健脾清化方治疗脾虚湿热型慢性肾脏病3期的多中心随机对照临床观察

A Clinical Multicenter Randomized Controlled Study on JianpiQinghua Decoction in Treating Stage 3 Chronic Kidney Disease with A Syndrome Type of Dampness-heat due to Spleen Deficiency

目的观察健脾清化方治疗脾虚湿热型慢性肾脏病3期的中医临床疗效。方法采用多中心、随机对照、前瞻性、双盲、双模拟的方法,6个研究中心将270例脾虚湿热型慢性肾脏病3期患者入组,分为替米沙坦+中药模拟剂组、中药+替米沙坦模拟剂组和替米沙坦+中药组,除基础治疗外,分别给予替米沙坦和中药模拟剂、中药和替米沙坦模拟剂、替米沙坦和中药,6个月后比较3组患者治疗前后肾功能及中医临床症候积分的变化。结果纳入的270例患者脱落30例,3组患者基线资料组间均衡。替米沙坦+中药模拟剂组各访视点脾气虚证、湿热内蕴证中医临床症候得分均大于中药+替米沙坦模拟剂组和替米沙坦+中药组(P<0.001)。随着治疗时间的推移,中药+替米沙坦模拟剂组的脾气虚证和湿热内蕴证中医临床症候总得分下降趋势与替米沙坦+中药组相近,异于替米沙坦+中药模拟剂组。治疗后患者肌酐异常率降低(P=0.003),3种治疗手段及其与各访视点的交互作用对血清尿素氮值的变化无影响(P=0.270,P=0.520),随着治疗时间延长,3组患者的肾小球滤过率值均出现了先上升后趋于稳定的变化趋势。治疗前后患者肝功能、血钾异常率无统计学意义(P>0.05)。结论单用健脾清化方或联合替米沙坦治疗慢性肾脏病3期安全有效。健脾清化方能够改善脾虚湿热型慢性肾脏病3期患者的中医临床症候,保护肾功能,提高患者生存质量、改善疾病预后,单用健脾清化方或联合替米沙坦治疗,其临床疗效均优于单用替米沙坦。

Objective To evaluate the clinical effectiveness of Jianpi Qinghua decoction in treating stage3 chronic kidney disease（ CKD3） with syndrome type of dampness-heat due to spleen deficiency. Methods A multicenter,randomized,controlled,prospective,double-blind,and double-simulation study was undertaken. A total of 270 CKD3 patients with syndrome type of dampness-heat due to spleen deficiency from the outpatient departments of six general hospitals were randomly divided into telmisartan ＋ analog traditional Chinese medicine（TA） group,traditional Chinese medicine ＋ analog telmisartan（ TCMA） group,and telmisartan ＋ traditional Chinese medicine（ TTCM） group,in which the corresponding treatment was applied in addition to basic treatment. Six months later,changes in the traditional Chinese medicine（ TCM） clinical symptom scores and renal functions before and after treatment were compared among these three groups. Results Of these 270 CKD3 patients who had been enrolled in this study,30 cases lost to follow-up. The baseline data were comparable among these three groups. After treatment,the TCM clinical symptom scores of both syndrome of spleen-qi deficiency and dampness-heat in TA group were significantly higher than those in TCMA group and TTCM group（ P〈0.001）. With the treatment time prolonged,the TCM clinical symptom scores showed similar descending trends in TCMA group and TTCM group but were different from that in TA group. After treatment,abnormal creatinine rate decreased（ P = 0. 003）,and these three treatments and their interactions with each visit had no effect on serum urea nitrogen value（ P = 0. 270,P = 0. 520）; with prolonged treatment,the estimated glomerular filtration rates in three groups tended to be relatively stable after the first rise. The liver function and abnormal serum potassium rate were not statistically significant before and after treatment（ P〉0.05）. Conclusions Jianpi Qinghua decoction can improve clinical symptoms of TCM in CKD3 patients with syndrome type of dampness-heat due to spleen deficiency and thus improve the quality of life and prognosis. The clinical efficacy of Jianpi Qinghua decoction alone or combined with telmisartan is superior to telmisartan monotherapy.