不同剂量大黄附子细辛汤治疗慢性肾功能衰竭疗效对比观察

Effect of Different Doses of Dahuang Fuzi Xixin Decoction on Chronic Renal Failure

目的观察不同剂量大黄附子细辛汤治疗慢性肾功能衰竭(CRF)的疗效与安全性。方法选择30例符合纳入标准的CRF患者,随机分为大剂量组、小剂量组,每组15例,经4～6周导入期治疗后,分别予大、小剂量的大黄附子细辛汤加减方煎剂口服,于治疗4周、8周、12周后比较两组中医证候积分、肾功能指标及生存质量积分变化。结果治疗后两组中医证候积分均下降,各时间点与治疗前比较差异均有统计学意义(P<0.05或P<0.01),治疗8周及12周后,大剂量组中医证候积分明显低于小剂量组,两组比较差异有统计学意义(P<0.05或P<0.01);治疗12周后肾功能指标与治疗前比较,大剂量组血肌酐(Scr)明显下降(P<0.01)、肾小球滤过率(eGFR)显著上升(P<0.05),治疗12周后两组Scr、eGFR比较有统计学意义(P<0.05);治疗12周后与治疗前比较,两组生存质量积分均显著提高(P<0.01),治疗12周后两组比较,大剂量组生存质量积分明显高于小剂量组(P<0.05)。两组均未出现与治疗有关的不良事件。结论大黄附子细辛汤具有改善中医证候、稳定肾功能及提高患者生存质量的作用,与小剂量相比,大剂量疗效更明显。

Objective To observe the effect and safety of different doses of Dahuang Fuzi Xixin Decoction ]-Decoction of Dahuang （Radix et Rhizoma Rhei ） , Fuzi （Radi＂ Aconiti Praeparata ）, and Xixin （Herba Asari ） ~ on chronic renal failure （CRF） patients. Methods Thirty CRF patients were randomized into large-dose group and small-dose group with 15 in each. After the basic treatment for 4- 6 weeks, they were administered large-dose or small-doses of modified Dahuang Fuzi Xixin De- coction respectively. The TCM symptom scores, indices of renal function, and after scores of quality of life of between the two groups was compared 4, 8, and 12 weeks treatment. Results After treatment, the TCM symptom scores of both groups de- creased, and the comparison of each time points with before treatment showed statistical difference （P^0.05 or P〈（0.01）. After 8 and 12 weeks＂ treatment, the TCM symptom score of the large-dose group was significantly lowered than that of the small-dose group, and the difference between the two groups was statistically significant （P〈0.05 or P〈0.01）. After 12 weeks＂ treatment, the serum creatinine was significantly lowered （P〈 0.01） and the estimated glomerular filtration rate （eGFR） was significantly increased （P〈0.05） in the large dose group. After 12 weeks＂ treatment, the comparison of creatinine and eGFR between the two groups was statistically different （P〈0.05）. After 12 weeks treatment, the scores of quality of life of both groups were significantly increased （P〈0. 01） compared with before treatment. After 12 weeks treatment, the comparison between the two groups showed that the score of quality of life of the large：dose group was higher than that of the smalldose group, and the difference was statistically significant （P〈0.05）. There was not adverse events related with treatment. Conclusion The modified Dahuang Fuzi Xixin Decoction is effective in improving the TCM symptoms, stabilizing the renal function, and improving quality of life of the patients. Compared with the small-dose, the effect of large-dose of Dahuang Fuzi Xixin Decoction is more significant.