Yoshiya N, Kodama S, Aoki Y, Takahashi T, Honma S, Endo M, Tokunaga A, Takeuchi Y, Hanaoka J, Maruhashi T, Oshima T, Tanaka K, Furue H
Dept. of Gynecology, Niigata University School of Medicine Hospital.
Gan To Kagaku Ryoho. 1997 Jul;24(9):1141-7.
The antiemetic effects on nausea and vomiting induced by anticancer drugs and safety of a 2-mg granisetron tablet were studied in cancer patients, particularly in the field of gynecology, who had been treated with anticancer drugs including cisplatin (CDDP) at 50 mg/m2 or more. The 1-mg granisetron tablet is already commercially available and used widely in clinical practice by oral administration of two tablets per dosage. In this investigation, the clinical efficacy, safety and usefulness of a 2-mg tablet, which can be taken more easily, were studied. The 2-mg granisetron tablet was judged to be "remarkably effective" or "effective" for nausea and vomiting in 22 (66.7%) of 33 patients. For safety, neither adverse experiences nor abnormal laboratory values were judged to be of clinical significance. The 2-mg granisetron tablet was considered "extremely useful" or "useful" in 22 (66.7%) of 33 patients. The above results confirmed the excellent antiemetic effect on nausea and vomiting induced by anticancer drugs including CDDP and the high degree of safety of a 2-mg granisetron tablet.
在接受包括顺铂(CDDP)且剂量为50mg/m²及以上的抗癌药物治疗的癌症患者中,尤其是妇科领域的患者,研究了2mg格拉司琼片对抗癌药物引起的恶心和呕吐的止吐作用及其安全性。1mg格拉司琼片已上市并在临床实践中广泛使用,每次口服两片。在本研究中,对服用更方便的2mg片剂的临床疗效、安全性和实用性进行了研究。33例患者中,22例(66.7%)的恶心和呕吐症状被判定为对2mg格拉司琼片“显著有效”或“有效”。在安全性方面,未发现具有临床意义的不良事件或实验室检查异常值。33例患者中,22例(66.7%)认为2mg格拉司琼片“极其有用”或“有用”。上述结果证实了2mg格拉司琼片对包括CDDP在内的抗癌药物引起的恶心和呕吐具有良好的止吐作用以及高度的安全性。