Dillman R O, Beauregard J C, Zavanelli M I, Halliburton B L, Wormsley S, Royston I
J Biol Response Mod. 1983;2(2):139-49.
Since patients with advanced cancer are usually immunodeficient, they might benefit from therapy with thymic hormones, which have an immunorestorative effect in immunosuppressed laboratory animals. We treated 14 patients with thymosin fraction 5 (TF5), and 14 patients with thymosin alpha 1 (TA1) over the dose ranges of 60-960 mg/m2 and 0.6-9.6 mg/m2, respectively. In addition to monitoring toxicity, we studied patients extensively using a variety of lymphocyte cell surface markers and in vitro functional assays, both before and following treatment. Approximately one-half of the in vitro tests were abnormal in the cancer patients prior to treatment. Overall, 28.4 and 18.3% of abnormal tests were improved following TA1 and TF5, respectively. On the other hand, 16% of normal tests became abnormal after therapy. Most of these responses occurred within 24-48 h and seldom persisted beyond 72 h. An optimum dose of TF5 was not readily identified, but 1.2 mg/m2 of TA1 was associated with substantial improvement in 46% of abnormal tests. Twelve of 14 cancer patients who received TF5 and 13 of 14 who received TA1 showed significant improvement in at least one in vitro test. Tumor responses were not seen, but the study suggested thymosin treatments would need to be repeated every 2-3 days to sustain an immune response. TF5 and TA1 are well tolerated as single i.m. injections, and have immunorestorative potential in cancer patients. Additional studies with repeated thymosin doses in more homogeneous cancer populations appear to be justified.
由于晚期癌症患者通常免疫功能低下，他们可能会从胸腺激素治疗中获益，胸腺激素在免疫抑制的实验动物中具有免疫恢复作用。我们分别以60 - 960mg/m²和0.6 - 9.6mg/m²的剂量范围治疗了14例使用胸腺素组分5（TF5）的患者和14例使用胸腺素α1（TA1）的患者。除了监测毒性外，我们在治疗前后广泛使用各种淋巴细胞细胞表面标志物和体外功能试验对患者进行了研究。在治疗前，癌症患者中约一半的体外试验结果异常。总体而言，TA1和TF5治疗后，分别有28.4%和18.3%的异常试验结果得到改善。另一方面，16%的正常试验在治疗后变为异常。这些反应大多在24 - 48小时内出现，很少持续超过72小时。TF5的最佳剂量不易确定，但1.2mg/m²的TA1使46%的异常试验有显著改善。接受TF5治疗的14例癌症患者中有12例，接受TA1治疗的14例中有13例在至少一项体外试验中显示出显著改善。未观察到肿瘤反应，但该研究表明胸腺素治疗需要每2 - 3天重复进行以维持免疫反应。TF5和TA1作为单次肌肉注射耐受性良好，对癌症患者具有免疫恢复潜力。在更同质的癌症人群中重复使用胸腺素剂量的进一步研究似乎是合理的。
