Suminaga M, Furue H, Taguchi T, Ota K, Niitani H, Tsukagoshi S, Ariyoshi Y, Ikeda M, Akasaka Y, Ohta J
Dept. of Internal Medicine IV, Teikyo University School of Medicine, Kawasaki, Japan.
Gan To Kagaku Ryoho. 1992 Sep;19(11):1891-903.
We examined the anti-emetic effect, safety and usefulness of ondansetron hydrochloride, a selective 5-HT3 receptor antagonist, given orally once daily at the dosage of 4 mg, for 3 to 5 consecutive days to patients with nausea and emesis induced by non-platinum anti-cancer drugs such as cyclophosphamide, doxorubicin and carboplatin. Out of 84 cases where anti-emetic effects were evaluated, numbers of cases assessed as excellent and good were 36 (83.3%) and 34 (40.5%), respectively, the efficacy rate being 83.3% (70/84). Side effects, such as moderate constipation (3 cases) and mild headache (3 cases), were observed in 8/85 cases (9.4%). Abnormalities in clinical laboratory findings including elevation of hepatic function and uricacid values and increase in eosinocyte counts, were observed in 3/85 cases (3.5%). As to overall safety, 78/85 cases (91.8%) were evaluated as having no problem in safety, and 7/85 cases (8.2%), as having minor problem in safety. As to clinical usefulness based on anti-emetic effect and overall safety, out of 79 cases the drug was assessed as very useful in 29 cases (36.7%) and useful in 35 cases (44.3%), the rate of "useful" or above being 81.0% (64/79). Furthermore, when ondansetron was administered in 3 courses of chemotherapy, though the number of patients was small, it was shown that anti-emetic effect of ondansetron did not decline and no problem in safety was observed. From the above, ondansetron which exerted adequate anti-emetic effect in 4 mg once daily doses was considered as a useful and safe anti-emetic in treatment of nausea and emesis associated with cancer chemotherapy.
我们研究了盐酸昂丹司琼（一种选择性5 - HT3受体拮抗剂）对因环磷酰胺、阿霉素和卡铂等非铂类抗癌药物引起恶心和呕吐的患者的止吐效果、安全性及实用性。以每日一次4毫克的剂量口服，连续服用3至5天。在84例评估了止吐效果的病例中，评定为优和良的病例数分别为36例（83.3%）和34例（40.5%），有效率为83.3%（70/84）。8/85例（9.4%）出现了副作用，如中度便秘（3例）和轻度头痛（3例）。85例中有3例（3.5%）观察到临床实验室检查结果异常，包括肝功能和尿酸值升高以及嗜酸性粒细胞计数增加。关于总体安全性，85例中有78例（91.8%）被评估为安全性无问题，7例（8.2%）被评估为安全性有小问题。基于止吐效果和总体安全性的临床实用性，在79例中，该药物被评定为非常有用的有29例（36.7%），有用的有35例（44.3%），“有用”及以上的比例为81.0%（64/79）。此外，当昂丹司琼用于3个疗程的化疗时，尽管患者数量较少，但结果显示昂丹司琼的止吐效果未下降，且未观察到安全性问题。综上所述，每日一次4毫克剂量的昂丹司琼在治疗与癌症化疗相关的恶心和呕吐方面被认为是一种有用且安全的止吐药。
