,袁野,皇甫海全,等.中医药治疗病毒性心肌炎的研究进展[J].中国中医急症,2016,25(8):1555-7.
[27]李廷谦,刘雪梅,冯敏,等.生脉注射液临床应用及不良反应的系统评价[J].中国中西医结合杂志,2009,29(11):965-9.
[28]周洪玉.生脉注射液药效物质基础研究[D].吉林大学,2011.
[2]Shauer A,Gotsman I,Keren A,et al.Acute viral myocarditis:current concepts in diagnosis and treatment[J].Isr Med Assoc J,2013,15(3):180-5.
[3]周亚滨,王毅然,陈会君.病毒性心肌炎中医药研究进展[J].辽宁中医药大学学报,2016,18(12):1-2.
[4]王艳玲,李康康,张曾譻.急性病毒性心肌炎的中医药研究概况[J].中西医结合心脑血管病杂志,2016,14(18):2118-21.
[5]全国心肌炎、心肌病专题研讨会.成人急性心肌炎诊断参考标准[S].临床心血管疾病杂志,1995,11(6):325.
[6]中华医学会儿科学分会心血管学组.病毒性心肌炎诊断标准(修订草案)[J].中华儿科杂志,2000,38(2):75-81.
[7]吴瑞萍,胡亚美,江载芳.实用儿科学[M].第6版.北京:人民卫生出版社,1997:1495-6.
[8]翁鸿,李胜,曾宪涛,等.试验序贯分析软件在Meta分析中的应用[J].中国循证医学杂志,2016,16(5):604-11.
[9]曾宪涛,冷卫东,李胜,等.如何正确理解及使用GRADE系统[J].中国循证医学杂志,2011,15(9):985-90.
[10]吕靖怡.生脉注射液辅助治疗病毒性心肌炎临床疗效分析[J].中国现代药物应用,2007,1(4):16-7.
[11]张俊彪.生脉辅助治疗病毒性心肌炎临床疗效分析[J].中国医疗前沿,2010,5(16):35.
[12]张秀萍.生脉注射液治疗小儿病毒性心肌炎70例[J].中国中医急症,2011,20(2):307-8.
[13]张育彬.生脉注射液治疗病毒性心肌炎40例疗效观察[J].山西中医学院学报,2007,8(5):20-1.
[14]李加.生脉注射液治疗病毒性心肌炎的临床观察[J].西南军医,2010,12(5):851-2.
[15]林勤劼.生脉注射液用于治疗病毒性心肌炎疗效评价[J].医学信息,2014,27(3):365-6.
[16]樊小平.中西医结合治疗病毒性心肌炎临床观察[J].实用中医药杂志,2006,22(5):295.
[17]罗志英,卿国忠.生脉注射液联合果糖二磷酸钠治疗小儿病毒性心肌炎疗效观察[J].儿科药学杂志,2006,12(2):12-4.
[18]赵亚佩.生脉注射液治疗小儿病毒性心肌炎疗效观察[J].现代保健:医学创新研究,2006,3(3):102.
[19]金丽杰,谢敬东.生脉注射液治疗病毒性心肌炎188例临床观察[J].中国当代医药,2012,19(7):80-1.
[20]高应红.应用生脉注射液治疗病毒性心肌炎的疗效分析[J].当代医药论丛,2015,13(7):250-1.
[21]魏洪伟,赵序云.生脉注射液治疗病毒性心肌炎临床疗效分析[J].世界中西医结合杂志,2010,5(1):64-5.
[22]鲍国颂.生脉注射液治疗病毒性心肌炎的效果分析[J].世界临床医学,2016,10(10):173-5.
[23]齐斌.生脉注射液治疗小儿病毒性心肌炎疗效观察与护理[J].中国医学创新,2010,7(20):153-4.
[24]郑纪宁,张凤英,高玉峰,等.生黄合剂对病毒性心肌炎小鼠心肌细胞的保护作用[J].辽宁中医杂志,2012,33(9):1195-6.
[25]赵述强,李翔宇.病毒性心肌炎中西医防治的研究进展[J].中西医结合心脑血管病杂志,2016,14(18):2115-8.
[26]范增光,袁野,皇甫海全,等.中医药治疗病毒性心肌炎的研究进展[J].中国中医急症,2016,25(8):1555-7.
[27]李廷谦,刘雪梅,冯敏,等.生脉注射液临床应用及不良反应的系统评价[J].中国中西医结合杂志,2009,29(11):965-9.
[28]周洪玉.生脉注射液药效物质基础研究[D].吉林大学,2011.