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

Efficacy Observation of Recombinant Tumor Necrosis Factor Receptor-Fc Fusion Protein Combined with Yinxie Granules for Moderate and Severe Vulgaris Psoriasis

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25mg,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%(PASI90)的患者继续口服银屑颗粒6g,bid,持续8周。比较两组患者12周后疗效及PASI90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PASI50、PASI75、PASI90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)。PASI90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。

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 mod- erate and severe vulgaris psoriasis were randomly divided into trial group and control group; trial group was given rhTNTR -Fc fu- sion protein 25 mg, twice a week, and Yinxie granules 6 g, rid. 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 con- trol group, respectively. There was no statistical significance （P〉0.05）. 6 PASI 90 patients in trial group （33.33%） and 8 in con- trol 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 of ADR （P〉0.05）. CONCLUSIONS： Therapeutic efficacy and ADR of rhTN- TR-Fc 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.