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恶性肿瘤患者化疗时常出现恶心呕吐,甲氧氯普胺(胃复安)与地塞米松或安定合用,虽有减少恶心呕吐的作用,但仍不够理想.恩丹西酮(ondansetron)为5-羟色胺(5-HT3)受体高选择性阻滞剂,具有止呕吐效果.我们选用由中国科学院上海药物研究所和山东省齐鲁制药厂共同研制的恩丹西酮进行Ⅲ期临床试验,在预防顺铂引起的恶心呕吐反应方面与甲氧氯普胺作比较.材料和方法一、病例选择 经病理证实的各种恶性肿瘤60例,均采用顺铂为主的化疗方案治疗.由于病种不同,化疗方案亦不同,但顺铂均在第1～3天应用,每天40mg.病例随机分为两组,每组各30例.甲组采用自身对照法,即同一患者用相同的化疗方案,一个周期用恩丹西酮加地塞米松作止吐药,另一个周期用甲氧氯普胺加地塞米松或再加安定作自身对照.其中肺癌9例,胃癌7例,大肠癌6例,恶性淋巴瘤3例,其他肿瘤5例.乙组采用随机对照法,即随机选择另30例,化疗方案与甲组相同,以甲氧氯普胺加地塞米松或再加安定作随机对照.其中肺癌6例,胃癌9例,大肠癌10例,其他肿瘤5例.患者Karnofsky评分均在60分以上.排除的病例有:①有消化道梗阻者;②颅内高压所致呕吐者;③在24h内用过止吐药或未用化疗前即有呕吐者;④肝、肾功能不全者;⑤妊娠;③心理异常者.二、给药方法 恩丹西酮8mg(4mg/支)静脉?
Nausea and vomiting often occur in patients with malignant tumors. Metoclopramide (metoclopramide) is combined with dexamethasone or diazepam. Although it may reduce nausea and vomiting, it is still not ideal. Ondansetron is 5- The 5-hydroxytryptamine (5-HT3) receptor selective blocker has antiemetic effect. We selected the ondansetron jointly developed by Shanghai Institute of Materia Medica, Chinese Academy of Sciences, and Qilu Pharmaceutical Factory of Shandong Province for Phase III clinical trials to prevent Cisplatin-induced nausea and vomiting were compared with metoclopramide. Materials and Methods I. Case selection All 60 malignant tumors confirmed by pathology were treated with cisplatin-based chemotherapy regimens. The chemotherapy regimen was also different, but cisplatin was applied on the first to third days, 40 mg per day. The cases were randomly divided into two groups of 30 cases each. The group A used its own control method, that is, the same patient used the same chemotherapy protocol. One cycle used ondansetron plus dexamethasone as an antiemetic drug, another cycle used metoclopramide plus dexamethasone or plus diazepam as its own control, including 9 cases of lung cancer, 7 cases of gastric cancer, and 6 cases of colorectal cancer. 3 cases of lymphoma, 5 cases of other tumors, group B Machine control method, that is randomly selected another 30 cases, the same chemotherapy regimen with group A, randomized control with metoclopramide plus dexamethasone or plus stability. Of which 6 cases of lung cancer, 9 cases of gastric cancer, 10 cases of large intestine cancer, other In 5 cases of tumor, Karnofsky scores were all above 60 points. Excluded cases were: 1 had digestive tract obstruction; 2 vomiting caused by intracranial hypertension; 3 used antiemetics within 24 hours or before chemotherapy Vomiting; 4 liver and kidney dysfunction; 5 pregnancy; 3 psychological abnormalities. Second, the method of administration ondansetron 8mg (4mg/branch) vein?