CAJ | 학술논문

目的：探讨静脉注射免疫球蛋白(IVIG)联合糖皮质激素、免疫抑制剂治疗重症系统性红斑狼疮(SLE)的疗效及安全性。方法采用前瞻性随机对照研究,重症 SLE 患者60例,随机分为对照组及 IVIG 组,两组患者均接受激素及免疫抑制剂治疗,IVIG 组同时接受 IVIG(400 mg·kg-1·d-1,连用5天)治疗。观察两组患者 SLE 疾病活动指数(SLEDAI)、平均住院日、院内感染率及不良反应发生率。结果治疗后12周,IVIG 组 SLEDAI 为4.0(3.0,6.3),对照组 SLEDAI 为5.5(4.0,8.5),两组比较差异具有统计学意义(Z =-2.420,P <0.05)；IVIG 组完全缓解率56.7%(17/30),对照组完全缓解率26.7%(8/30),两组比较差异具有统计学意义(χ2=4.389,P <0.05)；IVIG 组平均住院日较对照组缩短2.3天,平均(14.0±3.9)d vs (16.3±3.3)d(t =2.436,P <0.05)；两组患者院内感染发生率差异无统计学意义(χ2=0.647,P >0.05)；治疗过程中无严重不良反应发生。结论 IVIG 联合激素、免疫抑制剂治疗重症 SLE 具有良好的疗效及安全性。
목적：탐토정맥주사면역구단백(IVIG)연합당피질격소、면역억제제치료중증계통성홍반랑창(SLE)적료효급안전성。방법채용전첨성수궤대조연구,중증 SLE 환자60례,수궤분위대조조급 IVIG 조,량조환자균접수격소급면역억제제치료,IVIG 조동시접수 IVIG(400 mg·kg-1·d-1,련용5천)치료。관찰량조환자 SLE 질병활동지수(SLEDAI)、평균주원일、원내감염솔급불량반응발생솔。결과치료후12주,IVIG 조 SLEDAI 위4.0(3.0,6.3),대조조 SLEDAI 위5.5(4.0,8.5),량조비교차이구유통계학의의(Z =-2.420,P <0.05)；IVIG 조완전완해솔56.7%(17/30),대조조완전완해솔26.7%(8/30),량조비교차이구유통계학의의(χ2=4.389,P <0.05)；IVIG 조평균주원일교대조조축단2.3천,평균(14.0±3.9)d vs (16.3±3.3)d(t =2.436,P <0.05)；량조환자원내감염발생솔차이무통계학의의(χ2=0.647,P >0.05)；치료과정중무엄중불량반응발생。결론 IVIG 연합격소、면역억제제치료중증 SLE 구유량호적료효급안전성。
Objective To evaluate the efficacy and safety of intravenous immunoglobulin(IVIG)combined with corticosteroids and immunosuppressive agents in severe systemic lupus erythematosus(SLE).Methods A total of 60 severe SLE patients were enrolled in this study.The patients were randomly assigned to control group and IVIG group. All patients received standard therapy (corticosteroids combined with immunosuppressive agents,such as cyclophosphamide,mycophenolate mofetil or cyclosporin A).In addition to that,the patients in IVIG group received IVIG therapy (400 mg·kg-1 ·d-1 for five consecutive days).Outcome measures included SLE Disease Activity Index (SLEDAI),duration of hospitalization,hospital infection and adverse effect rate were observed.Results After treatment for 12 weeks,the patients in IVIG group had lower SLEDAI score than in control group,4.0(3.0,6.3)vs 5.5(4.0,8.5),Z =-2.420(P <0.05).About 56.7(1 7/30)percent of the patients in IVIG group achieved complete remission,while 26.7(8/30)percent of the patients in control group achieved complete remission (χ2 =4.389,P <0.05).Patients in IVIG group had a shorter mean hospitalization time compared with those in control group (14.0 ± 3.9)days vs (1 6.3 ±3.3)days(t =2.436,P <0.05).The incidence of hospital infection in two groups showed no statistical difference (χ2 =0.647,P >0.05).No severe adverse effects were reported in either group.Conclusion IVIG combined with standard therapy showed good efficacy and safety in treatment for severe SLE patients.