国产与进口精确放疗设备治疗食管癌的临床回顾性比较研究
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摘要
目的:比较国产和进口精确放疗设备在治疗食管癌方面的疗效异同,以期明确国产放疗设备在食管癌治疗中的治疗效果及性价比优势。方法:回顾性分析采用进口医用直线加速器/治疗计划系统(treatment planning system,TPS)(进口组,96例)和国产医用直线加速器/TPS(国产组,118例)治疗的214例食管癌患者的临床病例资料,统计分析2组患者所用加速器及TPS种类、放疗方式及放疗费用,并比较2组的近期疗效、毒副反应以及相关的剂量学参数。采用SPSS 17.0统计学软件进行统计学分析。结果:国产组与进口组比较,近期疗效方面均无统计学差异(P>0.05);采用三维适形放疗与调强放疗2种不同的放疗方式,近期疗效指标亦无统计学差异(P>0.05)。急性放射性肺炎、放射性食管炎及血液学毒性方面,2组比较无统计学差异(P>0.05)。在剂量学参数方面,2组心脏V_(40)、V_(30)之间有统计学差异(P<0.05),国产组低于进口组;大体肿瘤靶区平均剂量(GTVmean),双肺V_5、V_(10)及脊髓最大剂量方面,2组比较也存在统计学差异(P<0.05),进口组低于国产组;计划靶区平均剂量(PTVmean),双肺V_(20)、V_(30)及平均剂量(mean lung dose,MLD)方面,国产组和进口组比较无统计学差异(P>0.05)。结论:在食管癌根治性放疗方面,进口精确放疗设备较国产具有一定的剂量学优势,但其价格昂贵、患者治疗成本较高,且未显示出明显的近期疗效和毒副反应方面的优势,国产精确放疗设备基本可以满足食管癌根治性放疗的需要。
Objective To compare the differences of response rate, toxicity and treatment cost of domestic versus imported precision radiotherapy equipment in the treatment of esophageal cancer. Methods Totally 214 esophageal cancer patients had their clinical data analyzed retrospectively, of whom 96 ones treated with imported medical linear accelerator and treatment planning system(TPS) were enrolled into an imported equipment group and the remained 118 ones with domestic equipment and TPS were into a domestic equipment group. The two groups had the data on types of accelerators and TPSs,radiotherapy modes as well as cost discussed statistically, and were compared for short-term effect, toxic and side effects as well as dosimetry parameter. SPSS 17.0 software was used for statistical analysis. Results There were no statistical differences between the short-term effects of the two groups(P>0.05); 3D CRT and IMRT proved to have no statistically different shortterm effects(P >0.05); the two groups had no obvious differences in acute radiation pneumonia, radiation esophagitis and hematologic toxicity(P>0.05). In terms of dosimetry parameters, the domestic equipment group had the values of cardiac V_(40) and V_(30) significantly lower than those of the imported equipment group(P <0.05); the imported equipment group had the values of GTVmean, V_5, V_(10) and spine maximum dose statistically lower than those of the domestic equipment group(P<0.05);the t wo groups had no significant differences between the values of PTVmean, V_(20), V_(30) and mean lung dose(MLD)(P>0.05).Conclusion Domestic radiotherapy equipment proves to be applicable to esophageal cancer radical radiotherapy due to its low cost and like short-term effect and adverse responses, although the imported equipment gains advantages in dosimetry.[Chinese Medical Equipment Journal,2019,40(5):48-53]
Objective To compare the differences of response rate, toxicity and treatment cost of domestic versus imported precision radiotherapy equipment in the treatment of esophageal cancer. Methods Totally 214 esophageal cancer patients had their clinical data analyzed retrospectively, of whom 96 ones treated with imported medical linear accelerator and treatment planning system(TPS) were enrolled into an imported equipment group and the remained 118 ones with domestic equipment and TPS were into a domestic equipment group. The two groups had the data on types of accelerators and TPSs,radiotherapy modes as well as cost discussed statistically, and were compared for short-term effect, toxic and side effects as well as dosimetry parameter. SPSS 17.0 software was used for statistical analysis. Results There were no statistical differences between the short-term effects of the two groups(P>0.05); 3D CRT and IMRT proved to have no statistically different shortterm effects(P >0.05); the two groups had no obvious differences in acute radiation pneumonia, radiation esophagitis and hematologic toxicity(P>0.05). In terms of dosimetry parameters, the domestic equipment group had the values of cardiac V_(40) and V_(30) significantly lower than those of the imported equipment group(P <0.05); the imported equipment group had the values of GTVmean, V_5, V_(10) and spine maximum dose statistically lower than those of the domestic equipment group(P<0.05);the t wo groups had no significant differences between the values of PTVmean, V_(20), V_(30) and mean lung dose(MLD)(P>0.05).Conclusion Domestic radiotherapy equipment proves to be applicable to esophageal cancer radical radiotherapy due to its low cost and like short-term effect and adverse responses, although the imported equipment gains advantages in dosimetry.[Chinese Medical Equipment Journal,2019,40(5):48-53]
引文
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[6]CHEN W,ZHENG R,BAADE P D,et al.Cancer statistics in China,2015[J].CA Cancer J Clin,2016,66(2):115-132.
