托法替尼治疗斑块状银屑病的效果和安全性的Meta分析

Efficacy and Safety of Tofacitinib for Plaque Psoriasis:a Systematic Review and Meta-analysis of Randomized Controlled Trials

目的系统评价不同剂量的托法替尼治疗斑块状银屑病的效果和安全性,以探讨托法替尼最佳用药方案。方法检索PubMed、Embase、CNKI、维普网、万方数据、"www.clinictrials.gov"等,检索时限均为建库起至2019年3月6日。收集托法替尼治疗银屑病的所有随机对照试验,对符合纳入标准研究中银屑病皮损面积和严重指数积分下降75%的例数(psoriasis area and severity index score,PASI75)、医生总体评价皮损获得清除或几乎清除的例数(Physician's Global Assessment 0/1,PGA0/1)和不良反应发生率采用RevMan5.3软件进行统计学分析。结果共纳入5个随机对照试验,共包括2 945例患者。Meta分析结果显示:与安慰剂组相比,托法替尼组的疗效高于对照组,PASI75及PGA0/1比较差异均具有统计学意义(P均<0.01)。托法替尼10 mg组与托法替尼5 mg组比较,前者治疗疗效优于后者,其PASI70及PGA0/1比较差异均有统计学意义(P均<0.01)。与对照组轻微不良反应率相比,托法替尼组头痛(P<0.01)、上呼吸道感染(P=0.04)的发生率较安慰剂组高,差异有统计学意义;而两者的严重不良反应发生率差异无统计学意义(P=0.56)。不同剂量托法替尼组的严重不良反应发生率差异无统计学意义(P>0.05)。结论托法替尼治疗银屑病,10 mg组疗效较5 mg组更具有优势,但严重不良反应发生率,并未随着剂量的增大而增加。托法替尼可以作为对其他药物治疗效果不佳、耐受差或偏爱口服药物患者的替代方案。

Objective To assess the outcome and safety of different dosages of tofacitinib in the treatment of plaque psoriatic,and to investigate the better dosage regimen.Methods All the date were collected from PubMed,EMBASE,CNKI,Wanfang database,VIP,“www.clinictrials.gov”for relevant randomized controlled trials(RCTs)by 6th March 2019,then a systematic review and meta-analysis assessment of tofacitinib were conducted including the proportion of patients with PASI75(75%reduction in the psoriasis area),PGA0/1(Physician's Global),and the incidence of adverse drug event.RevMan 5.3 statistical software was used for statistical analysis.Results Totally five studies were included and 2 945 cases were involved. The results of metaanalysisshowed that tofacitinib significantly improved PASI75 and PGAO/1 ofpatients with psoriasis compared to placebo ( P < 0. 01) . For different doses,10 mghad better effect than 5 mg in treatment of plaque psoriasis( P < 0. 01) . Tofacitinibwas associated with the minor adverse events compared to placebo ( headache: P =0. 01);upper respiratory tract infection: P = 0. 04 ) . There was no statisticalsignificance in the incidence of serious adverse events( P > 0. 05) between differentregimens( P > 0. 05) . Conclusion Clinical trial data indicates that the efficacy oftofatinib in psoriasis treatment in the 10 mg group was better than that in the 5 mggroup,and the incidence of severe adverse reactions did not increase as the increase ofdosage. Tofacitinib is safe and efficient for patients with plaque psoriasis and may be atreatment option for patients with plaque psoriasis who are intolerable to othertherapies or prefer oral medications.