国产新药盐酸格拉司琼注射液与恩丹西酮预防化疗引起的恶心和呕吐的疗效比较

Comparing the Preventive Effect of Granisetron Home Made Versus Ondansetron on Chemotherapy-induced Nausea and Vomiting:A Report on a Prospective Multiple Center Ramdomized Trial

目的 :验证四川抗菌素工业研究所和德阳华康药业有限公司共同研制的盐酸格拉司琼注射液 (简称华康格拉司琼 )预防恶性肿瘤患者化疗所致恶心与呕吐的有效性和安全性。方法 :对 6 9例接受以顺铂为主化疗和39例接受以蒽环类抗肿瘤药为主化疗的恶性肿瘤患者 ,采用前瞻性多中心随机对照试验 ,比较该药和国产上市恩丹西酮预防化疗所致恶心与呕吐的疗效和不良反应。结果 :华康格拉司琼和恩丹西酮对预防强效致吐和中度致吐化疗药物所致的急性和迟发性恶心和呕吐的疗效基本相同 ;不良反应亦基本相似 ,以便秘、疲倦及头痛为多见 ,但程度轻 ,不影响继续治疗。结论

Objective:To evaluate the safety of the granisetron hydrochloride(Gran) made by Huakang Pharmacy Company Limited and its preventive effect of chemotherapy-induced nausea and vomiting.Methods:In three hospitals,69 patients treated with chemotherapeutic regimens including high dose cisplatin(more than 70mg/m 2)and 39 patients treated with chemotherapeutic regimens as anthracycline anticancer drugs were randomized and self-crossed over to receive 3mg of Gran intravenously(i.v) once a day,or 8mg of ondansetron(Onda) i.v.twice a day.Results:The preventive effects of Gran and Onda on chemotherapy-induced nausea and vomiting were similar.Their side-effects were similar,too;constipation,fatigue and headache were frequent,but mild.Conclusion:Gran made in China is effective and safe for preventing chemotherapy-induced nausea and vomiting.