丹参注射液与抗血栓药合用对急性冠脉综合征患者出血风险研究

Study on bleeding risk of Danshen injection and antithrombotic drugs in patients with acute coronary syndrome

目的:探讨丹参注射液联合抗血栓药物对急性冠脉综合征(ACS)患者的出血风险。方法:①检索中国生物医学文献数据库(CBM),1979年1月至2009年8月,记录各丹参注射液文献的不良事件类型等。②回顾2008年1月至2009年10月的ACS患者301例,丹参组(114例),对照组(187例),收集并记录病例不良事件等。③选择2009年11月至2010年3月于东方医院住院治疗的符合ACS诊断且未使用其他活血化瘀类中药及其制剂的患者47例,采用分层分段随机对照试验,两组均予阿司匹林+氯吡格雷+低分子肝素钠,治疗组加用注射用丹参(冻干)0.4g静脉点滴;对照组加用马来酸桂哌齐特160mg静脉点滴,每日1次,7d。结果:①检索到文献1 659篇,纳入统计86篇。报道不良反应病例7 900例,涉及丹参注射液395例(0.05%),出血16篇,占不良事件17.4%。出血事件与丹参注射液可能有关、肯定有关各1篇(2.13%)。②回顾性队列研究中丹参组与对照组发生不良事件为2例:1例,出血事件为1例:1例。③治疗组治疗后最大血小板聚集率(ADP和AA)较本组治疗前及对照组治疗后最大血小板聚集率显著性降低(P<0.05)。治疗后治疗组与对照组中医血瘀证积分均较治疗前有显著性差异(P<0.01,P<0.05),治疗组有效率95.7%,对照组有效率87.5%。不良事件治疗组:对照组为7例:5例;出血事件治疗组:对照组为3例:2例。结论:本研究表明丹参注射液与抗血栓药合用未增加ACS患者出血风险。

Objective： Discussion the bleeding risk on patients with ACS by Danshen injection in combination with western medicine.Methods： ①Search at CBM,from 1979.1to 2009.8,note every adverse events types of Salvia injection.②Study the patients with ACS 301 cases from 2008.1 to 2009.10,SM group（114 cases）,the control group（187 cases）,collect and record the adverse events of the cases.③Select the patients in Dongfang Hospital with diagnosis of ACS and use no other Traditional Chinese herbs or its preparations from 2009.11-2010.3.Use sub-stratified randomized clinical trail.Both groups use aspirin ＋ clopidogrel ＋ low molecular heparin.The treatment group add Danshen injection（lyophilized） 0.4g;Control group with cinepazide 160mg,intravenously,qd,7d.Result： ①Search the literatures at a total 1659 posts,bring in statistics 86 posts.It reports adverse events 7900 cases,refers to Danshen injection 395 cases（0.05%）,among them,about bleeding 16 cases（17.4%）.The bleeding events may be related and certain related with Danshen injection each 1 case（2.13%）.②In retrospective cohort study,the occurrence of adverse events between SM group and the control group is 2 cases to 1 case,the bleeding events is 1 case to 1 case.③In the treatment group after treatment,platelet aggregation rate max（ADP and AA） is significant lower than before treatment and decreased significantly compared with the control group（P〈0.05）.The score of Chinese blood stasis after the treatments compared with the ones before the treatments,the differences in both groups are significant（P〈0.01,P〈0.05）.The efficiency of the treatment group is 95.7%,while the control group is 87.5%.Adverse events between treatment group and control group is 7 cases ：5 cases;while bleeding event is 3 cases ：2 cases.Conclusion： It showed that Danshen injection and anti-thrombosis drug combination did not increase the risk of bleeding in patients with ACS.