[7]全力.我国医用直线加速器发展现状与进展[J].中国科技信息,2017(5):93-94.
[8]车宪民,王学梅.新华医疗承担的十二·五国家科技支撑计划课题通过验收[J].中国医疗器械信息,2014,20(11):73.
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[10]刘锐锋,张秋宁,魏世鸿,等.IMRT与3D-CRT治疗胸部食管癌的剂量学评价[J].肿瘤预防与治疗,2015,28(3):117-121.
[11]韩建军,贾霖,贾利,等.食管癌三维适形、调强放疗与常规放疗的临床效果比较[J].海南医学院学报,2016,22(13):1 469-1 472.
[12]COOPER J S,GUO M D,HERSKOVIC A,et al.Chemoradiotherapy of locally advanced esophageal cancer:long-term folow-up of a prospective randomized trial(RTOG 85-01)Radiation Therapy Oncology Group[J].JAMA,1999,281(17):1 623-1 627.
[13]曹晓岚,胡旭东.化疗方案对食管癌放疗的增效作用研究进展[J].肿瘤,2017,37(11):1 238-1 242.
[14]宋延波,李洪忠,何灿.乳腺癌保乳术后放射治疗技术前沿与进展[J].医疗卫生装备,2017,38(6):124-127.
[15]李全义,戴相昆,方春锋.国产医用直线加速器在早期乳腺癌术后放疗的剂量学特性分析[J].临床肿瘤学杂志,2016,21(9):805-809.
[16]胡红波,丘志芬,邵高峰.医用电子直线加速器应用质量检测结果分析[J].医疗卫生装备,2017,38(1):101-103.
[2]中国非手术治疗食管癌临床分期专家小组.非手术治疗食管癌的临床分期标准(草案)[J].中华放射肿瘤学杂志,2010,19(3):179-180.
[3]殷蔚伯,余子豪,徐国镇,等.肿瘤放射治疗学[M].4版.北京:中国协和医科大学出版社,2007:558-559.
[4]万钧,肖爱勤,高淑珍,等.食管癌放疗后近期疗效评价标准---附1000例分析[J].中国放射肿瘤学,1989,3(4):3-5.
[5]COX J D,STETZ J,PAJAK T F.Toxicity criteria of the Radiation Therapy Oncology Group(RTOG)and the European Organization for Research and Treatment of Cancer(EORTC)[J].Int J Radiat Oncol Biol Phys,1995,31:1 341-1 346.
[6]CHEN W,ZHENG R,BAADE P D,et al.Cancer statistics in China,2015[J].CA Cancer J Clin,2016,66(2):115-132.
[7]全力.我国医用直线加速器发展现状与进展[J].中国科技信息,2017(5):93-94.
[8]车宪民,王学梅.新华医疗承担的十二·五国家科技支撑计划课题通过验收[J].中国医疗器械信息,2014,20(11):73.
[9]夏育纯,朱培森.食管癌X线分型与放疗疗效关系61例分析[J].浙江肿瘤,1999,5(2):97-98.
[10]刘锐锋,张秋宁,魏世鸿,等.IMRT与3D-CRT治疗胸部食管癌的剂量学评价[J].肿瘤预防与治疗,2015,28(3):117-121.
[11]韩建军,贾霖,贾利,等.食管癌三维适形、调强放疗与常规放疗的临床效果比较[J].海南医学院学报,2016,22(13):1 469-1 472.
[12]COOPER J S,GUO M D,HERSKOVIC A,et al.Chemoradiotherapy of locally advanced esophageal cancer:long-term folow-up of a prospective randomized trial(RTOG 85-01)Radiation Therapy Oncology Group[J].JAMA,1999,281(17):1 623-1 627.
[13]曹晓岚,胡旭东.化疗方案对食管癌放疗的增效作用研究进展[J].肿瘤,2017,37(11):1 238-1 242.
[14]宋延波,李洪忠,何灿.乳腺癌保乳术后放射治疗技术前沿与进展[J].医疗卫生装备,2017,38(6):124-127.
[15]李全义,戴相昆,方春锋.国产医用直线加速器在早期乳腺癌术后放疗的剂量学特性分析[J].临床肿瘤学杂志,2016,21(9):805-809.
[16]胡红波,丘志芬,邵高峰.医用电子直线加速器应用质量检测结果分析[J].医疗卫生装备,2017,38(1):101-103.