Clinical trial of skuchizumab combined with calcipotriol in the treatment of patients with moderate to severe plaque psoriasis
Objective To observe the curative effect of skuchizumab combined with calcipotriol in patients with moderate to severe plaque psoriasis.Methods Patients with moderate and severe plaque psoriasis were divided into treatment group and control group by cohort method.The control group was given calcipotriol ointment,and an appropriate amount of ointment was evenly applied to the affected area,twice a day,while treatment group was given subcutaneous injection of skuchizumab injection(300 mg/once,once/week;once/4 weeks after 4 weeks of injection)on basis of control group.All patients were treated for 12 weeks.The clinical curative effect,score of psoriasis area and severity index(PASI),quality of life[score of dermatology life quality index(DLQI)],skin barrier function indexes(content of fat and water in stratum corneum),serum vascular endothelial growth factor(VEGF),interleukin-22(IL-22),IL-17 and safety were compared between the two groups after treatment.Results There were 42 cases in control group and 48 cases in treatment group.After treatment,total response rates of treatment group and control group were 93.75％(45 cases/48 cases)and 78.57％(33 cases/42 cases),the difference was statistically significant(P＜0.05).After treatment,PASI score in treatment group and control group were(6.57±1.52)and(10.68±2.13)points;DLQI score were(5.36±1.29)and(9.85±1.67)points;content of stratum corneum fat were(49.73±6.16)and(42.81±5.97)μg·cm-2;content of stratum corneum water were(36.84±4.59)％and(29.53±4.06)％;levels of serum VEGF were(136.43±25.05)and(183.52±29.56)pg·mL-1;levels of serum IL-22 were(5.27±1.15)and(7.93±1.43)pg·mL-1,and the differences were statistically significant(all P＜0.05).The adverse drug reactions were mainly on diarrhea,respiratory tract infection and rhinitis in treatment group,while which were mainly on skin irritation and dry skin in control group.There was no significant difference in total incidence of adverse drug reactions between treatment group and control group[8.33％(4 cases/48 cases)vs 7.14％(3 cases/42 cases),P＞0.05].Conclusion Skuchizumab combined with calcipotriol can reduce PASI scores,improve quality of life and skin barrier function,reduce levels of serum VEGF and IL-22 in patients with moderate to severe plaque psoriasis.
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