“Hexvix”的意思、由来-开放百科全书

Hexvix is an optical imaging agent developed by the Norwegian pharmaceutical company Photocure ASA. Hexvix is designed to enhance detection of bladder cancer, in particular carcinoma in situ (CIS). It reveals lesions that may not be seen with standard white light cystoscopy. Hexvix is marketed in USA as Cysview.

The importance and superior efficacy of fluorescence cystoscopy compared to white light cystoscopy alone with respect to detection of non-muscle invasive tumours and, specially CIS, is reflected in the 2008 European Association of Urology Guidelines on TaT1 (Non-muscle invasive) Bladder Cancer, which clearly endorse the technique in its recommendation: "It has been confirmed that fluorescence-guided biopsy and resection are more sensitive than conventional procedures in detecting malignant tumour, particularly CIS."

On 5 October 2010 it was announced a newly published publication in Journal of Urology on Hexvix. This publication shows that Hexvix guided fluorescence cystoscopy (Hexvix), as an adjunct to conventional white-light cystoscopy, improves the detection of bladder cancer and reduces the rate of early tumour recurrence, compared with white-light cystoscopy alone.^[2]

On 10 November 2010 Nature (journal) published online an article claiming that Photodynamic diagnosis can improve surgical outcome on bladder cancer.^[3]

In April 2011 a new publication on Hexvix in British Journal of Urology (BJUI) was published. The results of this study confirm the results from a large prospective international study published in the Journal of Urology in November 2010. The results of the trial demonstrate that Hexvix identified lesions (including residual tumors) that were not detected with whitelight alone in 49% of the

patients. It also demonstrated that the improved detection of lesions resulted in a significant reduction in tumour recurrence within 12 months.^[4]

On 12 May 2011 it was announced results from a clinical study included retrospective follow up from 526 patients in a prospective randomized Phase III trial in 28 centers in EU and North America. After a follow-up period up to 5.5 years, the number of patients who have experienced recurrence of their bladder cancer is lower, and the time it takes before the recurrence occurs is longer when they had Hexvix-guided fluorescence cystoscopy.^[6]

On May 16, 2018 the Hexvix/Cysview indication was expanded to include surveillance cystoscopy of bladder cancer. The FDA-approved indication was a result of a large Phase 3 study using blue light rigid and flexible cystoscopes. Results showed that Blue Light Cystoscopy with Cysview/Hexvix significantly (p<0.0001) improves detection of patients with recurrent bladder cancer.^[7]

References

1. ^{{Cite web|url=https://www.hexvix.com/|title=Hexvix {{!}} Confidence at First Sight|language=en-US|access-date=2019-02-25}}
2. ^{{cite web|url=http://www.biotekforum.no/article.php?articleID%3D724%26categoryID%3D6 |title=Archived copy |accessdate=2010-11-14 |deadurl=yes |archiveurl=https://web.archive.org/web/20110724174408/http://www.biotekforum.no/article.php?articleID=724&categoryID=6 |archivedate=24 July 2011 |df=dmy-all }} Hexvix guided fluorescence cystoscopy reduces recurrence in patients
3. ^http://www.nature.com/nrurol/journal/v7/n11/full/nrurol.2010.183.html Bladder cancer: Photodynamic diagnosis can improve surgical outcome Nature Reviews Urology 7, 598-599 (November 2010) | {{doi|10.1038/nrurol.2010.183}}
4. ^{{cite web|url=http://urotoday.com/bladder-cancer-1038/fluorescence-guided-transurethral-resection-of-bladder-tumours-reduces-bladder-tumour-recurrence-due-to-less-residual-tumour-tissue-in-t-at1-patients-a-randomized-two-centre-study-abstract.html |title=Archived copy |accessdate=2011-04-22 |deadurl=yes |archiveurl=https://web.archive.org/web/20120331151159/http://www.urotoday.com/bladder-cancer-1038/fluorescence-guided-transurethral-resection-of-bladder-tumours-reduces-bladder-tumour-recurrence-due-to-less-residual-tumour-tissue-in-t-at1-patients-a-randomized-two-centre-study-abstract.html |archivedate=31 March 2012 |df=dmy-all }} Fluorescence-guided transurethral resection of bladder tumours reduces bladder tumour recurrence due to less residual tumour tissue in Ta/T1 patients A randomized two-centre study
5. ^http://www.newsweb.no/newsweb/search.do?messageId=278275 British Journal of Urology publishes paper on Hexvix
6. ^http://www.medicalnewstoday.com/releases/225061.php Hexvix(R)/Cysview Demonstrates Long Term Benefit: Results From 5.5 Year Follow Up Of Recurrence Of Bladder Cancer
7. ^{{Cite web|url=https://photocure.com/news/blc_surveillance_launch/|title=Photocure Announces Blue Light Cystoscopy with Cysview® now available for surveillance of bladder cancer|last=|first=|date=|website=|archive-url=|archive-date=|dead-url=|access-date=}}

References

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