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

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、我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44组,阿霉素组29例,可评价疗效病例62例,可评价安全性病例70例,在化疗后0－24h,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％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,适用于因各种原因不能吞服药片的癌症患者。

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

OBJECTIVE: To evaluate the efficacy and safety of nausea oral, 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 nausea 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. Nausea DBT was as effective as kytril tablet in the control of anorexia, nausea and vomiting during the first 24 hours after chemotherapy, with response rates of 74.2%, 77.4%, 83.9% in nausea DBT and 74.2%, 71.0%, 88.7% DBT in kytril tablets. A high efficacy in the control of vommitting induced by cisplatin was observed in both nausea DBT and kytril tablets. The complete control rates and overall control rates were 83.3%, 91.7% in nausea DBT and 86.1%, 97.2% in kytril tablets, respectively. The side effects of nausea DBT were head heaviness, dry mouth and somnolence, which were mild and comparable with kytril in their frequencies. CONCLUSION: Nausea disintegrating buccal tablet is able to effectively prevent gastrointestinal reaction induced by anticancer drugs, with efficacy and side effects similar to kytril tablets. Nausea DB tablet, an intraoral disintegrator, is very convenient for patients who can not swallow tablets for various reasons.