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新型经导管动脉碘化油与可降解淀粉微球化疗栓塞治疗肝细胞癌的前瞻性随机试验。

A novel transcatheter arterial infusion chemotherapy using iodized oil and degradable starch microspheres for hepatocellular carcinoma: a prospective randomized trial.

机构信息

Department of Gastroenterology and Hepatology, Yamaguchi University Graduate School of Medicine, 1-1-1 Minamikogushi, Ube, Yamaguchi 755-8505, Japan.

出版信息

J Gastroenterol. 2011 Mar;46(3):359-66. doi: 10.1007/s00535-010-0306-5. Epub 2010 Aug 25.

DOI:10.1007/s00535-010-0306-5
PMID:20737175
Abstract

BACKGROUND

We designed a novel transcatheter arterial infusion chemotherapy (TAI) using iodized oil (lipiodol) and degradable starch microspheres (DSM) for hepatocellular carcinoma (HCC) patients. In this study, we investigated the efficacy of TAI using lipiodol and DSM in a prospective randomized trial.

METHODS

We randomly divided 45 patients with HCC into 3 groups: TAI using lipiodol (lipiodol group, n = 15), TAI using DSM (DSM group, n = 15), and TAI using lipiodol and DSM (lipiodol + DSM group, n = 15). In the lipiodol group, a mixture of cisplatin and lipiodol was administered. In the DSM group, a mixture of cisplatin and DSM was administered. In the lipiodol + DSM group, a mixture of cisplatin and lipiodol was administered, followed by DSM.

RESULTS

The response rates were 40% in the lipiodol group, 53.4% in the DSM group, and 80% in the lipiodol + DSM group, respectively. The response rate tended to improve in the lipiodol + DSM group (lipiodol group vs. lipiodol + DSM group, P = 0.07). The median progression-free survival time was 177 days in the lipiodol group, 287 days in the DSM group, and 377 days in the lipiodol + DSM group. The progression-free survival in the lipiodol + DSM group was significantly better than those in the DSM group (P = 0.020) and the lipiodol group (P = 0.035). There were no serious adverse effects among the 3 groups.

CONCLUSIONS

TAI using lipiodol and DSM was superior to TAI using lipiodol only and TAI using DSM only because of improvements in therapeutic effects and progression-free survival.

摘要

背景

我们设计了一种新型的经导管动脉化疗栓塞术(TAI),使用碘油(Lipiodol)和可降解淀粉微球(DSM)治疗肝细胞癌(HCC)患者。在这项研究中,我们进行了一项前瞻性随机试验,研究了 TAI 使用 Lipiodol 和 DSM 的疗效。

方法

我们将 45 例 HCC 患者随机分为 3 组:TAI 使用 Lipiodol(Lipiodol 组,n = 15)、TAI 使用 DSM(DSM 组,n = 15)和 TAI 使用 Lipiodol 和 DSM(Lipiodol + DSM 组,n = 15)。在 Lipiodol 组中,给予顺铂和 Lipiodol 的混合物。在 DSM 组中,给予顺铂和 DSM 的混合物。在 Lipiodol + DSM 组中,给予顺铂和 Lipiodol 的混合物,然后给予 DSM。

结果

Lipiodol 组的有效率为 40%,DSM 组为 53.4%,Lipiodol + DSM 组为 80%。Lipiodol + DSM 组的有效率有升高趋势(Lipiodol 组与 Lipiodol + DSM 组,P = 0.07)。Lipiodol 组的中位无进展生存期为 177 天,DSM 组为 287 天,Lipiodol + DSM 组为 377 天。Lipiodol + DSM 组的无进展生存期明显优于 DSM 组(P = 0.020)和 Lipiodol 组(P = 0.035)。三组均无严重不良反应。

结论

与 TAI 使用 Lipiodol 相比,TAI 使用 Lipiodol 和 DSM 可提高疗效和无进展生存期,优于 TAI 使用 Lipiodol 或 DSM。

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