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目的 :探讨超声内镜(endoscopic ultrasonography,EUS)引导下瘤体内注射H101治疗胰腺癌的方法及疗效。方法:92例中晚期胰腺癌根据意愿分为H101组(n=40)及化疗组(n=52)。其中H101组给予EUS引导下瘤体内注射H101联合吉西他滨治疗,化疗组给予静脉注射吉西他滨单药化疗。分析治疗后瘤体变化、KPS及VAS评分、生存分析及治疗不良反应。结果:H101组治疗4、12个月后部分缓解(PR)率及有效率(40.0%,62.5%)均显著高于化疗组(16.7%,20.0%)(P<0.05)。H101组及化疗组12个月内存活患者KPS评分在治疗4、8、12个月后均较治疗前显著升高(P<0.05),VAS评分均显著降低(P<0.05),而2组之间相比各时间点VAS及KPS评分均无显著差异(P>0.05)。H101组12个月内病死率(60.0%)较化疗组(80.8%)显著降低(χ~2=4.810,P=0.028)。H101组中位生存期为(8.8±0.5)个月(95%CI:7.87~9.68),较化疗组(7.6±0.4)个月显著延长(χ~2=3.976,P=0.046)。结论:EUS引导下瘤体内注射H101联合吉西他滨治疗中晚期胰腺癌是安全有效的,有助于提高患者生存质量、延长生存期。
Objective: To investigate the method and efficacy of H101 injection in the treatment of pancreatic cancer under the guidance of endoscopic ultrasonography (EUS). Methods: 92 patients with advanced pancreatic cancer were divided into H101 group (n = 40) and chemotherapy group (n = 52) according to their wishes. Among them, H101 group received EUS-guided intratumoral injection of H101 combined with gemcitabine, and the chemotherapy group received intravenous gemcitabine monotherapy. The changes of tumor after treatment, KPS and VAS score, survival analysis and treatment of adverse reactions were analyzed. Results: The rates of partial remission (PR) and effective rate (40.0%, 62.5%) in H101 group were significantly higher than those in chemotherapy group (16.7%, 20.0%) after 4 and 12 months of treatment (P <0.05). The KPS scores of surviving patients in H101 group and chemotherapy group within 12 months after treatment were significantly higher than those before treatment (P <0.05) and VAS scores were significantly lower at 4, 8 and 12 months after treatment (P <0.05) There was no significant difference between VAS and KPS scores at all time points (P> 0.05). The mortality rate (60.0%) in H101 group was significantly lower than that in chemotherapy group (80.8%) (χ ~ 2 = 4.810, P = 0.028) within 12 months. The median survival time in H101 group was (8.8 ± 0.5) months (95% CI: 7.87-9.68), significantly longer than that in chemotherapy group (7.6 ± 0.4) months (χ ~ 2 = 3.976, P = 0.046). Conclusion: EUS-guided injection of H101 combined with gemcitabine in the treatment of advanced pancreatic cancer is safe and effective, which can help improve the quality of life of patients and prolong the survival period.