以加味参芪地黄汤为主延缓慢性肾功能衰竭进展的队列研究

A Cohort Study on Delaying the Progress of Chronic Renal Failure Mainly with Modified Shenqi Dihuang Decoction

目的评价以加味参芪地黄汤为主的中医药治疗方案在延缓慢性肾功能衰竭(CRF)方面的作用。方法采用前瞻性队列研究,以血清肌酐(SCr)在133～442μmol/L的CRF患者为研究对象,以加味参芪地黄汤为主的中医治疗方案加西医基础治疗为中医治疗组(61例),以单纯西医基础治疗为对照组(57例),通过2年的随访观察,主要以血红蛋白(HB)、血浆白蛋白(ALB)、SCr、估算肾小球滤过率(eGFR)、血清肌酐倒数(1/SCr)与时间(月)直线回归斜率(b值)、终点事件等为观察指标,观察两组延缓CRF进展的疗效。结果 (1)肾功能进展情况:治疗24个月时中医治疗组SCr水平下降,eGFR水平上升,血清肌酐倒数(1/SCr)与时间(月)直线回归斜率b值总体呈正值,均优于对照组(P<0.05)。其中中医治疗组b值≥0者40例(65.57%),b值<0者21例(34.43%);对照组b值≥0者7例(12.28%),b值<0者50例(87.72%);两组比较差异有统计学意义(P<0.05)。(2)两组12、24个月时HB及ALB比较差异无统计学意义(P>0.05)。(3)24个月后中医治疗组出现终点事件6例(9.84%),对照组为9例(15.79%),两组比较差异无统计学意义(P>0.05)。结论加味参芪地黄汤配合西医常规治疗能延缓CRF的进展。

Objective To assess the therapeutic effects of Chinese medicine （CM） treatment mainly by Modified Shenqi Dihuang Decoction （MSDD） in delaying the progress of chronic renal failure （CRF）. Methods A prospective cohort method was employed. CRF patients with serum creatinine （SCr） ranging between 133 and 442 mol/L were recruited. Those in the CM treatment group （61 cases） were treated with MSDD as well as basic treatment of Western medicine, while those in the control group （57 cases） were treated with basic treat- ment of Western medicine alone. A 2-year follow-up study was carried out. The effects on postponing the pro- gression of CRF were observed mainly from the levels of hemoglobin （HB）, plasma albumin （ALB）, SCr, esti- mated glomerular filtration rate （eGFR）, reciprocal slope of serum creatinine （b value）, and endpoint events, etc. Results （1） The progression of the renal function： After 24 months of treatment, better therapeutic effects were shown in the CM treatment group than in the control group （ P 〈 0.05）, which could be illustrated by decreased SCr levels, increased eGFR levels, and the positive reciprocal slope of SCr （1/SCr） to the time linear regression slope （ b value）. There were 40 cases （65.57%） with a reciprocal slope of SCr （b value） I〉 0 （34.43%） and 21 cases with b 〈0 in the CM treatment group. However, there were 7 cases （12.28%） with b〉~0 and 50 cases （87.72%） with b 〈0 in the control group. The difference was statistically significant （P 〈 0. 05）. （2） There was no significant difference in HB or ALB between the two groups after 12 months and 24 months of treatment （P〉0.05）. （3） Twenty-four months later, there were 6 endpoint events （9.84%） in the CM treatment group and 9 （15.79%） in the control group, with insignificant difference （ P 〉 0.05）. Conclusion MSDD plus basic treatment of Western medicine could delay the progression of CRF patients.