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Article(id=1200026648667058640, tenantId=1146029695717560320, journalId=1189873630562394117, issueId=1200026645001241395, articleNumber=null, orderNo=null, doi=10.11855/j.issn.0577-7402.2225.2023.0524, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=research-article, receivedDate=1666800000000, receivedDateStr=2022-10-27, revisedDate=null, revisedDateStr=null, acceptedDate=1668441600000, acceptedDateStr=2022-11-15, onlineDate=1764038248458, onlineDateStr=2025-11-25, pubDate=1693152000000, pubDateStr=2023-08-28, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1764038248458, onlineIssueDateStr=2025-11-25, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1764038248458, creator=13701087609, updateTime=1764038248458, updator=13701087609, issue=Issue{id=1200026645001241395, tenantId=1146029695717560320, journalId=1189873630562394117, year='2023', volume='48', issue='8', pageStart='871', pageEnd='992', issueExtLink='null', onlineDate='null', pubDate='null', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=0, createTime=1764038247584, creator=13701087609, updateTime=1764038741950, updator=13701087609, preIssue=null, nextIssue=null, ext={EN=IssueExt(id=1200028718564474883, tenantId=1146029695717560320, journalId=1189873630562394117, issueId=1200026645001241395, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1200028718564474884, tenantId=1146029695717560320, journalId=1189873630562394117, issueId=1200026645001241395, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null}, startPage=929, endPage=935, ext={EN=ArticleExt(id=1200026650189591051, articleId=1200026648667058640, tenantId=1146029695717560320, journalId=1189873630562394117, language=EN, title=Evaluation of the therapeutic effect of everolimus on tuberous sclerosis related renal angiomyolipoma based on tumor components, columnId=1190310109000602400, journalTitle=Medical Journal of Chinese People’s Liberation Army, columnName=Clinical Research, runingTitle=null, highlight=null, articleAbstract=

Objective To evaluate the therapeutic effect of everolimus on tuberous sclerosis related renal angiomyolipoma (TSC-RAML) based on tumor components, and identify the types of main components in reducing RAML by everolimus. Methods To retrospectiely analyze the clinical data of 47 patients with TSC-RAML who were treated in the Urology Department of the First Affiliated Hospital of the Air Force Medical University and met the diagnostic criteria of ITSCCC from September 2017 to September 2022. According to the attenuation range of CT tissue specific threshold, patients were divided into fat rich group (HU ≤-10, n=26) and fat deficient group (HU ≥30, n=21). Collect patients' baseline CT data and 6 months after treatment, record the average CT value of RAML before and after treatment. Three-dimensional reconstruction of RAML was performed using Mimics software, and record the volume of RAML before and after treatment. The volume of RAML and mean CT value were compared between the two groups before and after treatment. Results No statistical difference existed in baseline characteristics between the two groups (P>0.05). The median reduction of tumor volume in fat rich group and fat deficient group of patients were 4.94 (3.12, 27.23) cm3 and 27.31 (10.83, 40.38) cm3, respectively, and the volume response rates were 11.52%±0.96% and 62.09%±12.60% respectively, the differences were statistically significant (P<0.05). The differences of average CT values between the fat rich group and fat deficient group were (4.23±3.01) HU and (14.52±3.61) HU respectively, and the reduction rates of CT values were 14.25%±11.94% and 29.23%±0.53% respectively, all were statistically significant (P<0.05). After treatment, the average CT value of tumors in fat deficient group decreased significantly compared to that in fat rich group with statistically significant difference (P<0.05). Six months after treatment with everolimus, the composition of high-density cord like vascular tissue in RAML tumors reduced significantly and fat conversion occurred. Conclusions The effect of everolimus on reducing tumor volume and average CT value of tumor in fat deficient RAML is better and significant, which confirmed that the reduction is the high-density component of TSC-RAML mainly composed of vascular components.

