目的 探討鹽酸西替利嗪片預防性治療PD-1抑制劑所致常見斑丘疹的臨床療效。方法 選擇2020年7月—2021年12月于深圳大學第三附屬醫(yī)院、中國科學院大學寧波華美醫(yī)院和麗水市中心醫(yī)院收治的60例適合PD-1抑制劑治療的腫瘤患者。隨機分為預防用藥組和治療用藥組，每組各30例。預防用藥組在給予PD-1抑制劑治療的當天同步口服鹽酸西替利嗪片，每晚10mg/次，每療程連續(xù)7d，7d內(nèi)未出現(xiàn)斑丘疹則停止使用，如在預防用藥期間出現(xiàn)斑丘疹，則繼續(xù)口服直到斑丘疹好轉(zhuǎn)停藥。治療用藥組使用PD-1抑制劑治療期間出現(xiàn)1級或以上級斑丘疹，則開始口服鹽酸西替利嗪片，每晚10mg/次，每療程使用的時間為出現(xiàn)1級或以上級斑丘疹開始口服鹽酸西替利嗪片至斑丘疹級別小于1級的用藥天數(shù)，觀察4個療程。比較治療前后兩組患者斑丘疹發(fā)生情況，斑丘疹發(fā)生后服用鹽酸西替利嗪片天數(shù)，不同PD-1抑制劑斑丘疹發(fā)生情況。結(jié)果 治療后，鹽酸西替利嗪片預防用藥組斑丘疹發(fā)生率（6.7%）顯著低于治療用藥組發(fā)生率（26.7%，P＜0.05）。斑丘疹發(fā)生后，預防用藥組較治療用藥組用藥天數(shù)減少（P＜0.05）。使用同種PD-1抑制劑中，預防用藥組斑丘疹發(fā)生率明顯低于治療用藥組（P＜0.05）。結(jié)論 預防性使用鹽酸西替利嗪片對PD-1抑制劑所致常見斑丘疹具有較好的預防作用，能顯著降低斑丘疹發(fā)生率及斑丘疹發(fā)生后鹽酸西替利嗪片的用藥天數(shù)。

Objective To investigate the clinical effect of prophylactic treatment of common macular papules caused by PD-1 inhibitors 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, 10 mg/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 10 mg/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.

R986

CSCO—麗珠中醫(yī)藥腫瘤研究基金資助項目（Y-L2019-13）