高强度体外聚焦超声热疗治疗局部晚期胰腺癌的多中心临床研究

目的：探讨临床单用HIFU治疗局部晚期胰腺癌(local advanced pancreatic carcinoma，APC)的可能性。方法：4个中心共41例患者入选进行非随机病例对照研究，其中HIFU组24例，单用HIFU治疗；对照组17例，接受HIFU及吉西他滨综合治疗。比较两组的疗效、治疗费用及安全性，采用Cox回归分析进一步确定吉西他滨化疗对生存期的影响。结果：HIFU组临床受益率、平均生存期与对照组相似，分别为66．7％比76．5％(P=10．740)和141．5天比176．5天(P=0．3510)；而治疗费用较低，为20500元比51805元(P=0．000)；安全性更高。Cox回归分析显示仅体力状态、HIFU次数及临床受益进入方程(P=0．000)，化疗对生存期无影响。结论：单用HIFU治疗APC，其疗效等同于HIFU和吉西他滨的综合治疗，但较综合治疗经济、安全。推测可以单独应用HIFU治疗局部晚期胰腺癌．值得临床进一步验证。

A Multicenter Non-randomized Clinical Study on High Intensity Focused Ultrasound in Treating Patients with Local Advanced Pancreatic Carcinoma

Objective:The high intensity focused ultrasound(HIFU)has shown activity in advanced pancreatic carcinoma both as a monotherapy and in combination with gemcitabine.The aim of this project was to evaluate the possibility of HIFU as a monotherapy in treating local ad-vanced pancreatic carcinoma (APC).Methods:A non-randomized and case control study of HIFU alone(HIFU group)versus combination with gemcitabine(control group)in APC patients was con-ducted in4centers.Forty-one APC patients were eligible for this study,24cases of them were assigned to HIFU group,17to control one.The effect,safety and cost were compared in two groups.Cox regression analysis was used to evaluate the effect of gemcitabine on the survival of APC patients.Results:The clinical benefit response rate and the average survival were66.7%and145.1days for HIFU group,similal to that of76.5%(p=0.740)and176.5days(p=0.3510)for control one respectively,and the average cost for HIFU arm was20500yan,less than that of51805(P=0.000)for contral one.The former was much more safety than the latter.Cox regression analysis shown that performance status,times of HIFU and clinical benefit response were the most important factors influced the survival of APC patients (P=0.000).Conclusions:HIFU as a monotherapy and in combination with gemcitabine are equally effective for palliation of APC,but the former was more economy and less toxicity than the latter.HIFU as a monotherapy might be adopted to treat APC,It is worthy of further clinical trail.