国产抗肿瘤药替尼泊甙临床研究报告

Clinical Studies with China-made Teniposide in the Treatment of Advanced Human Cancers

目的 评价替尼泊甙的临床应用价值。方法 多中心协作研究 ,观察单药及联合用药治疗152例晚期小细胞肺癌 (SCLC)、恶性淋巴瘤与脑瘤的疗效与毒性反应。结果 替尼泊甙单药组对SCLC及恶性淋巴瘤的有效率分别为 4 3 8%与 4 2 8% ,主要副作用为白细胞减少、胃肠道反应等。联合化疗组又分为研究组 (用国产替尼泊甙 )与对照组 (用威猛作对照 )、对SCLC与淋巴瘤的有效率分别为 77 4 %及 6 8 3% (P >0 0 5)。替尼泊甙联合化疗对脑瘤的有效率为 4 6 2 % ,其中对脑胶质瘤的有效率为 52 6 %。结论 国产替尼泊甙与进口威猛的疗效和毒性反应相似 ,值得临床推广应用。

Objective To evaluate the clinical usefulness of China made teniposide in the treatment of several advanced human cancers.methods A total of 152 Patients were enrolled in a multicenter cooperative study.Of them,24 patients were given iv teniposide 60mg/m 2 for consecutive five days among 21 days and 128 patients were given combination chemotherapy containing either China made teniposide or Vamon.Results Teniposide is effective in patients with small cell lung cancer (SCLC) and malignant lymphoma(ML),with response rate(RR) of 43 8% and 42 8%,respectively.The major side effects were leukopenia,gastrointestinal reaction and alopecia.In the controlled study of combination chemotherapy with teniposide and vamon,the total RR of combination chemotherapy either containing teniposide or Vamon in SCLC and HL were 77 4% and 68 3%,respectively( P >0 05).The RR of combination chemotherapy containing teniposide in brain tumors was 46 2%,with 52 6% in primary brain tumor.Conclusion The efficacy and side effect of both drugs were comparable.