The effectiveness of regional cooling for paclitaxel-induced peripheral neuropathy
Identifieur interne : 000D71 ( Pmc/Curation ); précédent : 000D70; suivant : 000D72The effectiveness of regional cooling for paclitaxel-induced peripheral neuropathy
Auteurs : Junya Sato [Japon] ; Megumi Mori [Japon] ; Satoru Nihei [Japon] ; Masumi Kumagai [Japon] ; Satoshi Takeuchi [Japon] ; Masahiro Kashiwaba [Japon] ; Kenzo Kudo [Japon]Source :
- Journal of Pharmaceutical Health Care and Sciences [ 2055-0294 ] ; 2016.
Abstract
There are currently no promising therapies available to treat or prevent peripheral neuropathy (PN) induced by anticancer drugs in a cumulative dose-dependent manner. In this study, we investigated the efficacy of regional cooling of hands and feet in preventing paclitaxel (PTX)-induced PN.
Patients with gynecologic cancer who received a tri-weekly cycle of chemotherapy including PTX at doses of 150–175 mg/m2 were included in this study. Regional cooling was performed by covering patient hands and feet with cold insulators during PTX administration (regional cooling group). The primary end-point was ≥grade 2 PN evaluated by the Common Terminology Criteria for Adverse Events (CTCAE) v4.0. The secondary end-points were the frequency of PN therapeutic drug use, PTX dose reduction due to PN, and adverse events due to regional cooling. The efficacy of regional cooling was compared with data retrospectively extracted from the medical records of patients who did not receive regional cooling (control group). All end-points were evaluated for up to six cycles.
There were 40 and 142 patients in the regional cooling and control groups, respectively. As a primary end-point, incidences of ≥grade 2 PN in the fourth to sixth cycles were significantly lower than that in the cooling group (5.0–9.1 % vs. 19.8–31.6 %,
Regional cooling of hands and feet during PTX administration might have good effectiveness and tolerability, suggesting this approach as a potentially effective supportive care to prevent PTX-induced PN.
The trial approval number in the institution; H25-26. Registered 5 June 2014.
Url:
DOI: 10.1186/s40780-016-0067-2
PubMed: 27891244
PubMed Central: 5111235
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<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">The effectiveness of regional cooling for paclitaxel-induced peripheral neuropathy</title><author><name sortKey="Sato, Junya" sort="Sato, Junya" uniqKey="Sato J" first="Junya" last="Sato">Junya Sato</name><affiliation wicri:level="1"><nlm:aff id="Aff1">Department of Pharmacy, Iwate Medical University Hospital, 19-1 Uchimaru, Morioka, Iwate, 020-8505 Japan</nlm:aff><country xml:lang="fr">Japon</country><wicri:regionArea>Department of Pharmacy, Iwate Medical University Hospital, 19-1 Uchimaru, Morioka, Iwate</wicri:regionArea></affiliation><affiliation wicri:level="1"><nlm:aff id="Aff2">Department of Clinical Pharmaceutics, School of Pharmacy, Iwate Medical University, 2-1-1 Nishitokuta, Yahaba, Iwate, 028-3694 Japan</nlm:aff><country xml:lang="fr">Japon</country><wicri:regionArea>Department of Clinical Pharmaceutics, School of Pharmacy, Iwate Medical University, 2-1-1 Nishitokuta, Yahaba, Iwate</wicri:regionArea></affiliation></author><author><name sortKey="Mori, Megumi" sort="Mori, Megumi" uniqKey="Mori M" first="Megumi" last="Mori">Megumi Mori</name><affiliation wicri:level="1"><nlm:aff id="Aff1">Department of Pharmacy, Iwate Medical University Hospital, 19-1 Uchimaru, Morioka, Iwate, 020-8505 Japan</nlm:aff><country xml:lang="fr">Japon</country><wicri:regionArea>Department of Pharmacy, Iwate Medical University Hospital, 19-1 