{"id":347,"date":"2015-08-10T12:16:28","date_gmt":"2015-08-10T12:16:28","guid":{"rendered":"https:\/\/www.alexandremiranda.com.br\/?p=347"},"modified":"2015-08-10T12:21:06","modified_gmt":"2015-08-10T12:21:06","slug":"clinical-safety-and-efficacy-of-xiaflex-clostridial-histolytic-collagenase-injection-in-patients-with-peyronies-disease-phase-3-open-label-study","status":"publish","type":"post","link":"https:\/\/www.alexandremiranda.com.br\/en\/seguranca-clinica-e-eficacia-da-injecao-da-colagenase-clostridial-histolitica-xiaflex-em-pacientes-com-doenca-de-peyronie-fase-3-estudo-open-label\/","title":{"rendered":"Clinical Safety and Efficacy of Clostridial Histolytic Collagenase Injection (Xiaflex) in Patients with Peyronie's Disease: Phase 3 Open-Label Study."},"content":{"rendered":"<p>[et_pb_section][et_pb_row][et_pb_column type=&#8221;4_4&#8243;][et_pb_text admin_label=&#8221;Texto&#8221; background_layout=&#8221;light&#8221; text_orientation=&#8221;left&#8221; use_border_color=&#8221;off&#8221; border_color=&#8221;#ffffff&#8221; border_style=&#8221;solid&#8221;]<\/p>\n\n\t\t<div class='author-shortcodes'>\n\t\t\t<div class='author-inner'>\n\t\t\t\t<div class='author-info'>\n\t\t\tData:\u00a0Fevereiro, 2015 \/Autores:\u00a0Laurence A. Levine,et all\n\t\t<\/div>\n\t\t\t<\/div>\n\t\t<\/div>\n<p><a href=\"https:\/\/www.alexandremiranda.com.br\/wp-content\/uploads\/2015\/08\/xiaflex.png\"><img loading=\"lazy\" decoding=\"async\" class=\"alignnone size-medium wp-image-348\" src=\"https:\/\/www.alexandremiranda.com.br\/wp-content\/uploads\/2015\/08\/xiaflex-300x240.png\" alt=\"xiaflex\" width=\"300\" height=\"240\" \/><\/a><\/p>\n<p><em>Journal of Sexual Medicine<\/em>. 2015;<strong>12<\/strong>: 248-258.<\/p>\n<p>Mais um bom trabalho sobre o uso do\u00a0<strong>Xiaflex<\/strong>.<\/p>\n<p><strong>347<\/strong>pacientes participaram do estudo. Eles receberam at\u00e9\u00a0<strong>8<\/strong>\u00a0inje\u00e7\u00f5es de xiaflex e foram seguidos por\u00a0<strong>36<\/strong>\u00a0semanas<\/p>\n<p>A curvatura m\u00e9dia inicial era de\u00a0<strong>53o<\/strong>. Ap\u00f3s 36 semas de acompanhamento a curvatura m\u00e9dia final foi de\u00a0<strong>34.7o<\/strong>, isto representa uma melhora de\u00a0<strong>18,3o<\/strong>\u00a0(ou\u00a0<strong>34,4%)<\/strong>\u00a0da curvatura peniana.<\/p>\n<p>Sabemos que o efeito placebo (uso de soro fisiol\u00f3gico no lugar do Xiaflex) cria uma melhora de 18,2% da curvatura (Gelbard M, et al. J Urol. 2013 Jul;190(1):199-207). Desta forma se n\u00f3s utilizar-mos o xiaflex em um paciente com\u00a0<strong>45o<\/strong>\u00a0de curvatura ele ir\u00e1 ter um resultado final de\u00a0<strong>29,5o<\/strong>\u00a0de desvio (melhora de\u00a0<strong>34,4%<\/strong>). Se n\u00f3s utilizar-mos soro fisiol\u00f3gico (placebo) no lugar do xiaflex o resultado ser\u00e1 de\u00a0\u00a0<strong>36,8o<\/strong>\u00a0de desvio (melhora de\u00a0<strong>18,3%<\/strong>). Para ajudar na visualiza\u00e7\u00e3o do resultado\u00a0<strong>Xiaflex vs. Placebo<\/strong>\u00a0coloco uma imagem com os resultados previamente citados ao final deste texto.