硫酸羟氯喹治疗特发性膜性肾病疗效及安全性研究

Efficacy and safety of hydroxychloroquine in the treatment of idiopathic membranous nephropathy

目的 评价硫酸羟氯喹治疗特发性膜性肾病的疗效与安全性。方法 收集2018年8月至2021年12月于陆军军医大学第一附属医院行肾活检确诊为特发性膜性肾病患者70例,随机分为2组(n=35),分别为对照组与研究组。对照组根据KDIGO指南推荐,在给予支持治疗基础上,予以中等剂量激素[醋酸泼尼松片0.5 mg/(kg·d)]+钙调神经磷酸酶抑制剂(环孢素/他克莫司)+肾素-血管紧张素系统(Renin-angiotensin system, RAS)抑制剂治疗,研究组在对照组基础上加用硫酸羟氯喹片口服。对两组患者的临床数据在基线水平和随访3个月、6个月分别进行分析,比较两组治疗前后24 h尿蛋白定量、血肌酐水平、估算肾小球滤过率及血脂指标水平变化,并记录不良反应发生情况。结果 对照组与研究组患者的基线情况相当。6个月随访期间,研究组有3例患者退出研究,对照组有5例患者退出研究。治疗6个月后,研究组尿蛋白缓解率明显高于对照组,差异有统计学意义(71.87%vs.60.00%,P<0.05)。治疗6个月,研究组低密度脂蛋白胆固醇(LDL-C)、三酰甘油(TG)、总胆固醇(TC)均低于治疗前,高密度脂蛋白胆固醇(HDL-C)高于治疗前。研究组LDL-C、TG、TC、HDL-C的变化率大于对照组,差异有统计学意义(P<0.05);与治疗前相比,两组患者治疗前后血肌酐、估算肾小球滤过率比较,差异均无统计学意义(P>0.05)。对照组和研究组均未发生严重不良反应。结论 在中等剂量激素+钙调神经磷酸酶抑制剂基础上联合硫酸羟氯喹治疗,更有助于特发性膜性肾病患者控制蛋白尿、调节血脂,且安全性较好。

Objective To evaluate the efficacy and safety of hydroxychloroquine in the treatment of idiopathic membranous nephropathy.Methods Seventy patients diagnosed with IMN by renal biopsy in the First Affiliated Hospital of Army Medical University from August 2018 to December 2021 were randomly divided into two groups(n=35).Both groups were given moderate dose of prednisone[0.5 mg/(kg·d)]+calcineurin inhibitor(cyclosporine/tachlimus) on the basis of supportive treatment recommended by KDIGO guidelines.The study group was additionally given hydroxychloroquine.Clinical data of the two groups were analyzed at baseline and at follow-up of 3 months and 6 months.The changes of 24 h urinary protein, serum creatinine level, estimated glomerular filtration rate and blood lipid indexes were compared between the two groups before and after treatment.Adverse reactions were recorded.Results Baseline conditions were similar among patients in the control and study groups.During the 6-month follow-up period, three patients in the study group dropped out of the study.In the control group, 5 patients dropped out of the study.After 6 months of treatment, the remission rate of urinary protein in the study group was significantly higher than that in the control group, with statistical significance(71.87% vs.60.00%,P<0.05);LDL-C,TG and TC in the study group were lower than before treatment, while HDL-C was higher than before treatment.The change rate of LDL-C,TG,TC and HDL-C in the study group was higher than that in the control group, and the difference was statistically significant(P<0.05);compared with before treatment, there was no statistically significant difference in serum creatinine or eGFR between the two groups(P>0.05).No serious adverse reactions occurred in both groups.Conclusion The treatment of hydroxychloroquine on the basis of medium dose of prednisone combined with calcineurin inhibitors can better control proteinuria and regulate blood lipids in patients with idiopathic membranous nephropathy.There is no serious adverse reaction and it is safe.