中国临床药理学杂志2026，Vol.42Issue(3)：338-343,6.DOI:10.13699/j.cnki.1001-6821.2026.03.007
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
Clinical trial of mycophenolate mofetil combined with belimumab in the treatment of systemic lupus erythematosus complicated with acute kidney injury
摘要
Abstract
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.关键词
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Key words
mycophenolate mofetil capsule/belimumab injection/systemic lupus erythematosus/acute kidney injury/clinical effect分类
医药卫生引用本文复制引用
祝艳丽,李玉霞,王莹莹,项继链..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[J].中国临床药理学杂志,2026,42(3):338-343,6.基金项目
甘肃省科技计划基金资助项目(21JR7RA436) （21JR7RA436）
