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国家卫生健康委员会
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单位:830011乌鲁木齐,新疆医科大学附属肿瘤医院消化内科
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【摘要】目的 比较伊立替康联合替吉奥与紫杉醇联合替吉奥作为二线化疗方案治疗晚期胃癌的临床效果及安全性。方法 选取2016年1月至2018年1月新疆医科大学附属肿瘤医院收治的晚期胃癌患者80例,均接受含铂类一线化疗失败,按照随机数字表法分为观察组和对照组,各40例。对照组患者予以紫杉醇联合替吉奥治疗,观察组予以伊立替康联合替吉奥治疗,以21 d为1个疗程。治疗1个疗程后1周,比较2组患者肝肾功能损伤程度、神经毒性及脱发情况和骨髓抑制反应情况;治疗2个疗程后1周,比较2组患者客观缓解率、疾病控制率及消化道反应发生情况;随访1年,比较2组患者远期疗效。结果 治疗1个疗程后1周,2组患者肝功能、肾功能损伤程度比较,差异均无统计学意义(均P>0.05),观察组患者神经毒性反应和脱发程度轻于对照组,白细胞减少程度重于对照组,差异均有统计学意义(均P<0.01),2组患者贫血及血小板减少程度比较,差异均无统计学意义(均P>0.05)。治疗 2个疗程后1周,观察组患者腹泻、恶心呕吐、胆碱能综合征程度均明显重于对照组,差异均有统计学意义(均P<0.01),2组患者客观缓解率及疾病控制率比较,差异均无统计学意义(均P>0.05)。随访1年,对照组和观察组患者1年生存率、平均生存时间及平均无进展生存时间比较[40.0%(16/40)比42.5%(17/40)、(6.6±1.3)个月比(6.7±1.3)个月、(9.4±1.3)个月比(9.3±1.2)个月],差异均无统计学意义(均P>0.05)。结论 伊立替康联合替吉奥与紫杉醇联合替吉奥治疗接受含铂类一线化疗方案失败的晚期胃癌患者,均有较好疗效,2种化疗方案的客观缓解率与疾病控制率相似,远期疗效相近。伊立替康联合替吉奥治疗的不良反应主要为骨髓抑制、腹泻和胆碱能综合征,紫杉醇联合替吉奥治疗的不良反应主要为神经毒性反应和脱发。
【Abstract】Objective To compare the clinical efficacy and safety of irinotecan combined with tegafur and paclitaxel combined with tegafur as second-line treatment for advanced gastric cancer. Methods Eighty patients with advanced gastric cancer who failed in first-line platinum chemotherapy were enrolled in Tumor Hospital Affiliated to Xinjiang Medical University from January 2016 to January 2018. The patients were randomly divided into observation group and control group, with 40 cases in each group. The control group was treated with paclitaxel plus tegafur; the observation group was treated with irinotecan plus tegafur; 1 course of chemotherapy lasted for 21 days. One week after 1 course of treatment, occurrences of hepatic and renal dysfunction, neurotoxicity, alopecia and bone marrow suppression were observed. One week after 2 courses of treatment, objective response rate, disease control rate and gastrointestinal adverse reactions were analyzed. Long-term efficacy was observed during 1 year follow-up. Results One week after 1 course of treatment, there was no significant difference in hepatic and renal dysfunction between groups(P>0.05); neurotoxicity and alopecia were much severer in control group while leukopenia was much sever in observation group(P<0.05); anemia and thrombocytopenia in observation group were comparable to those in control group(P>0.05). One week after 2 courses of treatment, occurrences of diarrhea, nausea and vomiting, cholinergic syndrome in observation group were significantly sever than those in control group(all P<0.05). There were no significant differences of the objective response rate and disease control rate between groups(both P>0.05). There were no significant differences of the 1-year survival rate, median survival time and median progression-free time between control group and observation group[40.0%(16/40) vs 42.5%(17/40), (6.6±1.3)months vs (6.7±1.3)months, (9.4±1.3)months vs (9.3±1.2)months](all P>0.05). Conclusions In patients with advanced gastric cancer who failed in first-line platinum-based chemotherapy, irinotecan and paclitaxel combined with tegafur show equal short-term response rate, disease control rate and long-term results. Adverse reactions of irinotecan are mainly myelosuppression, diarrhea and cholinergic syndrome; the main adverse reactions of paclitaxel are neurotoxicity and alopecia.
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