上海地区127例慢性肾脏病蛋白尿多中心前瞻性临床研究

A multi-center, prospective, cinical study on 127 cases of chronic kidney disease in Shanghai region

目的:观察上海地区优化中医辨证方案临床治疗慢性肾脏病蛋白尿127例的推广应用研究。方法:采用实用性随机对照试验,运用分层区组随机方法分组,以中心(医院)为分层因素,将合格病例按3∶1比例分成治疗组(94例)和对照组(33例),进行推广观察。在饮食营养、控制血压、血脂等基础治疗的基础上,治疗组加用中医辨证治疗,对照组加用氯沙坦治疗,观察两组临床疗效及24h尿蛋白定量、尿蛋白/肌酐、血肌酐(Scr)、血尿素氮(BUN)、肾小球滤过率(eGFR)、血胱抑素-C(Cys-C)等的变化情况。结果:相对自身基线水平,治疗组24h尿蛋白定量在16周、20周、24周下降明显(P<0.05、P<0.01),对照组24h尿蛋白定量在12周、16周、24周时下降(P<0.05),且治疗组在第24周时24h尿蛋白定量低于对照组(P<0.05)、24h尿蛋白定量下降值高于对照组(P<0.05);相对自身基线水平,治疗组血Cys-C下降(P<0.05),在24周时尤为明显(P<0.01),且明显低于对照组(P<0.01),对照组血Cys-C仅在8周时下降(P<0.05);随着疗程延长,治疗组对血Scr、eGFR的稳定作用有更优于对照组的趋势。第24周治疗组中医证候疗效及临床疗效均优于对照组(P<0.05)。结论:应用优化中医辨证方案临床治疗慢性肾脏病蛋白尿有较好的临床疗效,保持肾功能稳定并好转,且长期疗效更明显。

Objective： To observe applying the optimized program of TCM syndromes distribution to 127 cases of chronic nephritic proteinuria, and then to promote clinical application. Methods： Using a pragmatic randomized controlled trial, and a method of stratified blocked randomization, which stratified by centers （hospitals）, to group qualified cases to the treatment group （94 cases） and control group （33 cases） according to 3：1 ratio, then to observe and apply. Diet, control blood pressure, lipids and other basic treatment were applied to both two groups. In addition, treatment group accepted TCM syndromes distribution; control group accepted Losatan. In the end, the changes of clinical efficacy and laboratory data were compared, such as 24h urinary protein, urine protein/creatinine, serum creatinine, blood urea nitrogen, glomerular filtration rate, serum eystatin-C, etc. Results： Relative to their baseline, treatment group of 24h urine protein quantitative in 16 weeks, 20 weeks and 24 weeks decreased significantly （P〈0.05, P〈0.01）, the control group of 24h urine protein quantitative at 12 weeks, 16 weeks and 24 weeks decreased （P〈0.05）, and the treatment group at 24 weeks 24h urine protein quantitative lower than the control group （P〈0,05）,24h urine protein quantitative decline in value is higher than the control group （P〈0.05）; Relative to their baseline, treatment group blood Cys-C decreased （P〈0.05）, particularly in the 24 weeks （P〈0.01）, and significantly lower than the control group （P〈0.01）, whilecontrol group in blood Cys-C decreased only in 8 weeks （P〈0.05）; With treatment extended, blood ScrandeGFRof treatment grouptended to more stable than which of control group. In the twenty-fourth weeks, TCM syndromes and clinical efficacy of treatment group were better than the control group （P〈0.05）. Conclusion： The application of optimized program of TCM syndromes distribution in the treatment of chronic nephritic proteinuria seems to have a good clinical efficacy, and long-term efficacy, which maintains the stability and imorovement of renal function.