Noda K, Takeuchi S, Yajima A, Akiya K, Kasamatsu T, Tomoda Y, Ozawa M, Sekiba K, Sugimori H, Hashimoto S
Department of Obstetrics and Gynecology, Kinki University School of Medicine, Osaka.
Jpn J Clin Oncol. 1992 Feb;22(1):17-25.
To evaluate the clinical effect of a biological response modifier (BRM), sizofiran (SPG), combined with irradiation, a randomized controlled study was performed in patients with stage II or III cervical cancer involving the collaboration of 52 institutes throughout Japan. Patients were randomly allocated to the control group (radiotherapy only) and the SPG group (radiotherapy + SPG). SPG was given intramuscularly, 40 mg once and 20 mg twice, a week concomitantly with radiotherapy. A total 315 patients were enrolled for the study but 23 were excluded from analysis. Of the remaining 292 patients, 121 were of stage II (43 controls and 78 SPG) and 171 of stage III (49 controls and 122 SPG). The results were as follows. (1) The complete response (CR) rate among stage II patients was higher in the SPG group (91.0%) than in the control group (79.1%); also the CR rate among stage III patients was significantly higher in the SPG group (77.9%) than in the control group (61.2%). (2) The SPG group showed a significantly rapid recovery from the decreased lymphocyte counts due to radiotherapy (P less than 0.05). (3) Side effects, probably associated with SPG administration, were observed in 11 cases (5.2%).
为评估生物反应调节剂（BRM）西佐喃（SPG）联合放疗的临床效果，在全日本52家机构协作下，对II期或III期宫颈癌患者进行了一项随机对照研究。患者被随机分为对照组（单纯放疗）和SPG组（放疗+SPG）。SPG通过肌肉注射给药，每周一次40mg，两次20mg，与放疗同时进行。共有315例患者纳入研究，但23例被排除在分析之外。在其余292例患者中，121例为II期（43例对照组和78例SPG组），171例为III期（49例对照组和122例SPG组）。结果如下：（1）II期患者中，SPG组的完全缓解（CR）率（91.0%）高于对照组（79.1%）；III期患者中，SPG组的CR率（77.9%）也显著高于对照组（61.2%）。（2）SPG组因放疗导致的淋巴细胞计数减少恢复明显更快（P<0.05）。（3）观察到11例（5.2%）可能与SPG给药相关的副作用。
