预防性使用盐酸西替利嗪治疗PD-1抑制剂所致斑丘疹的多中心随机对照研究

Prophylactic use of cetirizine hydrochloride on macular papules caused by PD-1inhibitors:A multicenter randomized controlled trial

目的 探讨盐酸西替利嗪片预防性治疗PD-1抑制剂所致常见斑丘疹的临床疗效。方法 选择2020年7月—2021年12月于深圳大学第三附属医院、中国科学院大学宁波华美医院和丽水市中心医院收治的60例适合PD-1抑制剂治疗的肿瘤患者。随机分为预防用药组和治疗用药组,每组各30例。预防用药组在给予PD-1抑制剂治疗的当天同步口服盐酸西替利嗪片,每晚10 mg/次,每疗程连续7 d,7 d内未出现斑丘疹则停止使用,如在预防用药期间出现斑丘疹,则继续口服直到斑丘疹好转停药。治疗用药组使用PD-1抑制剂治疗期间出现1级或以上级斑丘疹,则开始口服盐酸西替利嗪片,每晚10mg/次,每疗程使用的时间为出现1级或以上级斑丘疹开始口服盐酸西替利嗪片至斑丘疹级别小于1级的用药天数,观察4个疗程。比较治疗前后两组患者斑丘疹发生情况,斑丘疹发生后服用盐酸西替利嗪片天数,不同PD-1抑制剂斑丘疹发生情况。结果 治疗后,盐酸西替利嗪片预防用药组斑丘疹发生率(6.7%)显著低于治疗用药组发生率(26.7%,P<0.05)。斑丘疹发生后,预防用药组较治疗用药组用药天数减少(P<0.05)。使用同种PD-1抑制剂中,预防用药组斑丘疹发生率明显低于治疗用药组(P<0.05)。结论 预防性使用盐酸西替利嗪片对PD-1抑制剂所致常见斑丘疹具有较好的预防作用,能显著降低斑丘疹发生率及斑丘疹发生后盐酸西替利嗪片的用药天数。

Objective To investigate the clinical effect of prophylactic treatment of common macular papules caused by PD-1inhibitors with Cetirizine Hydrochloride Tablets. Methods Patients(60 cases) with macular papules in the multicenter of the Third Affiliated Hospital of Shenzhen University, Hwa Mei Hospital, University of Chinese Academy of Sciences and Lishui Municipal Central Hospital from July 2020 to December 2021 were randomly divided into preventive(30 cases) and therapeutic(30 cases) group.Patients in the preventive group were administered with PD-1 inhibitors synchronously with Cetirizine Hydrochloride Tablets, 10mg/per night for 7 consecutive days, for each course, and the use was stopped if no macular papules appeared within 7 d, if macular papules occur during prophylaxis, continue oral administration until macular papules improve. In the therapeutic group, if grade 1 or superior macular papules occurred during the treatment with PD-1 inhibitors, cetirizine hydrochloride tablets were taken orally for 10mg/per night. The number of days in each course of treatment was grade 1 or from superior macular papules to macular papules less than grade 1. 4 courses of treatment were observed. The days of administration of cetirizine hydrochloride tablets after the occurrence of maculopapular rash, the occurrence of maculopapular rash among different PD-1 inhibitors in two groups before and after treatment were compared. Results After treatment, the incidence of macular papules in the cetirizine hydrochloride preventive group(6.7%)was significantly lower than that in the therapeutic group(26.7%, P < 0.05). After the occurrence of macular papule, the days of treatment in the preventive group were less than those in the treatment group(P < 0.05). Among the same PD-1 inhibitors, the incidence of maculopapular rash in the preventive medication group was significantly lower than that in the therapeutic medication group(P <0.05). Conclusion Prophylactic use of Cetirizine Hydrochloride Tablets has a good preventive effect on common macular papules caused by PD-1 inhibitors, and can significantly reduce the incidence of macular papules and the days of cetirizine hydrochloride tablets after macular papules.