Uglyanitsa K N, Nefyodov L I, Brzosko V
Oncology Department, Grodno Higher Medical School, Grodno, Belarus.
Drugs Exp Clin Res. 2000;26(5-6):223-30.
This study was carried out in 75 patients with histologically confirmed breast cancer. Patients were divided into three groups of 25. The control group received symptomatic corrective therapy prior to mastectomy. The two other groups were given neoadjuvant therapy with Ukrain injections. The first group received a total course dose of 50 mg Ukrain at single doses of 5 mg injected every second day (a total of 10 injections) and the second group received a total Ukrain dose of 100 mg but with single doses of 10 mg. Five to seven days after the last injection patients from all groups were subjected to mastectomy according to Halsted, Patey or Madden. No allergic reactions or adverse effects were observed after the first course of injections or the whole course of Ukrain therapy, regardless of the dose. After five to six injections some patients noticed slight burning sensations and insignificant morbidity in the tumor area, which, according to a number of authors, testifies to the therapeutic activity of the preparation. Practically all patients who were administered Ukrain noticed remarkable positive changes in the second half of treatment: improvement in appetite, normalization of sleep, disappearance of general weakness and the appearance of confidence in recovery. After the course of treatment with Ukrain, the contours of the tumorous node became more clearly defined, which facilitated mastectomy. Changes in the tumor tissue were one-sided in their qualitative differences in comparison to the control group and were not dose-dependent. Qualitative and quantitative reactions to Ukrain by both intact lymphatic nodes and those affected by the metastatic process contribute to more quantitative and radical performance of the most important stage of mastectomy--removal of the regional cellulose together with the lymphatic nodes. The results of this study showed the efficiency of both doses (50 and 100 mg) of Ukrain with neither performing significantly better than the other.
本研究对75例经组织学确诊的乳腺癌患者进行。患者被分为三组,每组25例。对照组在乳房切除术前行对症矫正治疗。另外两组接受 Ukrain 注射的新辅助治疗。第一组接受的 Ukrain 总疗程剂量为50mg,每隔一天注射5mg(共注射10次),第二组接受的 Ukrain 总剂量为100mg,但每次注射10mg。在最后一次注射后五至七天,所有组的患者均根据 Halsted、Patey 或 Madden 方法接受乳房切除术。在第一疗程注射或整个 Ukrain 治疗过程后,无论剂量如何,均未观察到过敏反应或不良反应。注射五至六次后,一些患者注意到肿瘤区域有轻微烧灼感和轻微不适,根据一些作者的说法,这证明了该制剂的治疗活性。实际上,所有接受 Ukrain 治疗的患者在治疗后半期均出现了明显的积极变化:食欲改善、睡眠正常化、全身乏力消失以及对康复充满信心。经过 Ukrain 治疗后,肿瘤结节的轮廓变得更加清晰,这有利于乳房切除术。与对照组相比,肿瘤组织的变化在质量差异上是单侧的,且与剂量无关。完整淋巴结和受转移过程影响的淋巴结对 Ukrain 的定性和定量反应有助于更定量、更彻底地进行乳房切除术中最重要的阶段——连同淋巴结一起切除区域纤维素。本研究结果表明,50mg和100mg这两种剂量的 Ukrain 均有效,且二者效果无显著差异。