Uchimaru, Morioka, Iwate</wicri:regionArea></affiliation></author><author><name sortKey="Nihei, Satoru" sort="Nihei, Satoru" uniqKey="Nihei S" first="Satoru" last="Nihei">Satoru Nihei</name><affiliation wicri:level="1"><nlm:aff id="Aff1">Department of Pharmacy, Iwate Medical University Hospital, 19-1 Uchimaru, Morioka, Iwate, 020-8505 Japan</nlm:aff><country xml:lang="fr">Japon</country><wicri:regionArea>Department of Pharmacy, Iwate Medical University Hospital, 19-1 Uchimaru, Morioka, Iwate</wicri:regionArea></affiliation><affiliation wicri:level="1"><nlm:aff id="Aff2">Department of Clinical Pharmaceutics, School of Pharmacy, Iwate Medical University, 2-1-1 Nishitokuta, Yahaba, Iwate, 028-3694 Japan</nlm:aff><country xml:lang="fr">Japon</country><wicri:regionArea>Department of Clinical Pharmaceutics, School of Pharmacy, Iwate Medical University, 2-1-1 Nishitokuta, Yahaba, Iwate</wicri:regionArea></affiliation></author><author><name sortKey="Kumagai, Masumi" sort="Kumagai, Masumi" uniqKey="Kumagai M" first="Masumi" last="Kumagai">Masumi Kumagai</name><affiliation wicri:level="1"><nlm:aff id="Aff3">Department of Nursing, Iwate Medical University Hospital, 19-1 Uchimaru, Morioka, Iwate, 020-8505 Japan</nlm:aff><country xml:lang="fr">Japon</country><wicri:regionArea>Department of Nursing, Iwate Medical University Hospital, 19-1 Uchimaru, Morioka, Iwate</wicri:regionArea></affiliation></author><author><name sortKey="Takeuchi, Satoshi" sort="Takeuchi, Satoshi" uniqKey="Takeuchi S" first="Satoshi" last="Takeuchi">Satoshi Takeuchi</name><affiliation wicri:level="1"><nlm:aff id="Aff4">Department of Obstetrics and Gynecology, School of Medicine, Iwate Medical University, 19-1 Uchimaru, Morioka, Iwate, 020-8505 Japan</nlm:aff><country xml:lang="fr">Japon</country><wicri:regionArea>Department of Obstetrics and Gynecology, School of Medicine, Iwate Medical University, 19-1 Uchimaru, Morioka, Iwate</wicri:regionArea></affiliation></author><author><name sortKey="Kashiwaba, Masahiro" sort="Kashiwaba, Masahiro" uniqKey="Kashiwaba M" first="Masahiro" last="Kashiwaba">Masahiro Kashiwaba</name><affiliation wicri:level="1"><nlm:aff id="Aff5">Department of Breast Surgery, Breastpia Miyazaki Hospital, 2-112-1 Maruyama, Miyazaki, Miyazaki, 880-0052 Japan</nlm:aff><country xml:lang="fr">Japon</country><wicri:regionArea>Department of Breast Surgery, Breastpia Miyazaki Hospital, 2-112-1 Maruyama, Miyazaki, Miyazaki</wicri:regionArea></affiliation></author><author><name sortKey="Kudo, Kenzo" sort="Kudo, Kenzo" uniqKey="Kudo K" first="Kenzo" last="Kudo">Kenzo Kudo</name><affiliation wicri:level="1"><nlm:aff id="Aff1">Department of Pharmacy, Iwate Medical University Hospital, 19-1 Uchimaru, Morioka, Iwate, 020-8505 Japan</nlm:aff><country xml:lang="fr">Japon</country><wicri:regionArea>Department of Pharmacy, Iwate Medical University Hospital, 19-1 Uchimaru, Morioka, Iwate</wicri:regionArea></affiliation><affiliation wicri:level="1"><nlm:aff id="Aff2">Department of Clinical Pharmaceutics, School of Pharmacy, Iwate Medical University, 2-1-1 Nishitokuta, Yahaba, Iwate, 028-3694 Japan</nlm:aff><country xml:lang="fr">Japon</country><wicri:regionArea>Department of Clinical Pharmaceutics, School of Pharmacy, Iwate Medical University, 2-1-1 Nishitokuta, Yahaba, Iwate</wicri:regionArea></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PMC</idno><idno type="pmid">27891244</idno><idno type="pmc">5111235</idno><idno type="url">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5111235</idno><idno type="RBID">PMC:5111235</idno><idno type="doi">10.1186/s40780-016-0067-2</idno><date when="2016">2016</date><idno type="wicri:Area/Pmc/Corpus">000D72</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Corpus" wicri:corpus="PMC">000D72</idno><idno