中西医结合治疗对冠心病患者生存质量改善的随机对照研究

A Randomized Controlled Study on Improvement of QOL of Acute Coronary Syndrome Patients by Combined TCM-WM Therapy

目的:编制一套有中华文化内涵的冠心病(CAD)生存质量量表,用以评价中西医结合治疗CAD的临床疗效。方法:采用随机、对照、单盲方法,将129例CAD患者分为中西医结合治疗组(简称治疗组)和常规治疗组(简称对照组),其中治疗组72例和对照组57例。对照组予常规西药如抗血小板药物、硝酸酯类药物、β-受体阻滞剂、钙离子拮抗剂、血管紧张素转化酶抑制剂(ACEI)等;治疗组在常规西药基础上辨证施治,加用中药汤剂和中成药。本研究主要观察治疗前后生存质量的改善情况。结果:(1)治疗后与治疗前相比,治疗组和对照组生存质量情况均有一定程度的改善,差异具有统计学意义(P<0.05),但治疗组改善更明显;(2)治疗前,治疗组和对照组各维度计分差别无统计学意义(P>0.05),治疗后,治疗组患者在"临床主要症状"、"疾病伴随情况"、"疾病认识程度"方面与对照组比较有提高,差异具有统计学意义(P<0.05),而在其余"躯体活动受限程度"、"疾病发作情况"、"疾病诱发因素"、"治疗满意程度"四个方面两组差异无统计学意义(P>0.05)。结论:(1)中西医结合治疗能显著改善冠心病患者的生存质量。(2)中西医结合治疗后的患者,生存质量随时间的推移改善越明显。

Objective：To observe the clinical efficacy of combination of Chinese medicine and western medicine for the treatment of Coronary artery disease（CAD）based on the compilation of Quality of Life Scale that keep their national characteristics and evaluate effect of TCM as well.Methods：By randomized and single blind principle,129 patients with CAD were assigned to 2 groups,the control group（n=57）treated with conventional treatment include Antiplatelet Drugs,nitrate,β-receptor blocker,CCB and ACEI,and the treated group（n=72）with Chinese herbal decoction and Chinese Patent Medicines in addition to the conventional treatment.The main outcome measure of this study was the improvement of QOL before and after the treatment.Results：（1）Some improved effects of QOL were also observed in the control and treated group after the treatment than that before the treatment,there was statistical difference（P0.05）.The treated one was better than the control one;（2）There was no significant difference between the two groups in terms of basic clinical characteristics before the treatment（P0.05）.Intergroup comparison：after the treatment,there was a statistical difference between treatment group and control group in the clinical symptoms,the main underlying diseases and knowledge about CAD（P0.05）.Meanwhile,there was no significant difference between the other four groups（P0.05）.Conclusion：（1）Combined TCM-WM Therapy can definitely improve the quality of life of the ACS patients;（2）Improvement of QOL of Acute Coronary Syndrome patients by Combined TCM-WM Therapy would be evidence with time process.