某院PD-1免疫检查点抑制剂致不良反应的发生情况及分析

Occurrence of adverse reactions caused by PD-1 immune checkpoint inhibitors

目的分析本院PD-1免疫检查点抑制剂在临床应用中引起的不良反应情况。方法回顾性调查2015年1月1日至2021年3月31日在本院接受PD-1免疫检查点抑制剂治疗各类恶性肿瘤的患者病历,记录患者接受治疗期间发生的所有不良反应信息,并进行严重程度分级、相关性评价和影响因素分析。结果共记录212例患者共574次入院记录,99例患者发生共193次不良反应,主要有发热(11.3%)、白细胞降低(10.4%)、全身乏力(7.5%)、转氨酶升高(6.6%)、血小板降低(6.6%)、肺炎(6.6%)、恶心(6.6%)、皮疹(6.1%)、腹泻(6.1%)等。其中1~2级不良反应共141次(73.1%),相关性为肯定和很可能共28次(14.5%)。72例患者在不良反应发生后再次接受治疗,有15例出现了新的不良反应,23例再次出现了相同的不良反应。经分析,是否联合其他抗肿瘤药物对不良反应的发生率有显著影响。结论PD-1免疫检查点抑制剂引起的不良反应严重程度较轻,具有一定安全性,但不良反应较为多样化,需要及时发现。

Objective To analyze the adverse reactions caused by PD-1 immune checkpoint inhibitors.Methods We retrospectively analyzed the medical records of patients who received PD-1 immune checkpoint inhibitors for various malignant tumors in our hospital from January 1st,2015 to March 31st,2021,and recorded all adverse reactions that occurred during the treatment.Severity grading,correlation and influencing factors were measured.Results A total of 212 patients and 574 records were collected.Totally 99 patients had 193 adverse reactions,including fever(11.3%),leukopenia(10.4%),malaise(7.5%),and elevated transaminase(6.6%),thrombocytopenia(6.6%),pneumonia(6.6%),nausea(6.6%),rash(6.1%),and diarrhea(6.1%).Among them,there were 141 times(73.1%)of grade 1~2 adverse reactions,with likely affirmative correlation 28 times(14.5%).Totally 72 patients received second treatment after the adverse reaction,15 patients developed new adverse reactions,and 23 experienced the same adverse reactions again.There was a significant difference in the incidence of adverse reactions in combination with other anti-tumor drugs.Conclusion Adverse reactions caused by PD-1 immune checkpoint inhibitors are generally mild and safe,but the adverse reactions are diverse and need caution.