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大剂量顺铂恩度申时灌注联合沙利度胺治疗中晚期肝癌
作者:余安平  李凌  冯龙  蒋为民  吴建兵  郭武华  魏建平 
单位:Department of Oncology  The Second Affiliated Hospital of Nanchang University  Nanchang  330006  China 
关键词:肝肿瘤/药物疗法 顺铂/治疗方法 恩度/治疗应用 肿瘤转移 
DOI:R735.7
出版年,卷(期):页码:2012,27(3):286-289
摘要:
目的 探讨不能手术切除的中晚期肝癌的治疗新途径,延长肝癌患者的生存期。方法 采用前瞻性临床试验的方法,设立治疗组和对照组,每组30例中晚期肝癌患者。治疗组在TACE前1天开始口服沙利度胺,每次50 mg,每天3次,连服14天。同日下午开始水化治疗。次日下午3:00~5:00(申时)经皮股动脉穿剌,经肝固有动脉将导管置于肿瘤供血动脉内,注入大剂量顺铂(90~180 mg)、5-FU 1.0 g,并分别将阿霉素40~50 mg及与超液态碘油10~20 mL充分乳化后注入,同时夹心注入恩度30 mg。对照组不采用大剂量顺铂申时肝动脉灌注及恩度和沙利度胺治疗,其余治疗包括TACE用药均与治疗组相同。治疗后1-2月视情况给予重复治疗。以总生存时间为主要终点,至疾病进展时间为次要终点。采用SPSS 11.5统计软件进行统计分析。结果 (1)总生存时间:治疗组1、2年生存率分别为48.8%和30.0%,中位生存时间10.8月;对照组1、2年生存率和中位生存时间分别为33.3%、16.7%和8.0月,差异有统计学意义(P=0.0452)。(2)疾病进展时间:治疗组1、2年无疾病进展率为38.3%、16.6%,中位至疾病进展时间为9.0月,对照组分别为16.7%、16.7%和5.8月,差异有统计学意义(P=0.0435)。(3)两组的不良反应包括肝肾功能变化、血常规尤其是反映骨髓功能的指标白细胞下降的幅度、胃肠道反应均无显着差异。结论 恩度+大剂量顺铂申时介入肝动脉灌注联合沙利度胺治疗中晚期肝癌疗效较为满意,优于常规的TACE治疗,值得临床进一步研究。
Objective To reseach the new therapy wich may raise the survival for the patients with advanced liver cancer who are not suitable for surgical resection. Methods All patients were randomly assigned to two groups: treatment group and control group and each group consisted of 30 cases. In treatment group, proximally before TACE (transcatheter arterial chemoembolization), each member was given orally thalidomide 50 mg, tid, in continuous 14 days. On the same afternoon each member was treated by means of hydration. Next day the large doses of cisplatin (90~180 mg), 5-FU(1.0 g) were infused into the tumor's blood-supply artery within 3 PM to 5 PM (ShenShi) by means of Seldinger's. Simultaneously doxorubicin (40~50 mg) emulsified in UFL (10~20 mL) completely and endostatin(30 mg) were infused by means of " sandwich". In control group: except using the large dose of cisplatinr and endostatin hepatic artery perfusion in ShenShi and thalidomaide, the treatments were the same as treatment group. After 1-2 months, the same treatment might be given repeatedly according to the situation. OSR(overall survival) was regarded as the primary endpoint and TTP(the time to disease progression) as the secondary endpoint. Statistical software SPSS 11.5 was used to analyze the data. Results (1) Compared with the control group, the OSR of the treatment group was better significantly. The 1-, 2-year survival was 48.78%, 30.02% vs 33.33%, 16.67%, respectively; the medial survival was 10.84 months vs 8.00 months (P=0.0452). (2) Compared with the control group, the TTP of the treatment group was much longer as well. The 1-, 2-year TTP was 38.31%, 16.60% vs 16.67%, 16.67%, respectively; the medial TTP was 8.97 months vs 5.80 months (P=0.0435). (3) The toxic reaction such as liver and kidney function damage and blood routine examination especially the reduction of white blood cells that reflected the index of function of bone marrow, and gastrointestinal reaction was not significantly different between the two groups. Conclusion The effect of large doses of cisplatin and endostatin perfusion in ShenShi combined with thalidomide for advanced liver cancer is satisfactory and better than conventional TACE treatment, which is worth studying furthermore.
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