长期服用麝香保心丸治疗冠心病临床疗效评价

目的评估口服麝香保心丸至少6个月对稳定型心绞痛患者临床事件发生情况的影响。方法前期为前瞻性、随机、非盲对照临床试验,后期为队列研究。选择2005年5月—2006年6月就诊的冠心病稳定型心绞痛患者200例,随机分为麝香保心丸组(治疗组)和对照组,每组100例。两组采用常规冠心病药物治疗,包括抗血小板、调脂、抗缺血等治疗,治疗组加用麝香保心丸(每次2丸,每天3次)至少6个月。所有患者随访终止时间为2008年1月,记录用药情况和临床事件等。主要终点为各类心血管事件的复合终点。结果随访时间0.5～2.75年,中位随访时间2.25年。治疗组发生各种临床事件23例次,其中主要临床事件20例,包括心绞痛事件9例,对照组分别为33、29、19例,两组比较差异有统计学意义(P0.05);治疗组硝酸酯类药物的使用比治疗前明显减少(P0.05)。全因死亡事件、因心血管疾病死亡事件、心衰事件、卒中事件、需行PCI/CABG、发生其他临床事件的患者例数治疗组较对照组有减少趋势,但差异无统计学意义(P0.05)。结论长期服用麝香保心丸(至少6个月)可明显减少心绞痛事件及部分其他临床事件的发生,减少硝酸酯类药物的使用量。

Evaluation on Clinical Effect of Long-term Shexiang Baoxin Pill Administration for Treatment of Coronary Heart Disease

Objective To evaluate the effect of long-term Shexiang Baoxin Pill （SXBXP） administration on cardiovascular events in patients with stable angina pectoris （SAP）. Methods A prospective randomized non-blind parallel controlled study was conducted in the early stage （the first 6 months） of the trial, then a cohort study was succeeded in the later stage. Two hundred patients with SAP, who visited the hospital between May 2005 and June 2006, were selected and randomly assigned to the trial group and the control group, 100 patients in each group. Both were treated with conventional therapy, including treatment for anti-platelet, blood lipid regulating, anti-ischemia, etc, and to patients in the trial group, SXBXP was administered additionally for 2 pills,three times a day by oral intake. The therapeutic course lasted for at least 6 months. All patients were followed up until January 2008, the clinical events and conditions of treatment were recorded. The composite terminal of various cardiovascular events was regarded as the primary endpoint. Results The median follow-up time of the study was 2.25 years （ranging from 0.5 to 2.75 years）. In the trial group, the occurrence （cases） was 23 for all-clinical event, 20 for primary-clinical event and 9 for angina pectoris event, which were lesser than those in the control group, 33, 29 and 19 cases respectively, showing a significant difference between groups （P0.05）. The dosage of nitrates used in the trial was decreased more than that before treatment. Besides, all the incidences （cases）, in terms of all-cause death （2 vs 5）, cardiovascular death （1 vs 2）, congestive heart failure （3 vs 4）, stroke （2 vs 4）, and other clinical （5 vs 6） events, as well as in the need for percutaneous coronary intervention or coronary artery bypass graft （2 vs 4）, showed somewhat lowering in the trial group as compared with the corresponding items in the control group, but statistical analysis showed an insignificant difference between them （P0.05）. Conclusion Long-term SXBXP administration could reduce the occurrence of angina pectoris events and some other clinical events, and cut down the dosage of nitrates used in patients with SAP.