益肾泄浊方改善痛风肾患者肾间质纤维化的随机对照研究

Randomized Controlled Study on Improving Renal Interstitial Lesion in Patients with Gouty Nephropathy Yishen Xiezhuo Decoction

目的:通过随机对照临床研究,评价益肾泄浊方治疗痛风性肾病的有效性与安全性。方法:本研究采用随机对照的方法,选取痛风性肾病临床病例共96例:治疗组50例,对照组46例。治疗组用药益肾泄浊方由黄芪、土茯苓、莪术、黄精等中药组成;疗程共12周。分别在第0、12周观察中医证候积分及主要指标,从而评价其临床疗效。结果:(1)组内前后比较结果显示:治疗组治疗后血肌酐(Scr)、血尿酸(UA)、尿单核细胞趋化因子-1(MCP-1)、Ⅲ型胶原(PC-Ⅲ)均值较治疗前下降,较治疗前比较差异有统计学意义(P<0.05);(2)对照组治疗后Scr、UA、尿MCP-1、尿视黄醇结合蛋白(RBP)、尿PC-Ⅲ均值较治疗前上升,尿MCP-1、尿RBP、尿PC-Ⅲ前后比较差异有统计学意义(P<0.05)。(3)两组治疗后Scr、UA、尿MCP-1、尿PC-Ⅲ差异有统计学意义。(P<0.05)。(4)治疗组中医症候改善的总有效率为92.00%,显著优于对照组63.04%。结论:益肾泄浊方能有效改善痛风肾患者的肾功能及临床症状;干预痛风肾患者肾间质病变的进程,并具有一定的安全性。

Evaluate the efficacy and safety of Yishen Xiezhuo Decoction on gouty nephropathy through observa- tion and research of clinical cases. Methods： We adopt the method of prospective cohort study. 96 clinical cases of gouty nephropathy are randomly selected with 50 cases in treatment group and 46 cases in control group. Yisheng Xiezhuo Decoction consisting of Astrag- alus, Tuckahoe, Curcuma, Huang Jing ete are adopted in treatment group. The treatment course is 12 weeks. The Chinese medicine symptom score and key indicators are observed in the zeroth and twelfth week respectively to evaluate its clinical efficacy. Results： 96 patients of gouty nephropathy are randomly divided into a treatment group of 50 cases and a control group of 46 cases. （ 1 ） The in- tragroup contrasted result shows： The means of Scr, UA, urine MCP - 1 of treatment group decrease after treatment;There is statisti- cal difference in Scr, UA, urine MCP - 1 before and after therapy for the treatment group（P 〈0.05）. （2） The means of Scr, UA, urine MCP - 1, urine RBP, urine PC -III of control group increase after treatment;There is statistical difference in urine MCP - 1, urine RBP, urine PC -III before and after therapy for the control group（P 〈0.05）. （3） The comparison of Scr, UA, urine MCP 1, urine PC - III is statistically significant before and after the treatment; The means of difference of Scr, UA, urine MCP - 1, urine PC - III in the treatment group are higher than those in the control group （P 〈 0.05）. （4） The total effective rate of Chinese medicine symptom improvement is 92%. Conclusion：Yisheng Xiezhuo Decoction significantly lowers the blood uric acid and serum creatinine of patients of gouty nephropathy with renal failure. It effectively improves the renal function and Chinese medicine symptom of patients of gouty nephropathy. It has therapeutic effects on renal interstitial fibrosis of gouty nephropathy. And it is also safety.