盐酸雷莫司琼口腔崩解片预防恶性血液疾病联合化疗所致的胃肠反应

Clinical evaluation of ramosetron hydrochloride disintegrating buccal tablet in the prevention of gastrointestinal reaction induced by combined chemotherapy in patients with malignant blood diseases

目的：观察盐酸雷莫司琼口腔崩解片预防恶性血液疾病患者联合化疗所致胃肠反应的疗效和安全性。方法：采用随机、对照方法，将入选病例随机分为治疗组（含服盐酸雷莫司琼口腔崩解片0．1mg）和对照组（静脉注射盐酸托烷司琼5mg）。结果：可评价疗效及安全性病例110例。两种药物对控制化疗所致食欲缺乏、恶心和呕吐的有效率相似。第1～7天盐酸雷莫司琼对食欲缺乏的完全控制率（52．7％～63．6％）、第4～7天对恶心的完全控制率（43．6％～56．4％）及第3、4、6天对呕吐的完全控制率（80．0％、87．3％和90．9％）明显优于盐酸托烷司琼注射剂，差异有显著性（P〈0．05）。盐酸雷莫司琼不良反应轻，主要为便秘、头痛、体热感和疲倦，为一过性，其发生率与盐酸托烷司琼注射剂相似。结论：盐酸雷莫司琼口腔崩解片能有效预防恶性血液病患者联合化疗所致的胃肠反应，适用于因各种原因不能吞服药片的患者。

Objective： To observe the efficacy and safety of ramosetron hydrochloride disintegrating buccal tablet （RHDBT） in the prophylaxis of gastrointestinal reaction induced by combined chemotherapy in patients with malignant blood diseases. Methods： A randomized controlled study was conducted. All the patients were randomized into treatment group （given RHDBT 0.1 mg ） or control group （given tropisetron hydrochloride 5 mg, iv）. Results： A total of 110 patients were enrolled. RHDBT was as effective as tropisetron hydrochloride in the prophylaxis of anorexia, nausea and vomiting. The overall control rates of anorexia from day 1 to day 7 （52.7%-63.6%）, of nausea from day 4 to day 7 （43.6%-56.4%） and of vomiting on day 3, day 4 and day 6 （80.0%, 87.3% and 90.9%） of RHDBT were higher than those of tropisetron hydrochloride（P〈0.05）. The side effects of RHDBT were mild, including constipation, headache and fatigue,which were comparable with those of tropisetron hydrochloride in their frequencies. Conclusion： RHDBT is effective to prevent gastrointestinal reaction induced by combined chemotherapy in patients with malignant blood diseases. It is very convenient for patients who can not swallow tablets for various reasons.