type="wicri:Area/Pmc/Curation">000D71</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Curation">000D71</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">The effectiveness of regional cooling for paclitaxel-induced peripheral neuropathy</title><author><name sortKey="Sato, Junya" sort="Sato, Junya" uniqKey="Sato J" first="Junya" last="Sato">Junya Sato</name><affiliation wicri:level="1"><nlm:aff id="Aff1">Department of Pharmacy, Iwate Medical University Hospital, 19-1 Uchimaru, Morioka, Iwate, 020-8505 Japan</nlm:aff><country xml:lang="fr">Japon</country><wicri:regionArea>Department of Pharmacy, Iwate Medical University Hospital, 19-1 Uchimaru, Morioka, Iwate</wicri:regionArea></affiliation><affiliation wicri:level="1"><nlm:aff id="Aff2">Department of Clinical Pharmaceutics, School of Pharmacy, Iwate Medical University, 2-1-1 Nishitokuta, Yahaba, Iwate, 028-3694 Japan</nlm:aff><country xml:lang="fr">Japon</country><wicri:regionArea>Department of Clinical Pharmaceutics, School of Pharmacy, Iwate Medical University, 2-1-1 Nishitokuta, Yahaba, Iwate</wicri:regionArea></affiliation></author><author><name sortKey="Mori, Megumi" sort="Mori, Megumi" uniqKey="Mori M" first="Megumi" last="Mori">Megumi Mori</name><affiliation wicri:level="1"><nlm:aff id="Aff1">Department of Pharmacy, Iwate Medical University Hospital, 19-1 Uchimaru, Morioka, Iwate, 020-8505 Japan</nlm:aff><country xml:lang="fr">Japon</country><wicri:regionArea>Department of Pharmacy, Iwate Medical University Hospital, 19-1 Uchimaru, Morioka, Iwate</wicri:regionArea></affiliation></author><author><name sortKey="Nihei, Satoru" sort="Nihei, Satoru" uniqKey="Nihei S" first="Satoru" last="Nihei">Satoru Nihei</name><affiliation wicri:level="1"><nlm:aff id="Aff1">Department of Pharmacy, Iwate Medical University Hospital, 19-1 Uchimaru, Morioka, Iwate, 020-8505 Japan</nlm:aff><country xml:lang="fr">Japon</country><wicri:regionArea>Department of Pharmacy, Iwate Medical University Hospital, 19-1 Uchimaru, Morioka, Iwate</wicri:regionArea></affiliation><affiliation wicri:level="1"><nlm:aff id="Aff2">Department of Clinical Pharmaceutics, School of Pharmacy, Iwate Medical University, 2-1-1 Nishitokuta, Yahaba, Iwate, 028-3694 Japan</nlm:aff><country xml:lang="fr">Japon</country><wicri:regionArea>Department of Clinical Pharmaceutics, School of Pharmacy, Iwate Medical University, 2-1-1 Nishitokuta, Yahaba, Iwate</wicri:regionArea></affiliation></author><author><name sortKey="Kumagai, Masumi" sort="Kumagai, Masumi" uniqKey="Kumagai M" first="Masumi" last="Kumagai">Masumi Kumagai</name><affiliation wicri:level="1"><nlm:aff id="Aff3">Department of Nursing, Iwate Medical University Hospital, 19-1 Uchimaru, Morioka, Iwate, 020-8505 Japan</nlm:aff><country xml:lang="fr">Japon</country><wicri:regionArea>Department of Nursing, Iwate Medical University Hospital, 19-1 Uchimaru, Morioka, Iwate</wicri:regionArea></affiliation></author><author><name sortKey="Takeuchi, Satoshi" sort="Takeuchi, Satoshi" uniqKey="Takeuchi S" first="Satoshi" last="Takeuchi">Satoshi Takeuchi</name><affiliation wicri:level="1"><nlm:aff id="Aff4">Department of Obstetrics and Gynecology, School of Medicine, Iwate Medical University, 19-1 Uchimaru, Morioka, Iwate, 020-8505 Japan</nlm:aff><country xml:lang="fr">Japon</country><wicri:regionArea>Department of Obstetrics and Gynecology, School of Medicine, Iwate Medical University, 19-1 Uchimaru, Morioka, Iwate</wicri:regionArea></affiliation></author><author><name sortKey="Kashiwaba, Masahiro" sort="Kashiwaba, Masahiro" uniqKey="Kashiwaba M" first="Masahiro" last="Kashiwaba">Masahiro Kashiwaba</name><affiliation