体外高频热疗联合化疗治疗晚期胰腺癌的随机对照临床研究

In vitro hyperthermia in combination with chemotherapy for patients with advanced pancreatic carcinoma：a randomized controlled clinical trial

目的：评价体外高频热疗联合化疗治疗晚期胰腺癌的疗效和不良反应。方法收集首都医科大学附属北京友谊医院收治的经病理学确诊的75例晚期胰腺导管腺癌患者，按照1∶1比例生成随机分配序列分为化疗组和化疗＋热疗（联合治疗）组，治疗4个周期后评价疗效。结果治疗4个周期后化疗组完全缓解0例，部分缓解10例，稳定10例，进展17例，客观缓解率27．0％，疾病控制率54．1％；联合治疗组分别为0、18、15、5例及47．4％、86．8％。两组间疾病控制率差异有统计学意义（P ＝0．002），而客观缓解率差异无统计学意义（P＝0．069）。联合治疗组的疼痛缓解率、体能改善有效率分别为92．1％及84．2％，显著高于化疗组的21．6％及27．0％，差异均有统计学意义（ P值均＜0．05）。联合治疗组的中位生存时间及1年生存率分别为8．8个月和31．6％（12／38）；化疗组分别为7．9个月和27．0％（10／37），两组间差异无统计学意义。两组患者不良反应轻微，发生率无统计学意义，两组均无Ⅲ度及以上消化道反应，未出现Ⅳ度骨髓抑制。结论体外高频热疗联合化疗治疗晚期胰腺癌的疾病控制率、症状改善率显著高于化疗组，不良反应轻微，患者耐受性好，值得临床推广应用。

Objective To evaluate the curative efficacy and adverse events of in vitro hyperthermia in combination with chemotherapy for treating patients with advanced pancreatic carcinoma .Methods Seventy-five patients with advanced pancreatic carcinoma by pathologic diagnosis admitted in Beijing Friendship Hospital were enrolled and randomly divided into Group Combination （ hyperthermia and chemotherapy ） and Group Chemotherapy at the ratio of 1∶1.All the patients were treated for 4 cycles and the clinical efficacy were evaluated.Results After being treated for 4 cycles, the number of the patients in Group Chemotherapy who had complete response（CR）, partial response（PR）, stable disease（SD）, progressive disease（PD） was 0, 10, 10 and 17, the objective response rate （ORR） was 27.0%, and the disease control rates （DCR） was 54.1%, which in Group Combination was 0, 18, 15 and 5, and 47.4% and 86.8%, respectively.DCR between the two groups was statistically significantly different （ P=0.002 ）, but there was no statistical significance on DCR（P=0.069）.In Group Combination, the pain relief rate and physical fitness improvement＆amp;nbsp;rate was 92.1% and 84.2%, which were significantly higher than 21.6% and 27.0% in Group Chemotherapy, which had statistical significance （ both P＆lt;0.05 ）.The median survival time and 1-year survival rate in Group Combination was 8.8 months and 31.6%（12/38）, which in Group Chemotherapy was 17.86 months and 27.0%（10/37）, and there was no statistically significant difference between the two groups .The adverse events in two groups were mild , and no digestive tract reaction with III and IV degree and bone marrow suppression with IV degree were observed .Conclusions DCR and symptom improvement rate in Group Combination were higher than those in Group Chemotherapy , while the adverse events were mild , and patients could tolerate .This combination therapy was worthy of clinical application .