目的分析顺铂致癌症患者严重不良反应的临床表现并探讨其影响因素。方法收集国家药品不良反应监测中心2009年1月1日至2010年12月31日收到的顺铂致严重不良反应报告进行回顾性分析。将患者分为老年组(≥60岁)和非老年组(18~59岁),比较2组患者性别与年龄分布、肿瘤发生部位、用药后发生严重不良反应的时间、临床表现、顺铂剂型、剂量、合并用药情况及转归。将老年组患者进一步分为60~69岁组和70~79岁组,对有统计学意义的因素进行亚组分析。结果共收集到顺铂致严重不良反应报告228份,涉及228例患者。老年组103例,男性72例(69.9%),女性31例(30.1%),平均年龄(67±5)岁;非老年组125例,男性59例(47.2%),女性66例(52.8%),平均年龄(48±9)岁。老年组男性构成比高于非老年组(χ~2=11.907,P=0.001)。2组患者均以呼吸系统肿瘤占比居首位,但老年组占比高于非老年组(χ~2=8.512,P=0.004)。老年组泌尿生殖系统肿瘤占比低于非老年组(χ~2=8.759,P=0.003)。2组用药后出现严重不良反应时间的差异有统计学意义(χ~2=-2.545,P=0.011)。2组患者使用顺铂粉针剂与注射剂的差异无统计学意义。老年组用药剂量为10~140 mg/d,非老年组为10~420 mg/d,差异有统计学意义(P=0.011)。老年组多合并应用吉西他滨、依托泊苷、多西他赛等,合并用药种数的中位数为0种(四分位间距0~1);非老年组多合并应用紫杉醇、吉西他滨、多西他赛等,合并用药种数的中位数为1种(四分位间距1~1),差异有统计学意义(P=0.032)。应用顺铂后出现的严重不良反应主要为骨髓抑制和白细胞减少。老年组出现骨髓抑制和白细胞计数减少者分别为50例(48.5%)和24例(23.3%);非老年组分别为69例(55.2%)和24例(19.2%),差异无统计学意义。老年组有2例患者出现肾功能损伤,非老年组有2例患者出现QT间期延长。经停药和对症治疗后,老年组严重不良反应治愈、好转、留有后遗症和死亡者分别为27例(26.2%)、72例(69.9%)、3例(2.9%)和1例(1.0%);非老年组分别为38例(30.4%)、83例(66.4%)、3例(2.4%)和1例(0.8%),差异无统计学意义。老年组70~79岁亚组男性构成比(87.1%)高于60~69岁亚组(62.5%),差异有统计学意义(χ~2=6.232,P=0.013)。2个亚组用药剂量和合并用药数量差异均无统计学意义。结论老年和非老年癌症患者使用顺铂所致严重不良反应相似。老年男性、特别是70~79岁老年男性癌症患者是应用顺铂后易出现严重不良反应的高危人群。 Objective To analyze the clinical manifestations of serious adverse reactions in patients with cisplatin-induced cancer and explore the influencing factors. Methods A retrospective analysis of serious adverse reactions caused by cisplatin received from the National Adverse Drug Reaction Monitoring Center from January 1, 2009 to December 31, 2010 was collected. The patients were divided into the elderly group (≥60 years old) and the non-elderly group (18-59 years old). The gender and age distribution, tumor location, time of severe adverse reactions after treatment, clinical manifestations, , Dosage, combined medication and outcome. The elderly patients were further divided into 60 to 69 years old group and 70 to 79 years old group, and statistically significant factors were analyzed subgroups. Results A total of 228 serious adverse reactions were reported in cisplatin, involving 228 patients. There were 103 cases in the elderly group, including 72 males (69.9%) and 31 females (30.1%), with an average age of 67 ± 5 years; 125 females, 59 males (47.2%) and 66 females (52.8% ), Mean age (48 ± 9) years old. The male ratio in the elderly group was higher than that in the non-elderly group (χ ~ 2 = 11.907, P = 0.001). The proportion of patients with respiratory system tumors in both groups ranked first, but the proportion of elderly patients was higher than that of non-elderly patients (χ ~ 2 = 8.512, P = 0.004). The proportion of genitourinary tumors in the elderly group was lower than that in the non-elderly group (χ ~ 2 = 8.759, P = 0.003). There were significant differences in the time of serious adverse reactions between the two groups (χ ~ 2 = -2.545, P = 0.011). There was no significant difference between the two groups in the use of Cisplatin injection and injection. The dosage of the elderly group was 10 ~ 140 mg / d, while the non-elderly group was 10 ~ 420 mg / d, the difference was statistically significant (P = 0.011). Elderly group combined gemcitabine, etoposide, docetaxel, etc., the median drug combination was 0 species (interquartile range 0 ~ 1); non-elderly group combined with paclitaxel, gemcitabine, He and other race, the median number of combinations of drugs for a species (interquartile range 1 ~ 1), the difference was statistically significant (P = 0.032). Serious adverse reactions after cisplatin are mainly myelosuppression and leukopenia. There were 50 (48.5%) and 24 (23.3%) patients with bone marrow suppression and white blood cell count reduction in the elderly group, 69 (55.2%) and 24 (19.2%) in the non-elderly group, respectively, with no significant difference . Renal impairment occurred in 2 patients in the elderly group and 2 patients in the non-elderly group had QT prolongation. After discontinuation and symptomatic treatment, serious adverse reactions were cured and improved in the elderly group, with 27 cases (26.2%), 72 cases (69.9%), 3 cases (2.9%) and 1 case %). There were no significant differences in 38 cases (30.4%), 83 cases (66.4%), 3 cases (2.4%) and 1 case (0.8%) in the non-elderly group. The proportion of male in the age group of 70-79 years old was higher than that in the group of 60-69 years old (87.1%) (62.5%). The difference was statistically significant (χ ~ 2 = 6.232, P = 0.013). There was no significant difference in the dosage of the two subgroups and the number of the combination medication. Conclusion The serious side effects caused by cisplatin in elderly and non-elderly cancer patients are similar. Elderly men, especially 70 to 79-year-old male cancer patients are at high risk of serious adverse reactions after cisplatin.