, correspAuthors=Guo-Jun Wu, authorNote=null, correspAuthorsNote=
E-mail:
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目的 基于肿瘤成分评估依维莫司对结节性硬化症相关肾血管平滑肌脂肪瘤(TSC-RAML)的治疗作用，明确依维莫司治疗后RAML中缩小的主要成分。方法 回顾性分析2017年9月-2022年9月于空军军医大学第一附属医院泌尿外科就诊且符合国际结节性硬化症共识会议(ITSCCC)诊断标准的47例TSC-RAML患者的临床资料。依据CT组织特异性阈值的衰减范围，将患者分为富脂肪组(HU≤-10，n=26)与乏脂肪组(HU≥30，n=21)。收集患者基线资料及治疗6个月后的CT数据，记录治疗前后RAML的平均CT值，并采用Mimics软件对RAML进行三维重建，记录治疗前后RAML的体积。比较两组治疗前后RAML的体积及平均CT值。结果 两组基线特征比较差异无统计学意义(P>0.05)。两组患者肿瘤体积缩小的中位数分别为4.94(3.12，27.23) cm3和27.31(10.83，40.38) cm3，体积反应率分别为11.52%±0.96%和62.09%±12.60%，差异均有统计学意义(P<0.05)。治疗前后富脂肪组与乏脂肪组肿瘤平均CT差值分别为(4.23±3.01) HU、(14.52±3.61) HU，肿瘤平均CT值降低率分别为14.25%±11.94%、29.23%±0.53%，差异均有统计学意义(P<0.05)。治疗后乏脂肪组肿瘤平均CT值降低程度明显高于富脂肪组，差异有统计学意义(P<0.05)。依维莫司治疗6个月后，RAML肿瘤内高密度条索状血管组织成分明显减少并出现脂肪转化现象。结论 依维莫司治疗乏脂肪性RAML时，缩小肿瘤体积及降低肿瘤平均CT值的效果更加显著，且缩小的是TSC-RAML中以血管成分为主的高密度成分。

, correspAuthors=武国军, authorNote=null, correspAuthorsNote=
武国军，E-mail：
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段永飞，硕士研究生，主要从事泌尿系肿瘤的临床研究

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段永飞，硕士研究生，主要从事泌尿系肿瘤的临床研究

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段永飞，硕士研究生，主要从事泌尿系肿瘤的临床研究

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PLoS One, 2011, 6(9): e23379., articleTitle=Multicenter phase 2 trial of sirolimus for tuberous sclerosis: kidney angiomyolipomas and other tumors regress and VEGF-D levels decrease, refAbstract=null), Reference(id=1200074167279255924, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1200026648667058640, doi=null, pmid=null, pmcid=null, year=2021, volume=67, issue=null, pageStart=101821, pageEnd=null, url=null, language=null, rfNumber=[25], rfOrder=26, authorNames=Heller N, Isensee F, Maier-Hein KH, journalName=Med Image Anal, refType=null, unstructuredReference=Heller N, Isensee F, Maier-Hein KH, et al. The state of the art in kidney and kidney tumor segmentation in contrast-enhanced CT imaging: results of the KiTS19 challenge[J]. Med Image Anal, 2021, 67: 101821., articleTitle=The state of the art in kidney and kidney tumor segmentation in contrast-enhanced CT imaging: results of the KiTS19 challenge, refAbstract=null), Reference(id=1200074167371530614, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1200026648667058640, doi=null, pmid=null, pmcid=null, year=2022, volume=221, issue=null, pageStart=106861, pageEnd=null, url=null, language=null, rfNumber=[26], rfOrder=27, authorNames=Hsiao CH, Sun TL, Lin PC, journalName=Comput Methods Programs Biomed, refType=null, unstructuredReference=Hsiao CH, Sun TL, Lin PC, et al. A deep learning-based precision volume calculation approach for kidney and tumor segmentation on computed tomography images[J]. 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TSC-RAML. 结节性硬化症相关肾血管平滑肌脂肪瘤

, figureFileSmall=ISLZTv5unJ/cACc1USqVGg==, figureFileBig=TODS83HJxZ7eoPUATntPXQ==, tableContent=null), ArticleFig(id=1200074163437273365, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1200026648667058640, language=EN, label=Fig.2, caption=Average CT difference of TSC-RAML in the two groups of patients after treatment with everolimus, figureFileSmall=ZB68uQUsoRz7SUbgzxmAFA==, figureFileBig=gDUreZ8BODOANb2iM+lG5w==, tableContent=null), ArticleFig(id=1200074163529548057, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1200026648667058640, language=CN, label=图2, caption=两组患者依维莫司治疗前后TSC-RAML的平均CT差值

TSC-RAML. 结节性硬化症相关肾血管平滑肌脂肪瘤

, figureFileSmall=ZB68uQUsoRz7SUbgzxmAFA==, figureFileBig=gDUreZ8BODOANb2iM+lG5w==, tableContent=null), ArticleFig(id=1200074163609239834, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1200026648667058640, language=EN, label=Fig.3, caption=Transformation of high-density vascular components and low-density fat components in RAML tumors after everolimus treatment, figureFileSmall=mWs63lcUwV6HVBnWetPunQ==, figureFileBig=+BSQjF5yhT4DdyGAXs8bog==, tableContent=null), ArticleFig(id=1200074163697320222, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1200026648667058640, language=CN, label=图3, caption=依维莫司治疗后RAML肿瘤内高密度血管成分及低密度脂肪成分的转化

