【作者】 周颖；

【导师】 曾佳；

【作者基本信息】 石河子大学 ， 皮肤病与性病学（专业学位）， 2022， 硕士

【摘要】 目的:通过观察司库奇尤单抗治疗中重度寻常型银屑病患者前后主观症状、皮肤病生活质量指数评分(DLQI评分)、银屑病面积与严重指数评分(PASI评分)的改变,治疗12周及随访12周期间有无药物不良反应,停药后的皮损复发情况等。通过观察其临床疗效及安全性,为中重度寻常型银屑病的治疗提供一定临床资料。方法:收集2018年11月-2021年7月就诊于石河子大学医学院第一附属医院皮肤科中的中重度寻常型银屑病患者,根据纳入及排除标准,最终纳入50例患者,试验组25例,对照组25例。试验组给予司库奇尤单抗使用剂量为:每次两支(300mg);使用频率为:从第0周开始,每周注射1次,总共注射5次后,改为每月1次。对照组给予皮下注射注射用重组人Ⅱ型肿瘤坏死因子受体-抗体融合蛋白每次1支(25mg),每周2次。分别从治疗开始时(第0周)、治疗4周和治疗后12周计算患者PASI评分和DLQI评分。对比两组患者的PASI75、PASI90、PASI100数值,计算DLQI0/1应答率,评价治疗疗效。50例患者全部完成12周治疗。同时治疗期,观察并记录有无药物副作用及并发症。且至少随访患者12周,进一步观察患者有无并发症,是否有患者自行停药,记录停药时间及复发情况等。结果:经过12周的治疗后,两组患者皮损均有改善,PASI评分下降,DLQI评分降低,生活质量提高。差异具有统计学意义(P<0.01)。试验组患者治疗4周、12周的临床疗效均明显优于对照组。差异具有统计学意义(P<0.01)。试验组25例寻常型银屑病患者,治疗4周后,25例达到PASI50,25例达到PASI 75,19例达到PASI90。经过12周的治疗后,25例患者均达到PASI90,3例患者达到PASI 100,总有效率(大于PASI75)为100%;对照组25例寻常型银屑病患者中,治疗4周后,11例达PASI50,2例达PASI75,0例达PASI90。治疗12周后,7例达PASI75,0例达PASI90,0例达PASI100,总有效率为28%。试验组总有效率明显高于对照组,且两组间差异具有统计学意义(P<0.01),经过两种不同生物制剂治疗后,两组患者DLQI评分明显下降,患者生活质量均明显改善,且试验组生活质量改善明显优于对照组。50例患者治疗期间,随访期间均未出现严重的并发症及不良反应。结论:司库奇尤单抗相较于注射用重组人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起效更迅速,能在短期内迅速消除皮损,降低患者PASI评分,降低DLQI评分,明显改善患者的生活质量,副作用较少,安全性较高,值得早期应用于中重度寻常型银屑病患者。更多还原

【Abstract】 Objective: To observe the changes of subjective symptoms,quality of life improvement(DLQI),psoriasis area and severity index(PASI)score in patients with moderate and severe psoriasis vulgaris before and after treatment with Secukinumab,adverse drug reactions during 12 weeks of treatment and follow-up,and recurrence of skin lesions after drug withdrawal.To provide some clinical data for the treatment of moderate and severe psoriasis vulgaris by studying the effect and safety of clinical treatment.Methods: A total of 50 patients with moderate to severe psoriasis vulgaris admitted to the dermatology department of the First Affiliated Hospital of Shihezi University Medical College from November 2018 to July 2021 were enrolled according to inclusion and exclusion criteria,including 25 patients in the experimental group and 25 patients in the control group.The experimental group received subcutaneous injection of Secukinumab,and control group received subcutaneous injection of Etanercept.The experimental group was given two doses of Secukinumab(300mg)each time;Frequency of use: once a week in the first month,including week 0,once a month after a total of 5 injections.The control group received hypodermic injection of Etanercept,25 mg subcutaneously,twice a week.PASI score and DLQI score were calculated at the beginning of treatment(week 0),week 4 and week 12.PASI75,PASI90 and PASI100 values were compared between the two groups,DLQI0/1 response rate was calculated,and evaluate the effectiveness of the treatment.all 50 patients completed 12 weeks of treatment.At the same time observe and record the adverse drug reactions and complications of the treatment period.Follow up for at least 12 weeks for further complications,whether there were patients who stopped medication by themselves,and record the time of drug withdrawal and recurrence.Results: After 12 weeks of treatment,patients in both groups had improved skin lesion,PASI score went down,quality of life improved,and DLQI score went down.The difference was statistically significant(P <0.01).After 4 weeks and 12 weeks of treatment,the clinical therapeutic effects of experimental group were all distinctly superior to control group.The difference was statistically significant(P < 0.01).In the experimental group of 25 patients with psoriasis vulgaris,after 4 weeks of treatment,25 patients reached PASI50,25 patients reached PASI75,19 patients reached PASI90;After 12 weeks of treatment,all 25 patients achieved PASI90 and 3 patients achieved PASI 100.After treatment,the effect is 100%.Control group 25-patients with the same type of coronary artery after 4 weeks of treatment,11 patients achieved PASI50,2 patients achieved PASI75,and 0 patients achieved PASI90.After 12 weeks of treatment,7patients achieved PASI75,0 achieved PASI90,and 0 achieved PASI100,with a total effective rate of 28%.The difference between the two groups was statistically significant(P < 0.01),and the quality of life of the patients was significantly improved after the treatment of the two different biologic agents.DLQI score was significantly decreased,and also the quality of life in experimental group was significantly improved than that in control group.None of the 50 patients had serious complications or adverse reactions during treatment or follow-up.Conclusion: Compared with Etanercept,Secukinumab has a more rapid onset of action in the treatment of moderate and severe psoriasis vulgaris,which can rapidly eliminate skin lesions in a short term,reduce PASI score of patients,It dramatically improves the quality of life of patients who have fewer side effects and are safe.Therefore,for patients with moderate and severe psoriasis,early application is worthwhile.更多还原