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美罗华治疗B细胞淋巴瘤Ⅱ期临床验证报告

RESULT OF A CLINICAL PHASE Ⅱ TRIAL OF MABTHERA IN 30 CHINESE B CELL LYMPHOMAS PATIENTS

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【作者】 孙燕; 何友兼; 许立功; 勇威本; 周立强; 李维廉; 李丽庆; 叶小平; 张和平; 陈荣楷; 朱军;

【Author】 Sun Yan; He Youjian; Xu ligong; et al.(Cancer Institute and Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College 100021 )

【机构】 中国医学科学院中国协和医科大学肿瘤医院!北京; 100021; 中山医科大学肿瘤医院; 上海医科大学肿瘤医院; 北京市肿瘤医院; 天津市第二中心医院; 天津市肿瘤医院; 上海罗氏制药有限公司; 中国医学科学院中国协和医科大学肿瘤医院!北;

【摘要】 目的:观察美罗华的临床疗效和安全性。方法:根据GCP指导原则开展多中心Ⅱ期临床研究。所有的患者均为病理检查证实CD20阳性的B细胞淋巴瘤患者。375mg/m2,静脉滴注,一次/周,共4周为一疗程并评价疗效。结果:全组31例中1例因注射1次后病变进展、肝功能严重损伤未能完成治疗外.可评价疗效的30例。治疗后完全缓解3例,部分缓解10例,无效12例,进展5例,有效率43%。30例中不良反应有不同程度的发热9例,乏力5例,皮肤反应1例,肝功能轻度损伤1例.低血压1例。无骨髓抑制。结论:CD20阳性的B细胞淋巴瘤疗效肯定,多数患者耐受良好,是一有希望的新药。

【Abstract】 To observe clinical efficacy and adverse effects of MabThera in Chinese B cell lymphomas patients. METHODS: MabThera was administered 375 mg/m2 intravenous infusion every week for 4 weeks. RESULTS: 31 B cell lymphoma patients were entered, one patient was not able to observe further due to severe abnormal hepatic function after one week of treatment. Among 30 evaluable cases, three reached complete remission, 10 with partial remission, 12 no effect and 5 with progression, response rate being 43%. The adverse effects were fever (9 patients), fatigue (5patients), skin rash (1 patient), liver function impairment (1 patient), and hypotention (1 patient).No bone marrow suppression was observed. CONCLUSION: Clinical results show that MabThera is a effective new drug for B cell lymphomas and the adverse effects were well tolerated by patients.

【关键词】 B细胞淋巴瘤; 美罗华;
【Key words】 B cell lymphomas; rituximab; MabThera;
  • 【文献出处】 中国新药杂志 ,CHINESE NEW DRUGS JOURNAL , 编辑部邮箱 ,1999年12期
  • 【分类号】R979.1
  • 【被引频次】37
  • 【下载频次】200
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