摘要
目的观察中医辨证治疗方案对糖尿病肾病(DN)肾功能不全患者生存质量的影响。方法采用随机、单盲、平行对照、多中心临床研究方法,将入选的221例DN肾功能不全患者分为辨证组、氯沙坦组和辨证+氯沙坦组3组。应用世界卫生组织(WHO)生存质量量表简表(QOL-BREF)和糖尿病患者生存质量特异量表(DQOL),在各组治疗前和治疗3个月后各测评1次。结果各治疗方案可增加患者生存质量评分和自我评分,降低疾病对生理功能和心理/精神的影响评分,与治疗前比较差异均有统计学意义(P<0.05或P<0.01)。各组治疗前后差值比较患者自我评分差异有统计学意义(P<0.05),其他各项生存质量指标评分在治疗前后差值的组间比较差异均无统计学意义(P>0.05),意向性分析(ITT)和符合方案数据分析(PP)分析结果一致。结论建立在饮食、降糖、对症治疗基础上的中医辨证治疗方案可显著提高DN肾功能不全患者的生存质量,其可能在提高患者自我评分方面具有一定优势。
Objective To observe the effect of TCM treatment on quality of life in the patients of diabetic nephropathy （DN） with renal failure. Methods Multi-centered randomized-controlled, single-blinded design was carried out. The selected 221 diabetic nephropathy patients were randomized into TCM treatment group, Losartan group, and TCM treatment 4- Losartan group. Use WHO QOL-BREF and DQOI, before treatment and 3 months after treatment respectively to evaluate the quality of life （QOL）. Re- sults All the treatment plans could increase the scores of QOL and self-scoring and decrease the influence of disease on physiological function and psychological state. Compared with before treatment, there was a significant difference （P〈0.05 or P〈0.01）. Among all the three groups, there was a significant difference in self-scoring of patients before and after treatment （P〈0.05）. There was no significant difference among groups in changes of other scores of QOL after treatment （P〉0.05）. The result of intention-to-treat （ITT） analysis and PP analysis accorded with each other. Conclusion The TCM treatment based on the diet, glucose control, and symptomatic treatment can improve the quality of life of the patients with diabetic nephropathy. The TCM treatment may have advan- tage in increasing the self-scoring of patients.
出处
《中医杂志》
CSCD
北大核心
2008年第2期119-122,共4页
Journal of Traditional Chinese Medicine
基金
国家“十五”科技攻关计划资助项目(2001BA701A13c)
