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[丝裂霉素与云芝多糖用于胃癌根治术后辅助免疫化疗效果的随机对照试验临床结果。东海胃肠肿瘤组癌症免疫化疗合作研究组]

[Clinical results of a randomized controlled trial on the effect of adjuvant immunochemotherapy using Esquinon and Krestin in patients with curatively resected gastric cancer. Cooperative Study Group of Cancer Immunochemotherapy, Tokai Gastrointestinal Oncology Group].

作者信息

Nakazato H, Ichihashi H, Kondo T

出版信息

Gan To Kagaku Ryoho. 1986 Feb;13(2):308-18.

PMID:3947108
Abstract

From July 1977, a controlled clinical trial in 168 patients who received curative surgery for stomach cancer and 111 similarly treated for colorectal cancer was conducted in the form of a cooperative study involving 22 institutions. One week after surgery, carboquon (CQ) was given at a dose of 2 mg/m2 once a week, followed by PSK at a dose of 2 g/m2 every day for 4 weeks. This regimen was repeated 9 times for 55 weeks. For stomach cancer, patients were divided into 3 groups; Group A: CQ intermittently, Group B: CQ PSK in alternate doses, Group C: controls. For colorectal cancer, the patients were divided into 2 groups; Group D: CQ + PSK in alternate doses, Group E: controls. Survival rate of stage III stomach cancer patients in Group B was higher than that in Group A, the difference being statistically significant between 20 and 24 months after surgery. For colorectal cancer, the survival rate of patients with Dukes C in Group D was statistically superior to that in Group E. These differences were much more apparent among patients who received more than 6 courses of the regimen.

摘要

自1977年7月起,一项涉及22个机构的合作研究以对照临床试验的形式展开,该试验针对168例接受胃癌根治性手术的患者以及111例接受类似治疗的结直肠癌患者。术后一周,以2mg/m²的剂量每周一次给予卡波醌(CQ),随后每天给予2g/m²的PSK,持续4周。此方案重复9次,共55周。对于胃癌患者,分为3组;A组:间歇性给予CQ;B组:交替给予CQ和PSK;C组:对照组。对于结直肠癌患者,分为2组;D组:交替给予CQ + PSK;E组:对照组。B组III期胃癌患者的生存率高于A组,术后20至24个月时差异具有统计学意义。对于结直肠癌,D组Dukes C期患者的生存率在统计学上优于E组。这些差异在接受超过6个疗程该方案的患者中更为明显。

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