麒麟心痛舒联合阿司匹林对不稳定型心绞痛合并上消化道损伤高危患者的疗效观察

A clinical observation on therapeutic effect of Qilinxintongshu pill combined with aspirin for treatment of critical patients with unstable angina pectoris accompanied by upper alimentary tract damage

目的观察麒麟心痛舒对不稳定型心绞痛（UAP）合并上消化道损伤高危患者的临床疗效。方法采用前瞻性随机对照研究方法，选择2011年11月至2015年1月在琼海市中医院心内科住院或门诊确诊的UAP合并上消化道损伤高危患者60例，按随机数字表法分为试验组和对照组，每组30例。两组均给予内科常规基础治疗，试验组在内科常规治疗基础上口服自拟麒麟心痛舒（由三七、血竭、枳实等药物组成），每次5g，每日3次；对照组口服硫酸氯吡格雷每日75mg，连续治疗30d。比较两组治疗后主要心血管事件（包括死亡、新发心肌梗死、顽固性缺血）的发生率和消化道损伤事件的发生率，并观察不良反应发生情况。结果试验组和对照组心血管事件发生率比较差异无统计学意义[6．7％（2／30）比16．7％（5／30），P〉0．05]；试验组消化道损伤事件发生率较对照组明显降低[10．0％（3／30）和36．7％（11／30）]，差异有统计学意义（P〈0．05）。两组患者治疗前后血尿常规及肝肾功能未见异常。结论麒麟心痛舒治疗UAP合并上消化道损伤高危患者安全有效，且不增加上消化道损伤事件的发生率。

Objective To evaluate the clinical efficacy of Qilinxintongshu pill for treatment of critical patients with unstable angina pectoris （UAP） accompanied by upper alimentary tract damage. Methods A prospective randomized controlled trial was conducted. A total of 60 critical outpatients or inpatients with confirmed diagnosis of UAP accompanied by upper alimentary tract damage in Cardiology Department of Hospital of Traditional Chinese Medicine of Qionghai City from November 2011 to January 2015 were enrolled in the study, and they were assigned to a therapy group （30 cases） and a control group （30 cases） by table of r~/ndom number. The conventional medical basic therapy was given to both groups, in addition, the patients in therapy group took Qilinxintongshu pill （made of notoginseng, dragon＇s blood, fruit of immature citron, etc.） 5 g once, three times a day, and the patients in control group orally administered clopidogrel 75 mg once a day, the therapeutic course being consecutive 30 days. After treatment, the rates of main cardiovascular events [including death, a newly-happened myocardial infarction （MI）, and obstinate ischemia] and events of alimentary damage were compared between the two groups, and adverse effects were observed. Results There was no statistically significant difference in incidence of cardiovascular events between the therapy group and control group [6.7% （2/30） vs. 16.7% （5/30）, P 〉 0.05]. The incidence of massive hemorrhage of gastrointestinal tract was significantly lower in therapy group than that in control group [10.0% （3/30） vs. 36.7% （11/30）, P 〈 0.05]. In the treatment process, there was no significant untoward side effect, and no abnormalities in routine blood and urine tests, liver and renal functions were found. Conclusion Qilinxintongshu pill for treatment of critical patients with UAP accompanied by upper alimentary damage is safe and effective, and does not enhance the incidence of massive hemorrhage of gastrointestinal tract.