Abstract：
BACKGROUND: Diabetes leads to chronic kidney disease (CKD) and kidney failure, requiring dialysis or transplantation. Astragalus, a common herbal medicine and US pharmacopeia-registered food ingredient, is shown kidney protective by retrospective and preclinical data but with limited long-term prospective clinical evidence. This trial aimed to assess the effectiveness of astragalus on kidney function decline in macroalbuminuric diabetic CKD patients.
METHODS: This randomized, assessor-blind, standard care-controlled, multi-center clinical trial randomly assigned 118 patients with estimated glomerular filtration rate (eGFR) of 30-90 ml/min/1.73m2 and urinary albumin-to-creatinine ratio (UACR) of 300-5000 mg/g from 7 public outpatient clinics and the community in Hong Kong between July 2018 and April 2022 to add-on oral astragalus granules (15 gs of raw herbs daily equivalent) or to continue standard care alone as control for 48 weeks. Primary outcomes were the slope of change of eGFR (used for sample size calculation) and UACR of the intention-to-treat population. Secondary outcomes included endpoint blood pressures, biochemistry, biomarkers, concomitant drug change and adverse events. (ClinicalTrials.gov: NCT03535935) RESULTS: During the 48-week period, the estimated difference in the slope of eGFR decline was 4.6 ml/min/1.73m2 per year (95 %CI: 1.5 to 7.6, p = 0.003) slower with astragalus. For UACR, the estimated inter-group proportional difference in the slope of change was insignificant (1.14, 95 %CI: 0.85 to 1.52, p = 0.392). 117 adverse events from 31 astragalus-treated patients and 41 standard care-controlled patients were documented. The 48-week endpoint systolic blood pressure was 7.9 mmHg lower (95 %CI: -12.9 to -2.8, p = 0.003) in the astragalus-treated patients. 113 (96 %) and 107 (91 %) patients had post-randomization and endpoint primary outcome measures, respectively.
CONCLUSIONS: In patients with type 2 diabetes, stage 2 to 3 CKD and macroalbuminuria, add-on astragalus for 48 weeks further stabilized kidney function on top of standard care.
METHODS: This randomized, assessor-blind, standard care-controlled, multi-center clinical trial randomly assigned 118 patients with estimated glomerular filtration rate (eGFR) of 30-90 ml/min/1.73m2 and urinary albumin-to-creatinine ratio (UACR) of 300-5000 mg/g from 7 public outpatient clinics and the community in Hong Kong between July 2018 and April 2022 to add-on oral astragalus granules (15 gs of raw herbs daily equivalent) or to continue standard care alone as control for 48 weeks. Primary outcomes were the slope of change of eGFR (used for sample size calculation) and UACR of the intention-to-treat population. Secondary outcomes included endpoint blood pressures, biochemistry, biomarkers, concomitant drug change and adverse events. (ClinicalTrials.gov: NCT03535935) RESULTS: During the 48-week period, the estimated difference in the slope of eGFR decline was 4.6 ml/min/1.73m2 per year (95 %CI: 1.5 to 7.6, p = 0.003) slower with astragalus. For UACR, the estimated inter-group proportional difference in the slope of change was insignificant (1.14, 95 %CI: 0.85 to 1.52, p = 0.392). 117 adverse events from 31 astragalus-treated patients and 41 standard care-controlled patients were documented. The 48-week endpoint systolic blood pressure was 7.9 mmHg lower (95 %CI: -12.9 to -2.8, p = 0.003) in the astragalus-treated patients. 113 (96 %) and 107 (91 %) patients had post-randomization and endpoint primary outcome measures, respectively.
CONCLUSIONS: In patients with type 2 diabetes, stage 2 to 3 CKD and macroalbuminuria, add-on astragalus for 48 weeks further stabilized kidney function on top of standard care.
摘要：
背景：糖尿病会导致慢性肾脏疾病（CKD）和肾衰竭，需要透析或移植。黄芪,一种常见的草药和美国药典注册的食品成分，通过回顾性和临床前数据显示肾脏具有保护作用，但长期前瞻性临床证据有限。该试验旨在评估黄芪对糖尿病CKD患者肾功能下降的有效性。
方法：这是随机的，评估员-盲，标准护理控制，2018年7月至2022年4月,多中心临床试验从7家公共门诊诊所和香港社区随机分配了118例估计肾小球滤过率(eGFR)为30~90ml/min/1.73m2,尿白蛋白与肌酐比值(UACR)为300~5000mg/g的患者,接受口服黄芪颗粒(每日15g生药当量)或单独继续标准治疗作为对照48周.主要结果是eGFR变化的斜率（用于样本量计算）和意向治疗人群的UACR。次要结果包括终点血压，生物化学,生物标志物，伴随的药物变化和不良事件。（ClinicalTrials.gov：NCT03535935）结果：在48周期间，使用黄芪时,eGFR下降斜率的估计差异为每年4.6ml/min/1.73m2(95CI:1.5~7.6,p=0.003).对于UACR，估计的组间变化斜率的比例差异不显著(1.14,95CI:0.85~1.52,p=0.392).记录了31例黄芪治疗患者和41例标准护理控制患者的117例不良事件。在黄芪治疗的患者中，48周的终点收缩压降低了7.9mmHg（95CI：-12.9至-2.8，p=0.003）。113例（96%）和107例（91%）患者有随机化后和终点主要结局指标，分别。
结论：在2型糖尿病患者中，2至3期CKD和大量白蛋白尿，添加黄芪48周，在标准护理的基础上进一步稳定肾功能。
方法：这是随机的，评估员-盲，标准护理控制，2018年7月至2022年4月,多中心临床试验从7家公共门诊诊所和香港社区随机分配了118例估计肾小球滤过率(eGFR)为30~90ml/min/1.73m2,尿白蛋白与肌酐比值(UACR)为300~5000mg/g的患者,接受口服黄芪颗粒(每日15g生药当量)或单独继续标准治疗作为对照48周.主要结果是eGFR变化的斜率（用于样本量计算）和意向治疗人群的UACR。次要结果包括终点血压，生物化学,生物标志物，伴随的药物变化和不良事件。（ClinicalTrials.gov：NCT03535935）结果：在48周期间，使用黄芪时,eGFR下降斜率的估计差异为每年4.6ml/min/1.73m2(95CI:1.5~7.6,p=0.003).对于UACR，估计的组间变化斜率的比例差异不显著(1.14,95CI:0.85~1.52,p=0.392).记录了31例黄芪治疗患者和41例标准护理控制患者的117例不良事件。在黄芪治疗的患者中，48周的终点收缩压降低了7.9mmHg（95CI：-12.9至-2.8，p=0.003）。113例（96%）和107例（91%）患者有随机化后和终点主要结局指标，分别。
结论：在2型糖尿病患者中，2至3期CKD和大量白蛋白尿，添加黄芪48周，在标准护理的基础上进一步稳定肾功能。
