甲磺酸伊马替尼治疗胃肠间质瘤毒副作用的深化研究

Further study on the side effects of imatinib for patients with gastrointestinal stromal tumors

目的进一步观察甲磺酸伊马替尼治疗胃肠间质瘤（GIST）患者的毒副反应。方法入组128例患者,均口服甲磺酸伊马替尼剂量400mg/天,病情进展患者部分加量至600mg/天。自服药起观察毒副反应,直至患者死亡或随访结束。结果甲磺酸伊马替尼毒副反应多发生于治疗的最初1年内,大多数长期服药患者的毒副反应发生率及严重程度增加不显著。常见毒副反应多为1~2级,高剂量组毒副反应未见明显增加。新观察到的毒副反应包括记忆力下降、语言迟缓、阴囊水肿、指甲凸凹不平、皮下瘀斑、肾病综合征样表现,未出现消化道大出血及肿瘤溶解综合征。原发部位、剂量水平、有无肝转移对毒副反应的发生率无显著影响（P〉0.05）;性别和年龄对毒副反应的发生率有显著影响（P〈0.05）。结论甲磺酸伊马替尼毒副反应轻微,患者耐受性较好,但药物说明书和文献未提及的毒副反应尤其值得关注。

Objective To observe the side effects of imatinib in the treatment of patients with gastrointestinal stromal tumors（GIST） furtherly.Methods One hundred and twenty-eight patients received imatinib mesylate 400mg/day,and dosage in some patients with disease progression increased to 600mg/day.The incidence of toxicity since patients received treatment was observed until death or at the end of follow-up.Results The side effects often occurred in the first year of treatment,and the rate of toxicities and its severity did not increase remarkably in long-term.The side effects were mostly grade 1-2,which did not increase significantly in high-dose arm.Some new side effects,such as memory decline,language delay,scrotal edema,uneven nails,subcutaneous ecchymosis and nephrotic syndrome were observed.The performance of gastrointestinal bleeding and tumor lysis syndrome were not observed.Original tumor site,dose level,with or without liver metastasis had no effect on the incidence of side effects（P0.05）,while sex and age to some extent affected the incidence of side effects,such as women got a high incidence of neutropenia（P0.05） and elderly patients were easy to be fatigue（P0.05）.Conclusion The side effects were mild and tolerable;but that were not mentioned by package insert and literature worth particular concern.