国产CalliSpheres载药微球治疗原发性肝癌12例

Interventional chemoembolization with drug-eluting microspheres of domestic CalliSpheres for the treatment of primary hepatocellular carcinomas: preliminary results in 12 patients

目的观察国产Calli Spheres载药微球治疗原发性肝癌的安全性及临床疗效。方法对12例应用国产Calli Spheres载药微球治疗的原发性肝癌患者,回顾性分析术前及随访的临床资料、实验室检查和影像学检查资料。结果 12例患者首次化疗栓塞技术成功率为100%,中位随访时间为7.5个月(6~9个月),术后1周患者AST和ALT较术前升高,差异有统计学意义(P<0.05),但其均值均未超过正常值上限(40 U/L);肝功能Child-Pugh分级、血肌酐、血红蛋白含量、白细胞及血小板计数与术前差异无统计学意义(P>0.05)。术后3、6个月的疾病缓解率(CR+PR)分别为75.0%、66.7%,疾病控制率(CR+PR+SD)分别为91.7%和83.3%。其中10例AFP≥200μg/L患者,术后AFP水平明显下降。术后3个月Calli Spheres载药微球联合碘化油序贯栓塞组的完全缓解率、疾病缓解率及疾病控制率大于单纯Calli Spheres载药微球栓塞组,但差异无统计学意义(P>0.05)。术后不良反应主要以腹痛及发热为主,随访期间出现胸腔积液2例,肝脓肿1例,肺转移1例。结论国产Calli Spheres载药微球对原发性肝癌的治疗安全可行,其近期临床疗效较好,远期疗效及与碘化油联合应用的疗效需多中心、大样本的进一步研究。

Objective To evaluate the clinical safety and efficacy of CalliSpberes, a domestic drugeluting microspheres, in treating primary hepatocellular carcinoma （HCC）. Methods A total of 12 HCC patients were enrolled in this study. Interventional chemoembolization with CalliSpheres was carried out in all patients. The preoperative and postoperative elinical data, laboratory results and imaging findings were retrospectively analyzed. Results The success rate of initial interventional chemoembolization in 12 patients was 100%, the median follow-up time was 7.5 months （6-9 months）. One week after the treatment, both AST and ALT levels were obviously increased when compared with preoperative ones, the differences were statistically significant （P〈O.05）, although their mean values did not exceed the normal upper limit of 40 U/L. No statistically significant differences in Child-Pugh grading, creatinine level, hemoglobin, white blood cell count and platelet count existed between preoperative data and postoperative ones （P〉0.05）. At 3 months and 6 months after treatment, the disease remission rates （CR＋PR） were 75.00% and 66.67% respectively, the disease control rates （CR＋PR＋SD） were 91.67% and 83.33% respectively. In 10 HCC patients whose preoperative AFP was ≥200 μg/L, the postoperative AFP levels showed a significant decrease. Three months after the treatment, the complete remission rate, disease remission rate and disease control rate in the CalliSpheres combined with Lipiodol sequential transarterial chemoembolization group were better than those in the simple CalliSpheres embolization group, but the differences were not statistically significant （P〉0.05）. Postoperative complications were mainly abdominal pain and fever＇. During follow-up period, the complications included pleura1 effusion （n=2）, liver abscess （n=l） and lung metastasis （n=l）. Conclusion The use of domestic CalliSpheres, as a drug-eluting microspheres, for the treatment of primary HCC is safe and feasible with satisfactory short-term efficacy. Its long-term efficacy and the effect of combination use of CalliSpheres and Lipiodol need to be further clarified with multicenter and large sample researches.