丹红注射液干预择期PCI围手术期心肌保护与安全性的系统评价
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首都卫生发展科研专项—重点攻关项目(编号:首发2014-1-2231);北京市中医药管理局重点学科项目;合作建立步长脑心同治重点实验室


Danhong Injection for Periprocedural Myocardical Injury in Elective Percutaneous Coronary:A Systemactic Review
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    摘要:

    目的:采用系统评价的方法评价丹红注射液干预择期PCI围手术期的心肌保护与安全性。方法:电子检索Cochrane图书馆临床对照试验资料库,MEDLINE,中国生物医学文献数据库(CBM),中国学术期刊全文数据库(CNKI),中文科技期刊全文数据库(VIP),万方医学数据库、中国生物数据库(CMCI)等中外生物医学数据库,检索年限均为建库起至2017年1月31日。纳入有关丹红注射液干预择期PCI围手术期方面的临床随机对照试验,由2名研究者按纳入与排除标准独立选择研究、交叉核对,按照数据提取表格提取数据。采用Cochrane协作网推荐的评价标准对纳人试验进行质量评价,RevMan5.3软件进行资料分析。结果:最终纳入符合标准的11篇临床随机对照研究,所有研究均在中国大陆进行,其中对照组(C组)患者予以西医常规治疗,试验组(T组)患者在此基础上给予丹红注射液,共计956例患者,单纯常规西医治疗组(C组)471例,丹红注射液联合常规西医治疗组(T组)485例。系统评价结果显示:1)丹红注射液能减少PCI围手术期心肌损伤及心肌梗死的发生率。2)围手术期心肌损伤标志物方面:丹红注射液能降低PCI术后24 h CK-MB水平,差异有统计学意义[MD=-6.46,95%CI(-8.57,-4.34),Z=5.99,P<0.00001];可降低PCI术后24 h cTNI水平,差异有统计学意义[SMD=-0.36,95%CI(-0.68,-0.03),Z=2.16,P=0.03]。3)围手术期炎性反应指标方面:丹红注射液能降低PCI术后24 h hs-CRP水平[SMD=-0.53,95%CI(-0.70,-0.35),6.02,P<0.00001],差异有统计学意义;可降低PCI术后24 h IL-6水平,[SMD=-0.66,95%CI(-0.92,-0.40),Z=5.02,P<0.00001],差异有统计学意义。4)围手术期氧化应激指标方面:丹红注射液可升高PCI围手术期SOD水平,同时降低MDA水平。5)围手术期内皮功能指标方面:丹红注射液能降低PCI围手术期ET水平。6)丹红注射液能降低择期PCI患者的心血管事件发生率,且纳入研究均未提及丹红临床应用的不良反应。结论:择期行PCI术患者围手术期应用常规西药联合丹红注射液可改善心肌坏死程度,抑制炎性反应,减轻氧化应激的损伤,减轻内皮功能损伤,并能降低PCI术后心血管事件发生率,提示丹红注射液对择期PCI围手术期心肌具有一定的保护作用。但由于样本量有限、纳入研究文献的质量存在一定缺陷,仍需进一步深入研究。

    Abstract:

    To observe the protective effect and safety of Danhong Injection (DHI) in combination with western medicine for PMI following elective PCI through systematic review.Methods:A systematic review of RCTs of DHI for the treatment and prevention of PMI following elective PCI were conducted on the basis of Cochrane,Medline,CNKI,VIP,CMCI and Wanfang.Data included the founding year to 31 Jan,2017.Two researchers independently selected the articles and extracted data.Then the quality was assessed and results cross-cheecked.Revman 5.3 was used in the analysis of the results.Results:Eleven RCTs that enrolled 956 patients were included.All were conducted in China.The control group(C,471 cases) was given conventional western medicine,and treatment group(T,485 cases) was given Danhong injection on that basis.It implies that,1) Danhong Injection can decrease the occurrence of myocardial infarction.2) After PCI 24hr,Danhong Injection can lower down CK-MB level with statistical difference [MD=-6.46,95%CI (-8.57,-4.34),Z=5.99,P<0.00001];and the level of cTNI,with statistical difference [SMD=-0.36,95%CI(-0.68,-0.03),Z=2.16,P=0.03].3)After PCI 24hr,it can reduce the level of hs-CRP [SMD=-0.53,95%CI(-0.70,-0.35),6.02,P<0.00001] and the level of IL-6,[SMD=-0.66,95%CI (-0.92,-0.40),Z=5.02,P<0.00001] with statistical significance.4) It can increase the level of SOD and decrease that of MDA.5) Decrease the level of ET.6) Decrease occurrence of cardiovascular disease without inducing further adverse reactions.Conclusion:DHI might be a potentially efficacious treatment of PMI following elective PCI.Nevertheless,its safety remains uncertain because of limited information.Owing to the fact that the overall quality of the studies was low,higher qualified RCTs are expected.

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张玉灵,尚菊菊,邢文龙,李享,周琦,来晓磊,杨志海,刘红旭.丹红注射液干预择期PCI围手术期心肌保护与安全性的系统评价[J].世界中医药,2017,(02).

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  • 收稿日期:2017-02-10
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  • 在线发布日期: 2017-03-28
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