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作 者:王宏羽[1] 张湘茹[1] 孙燕[1] 李峻岭[1] 王燕[1] 胡兴胜[1] 王彬[1] 王惠杰[1] 屈风莲[1] 罗健[1] 马飞[1] 张和平[1]
机构地区:[1]中国医学科学院中国协和医科大学肿瘤医院内科,北京100021
出 处:《癌症进展》2004年第6期472-477,共6页Oncology Progress
摘 要:目的 观察盐酸托烷司琼注射液(THI)防治NP长春瑞宾(NVB)+顺铂(PDD)方案治疗非小细胞肺癌引起胃肠道反应的止吐作用和安全性,并与欧必亭相对比。方法 应用随机、双盲、自身交叉对照试验,22例NSCLC患者随机分为AB组和BA组,22例可评价疗效和不良反应。AB组:盐酸托烷司琼(第1周期)→欧必亭(第2周期);BA组:欧必亭(第1周期)→盐酸托烷司琼(第2周期)。结果 化疗d1-6,盐酸托烷司琼对化疗药物引起食欲不振的完全控制率分别为70%、40%、10%、20%、25%、35%;欧必亭分别为70%、45%、30%、5%、20%、30%;盐酸托烷司琼对恶心的完全控制率分别为60%、30%、10%、0%、15%、25%;欧必亭分别为50%、35%、10%、0%、10%、25%;盐酸托烷司琼对化疗药物引起呕吐的完全控制率分别为95%、65%、40%、40%、50%、55%;欧必亭分别为70%、75%、40%、35%、45%、55%;所有P值均>0.05。化疗第d1-6,盐酸托烷司琼的不良反应头痛、头晕、失眠、焦虑不安、口干的发生率分别为4.76%、0%、9.52%及4.76%;欧必亭分别为0%、5%、0%及4.76%,两组头晕发生率P<0.05,即盐酸托烷司琼、欧必亭头晕不良反应发生率差异有统计学意义,其余的不良反应两药发生率相似,P>0.05,差异无统计学意义。结论 盐酸托烷司琼在控制?<abstract>jective To study the efficacy and safety of tropisetron hydrochloride injection (THI) in prevention of PDD and NVB induced nausea and vomiting in comparison with navoban. Methods Randomised double blind crossover study comparing THI and navoban 22 patients were enrolled. THI or navoban was administered before in the first cycle of chemotherapy, and cross-over to the other antiemetic agent in the second cycle of the same chemotherapy. Results Twenty two patients were evaluated adverse effects and response. The complete controlof anorexia of THI was 70% , 40% , 10% , 20% , 25% and 35% respectively during d1-6, navoban was 70% , 45% , 30% , 5% , 20% and 30% respectively; the complete control of nausea of THI was 60%, 30%, 10%, 0%, 15% and 25% respectively; navoban waw 50%, 35%, 10%, 0%, 10% and 25% respectively; the complete control of vomiting of the THI was 95% , 65% , 40% , 40% , 50% and 55% respectively; navoban was 70%, 75%, 40%, 35%, 45% and 55% respectively. The complete control of anorexia nausea and vomiting was no significant difference between THI and navoban. P > 0.05. The incidence of headache, dizziness, anxiety and thirst of THI was 4.76% , 0% , 9.52% and 4.76% respectively during dl-6, navoban was 0% , 5% , 0% and 4.76% respectively; the incidence of dizziness was significant difference between the two antiemetic agents, P < 0.05, the other frequent adverse events were similar, and there was no significant difference between the two antiemetic agents, P > 0.05. Conclusion Tropise-tron hydrochloride injection was similar to navoban for the prevention of PDD and NVB induced nausea and vomiting in the trement of NSCLC. It was safe and effective in control of highly emetogenic drugs, the incidence of its adverse effects were mild and well tolerated.
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