阿达木单抗治疗克罗恩病患者的有效性和安全性观察

Efficacy and safety of adalimumab in patients with Crohn′s disease

目的初步观察阿达木单抗治疗克罗恩病患者的有效性及安全性。方法回顾性分析2020年1月—2021年8月于东南大学附属中大医院使用阿达木单抗的41例克罗恩病患者, 收集患者的一般临床资料、实验室检查、内镜及影像学检查结果, 同时评估基线及用药12周、24周、48周疾病活动情况及不良事件发生情况。阿达木单抗每2周皮下注射给药1次, 按照160 mg/第1次、80 mg/第2次、此后每次40 mg的剂量用药。结果阿达木单抗用药后12周、24周、48周的临床缓解率分别为43.9%(18/41)、60.6%(20/33)、60.9%(14/23), 临床应答率分别为75.6%(31/41)、69.7%(23/33)、56.5%(13/23)。12周、24周、48周的内镜下缓解率分别为4/14、2/6、1/4, 有1/14患者在用药24周达到黏膜愈合。原发性失应答率为17.1%(7/41), 继发性失应答率为14.6%(6/41)。不良反应发生率为9.8%(4/41)。结论阿达木单抗能有效地缓解克罗恩病患者的临床症状及肠内疾病活动, 值得广泛使用。病程<2年、无英夫利西用药史、基线简化CD活动指数评分(HBI)低、疗程长的患者疗效可能会更好。

Objective To assess the effectiveness and safety of adalimumab in Crohn′s disease(CD)patients.Methods We retrospectively reviewed the charts of 41 CD patients who received adalimumab in Zhongda Hospital Southeast University from January 2020 to August 2021.General clinical data,laboratory results,endoscopy and radiologic findings were collected,meanwhile,disease activity and safety events were evaluated at baseline and at 12,24 and 48 weeks of administration.Adalimumab was given subcutaneously once every 2 weeks in doses of 160 mg for the first time,80 mg for the second time,and 40 mg for each subsequent time.Results The clinical remission rates at 12,24,and 48 weeks of treatment were 43.9%(18/41),60.6%(20/33),60.9%(14/23),and the clinical response rates were 75.6%(31/41),69.7%(23/33),and 56.5%(13/23),respectively.The proportion of endoscopic remission at 12,24 and 48 weeks were 4/14,2/6,1/4 in patients undergoing endoscopy,and 1/14 patients achieved mucosal healing at 24 weeks.Primary nonresponse rate(PNR)was 17.1%(7/41),loss of response(LOR)rate was 14.6%(6/41).The incidence of adverse reactions was 9.8%(4/41).Conclusion Adalimumab can effectively relieve the clinical symptoms and intestinal disease activities of Crohn′s disease,and deserves to be popularized clinically.Patients with disease course<2 years,first-line biologics,low baseline HBI score,and longer duration of medication may have better results.