| 覃雪,丁莉,蒋蜀梅.肝动脉灌注化疗栓塞术联合信迪利单抗治疗晚期原发性肝癌近期疗效及远期生存率[J].安徽医药,2024,28(2):390-395. |
| 肝动脉灌注化疗栓塞术联合信迪利单抗治疗晚期原发性肝癌近期疗效及远期生存率 |
| Short-term efficacy and long-term survival of hepatic arterial chemoembolization combined with sintilimab in treatment of advanced liver cancer |
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| DOI：10.3969/j.issn.1009-6469.2024.02.040 |
| 中文关键词: 原发性肝癌 化学疗法，肿瘤，局部灌注 肝动脉热灌注化疗栓塞 信迪利单抗 疗效 生存率 |
| 英文关键词: Primary liver cancer Chemotherapy,cancer,regional perfusion Hepatic arterial hyperthermic perfusion chemoemboli. zation Sintilimab Efficacy Survival rate |
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| 中文摘要: |
| 目的探讨肝动脉灌注化疗栓塞术( TACE)联合信迪利单抗治疗晚期原发性肝癌( PLC)的近期疗效及远期生存率。方法 2018年 4月至 2019年 4月在资阳市人民医院 82个随机双盲实验中，对符合 AASLD指南，巴塞罗那( BCLC)分期为 B/C期者；肝功能 Child-Pugh分级 A/B级的 PLC进行研究。经计算机生成的随机列表随机分配，对照组仅行 TACE治疗，研究组则采用 TACE联合信迪利单抗治疗，连续治疗 4周期比较两组临床疗效、肿瘤标志物水平 T淋巴细胞亚群指标变化，随访观察远期生存情况。结果对照组和研究组病人各 41例，治疗后 1个月时对照组肿瘤控制率( DCR)为 80.49%，研究组 DCR为 92.68%，组间差异无统计学意义( χ2=2.63，P=0.105)；治疗后 3个月时研究组 DCR为 87.80%，明显高于对照组的 73.17%，组间差异有统计学意义(χ2=4.00，P=0.046)。治疗前，研究组甲胎蛋白(AFP)、高尔基体蛋白 73(GP-73)及甲胎蛋白异质体 3(AFP-L3)水平分别为( 82.74±5.77)μg/L、(90.27±4.67)μg/L及( 148.74±62.15)mg/L，对照组 3项指标水平依次为( 84.28±6.02)μg/L、(89.74±5.32) μg/L、(156.20±41.03)mg/L，组间数据差异无统计学意义( t=1.18，t=0.48，t=0.64，P>0.05)；治疗后研究组 AFP、GP-73及 AFP-L水平分别为(14.22±2.60)μg/L、(49.39±5.63)μg/L、(82.41±21.75)mg/L，均显著低于对照组的(57.13±6.21)μg/L、(65.28±3.74)μg/L、(117.20±35.62)mg/L，组间差异有统计学意义( t=40.81，t=15.05，t=5.34，P<0.05)。治疗前，研究组 CD4+、CD8+及 CD4+/CD8+水平分别为( 29.17±6.33)%、(27.86±3.92)%、(1.04±0.25)对照组依次为( 28.63±5.41)%、(28.53±4.63)%及( 1.01±0.20)组间差异无统计学意义( t=0.42，t=0.73，t=0.60，P>0.05)；治疗后组 CD4+、CD4+/CD8+水平分别为( 36.28±4.11)%、(1.33±0.40，显著高于对照组的( 30.52±5.01)%及( 1.09±0.32)，组间差异有统计学意义( t=5.69，t=3.00，P<0.05)。治疗前，研究组 CD151、CD168、CD9及 CD63分别为( 94.18±18.33)%、(96.27±16.08)%、(98.52±16.33)%、(94.57±10.96)%，对照组 4项数据水平依次为( 96.31± 研究，)，21.05)%、(97.24±14.20)%、(99.36±17.41)%、(93.64±12.60)%，组间差异无统计学意义( t=0.49，t=0.29，t=0.23，t=0.36，P>0.05)；治疗后研究组 CD151、CD168指标水平分别为( 32.06±6.34)%、(31.28±4.78)%，显著低于对照组的( 87.36±15.03)%、(76.34±11.52)%，而 CD9及 CD63水平分别为( 210.54±27.12)%、(247.02±30.21)%，显著高于对照组的( 104.52±12.94)%、(110.32±16.30)%，组间差异有统计学意义( t=21.71，t=23.13，t=22.59，t=25.50，P<0.05)。治疗后随访 36~48个月，研究组失访 3例，总生存率为 47.37%，对照组失访 1例，总生存率为 25.0%，组间差异有统计学意义( χ2=4.24，P=0.040)。研究组 ≥3级毒副反应总发生率为 13.16%，与对照组 27.5%差异无统计学意义(χ2=2.46，P=0.117)。结论 TACE联合 PD-1治疗晚期 PLC可降低机体肿瘤标志物水平、提升病人的免疫功能及近期疗效，同时可延长病人远期生存率，严重毒副反应发生率较低。 |
| 英文摘要: |
| Objective To investigate the short-term efficacy and long-term survival rate of hepatic arterial infusion chemoemboliza.tion (TACE) combined with sindillizumab in the treatment of advanced primary liver cancer (PLC). Methods The liver function of Child-Pugh grade A/B PLC was studied from April 2018 to April 2019. The control group received only TACE treatment, while thestudy group received TACE combined with sidillizumab treatment for 4 consecutive cycles. The clinical efficacy and changes in T lym.phocyte subsets of tumor markers were compared between the two groups, and the long-term survival was followed up.Results There were 41 patients in the control group and the study group respectively. At one month after treatment, the DCR of the control group was80.49% and that of the study group was 92.68%, with no significant