抗人白介素8单克隆抗体乳膏治疗湿疹的多中心随机双盲对照研究

目的评价外用抗人白介素8单克隆抗体(抗IL-8单抗)乳膏治疗湿疹的疗效和安全性。方法随机、双盲、安慰剂对照的多中心临床研究,受试者每日外用抗IL-8单抗乳膏或乳膏基质2次,疗程3周,于治疗前及治疗后第1、2、3周各随访1次,进行疗效和安全性评价。结果4个中心共入选湿疹患者229例,纳入疗效分析209例,其中使用抗IL-8单抗乳膏治疗组104例,基质对照组105例。治疗后第1、2、3周,治疗组患者症状/体征的总计分与对照组比较均有明显下降(P<0.05～0.01)。疗程结束时,治疗组和对照组的基本痊愈率分别为27.88%、2.86%;有效率分别为56.73%、15.24%。治疗组的基本痊愈率及有效率均高于对照组(P<0.01)。两组不良反应发生率分别为4.42%和1.79%,差异无统计学意义(P=0.45),主要表现为皮损局部红斑、瘙痒加重或灼热、疼痛等,无系统不良反应。结论抗IL-8单抗乳膏治疗湿疹安全有效。

A multicentre, randomized, double-blind, placebo-controlled study on the efficacy and safety of interleukin-8 monoclonal antibody cream in the treatment of eczema

Objective To evaluate the efficacy and safety of interleukin-8 monoclonal antibody (IL-8 monAb) cream (45 p.g/g) in the treatment of eczema.Methods A multicentre,randomized,doubleblind,placebo-controlled study was performed.The patients were randomly divided into two groups to receive IL-8 monAb cream (45μg/g) or vehicle,twice daily for 3 weeks.All the patients were evaluated prior to the treatment,and 1,2,3 weeks after the therapy,with clinical effects as well as adverse drug reactions recorded.Results Two hundred and twenty-nine patients were recruited in four clinical centers,and 209 patients completed the trial,of whom 104 were in the treatment group and 105 in the control group.All symptom/sign total scores were significantly decreased (all P<0.05)1,2,3 weeks after the treatment in the treatment group compared with those in the control group.Efficacy assessment based on symptom/sign reducing index (SSRI) showed statistical difference in the cure rates (27.88% vs.2.86%,P<0.05) and responsive rates (56.73% vs.15.24%,P<0.05) between the treatment and control groups.Five (4.71%) patients experienced side effects of burning,local erythema and worsening of itch in the treatment group,and 2 (1.79%)in the control group.The rates of side effects were of no significant difference (P>0.05)between the two groups.No systemic side effects were found.Conclusion Topical use of IL-8 monAb cream (45μg/g) is safe and effective for the treatment of eczema.