重组人Ⅱ型肿瘤坏死因子受体-抗体融合蛋白联合银屑颗粒治疗中、重度寻常型银屑病的疗效观察

摘要

OBJECTIVE:To observe the clinical efficacy and safety of recombinant tumor necrosis factor receptor (rhTN-TR)-Fc fusion protein combined with Yinxie granules for moderate and severe vulgaris psoriasis.METHODS:62 patients with moderate and severe vulgaris psoriasis were randomly divided into trial group and control group; trial group was given rhTNTR-Fc fusion protein 25 mg,twice a week,and Yinxie granules 6 g,tid.Control group was given rhTNTR-Fc fusion protein 25 mg,twice a week.Treatment course of 2 groups lasted for 12 weeks.Psoriasis area and severity index (PASI) of trial group was improved nu 90％ (PASI 90) 12 weeks later,and then they were given Yinxie granules 6 g,bid for consecutive 8 weeks.Therapeutic efficacy of 12-week treatment,the recurrence time and rate of PASI 90 patients during 2 years were compared between 2 groups.RE-SULTS:30 patients of trial group and 29 patients of control group finished the 12-week course of treatment.PASI 50,PASI 75 and PASI 90 was achieved by 96.7％,83.3％,60.6％ of patients in treatment group,and by 89.7％,82.8％,55.2％ of patients in control group,respectively.There was no statistical significance (P＞0.05).6 PASI 90 patients in trial group (33.33％) and 8 in control group (50.0％) suffered from psoriasis again during followed-up of 2 years; there was no statistical significance between 2 groups (P＞0.05),but recurrence time of trial group had delayed (P＜0.05).No severe ADR were observed in 2 groups,and there was no statistical significance in the incidence ofADR (P＞0.05).CONCLUSIONS:Therapeutic efficacy and ADR of rhTN-TR-Fe fusion protein combined with Yinxie granules is similar to rhTNTR-Fc fusion protein alone in the treatment of moderate and severe vulgaris psoriasis.However,combination therapy decreases the recurrence rate and delays the recurrence.%目的:观察重组人Ⅱ型肿瘤坏死因子受体-抗体融合蛋白联合银屑颗粒治疗中、重度寻常型银屑病的临床疗效和安全性.方法:将62例中、重度寻常型银屑病患者随机均分为试验组与对照组,两组患者均皮下注射重组人Ⅱ型肿瘤坏死因子受体-抗体融合蛋白25 mg,2次/周,试验组患者加服银屑颗粒6g,tid.两组患者疗程均为12周.试验组12周后皮损面积和严重程度指数(PASI)改善率达到90％ (PASI 90)的患者继续口服银屑颗粒6 g,bid,持续8周.比较两组患者12周后疗效及PASI 90患者2年内复发时间、复发率,并观察不良反应情况.结果:试验组30例、对照组29例患者完成了12周的试验.试验组患者PASI 50、PASI75、PASI 90的比例分别为96.7％、83.3％、60.0％,对照组患者分别为89.7％、82.8％、55.2％,两组比较差异均无统计学意义(P＞0.05).PASI 90患者2年随访期内试验组有6例复发,占33.33％,对照组有8例,占50.0％,两组比较差异无统计学意义(P＞0.05),但试验组复发时间较对照组显著延迟(P＜0.05).两组患者均未见严重不良反应发生,不良反应发生率差异无统计学意义(P＞0.05).结论:重组人Ⅱ型肿瘤坏死因子受体-抗体融合蛋白联合银屑颗粒与单用重组人Ⅱ型肿瘤坏死因子受体-抗体融合蛋白治疗中、重度寻常型银屑病的疗效及不良反应相近,但前者2年内复发率有所降低,复发时间显著延迟.