贝利尤单抗在治疗儿童狼疮性肾炎中的有效性及安全性分析  

Analysis on the efficacy and safety of belimumab in treatment of lupus nephritis in children

作　　者：唐慧荷 代艳[1] 李新叶 陆福情 张迪雯 温晓灵 温志红[1] 尤燕舞 TANG Huihe;DAI Yan;LI Xinye;LU Fuqing;ZHANG Diwen;WEN Xiaoling;WEN Zhihong;YOU Yanwu(Department of Pediatrics,the People′s Hospital of Guangxi Zhuang Autonomous Region(Guangxi Academy of Medical Sciences),Nanning 530021,China;Department of Nephrology,the People′s Hospital of Guangxi Zhuang Autonomous Region(Guangxi Academy of Medical Sciences),Nanning 530021,China)

机构地区：[1]广西壮族自治区人民医院(广西医学科学院)儿科,南宁530021 [2]广西壮族自治区人民医院(广西医学科学院)肾内科,南宁530021

出　　处：《中国临床新医学》2024年第9期983-987,共5页CHINESE JOURNAL OF NEW CLINICAL MEDICINE

基　　金：广西壮族自治区卫生健康委自筹经费科研课题(编号:Z-A20230046)。

摘　　要：目的分析贝利尤单抗治疗儿童狼疮性肾炎(LN)的有效性和安全性。方法回顾性收集2021年7月1日至2024年7月31日在广西壮族自治区人民医院儿科接受贝利尤单抗治疗20周的12例LN患儿的临床资料。分析患儿治疗前后的临床表现、免疫和泌尿系统相关指标变化、疾病活动度变化、糖皮质激素减量情况以及药物不良反应情况。结果与贝利尤单抗治疗前相比,治疗后皮疹、发热、LN和血液系统损伤的患儿比例下降,糖皮质激素用量减少,CD19^(+)细胞计数降低,抗dsDNA抗体阳性率下降,24 h尿蛋白定量、尿红细胞计数、尿白细胞计数下降,差异有统计学意义(P<0.05)。贝利尤单抗治疗不同时间点(0、2、4、8、12、16、20周)的系统性红斑狼疮疾病活动指数-2000(SLEDAI-2000)评分差异有统计学意义(P<0.05),随治疗时间延长评分呈下降趋势。在12例LN患儿中,5例至观察终点(20周)达到狼疮低疾病活动状态(LLDAS),3例达到临床缓解。研究期间未发生严重感染事件,也未发现对贝利尤单抗过敏。结论贝利尤单抗有助于LN患儿SLEDAI-2000评分下降,减轻肾脏损伤,有助于达到LLDAS和临床缓解状态,且可以减少糖皮质激素使用剂量,从而减少不良反应。Objective To analyze the efficacy and safety of belimumab in treatment of lupus nephritis(LN)in children.Methods The clinical data of 12 pediatric patients with LN who received the treatment of belimumab for 20 weeks in Department of Pediatrics,the People′s Hospital of Guangxi Zhuang Autonomous Region from July 1,2021 to July 31,2024 were retrospectively collected.The clinical manifestations,changes in immune and urinary system-related indicators,changes in disease activity,reduction of glucocorticoids and adverse drug reactions of the pediatric patients were analyzed before and after treatment.Results Compared with those before belimumab treatment,the proportions of the pediatric patients with rash,fever,lupus nephritis and blood system damage decreased,and the dosage of glucocorticoids decreased,and the CD19+cell count decreased,and the positive rate of anti-double stranded deoxyribonucleic acid(dsDNA)antibodies decreased,and 24-hour urinary protein quantification,urinary red blood cell count and urinary white blood cell count decreased after belimumab treatment,and the differences were statistically significant(P<0.05).There were statistically significant differences(P<0.01)in the Systemic Lupus Erythematosus(SLE)Disease Activity Index-2000(SLEDAI-2000)scores of the pediatric patients treated with belimumab at different time points(0,2,4,8,12,16,20 weeks),and the scores showed a downward trend with the extension of treatment time.Among the 12 pediatric patients with LN,5 cases reached lupus low disease activity state(LLDAS)by the observation endpoint(20 weeks),and 3 cases reached clinical remission.During the study period,none of the pediatric patients had severe infection events and allergic reactions to belimumab.Conclusion Belimumab helps to reduce SLEDAI-2000 scores and alleviate kidney injury in padiatric patients with LN,and helps to achieve LLDAS and clinical remission status,and helps to reduce the dosage of glucocorticoids to reduce adverse reactions.

关 键 词：系统性红斑狼疮 狼疮性肾炎 贝利尤单抗 临床疗效 儿童 

分 类 号：R725.9[医药卫生—儿科]