difference between the two groups (χ2=2.63, P=0.105). At 3 months after treatment, the DCR of the study group was 87.80%, which was significantly higher than that of the control group (73.17%), and thedifference was statistically significant (χ2=4.00, P=0.046). Before treatment, AFP, GP-73 and AFP-L3 levels in the study group were(82.74±5.77)μg/L, (90.27±4.67)μg/L and (148.74±62.15)mg/L, respectively. The levels of the three indexes in the control group were(84.28±6.02)μg/L, (89.74±5.32)μg/L, and (156.20±41.03)mg/L, respectively, and there was no statistical difference between the groups(t=1.18, t=0.48, t=0.64, all P>0.05). After treatment, the levels of AFP, GP-73 and AFP-L in the study group were (14.22±2.60) μg/L,(49.39±5.63)μg/L and (82.41±21.75)mg/L, respectively. They were significantly lower than (57.13±6.21)μg/L, (65.28±3.74)μg/L, and(117.20±35.62)mg/L in the control group, with statistical significance between groups (t=40.81, t=15.05, t=5.34, all P<0.05). Before treatment, the levels of CD4+, CD8+ and CD4+/CD8+ in the study group were (29.17±6.33)%, (27.86±3.92)% and (1.04±0.25), respec.tively, while those in the control group were (28.63±5.41)%,(28.53±4.63)% and (1.01±0.20), respectively.There was no significant dif.ference between groups (t=0.42,t=0.73,t=0.60, all P>0.05).After treatment, the levels of CD4+ and CD4+/CD8+ in the study group were(36.28±4.11)% and (1.33±0.40), respectively,which were significantly higher than those in the control group (30.52±5.01)% and (1.09±0.32), and the differences between groups were statistically significant (t=5.69,t=3.00,P<0.05).Before treatment, CD151, CD168, CD9and CD63 in the study group were (94.18±18.33)%,(96.27±16.08)%,(98.52±16.33)%, (94.57±10.96)%, respectively. The four data lev.els of the control group were (96.31±21.05)%,(97.24±14.20)%,(99.36±17.41)%,(93.64±12.60)%, and there was no significant differ.ence between groups (t=0.49,t=0.29,t=0.23,t=0.36,all P>0.05).After treatment, the levels of CD151 and CD168 in the study group were(32.06±6.34)% and (31.28±4.78)% , which were significantly lower than those in the control group (87.36±15.03)% and (76.34±11.52)%, respectively.The levels of CD9 and CD63 were (210.54±27.12)% and (247.02±30.21)%, respectively, which were significant.ly higher than those of the control group (104.52±12.94)% and (110.32±16.30)%, and the difference between groups was statisticallysignificant (t=21.71, t=23.13,t=22.59, t=25.50,P<0.05). After 36 to 48 months of follow-up, 3 cases were lost to follow-up in the study group, and 1 case was lost to follow-up in the control group, with the overall survival rate of 47.37%, and the overall survival rate of25.0%, the difference between the groups was statistically significant (χ2=4.24,P=0.040). The total incidence of grade 3 in the studygroup was 13.16%,in the control group was 27.5%, and there was no statistically significant difference between the groups (χ2=2.46,P= 0.117).Conclusion TACE combined with PD-1 in the treatment of advanced PLC can reduce the level of tumor markers,improve the immune function and short-term efficacy of patients, and prolong the long-term survival rate of patients, with a low incidence of severe side effects. |
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