Alfthan O, Andersson L, Esposti P L, Fosså S D, Gammelgaard P A, Gjöres J E, Isacson S, Rasmussen F, Ruutu M, von Schreeb T, Setterberg G, Strandell P, Strindberg B
Scand J Urol Nephrol. 1983;17(1):37-43. doi: 10.3109/00365598309179778.
Cisobitan, an organosilicon compound with estrogenic and antigonadotropic properties has been evaluated clinically in comparison with an estrogen preparation. In a multicenter study a total of 140 patients with well and moderately well differentiated prostatic cancer were randomly allocated to treatment with Cisobitan or Estradurin/Etivex, 70 to each group. Of 34 patients with poorly differentiated prostatic cancer 18 were given Cisobitan--and 16 were given Estracyt-treatment. Among the patients with well and moderately well differentiated prostatic cancer there were, disregarding mortality, no major differences in subjective, objective or laboratory response to the two kinds of treatment. The pattern of side effects was similar, but oedema requiring diuretics occurred more often in the estrogen treated group. There was a significant difference in mortality at 12 months between the groups, two in the Cisobitan group and ten in the estrogen treated group. Cancer was the cause of death in two patients in the estrogen treated group. All other patients succumbed in cardiovascular diseases. At 24 months the difference in mortality rate was less pronounced: Another ten patients had died in the Cisobitan treated group and seven among the estrogen treated patients. Cancer was responsible for the deaths in seven of the Cisobitan patients compared to four of the estrogen treated patients. Within three years one more patient in both groups had died. Of the 34 patients with poorly differentiated cancer, twelve were alive at the 24 months' follow up, six in the Cisobitan group and six in the Estracyt group.
西索比坦是一种具有雌激素和抗促性腺激素特性的有机硅化合物,已与一种雌激素制剂进行了临床对比评估。在一项多中心研究中,总共140例高分化和中分化前列腺癌患者被随机分为两组,分别接受西索比坦或雌二醇/雌氮芥治疗,每组70例。在34例低分化前列腺癌患者中,18例接受西索比坦治疗,16例接受癌腺治治疗。在高分化和中分化前列腺癌患者中,不考虑死亡率,两种治疗方法在主观、客观或实验室反应方面没有重大差异。副作用模式相似,但需要使用利尿剂治疗的水肿在雌激素治疗组中更常见。两组在12个月时的死亡率有显著差异,西索比坦组有2例死亡,雌激素治疗组有10例死亡。雌激素治疗组中有2例患者死于癌症。所有其他患者均死于心血管疾病。在24个月时,死亡率差异不那么明显:西索比坦治疗组又有10例患者死亡,雌激素治疗组有7例患者死亡。西索比坦组有7例患者死于癌症,而雌激素治疗组有4例。在三年内,两组又各有1例患者死亡。在34例低分化癌症患者中,24个月随访时有12例存活,西索比坦组和癌腺治组各有6例。