胃癌根治性手术后使用溶链菌制剂进行免疫化疗的随机对照研究。
A randomized controlled study of immunochemotherapy with OK-432 after curative surgery for gastric cancer.
作者信息
Sato Yuji, Kondo Masao, Kohashi Shigechika, Takahashi Norihiko, Takahashi Syusaku, Sinohara Toshiki, Ono Ken-Ichi, Matsuda Miyuki, Ryoma Yoshiki, Shiroto Hiroshi, Kondo Yukihumi, Uchino Jun-Ichi, Saito Kazuo, Todo Satoru
机构信息
First Department of Surgery, School of Medicine, Hokkaido University, Sapporo, Japan.
出版信息
J Immunother. 2004 Sep-Oct;27(5):394-7. doi: 10.1097/00002371-200409000-00008.
The effect of adjuvant immunochemotherapy including OK-432 (Picibanil) on survival was assessed in patients who underwent curative resection of gastric cancer. Patients enrolled in this randomized controlled study were randomly assigned to group A or group B. Group A patients received 800 mg/d 5'-DFUR (Furtulon) for 2 years from 2 weeks after the operation. Group B patients received OK-432 plus 5'-DFUR by the same regimen as in group A. This study enrolled 288 patients, and 1 patient with malignant lymphoma was excluded. Among the remaining 287 patients, 143 and 144 were allocated to group A and group B, respectively, and their data were included in statistical analysis. The 5-year survival rates for groups A and B were 62.9% and 63.8%, respectively, showing no significant difference (P = 0.7996).
对接受胃癌根治性切除术的患者评估了包括溶链菌制剂（沙培林）在内的辅助免疫化疗对生存率的影响。参与这项随机对照研究的患者被随机分配到A组或B组。A组患者在术后2周起接受2年的5'-去氧氟尿苷（氟铁龙），剂量为800mg/d。B组患者接受溶链菌制剂加5'-去氧氟尿苷，用药方案与A组相同。本研究共纳入288例患者，其中1例恶性淋巴瘤患者被排除。在其余287例患者中，分别有143例和144例被分配到A组和B组，他们的数据被纳入统计分析。A组和B组的5年生存率分别为62.9%和63.8%，差异无统计学意义（P = 0.7996）。
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