灯盏花素滴丸治疗冠心病心绞痛的临床研究

中国药物评价 ›› 2020, Vol. 37 ›› Issue (1): 46-49.

灯盏花素滴丸治疗冠心病心绞痛的临床研究

赵岩¹,李华², 陈图刚³,丁春平⁴,颜程光⁵,陈远平⁶

1. 南昌弘益药业有限公司
2. 江西省中西医结合医院
3. 南昌大学第四附属医院
4. 宜春市人民医院
5. 井冈山大学附属医院
6. 广西中医药大学第一附属医院

收稿日期:2020-03-25 修回日期:2020-01-01 出版日期:2020-02-28 发布日期:2020-03-30

Clinical Study of Dengzhanhuasu Dropping Pill on Angina Pectoris of Coronary Heart Disease

Received:2020-03-25 Revised:2020-01-01 Online:2020-02-28 Published:2020-03-30

摘要/Abstract

摘要： 目的：评价灯盏花素滴丸治疗冠心病心绞痛的临床疗效。方法：收集符合纳入标准的240例患者，随机分为试验组 (180例)和对照组(60例)。试验组给予灯盏花素滴丸和血塞通片模拟剂，对照组给予血塞通片和灯盏花素滴丸模拟剂，疗程为28天。以心绞痛症状积分、西雅图心绞痛量表为主要有效性评价指标，观察两组的临床疗效和不良反应/事件。结果：试验组显效率比对照组显效率高20%（95% CI：8.45%～32.66%)，试验组优于对照组；试验组愈显率优于对照组（P=0.000 6）；试验组治疗前后西雅图量表总分差值（平均为-22.5）与对照组（平均为-14.9）比较差异有统计学意义（P=0.000 1），试验组优于对照组；心绞痛症状缓解试验组好于对照组。试验组和对照组均无不良反应出现，患者生命体征各次访视和治疗前后变比值均无统计学意义（P＞0.05）和临床意义。结论：灯盏花素滴丸治疗冠心病心绞痛（心血瘀阻证）安全、有效，可为临床用药提供参考。

关键词: 灯盏花素滴丸, 冠心病心绞痛, 临床研究

Abstract: Objective：To evaluate the safety and efficacy of breviscapine dripping pill in the treatment of coronary heart disease angina. Methods： 240 patients were randomly divided into the experimental group (180 cases) and the control group (60 cases). The test group was given breviscapine dropping pill and Xuesaitong tablet simulator， while the control group was given Xuesaitong tablet and breviscapine dropping pill simulator for 28 days. Angina symptom score and Seattle Angina Scale were used as the main evaluation indicators to observe the clinical efficacy and adverse events. Results： The efficiency of the test group was 20% higher than that of the control group(95% CI： 8.45%-32.66%，P=0.0006). The difference of the total score of Seattle Scale between pre-treatment and pro-treatment in the test group was significantly different from that of the control group (average-22.5 vs.average-14.9，P=0.0001)， the test group was better than the control group. The angina symptoms relief of the test group was better than the control group. There were no adverse events in both group. There was no significant clinical difference in the ratio of changes of vital signs between pre-treatment and pro-treatment(P>0.05). Conclusion： Breviscapine dripping pill in treating coronary heart disease angina (heart blood stasis syndrome) is safe and effective.

Key words: Breviscapine dripping pill, Coronary heart disease angina, Clinical study

中图分类号:

R972.3

赵岩李华陈图刚丁春平颜程光陈远平. 灯盏花素滴丸治疗冠心病心绞痛的临床研究[J]. 中国药物评价, 2020, 37(1): 46-49.

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