金龙胶囊联合三维适形放疗治疗原发性肝癌
Combination therapy of Jinlong capsule and three-dimensional conformal radiotherapy for primary hepatocellular carcinoma
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摘要:目的 探讨金龙胶囊联合三维适形放疗治疗原发性肝癌的疗效和不良反应。方法 85例不能手术的原发性肝癌分成三维适形放疗联合金龙胶囊治疗组(研究组)和单纯三维适形放疗组(对照组)。所有病例均采用6MVX线三维适形放疗, 每天1次, 每次2 Gy, 每周照射5次, 共计6周, 总量60 Gy。42例对照组仅接受三维适形放疗, 研究组43例接受三维适形放疗同时金龙口服胶囊, 每次1 g, 每日3次, 直至病变进展或至少1年。治疗结束后2个月评价近期疗效和不良反应, 随访结束后评价远期疗效。结果 研究组客观有效率74.4%(32/43)明显高于对照组47.6%(20/42, P=0.011);研究组疾病控制率97.7%(42/43)高于对照组83.3%(35/42, P=0.030);两组CR率20.9%(9/43)和14.3%(6/42)无显著性差异, P=0.422。研究组1年、3年总生存率74.4%(32/43)和34.9%(15/43)高于对照组66.7%(28/42)和16.7%(7/42, P=0.046)。研究组1年、3年无进展生存率74.4%(32/43)和27.9%(12/43)明显高于对照组61.9%(26/42)和9.5%(4/42, P=0.034)。主要不良反应为1~2度骨髓抑制, 腹胀恶心呕吐, 转氨酶升高, 两组无显著性差异。结论 三维适形放疗联合金龙胶囊治疗原发性肝癌优于单纯适形放疗, 不良反应可以耐受。Abstract:Objective This study aimed to investigate the effects and side effects of Jinlong Capsule with concurrent three-dimensional conformal radiotherapy for advanced primary hepatic carcinoma.Methods A total of 85 patients with inoperable primary hepatic carcinoma were randomly divided into a research group and a control group.Forty-two cases in the control group were treated with three-dimensional conformal radiotherapy alone, whereas 45 cases in the research group were treated with three-dimensional conformal radiotherapy and Jinlong Capsule oral administration.All cases were irradiated with 6 MV X-rays, 2 Gy per day, 5 days a week to a total dose of 60 Gy in 6 weeks.Jinlong Capsule(1 g) was administered orally three times daily until disease progression for at least one year.The short-term therapeutic effect and adverse events were evaluated for 2 months after treatment.The long-term therapeutic effect was assessed at the end of follow-up.Results The objective response rate of the research group was significantly higher than that of the control group at 74.4% and 47.6%, respectively(P=0.011).The disease control rates were 97.7% and 85.3%(P=0.030) for the research and control groups, respectively.No obvious difference was found between the complete response rates of the two groups, 20.9% and 14.3%(P=0.422).The 1-and 3-year overall survival rates of the research group(74.4% and 34.9%) were significantly higher than those of the control group(66.7% and 16.7%) at P=0.046.The 1-and 3-year progression free survival rates of the research group(74.4% and 27.9%) were significantly higher than those of the control group(61.9% and 9.5%) at P=0.038.The main adverse events were grade 1–2 bone marrow suppression, abdominal distension, nausea, vomiting, and transaminase elevation.No obvious difference was observed between the adverse events in the two groups.Conclusion The short-and long-term effects of the combination therapy of Jinlong Capsule and three-dimensional conformal radiotherapy on primary hepatocellular carcinoma were significantly higher than those of three-dimensional conformal radiotherapy alone.The patients also tolerated the adverse effects.
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