百令胶囊联合他克莫司治疗狼疮性肾炎的临床研究

目的探讨百令胶囊联合他克莫司治疗狼疮性肾炎的临床疗效。方法选取郑州大学第一附属医院2014年9月—2016年2月收治的狼疮性肾炎患者118例,随机分为对照组和治疗组,每组各59例。对照组患者空腹口服他克莫司胶囊,初始剂量为0.1 mg/(kg·d),2次/d,治疗3 d后维持血药浓度5~15μg/L。治疗组在对照组的基础上口服百令胶囊,1 g/次,3次/d。两组患者均持续治疗12个月。比较两组患者治疗前后临床疗效、SLEDAI评分、血尿指标和不良反应情况。结果治疗后,对照组和治疗组总有效率分别为69.49%、88.14%,两组比较差异具有统计学意义(P0.05)。治疗6、12个月,两组系统性狼疮性疾病活动度(SLEDAI)评分均较同组治疗前明显降低(P0.05);且治疗6、12个月治疗组患者SLEDAI评分明显低于同期对照组(P0.05)。治疗6、12个月,两组患者白蛋白(ALB)和补体C3均较治疗前明显升高(P0.05),血肌酐(Scr)、24 h尿蛋白定量(TP/24 h)和尿红细胞(RBC)水平比治疗前显著降低(P0.05);与治疗6个月相比,治疗12个月两组患者ALB、C3、Scr、TP/24 h和RBC水平均明显改善(P0.05);且治疗6、12个月治疗组患者ALB、TP/24h和RBC水平明显优于同期对照组(P0.05);治疗12个月后治疗组患者血C3水平显著高于同期对照组(P0.05)。治疗期间对照组不良反应发生率为47.46%,显著高于治疗组的27.12%,两组不良反应比较差异具有统计学意义(P0.05)。结论百令胶囊联合他克莫司能有效提高狼疮性肾炎的临床治疗效果,具有一定的临床推广应用价值。

Clinical study on Bailing Capsules combined with tacrolimus in treatment of lupus nephritis

Objective To explore the clinical curative effect of Bailing Capsules combined with tacrolimus in treatment of lupus nephritis. Methods Patients (118 cases) with lupus nephritis in the First Affiliated Hospital of Zhengzhou University from November 2014 to February 2016 were randomly divided into control and treatment groups, and each group had 59 cases. Patients in the control group were fasting po administered with Tacrolimus Capsules, the initial dosage was 0.1 mg/(kg·d), twice daily, the blood concentration was maintained at 5 — 15 μg/L after treatment for 3 d. Patients in the treatment group were po administered with Bailing Capsules on the basis of the control group, 1 g/time, three times daily. Patients in two groups were treated for 12 months. After treatment, clinical efficacy, SLEDAI scores, hematuria index, and adverse reaction in two groups before and after treatment were compared. Results After treatment, the clinical efficacy in the control and treatment groups were 69.49% and 88.14%, respectively, and there was difference between two groups (P < 0.05). After treatment for 6 and 12 months, the SLEDAI scores in two groups significantly decreased (P < 0.05). And the SLEDAI scores in treatment group were significantly lower than those in the same period in the control group (P < 0.05). After treatment for 6 and 12 months, the ALB and C3 in two groups were significantly increased (P <0.05), while Scr, TP/24 h and RBC levels were significantly decreased (P < 0.05). Compared with those after treatment for 6 months, ALB, C3, Scr, TP/24 h and RBC levels in two groups were significantly improved after treatment for 12 months (P < 0.05). And after treatment for 6 and 12 months, ALB, TP/24 h and RBC levels in the treatment group were significantly better than those in the same period in the control group (P < 0.05). After treatment for 12 months, C3 levels in the treatment group were significantly higher than those in the same period in the control group (P < 0.05). After treatment, the adverse reaction rate in the control group was 47.46%, which were significantly higher than 27.12% in the treatment group, and there were differences between two groups (P < 0.05). Conclusion Bailing Capsules combined with tacrolimus can effectively improve the clinical therapeutic effect in treatment of lupus nephritis, which has a certain clinical application value.