清肾颗粒对慢性肾脏病湿热证患者生存质量的影响

摘要

Objective To observe the improvement effects of Qingshen Granule on the life quality of chronic kidney disease (CKD) patients with damp-heat syndrome. Methods The CKD patients with damp-heat syndrome were randomly divided into experimental group and control group. The control group was treated with Western medicine, and the treatment group was treated with Qingshen Granules additionally for 12 weeks. SCr and eGFR were observed before and after treatment, and the life quality was investigated by KDQOL-SFTM1.3. Results Actually 156 cases were completed, including 77 cases in the treatment group and 79 cases in the control group. The total rate of curative effect was 81.82% (63/77) in teatment group, and (63.29%, 50/79) in control group, with significent difference (P<0.05). Multivariate linear regression analysis indicated that gender, education level, TCM syndrome score, CKD stage, eGFR and Hb level could affect the life quality. The scores of KDQOL-SFTM and its containing the MOS item short from health survey (SF-36) and kidney disease targeted areas (KDTA) were significantly improved after treatment in experimental group (P<0.05), while the scores in control group were with no significant improvement. The improving effects of PCS, and SPL, SLEEP, PS in KDTA in treatment group were significantly superior to those in control group (P<0.05). The scores of life quality in effective and stable cases increased significantly after treatment compared with before treatment (P<0.05). Conclusion Qingshen Granules can effectively improve the life quality of CKD patients with damp-heat syndrome, and the effect is not dependent on the improvement of laboratory indexes (renal function).%目的：观察清肾颗粒对慢性肾脏病（CKD）湿热证患者生存质量的作用。方法将 CKD 湿热证患者随机分为试验组和对照组，对照组予西医基础治疗，治疗组在对照组治疗基础上予清肾颗粒口服，疗程12周。观察治疗前后患者血肌酐（SCr）、估算肾小球滤过率（eGFR）变化，采用 KDQOL-SFTM1.3量表进行生存质量评价。结果156例患者完成观察（试验组77例，对照组79例）。试验组总有效率为81.82%（63/77），对照组为63.29%（50/79），差异有统计学意义（P＜0.05）。多元线性回归分析提示，性别、受教育程度、中医证候积分、CKD 分期、eGFR 和血红蛋白等因素均可影响生存质量。治疗组治疗后 KDQOL-SFTM1.3量表总分及 SF-36量表评分和肾脏疾病相关领域（KDTA）量表评分均较治疗前显著提高（P＜0.05），对照组均无明显改善（P＞0.05）；试验组 SF-36量表下属的生理健康评分、KDTA 量表的症状与不适、睡眠和患者满意度维度评分改善显著优于对照组（P＜0.05）。治疗组有效、稳定病例的治疗后 SF-36评分、KDTA 评分及量表总分均较治疗前显著升高（P＜0.05），无效病例除 SF-36量表下属的心理健康评分外，其 SF-36评分、KDTA 评分及量表总评分均较治疗前显著升高（P＜0.05）。结论清肾颗粒能显著提高患者的生存质量，且这种作用并不依赖于患者实验室指标（肾功能水平）的改善。