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小粒径聚乙烯醇微球与传统TACE治疗不可切除肝细胞癌的近期疗效及安全性比较
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| 篇名： | 小粒径聚乙烯醇微球与传统TACE治疗不可切除肝细胞癌的近期疗效及安全性比较 |
| TITLE： | A comparison of short-term efficacy and safety of small-caliber polyvinyl alcohol microsphere-based versus conventional TACE for unresectable hepatocellular carcinoma |
| 摘要： | 目的 比较小粒径聚乙烯醇（PVA）微球经导管动脉化疗栓塞术（TACE）与传统碘油乳剂TACE治疗不可切除肝细胞癌（HCC）的近期疗效及安全性。方法回顾性纳入2024年6月1日至2025年6月30日在甘肃省第二人民医院（西北民族大学附属医院）接受TACE治疗的146例不可切除HCC患者的临床资料，根据TACE方案不同将其分为对照组（传统碘油乳剂TACE治疗，79例）和观察组（小粒径PVA微球TACE治疗，67例）。采用1∶1倾向评分匹配（PSM），以匹配队列（每组各62例）为主要分析人群，比较其治疗后1、3个月时的客观缓解率（ORR）和疾病控制率（DCR），治疗前及治疗后1、3个月时的肿瘤标志物（甲胎蛋白、甲胎蛋白异质体L3、维生素K缺乏或拮抗剂Ⅱ诱导蛋白）水平，不良事件发生情况，以及其无进展生存期（PFS）和总生存期（OS）。以原始队列为对象，进行敏感性分析和交互作用分析。结果PSM后，观察组患者治疗后1、3个月时的ORR均为59.7%，DCR分别为91.9%、93.5%，均显著高于对照组的ORR（41.9%、38.7%）和DCR（77.4%、75.8%）（P＜0.05）；两组患者治疗后1、3个月时的肿瘤标志物水平均较同组治疗前显著降低，且观察组显著低于同期对照组（P＜0.05）；两组患者不良事件总发生率及≥3级不良事件发生率比较，差异均无统计学意义（P＞0.05）。对照组、观察组患者的中位PFS分别为10.6、14.3个月，组间比较差异无统计学意义（风险比为0.69，95%置信区间为0.44～1.09，P＝0.111）；两组分别有8、9例患者死亡，均未达到中位OS，12个月的OS率分别为88.8%、87.3%，组间比较差异亦无统计学意义（风险比为0.88，95%置信区间为0.35～2.24，P＝0.790）。原始队列经混杂因素校正后，观察组患者治疗后3个月时的ORR仍显著高于对照组（校正后比值比为2.67，95%置信区间为1.28～5.56，P＝0.009），且治疗方式与巴塞罗那临床肝癌分期的交互作用对患者治疗后3个月时ORR的影响无统计学意义（P＝0.391）。结论对于不可切除HCC患者，与传统碘油乳剂TACE相比，小粒径PVA微球TACE在近期影像学缓解、肿瘤标志物改善方面的效果更优，且两种方案的安全性相当。 |
| ABSTRACT： | OBJECTIVE To compare the short-term efficacy and safety of small-caliber polyvinyl alcohol （PVA） microsphere-based transcatheter arterial chemoembolization （TACE） versus conventional iodized oil emulsion-based TACE in the treatment of unresectable hepatocellular carcinoma （HCC）.METHODS Clinical data of 146 patients with unresectable HCC who underwent TACE at Gansu Provincial Second People’s Hospital （Affiliated Hospital of Northwest Minzu University） from June 1， 2024， to June 30， 2025， were retrospectively collected. According to the treatment strategy， the patients were divided into the control group （conventional iodized oil emulsion-based TACE， n ＝79） and the observation group （small-caliber PVA microsphere-based TACE， n ＝67）. One-to-one propensity score matching （PSM） was performed， and the matched cohort （62 patients in each group） was used for the primary analysis. The objective response rate （ORR） and disease control rate （DCR） at 1 and 3 months post-treatment， serum levels of tumor markers （alpha-fetoprotein， alpha-fetoprotein lectin-binding fraction L3， and protein induced by vitamin K absence or antagonist-Ⅱ） before treatment and at 1 and 3 months post-treatment， the occurrence of adverse events， progression-free survival （PFS）， and overall survival （OS） were compared between the two groups. Sensitivity and interaction analyses were also performed.RESULTS After PSM， the ORRs in the observation group at 1 and 3 months post-treatment were both 59.7%， and the DCRs were 91.9% and 93.5%， respectively， significantly higher than those in the control group （ORRs： 41.9% and 38.7%； DCRs： 77.4% and 75.8%； P ＜0.05）. At 1 and 3 months post-treatment， the serum levels of tumor markers decreased significantly from baseline in both groups， with significantly lower levels in the observation group than in the control group （ P ＜0.05）. No statistically significant differences were observed in the overall incidence of adverse events or the incidence of grade≥3 adverse events between the two groups （ P ＞0.05）. The median PFS was 10.6 months in the control group and 14.3 months in the observation group， with no statistically significant difference [hazard ratio （HR） of 0.69， 95% confidence interval （CI） of 0.44-1.09， P ＝0.111]. During follow-up， 8 and 9 patients died in the control and observation groups， respectively， and the median OS was not reached in either group. The 12-month OS rates were 88.8% and 87.3%， respectively， with no statistically significant difference （HR of 0.88， 95%CI of 0.35-2.24， P ＝0.790）. After adjustment for potential confounding factors in the original cohort， the ORR at 3 months post-treatment remained significantly higher in the observation group than in the control group （adjusted odds ratio of 2.67， 95%CI of 1.28-5.56， P ＝0.009）. Additionally， the interaction between treatment modality and Barcelona Clinic Liver Cancer staging had no statistically significant impact on the ORR at 3 months post-treatment （ P ＝0.391）.CONCLUSIONS For patients with unresectable HCC， compared with conventional iodized oil emulsion-based TACE， small-caliber PVA microsphere-based TACE demonstrates superior efficacy in terms of early radiological response and improvement in tumor markers， and the two regimens are comparable in terms of safety. |
| 期刊： | 2026年第37卷第20期 |
| 作者： | 李少伟；李建国；王骏臣；王淑霞；马国强；李育民；郭丽；胡玮 |
| AUTHORS： | LI Shaowei，LI Jianguo，WANG Junchen，WANG Shuxia，MA Guoqiang，LI Yumin，GUO Li，HU Wei |
| 关键字： | 小粒径聚乙烯醇微球;碘油乳剂;经导管动脉化疗栓塞术;肝细胞癌;倾向评分匹配;近期疗效;安全性 |
| KEYWORDS： | small-caliber polyvinyl alcohol microsphere;iodized oil emulsion;transcatheter arterial chemoembolization;Hepatocellular carcinoma;propensity score matching;Short-term efficacy;Safety |
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