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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。
Objective: To observe the clinical efficacy and safety of rituximab. Methods: According to GCP guidelines to carry out multi-center Phase Ⅱ clinical study. All patients were pathologically confirmed to have CD20-positive B-cell lymphoma. 375mg / m2, intravenous infusion, once / week, a total of 4 weeks and evaluate the efficacy. Results: Among the 31 patients in the whole group, 1 patient developed the pathological changes after one injection and the serious liver function failure failed to complete the treatment. Evaluation of the efficacy of 30 cases. After treatment, complete remission in 3 cases, partial remission in 10 cases, ineffective in 12 cases, 5 cases of progress, the effective rate of 43%. Adverse reactions in 30 cases had different degrees of fever in 9 cases, 5 cases of fatigue, skin reaction in 1 case, mild liver injury in 1 case. 1 case of hypotension. No bone marrow suppression. Conclusion: The positive result of CD20 positive B cell lymphoma is positive, and most patients are well tolerated. It is a hopeful new drug.