[Analysis of curative effects of chemoembolization with drug-loaded microspheres of different particle sizes for the treatment of hepatocellular carcinoma].

Objective: To compare and analyze the clinical curative effect and safety of chemoembolization with drug-loaded microspheres of different particle sizes (D-TACE) for the treatment of hepatocellular carcinoma. Methods: Clinical data of 281 cases with hepatocellular carcinoma treated with drug-loaded microspheres-transarterial chemoembolization (TACE) were retrospectively analyzed. According to the different particle sizes of drug-loaded microspheres, they were divided into 100~300 µm (small particle size) and 300~500 µm (large particle size) group. Tumor response rate and complication conditions at 1, 3, and 6 months after chemoembolization were compared. The overall survival time of the two groups were analyzed. Quantitative data conformed to normal distribution and homogeneity of variance were compared using t-test, while other with Wilcoxon signed rank-sum test. Qualitative data were compared using χ2 test. Kaplan-Meier method was used for survival analysis, and the differences in survival were analyzed using Log-rank test. P＜0.05 was considered as statistically significant. Survival curves and histograms were drawn using GraphPad Prism9.1 software. Results: The complete remission rates at 1, 3 and 6 months after surgery in the small and large particle size groups were 31.25%, 30.15%, and 42.45% and 18.25%, 15.79% and 24.74%, respectively, and the differences were statistically significant between groups (P1 month=0.012, P3 month=0.009, P6 month=0.008, P＜0.05). The objective remission rates at 1, 3 and 6 months after surgery in the small and large particle size groups were 88.19%, 76.99%, and 70.75% and 81.02%, 72.81% and 53.60%, respectively. Six months after surgery, the small particle size group (objective response rate = 70.75%) was significantly higher than the large particle size group (objective response rate=53.6%, P=0.012). The disease control rates of the small particle size group were 95.14%, 83.33%, and 74.53%, while large particle size group were 91.24%, 81.58%, and 64.95%, respectively, with no statistically significant difference between the two groups. However, the incidence of postoperative biliary tumors (6.20%) was significantly higher in the small-size than large-size group (0.70%), and the difference was statistically significant (P＜0.05, P=0.03). There were no statistically significant differences between other adverse events such as post-embolization syndrome, liver abscess, and myelosuppression. The median survival time of the small and large particle size groups was 31.8 months and 20.5 months, respectively, but the difference was not statistically significant (P=0.182). Conclusions: In the treatment of hepatocellular carcinoma with D-TACE, the short-term curative effect of the small particle size group was better than large particle size group, but the incidence of biliary tumors was high, and D-TACE of different particle sizes had no significant effect on long-term survival.目的： 对比分析不同粒径载药微球经动脉化学治疗栓塞（D-TACE）治疗肝细胞癌的临床疗效及安全性。 方法： 回顾性分析281例经动脉载药微球化学治疗栓塞术（TACE）治疗的肝细胞癌患者的临床资料，根据载药微球粒径不同分为100～300μm（小粒径）组与300～500μm（大粒径）组，比较化学治疗栓塞术后1、3、6个月的肿瘤反应率及并发症情况，并对比分析两组患者总生存期有无差别。定量资料比较若符合正态分布、方差齐则采用t检验，否则采用Wilcoxon符号秩和检验。定性资料的比较采用χ2检验，以Kaplan-Meier法进行生存分析，生存差异采用Log-rank检验分析；P＜0.05为差异有统计学意义。生存曲线图及柱状图采用GraphPad Prism 9.1软件绘制。 结果： 小粒径组术后1、3、6个月完全缓解率分别为31.25%、30.15%、42.45%，大粒径组术后1、3、6个月完全缓解率分别为18.25%、15.79%、24.74%，组间比较，差异均有统计学意义（P1个月=0.012，P3个月=0.009，P6个月=0.008，P值均＜0.05）。小粒径组术后1、3、6个月客观缓解率分别为88.19%、76.99%、70.75%，大粒径组术后1、3、6个月客观缓解率分别为81.02%、72.81%、53.60%，其中术后6个月小粒径组（客观缓解率=70.75%）显著高于大粒径组（客观缓解率=53.6%，P=0.012）。小粒径组术后1、3、6个月疾病控制率分别为95.14%、83.33%、74.53%，大粒径组术后1、3、6个月疾病控制率分别为91.24%、81.58%、64.95%，两组相比差异均无统计学意义（P值均>0.05）。但小粒径组术后胆汁瘤发生率（6.20%）明显高于大粒径组（0.70%），且差异有统计学意义（P＜0.05），其他不良反应如栓塞后综合征、肝脓肿、骨髓抑制等组间对比差异均无统计学意义。小粒径组与大粒径组的中位生存期分别为31.8个月、20.5个月，但差异无统计学意义（P=0.182）。 结论： 小粒径组载药微球D-TACE治疗肝细胞癌的近期疗效优于大粒径组，但胆汁瘤发生率高；不同粒径的D-TACE对患者远期生存无显著影响。.