沙利度胺预防非小细胞肺癌GP方案化疗所致延迟性恶心呕吐的效果观察

目的 观察沙利度胺对晚期非小细胞肺癌(NSCLC)使用高致吐性化疗药物(顺铂)化疗所致的恶心、呕吐的预防作用.方法 采用随机对照研究方法,将61例晚期NSCLC患者随机分为对照组(31例)和试验组(30例).采用相同的化疗方案:吉西他滨1000 mg/m~2,第1、8天;顺铂75mg/m~2,第1天.对照组使用的止吐方案为雷莫司琼0.3 mg+甲氧氯普胺20 mg,分别于化疗前30min静脉推注和肌肉注射.试验组在对照组的基础上加用沙利度胺50 mg口服,2次/d,第1～5天.结果 试验组和对照组急性恶心的有效率分别为90.0%和74.2%,急性呕吐的有效率分别为93.3%和90.3%,两组差异均无统计学意义(P=0.108,P=1.000).试验组和对照组化疗所致延迟性恶心的有效率分别为56.7%和19.4%,延迟性呕吐的有效率分别为76.7%和48.4%,试验组均高于对照组(P=0.003,P=0.023).试验组和对照组的不良反应均较轻,嗜睡、乏力、便秘、头痛和皮疹的发生率差异均无统计学意义(均P>0.05).结论 沙利度胺预防高致吐性药物引起的延迟性恶心、呕吐疗效显著,不良反应轻微.

The effect of thalidomide in preventing delayed nausea and vomiting induced by GP regimen of chemotherapy for non-small cell lung cancer

Objective To observe the effect of thalidomide in preventing nausea and vomiting induced by emetogenic cisplatin(CDDP)chemotherapy in patients with advanced non-small cell lungcancer.Methods This study was carried out as a prospective.randomized control clinical trim.61 patients with advanced non-small cell lung cancer were scheduled to receive chemotherapy(gemcitabin 1 000 mg/m~2 i.v.gtt d1,8 and CDDP 75 mg/m~2 i.v.gtt d1,GP regimen).The patients were randomly divided into a treatment and control groups.All patients in both groups received ramosetron 0.3 mg intravenously(i.V.) and metoclopramide 20 mg intramuscularly(i.m.)30 min prior to chemotherapy to prevent nausea andemesis on day 1.In the treatment group.addition of thalidomide(50 mg P.0.bid)were administered on days 1 to 5 after the start of chemotherapy.Results Acute nausea was effectively controlled in 74.2%of the patients in the control group and in 90.0%oftreatment group.Acute vomiting was effectively controlled in 90.3%of the patients in the control group and in 93.3%of treatment group.No statistically significant differences showed in effective control of acute nausea and vomiting between the 2 groups(P=0.108;P=1.000).Delayed nausea was effectively controlled in 19.4% of the patients in control group and in 56.7% in the treatment group.Delayed vomiting was effectively controlled in 48.4% of the patients in control group and 76.7%in treatment group.Statistically there was a significant differences in effective control of delayed nausea and vomiting between the 2 groups(P=0.003,P=0.023).Both antiemetic regimens were well tolerated.and no significant difference was observed in adverse events between the 2 groups(P>0.05).Conclusion Our results demonstrate that thalidomide is hishly effective in controlling delayed nausea and vomiting episodes in patients induced by moderately emetogenic chemotherapy.Moreover,no serious toxic effects arc induced by this treatment.