黄色箭头示高密度条索状血管组织成分；红色箭头示低密度脂肪成分；A. 治疗前RAML的CT图像；B. 治疗6个月后RAML的CT图像

, figureFileSmall=mWs63lcUwV6HVBnWetPunQ==, figureFileBig=+BSQjF5yhT4DdyGAXs8bog==, tableContent=null), ArticleFig(id=1200074163860898081, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1200026648667058640, language=EN, label=Tab.1, caption=

Comparison of the baseline data of two groups of TSC-RAML patients

, figureFileSmall=null, figureFileBig=null, tableContent=
特征富脂肪组(n=26)乏脂肪组(n=21)t/χ2/ZP
年龄(岁, $\bar{x}±s$)43.1±11.439.5±12.01.0490.300
性别[例(%)]0.3340.563
男9(34.6)9(42.9)
女17(65.4)12(57.1)
肿瘤位置[例(%)]0.0010.970
左15(57.7)12(57.1)
右11(42.3)9(42.9)
BMI(kg/m2, $\bar{x}±s$)22.09±2.0822.45±2.10-0.5930.556
基线体积[cm3, M(Q1, Q3)]45(19.27, 99.82)40.14(19.60, 65.25)-0.7700.441
基线体积>100 cm3[例(%)]6(23.08)2(9.52)1.5110.219
皮肤特征[例(%)]
色素脱失斑14(53.8)8(38.1)1.1580.282
面部纤维瘤或头部纤维斑块18(69.2)13(61.9)0.2780.598
指(趾)甲纤维瘤12(52.2)11(52.4)0.1800.671
鲨革斑10(38.5)7(33.3)0.1320.716
大脑特征[例(%)]
皮质结节15(57.7)14(66.7)0.3960.529
室管膜下结节7(26.9)8(38.1)0.6670.414
室管膜下巨细胞星形细胞瘤9(34.6)6(28.6)0.1950.659
其他特征[例(%)]
肺淋巴管肌瘤病5(19.2)4(19.0)0.0000.987
肝血管平滑肌脂肪瘤1(3.80)3(14.3)1.6260.202
心脏横纹肌瘤4(15.4)2(9.5)0.3580.549
视网膜错构瘤6(23.1)4(19.0)0.1130.737
口内纤维瘤5(19.2)8(38.1)2.0660.152
牙釉质点状凹陷10(38.5)6(28.6)0.5060.477
), ArticleFig(id=1200074163953172772, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1200026648667058640, language=CN, label=表1, caption=

两组TSC-RAML患者基线资料比较

, figureFileSmall=null, figureFileBig=null, tableContent=
特征富脂肪组(n=26)乏脂肪组(n=21)t/χ2/ZP
年龄(岁, $\bar{x}±s$)43.1±11.439.5±12.01.0490.300
性别[例(%)]0.3340.563
男9(34.6)9(42.9)
女17(65.4)12(57.1)
肿瘤位置[例(%)]0.0010.970
左15(57.7)12(57.1)
右11(42.3)9(42.9)
BMI(kg/m2, $\bar{x}±s$)22.09±2.0822.45±2.10-0.5930.556
基线体积[cm3, M(Q1, Q3)]45(19.27, 99.82)40.14(19.60, 65.25)-0.7700.441
基线体积>100 cm3[例(%)]6(23.08)2(9.52)1.5110.219
皮肤特征[例(%)]
色素脱失斑14(53.8)8(38.1)1.1580.282
面部纤维瘤或头部纤维斑块18(69.2)13(61.9)0.2780.598
指(趾)甲纤维瘤12(52.2)11(52.4)0.1800.671
鲨革斑10(38.5)7(33.3)0.1320.716
大脑特征[例(%)]
皮质结节15(57.7)14(66.7)0.3960.529
室管膜下结节7(26.9)8(38.1)0.6670.414
室管膜下巨细胞星形细胞瘤9(34.6)6(28.6)0.1950.659
其他特征[例(%)]
肺淋巴管肌瘤病5(19.2)4(19.0)0.0000.987
肝血管平滑肌脂肪瘤1(3.80)3(14.3)1.6260.202
心脏横纹肌瘤4(15.4)2(9.5)0.3580.549
视网膜错构瘤6(23.1)4(19.0)0.1130.737
口内纤维瘤5(19.2)8(38.1)2.0660.152
牙釉质点状凹陷10(38.5)6(28.6)0.5060.477
), ArticleFig(id=1200074164058030375, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1200026648667058640, language=EN, label=Tab.2, caption=

Volume changes of TSC-RAML in the two groups of patients after treatment with everolimus

