目的 探討來氟米特聯合厄貝沙坦治療狼瘡性腎炎的臨床療效和安全性.方法 選取2012年1月—2013年9月在金湖縣人民醫(yī)院住院治療的狼瘡性腎炎患者80例,隨機分為對照組(40例)和治療組(40例).兩組均采用標準激素治療,給予醋酸潑尼松片1.0 mg/(kg·d),服用2個月后逐漸減量至10 mg/d;同時均口服厄貝沙坦片,2片/次,1次/d.在此基礎上,對照組口服環(huán)磷酰胺片3 mg/(kg·d),連用10～14 d,休息1～2周重復.治療組口服來氟米特片,開始治療的最初3 d給予負荷劑量50 mg/d,之后給予維持劑量20 mg/d.兩組均連續(xù)治療6個月.對比兩組治療前后24 h尿蛋白定量、尿紅細胞計數、尿β₂微球蛋白(β₂-MG)、血白蛋白、血β₂-MG、血肌酐(Cr)和補體C3等指標和不良反應.結果 治療3個月,治療組總有效率為95.0%,對照組為77.5%;治療6個月,治療組總有效率為95.0%,對照組為82.5%,兩組總有效率比較差異均有統(tǒng)計學意義(P<0.05).治療后,兩組患者尿液指標包括24 h尿蛋白、β₂-MG、尿紅細胞計數,血液指標包括血白蛋白、血β₂-MG、Cr、C3、血沉均較治療前顯著改善,同組治療前后差異有統(tǒng)計學意義(P<0.05、0.01);且同組患者治療6個月時這些項指標的改善程度優(yōu)于治療3個月,差異有統(tǒng)計學意義(P<0.05);治療后,治療組指標改善程度優(yōu)于對照組治療同期,兩組比較差異有統(tǒng)計學意義(P<0.05、0.01).治療組不良反應發(fā)生率為8.0%,對照組為25%,兩組比較差異有統(tǒng)計學意義(P<0.05).結論 來氟米特聯合厄貝沙坦治療狼瘡性腎炎有較好的臨床療效,起效迅速,不良反應生率低,具有臨床運用價值.

Objective To explore the effect and safety of leflunomide combined with irbesartan in treatment of lupus nephritis. Methods Patients (80 cases) with lupus nephritis who came to the People's Hospital of Jinhu County from January 2012 to September 2013 were randomly divided into control (40 cases) and treatment (40 cases) groups. Patients in two groups accepted standard hormone therapy, and they were given Prednisone Acetate Tablets 1.0 mg/(kg·d), gradually reduced to 10 mg/d after taking for 2 months. The patients in the two groups were po administered with Irbesartan Tablets, 2 tablets/time, once daily. The patients in the control group were po administered with Cyclophosphamide Tablets 3 mg/(kg·d) for 10 — 14 d, and rested for 1 — 2 weeks, then the administration was repeated. The patients in the treatment group were po administered with Leflunomide Tablets, they were given loading dose of 50 mg/d at the first 3 d of treatment, and then given the maintenance dose of 20 mg/d. The patients in two groups were treated for 6 months. After treatment, the changes of 24 h urine protein, count of urine red blood cell, β₂-MG, albumin, blood β₂-MG, Cr, C3 and adverse reactions in two groups were compared. Results After treatment for 3 months, the efficacies in the treatment and control groups were 95.0% and 77.5%, and after 6 months treatment, the efficacies in the treatment and control groups were 95.0% and 82.5%, with difference between the two groups (P < 0.05). After treatment, urine indexes including 24 h urine protein, count of urine red blood cell, β₂-MG, and blood indexes including blood albumin, blood β₂-MG, Cr, C3, and blood sedimentation were improved significantly, and the differences were statistically significant before and after treatment in the same group (P < 0.05, 0.01). The indexes after 3 months treatment were improved more obviously than those after 6 months treatment, with significant difference (P < 0.05). After treatment, these indexes in the treatment group were improved better than those of control group during the same period, with significant difference between the two groups (P < 0.05, 0.01). The incidence rate of adverse reactions in the treatment and control groups were 8.0% and 25.0%, respectively, and there were differences between the two groups (P < 0.05). Conclusion Leflunomide combined with irbesartan has good clinical effect in treatment of lupus nephritis, and can play the role quickly with less adverse reaction, which has clinical application value.

國家自然科學基金資助項目(81070588)