CAJ | 학술논문

目的：观察可达灵片治疗冠心病心绞痛（气滞血瘀型）的临床疗效及安全性。方法：采用多中心、随机、双盲双模拟、阳性药、安慰剂平行对照的试验方法，将399例冠心病心绞痛（气滞血瘀型）患者随机分为试验组199例，复方丹参滴丸组100例，安慰剂组100例，疗程4周。结果：符合方案集心绞痛疗效总有效率试验组65.44%，复方丹参滴丸组69.51%，安慰剂组22.91%；三组比较有统计学意义的差异，试验组与复方丹参滴丸组疗效无显著性统计学差异，且试验组与复方丹参滴丸组疗效均明显优于安慰剂组。心电图疗效试验组总有效率为37.04%，复方丹参滴丸组33.33%，安慰剂组16.66%；三组比较有统计学差异，试验组与复方丹参滴丸组疗效无统计学差异，且试验组与复方丹参滴丸组疗效均明显优于安慰剂组。心电图活动平板试验阳转阴率，三组比较无统计学差异。中医证候总疗效试验组总有效率为85.87%，复方丹参滴丸组75.53%，安慰剂组31.25%；三组在治疗后均有明显改善，三组比较有统计学差异，试验组与复方丹参滴丸组疗效无显著性统计学差异，且试验组与复方丹参滴丸组疗效均明显优于安慰剂组。结论：可达灵片治疗冠心病心绞痛（气滞血瘀型）安全有效。
목적：관찰가체령편치료관심병심교통（기체혈어형）적림상료효급안전성。방법：채용다중심、수궤、쌍맹쌍모의、양성약、안위제평행대조적시험방법，장399례관심병심교통（기체혈어형）환자수궤분위시험조199례，복방단삼적환조100례，안위제조100례，료정4주。결과：부합방안집심교통료효총유효솔시험조65.44%，복방단삼적환조69.51%，안위제조22.91%；삼조비교유통계학의의적차이，시험조여복방단삼적환조료효무현저성통계학차이，차시험조여복방단삼적환조료효균명현우우안위제조。심전도료효시험조총유효솔위37.04%，복방단삼적환조33.33%，안위제조16.66%；삼조비교유통계학차이，시험조여복방단삼적환조료효무통계학차이，차시험조여복방단삼적환조료효균명현우우안위제조。심전도활동평판시험양전음솔，삼조비교무통계학차이。중의증후총료효시험조총유효솔위85.87%，복방단삼적환조75.53%，안위제조31.25%；삼조재치료후균유명현개선，삼조비교유통계학차이，시험조여복방단삼적환조료효무현저성통계학차이，차시험조여복방단삼적환조료효균명현우우안위제조。결론：가체령편치료관심병심교통（기체혈어형）안전유효。
Objective:To observe the clinical efficacy and safety of Kodaling Tablets in treating angina pectoris of coronary heart disease (CHD) and stagnation of Qi and stasis of blood in TCM) comparing with compound Danshen dripping pill and placebo. Methods:Multicenter, randomized, double-blind and double-dummy, positive medicine and placebo controlled, 399 patients were divided randomly into several groups, 199 cases in pilot group, 100 cases in compound Danshen dripping pills and the remaining 100 cases in the placebo group. The course lasted 4 weeks. Results:The Per protocol set (PPS) analysis showed that the effective rate in Angina Pectoris severity in test group was 65.45%, 69.16%in compound Danshen dripping pill group and 22.91%in placebo group;The three groups had statistical differences,the test group and the compound Danshen dripping pill group had no statistical differences, both of them were much better than the placebo group. The recovery rate of ECG in test group was 37.04%, 33.33%in compound Danshen dripping pill group and 16.66%in placebo group;The three groups had statistical differences, the test group and the compound Danshen dripping pill group had no statistical differences, both of them were much better than the placebo group. The Electrocardiogram treadmill exercise test positive negative conversion rates of three groups were not statistically significant different. The improved effective rate of symptoms in TCM in test group was 85.87%, 75.53%in compound Danshen dripping pill group and 31.25%in placebo group;the three groups had statistical differences and significantly improved during the treatment. The test group and the compound Danshen dripping pill group had no statistical differences, both of them were much better than the placebo group. Conclusion: Treating Coronary heart disease and angina pectoris (stagnation of Qi and blood stasis type) with Kodaling Tablets is safe and effective.