载药微球与空白微球联合表阿霉素治疗肝细胞癌的临床对比研究

Clinical comparison of Drug-loaded beads and blank microspheres combined with epirubicin in treatment of hepatocellular carcinoma

目的探讨并对比在经导管肝动脉化疗栓塞术(TACE)中使用载药微球或空白微球联合表阿霉素治疗肝细胞癌的临床效果和安全性。方法对50例经临床确诊分期为BCLC-A/B期的肝细胞癌患者,随机分成两组A、B,每组25人。分别行TACE,其中A组使用Hepasphere载药微球进行栓塞,B组使用相同粒径的Embosphere空白微球进行栓塞。两组均采用改良实体瘤疗效评价标准(mRECIST)评价疗效,并比较患者治疗前后肝功能及甲胎蛋白变化,观察并记录术后不良反应、并发症的发生情况。结果两组共50例患者均顺利接受TACE,技术成功率为100%。两组分别随访6个月,根据mRECIST标准,A组:3个月疾病缓解率CR+PR为92%, 6个月CR+PR为88%。B组:3个月疾病缓解率CR+PR为84%,6个月CR+PR为80%。术后3个月复查患者肝功能情况,两组患者肝功能与术前差异均无统计学意义,所有患者均未出现肝脓肿、肿瘤破裂、消化道出血、胆囊炎、胆汁漏并发感染等严重并发症。结论对BCLC-A/B期肝细胞癌患者,应用载药微球相比空白微球进行TACE治疗近期临床效果和安全性都更有优势,远期疗效尚待进一步观察。

Objective To investigate and compare the clinical efficacy and safety of drug-loaded microspheres and blank microspheres combined with epirubicin in the treatment of hepatocellular carcinoma in transcatheter arterial chemoembolization (TACE). Methods Fifty cases with hepatocellular carcinoma at the stage of BCLC-A/B were randomly divided into two groups (A and B), with 25 in each group. Patients in group A were embolized with Hepasphere drug-eluting beads, and cases in group B were embolized with Embosphere blank microspheres with the same particle. Both groups’ efficacy was evaluated by modified RECIST(mRECIST), the change of liver function and alpha-fetoprotein in patients were compared before and after treatment, at the same time , postoperative adverse reactions as well as complications should be observed and recorded. Results TACE was successfully performed in 50 patients in both groups, and the technical success rate was 100%.The two groups were followed up for 6 months. According to mRECIST criteria, in group A. 3-month disease remission rate (CR+PR) was 92% and 6-month (CR+PR) was 88%. In group B,(CR+PR) was 84% in 3 months and (CR+PR) was 80% in 6 months. The liver function of the patient was reviewed 3 months after operation. There was no statistical difference in liver function of the two groups between preoperative and postoperative. All patients had no serious complications such as liver abscess, tumor rupture, gastrointestinal bleeding, cholecystitis, and bile leakage. Conclusion For patients with hepatocellular carcinoma at the stage of BCLC-A/B, compared with blank microspheres, drug-loaded microspheres have more advantages in short-term clinical efficacy and safety, and long-term efficacy remains to be further observed.