Kitamura S, Ohtani T, Kurihara M, Kosaki G, Akazawa S, Sasaki T, Takahashi H, Nakano S, Tokunaga K
Third Dept. of Internal Medicine, Center for Adult Diseases, Osaka.
Gan To Kagaku Ryoho. 1995 May;22(6):765-75.
The results of recent preclinical and clinical studies suggest that AO-90, a methionine-free intravenous amino acid solution (7.43%), potentiates the antitumor effect of 5-fluorouracil (5-FU). In the present multi-center, randomized, controlled study conducted at the internal medicine departments of 24 institutions between July 1991 and May 1993, patients with advanced gastric cancer were randomly allocated to receive either AO-90 (500-750 mL/day, AO/MF group) or Amiparen, a commercial intravenous amino acid solution (600-800 mL/day, C/MF group) by total parenteral nutrition for 14 days. Both groups received MF therapy which consisted of a continuous infusion of 5-FU at 350 mg/m2/day for 14 days and an i.v. push of mitomycin C 7 mg/m2 on days 7 and 14 (one course). Additional treatment courses were initiated after a withdrawal period when appropriate. Of the 53 subjects enrolled, 52 (98.1%) were eligible and 47 (88.7%) completed the scheduled treatment (AO/MF group: 23, C/MF group: 24). Although there were significant differences for age and sex between the groups, the Mantel-Haenszel test showed that these unevenly distributed characteristics did not affect the study results. The overall clinical response rates in the completed cases were 30.4% (7/23) in the AO/MF group and 16.7% (4/24) in the C/MF group. In particular, the response rate in the inoperable advanced cases with liver metastases, ascites or distant metastases was 45.5% (5/11) in the AO/MF group versus 16.7% (2/12) in the C/MF group. The treatment-related adverse reactions observed were mainly hematologic and subjective/objective symptoms, such as decreased leukocyte count, hemoglobin level and platelet count, nausea/vomiting, diarrhea, stomatitis, and fever. The differences in the incidence were not significant between the groups. These results show that AO-90 in combination with MF therapy is efficacious in the treatment of patients with gastric cancer.
近期临床前和临床研究结果表明，AO - 90（一种不含蛋氨酸的静脉用氨基酸溶液，浓度为7.43%）可增强5 - 氟尿嘧啶（5 - FU）的抗肿瘤作用。在1991年7月至1993年5月期间于24家机构的内科进行的这项多中心、随机、对照研究中，晚期胃癌患者被随机分配接受AO - 90（500 - 750 mL/天，AO/MF组）或一种市售静脉用氨基酸溶液氨复命（600 - 800 mL/天，C/MF组）进行全胃肠外营养14天。两组均接受MF疗法，包括持续输注5 - FU，剂量为350 mg/m²/天，共14天，以及在第7天和第14天静脉推注丝裂霉素C 7 mg/m²（一个疗程）。在适当的停药期后开始额外的治疗疗程。在纳入的53名受试者中，52名（98.1%）符合条件，47名（88.7%）完成了预定治疗（AO/MF组：23名，C/MF组：24名）。尽管两组在年龄和性别上存在显著差异，但Mantel - Haenszel检验表明，这些分布不均的特征并未影响研究结果。完成病例中的总体临床缓解率在AO/MF组为30.4%（7/23），在C/MF组为16.7%（4/24）。特别是，在有肝转移、腹水或远处转移的不可手术晚期病例中，AO/MF组的缓解率为45.5%（5/11），而C/MF组为16.7%（2/12）。观察到的与治疗相关的不良反应主要是血液学方面的以及主观/客观症状，如白细胞计数、血红蛋白水平和血小板计数降低、恶心/呕吐、腹泻、口腔炎和发热。两组之间发生率的差异不显著。这些结果表明，AO - 90联合MF疗法在治疗胃癌患者方面是有效的。
