Tzeng Wen-Sheng, Wu Reng-Hong, Chang Shih-Chin, Chou Chung-Kuao, Lin Ching-Yih, Chen Jyh-Jou, Yang Shun-Chun, Lin Chi-Hung
Department of Radiology, Chi-Mei Medical Center, Yung Kang City, Tainan County, Taiwan, Republic of China.
J Vasc Interv Radiol. 2008 Mar;19(3):342-50. doi: 10.1016/j.jvir.2007.10.021.
To compare the stability of epirubicin-iodized oil emulsions prepared with ionic or nonionic contrast medium and to compare the efficacy of these emulsions in a prospective, randomized, controlled trial of transarterial chemoembolization (TACE) for hepatocellular carcinoma (HCC).
Epirubicin-iodized oil emulsions prepared with ionic and nonionic contrast media was evaluated for stability with light microscopy and magnetic resonance imaging. One hundred ninety-seven patients with inoperable HCC were randomized to receive TACE with epirubicin, prepared either with ionic (control group, n = 99) or nonionic (experimental group, n = 98) contrast medium. Tumor response was graded according to iodized oil retention (grade 1 = >90% retention, grade 2 = 50%-90% retention, and grade 3 = <50% retention), as characterized with computed tomography. Survival probabilities were calculated with the Kaplan-Meier method.
The epirubicin-iodized oil emulsions prepared with ionic contrast medium were less stable, exhibiting rapid separation of the oil and aqueous phases, compared with emulsions prepared with nonionic medium. Ninety-one patients in the control group and 87 in the experimental group underwent follow-up CT. Thirty-seven of the 91 patients in the control group (41%) had grade 1 tumors, 41 (45%) had grade 2 tumors, and 13 (14%) had grade 3 tumors. Forty-eight of the 87 patients in the experimental group (55%) had grade 1 tumors, 22 (25%) had grade 2 tumors, and 17 (20%) had grade 3 tumors. The number of patients with grade 1 tumors was significantly higher in the experimental group than in the control group (P = .02); however, there was no difference in patient survival (P = .94).
Epirubicin-iodized oil emulsions prepared with nonionic contrast medium are more stable and are associated with lower tumor grade in patients with inoperable HCC. The choice of solvent, however, does not appear to have an effect on patient survival.
比较用离子型或非离子型造影剂制备的表柔比星-碘化油乳剂的稳定性，并在一项针对肝细胞癌（HCC）的经动脉化疗栓塞术（TACE）的前瞻性、随机、对照试验中比较这些乳剂的疗效。
用光学显微镜和磁共振成像评估用离子型和非离子型造影剂制备的表柔比星-碘化油乳剂的稳定性。197例无法手术的HCC患者被随机分为两组，分别接受用离子型（对照组，n = 99）或非离子型（试验组，n = 98）造影剂制备的表柔比星进行TACE治疗。根据碘化油滞留情况对肿瘤反应进行分级（1级 =>90% 滞留，2级 = 50%-90% 滞留，3级 = <50% 滞留），通过计算机断层扫描进行评估。用Kaplan-Meier方法计算生存概率。
与用非离子型造影剂制备的乳剂相比，用离子型造影剂制备的表柔比星-碘化油乳剂稳定性较差，油相和水相迅速分离。对照组91例患者和试验组87例患者接受了随访CT检查。对照组91例患者中，37例（41%）为1级肿瘤，41例（45%）为2级肿瘤，13例（14%）为3级肿瘤。试验组87例患者中，48例（55%）为1级肿瘤，22例（25%）为2级肿瘤，17例（20%）为3级肿瘤。试验组1级肿瘤患者数量显著高于对照组（P = .02）；然而，患者生存率无差异（P = .94）。
用非离子型造影剂制备的表柔比星-碘化油乳剂更稳定，且与无法手术的HCC患者较低的肿瘤分级相关。然而，溶剂的选择似乎对患者生存率没有影响。