wicri:level="1"><nlm:aff id="Aff5">Department of Breast Surgery, Breastpia Miyazaki Hospital, 2-112-1 Maruyama, Miyazaki, Miyazaki, 880-0052 Japan</nlm:aff><country xml:lang="fr">Japon</country><wicri:regionArea>Department of Breast Surgery, Breastpia Miyazaki Hospital, 2-112-1 Maruyama, Miyazaki, Miyazaki</wicri:regionArea></affiliation></author><author><name sortKey="Kudo, Kenzo" sort="Kudo, Kenzo" uniqKey="Kudo K" first="Kenzo" last="Kudo">Kenzo Kudo</name><affiliation wicri:level="1"><nlm:aff id="Aff1">Department of Pharmacy, Iwate Medical University Hospital, 19-1 Uchimaru, Morioka, Iwate, 020-8505 Japan</nlm:aff><country xml:lang="fr">Japon</country><wicri:regionArea>Department of Pharmacy, Iwate Medical University Hospital, 19-1 Uchimaru, Morioka, Iwate</wicri:regionArea></affiliation><affiliation wicri:level="1"><nlm:aff id="Aff2">Department of Clinical Pharmaceutics, School of Pharmacy, Iwate Medical University, 2-1-1 Nishitokuta, Yahaba, Iwate, 028-3694 Japan</nlm:aff><country xml:lang="fr">Japon</country><wicri:regionArea>Department of Clinical Pharmaceutics, School of Pharmacy, Iwate Medical University, 2-1-1 Nishitokuta, Yahaba, Iwate</wicri:regionArea></affiliation></author></analytic><series><title level="j">Journal of Pharmaceutical Health Care and Sciences</title><idno type="eISSN">2055-0294</idno><imprint><date when="2016">2016</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><sec><title>Background</title><p>There are currently no promising therapies available to treat or prevent peripheral neuropathy (PN) induced by anticancer drugs in a cumulative dose-dependent manner. In this study, we investigated the efficacy of regional cooling of hands and feet in preventing paclitaxel (PTX)-induced PN.</p></sec><sec><title>Methods</title><p>Patients with gynecologic cancer who received a tri-weekly cycle of chemotherapy including PTX at doses of 150–175 mg/m<sup>2</sup> were included in this study. Regional cooling was performed by covering patient hands and feet with cold insulators during PTX administration (regional cooling group). The primary end-point was ≥grade 2 PN evaluated by the Common Terminology Criteria for Adverse Events (CTCAE) v4.0. The secondary end-points were the frequency of PN therapeutic drug use, PTX dose reduction due to PN, and adverse events due to regional cooling. The efficacy of regional cooling was compared with data retrospectively extracted from the medical records of patients who did not receive regional cooling (control group). All end-points were evaluated for up to six cycles.</p></sec><sec><title>Results</title><p>There were 40 and 142 patients in the regional cooling and control groups, respectively. As a primary end-point, incidences of ≥grade 2 PN in the fourth to sixth cycles were significantly lower than that in the cooling group (5.0–9.1 % vs. 19.8–31.6 %, <italic>p</italic> < 0.05 after the fourth cycle and <italic>p</italic> < 0.01 after the fifth cycle). Among secondary end-points, neither the use of PN therapeutic drugs nor the PTX dose reduction due to PN were significantly lower in the cooling group than in the control group (27.5 vs. 36.6 %, <italic>p</italic> = 0.378 and 5.0 vs. 3.5 %, <italic>p</italic> = 0.645, respectively). There were no serious regional cooling-associated adverse events such as frostbite.</p></sec><sec><title>Conclusions</title><p>Regional cooling of hands and feet during PTX administration might have good effectiveness and tolerability, suggesting this approach as a potentially effective supportive care to prevent PTX-induced PN.</p></sec><sec><title>Trial registration</title><p>The trial approval number in the institution; H25-26. 