慢性心力衰竭主观报告结局量表的反应度比较研究

目的：比较3种中西医结合治疗慢性心力衰竭主观报告结局量表，包括心功能不全症状积分表（ChineseMedicalSymptomRatingScaleforHeartFailure，CMSRS-HF）、明尼苏达心功能不全问卷（MinnesotaLivingwithHeartFailureQuestionnaire，MLHFQ）、简明健康状况问卷（MedicalOutcomesStudyShort-form36，SF-36）的反应度，为中西医结合临床疗效评价结局指标的选择提供依据。方法：对3个临床研究中心招募的156例慢性心力衰竭患者实施调查，采用治疗前后差异的配对t检验、效应量（effectsize，ES）和标准反应均数（standardizedresponsemeans，SRM）评价反应度。结果：（1）中西医结合干预2周后，中医症状评分表得分显著降低，MLHFQ身体领域、情绪领域及综合得分显著升高；SF-36的8个维度及生理领域、心理领域、总分显著升高（P=0．000）。（2）中医症状评分表的ES大于0．8，MLHFQ身体领域、情绪领域及综合得分的ES为0．37～0．61，SF-36的8个维度及生理领域、心理领域、总分的ES为0．14～0．49。（3）标准反应均数SRM：中医症状评分表大于0．8，MLHFQ身体领域、情绪领域及综合得分为0．53～0．92，SD36的8个维度及生理领域、心理领域、总分为0．23～0．83。（4）不同NYHA分级分层分析，各主观报告结局量表对中西医结合治疗中、重度（NHYAⅢ、Ⅳ级）慢性心衰更敏感。结论：中医症状评分表反应度较好，MLHFQ反应度适中，SF-36大部分维度反应度适中。慢性心力衰竭中西医结合临床疗效评价时，可根据实际情况选择应用不同的结局评价量表。

Responsiveness of three subjective report of outcome measures for chronic heart failure

OBJECTIVE： To compare the responsiveness of a newly designed symptom scale, the Chinese Medical Symptom Rating Scale for Heart Failure （CMSRS-HF）, with the Chinese version of Minnesota Living with Heart Failure Questionnaire （MLHFQ） and the Medical Outcomes Study Short-form 36 （SF-36）, and provide basis for the selection of subjective outcome measures for clinical evaluation of treatment of chronic heart failure by integrated traditional Chinese and Western medicine. METHODS： One hundred and fifty-six patients with chronic heart failure were recruited from three clinical centers and were treated with Chinese herbal medicine based on syndrome classification. The patients were classified with standard of New York Heart Association and evaluated with CMSRS-HF, MLHFQ and SF-36. Three techniques for the quantification of responsiveness were utilized： paired t-test, effect sizes （ES） and standardized response means （SRM）. RESULTS：a） After 2-week treatment, patients scored significantly lower in CMSRS-HF, while scores of each dimension on MLHFQ and SF-36 increased significantly （P=0. 000）. b） ES of CMSRS-HF was greater than 0. 8 ; ES of physical and emotional dimensions and comprehensive scores of MLHFQ were between 0.37 and 0. 61; ES of each dimension, physical and emotional domains, and comprehensive scores were between0. 14 and 0. 49. c） SRM of CMSRS-HF was greater than 0. 8; SRM of physical and emotional dimensions and comprehensive scores of MLHFQ ranged from 0. 53 to 0. 92; SRM of each dimension, physical and emotional domains, and comprehensive scores were between 0. 23 and 0.83. d） By stratified analysis according to NYHA classification, the acute patients （NYHAⅢ, Ⅳ） were more sensitive to subjective outcome measures. CONCLUSION= Responsiveness of the newly designed CMSRS-HF is high. However, responsiveness of MLHFQ and most dimensions in SF-36 is moderate. When evaluating clinical effects of integrated traditional Chinese and Western medicine on chronic heart failure, different scales can beapplied according to actual clinical presentations.