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(Chinese Medical Symptom Rating Scale for Heart Failure,CMSRS-HF)、明尼苏达心功能不全问卷(Minnesota Living with Heart Failure Questionnaire,MLHFQ)、简明健康状况问卷(Medical Outcomes Study Short-form 36,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(effect size,ES)和标准反应均数(standardized response means,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,SF-36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。
Objective: To investigate the effects of health education based on integrative therapy of Chinese and Western medicine for type 2 diabetes mellitus(T2DM) from the aspects of knowledge, attitude and practice(KAP), health-related quality of life(HRQo L), body mass index(BMI) and glucose control. Methods: Patients were individually randomized into intervention group(receiving integrative education, n=120) and control group(receiving usual education, n=120). The primary outcome was the changes in glycosylated hemoglobin A1c(HbA1c) levels after 3, 6, 9 and 12 months from baseline. Hierarchical linear models(HLMs) were used to assess within-group changes in outcomes over time and between-group differences in patterns of change. Secondary outcomes were KAP scores, HRQo L scores and BMI after 6 and 12 months, paired-sample t test was used to assess within-group changes in outcomes in 6 and 12 months, independent-sample t test was used to assess between-group differences in patterns of change. Results: HbA1c decreased statistically from baseline to 3 months, from 3 to 6 months, from 6 to 9 months and from 9 to 12 months in the intervention group(all P<0.01); and decreased significantly from baseline to 3 months, and from 3 to 6 months in the control group(P<0.01). There were significant between-group differences from baseline to 3 months(P=0.044), from 6 to 9 months(P<0.01) and from 9 to 12 months(P<0.01). Significant improvements in the intervention group along with significant between-group differences were found in KAP and HRQo L scores respectively(all P<0.05). The number in the intervention group of normal weight increased from 56 at baseline to 81(6 months), 94(12 months), the number in the control group were 63(baseline), 69(6 months), 70(12 months), the χ~2 of hierarchical analysis of BMI were 6.93(P=0.075), 10.31(P=0.016), 15.53(P<0.01), respectively. Conclusion: Health education based on integrative therapy of Chinese and Western medicine is beneficial to the control of T2DM and should be recommended for T2DM.
SHI MaiLIU Zhao-lanZHU Yan-boXU Mei-yanDUAN Xue-yingSHI Hui-meiJIANG BoZHANG Xiao-meiYU Xiao-han
