国产抗肿瘤新药异环磷酰胺及辅助药美司钠临床Ⅱ期试用结果

RESULTS OF PHASE Ⅱ CLINICAL TRIAL OF DOMESTIC IFOSFAMIDE/MESNA

通过多中心前瞻性研究对国产的导环磷酰胺（ＩＦＯ）及其泌尿系统保护剂美司纳（ｍｅｓｎａ）进行了Ⅱ期临床观察。全组共２５２例，其中单用ＩＦＯ／ｍｅｓｎａ治疗的１０９例，与其他药联合治疗的１４３例。另有主要以环磷酰胺代替ＩＦＯ／ｍｅｓｎａ的同期对照９６例。结果说明ＩＦＯ对肺癌、恶性淋巴瘤、肉瘤和少数其他肿瘤有较好的疗效，与我们既往应用Ａｓｔａ药厂生产的ＩＦＯ结果和文献报道相近。ｍｅｓｎａ可以有效地消除ＩＦＯ的泌尿系统刺激，但在７．３％（单用ＩＦＯ）和７．７％（联合其他药）的病人中由于应用ｍｅｓｎａ不及时或不正确仍有一定泌尿系刺激症状。此外，ＩＦＯ／ｍｅｓｎａ的消化道反应和神经系统毒性也略高于对照组。

A multicenter prospective phase Ⅱ clinical trial on ifosfamide/mesna(IFO/mesna)was conducted on 252 patients.Among them l09 cases received IFO/mesna as single agent,and l 43 cases were treated with combination chemotherapy containing IFO/ mesna。96 patients received cyclophosphamide(CTX)in stead of IFO/mesna in control group.Results obtained revealed that IFO/mesna was effective in lung cancer,malignant lymphomas,sarcomas,and other cancers,Mesna can effectively reduce the urinary toxicity of IFO,but there were 7. 3% patients in single agent group and 7.7%in combination chemotherapy group suffered from urinary tract toxicities when mesna was not used proper- ly.The gastrointestinal tract side effects and neuroltoxicities were also slightly higher than those in control group。