奈西雅注射剂预防化疗药物所致胃肠反应的临床研究

目的　观察奈西雅注射剂预防顺铂或 (和 )阿霉素引起的胃肠反应作用和毒副作用 ,并与康泉比较。方法　采用开放、多中心 ,中心内均衡随机 ,自身交叉对照方法。入选患者随机分为AB组或BA组 ,AB组第 1周期给予奈西雅 ,第 2周期给予康泉 ,BA组则相反。结果　收治患者 111例 ,可评价疗效 98例 ,其中顺铂组 6 1例 ,阿霉素组 37例。在化疗后 0～ 6h ,奈西雅对食欲不振、恶心、呕吐的控制率与康泉相似 ,但在 0～ 2 4h ,奈西雅对食欲不振的完全控制率 (38.8% )明显优于康泉(2 5 .5 % )。在 0～ 12h、0～ 18h、0～ 2 4h对恶心的改善作用 (73.6 %、71.4%、6 7.3% )也明显优于康泉(6 5 .3%、6 1.2 %、48% ,P <0 .0 5 ) ,提示奈西雅作用时间较康泉长。奈西雅在 0～ 2 4h对呕吐的抑制作用虽与康泉比较差异无显著性 ,但有效率前者 73.5 %高于后者 6 1.2 %。对顺铂组或阿霉素组化疗药所致食欲不振、恶心及呕吐的抑制作用 ,两药效果相似 ,差异无显著性。奈西雅不良反应轻 ,主要为头重感、头痛、口干、便秘等 ,其发生率与康泉相似。结论　奈西雅能有效预防化疗药物所致胃肠反应 ,其疗效与康泉相似 ,但作用时间较康泉长 ,不良反应轻 ,是良好的化疗止吐药。

Nasea injection in the prophylaxis of gastrointestinal reaction induced by chemotherapeutic agents]

Objective To evaluate the efficacy and side effects of nasea injection for the prophylaxis of gastrointestinal reactions induced by chemotherapeutic agents, and compare them with those of kytril.Methods A multicenter, open, randomized self crossover control trial was carried out. All the eligible patients were randomized into AB or BA group. The patients in AB group were treated by nasea in the first cycle and kytril in the second cycle, those in BA group were treated with the drugs in the reverse order. Results In patients enrolled in this study, 98 patients were evaluable for response, including 61 patients in DDP arm and 37 in ADM arm. Nasea was as effective as kytril in the control of anorexia, nausea and vomiting in the 0 6 hour period after chemotherapy. Nasea was significantly superior to kytril in the complete control of anorexia (38.8% vs 25.5%, P <0.05) in the 0 24 hour period. The overall control rate of nausea by nasea in the 0 12, 0 18, and 0 24 hour period was 73.6%, 71.4%, 67.3%, respectively, which was significantly higher than that by kytril (65.3%, 61.2%, 48%). Nevertheless, in the control of vomiting in the 0 24 hour period, no statistical difference between the two drugs was observed. Nasea and kytril were equally effective in the control of anorexia, nausea and vomiting induced by DDP and ADM. The side effects of nasea were head heaviness, headache, dry mouth and constipation, etc. All of these were mild and comparable with kytril in their frequencies.Conclusion Nasea can effectively prevent the gastrointestinal reaction induced by chemotherapeutic agents. The side effects of nasea are similar to those of kytril but its effect to alleviate gastrointestinal reactions is of longer duration.