奈西雅崩解片预防抗肿瘤药物所致急性胃肠反应的临床研究  

Nasea disintegrating buccal tablet in the prevention of gastrointestinal reaction induced by anticancer drugs

作　　者：张频[1] 冯奉仪[1] 何友兼[2] 李宇红[2] 周美珍[3] 程刚[3] 陈岩[3] 

机构地区：[1]中国医学科学院中国协和医科大学肿瘤研究所肿瘤医院,北京100021 [2]中山医科大学肿瘤医院 [3]卫生部北京医院

出　　处：《中华肿瘤杂志》2002年第5期504-507,共4页Chinese Journal of Oncology

摘　　要：目的　观察奈西雅口内崩解片 (OD片 )预防顺铂或阿霉素所致胃肠反应的疗效和安全性 ,并与凯特瑞片进行对照。方法　采用开放、多中心随机自身交叉对照方法。入选患者按照随机表随机分为AB或BA组。AB组第 1周期含服奈西雅OD片 0 .1mg ,第 2周期口服凯特瑞片 2mg ;BA组则相反。结果　入选患者 73例 ,其中顺铂组 4 4例 ,阿霉素组 2 9例。可评价疗效病例 6 2例 ,可评价安全性病例 70例。在化疗后 0～ 2 4h ,奈西雅OD片控制食欲不振、恶心、呕吐的有效率分别为 74 .2 %、77.4 %和 83.9% ,凯特瑞片为 74 .2 %、71.0 %和 88.7% ,两者相似。在控制顺铂所致呕吐反应中 ,奈西雅OD片和凯特瑞片均显示了较高的疗效 ,其对呕吐的完全控制率分别为 83.3%和 86 .1% ,有效率分别为 91.7%和 97.2 %。奈西雅OD片不良反应轻 ,主要为头重、口干、嗜睡 ,为一过性 ,其发生率与凯特瑞片相似。结论　奈西雅OD片能有效预防抗肿瘤药物所致的胃肠反应 。Objective To evaluate the efficacy and safety of nasea orall, disintegrating buccal tablet (DBT) in the prevention of gastrointestinal reaction induced by anticancer drugs (cisplatin DDP 30 50 mg/m 2 or adramycin ADM≥40 mg/m 2), as compared with those of kytril tablets. Methods A multicenter, open and randomized self crossover control trial was carried out with all the eligible patients randomized into AB or BA group. Patients in AB group were given nasea 0.1 mg as buccal tablet one hour before chemotherapy in the first cycle and kytril tablet 2 mg in the second cycle, those in BA group were given these drugs in the reverse order. Results Seventy three patients were allotted to this study, including 44 patients in DDP arm and 29 in ADM arm. Sixty two patients were evaluable for response and 70 patients for safety. Nasea DBT was as effective as kytril tablet in the control of anorexia, nasea and vomiting during the first 24 hours after chemotherapy, with response rates of 74.2%, 77.4%, 83.9% in nasea DBT and 74.2%, 71.0%, 88.7% DBT in kytril tablets. A high efficacy in the control of vomitting induced by cisplatin was observed in both nasea DBT and kytril tablets. The complete control rates and overall control rates were 83.3%, 91.7% in nasea DBT and 86.1%, 97.2% in kytril tablets, respectively. The side effects of nasea DBT were head heaviness, dry mouth and somnolence, which were mild and comparable with kytril in their frequencies. Conclusion Nasea distintegrating buccal tablet is able to effectively prevent gastrointestinal reaction induced by anticancer drugs, with efficacy and side effects similar to kytril tablets. Nasea DB tablet, an intraoral disintegrator, is very convenient for patients who can not swallow tablets for various reasons.

关 键 词：奈西雅崩解片 预防 抗肿瘤药物 胃肠反应 临床研究 

分 类 号：R730.5[医药卫生—肿瘤]