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免疫球蛋白联合吗替麦考酚酯胶囊治疗重症系统性红斑狼疮的疗效观察
引用本文:李姝玉,包瑾芳. 免疫球蛋白联合吗替麦考酚酯胶囊治疗重症系统性红斑狼疮的疗效观察[J]. 现代药物与临床, 2016, 31(11): 1838-1841. DOI: 10.7501/j.issn.1674-5515.2016.11.036
作者姓名:李姝玉  包瑾芳
作者单位:1. 上海国际医学中心风湿免疫科,上海,200121;2. 上海市第一人民医院肾内科,上海,200121
摘    要:目的探讨免疫球蛋白联合吗替麦考酚酯胶囊治疗重症系统性红斑狼疮的临床疗效。方法选择2013年12月—2014年12月上海国际医学中心收治的重症系统性红斑狼疮的患者80例,随机分为对照组和治疗组,每组各40例。对照组口服吗替麦考酚酯胶囊,起始剂量为3粒/次,2次/d;3个月后为2粒/次,2次/d;6个月后根据患者的病情用量为2~3粒/d,同时不使用其他免疫抑制剂。治疗组患者在对照组的基础上静脉注射静注人免疫球蛋白(p H 4)0.4 g/kg,1次/d,连续使用3 d,每月重复1次。两组治疗时间为6~12个月。观察两组治疗前后系统性红斑狼疮疾病活动指数(SLEDAI)、血清白蛋白、24 h尿蛋白、Ig G、血肌酐(Scr)的变化情况。比较两组ANA阳性例数、A-ds DNA阳性例数、贫血例数的变化情况。结果治疗后,两组SLEDAI评分、24 h尿蛋白、Ig G、Scr水平均显著降低,血清白蛋白升高,同组治疗前后差异有统计学意义(P0.05);治疗后治疗组SLEDAI评分、24 h尿蛋白、Ig G、Scr低于对照组,血清白蛋白高于对照组,两组比较差异具有统计学意义(P0.05)。治疗后,两组ANA阳性例数、A-ds DNA阳性例数、贫血例数均显著减少,同组治疗前后差异有统计学意义(P0.05);治疗组治疗后ANA阳性例数、A-ds DNA阳性例数、贫血例数少于对照组,两组比较差异具有统计学意义(P0.05)。对照组和治疗组不良反应发生率分别为82.5%、47.5%,两组比较差异有统计学意义(P0.05)。结论免疫球蛋白联合吗替麦考酚酯胶囊治疗重症系统性红斑狼疮具有良好的效果,能够改善患者的病情,具有一定的临床推广应用价值。

关 键 词:静注人免疫球蛋白(pH 4)  吗替麦考酚酯胶囊  系统性红斑狼疮  疾病活动指数
收稿时间:2016-01-15

Clinical observation of immunoglobulin combined with Mycophenolate Mofetil Capsules in treatment of severe systemic lupus erythematosus
LI Shu-yu and BAO Jin-fang. Clinical observation of immunoglobulin combined with Mycophenolate Mofetil Capsules in treatment of severe systemic lupus erythematosus[J]. Drugs & Clinic, 2016, 31(11): 1838-1841. DOI: 10.7501/j.issn.1674-5515.2016.11.036
Authors:LI Shu-yu and BAO Jin-fang
Affiliation:Department of Rheumatoid Immune, Shanghai International Medical Center, Shanghai 200121, China;Department of Kidney, Shanghai General Hospital, Shanghai 200080, China
Abstract:Objective To investigate the clinical effect of immunoglobulin combined with Mycophenolate Mofetil Capsules in treatment of severe systemic lupus erythematosus. Methods Patients (80 cases) with severe systemic lupus erythematosus in Shanghai International Medical Center from December 2013 to December 2014 were randomly divided into control and treatment groups, and each group had 40 cases. The patients in the control group were po administered with Mycophenolate Mofetil Capsules, starting dosage of 3 grains/time, twice dailiy; After 3 months, 2 grains/time, twice daily; the dosage was adjusted to 2-3 grains/d according to the illness state after 6 months, and other immunosuppressants were not used. The patients in the treatment group were iv administered with Human Immunoglobulin (pH 4) for Intravenous Injection on the basis of the control group, 0.4 g/kg, once daily, consecutive for 3 d, repeat once monthly. The patients in two groups were treated for 6-12 months. The changes of SLEDAI, serum albumin, 24 h urinary protein, IgG, and Scr in two groups before and after treatment were compared. The changes of ANA positive cases, A-dsDNA positive cases, and anemia cases in two groups were compared. Results After treatment, SLEDAI, 24 h urinary protein, IgG, and Scr in two groups were significantly reduced, and serum albumin in two groups were significantly increased, and the difference was statistically significant in the same group (P<0.05). After treatment, SLEDAI, 24 h urinary protein, IgG, and Scr in the treatment group were lower than those in the control group, and serum albumin was higher than that in the control, and there were differences between two groups (P<0.05). ANA positive cases, A-dsDNA positive cases, and anemia cases in two groups were reduced, and the difference was statistically significant in the same group (P<0.05). After treatment, ANA positive cases, A-dsDNA positive cases, and anemia cases in the treatment group were less than those in the control group, with significant difference between two groups (P<0.05). The incidences of adverse reactions in the control and treatment groups were 82.5% and 47.5%, and there were differences between two groups (P<0.05). Conclusion Immunoglobulin combined with Mycophenolate Mofetil Capsules has clinical curative effect in treatment of severe systemic lupus erythematosus, can improve the patient''s condition, which has a certain clinical application value.
Keywords:Human Immunoglobulin (pH 4) for iv injection  Mycophenolate Mofetil Capsules  systemic lupus erythematosus  SLEDAI
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