, figureFileSmall=null, figureFileBig=null, tableContent=
指标富脂肪组(n=26)乏脂肪组(n=21)Z/tP
基线体积[cm3, M(Q1, Q3)]45.00(19.27, 99.82)40.14(19.60, 65.25)-0.7700.441
治疗6个月后肿瘤体积[cm3, M(Q1, Q3)]40.05(15.28, 83.59)12.83(9.37, 17.47)-3.317<0.05
体积差值[cm3, M(Q1, Q3)]4.94(3.12, 27.23)27.31(10.83, 40.38)-4.044<0.05
体积反应率(%, $\bar{x}±s$)11.52±0.9662.09±12.6015.622<0.05
), ArticleFig(id=1200074164133527853, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1200026648667058640, language=CN, label=表2, caption=

依维莫司治疗后两组患者TSC-RAML的体积变化

, figureFileSmall=null, figureFileBig=null, tableContent=
指标富脂肪组(n=26)乏脂肪组(n=21)Z/tP
基线体积[cm3, M(Q1, Q3)]45.00(19.27, 99.82)40.14(19.60, 65.25)-0.7700.441
治疗6个月后肿瘤体积[cm3, M(Q1, Q3)]40.05(15.28, 83.59)12.83(9.37, 17.47)-3.317<0.05
体积差值[cm3, M(Q1, Q3)]4.94(3.12, 27.23)27.31(10.83, 40.38)-4.044<0.05
体积反应率(%, $\bar{x}±s$)11.52±0.9662.09±12.6015.622<0.05
), ArticleFig(id=1200074164200636720, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1200026648667058640, language=EN, label=Tab.3, caption=

Changes in average CT values of TSC-RAML in the two groups of patients after treatment with everolimus ($\bar{x}±s$)

, figureFileSmall=null, figureFileBig=null, tableContent=
指标富脂肪组(n=26)乏脂肪组(n=21)tP
基线平均CT值(HU)-42.12±19.2549.91±10.15-19.767<0.05
治疗6个月后平均CT值(HU)-46.35±17.8035.38±7.93-19.506<0.05
平均CT差值(HU)4.23±3.0114.52±3.61-10.655<0.05
平均CT值降低率(%)14.25±11.9429.23±0.53-15.458<0.05
), ArticleFig(id=1200074164267745587, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1200026648667058640, language=CN, label=表3, caption=

两组患者依维莫司治疗后TSC-RAML平均CT值的变化($\bar{x}±s$)

, figureFileSmall=null, figureFileBig=null, tableContent=
指标富脂肪组(n=26)乏脂肪组(n=21)tP
基线平均CT值(HU)-42.12±19.2549.91±10.15-19.767<0.05
治疗6个月后平均CT值(HU)-46.35±17.8035.38±7.93-19.506<0.05
平均CT差值(HU)4.23±3.0114.52±3.61-10.655<0.05
平均CT值降低率(%)14.25±11.9429.23±0.53-15.458<0.05
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基于肿瘤成分评估依维莫司对结节性硬化症相关肾血管平滑肌脂肪瘤的治疗作用
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段永飞 1, 2 , 武国军 2, * , 倪建鑫 2 , 严奉奇 3 , 郭佳恒 1 , 王东升 1
解放军医学杂志 | 临床研究 2023,48(8): 929-935
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解放军医学杂志 | 临床研究 2023, 48(8): 929-935
基于肿瘤成分评估依维莫司对结节性硬化症相关肾血管平滑肌脂肪瘤的治疗作用
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段永飞1, 2, 武国军2, * , 倪建鑫2, 严奉奇3, 郭佳恒1, 王东升1
作者信息
  • 1空军军医大学第一附属医院泌尿外科，陕西西安 710032
  • 2西安市人民医院泌尿肾脏病院，陕西西安 710004
  • 3空军军医大学第二附属医院泌尿外科，陕西西安 710038

    • 段永飞，硕士研究生，主要从事泌尿系肿瘤的临床研究

通讯作者:

武国军，E-mail：
Evaluation of the therapeutic effect of everolimus on tuberous sclerosis related renal angiomyolipoma based on tumor components
Yong-Fei Duan1, 2, Guo-Jun Wu2, * , Jian-Xin Ni2, Feng-Qi Yan3, Jia-Heng Guo1, Dong-Sheng Wang1
Affiliations
  • 1Department of Urology, the First Affiliated Hospital of the Air Force Medical University, Xi'an, Shaanxi 710032, China
  • 2Urology and Nephrology Hospital, Xi'an People's Hospital, Xi'an, Shaanxi 710004, China
  • 3Department of Urology, the Second Affiliated Hospital of the Air Force Medical University, Xi'an, Shaanxi 710038, China
出版时间: 2023-08-28 doi: 10.11855/j.issn.0577-7402.2225.2023.0524
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摘要
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目的 基于肿瘤成分评估依维莫司对结节性硬化症相关肾血管平滑肌脂肪瘤(TSC-RAML)的治疗作用，明确依维莫司治疗后RAML中缩小的主要成分。方法 回顾性分析2017年9月-2022年9月于空军军医大学第一附属医院泌尿外科就诊且符合国际结节性硬化症共识会议(ITSCCC)诊断标准的47例TSC-RAML患者的临床资料。依据CT组织特异性阈值的衰减范围，将患者分为富脂肪组(HU≤-10，n=26)与乏脂肪组(HU≥30，n=21)。收集患者基线资料及治疗6个月后的CT数据，记录治疗前后RAML的平均CT值，并采用Mimics软件对RAML进行三维重建，记录治疗前后RAML的体积。比较两组治疗前后RAML的体积及平均CT值。结果 两组基线特征比较差异无统计学意义(P>0.05)。两组患者肿瘤体积缩小的中位数分别为4.94(3.12，27.23) cm3和27.31(10.83，40.38) cm3，体积反应率分别为11.52%±0.96%和62.09%±12.60%，差异均有统计学意义(P<0.05)。治疗前后富脂肪组与乏脂肪组肿瘤平均CT差值分别为(4.23±3.01) HU、(14.52±3.61) HU，肿瘤平均CT值降低率分别为14.25%±11.94%、29.23%±0.53%，差异均有统计学意义(P<0.05)。治疗后乏脂肪组肿瘤平均CT值降低程度明显高于富脂肪组，差异有统计学意义(P<0.05)。依维莫司治疗6个月后，RAML肿瘤内高密度条索状血管组织成分明显减少并出现脂肪转化现象。结论 依维莫司治疗乏脂肪性RAML时，缩小肿瘤体积及降低肿瘤平均CT值的效果更加显著，且缩小的是TSC-RAML中以血管成分为主的高密度成分。

依维莫司  /  结节性硬化症  /  肾血管平滑肌脂肪瘤  /  体积  /  CT值

Objective To evaluate the therapeutic effect of everolimus on tuberous sclerosis related renal angiomyolipoma (TSC-RAML) based on tumor components, and identify the types of main components in reducing RAML by everolimus. Methods To retrospectiely analyze the clinical data of 47 patients with TSC-RAML who were treated in the Urology Department of the First Affiliated Hospital of the Air Force Medical University and met the diagnostic criteria of ITSCCC from September 2017 to September 2022. According to the attenuation range of CT tissue specific threshold, patients were divided into fat rich group (HU ≤-10, n=26) and fat deficient group (HU ≥30, n=21). Collect patients' baseline CT data and 6 months after treatment, record the average CT value of RAML before and after treatment. Three-dimensional reconstruction of RAML was performed using Mimics software, and record the volume of RAML before and after treatment. The volume of RAML and mean CT value were compared between the two groups before and after treatment. Results No statistical difference existed in baseline characteristics between the two groups (P>0.05). The median reduction of tumor volume in fat rich group and fat deficient group of patients were 4.94 (3.12, 27.23) cm3 and 27.31 (10.83, 40.38) cm3, respectively, and the volume response rates were 11.52%±0.96% and 62.09%±12.60% respectively, the differences were statistically significant (P<0.05). The differences of average CT values between the fat rich group and fat deficient group were (4.23±3.01) HU and (14.52±3.61) HU respectively, and the reduction rates of CT values were 14.25%±11.94% and 29.23%±0.53% respectively, all were statistically significant (P<0.05). After treatment, the average CT value of tumors in fat deficient group decreased significantly compared to that in fat rich group with statistically significant difference (P<0.05). Six months after treatment with everolimus, the composition of high-density cord like vascular tissue in RAML tumors reduced significantly and fat conversion occurred. Conclusions The effect of everolimus on reducing tumor volume and average CT value of tumor in fat deficient RAML is better and significant, which confirmed that the reduction is the high-density component of TSC-RAML mainly composed of vascular components.