<\/p>\n<p>Como poder ser visto na figura abaixo, o uso do Xiaflex n\u00e3o parece ter feito uma diferen\u00e7a t\u00e3o grande para o placebo. Embora exista forte evid\u00eancia cient\u00edfica de que o Xiaflex funcione melhor do que o placebo, n\u00e3o me parece que ele retifique de forma efetiva as curvaturas penianas, principalmente em casos mais graves (&gt; 60o).<\/p>\n<p>Temos de lembrar tamb\u00e9m que a medica\u00e7\u00e3o tem um custo elevado. Nos Estados Unidos cada dose custa em m\u00e9dia $3.300,00 por aplica\u00e7\u00e3o. Isto quer dizer que em 8 aplica\u00e7\u00f5es o custo final do tratamento ser\u00e1 de $ 26.400,00.<\/p>\n<p>Ainda n\u00e3o temos a medica\u00e7\u00e3o liberada para uso no Brasil.<\/p>\n<p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section]<\/p>\n","protected":false},"excerpt":{"rendered":"<p><div class=\"et_pb_section et_pb_section_0 et_section_regular\" >\n\t\t\t\t\n\t\t\t\t\n\t\t\t\t\n\t\t\t\t\n\t\t\t\t\n\t\t\t\t\n\t\t\t\t\n\t\t\t\t\n\t\t\t\t\n\t\t\t<\/div><div class=\"et_pb_row et_pb_row_0 et_pb_row_empty\">\n\t\t\t\t\n\t\t\t\t\n\t\t\t\t\n\t\t\t\t\n\t\t\t\t\n\t\t\t<\/div> \n\t\t<div class='author-shortcodes'>\n\t\t\t<div class='author-inner'>\n\t\t\t\t<div class='author-info'>\n\t\t\tData:\u00a0Fevereiro, 2015 \/Autores:\u00a0Laurence A. Levine,et all\n\t\t<\/div>\n\t\t\t<\/div>\n\t\t<\/div> Journal of Sexual Medicine. 2015;12: 248-258. Mais um bom trabalho sobre o uso do\u00a0Xiaflex. 347pacientes participaram do estudo. Eles receberam at\u00e9\u00a08\u00a0inje\u00e7\u00f5es de xiaflex e foram seguidos por\u00a036\u00a0semanas A curvatura m\u00e9dia inicial era de\u00a053o. Ap\u00f3s 36 semas de acompanhamento a curvatura m\u00e9dia final foi de\u00a034.7o, isto representa uma melhora [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_et_pb_use_builder":"on","_et_pb_old_content":"","_et_gb_content_width":"","_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"categories":[8],"tags":[],"class_list":["post-347","post","type-post","status-publish","format-standard","hentry","category-noticias"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v26.8 (Yoast SEO v26.8) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Seguran\u00e7a Cl\u00ednica e Efic\u00e1cia da Inje\u00e7\u00e3o da Colagenase Clostridial Histol\u00edtica (Xiaflex) em Pacientes com Doen\u00e7a de Peyronie: Fase 3 estudo Open-Label. - Dr. Alexandre Miranda \/ Andrologia &amp; Urologia<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.alexandremiranda.com.br\/en\/clinical-safety-and-efficacy-of-xiaflex-clostridial-histolytic-collagenase-injection-in-patients-with-peyronies-disease-phase-3-open-label-study\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Seguran\u00e7a Cl\u00ednica e Efic\u00e1cia da Inje\u00e7\u00e3o da Colagenase Clostridial Histol\u00edtica (Xiaflex) em Pacientes com Doen\u00e7a de Peyronie: Fase 3 estudo Open-Label.\" \/>\n<meta property=\"og:description\" content=\"Journal of Sexual Medicine. 2015;12: 248-258. Mais um bom trabalho sobre o uso do\u00a0Xiaflex. 