42例抗肿瘤药致重度骨髓抑制不良反应分析与警戒

Analysis and warning of adverse reactions of 42 cases of severe myelosuppression caused by antineoplastic drugs

目的分析抗肿瘤药致重度骨髓抑制药品不良反应(ADR)的发生特点与一般规律,为临床提供参考与警示。方法对2020年1月1日~2022年12月31日上报至国家药品不良反应监测中心的42例抗肿瘤药致重度骨髓抑制ADR报告按照肿瘤类型、肿瘤分期、治疗方案、个人危险因素、骨髓抑制类型、发生时间、预防措施等方面进行回顾性分析。结果42例ADR报告中,女24例(57.14%),男18例(42.86%),Ⅳ期肿瘤患者居多(78.57%),中年人(45~59岁)和老人(60~74岁)构成比最高(73.81%);给药途径以静脉给药居多(90.48%);66.67%患者ADR发生在用药后4~9 d;抗肿瘤治疗方案以2种细胞毒药物联合使用居多(47.62%),涉及药物构成比最多的为金属铂类药物(31.58%)和植物来源类药物(26.32%);14例(33.33%)患者具有预防使用人粒细胞集落刺激因子(G-CSF)指征,但均无使用;35例(83.33%)患者经治疗后痊愈或好转,3例患者未好转,4例患者死亡。结论需加强监测特殊人群及高风险药物,加强药学监护,必要时采取相应防范措施,以预防或减少重度骨髓抑制ADR的发生。

Objective To analyze the characteristics and regularities of adverse drug reactions(ADR)of severe myelosuppression caused by antineoplastic drugs in our hospital,provide reference and warning for clinical.Methods Totally 42 reports about ADR of severe myelosuppression caused by antineoplastic drugs reported to the national adverse drug reaction monitoring center between January 1,2020 to December 31,2022 were collected and retrospectively analyzed based on the tumor type,tumor stage,treatment plan,personal risk factors,myelosuppression type,occurrence time and preventive measures.Results Amon the 42 reports of ADR,24 females involved(57.14%)and 18 males involved(42.84%).Most of the tumor patients with staged IV(78.57%),the percentage of middle-aged(45~59 years old)and elderly(60~74 years old)was the highest(73.81%).Intravenous administration is the most common route of administration(90.48%).66.67%of ADRs occurred at 4~9 d after treatment.The combination of two cytotoxic drugs is the most common anti-tumor therapy(47.62%),the largest proportion involved were platinum drugs(31.58%)and plant-derived drugs(26.32%).14 patients(33.33%)had the indication of prophylactic administration of human granulocyte colony stimulating factor(G-CSF),but none of them were used.35 patients(83.33%)were cured or improved after treatment,3 patients did not improve,and 4 patients died.Conclusion Monitoring of special populations and high-risk drugs,pharmaceutical care should be strengthened.Take corresponding preventive measures when necessary,to prevent or reduce the occurrence of severe myelosuppression ADRs.