everolimus  /  tuberous sclerosis  /  renal angiomyolipoma  /  volume  /  CT value
段永飞, 武国军, 倪建鑫, 严奉奇, 郭佳恒, 王东升. 基于肿瘤成分评估依维莫司对结节性硬化症相关肾血管平滑肌脂肪瘤的治疗作用. 解放军医学杂志, 2023 , 48 (8) : 929 -935 . DOI: 10.11855/j.issn.0577-7402.2225.2023.0524
Yong-Fei Duan, Guo-Jun Wu, Jian-Xin Ni, Feng-Qi Yan, Jia-Heng Guo, Dong-Sheng Wang. Evaluation of the therapeutic effect of everolimus on tuberous sclerosis related renal angiomyolipoma based on tumor components[J]. Medical Journal of Chinese People’s Liberation Army, 2023 , 48 (8) : 929 -935 . DOI: 10.11855/j.issn.0577-7402.2225.2023.0524
正文
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结节性硬化症(tuberous sclerosis complex，TSC)是由TSC1或TSC2基因突变导致的多系统遗传病[1]，以全身多器官的错构瘤为主要特征，在肾脏主要表现为由畸形血管、平滑肌和脂肪组织组成的肾血管平滑肌脂肪瘤(renal angiomyolipoma，RAML)，可见于80%以上的TSC患者[2]。随着RAML体积的增加，其破裂导致的出血及动脉高压等并发症是成年TSC患者死亡的主要原因之一[3]。影像学检查在TSC相关RAML(tuberous sclerosis complex-renal angiomyolipoma，TSC-RAML)的诊疗中具有重要地位，CT和磁共振成像(magnetic resonance imaging，MRI)诊断RAML均具有较高的准确性，2020年《中国结节性硬化症相关肾血管平滑肌脂肪瘤诊疗与管理专家共识》指南(简称指南)推荐MRI为RAML的首选检查方法，但CT仍因价格低、预约及检查过程容易等优点而广泛应用于临床[4]。维持肾功能、防止RAML扩大及破裂是TSC-RAML治疗的主要目的[5]。哺乳动物雷帕霉素靶蛋白(mammalian target of rapamycin，mTOR)抑制剂依维莫司已被证实对TSC-RAML有效[6]。指南明确遵循国际结节性硬化症共识会议(International Tuberous Sclerosis Complex Consensus Conference，ITSCCC)制定的治疗准则，将mTOR抑制剂作为无症状且RAML直径>3 cm成年患者的首选方案[4，7]。经过依维莫司治疗，RAML总体积虽然减小，但依维莫司影响TSC-RAML中的何种成分尚不清楚，这关系到患者后续治疗的选择，而国内相关研究报道较少。为此，本研究基于肿瘤成分评估依维莫司对TSC-RAML的治疗作用，以期为国内TSC-RAML患者的治疗及后期管理提供参考。
1 资料与方法
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1.1 研究对象
回顾性分析2017年9月-2022年9月于空军军医大学第一附属医院泌尿外科就诊且符合ITSCCC诊断标准的47例TSC-RAML患者的临床资料。纳入标准：(1)CT报告TSC-RAML最大直径≥3 cm，无出血史且未接受栓塞或手术治疗；(2)年龄≥18岁；(3)接受标准剂量依维莫司治疗且随访6个月。排除标准：CT显示肿瘤平均CT值为-10~+30 HU。
1.2 分组标准
根据放射学分类标准，一般小于-10 HU的衰减被认为是脂肪组织[8]，骨骼肌和平滑肌的衰减值为30~50 HU[9]，衰减大于100 HU的像素主要代表血管和高度血管化的肿瘤部分[10]。由于RAML中的脂肪分布可能是局灶性、分散性或弥漫性的，目前仅在病理学分析中形成了RAML的分类标准，当每个高倍视野中包含的脂肪细胞不超过25%时，可认为是乏脂肪性RAML[11]，而基于RAML的放射学分类并未建立共识[12]。本研究根据既往发表的阈值衰减范围创建了一个新的分类：当HU≤-10时，认为是富脂肪性RAML；当HU≥30时，认为是乏脂肪性RAML。依据CT组织特异性阈值的衰减范围，将患者分为富脂肪组(HU≤-10，n=26)与乏脂肪组(HU≥30，n=21)。
1.3 资料收集
收集患者的基本资料，记录其TSC相关临床表现，收集基线时和依维莫司治疗6个月后的CT数据，并以医学数字影像和通讯(digital imaging and communications in medicine，DICOM)格式接收保存相关数据，分别记录治疗前后RAML的平均CT值。利用Mimics软件对RAML进行三维重建，并记录软件所生成RAML的体积。密度评估为轴向CT图像上RAML整个区域的平均CT值。所有图像均由两名放射诊断专家分别进行评估。
