纳米刀消融肝脏恶性肿瘤的有效性与安全性研究

Study on the Efficacy and Safety of Nanoknife Ablation for Liver Malignant Tumors

摘要: 目的：本研究通过与射频消融做比较，评估纳米刀消融肝脏恶性肿瘤的有效性与安全性。方法：组织收集我院2019年4月~2019年11月不适合手术切除的肝脏恶性肿瘤患者40例，随机分为试验组和对照组各20例，试验组行全麻下纳米刀消融，对照组行局麻射频消融。本研究消融术后立刻做增强CT进行评估，并在术后1周、3个月通过增强MR进行观察随访，以肿瘤消融成功率为有效性的主要评价指标，以3个月肿瘤复发率、肿瘤消融时间、手术并发症等为次要评价指标，以不良反应发生率、实验室检查结果为安全性评价指标，对其临床有效性及安全性进行评价。采用非劣效检验，非劣效界值为10%。结果：所有手术均顺利完成，两组患者在基本资料方面不存在明显差异。试验组消融成功率pT为91.7% (22/24)，对照组pC为96.2% (25/26)，试验组消融成功率非劣于对照组(H > −10%)。3个月后复查动态增强MR，试验组复发率为8.33% (2/24)，对照组为7.69% (2/26)，两组差异亦无统计学意义(P > 0.05)，无失访病例。平均消融时间分别为13 min (6~17 min)、17 min (10~28 min)，两组差异具有统计学意义(P < 0.05)。两组不良反应发生率及实验室检查结果比较无明显差异(P > 0.05)，不良反应主要为发热、腹痛、恶心呕吐及转氨酶一过性升高等，经积极对症治疗后均好转。结论：纳米刀消融创伤小、安全、有效，不劣于射频消融术，是肝脏恶性肿瘤的有效治疗模式。

Abstract: Objective: This study evaluates the effectiveness and safety of nanoknife ablation for liver malig-nant tumors by comparing it with radiofrequency ablation. Method: 40 patients with liver malig-nant tumors who were not suitable for surgical resection in our hospital from April 2019 to No-vember 2019 were collected and randomly divided into an experimental group and a control group of 20 cases each. The experimental group received nanoknife ablation under general anesthesia, while the control group received radiofrequency ablation under local anesthesia. In this study, en-hanced CT was performed immediately after ablation for evaluation, and enhanced MR imaging was used for observation and follow-up at 1 week and 3 months after surgery. The success rate of tumor ablation was the main evaluation indicator for effectiveness, and the 3-month tumor recurrence rate, tumor ablation time, surgical complications, etc. were secondary evaluation indicators. The in-cidence of adverse reactions and laboratory test results were used as safety evaluation indicators to evaluate its clinical efficacy and safety. Using non inferiority testing, the non inferiority threshold is 10%. Result: All surgeries were successfully completed, and there was no significant difference in basic information between the two groups of patients. The success rate of ablation in the experi-mental group pT = 91.7% (22/24), control group pC was 96.2% (25/26), and the success rate of ab-lation in the experimental group was not inferior to that in the control group (H > −10%). After 3 months of follow-up with dynamic enhanced MR imaging, the recurrence rate in the experimental group was 8.33% (2/24) and 7.69% (2/26) in the control group. There was no statistically signifi-cant difference between the two groups (P > 0.05), and there were no lost cases. The average abla-tion time was 13 minutes (6~17 minutes) and 17 minutes (10~28 minutes), respectively, and the difference between the two groups was statistically significant (P < 0.05). There was no significant difference in the incidence of adverse reactions and laboratory test results between the two groups (P > 0.05). The main adverse reactions were fever, abdominal pain, nausea and vomiting, and tran-sient elevation of transaminases. After active symptomatic treatment, all improved. Conclusion: Nanoknife ablation is minimally invasive, safe, and effective, not inferior to radiofrequency ablation, and is an effective treatment mode for liver malignant tumors.