Lissoni P, Barni S, Crispino S, Tancini G, Fraschini F
Divisione di Radioterapia Oncologica, Ospedale San Gerardo, Milano, Italy.
Eur J Cancer Clin Oncol. 1989 May;25(5):789-95. doi: 10.1016/0277-5379(89)90122-3.
Melatonin, the most important indole hormone produced by the pineal gland, appears to inhibit tumor growth; moreover, altered melatonin secretion has been reported in cancer patients. Despite these data, the possible use of melatonin in human neoplasms remains to be established. The aim of this clinical trial was to evaluate the therapeutic, immunological and endocrine effects of melatonin in patients with metastatic solid tumor, who did not respond to standard therapies. The study was carried out on 14 cancer patients (colon, six; lung, three; pancreas, two; liver, two; stomach, one). Melatonin was given intramuscularly at a daily dose of 20 mg at 3.00 p.m., followed by a maintenance period in an oral dose of 10 mg daily in patients who had a remission, stable disease or an improvement in PS. Before and after the first 2 months of therapy, GH, somatomedin-C, beta-endorphin, melatonin blood levels and lymphocyte subpopulations were evaluated. A partial response was achieved in one case with cancer of the pancreas, with a duration of 18+ months; moreover, six patients had stable disease, while the other eight progressed. An evident improvement in PS was obtained in 8/14 patients. In patients who did not progress, T4/T8 mean ratio was significantly higher after than before melatonin therapy, while it decreased in patients who progressed. On the contrary, hormonal levels were not affected by melatonin administration. This study would suggest that melatonin may be of value in untreatable metastatic cancer patients, particularly in improving their PS and quality of life; moreover, based on its effects on the immune system, melatonin could be tested in association with other antitumor treatments.
褪黑素是松果体产生的最重要的吲哚类激素，似乎具有抑制肿瘤生长的作用；此外，癌症患者中已报告有褪黑素分泌改变的情况。尽管有这些数据，但褪黑素在人类肿瘤中的潜在用途仍有待确定。本临床试验的目的是评估褪黑素对标准疗法无反应的转移性实体瘤患者的治疗、免疫和内分泌作用。该研究对14例癌症患者进行（结肠癌6例；肺癌3例；胰腺癌2例；肝癌2例；胃癌1例）。褪黑素于下午3点肌肉注射，每日剂量为20mg，对于病情缓解、稳定或体能状态（PS）改善的患者，后续维持期改为口服，每日剂量为10mg。在治疗的前2个月前后，评估生长激素（GH）、胰岛素样生长因子C（somatomedin-C）、β-内啡肽、褪黑素血药浓度及淋巴细胞亚群。1例胰腺癌患者取得部分缓解，缓解期持续18 +个月；此外，6例患者病情稳定，其余8例病情进展。14例患者中有8例PS明显改善。病情未进展的患者，褪黑素治疗后T4/T8平均比值显著高于治疗前，而病情进展的患者该比值下降。相反，激素水平不受褪黑素给药的影响。本研究表明，褪黑素可能对无法治疗的转移性癌症患者有价值，尤其是在改善其PS和生活质量方面；此外，基于其对免疫系统的作用，褪黑素可与其他抗肿瘤治疗联合进行试验。
