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目的探讨替吉奥单药口服治疗老年晚期胃癌的近期临床疗效及不良反应。方法选取120例老年晚期胃癌患者,随机分为替吉奥组和对照组,每组各60例。替吉奥组患者给予替吉奥胶囊40~60 mg,2次/d,第1~14天,休息7 d,即每21天一个周期,至少完成2个周期,每2个周期评估1次疗效;对照组患者给予奥沙利铂130 mg/m~2,泵入2 h,第1天,替吉奥胶囊按照80 mg/(m~2·d),分2次,第1~14天,休息7 d,即每21天一个周期,至少完成2个周期评估疗效。不良反应处理同替吉奥组。按RECIST 1.1标准评价客观疗效,按WHO标准评价不良反应。结果替吉奥组中CR 0例,PR 16例,客观有效率26.67%;对照组中CR 0例,PR 20例,客观有效率33.33%。两组有效率比较差异无统计学意义(P>0.05);两组化疗不良反应主要包括:血液学毒性、恶心呕吐、周围神经毒性。血液学毒性方面:替吉奥组患者的白细胞减少、血小板下降、血红蛋白减少发生率(分别为:46.67%、16.67%、26.67%)均低于对照组(分别为:80.00%、43.33%、56.67%),差异有统计学意义(P<0.05)。恶心呕吐、周围神经毒性方面:替吉奥组发生率(分别为:40.00%、3.33%)低于对照组发生率(分别为:73.33%、36.67%),差异有统计学意义(P<0.05)。结论单药口服替吉奥胶囊相较于联合奥沙利铂治疗老年晚期胃癌,近期疗效肯定,不良反应发生率较低,值得进一步研究应用。
Objective To investigate the short-term clinical efficacy and adverse reactions of oral administration of tioguanoside in the treatment of elderly patients with advanced gastric cancer. Methods A total of 120 elderly patients with advanced gastric cancer were enrolled in this study. They were randomly divided into two groups, 60 patients in each group. Patients in the group of Teglitazumab were treated with TegGIO capsules 40-60 mg twice a day for days 1-14 and for a rest 7 days, ie one cycle every 21 days, at least 2 cycles completed, and once every 2 cycles The patients in the control group were given Oxaliplatin 130 mg / m ~ 2 and pumped for 2 h. On the first day, the control group was given 80 mg / (m ~ 2 · d) Day, rest for 7 days, that is, every 21 days for a cycle, at least 2 cycles to complete the assessment of efficacy. Adverse reactions to treatment with the same group. According to RECIST 1.1 standard objective evaluation of efficacy, according to WHO standard evaluation of adverse reactions. Results There were 0 cases in CR and 16 cases in PR, the objective response rate was 26.67%. CR 0 cases and PR 20 cases in control group were objectively effective rate 33.33%. There was no significant difference in the effective rate between the two groups (P> 0.05). The adverse reactions in the two groups included hematologic toxicity, nausea and vomiting, and peripheral neurotoxicity. In the area of hematologic toxicity, leukopenia, thrombocytopenia and hemoglobin decrease (46.67%, 16.67%, 26.67%, respectively) in patients in treatment group were lower than those in control group (80.00%, 43.33%, 56.67 %), The difference was statistically significant (P <0.05). The incidence of nausea and vomiting and peripheral neurotoxicity were lower than that of control group (40.00% and 3.33% respectively) (P <0.05 for the control group, 73.33% and 36.67%, respectively) ). Conclusions Compared with oxaliplatin combined with oxaliplatin in the treatment of elderly patients with advanced gastric cancer, the single-agent oral administration of tegaserod has certain curative effect in the near future and low incidence of adverse reactions, which deserves further study and application.