冠心病合剂配方颗粒与传统汤剂的临床疗效比较

Comparison of Dispensing Granules and Traditional Decoction for Coronary Heart Disease Mixture

目的:对比观察冠心病合剂配方颗粒与传统汤剂对冠心病稳定型心绞痛,中医胸痹心痛病证属胸阳痹阻,气滞血瘀证患者的临床疗效。方法:将252例该病证患者随机分为治疗组(126例),对照组(126例),治疗组予冠心病合剂配方颗粒及常规西医治疗,对照组予冠心病合剂传统汤剂及常规西医治疗。观察对比两组治疗前,治疗2,4,6周后中医证候疗效积分评分,西雅图心绞痛量表评分,心电图、血脂、血流变、左心室射血分数、硝酸甘油使用情况等。分别比较中医证候,中西医疗效,生活质量等方面改善程度。结果:冠心病合剂对心绞痛各程度分层患者均有较好疗效,该方配方颗粒总有效率为88.0%,传统汤剂总有效率为76.0%,分层比较不同剂型对轻度、较重度患者疗效影响无明显差异,配方颗粒对中度患者疗效更为突出,与其稳定性,含量纯度等因素相关,亦受到患者生活起居等客观因素的影响,有待进一步深入观察。结论:冠心病合剂配方颗粒效果较好,有一定的临床推广价值。

Objective： To compare and observe the clinical effect of dispensing granules and traditional decoction of coronary heart disease mixture on stable angina pectoris of coronary heart disease, Qi-stagnancy and blood stasis, and stagnation of Yang in chest. Method： The 252 patients were randomly divided into control group （n=126） and treatment group （n=126）. Patients in treatment group were treated with dispensing granules of coronary heart disease mixture and routine west medicine; patients in control group were treated with traditional decoction of coronary heart disease mixture and routine west medicine. Before treatment, at week 2 of treatment, week 4 of treatment and after treatment （week 6）, traditional Chinese medicine（TCM） syndrome efficacy scores, Seattle angina scale scores, the changes of electrocardiogram（ECG）, blood lipid, blood rheology, left ventricular ejection fraction, nitroglycerin usage and other indexes were observed and compared. Symptoms of TCM syndrome, curative effect of Chinese and Western medicine, as well as quality of life were compared respectively. Result： Coronary heart disease mixture had good effect on patients with different degrees of angina pectoris. Total effective rate was 88.0% in treatment group （granule form） and 76% in the control group （traditional decoction form）.Effect of different forms had no significant difference for mild and severe patients, but dispensing granules had more prominent effect for patients with moderate conditions. This may be related to its stability and content purity as well as the objective factors such as daily life of patients, requiring further deep research. Conclusion： Coronary heart disease mixture＇s dispensing granules have better efficacy than traditional decoction form, with certain clinical popularization value. It provides strong support for the improvement of Chinese medicine in the treatment of coronary heart disease and stable angina pectoris, not only adapts to the increasingly fast pace of work and life, but also provides overall solution for the application of TCM in modern society.