1.4 Mimics软件下RAML的三维重建
将储存为DICOM格式的原始CT数据导入Mimics软件，获得初始蒙版图像，在感兴趣区域内进行所有像素点的灰度框选，框选范围内的像素点组成新的蒙版图像，然后借助阈值法、区域生长法等对图像进行逐层的自动及手动分割，分割成功后，对分割图像进行降噪、平滑、去除伪影等处理，最后获得RAML的三维重建模型(图1)。以上过程由具有丰富的Mimics使用经验的医师进行操作，获得的三维模型均经过放射科专家评审，以确保其精准性。
1.5 观察指标
比较两组患者基线时所有特征及临床表现，以及治疗前后RAML的体积及平均CT值。
1.6 统计学处理
采用SPSS 26.0软件进行统计分析。采用Shapiro-Wilk检验对连续变量数据进行正态性分析。符合非参数分布的计量资料以M(Q1，Q3)表示，组间比较采用两独立样本Wilcoxon符号秩检验；符合正态分布的计量资料以$\bar{x}±s$表示，组间比较采用独立样本t检验。计数资料以例(%)表示，组间比较采用χ2检验。P<0.05为差异有统计学意义。
2 结果
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2.1 两组基线资料比较
共纳入47例TSC-RAML患者，其中富脂肪组26例，乏脂肪组21例，均符合TSC的诊断标准。两组性别、年龄、体重指数(BMI)、肿瘤位置、基线体积、基线体积>100 cm3的肿瘤个数以及TSC的各临床特征比较，差异均无统计学意义(P>0.05，表1)。
2.2 依维莫司治疗后两组TSC-RAML的体积变化
治疗前，富脂肪组与乏脂肪组的基线肿瘤体积分别为45.00(19.27，99.82) cm3、40.14(19.60，65.25) cm3。依维莫司治疗6个月后，TSC-RAML的体积发生了不同程度的改变，但肿瘤体积反应在两组中分布不均。治疗后，富脂肪组与乏脂肪组的肿瘤体积分别为40.05(15.28，83.59) cm3、12.83(9.37，17.47) cm3，治疗前后肿瘤体积的差值分别为4.94(3.12，27.23) cm3、27.31(10.83，40.38) cm3，体积反应率分别为11.52%±0.96%、62.09%±12.60%。治疗后乏脂肪组肿瘤缩小程度明显高于富脂肪组，差异有统计学意义(P<0.05，表2)。
2.3 依维莫司治疗后两组TSC-RAML的平均CT值变化
依维莫司治疗6个月后，两组肿瘤平均CT值出现不同程度的改变，所有患者(n=47)RAML的平均CT值呈现下降趋势。富脂肪组中，3例肿瘤平均CT值增加，1例肿瘤平均CT值无变化，其余22例均出现不同程度的降低；乏脂肪组所有患者肿瘤的平均CT值均表现为不同程度的下降(图2)。治疗前，富脂肪组与乏脂肪组肿瘤基线平均CT值分别为(-42.12±19.25) HU、(49.91±10.15) HU，治疗6个月后肿瘤的平均CT值分别为(-46.35±17.80) HU、(35.38±7.93) HU，治疗前后肿瘤平均CT差值分别为(4.23±3.01) HU、(14.52±3.61) HU，肿瘤平均CT值降低率分别为14.25%±11.94%、29.23%±0.53%。治疗后乏脂肪组肿瘤平均CT值降低程度明显高于富脂肪组，差异有统计学意义(P<0.05，表3)。
此外，依维莫司治疗6个月后，RAML肿瘤内高密度条索状血管组织成分明显减少(图3，黄色箭头所示)，替代增多的为低密度脂肪成分，推测依维莫司缩小的高密度成分主要为血管成分，且在治疗后出现脂肪转化现象(图3，红色箭头所示)。
3 讨论
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RAML是肾脏最常见的良性肿瘤之一，约80%的TSC患者发生RAML且并发肿瘤破裂出血，而肿瘤大小是出血风险最常用的预测因子。目前通过肿瘤最大直径或椭球体积公式(π/6×长×宽×高)来衡量肿瘤大小及变化的方法不可避免地会导致主观性误差[13-14]。三维重建技术可最大程度地保真肿瘤的形状，且对肿瘤体积的预测具有较高的准确性。von Rundstedt等[15]研究发现，三维模型与实体肿瘤在形状及体积大小方面高度一致，表明三维模型可较准确地预测肿瘤的体积。Chung等[16]在监测依维莫司治疗TSC-RAML的反应性时发现，三维模型评估病灶体积的准确性优于二维测量病灶直径评估病灶体积。因此，本研究借助三维重建技术来获得更加准确的体积参数，以更精准地评估TSC-RAML在治疗前后的体积变化情况。
本研究纳入了47例TSC-RAML患者，并依据组织特异性阈值衰减范围分为富脂肪组(HU≤-10)与乏脂肪组(HU≥30)，两组性别、年龄、肿瘤位置、BMI、基线体积、基线体积>100 cm3的肿瘤个数以及TSC的各临床特征差异均无统计学意义(P>0.05)，排除了基线特征的影响。进一步分析治疗前后肿瘤体积的变化，结果显示，富脂肪组与乏脂肪组肿瘤体积的差值比较差异有统计学意义[4.94(3.12，27.23) cm3 vs. 27.31(10.83，40.38) cm3，P<0.05]，表明平均CT值较高的乏脂肪性RAML对治疗的反应较好；由于脂肪成分的CT值较低，血管平滑肌成分的CT值较高，提示肿瘤中血管平滑肌成分影响了治疗效果。Watanabe等[10]分析了富脂肪性与贫脂肪性RAML对西罗莫司治疗的反应性，结果显示，两组反应率分别为14.8%与66.7%，与本研究结果(分别为11.52%和62.09%)相似，表明西罗莫司与依维莫司治疗TSC-RAML可达到相似的效果。
