摘要
目的探讨贝利尤单抗联合硫酸羟氯喹治疗狼疮性肾炎(LN)的疗效及安全性。方法选取2021年5月至2024年12月于空军军医大学第二附属医院予以针对性治疗的LN患者共104例,采用计算机生成随机数字表法分成2组,对照组52例患者予以基础免疫抑制+硫酸羟氯喹治疗,观察组52例患者予以基础免疫抑制+硫酸羟氯喹、贝利尤单抗治疗。比较观察组和对照组的临床疗效、治疗前后肾功能指标[血肌酐(Scr)、血尿素氮(BUN)、24 h尿蛋白定量(24 h-UPro)]、红细胞沉降率(ESR)及C反应蛋白(CRP)、免疫功能指标[补体(C3、C4)、免疫球蛋白(IgA、IgG、IgM)]水平以及不良反应情况。结果观察组总有效率为92.31%(48/52),高于对照组78.85%(41/52)(χ^(2)=5.279,P<0.05);观察组和对照组Scr、BUN、24 h-UPro水平均较治疗前降低,且观察组水平[分别为(95.48±14.66)µmol/L、(7.16±1.22)mmol/L、(0.41±0.09)mg/24 h]低于对照组[分别为(124.65±15.42)µmol/L、(9.27±1.33)mmol/L、(0.68±0.12)mg/24h](t=9.886、8.431、12.980,均P<0.05);观察组和对照组ESR、CRP水平较治疗前降低,且观察组水平[分别为(21.88±6.01)mm/h、(4.03±1.85)mg/L]低于对照组[分别为(35.49±5.82)mm/h、(6.57±1.51)mg/L](t=4.446、7.670,均P<0.05);观察组和对照组C3、C4水平较治疗前升高,且观察组水平[分别为(1.22±0.30)g/L、(0.33±0.10)g/L]高于对照组[分别为(0.87±0.25)g/L、(0.24±0.07)g/L](t=8.286、3.379,均P<0.05);观察组和对照组IgG、IgM、IgA水平较治疗前降低,且观察组水平[分别为(12.85±1.64)g/L、(1.71±0.22)g/L、(2.27±0.39)g/L]低于对照组[分别为(17.87±1.51)g/L、(2.16±0.31)g/L、(2.91±0.47)g/L](t=16.238、8.537、7.557,均P<0.05);不良反应发生率观察组7.69%(4/52)、对照组19.23%(10/52),两组差异无统计学意义(χ^(2)=2.971,P>0.05)。结论贝利尤单抗与硫酸羟氯喹联合治疗LN具有良好疗效,能有效改善患者炎症状态,纠正免疫紊乱水平,保护肾功能,且安全性较好。
Objective To explore the efficacy and safety of belimumab combined with hydroxychloroquine sulfate in the treatment of lupus nephritis(LN).Methods A total of 104 LN patients who received targeted treatment at the Second Affiliated Hospital of the Air Force Military Medical University from May 2021 to December 2024 were selected as subjects for this trial and randomly allocated into two groups:the control group(52 patients)received hydroxychloroquine sulfate treatment,and the observation group(52 patients)received belimumab combined with hydroxychloroquine sulfate treatment.The clinical efficacy,renal function indicators(serum creatinine(Scr),blood urea nitrogen(BUN),24-hour urinary protein quantification(24 h-UPro)),erythrocyte sedimentation rate(ESR),C-reactive protein(CRP),immune function indicators(complement(C3,C4),immunoglobulins(IgA,IgG,IgM))levels,and the incidence of adverse reactions were compared between the two groups before and after treatment.Results The total effective rate in observation group was 92.31%(48/52),higher than that in the control group(78.85%,41/52)(χ^(2)=5.279,P<0.05).After treatment,both groups showed decreased Scr,BUN,and 24 h-UPro levels compared to pre-treatment levels,and the levels in the observation group((95.48±14.66)µmol/L,(7.16±1.22)mmol/L,(0.41±0.09)mg/24 h,respectively)were lower than those in the control group((124.65±15.42)µmol/L,(9.27±1.33)mmol/L,(0.68±0.12)mg/24 h,respectively)(t=9.886,8.431,12.980,all P<0.05).After treatment,ESR and CRP levels decreased in both groups,with the observation group exhibiting lower levels((21.88±6.01)mm/h,(4.03±1.85)mg/L)than the control group((35.49±5.82)mm/h,(6.57±1.51)mg/L)(t=4.446,7.670,both P<0.05).After treatment,C3 and C4 levels increased in both groups,and the levels in the observation group((1.22±0.30)g/L,(0.33±0.10)g/L)were higher than those in the control group((0.87±0.25)g/L,(0.24±0.07)g/L)(t=8.286,3.379,both P<0.05).After treatment,IgG,IgM,and IgA levels decreased in both groups,with the observation group showing lower values((12.85±1.64)g/L,(1.71±0.22)g/L,(2.27±0.39)g/L)than the control group((17.87±1.51)g/L,(2.16±0.31)g/L,(2.91±0.47)g/L)(t=16.238,8.537,7.557,all P<0.05).The incidence of adverse reactions was 7.69%(4/52)in the observation group and 19.23%(10/52)in the control group,with no statistically significant difference between the two groups(χ^(2)=2.971,P>0.05).Conclusion The combination therapy of belimumab and hydroxychloroquine sulfate in the treatment of LN demonstrates significant efficacy,effectively improving patients’inflammatory status,correcting immune dysfunction,protecting renal function,and demonstrating good safety.
作者
郑莉莉
冯媛
赵翠芬
晁少荣
李玉莹
曹雪
ZHENG Lili;FENG Yuan;ZHAO Cuifen;CHAO Shaorong;LI Yuying;CAO Xue(Department of Rheumatology and Immunology,The Second Affiliated Hospital of Air Force Medical University,Xi’an 710038,China)
出处
《中国药物应用与监测》
2025年第9期1517-1521,共5页
Chinese Journal of Drug Application and Monitoring
关键词
狼疮性肾炎
系统性红斑狼疮
临床疗效
贝利尤单抗
硫酸羟氯喹
lupus nephritis
systemic lupus erythematosus
clinical efficacy
belimumab
hydroxychloroquine sulfate
