Ariyoshi Y, Ota K, Taguchi T, Furue H, Niitani H, Tsukagoshi S, Ikeda M, Akasaka Y, Ohta J, Suminaga M
Dept. of Hematology & Chemotherapy, Aichi Cancer Center.
Gan To Kagaku Ryoho. 1992 Oct;19(12):2057-70.
Ondansetron, a selective 5-HT3 receptor antagonist, has already been reported to have a marked effect to alleviate or prevent nausea and vomiting associated with cancer chemotherapy, after its intravenous administration. The present study was planned to examine the usefulness of its tablet form, which was prepared for the convenient use in outpatients receiving chemotherapy. In order to make an objective evaluation of anti-emetic effect and safety of ondansetron 4 mg tablet, this study was conducted in double-blind comparison versus placebo in patients receiving cisplatin at a single dose of 50mg/m2 or higher. Either 4 mg of ondansetron or placebo (lactose tablet) was administered orally once at 2 hrs prior to administration of cisplatin. If any satisfactory anti-emetic effects were not obtained, 4 mg of ondansetron injection was given once intravenously as a rescue medication. The inhibitory effect on nausea and vomiting was assessed in 4 grades as "excellent", "good", "fair" and "poor" based on severity of nausea and number of vomiting that occurred during the first 24hrs after administration of cisplatin. When rescue medication was conducted, the case was assessed as "poor". Ondansetron was significantly superior to placebo in inhibition of nausea and vomiting, in which efficacy rates (excellent+good) of ondansetron and placebo groups were 58.1% (25/43 cases) and 16.7% (7/42 cases), respectively. Number of cases requiring rescue medication with ondansetron injection was obviously greater in placebo group (31 cases) than that in ondansetron group (12 cases). In those patients given ondansetron injection as the rescue medication, satisfactory effects were obtained in 5 cases in ondansetron group and in 18 cases in placebo group. Although side effects including chest itching (ondansetron group), headache and dull headache (placebo group) were observed after the rescue medication with ondansetron injection, these symptoms were not severe and disappeared after 1-2 days. As mentioned above, ondansetron tablet was shown to possess excellent anti-emetic effect on nausea and emesis induced by high dose of cisplatin and to have no problem in safety. Hence ondansetron was proven to be clinically very useful anti-emetic.
昂丹司琼是一种选择性5 - HT3受体拮抗剂，已有报道称其静脉注射后对缓解或预防癌症化疗相关的恶心和呕吐有显著效果。本研究旨在考察其片剂形式的效用，该片剂是为方便接受化疗的门诊患者使用而制备的。为了客观评估4毫克昂丹司琼片剂的止吐效果和安全性，本研究在接受单次剂量50毫克/平方米或更高剂量顺铂治疗的患者中与安慰剂进行双盲比较。在顺铂给药前2小时口服4毫克昂丹司琼或安慰剂（乳糖片）一次。如果未获得任何满意的止吐效果，则静脉注射4毫克昂丹司琼注射液一次作为急救药物。根据顺铂给药后最初24小时内出现的恶心严重程度和呕吐次数，将对恶心和呕吐的抑制效果分为“优”“良”“中”“差”四个等级进行评估。进行急救药物治疗时，该病例评估为“差”。昂丹司琼在抑制恶心和呕吐方面明显优于安慰剂，其中昂丹司琼组和安慰剂组的有效率（优 + 良）分别为58.1%（25/43例）和16.7%（7/42例）。安慰剂组（31例）需要注射昂丹司琼进行急救药物治疗的病例数明显多于昂丹司琼组（12例）。在那些接受昂丹司琼注射液作为急救药物治疗的患者中，昂丹司琼组有5例获得了满意效果，安慰剂组有18例。尽管在注射昂丹司琼进行急救药物治疗后观察到了包括胸部瘙痒（昂丹司琼组）、头痛和隐痛（安慰剂组）在内的副作用，但这些症状并不严重，1 - 2天后就消失了。如上所述，昂丹司琼片剂对高剂量顺铂引起的恶心和呕吐显示出优异的止吐效果，且安全性方面没有问题。因此，昂丹司琼被证明是临床上非常有用的止吐药。
