黄芪当归合剂对慢性肾脏病3～4期患者肾功能及中医证候要素影响的研究

Therapeutic Effect of Astragalus and Angelica Mixture on the Renal Function and TCM Syndrome Factors in Treating Stage 3 and 4 Chronic Kidney Disease Patients

目的评价黄芪当归合剂与慢性肾脏病（CKD）不同原发病、不同CKD分期以及不同中医证候疗效间的关系。方法采用多中心、开放标签、患者自身治疗前后对照试验设计，符合纳入标准的32例CKD 3～4期患者，在维持原CKD基本治疗的基础上，加用黄芪当归合剂（黄芪、当归各30 g），每日1剂，疗程3个月。比较患者治疗前、治疗1、2、3个月末血肌酐（SCr）、估算的肾小球滤过率（eGFR）、24 h尿蛋白定量（UTP）、血浆白蛋白（ALB）、血红蛋白（Hb）以及相关中医证候要素积分的变化，并分别比较不同原发病（慢性肾小球肾炎、慢性肾小管间质病及高血压肾损害）、不同CKD分期（CKD 3期及CKD 4期）以及符合气血两虚证与非气血两虚证的患者上述疗效指标的差异。结果黄芪当归合剂可使78.12%（25/32）的受试者肾功能得到改善。与治疗前比较，治疗3月末患者SCr下降［（12.08±10.11）%］，eGFR上升［（21.14±18.55）%］，ALB上升［（2.76±1.97）%］，差异有统计意义（均P〈0.05）。中医证候要素积分方面，与治疗前比较，治疗3月末患者气虚、血虚及阴虚证积分下降，而湿热、浊毒证积分升高（均P〈0.05）。除了高血压肾损害的阴虚证候要素积分差值较肾小球肾炎和肾小管间质病升高（P〈0.05），不同CKD原发病以及不同CKD分期患者之间各指标无明显差异（P〉0.05）。气血两虚证与非气血两虚证患者SCr下降率分别为（19.82±8.30）%和（5.24±10.75）%，气虚两虚证患者SCr下降率更高，差异有统计学意义 （P〈0.05）；中医证候要素积分差值方面，与非气血两虚证比较，气血两虚证患者治疗后气虚和血虚证候要素积分差值明显升高，差异具有统计学意义（P〈0.05）。结论黄芪当归合剂可改善CKD患者肾功能、提高患者ALB，对CKD相关的气虚、血虚及阴虚证亦有改善，尤其适合CKD患者中辨证属气血两虚证者。

Objective To compare the therapeutic effect of Astragalus and Angelica Mixture （AAM） on treating CKD patients according to different CKD primary diseases, staging and TCM syndromes. Methods A multicentre, open-label, and self control clinical design was used, and thirty-two patients in line with inclusive criteria were recruited. Based on maintaining their previous basic CKD treatment, patients additionally took AAM （Astragalus and Angelica each 30 g）, once a day, three months consisted of one therapeutic course. Serum creatinine （SCr）, estimated glomerular filtration rate （eGFR）, 24 h urinary total protein （UTP）, plasma albumin （ALB）, hemoglobin （Hb）, and changes of TCM syndrome factor integrals were compared before treatment, at the end of month 1, 2, and 3. The differences in the aforesaid indices were compared between CKD patients with different CKD primary diseases （chronic glomerulonephritis, chronic renal tubulointerstitial disease, hypertensive renal damage）, different CKD stages （CKD 3 and CKD 4）, and patients of qi-blood deficiency syndrome （QBDS） and non- QBDS. Results AAM could improve 78.12% （25/32） patients＇ renal function. Compared with before treatment, SCr decreased （12.08% ±10.11%）, eGFR increased （21.14% ±18.55%）, and ALB increased （2.76% ±1.97%） at the end of 3-month treatment Call P 〈0.05）. As for TCM syndrome factor integrals, compared with before treatment, the integrals for qi deficiency syndrome, blood deficiency syndrome, and yin deficiency syndrome decreased, while the integrals for dampness heat syndrome and turbid-toxin syndrome increased Call P 〈0.05）. There was no obvious difference in all indices except the integral for hypertensive renal damage patients of yin deficiency syndrome （P 〉0.05）. The SCr decrea- sing percent was 19.82% ±8.30% for patients of non-QBDS and 5.24% ±10.75% for patients of QBDS. The latter was higher with statistical difference （P 〈0.05）. As for TCM syndrome factor integrals, the integral differences of qi deficiency and blood deficiency were obviously higher in patients of QBDS, when compared with patients of non-QBDS （P 〈0.05）. Conclusion AAM could improve the renal function of CKD patients, elevate their ALB levels, and ameliorate associated qi deficiency syndrome, blood defi- ciency syndrome, and yin deficiency syndrome, especially for CKD patients of QBDS.