辨证论治慢性肾炎CKD 1~2期蛋白尿的多中心随机对照研究

Multi-center Randomized Control Study on the Effects of Syndrome Differentiated Traditional Chinese Medicine Therapy on CKD 1-2 with Chronic Nephritis Proteinuria

目的观察中药辨证治疗对慢性肾脏疾病（CKD）1~2期的慢性肾炎患者蛋白尿及临床疗效的影响。方法对11个医疗治疗中心的396例慢性肾炎患者采取前瞻性随机对照研究。396例患者分为治疗组297例,对照组99例。中医辨证为脾肾气阴两虚或脾肾气阳两虚,兼证为水湿、湿热、血瘀。治疗组予中药免煎颗粒每日一袋,对照组予氯沙坦50mg/d10疗程24周。观察治疗前后（治疗后4、8、12、16、20、24周）24h尿蛋白定量、肾小球滤过率估算值（eGFR）等肾功能及临床疗效（治疗后8、16、24周）的变化。结果最终361例患者纳入符合方案受试者分析（PPS）。治疗前两组患者24h尿蛋白定量、eGFR差异无统计学意义。治疗后治疗组24h尿蛋白定量呈现逐步下降趋势,治疗前后比较差异有统计学意义（P〈0.001）。对照组治疗前后无明显变化。在治疗20周、24周后治疗组24h尿蛋白量较对照组低,差异有统计学意义（P〈0.05）;所有患者的eGFR在治疗后均下降（P=0.001 4）。治疗组在3个随访时间点eGFR均略高于对照组,但组间差异均无统计学意义。治疗后24周治疗组和对照组临床缓解率、显效率、总有效率比较差异有统计学意义（P〈0.001）。结论中药辨证治疗能显著下降慢性肾炎CKD1~2期的蛋白尿水平,提高总有效率,保护肾功能。

Objective To determine the effects of Syndrome Differentiated Chinese Medicine （TCM） Therapy on （CKD） 1-2 stage chronic kidney disease with proteinuria. Methods A prospective randomized control study was undertaken in 11 centers. A total of 396 chronic nephritis patients were divided into a treatment group （n=297） and a control group （n=99）. Their TCM syndrome was classified as ＂Qi and Yin Deficiency of spleen and kidney＂ or ＂Qi and Yang Deficiency of spleen and kidney＂, with accompanying syndromes showing as ＂water and dampness＂, ＂damp-heat＂, and ＂blood stasis＇. Patients in the treatment group took a dose of Chinese medicine daily in response to their syndromes, while the controls took 50 mg/d losartan. The course of treatment was 24 weeks. Changes of 24-hour urinary protein excretion and glomerular filtration rate （eGFR） before and after treatments （4, 8, 12, 16, 20, 24 weeks）, as well as clinical efficacy （after 4, 16, 24 weeks treatments） were measured. Results361 patients were included in the final program participants comply analysis （PPS）. Patients in the treatment group showed gradual decreased 24-hour urinary protein excretion, whereas the controls remained unchanged. Significant differences in 24-hour urinary protein excretion appeared between the experimental and control group at week 20 and 24 （P〈0.05）. eGFR decreased in all of the patients after treatments （P=0. 001 4）. At three follow-up points, patients in the treatment group had higher eGFR than the controls, but without statistical significance （P〉0.05）. Significant differences in clinical remission rate, marked effect rate and total effective rate were observed between the treatment and control groups at week 24 （P〈 0. 001）. Conclusion Syndrome differentiated TCM therapy can reduce the level of proteinuria in CKD 1-2 nephritis patients, promoting clinical effectiveness and protecting renal functions.