本研究结果显示，富脂肪组与乏脂肪组患者治疗前后的平均CT差值分别为(4.23±3.01) HU和(14.52±3.61) HU(P<0.05)，乏脂肪组RAML的平均CT值降低更明显，分析原因为乏脂肪性RAML中高密度的血管平滑肌成分占比高、收缩率高，而富脂肪性RAML中脂肪含量多，高密度血管平滑肌成分收缩比例低，致使RAML整体平均CT值降低幅度小。此外，本研究发现，RAML内部的高密度条索状血管成分随着治疗被低密度脂肪组织所取代，表明依维莫司治疗后，RAML减少的主要是高密度血管成分。Brakemeier等[17]证实，TSC患者接受mTOR抑制剂治疗后，MRI检查显示RAML发生了明显的脂肪转化。另外，早期EXIST-2的扩展研究对107例服用依维莫司的患者进行了长达近30个月的随访，但随访期间并未发生RAML出血事件，证实依维莫司具有出血保护作用[18]。本研究证实依维莫司治疗后缩小的主要为高密度血管成分，提示治疗后血管成分减少，因此可降低出血风险，与EXIST-2的扩展研究结果一致。
依维莫司减少血管成分的效果显著，其原因可能是其损伤了哺乳动物雷帕霉素靶蛋白复合物1(mammalian target of rapamycin complex 1，mTORC1)而导致肿瘤内微血管阻塞和透明化，从而抑制了血管内皮细胞的增殖和血管生成[19-20]。人体内存在两种血管上皮生长因子(vascular endothelial growth factor，VEGF)，分别为VEGF-A和VEGF-D[21]，其中VEGF-A在体内的含量受mTOR通路的调节，mTORC1通过多条途径来驱动VEGF-A的信号转导，从而促进血管组织的生成[22]。TSC患者TSC1或TSC2基因失活可导致mTOR通路异常激活，从而增加了VEGF-A的含量，导致血管组织异常增生[23]。mTOR抑制剂依维莫司则可通过抑制mTORC1的合成，导致VEGF-A无法被激活，最终使TSC-RAML患者体内VEGF-A的含量下降，而且mTOR抑制剂治疗后，TSC患者体内的VEGF-D含量也会降低[24]。VEGF-A和VEGF-D含量降低均可导致TSC-RAML内血管成分的抑制，因此，对于具有更多血管成分的乏脂肪性RAML患者，使用mTOR抑制剂治疗可以获得更好的疗效。
本研究仍存在一定的局限性：首先，研究对象仅包括成年患者，且排除了TSC-RAML平均CT值为-10~+30HU的患者，存在一定的选择偏倚。其次，虽然目前三维成像评估肿瘤体积的方法更加准确已得到证实，但由于仍然缺乏专业的肾脏重建软件和精准的肾脏增强CT数据，不同组织的识别差异将导致重建模型具有一定的假阳性[25]。目前人工智能下以深度学习为代表的卷积神经网络分割技术正在兴起，且基于深度学习的肾脏分割算法计算出的体积与实际值相差微乎其微[26]，未来可能用于器官及肿瘤体积的精准评估。最后，虽然可观察到肿瘤内部血管组织减少或消失，但由于CT成像的精度问题以及TSC-RAML患者的个体差异，无法观察到每位患者血管成分的变化，后续仍需通过增加样本含量以及提高影像学精度来对本研究结果进行验证。
综上所述，本研究结果表明，依维莫司在乏脂肪性RAML中缩小肿瘤体积以及降低肿瘤平均CT值的效果更加显著，且其缩小的是TSC-RAML中以血管成分为主的高密度成分。TSC-RAML的平均密度可能是预测依维莫司对其治疗效果的一个重要指标。
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  • 国家自然科学基金(82002686)
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2023年第48卷第8期
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doi: 10.11855/j.issn.0577-7402.2225.2023.0524
  • 接收时间：2022-10-27
  • 首发时间：2025-11-25
  • 出版时间：2023-08-28
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  • 收稿日期：2022-10-27
  • 录用日期：2022-11-15
基金
National Natural Science Foundation of China(82002686)
国家自然科学基金(82002686)
作者信息
    1空军军医大学第一附属医院泌尿外科，陕西西安 710032
    2西安市人民医院泌尿肾脏病院，陕西西安 710004
    3空军军医大学第二附属医院泌尿外科，陕西西安 710038

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