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<front><journal-meta><journal-id journal-id-type="nlm-ta">J Pharm Health Care Sci</journal-id><journal-id journal-id-type="iso-abbrev">J Pharm Health Care Sci</journal-id><journal-title-group><journal-title>Journal of Pharmaceutical Health Care and Sciences</journal-title></journal-title-group><issn pub-type="epub">2055-0294</issn><publisher><publisher-name>BioMed Central</publisher-name><publisher-loc>London</publisher-loc></publisher></journal-meta><article-meta><article-id pub-id-type="pmid">27891244</article-id><article-id pub-id-type="pmc">5111235</article-id><article-id pub-id-type="publisher-id">67</article-id><article-id pub-id-type="doi">10.1186/s40780-016-0067-2</article-id><article-categories><subj-group subj-group-type="heading"><subject>Research Article</subject></subj-group></article-categories><title-group><article-title>The effectiveness of regional cooling for paclitaxel-induced peripheral neuropathy</article-title></title-group><contrib-group><contrib contrib-type="author" corresp="yes"><name><surname>Sato</surname><given-names>Junya</given-names></name><address><email>Junya02377@nifty.com</email></address><xref ref-type="aff" rid="Aff1">1</xref><xref ref-type="aff" rid="Aff2">2</xref></contrib><contrib contrib-type="author"><name><surname>Mori</surname><given-names>Megumi</given-names></name><address><email>megumi.mori@j.iwate-med.ac.jp</email></address><xref ref-type="aff" rid="Aff1">1</xref></contrib><contrib contrib-type="author"><name><surname>Nihei</surname><given-names>Satoru</given-names></name><address><email>satoru.2hei@gmail.com</email></address><xref ref-type="aff" rid="Aff1">1</xref><xref ref-type="aff" rid="Aff2">2</xref></contrib><contrib contrib-type="author"><name><surname>Kumagai</surname><given-names>Masumi</given-names></name><address><email>masumi.kumagai@j.iwate-med.ac.jp</email></address><xref ref-type="aff" rid="Aff3">3</xref></contrib><contrib contrib-type="author"><name><surname>Takeuchi</surname><given-names>Satoshi</given-names></name><address><email>s-take-imugo@zeus.eonet.ne.jp</email></address><xref ref-type="aff" rid="Aff4">4</xref></contrib><contrib contrib-type="author"><name><surname>Kashiwaba</surname><given-names>Masahiro</given-names></name><address><email>mksoudan@yahoo.co.jp</email></address><xref ref-type="aff" rid="Aff5">5</xref></contrib><contrib contrib-type="author"><name><surname>Kudo</surname><given-names>Kenzo</given-names></name><address><email>kenzkudo@iwate-med.ac.jp</email></address><xref ref-type="aff" rid="Aff1">1</xref><xref ref-type="aff" rid="Aff2">2</xref></contrib><aff id="Aff1"><label>1</label>Department of Pharmacy, Iwate Medical University Hospital, 19-1 Uchimaru, Morioka, Iwate, 020-8505 Japan</aff><aff id="Aff2"><label>2</label>Department of Clinical Pharmaceutics, School of Pharmacy, Iwate Medical University, 2-1-1 Nishitokuta, Yahaba, Iwate, 028-3694 Japan</aff><aff id="Aff3"><label>3</label>Department of Nursing, Iwate Medical University Hospital, 19-1 Uchimaru, Morioka, Iwate, 020-8505 Japan</aff><aff id="Aff4"><label>4</label>Department of Obstetrics and Gynecology, School of Medicine, Iwate Medical University, 19-1 Uchimaru, Morioka, Iwate, 020-8505 Japan</aff><aff id="Aff5"><label>5</label>Department of Breast Surgery, Breastpia Miyazaki Hospital, 2-112-1 Maruyama, Miyazaki, Miyazaki, 880-0052 Japan</aff></contrib-group><pub-date pub-type="epub"><day>15</day><month>11</month><year>2016</year></pub-date><pub-date pub-type="pmc-release"><day>15</day><month>11</month><year>2016</year></pub-date><pub-date pub-type="collection"><year>2016</year></pub-date><volume>2</volume><elocation-id>33</elocation-id><history><date date-type="received"><day>11</day><month>8</month><year>2016</year></date><date date-type="accepted"><day>5</day><month>11</month><year>2016</year></date></history><permissions><copyright-statement>© The Author(s). 