司库奇尤单抗治疗重度斑块型银屑病伴肝功能异常患者的临床观察

Clinical observation on the treatment of severe plaque psoriasis with liver dysfunction with secukinumab

目的观察司库奇尤单抗对重度斑块型银屑病伴肝功能异常患者的疗效及对肝功能的影响。方法纳入7例重度斑块型银屑病伴轻中度肝功能异常患者,予司库奇尤单抗皮下注射治疗,300 mg/次,0~4周每周1次,后每4周1次,并于治疗后第1、2、3、4周以及之后每4周复查一次血常规、肝肾功能、血脂和血糖至32周。记录患者的银屑病皮损面积和严重程度指数(PASI)、医生整体评估(PGA)、银屑病患者生活质量表(DLQI)评分变化来评估疗效,并对其安全性进行分析。结果不同时间点患者PASI、PGA、DLQI评分差异均有统计学意义(均P<0.001)。第1周起PASI评分均显著低于基线评分(均P<0.05),PASI评分在4周内迅速下降,随着时间的增加总体呈下降趋势,均值减少的趋势符合线性变化(F=233.08,P<0.001);第8周起PGA评分均显著低于基线评分(均P<0.05),PGA评分在第3~16周内呈下降趋势,均值减少的趋势符合线性变化(F=81.04,P<0.001);第12周起DLQI评分均显著低于基线评分(均P<0.05),DLQI评分在2周内迅速下降,随着时间的增加总体呈下降趋势,均值减少的趋势符合线性变化(F=71.09,P=0.001)。谷草转氨酶(AST)、谷丙转氨酶(ALT)、谷氨酰转肽酶(r-GT)、白蛋白(ALB)、甘油三酯(TG)、胆固醇(CHOL)、低密度脂蛋白(LDL-C)、高密度脂蛋白(HDL-C)、尿酸(UA)、葡萄糖(GLu)、间接胆红素(IBIL)、直接胆红素(DBIL)、总胆红素(TBIL)、肌酐(SCr)在不同治疗时间的水平比较,均无统计学差异(均P>0.05)。所有患者治疗期间均未出现严重的药物不良反应。结论司库奇尤单抗在治疗伴肝功能异常的重度斑块型银屑病患者中疗效显著,对肝功能无明显影响,不良反应少。

Objective To observe the efficacy of secukinumab in the treatment of severe plaque psoriasis with abnormal liver function and the changes in liver function after the treatment.Methods Seven patients with severe plaque psoriasis with abnormal liver function were subcutaneously given secukinumab 300 mg/time,once-weekly from weeks 0 to 4,followed by once every 4 weeks.Routine blood test,liver and kidney functions,blood lipids and glucose were tested at weeks 1,2,3,and 4,and every 4 weeks thereafter until week 32.At the same time,the psoriatic lesion area and severity index(PASI),physician global assessment(PGA),and dermatology life quality index(DLQI)were recorded to assess the efficacy and safety.Results The PASI scores,PGA scores and DLQI were changed significantly from the baseline at all time points(P<0.001).The PASI scores were significantly lower than the baseline scores at week 1(all P<0.05)and rapidly declined in the first 4 weeks,with a linear decline over time(F=233.08,P<0.001).Similarly,PGA scores were significantly lower than the baseline scores after 8-week treatments(all P<0.05),with a linear decline from weeks 3 to 16(F=81.04,P<0.001).Moreover,DLQI scores rapidly declined in the first 2 weeks of treatment,with a significant decrease at week 12(all P<0.05).DLQI scores linearly declined over time(F=71.09,P=0.001).However,no significant changes were observed in liver function,blood lipid profile,blood glucose level and renal function at any time points following the treatments.All patients did not show serious adverse drug reactions during the treatment.Conclusion Secukinumab is effective and safe for patients with severe plaque psoriasis with abnormal liver function.