美罗华治疗B细胞淋巴瘤Ⅱ期临床验证报告
미라화치료B세포림파류Ⅱ기림상험증보고
RESULT OF A CLINICAL PHASE II TRIAL OF MABTHERA IN 30 CHINESE B CELL LYMPHOMAS PATIENTS
  • 万方数据
    中国新药杂志 중국신약잡지
    CHINESE NEW DRUGS JOURNAL
    1999年 12期 822-824 ,共3页

    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

    손연%하우겸%허립공%용위본%주립강%리유렴%리려경%협소평%장화평%진영해%주군

    B细胞淋巴瘤%美罗华 B細胞淋巴瘤%美囉華
    B세포림파류%미라화
    B cell lvmphomas%rituximab%MabThera
    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。375 mg/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。
    목적：관찰미라화적림상료효화안전성。방법：근거GCP지도원칙개전다중심Ⅱ기림상연구。소유적환자균위병리검사증실CD20양성적B세포림파류환자。375 mg/m2，정맥적주，일차/주，공4주위일료정병평개료효。결과：전조31례중1례인주사1차후병변진전、간공능엄중손상미능완성치료외，가평개료효적30례。치 료후완전완해3례，부분완해10례，무효12례，진전5례，유효솔43％。30례중불량반응유불동정도적발열9례，핍력5례，피부반응1례，간공능경도손상1례，저혈압1례。무골수억제。결론：CD20양성적B세포림파류료효긍정，다수환자내수량호，시일유희망적신약。
    OBJECTIVES: 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.
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