摘要
目的:探讨在加味黄芪赤风汤治疗基础上君药生黄芪高、中、低剂量治疗免疫球蛋白A(IgA)肾病患者蛋白尿的量效关系及安全性,为临床大剂量使用黄芪治疗IgA肾病蛋白尿提供科学依据.方法:纳入120例辨证为气虚血瘀证兼有风邪热毒的IgA肾病患,随机分为对照组和治疗组,对照组给予替米沙坦联合中药安慰剂,治疗组给予替米沙坦联合不同剂量黄芪的加味黄芪赤风汤(生黄芪60、30、15 g),每组各30例,治疗周期为12周.观察治疗前后24 h尿蛋白定量(24hUTP)、中医证候积分、有效率和肾功能的变化,并检测肝功能和血常规评估安全性.结果:与本组治疗前比较,治疗12周后,黄芪高、中、低剂量组和对照组的24 hUTP均明显下降(P＜0.05,P＜0.01),黄芪高、中、低剂量组的中医证候积分均明显下降(P＜0.05);各组间治疗后比较,黄芪高剂量组24 hUTP明显低于黄芪中、低剂量组及对照组(P＜0.05,P＜0.01),黄芪中剂量组24 hUTP明显低于对照组(P＜0.05),且黄芪高、中剂量组患者中医证候积分明显低于黄芪低剂量组和对照组(P＜0.05,P＜0.01).黄芪高、中、低剂量组和对照组的蛋白尿总有效率分别为92.59％(25/27)、85.19％(23/27)、60.71％(17/28)、57.14％(16/28),黄芪高、中剂量组的有效率明显高于黄芪低剂量组和对照组(x2=13.185,P＜0.05,P＜0.01).黄芪高、中、低剂量组和对照组的中医证候积分有效率分别为88.89％(24/27)、81.48％(22/27)、71.43％(20/28)、46.43％(13/28),黄芪高、中剂量组的中医证候积分疗效显著高于对照组(x2=14.053,P＜0.01).与本组治疗前比较,黄芪高、中剂量组治疗后的肾小球滤过率(eGFR)和血肌酐差异无统计学意义,黄芪低剂量组和对照组治疗后的eGFR明显下降(P＜0.05),对照组治疗后的血肌酐水平明显增加(P＜0.05);黄芪高、中、低剂量组和对照组治疗前后的尿素氮、尿酸、白蛋白、总胆固醇、甘油三酯、肝功能及血常规差异无统计学意义.结论:在加味黄芪赤风汤治疗基础上君药生黄芪高、中、低剂量治疗IgA肾病存在量效关系,黄芪高剂量组疗效最优,并且安全性良好.
Abstract
Objective:To explore the dose-effect relationship and safety of high,medium,and low doses of raw Astragali Radix in the modified Huangqi Chifengtang(MHCD)for treating proteinuria in immunoglobulin A(IgA)nephropathy,and to provide scientific evidence for the clinical use of high-dose Astragali Radix in the treatment of proteinuria in IgA nephropathy.Methods:A total of 120 patients with IgA nephropathy,diagnosed with Qi deficiency and blood stasis combined with wind pathogen and heat toxicity,were randomly divided into a control group and three treatment groups.The control group received telmisartan combined with a Chinese medicine placebo,while the treatment groups were given telmisartan combined with MHCD containing different doses of raw Astragali Radix(60,30,15 g).Each group contained 30 patients,and the treatment period was 12 weeks.Changes in 24-hour urinary protein(24 hUTP),traditional Chinese medicine(TCM)syndrome scores,effective rate,and renal function were observed before and after treatment.Safety was assessed by monitoring liver function and blood routine.Results:After 12 weeks of treatment,24 hUTP significantly decreased in the high,medium,and low-dose groups,as well as the control group(P＜0.05,P＜0.01).The TCM syndrome scores in the high,medium,and low-dose groups also significantly decreased(P＜0.01).Comparisons between groups showed that the 24 hUTP in the high-dose group was significantly lower than in the medium,low-dose,and control groups(P＜0.05,P＜0.01),and the 24 hUTP in the medium-dose group was significantly lower than in the control group(P＜0.05).The TCM syndrome scores in the high and medium-dose groups were significantly lower than in the low-dose and control groups(P＜0.05,P＜0.01).The total effective rates for proteinuria in the high,medium,low-dose,and control groups were 92.59％(25/27),85.19％(23/27),60.71％(17/28),and 57.14％(16/28),respectively.The effective rates in the high and medium-dose groups were significantly higher than in the low-dose and control groups(x2=13.185,P＜0.05,P＜0.01).The effective rates for TCM syndrome scores in the high,medium,low-dose,and control groups were 88.89％(24/27),81.48％(22/27),71.43％(20/28),and 46.43％(13/28),respectively.The efficacy of TCM syndrome scores in the high and medium-dose groups was significantly higher than in the control group(x2=14.053,P＜0.01).Compared with pre-treatment values,there was no statistically significant difference in eGFR and serum creatinine in the high and medium-dose groups.However,eGFR significantly decreased in the low-dose and control groups after treatment(P＜0.05),and serum creatinine levels increased significantly in the control group(P＜0.05).No statistically significant differences were observed in urea nitrogen,uric acid,albumin,total cholesterol,triglycerides,liver function,and blood routine before and after treatment in any group.Conclusion:There is a dose-effect relationship in the treatment of IgA nephropathy with high,medium,and low doses of raw Astragali Radix in MHCD.The high-dose group exhibited the best therapeutic effect and good safety profile.
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