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重庆医科大学附属第一医院泌尿外科,重庆,400016
纸质出版日期:2014,
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杨 帆, 王德林, 吴小候, 等. 索拉非尼治疗25例晚期肾癌的长期不良反应研究[J]. 重庆医科大学学报, 2014,38(6):832-836.
Yang Fan, Wang Delin, Wu Xiaohou, et al. Long-term adverse reaction of sorafenib in the treatment of advanced renal cell carcinoma in 25 cases[J]. Journal of Chongqing Medical University, 2014,38(6):832-836.
目的:了解索拉非尼治疗晚期肾细胞癌(renal cell carcinoma,RCC)患者长期不良反应,评估其对患者预后的预测作用。方法:25例晚期RCC患者口服索拉非尼,观察其不良反应的发生、分级及转归,并采用Kaplan-Meier单因素分析其对患者预后预测作用。结果:25例晚期RCC患者随访6~59月,中位随访时间23.8月。不良反应出现在1~8周,中位不良反应发生时间3周。常见不良反应发生率:高血压48%、贫血36%、疲乏44%、腹泻40%、皮疹40%、手足综合征56%,体质量减轻、恶心、厌食、疼痛、脱发等不良反应少见,多为Ⅰ、Ⅱ级。76%患者对症处理后,部分不良反应症状减轻或消失,中位时间20周,20%患者反应较轻,4%患者反应较重,药物减量后不良反应减轻。高血压的患者较未发生高血压的患者中位总生存期(overall survival,OS)及无进展生存时间(progression-free survival,PFS)明显缩短(OS:P=0.005;PFS:P=0.049)。结论:索拉非尼治疗RCC不良反应发生较早,长期使用大部分不良反应可以耐受,高血压对患者生存期有预测作用。
Objective:To investigate the long-term adverse effects of sorafenib on patients suffering from renal cell carcinoma(RCC) and to evaluate its predictive effects on survival time of patients with RCC. Methods:The occurrence,grading and prognosis of adverse effects of 25 advanced RCC patients treated by sorafenib were recorded and their predictive effects on survival time of patients were evaluated by Kaplan-Meier estimator. Results:According to 6-59 months’ follow-up;median follow-up of 23.8 months with 25 advanced RCC patients,the adverse effects appeared in 1-8 weeks;medium follow-up of 3 weeks. The common adverse reactions were hypertension(48%),anemia(36%),fatigue(44%),diarrhea(40%),skin rash(40%),and PPE(56%). The relatively rare adverse reactions were mostly between level Ⅰ and level Ⅱ,including weight loss,nausea,anorexia,pain,and hair loss,etc. After the symp-tomatic treatment,the symptoms of 76% patients were partly relieved or disappeared,median relieving period of 20 weeks,20% pa-tients got relatively mild adverse reaction while 4% patients got relatively severe adverse reaction. The adverse effects were relieved after reducing medicine dose. The overall survival and progression-free survival of patients with hypertension were significantly shorter than those without hypertension(P=0.005;PFS:P=0.049). Conclusion:The adverse effect appears at early period of patients with advanced RCC when taking sorafenib and most adverse effects are acceptable in long-term medicating for patients. Hypertension might have a predictive effect on survival period of patients.
肾肿瘤索拉非尼药物副反应疗效预测
kidney neoplasmssorafenibadverse drug reactionscurative effects
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