基于中华生存质量量表评估稳心律合剂疗效的思考

目的:观察稳心律合剂治疗永久性房颤的疗效。方法:40例永久性心房颤动心阳不振证患者,随机分为稳心律合剂组和对照组各20例,观察周期28d,采用中华生存质量量表(ChQOL)、心悸证候学评分表进行治疗前后的评分。结果:稳心律合剂组较对照组在生存质量第一维度"睡眠"、"饮食消化"和"眼神"以及第二维度"形"、"总体主观健康"上的改善更为明显;稳心律合剂组较对照组证候改善更为明显。结论:运用ChQOL评估稳心律合剂疗效的可行性,仍需进一步检验;中医药疗效评估需要更合适的体系,循证医学方法及终点指标、生存质量、患者报告结果等均值得借鉴。

On the clinical efficacy evaluation of Wenxinlv Mixture in treating PAF by ChQOL

Objective: To observe the healing effect of Wenxinlv Mixture on treating permantent atrial fibrillation(PAF).Methods: 40 PAF patients especially with devitalization of heart yang were classified into two groups at random,the Wenxinlv mixture group and the control one,each of 20 patients.The first questionnaire survey began after the patient’s hospitalization,and the second could be done at 28 days later.Results: The score of’sleep’,’appetite’and’spirit of eye’improves more in Wenxinlv mixture group than the control one significantly after treatment.Wenxinlv mixture group has higher scores of ’physical form’and’overall quality of life’than the control one in the second survey.The difference between the scores of TCM clinical presentation after treatment is statistically significant.And Wenxinlv Mixture dose better compared with the control group.Conclusion: We need parallel control study to assess the reliability,validity and responsiveness of ChQOL in patients with PAF.It’s high time to establish appropriate evaluation standards of TCM efficacy.We should use the marks in clinical study of evidence-based medicine,such as end points,Quality of Life(QOL) and Patient-Reported Outcomes(PRO),for reference.