首页|期刊导航|中国临床药理学杂志|吗替麦考酚酯联合贝利尤单抗治疗系统性红斑狼疮合并急性肾损伤的临床研究

吗替麦考酚酯联合贝利尤单抗治疗系统性红斑狼疮合并急性肾损伤的临床研究OA

Clinical trial of mycophenolate mofetil combined with belimumab in the treatment of systemic lupus erythematosus complicated with acute kidney injury

中文摘要英文摘要

目的 观察吗替麦考酚酯胶囊联合贝利尤单抗注射液治疗系统性红斑狼疮(SLE)合并急性肾损伤(AKI)的临床疗效及安全性.方法 将患者按随机数表法分为对照组与试验组.对照组用吗替麦考酚酯胶囊治疗,口服吗替麦考酚酯胶囊,每次0.5 g,每天2次.试验组在对照组的基础上用贝利尤单抗注射液治疗,取10 mg·kg-1贝利尤单抗注射液,溶于250 mL生理盐水中,静脉滴注,前3次每2周静脉滴注1次,此后每4周静脉滴注1次.2组均治疗6个月.比较2组的症状评分、炎性损伤指标、肾功能指标、免疫功能、临床疗效,并进行安全性评价.结果 本研究共筛选197例,127例入组,试验组入组63例,对照组入组64例.对照组因中途转院脱落4例,纳入60例,试验组因放弃治疗脱落4例,纳入59例.治疗后,试验组和对照组的英国狼疮评价量表(BILAG)评分分别为(12.05±2.14)和(17.24±3.27)分,系统性红斑狼疮疾病活动度量表(SLEDAI)评分分别为(6.41±1.33)和(9.25±1.98)分,甘露糖结合凝集素(MBL)水平分别为(62.09±6.10)和(78.34±8.51)ng·L-1,血肌酐(Scr)水平分别为(172.20±21.08)和(228.36±25.42)μmol·L-1,血尿素氮(BUN)水平分别为(10.07±1.96)和(15.24±3.17)mmol·L-1,免疫球蛋白 M(IgM)水平分别为(1.17±0.21)和(2.19±0.30)g·L-1,IgG 分别为(5.93±0.89)和(4.87±0.65)g·L-1,试验组的上述指标与对照组比较,在统计学上差异均有统计学意义(均P<0.05).试验组和对照组的临床总有效率分别为88.14%(52例/59例)和71.67%(43例/60例),试验组显著高于对照组(P<0.05).对照组的主要药物不良反应有转氨酶升高、恶心呕吐和腹泻;试验组主要有转氨酶升高、恶心呕吐、血管水肿和腹泻.对照组和试验组的总药物不良反应发生率分别为10.00%(6例/60例)和13.56%(8例/59例),在统计学上差异无统计学意义(P>0.05).结论 吗替麦考酚酯胶囊联合贝利尤单抗注射液治疗SLE合并AKI患者疗效确切,可改善患者临床症状与肾功能,减轻炎症反应,改善免疫功能,且安全性良好.

Objective To observe the efficacy and safety of mycophenolate mofetil capsules combined with belimumab injection in the treatment of systemic lupus erythematosus(SLE)with acute kidney injury(AKI).Methods Patients were divided into control group and treatment group according to random number table method.The control group was treated with mycophenolate mofetil capsules,mycophenolate orally,0.5 g per time,twice a day.The treatment group was treated with belimumab injection on the basis of control group.Take 10 mg·kg-1 belimumab injection,dissolve in 250 mL normal saline,intravenous infusion,once every 2 weeks for the first 3 times,and once every 4 weeks thereafter.Both groups were treated for 6 months.Symptom score,inflammatory injury index,renal function index,immune function and clinical efficacy were compared between the two groups,and safety evaluations conducted.Results A total of 197 cases were screened,with 127 cases enrolled.The treatment group consisted of 63 cases and the control group consisted of 64 cases.In control group,4 cases dropped out due to mid course transfer,and 60 cases were included.In treatemnt group,4 cases dropped out due to giving up treatment,and 59 cases were included.After treatment,the British isles lupus assessment group(BILAG)scores in treatment group and control group were(12.05±2.14)and(17.24±3.27)points,respectively;the systemic lupus erythematosus disease activity index(SLEDAI)scores were(6.41±1.33)and(9.25±1.98)points,respectively;the levels of mannose-binding lectin(MBL)were(62.09±6.10)and(78.34±8.51)ng·L-1,respectively;the levels of serum creatinine(Scr)were(172.20±21.08)and(228.36±25.42)μmol·L-1,respectively;the levels of blood urea nitrogen(BUN)were(10.07±1.96)and(15.24±3.17)mmol·L-1,respectively;the levels of immunoglobulin M(IgM)were(1.17±0.21)and(2.19±0.30)g·L-1,respectively;the levels of IgG were(5.93±0.89)and(4.87±0.65)g·L-1,respectively.The above indicators in treatment group showed statistically significant differences compared to control group(all P<0.05).The total clinical effective rates of treatment group and control group were 88.14%(52 cases/59 cases)and 71.67%(43 cases/60 cases),respectively,with treatment group significantly higher than control group(P<0.05).The main adverse drug reactions of control group were elevated transaminase levels,nausea,vomiting and diarrhea;treatment group mainly had elevated transaminase levels,nausea and vomiting,vascular edema and diarrhea.The total incidence of adverse drug reactions in control group and treatment group were 10.00%(6 cases/60 cases)and 13.56%(8 cases/59 cases),respectively,with no statistically significant difference(P>0.05).Conclusion Mortimycophanate capsules combined with belimumab injection in the treatment of SLE patients with AKI is effective,can improve clinical symptoms and renal function,reduce inflammation,improve immune function,and has good safety.

祝艳丽;李玉霞;王莹莹;项继链

定西市人民医院肾病科,甘肃定西 743000定西市人民医院肾病科,甘肃定西 743000兰州大学第二医院/第二临床医学院 肾内科,甘肃兰州 730030||兰州大学第二医院/第二临床医学院 肾病临床医学研究中心,甘肃兰州 730030甘肃省第三人民医院肾病科,甘肃兰州 730020

医药卫生

吗替麦考酚酯胶囊贝利尤单抗注射液系统性红斑狼疮急性肾损伤临床疗效

mycophenolate mofetil capsulebelimumab injectionsystemic lupus erythematosusacute kidney injuryclinical effect

《中国临床药理学杂志》 2026 (3)

338-343,6

甘肃省科技计划基金资助项目(21JR7RA436)

10.13699/j.cnki.1001-6821.2026.03.007

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