麒麟心痛舒对非ST段抬高型急性冠脉综合征合并消化道出血患者的疗效观察

An observation on therapeutic effect of Qilin Xintongshu pill for treatment of patients with non-ST segment elevation acute coronary syndromes accompanied by gastrointestinal bleeding

目的：观察自拟中药组方麒麟心痛舒对非ST段抬高型急性冠脉综合征（NSTE-ACS）合并消化道出血（GIB）患者的临床疗效。方法采用前瞻性随机对照研究方法，选择海南省琼海市中医院心内科收治的67例NSTE-ACS合并GIB患者，按随机数字表法分为治疗组（35例）和对照组（32例）。两组在常规给予内科治疗（除抗凝外）的基础上，治疗组给予麒麟心痛舒丸（由三七、血竭、枳实等药物组成），每次5 g，每日3次口服；对照组给予硫酸氯吡格雷每次75 mg，每日1次口服，两组均治疗30 d。比较两组治疗后主要心血管事件发生率（包括死亡、新发心肌梗死、再梗死、顽固性缺血）和消化道大出血事件的发生率，并观察不良反应发生情况。结果治疗后治疗组心血管事件和消化道大出血发生率均较对照组明显降低〔心血管事件发生率：8.57%（3/35）比28.13%（9/32），消化道大出血发生率：2.86%（1/35）比21.88%（7/32），均P＜0.05〕。两组均未见不良反应发生，治疗前后血尿常规及肝肾功能未见异常。结论麒麟心痛舒丸能有效降低NSTE-ACS合并GIB患者30 d内的心血管事件和消化道大出血事件的发生率，是NSTE-ACS合并GIB患者理想的治疗药物。

Objective To observe the therapeutic effect of Qilin Xintongshu pill for treatment of patients with non-ST segment elevation acute coronary syndromes（NSTE-ACS）accompanied by gastrointestinal bleeding （GIB）. Methods A prospective randomized controlled trial was conducted. A total of 67 hospitalized patients in Cardiovascular Department of Qionghai City Hospital of Traditional Chinese Medicine were divided into therapy group（35 cases）and control group（32 cases）. Both groups were given conventional medical treatment（except anti-coagulative agent）. In the therapy group,the patients received Qilin Xintongshu pill（the ingredients consisting of panax pseudo-ginsen,dragon＇s blood,immature orange fruit,etc.）oral administration,once 5 mg and 3 times a day,while in the control group,the patients accepted clopidogrel orally,once 75 g and once a day,the therapeutic course in both groups being 30 days. The major cardiovascular events（such as death,a newly-happened myocardial infarction（MI）,MI secondary,obstinately ischemia）and incidence of massive hemorrhage of gastrointestinal tract were compared between the two groups,and the adverse events were observed. Results After treatment,the incidence of cardiovascular events and massive hemorrhage of gastrointestinal tract in the therapy group were decreased significantly compared to those in the control group 〔incidence of cardiovascular events：8.57%（3/35）vs. 28.13%（9/32）, incidence of massive hemorrhage of gastrointestinal tract：2.86%（1/35）vs. 21.88%（7/32）,both P〈0.05〕. Adverse events were not observed in both groups,and the examinations of blood,urine,liver and renal functions were of no abnormalities before and after treatment. Conclusion Qilin Xintongshu pill can effectively reduce the incidences of cardiovascular events and massive hemorrhage of gastrointestinal tract in patients with NSTE-ACS accompanied by GIB in the therapeutic course of 30 days,therefore this traditional Chinese herbal medicine is an ideal agent for treatment of such disease.