“补脾益肾”法治疗早期慢性肾脏病的随机对照临床研究

Randomized controlled clinical research of the ＂bupiyishen＂ method in the treatment of early chronic kid-ney disease

目的探讨“补脾益。肾”中药治疗早期慢性肾脏病（CKD）的疗效。方法将44例CKD（1～2期）患者随机分为治疗组33例，对照组11例。分别采用中药、氯沙坦治疗，疗程24周；对患者在投药初始以及8、16周的实验室指标及中医症候积分进行对照分析。结果经24周治疗，中医症候积分：两组较治疗前均下降（P〈（）．01），其中，治疗组较对照组下降差异有统计学意义（P〈（）．05）。24小时尿蛋白定量：两组较治疗前均下降（P〈0．05）。血尿素氮（BUN）：治疗组较治疗前下降（P〈0．01），对照组较治疗前上升（P〈（）．05）。血肌酐（Scr）：对照组较治疗前上升（P〈0．05）。肾小球滤过率（eGFR）：两组治疗前后差异无统计学意义（P〉0．05）。两组在各实验室指标上差异均无统计学意义。总疗效比较：依据中医证侯疗效判定，治疗组中，有效率为84．84％；对照组中，有效率54．55％；组间差异有统计学意义（P〈0．05）。依据临床疗效判定，治疗组中，有效率为78．79％；对照组中，有效率45．45％；组间差异有统计学意义（P〈0．05）。结论“补脾益肾”中药与氯沙坦在降低尿蛋白方面疗效相当，但较单纯氯沙坦能更好的降低早期CKD的症候积分，改善临床症状，治疗早期CKD。

Objective To observe the effectiveness of ＂bupiyishen＂ Chinese medicine for chronic kidney disease（CKD）. Methods Forty-four cases of CKD at stage 1-2 were divided into treatment group （n = 33）, and control group（n = 11）. The patients were differently given Chinese medicine and losartan-blindly for 24 weeks. The scores of TCM syndrome and laboratory indicators were compared at 0th,8th, 16th,24th weeks. Results At 24th, scores of TCM syndromes in two groups decreased sig- nificantly comparing to 0th（P〈：0. 01）, more obviously in treatment group（P〈0. 05）. At 24th, 24h uri- nary protein in two groups decreased significantly comparing to 0th（P0. 05）. At 24th, BUN in treat- ment group decreased than baseline（P〈0. 01）, in control group increased than baseline（P〈0. 05）. At 24th,Scr in control group increased than baseline（P〈0. 05）. At 24th, eGFR in two groups was not statistically significant difference at 0th and 24th. At 24th, two groups were different significantly on the scores of TCM syndromes, and had no difference on the other laboratory indicators. At 24th, Ac- cording to the criterion of TCM syndrome therapeutical effect, the effective in treatment and control group was 84. 84% ,54. 55%. And, the effective rate to Western medicines standards was 78. 79 in treatment group, 45.45 in control group. Conclusions The ＂bupiyishen＂ Chinese medicine and losartan in reducing urinary protein were effective, but The ＂bupiyishen＂ Chinese medicine than losar- tan can better reduce scores of CKD syndromes, improve clinical symptoms, treat the early CKD.