国产内镜新光学染色技术应用价值的多中心研究
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1.河北医科大学第一医院内镜中心;2.上海市第十人民医院消化科;3.苏州大学附属第二医院消化科;4.河北医科大学第一医院健康学院、健康管理中心;5.河北医科大学第一医院病理科

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河北省政府资助临床医学优秀人才培养项目(LS201905); 河北省高层次人才资助项目(A201802017);河北省老年病防治项目(LNB201809,LNB201909);河北省医学适用技术跟踪项目(G2019035);河北省重点研发计划项目(18277741D);中国消化道癌医师共同成长计划科研项目(GTCZ-2020-HB-13-0003);河北医科大学第一医院“星火”科研项目(XH201805)


Diagnostic value of the new optical staining technology for domestic endoscope: a multicenter clinical study
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Affiliation:

the First Hospital of Hebei Medical University

Fund Project:

Hebei Government Outstanding Clinical Medical Talent Training Project (LS201905); Hebei High?level Talent Fund (A201802017); Geriatric Disease Prevention and Control Project of Hebei (LNB201809, LNB201909); Hebei Medical Applicable Technology Tracking Project (G2019035); Key Research and Development Program of Hebei (18277741D); Growth Plan of Chinese Physicians in Gastrointestinal Cancer (GTCZ?2020?HB?13?0003);

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    摘要:

    目的 采取前瞻性设计、多中心随机对照临床研究方法,探讨国产内镜新光学染色技术——聚谱成像(spectral focused imaging,SFI)及光电复合染色成像(variable intelligent staining technology,VIST)对于胃癌前病变的诊断价值。方法 2020年8月—2021年5月,采用同一技术方案在河北医科大学第一医院、上海市第十人民医院、苏州大学附属第二医院,将拟行胃镜检查的患者随机分成白光组和新光学染色组,采取序贯检查方式(白光→新光学染色或新光学染色→白光),分别记录两组先行白光或先行新光学染色检查时的内镜诊断结果和幽门螺杆菌(Helicobacter pylori, HP)感染的判断结果;同时对两组的胃黏膜萎缩、肠上皮化生、皱襞肿大、结节性胃炎和弥漫性发红5个方面进行内镜胃癌风险评分。结果 共入组病例合计419例,白光组208例,新光学染色组211例。结合内镜及病理学结果,对胃内炎症、萎缩、肠上皮化生、低级别上皮内瘤变、高级别上皮内瘤变、进展期癌病变,白光组检出率分别为:28.9%、40.4%、64.9%、17.8%、0.5%、0.5%,新光学染色组检出率为:30.8%、42.7%、62.6%、15.2%、2.8%、0.5%,检出率组间差异无统计学意义(P>0.05);以病理结果为金标准,计算国产内镜诊断各类病变的灵敏度、特异度、准确度、阳性预测值、阴性预测值,对胃黏膜萎缩的诊断白光组分别为92.9%、61.3%、74.0%、61.9%、92.7%,新光学染色组(SFI模式)为94.4%、64.5%、77.3%、66.4%、94.0%;对胃黏膜肠上皮化生的诊断,白光组为68.1%、72.6%、69.7%、82.1%、55.2%,新光学染色组(VIST模式)为87.1%、89.9%、88.2%、93.5%、80.7%,两组间比较差异有统计学意义(P<0.05);以13C尿素呼气试验(13C‑urea breath test, 13C‑UBT)结果为金标准,对HP感染判断,白光组为90.2%、84.3%、87.4%、86.8%、88.2%,新光学染色组为92.6%、77.1%、85.4%、82.2%、90.1%;胃癌风险评分≥4分的病例,新光学染色组高危病变的占比更高(P<0.05)。结论 国产内镜新光学染色技术对胃黏膜肠上皮化生有较高的诊断价值,优于白光内镜;以胃癌风险评分为工具进行精查胃镜有助于胃癌前病变的检出;国产内镜新光学染色技术对胃癌前病变及HP感染诊断效能与进口内镜相近,是发现胃黏膜癌前病变的有效手段。

    Abstract:

    Objective A prospective, multicenter randomized controlled clinical research was conducted to explore the diagnostic value of the new optical staining technology for domestic endoscope, spectral focused imaging (SFI) and variable intelligent staining technology (VIST), for gastric precancerous lesions. Methods Patients who intended to undergo gastroscopy between August 2020 and May 2021 were randomly divided into the white light group and the new optical staining group at the First Hospital of Hebei Medical University, Shanghai Tenth People""s Hospital and the Second Affiliated Hospital of Soochow University. A sequential examination method was applied (white light to new optical staining or new optical staining to white light). The endoscopic diagnostic results and the detection results of Helicobacter pylori (HP) of the two groups were recorded. At the same time, such five variables as gastric mucosal atrophy, intestinal metaplasia, fold enlargement, nodular gastritis and diffuse redness were evaluated for the risk of gastric cancer in the two groups. Results A total of 419 cases were enrolled, including 208 cases in the white light group and 211 cases in the new optical staining group. Compared with pathological findings, the detection rates of gastric inflammation, atrophy, intestinal metaplasia, low-grade intraepithelial neoplasia, high-grade intraepithelial neoplasia and advanced cancer lesions in the white light group were 28.9%, 40.4%, 64.9%, 17.8%, 0.5% and 0.5% respectively; while those in the new optical staining group were 30.8%, 42.7%, 62.6%, 15.2%, 2.8% and 0.5%. There were no significant differences in the detection rates between the two groups (P>0.05). Compared with pathology, the sensitivity, the specificity, the accuracy, the positive predictive value and the negative predictive value for gastric mucosal atrophy in the white light group were 92.9%, 61.3%, 74.0%, 61.9% and 92.7% respectively and those in the new optical staining group (SFI mode) were 94.4%, 64.5%, 77.3%, 66.4% and 94.0% respectively. The above 5 measures for gastric mucosal intestinal metaplasia were 68.1%, 72.6%, 69.7%, 82.1% and 55.2% in the white light group, and 87.1%, 89.9%, 88.2%, 93.5% and 80.7% in the new optical staining group (VIST mode), with significant difference between the two groups (P<0.05). In terms of HP infection with 13C-urea breath test (13C-UBT) results as the gold standard, the above 5 measures were 90.2%, 84.3%, 87.4%, 86.8% and 88.2% in the white light group and 92.6%, 77.1%, 85.4%, 82.2% and 90.1% in the new optical staining group respectively. The proportion of high-risk gastric lesions in the new optical staining group was higher in cases of a gastric cancer risk score≥ 4 (P<0.05). Conclusion The new optical staining technology of domestic endoscopy has higher diagnostic value for gastric mucosal intestinal metaplasia. Gastroscopy is helpful for the detection of precancerous lesions with gastric cancer risk score as a tool. The new optical staining technology of domestic endoscopy is similar to imported endoscopy in diagnosing gastric precancerous lesions and HP infection, which is an effective means to detect gastric mucosal precancerous lesions.

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韩双双,邬瑞金,陆一峰,等.国产内镜新光学染色技术应用价值的多中心研究[J].中华消化内镜杂志,2022,39(4):281-289.

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  • 收稿日期:2021-08-03
  • 最后修改日期:2022-04-01
  • 录用日期:2021-09-06
  • 在线发布日期: 2022-04-25
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