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用于检测膀胱癌患者原位癌的六氨基乙酰丙酸荧光膀胱镜检查与白光膀胱镜检查的比较:一项III期多中心研究。

A comparison of hexaminolevulinate fluorescence cystoscopy and white light cystoscopy for the detection of carcinoma in situ in patients with bladder cancer: a phase III, multicenter study.

作者信息

Fradet Yves, Grossman H Barton, Gomella Leonard, Lerner Seth, Cookson Michael, Albala David, Droller Michael J

机构信息

L'Hotel-Dieu de Québec, Centre Hospitalier Universitaire de Québec, Québec, Province de Québec, Canada.

出版信息

J Urol. 2007 Jul;178(1):68-73; discussion 73. doi: 10.1016/j.juro.2007.03.028. Epub 2007 May 11.

DOI:10.1016/j.juro.2007.03.028
PMID:17499291
Abstract

PURPOSE

We compared hexaminolevulinate (Hexvix) fluorescence cystoscopy with white light cystoscopy for detecting carcinoma in situ.

MATERIALS AND METHODS

In this multicenter study 298 patients with known or suspected bladder cancer underwent bladder instillation with 50 ml 8 mM hexaminolevulinate for 1 hour. Cystoscopy was then performed, first using standard white light and then hexaminolevulinate fluorescence cystoscopy. Lesions or suspicious areas identified under the 2 illumination conditions were mapped and biopsied for histological examination. In addition, 1 directed biopsy was obtained from an area appearing to be normal.

RESULTS

Of 196 evaluable patients 29.6% (58 of 196) had carcinoma in situ, including 18 with carcinoma in situ alone, and 35 with carcinoma in situ and concomitant papillary disease, which was only detected on random biopsy in 5. Of the 18 patients with no concomitant papillary disease carcinoma in situ was detected only by hexaminolevulinate fluorescence in 4 and only by white light in 4. In the group with concomitant papillary disease carcinoma in situ was found only by hexaminolevulinate fluorescence in 5 patients and only by white light in 3. The proportion of patients in whom 1 or more carcinoma in situ lesions were found only by hexaminolevulinate cystoscopy was greater than the hypothesized 5% (p=0.0022). Overall more carcinoma in situ lesions were found by hexaminolevulinate than by white light cystoscopy in 22 of 58 patients (41.5%), while the converse occurred in 8 of 58 (15.1%). Biopsy results confirmed cystoscopy findings. Of a total of 113 carcinoma in situ lesions in 58 patients 104 (92%) were detected by hexaminolevulinate cystoscopy and 77 (68%) were detected by white light cystoscopy, while 5 were detected only on directed visually normal mucosal biopsy. Hexaminolevulinate instillation was well tolerated with no local or systemic side effects.

CONCLUSIONS

In patients with bladder cancer hexaminolevulinate fluorescence cystoscopy with blue light can diagnose carcinoma in situ that may be missed with white light cystoscopy. Hexaminolevulinate fluorescence cystoscopy can be used in conjunction with white light cystoscopy to aid in the diagnosis of this form of bladder cancer.

摘要

目的

我们比较了六氨基乙酰丙酸(Hexvix)荧光膀胱镜检查与白光膀胱镜检查在检测原位癌方面的效果。

材料与方法

在这项多中心研究中,298例已知或疑似膀胱癌患者接受膀胱灌注50毫升8毫摩尔六氨基乙酰丙酸,持续1小时。然后进行膀胱镜检查,首先使用标准白光,然后进行六氨基乙酰丙酸荧光膀胱镜检查。在两种照明条件下识别出的病变或可疑区域进行标记并活检以进行组织学检查。此外,从看似正常的区域获取1次定向活检。

结果

在196例可评估患者中,29.6%(196例中的58例)患有原位癌,其中18例仅患有原位癌,35例患有原位癌并伴有乳头状病变,后者仅在随机活检中发现5例。在18例无伴发乳头状病变的患者中,4例仅通过六氨基乙酰丙酸荧光检测到原位癌,4例仅通过白光检测到。在伴有乳头状病变的组中,5例仅通过六氨基乙酰丙酸荧光发现原位癌,3例仅通过白光发现。仅通过六氨基乙酰丙酸膀胱镜检查发现1个或更多原位癌病变的患者比例大于假设的5%(p = 0.0022)。总体而言,在58例患者中的22例(41.5%)中,通过六氨基乙酰丙酸发现的原位癌病变比白光膀胱镜检查更多,而在58例中的8例(15.1%)中情况相反。活检结果证实了膀胱镜检查结果。在58例患者共113个原位癌病变中,104个(92%)通过六氨基乙酰丙酸膀胱镜检查检测到,77个(68%)通过白光膀胱镜检查检测到,而5个仅在定向视觉正常黏膜活检时检测到。六氨基乙酰丙酸灌注耐受性良好,无局部或全身副作用。

结论

在膀胱癌患者中,蓝光六氨基乙酰丙酸荧光膀胱镜检查可诊断出白光膀胱镜检查可能遗漏的原位癌。六氨基乙酰丙酸荧光膀胱镜检查可与白光膀胱镜检查联合使用,以辅助诊断这种形式的膀胱癌。

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