【摘要】 目的 探讨注射用重组人Ⅱ型肿瘤坏死因子受体-抗体融合蛋白(益赛普)联合中药清热凉血方治疗中重度难治性银屑病的疗效和安全性。方法 选取中日友好医院皮肤科30例中重度银屑病患者,完全随机分为益赛普联合清热凉血方组、阿维A联合清热凉血方组和清热凉血方组,每组10例。益赛普联合中药组在口服中药清热凉血方的基础上予以益赛普50 mg皮下注射,每周1次;阿维A联合清热凉血方组为口服中药基础上每日口服阿维A胶囊30 mg,1次/d;清热凉血方组给予中药清热凉血方治疗,每日2次;疗程均为12周。观察3组患者治疗4、8、12周后银屑病皮损面积和严重程度指数(PASI)、患者整体评价(PGA)、视觉模拟评分(VAS)、生活质量评分及不良反应。结果 治疗12周后,益赛普联合清热凉血方组、阿维A联合清热凉血方组和清热凉血方组的PASI、PGA、VAS评分较治疗前明显降低[PASI评分:(4.6±1.0)分比(28.7±2.3)分,(15.0±0.9)分比(31.9±2.1)分,(19.0±1.7)分比(26.8±1.7)分:PGA评分:(1.40±0.22)分比(5.20±0.20)分,(3.10±0.18)分比(5.60±0.22)分,(4.00±0.21)分比(5.20±0.20)分;VAS评分:(2.20±0.44)分比(7.40±0.43)分。(4.40±0.16)分比(7.90±0.41)分.(5.50±0.27)分比(6.90±0.38)分](P<0.05)。治疗8周后,益赛普联合清热凉血方组和阿维A联合清热凉血方组PASI[(9.8±1.3)、(19.2±0.9)分]、PGA[(2.60±0.31)、(4.00±0.15)分]、VASf(4.20±0.33)、(5.20±0.25)分]评分均低于治疗前(P<0.05);治疗4周后,益赛普联合清热凉血方组的PASI[(16.6±1.7)分]、PGA[(3.80±0.33)分]、VAS[(5.40±0.16)分]评分均低于治疗前,阿维A联合清热凉血方组PASI[(27.5±1.7)分]评分低于治疗前,差异均有统计学意义(均P<0.05)。益赛普联合清热凉血方组治疗4、8、12周后的PASI、PGA、VAS评分和阿维A联合清热凉血方组治疗后8、12周的PASI、PGA、VAS评分均低于清热凉血方组同期指标(均P<0.05)。益赛普联合清热凉血方组治疗4、8、12周后PASI评分与阿维A联合清热凉血方组比较,差异均有统计学意义(均P<0.05)。益赛普联合清热凉血方组、阿维A联合清热凉血方组和热凉血方组治疗12周后生活质量评分与治疗前比较,差异有统计学意义[(3.2±0.9)分比(25.1±3.1)分,(16.1±1.6)分比(30.4±2.0)分,(18.9±2.0)分比(25.8±1.7)分](P<0.05)。益赛普联合清热凉血方组和阿维A联合清热凉血方组的生活质量评分均低于清热凉血方组。差异有统计学意义(P<0.05);益赛普联合清热凉血方组的生活质量评分明显低于阿维A联合清热凉血方组,差异有统计学意义(P<0.05)。结论 重组人Ⅱ型肿瘤坏死因子受体.抗体融合蛋白治疗中重度的银屑病,起效迅速、疗效好,是顽固难治性银屑病的治疗方法的选择,其长期疗效以及安全性有待进一步观察。更多还原

【Abstract】 Objective To assess the efficacy and safety of recombinant human tumor necrosis factor-α receptor II:IgG Fc fusion protein combined with heat-clearing and blood-cooling recipe(HCBCR) in the the treatment of moderate and severe refractory psoriasis.Methods Totally 30 patients with moderate and severe psoriasis of China-Japan Friendship Hospital were selected,and divided into the YiSaipu with HCBCR group,acitretin capsules with HCBCR group and HCBCR group,each with 10 patients.The YiSaipu with HCBCR applied YiSaipu SO mg once-weekly subcutaneous injections except the HCBCR.The acitretin capsules with HCBCR group applied acitretin capsules 30 mg once a day except the HCBCR.HCBCR group just take HCBCR twice a day.The period takes continuously 3 months.Observation of changes of psoriasis area and severity index(PASI) score,patient global assessment(PGA),visual analogue scale(VAS) score,quality of life scores before and after drug administration and adverse reaction.Results After 12 weeks treatment,PASI,PGA,VAS score of YiSaipu with HCBCR group,acitretin capsules with HCBCR group and HCBCR group were lower than that of before treatment[PASI:(4.6 ±1.0)scores vs(28.7 ±2.3)scores,(15.0 ±0.9) scores vs(31.9 ±2.1) scores,(19.0 ± 1.7) scores vs(26.8±1.7)scores;PGA:(1.40±0.22)scores vs(5.20 ±0.20) scores,(3.10±0.18)scores vs(5.60±0.22)scores,(4.00±0.21)scores vs(5.20 ±0.20) scores;VAS:(2.20 ±0.44)scores vs(7.40 ±0.43)scores,(4.40 ±0.16)scores vs(7.90 ±0.41)scores,(5.50 ±0.27)scores vs(6.90 ±0.38)scores](P<0.05).After8 weeks treatment,PASI[(9.8 ± 1.3),(19.2 ±0.9)scores],PGA[(2.60 ±0.31),(4.00±0.15)scores],VAS[(4.20 ±0.33),(5.20 ±0.25) scores]of YiSaipu with HCBCR group and acitretin capsules with HCBCR group were lower than that of before treatment(P <0.05).After 4 weeks treatment,PASI[(16.6 ± 1.7)scores],PGA[(3.80 ±0.33)scores],VAS[(5.40 ±0.16)scores]of YiSaipu with HCBCR group were lower than that of before treatment,PASI[(27.5±1.7) scores]of acitretin capsules with HCBCR group were lower than that of before treatment(P < 0.05).PASI,PGA,VAS score of YiSaipu with HCBCR group after 4,8,12 weeks and acitretin capsules with HCBCR group after 8,12 weeks were were lower than that of HCBCR group(P < 0.05).There were significant differences on PASI score of YiSaipu with HCBCR group after 4,8,12 weeks compared with acitretin capsules with HCBCR group(P <0.05).There were significant differences on quality of life scores of YiSaipu with HCBCR group,acitretin capsules with HCBCR group and HCBCR group after 12 weeks compared with before treatment[(3.2 ±0.9)scores vs(25.1 ±3.1)scores,(16.1 ± 1.6)scores vs(30.4 ±2.0)scores,(18.9 ±2.0)scores vs(25.8 ± 1.7) scores](P < 0.05).Quality of life scores of YiSaipu with HCBCR group,acitretin capsules with HCBCR group were lower than that of HCBCR group(P <0.05).Quality of life scores of YiSaipu with HCBCR group was lower than that of acitretin capsules with HCBCR group(P < 0.05).Conclusion YiSaipu combined with heat-clearing and blood-cooling recipe is significantly able to improve clinical sign and symptoms of moderate to severe psoriasis with effective and safety.更多还原