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400037 重庆,陆军军医大学(第三军医大学)第二附属医院肾内科,重庆市慢性肾脏病防治重点实验室,重庆市肾病与泌尿系统疾病临床医学研究中心
[赵景宏,E-mail: zhaojh@tmmu.edu.cn ZHAO Jinghong, E-mail: zhaojh@tmmu.edu.cn
收稿:2022-02-11,
修回:2022-03-31,
纸质出版:2022-07-15
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秦剑, 熊加川, 赵景宏. RAASi基础上羟氯喹对比螺内酯治疗IgA肾病的疗效和安全性分析[J]. 陆军军医大学学报, 2022,44(13):1362-1369.
Jian QIN, Jiachuan XIONG, Jinghong ZHAO. Efficacy and safety of HCQ versus spironolactone in treatment of IgA nephropathy based on RAASi: a real-world study[J]. Journal of Army Medical University, 2022, 44(13): 1362-1369.
秦剑, 熊加川, 赵景宏. RAASi基础上羟氯喹对比螺内酯治疗IgA肾病的疗效和安全性分析[J]. 陆军军医大学学报, 2022,44(13):1362-1369. DOI: 10.16016/j.2097-0927.202202035.
Jian QIN, Jiachuan XIONG, Jinghong ZHAO. Efficacy and safety of HCQ versus spironolactone in treatment of IgA nephropathy based on RAASi: a real-world study[J]. Journal of Army Medical University, 2022, 44(13): 1362-1369. DOI: 10.16016/j.2097-0927.202202035.
目的
2
对比羟氯喹(hydroxychloroquine,HCQ)和螺内酯在充分肾素-血管紧张素-醛固酮系统抑制剂(renin-angiotensin-aldosterone system inhibitors,RAASi)治疗的基础上对IgA肾病(immunoglobin A nephropathy)患者的疗效和安全性。
方法
2
采用前瞻性、非随机对照研究,纳入2019年4月至2021年3月陆军军医大学第二附属医院肾内科门诊原发性IgA肾病患者172例,其中男性56例,女性116例,年龄(37.5±10.7)岁,分为HCQ组(
n
=104)和双RAASi组(
n
=68),均随访6个月。比较两组患者随访期间尿蛋白肌酐比值(UPCR)下降率和肾小球滤过率(eGFR)下降率,以及亚组分析探讨激素或免疫抑制剂对治疗的影响。
结果
2
与双RAASi组比较,HCQ组基线血肌酐平均水平更高,eGFR更低,Lee氏分级中Ⅲ~Ⅳ比例更高,差异有统计学意义(
P
<
0.05)。随访6个月,两组UPCR下降率相当(-54.7%
vs
-52.0%,
P
=0.551),而HCQ组的eGFR下降率显著低于双RAASi组(-3.3%
vs
-11.5%,
P
<
0.01)。进一步评价激素或免疫抑制剂对两组治疗的影响,采用亚组分析发现,HCQ和螺内酯对降尿蛋白无显著差异,但对于入组前和入组后全程未使用激素或免疫抑制剂的人群,入组前未使用激素或免疫抑制剂但入组后加用的人群,以及入组前和入组后全程使用激素或免疫抑制剂的人群,HCQ组在随访第6个月时的eGFR下降率显著低于双RAASi组(
P
<
0.05)。在随访过程中两组均未观察到严重不良事件。
结论
2
在充分RAASi治疗的基础上尿蛋白不达标的IgA肾病患者,HCQ和螺内酯控制尿蛋白水平效果相当,无严重不良事件,但HCQ在eGFR保护作用显著优于螺内酯。
Objective
2
To investigate the efficacy and safety of hydroxychloroquine (HCQ) versus spironolactone in patients with IgA nephropathy based on sufficient renin-angiotensin-aldosterone system inhibitors (RAASi) treatment.
Methods
2
A prospective
non-randomized study was carried out on 172 patients with primary IgA nephropathy admitted in our department from April 2019 to March 2021. They were 56 males and 116 females
at an average age of 37.5±10.7 years
. They were divided into HCQ group (
n
=104) and double RAASi group (
n
=68) and were followed up for 6 months. The decreasing rate of urine protein creatinine ratio (UPCR) and estimated glomerular filtration rate (eGFR) were compared between the 2 groups during follow-up
and subgroup analysis was conducted to explore the effects of corticosteroids or immunosuppressants on the outcomes.
Results
2
Compared with the dual RAASi group
the patients in the HCQ group had worse baseline renal function
lower eGFR and larger proportion of Lee's grades Ⅲ~Ⅳ (
P
<
0.05). At the 6th month of follow-up
the decreasing rate of UPCR was comparable between the 2 groups (-54.7%
vs
-52.0%
P
=0.551)
but the decreasing rate of eGFR was significantly lower in the HCQ group than that in the dual RAASi group (-3.3%
vs
-11.5%
P
<
0.001). In addition
subgroup analysis found that there was no significant difference between HCQ and spironolactone in reducing urine protein
but for those who did not use corticosteroids or immunosuppressants before and after enrollment
those who did not use corticosteroids or immunosuppressants before enrollment but added them after enrollment
and those who used corticosteroids or immunosuppressants before and after enrollment
the HCQ group had a significantly lower eGFR decline rate at 6 months of follow-up than the dual RAAS group (
P
<
0.05). Moreover
no serious adverse events (SAEs) were observed in either group during the course of the study.
Conclusion
2
On the basis of sufficient RAASi treatment
HCQ and spironolactone have similar effects in controlling urine protein level in patients with IgA nephropathy whose urine protein does not reach the target level
and there are no serious adverse events. But HCQ has a significantly better renal protective effect of eGFR than spironolactone.
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