2016</copyright-statement><license license-type="OpenAccess"><license-p><bold>Open Access</bold>This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (<ext-link ext-link-type="uri" xlink:href="http://creativecommons.org/licenses/by/4.0/">http://creativecommons.org/licenses/by/4.0/</ext-link>), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (<ext-link ext-link-type="uri" xlink:href="http://creativecommons.org/publicdomain/zero/1.0/">http://creativecommons.org/publicdomain/zero/1.0/</ext-link>) applies to the data made available in this article, unless otherwise stated.</license-p></license></permissions><abstract id="Abs1"><sec><title>Background</title><p>There are currently no promising therapies available to treat or prevent peripheral neuropathy (PN) induced by anticancer drugs in a cumulative dose-dependent manner. In this study, we investigated the efficacy of regional cooling of hands and feet in preventing paclitaxel (PTX)-induced PN.</p></sec><sec><title>Methods</title><p>Patients with gynecologic cancer who received a tri-weekly cycle of chemotherapy including PTX at doses of 150–175 mg/m<sup>2</sup> were included in this study. Regional cooling was performed by covering patient hands and feet with cold insulators during PTX administration (regional cooling group). The primary end-point was ≥grade 2 PN evaluated by the Common Terminology Criteria for Adverse Events (CTCAE) v4.0. The secondary end-points were the frequency of PN therapeutic drug use, PTX dose reduction due to PN, and adverse events due to regional cooling. The efficacy of regional cooling was compared with data retrospectively extracted from the medical records of patients who did not receive regional cooling (control group). All end-points were evaluated for up to six cycles.</p></sec><sec><title>Results</title><p>There were 40 and 142 patients in the regional cooling and control groups, respectively. As a primary end-point, incidences of ≥grade 2 PN in the fourth to sixth cycles were significantly lower than that in the cooling group (5.0–9.1 % vs. 19.8–31.6 %, <italic>p</italic> < 0.05 after the fourth cycle and <italic>p</italic> < 0.01 after the fifth cycle). Among secondary end-points, neither the use of PN therapeutic drugs nor the PTX dose reduction due to PN were significantly lower in the cooling group than in the control group (27.5 vs. 36.6 %, <italic>p</italic> = 0.378 and 5.0 vs. 3.5 %, <italic>p</italic> = 0.645, respectively). There were no serious regional cooling-associated adverse events such as frostbite.</p></sec><sec><title>Conclusions</title><p>Regional cooling of hands and feet during PTX administration might have good effectiveness and tolerability, suggesting this approach as a potentially effective supportive care to prevent PTX-induced PN.</p></sec><sec><title>Trial registration</title><p>The trial approval number in the institution; H25-26. Registered 5 June 2014.</p></sec></abstract><kwd-group xml:lang="en"><title>Keywords</title><kwd>Regional cooling</kwd><kwd>Peripheral neuropathy</kwd><kwd>Paclitaxel</kwd><kwd>Gynecologic cancer</kwd><kwd>Chemotherapy</kwd></kwd-group><custom-meta-group><custom-meta><meta-name>issue-copyright-statement</meta-name><meta-value>© The Author(s) 2016</meta-value></custom-meta></custom-meta-group></article-meta></front></pmc></record>Pour manipuler ce document sous Unix (Dilib)
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