347pacientes participaram do estudo. Eles receberam at\u00e9\u00a08\u00a0inje\u00e7\u00f5es de xiaflex e foram seguidos por\u00a036\u00a0semanas A curvatura m\u00e9dia inicial era de\u00a053o. Ap\u00f3s 36 semas de acompanhamento a curvatura m\u00e9dia final foi de\u00a034.7o, isto representa uma melhora [&hellip;]\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.alexandremiranda.com.br\/en\/clinical-safety-and-efficacy-of-xiaflex-clostridial-histolytic-collagenase-injection-in-patients-with-peyronies-disease-phase-3-open-label-study\/\" \/>\n<meta property=\"og:site_name\" content=\"Dr. Alexandre Miranda \/ Andrologia &amp; Urologia\" \/>\n<meta property=\"article:published_time\" content=\"2015-08-10T12:16:28+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2015-08-10T12:21:06+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.alexandremiranda.com.br\/wp-content\/uploads\/2015\/08\/xiaflex-300x240.png\" \/>\n<meta name=\"author\" content=\"dralexm\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"dralexm\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"2 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\/\/www.alexandremiranda.com.br\/seguranca-clinica-e-eficacia-da-injecao-da-colagenase-clostridial-histolitica-xiaflex-em-pacientes-com-doenca-de-peyronie-fase-3-estudo-open-label\/#article\",\"isPartOf\":{\"@id\":\"https:\/\/www.alexandremiranda.com.br\/seguranca-clinica-e-eficacia-da-injecao-da-colagenase-clostridial-histolitica-xiaflex-em-pacientes-com-doenca-de-peyronie-fase-3-estudo-open-label\/\"},\"author\":{\"name\":\"dralexm\",\"@id\":\"https:\/\/www.alexandremiranda.com.br\/#\/schema\/person\/53b78121d4cc4c3fe718977b028668fb\"},\"headline\":\"Seguran\u00e7a Cl\u00ednica e Efic\u00e1cia da Inje\u00e7\u00e3o da Colagenase Clostridial Histol\u00edtica (Xiaflex) em Pacientes com Doen\u00e7a de Peyronie: Fase 3 estudo Open-Label.\",\"datePublished\":\"2015-08-10T12:16:28+00:00\",\"dateModified\":\"2015-08-10T12:21:06+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\/\/www.alexandremiranda.com.br\/seguranca-clinica-e-eficacia-da-injecao-da-colagenase-clostridial-histolitica-xiaflex-em-pacientes-com-doenca-de-peyronie-fase-3-estudo-open-label\/\"},\"wordCount\":356,\"publisher\":{\"@id\":\"https:\/\/www.alexandremiranda.com.br\/#\/schema\/person\/a717bb096b1f5aff66256d250d24d25e\"},\"image\":{\"@id\":\"https:\/\/www.alexandremiranda.com.br\/seguranca-clinica-e-eficacia-da-injecao-da-colagenase-clostridial-histolitica-xiaflex-em-pacientes-com-doenca-de-peyronie-fase-3-estudo-open-label\/#primaryimage\"},\"thumbnailUrl\":\"https:\/\/www.alexandremiranda.com.br\/wp-content\/uploads\/2015\/08\/xiaflex-300x240.png\",\"articleSection\":[\"Noticias\"],\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\/\/www.alexandremiranda.com.br\/seguranca-clinica-e-eficacia-da-injecao-da-colagenase-clostridial-histolitica-xiaflex-em-pacientes-com-doenca-de-peyronie-fase-3-estudo-open-label\/\",\"url\":\"https:\/\/www.alexandremiranda.com.br\/seguranca-clinica-e-eficacia-da-injecao-da-colagenase-clostridial-histolitica-xiaflex-em-pacientes-com-doenca-de-peyronie-fase-3-estudo-open-label\/\",\"name\":\"Seguran\u00e7a Cl\u00ednica e Efic\u00e1cia da Inje\u00e7\u00e3o da Colagenase Clostridial Histol\u00edtica (Xiaflex) em Pacientes com Doen\u00e7a de Peyronie: Fase 3 estudo Open-Label. - Dr. Alexandre Miranda \/ Andrologia &amp; 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