5-Fu持续静脉输注联合奥曲肽治疗晚期原发性肝癌的多中心临床研究

目的 评价5-Fu持续静脉输注联合奥曲肽治疗晚期原发性肝癌(PHC)的疗效、对生活质量的改善及其耐受性。方法 治疗组58例给予奥曲肽0.1mg,皮下注射,每8 h 1次;5-Fu 0.25 g/(m~2·d),深静脉24 h持续输注,使用时间均为第1～21天;对照组34例给予5-Fu(用法同治疗组),PDD6 mg/(m~2·d)静脉滴注,每周用5 d,连用3周。2组均每4周为1周期。结果 2组临床受益率(PR+NC)分别为59.3%和41.2%,无统计学差异。治疗组腹痛、腹胀、纳差、乏力症状改善好于对照组,腹胀和纳差症状改善明显高于对照组(P<0.05)。治疗组42.6%KS评分提高,对照组26.5%,无统计学差异。2组毒副作用主要表现为Ⅰ、Ⅱ度血液学毒性和胃肠道反应,治疗组的腹泻和口腔炎发生率低于对照组。结论 奥曲肽联合5-Pu持续静脉输注对晚期PHC有一定的疗效,对减轻晚期患者的症状和改善生活质量有较好作用。

MULTI-CENTER CLINICAL TRAIL OF 5-Fu CONTINUOUS INTRAVENOUS INFUSION COMBINED WITH OCTREOTIDE IN THE TREATMENT OF ADVANCED PRIMARY HEPATIC CANCER

Objective: To evaluate the efficacy quality of life and tolerance of 5-Fu continuous intravenous infusion combined with octreotide in the treatment of advanced primary hepatic cancer. Methods: Octreotide group: 58 cases were treated with octreotide 0.1 mg/h/q8h combined with 5-Fu 0.25 g/(m2·d) continuous intravenous infusion, d 1-21; control group: 34 cases were treated with 5-Fu combined with cisplatin 6 mg/(m2·d) 5 d/week×3 weeks. The schedule was repeated every 28, with at least 2 cycles. Results: The rate of PR + NC was 59.3% in octreotide group and 41.2% in control group(P=0.98).The improvement of symptoms included abdominalgia, abdominal distension, anorexia and asthenia in octreotide group was better than that of control group, especially diarrhea and stomatitis less in octreotide group (P< 0.05).The increasing of Karnofsky score was 42.6% in octreotide group and 26.5% in control group(P=0.126).The main toxicity was hematological and gastrointestinal. Conclusions: The regimen of 5-Fu continuous intravenous infusion combined with octreotide is effective in the treatment of advanced primary hepatic cancer, which can alleviate symptoms and has better QOL.