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The efficacy and safety of intralesional injection of collagenase Clostridium histolyticum for Peyronie’s disease: A meta-analysis of published prospective studies
Background: Peyronie’s disease (PD) is a progressive fibrotic disorder of the penis that is adverse to men’s health. Currently, effective and reliable non-surgical options for PD are limited. Since the Food and Drug Administration (FDA) approved it in 2013, intralesional injection of collagenase Clo...
Autores principales: | , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Frontiers Media S.A.
2022
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9581257/ https://www.ncbi.nlm.nih.gov/pubmed/36278151 http://dx.doi.org/10.3389/fphar.2022.973394 |
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author | Zhang, Fuxun Xiong, Yang Wang, Wei Wu, Changjing Qin, Feng Yuan, Jiuhong |
author_facet | Zhang, Fuxun Xiong, Yang Wang, Wei Wu, Changjing Qin, Feng Yuan, Jiuhong |
author_sort | Zhang, Fuxun |
collection | PubMed |
description | Background: Peyronie’s disease (PD) is a progressive fibrotic disorder of the penis that is adverse to men’s health. Currently, effective and reliable non-surgical options for PD are limited. Since the Food and Drug Administration (FDA) approved it in 2013, intralesional injection of collagenase Clostridium histolyticum (CCH) became the only licensed treatment for PD. This meta-analysis aims to evaluate the clinical efficacy and safety of CCH in treating PD, predominantly based on post-FDA studies. Methods: The primary outcome was clinical efficacy evaluated by the percentages of improvement in penile curvature (PC) and Peyronie’s disease symptom bother score (PD bother score). The secondary outcome was the safety assessed by treatment-related adverse events (TRAEs). Heterogeneity was assessed by Cochran’s Q and I ( 2 ) tests. Sensitivity and subgroup analyses were performed to explore the source of heterogeneity. Funnel plots and Egger’s test were used to evaluate the publication bias. Results: A total of 11 studies with 1,480 intentions to treat (ITT) population were included. The pooled effect of the improvement of PC was 35% (95% CI: 0.33–0.38), and the pooled improvement of the PD bother score was 41% (95% CI: 0.37–0.45). No heterogeneity was found at the pooled improvement of PC (p = 0.845, I ( 2 ) = 0.00%). Meanwhile, some heterogeneity existed in the pooled improvement of the PD bother score (p = 0.069, I ( 2 ) = 43.4%). The pooled effect of TRAEs was 93% (95% CI 0.88–0.97) with significant heterogeneity (p < 0.000, I ( 2 ) = 92.3%). Conclusion: The intralesional injection of CCH could significantly improve the penile deformity of PD patients. Meanwhile, CCH appears to ameliorate the PD bother score to some extent and has acceptable clinical safety. Future studies are required to clarify the long-term outcomes of CCH injection in the treatment of PD. |
format | Online Article Text |
id | pubmed-9581257 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | Frontiers Media S.A. |
record_format | MEDLINE/PubMed |
spelling | pubmed-95812572022-10-20 The efficacy and safety of intralesional injection of collagenase Clostridium histolyticum for Peyronie’s disease: A meta-analysis of published prospective studies Zhang, Fuxun Xiong, Yang Wang, Wei Wu, Changjing Qin, Feng Yuan, Jiuhong Front Pharmacol Pharmacology Background: Peyronie’s disease (PD) is a progressive fibrotic disorder of the penis that is adverse to men’s health. Currently, effective and reliable non-surgical options for PD are limited. Since the Food and Drug Administration (FDA) approved it in 2013, intralesional injection of collagenase Clostridium histolyticum (CCH) became the only licensed treatment for PD. This meta-analysis aims to evaluate the clinical efficacy and safety of CCH in treating PD, predominantly based on post-FDA studies. Methods: The primary outcome was clinical efficacy evaluated by the percentages of improvement in penile curvature (PC) and Peyronie’s disease symptom bother score (PD bother score). The secondary outcome was the safety assessed by treatment-related adverse events (TRAEs). Heterogeneity was assessed by Cochran’s Q and I ( 2 ) tests. Sensitivity and subgroup analyses were performed to explore the source of heterogeneity. Funnel plots and Egger’s test were used to evaluate the publication bias. Results: A total of 11 studies with 1,480 intentions to treat (ITT) population were included. The pooled effect of the improvement of PC was 35% (95% CI: 0.33–0.38), and the pooled improvement of the PD bother score was 41% (95% CI: 0.37–0.45). No heterogeneity was found at the pooled improvement of PC (p = 0.845, I ( 2 ) = 0.00%). Meanwhile, some heterogeneity existed in the pooled improvement of the PD bother score (p = 0.069, I ( 2 ) = 43.4%). The pooled effect of TRAEs was 93% (95% CI 0.88–0.97) with significant heterogeneity (p < 0.000, I ( 2 ) = 92.3%). Conclusion: The intralesional injection of CCH could significantly improve the penile deformity of PD patients. Meanwhile, CCH appears to ameliorate the PD bother score to some extent and has acceptable clinical safety. Future studies are required to clarify the long-term outcomes of CCH injection in the treatment of PD. Frontiers Media S.A. 2022-10-05 /pmc/articles/PMC9581257/ /pubmed/36278151 http://dx.doi.org/10.3389/fphar.2022.973394 Text en Copyright © 2022 Zhang, Xiong, Wang, Wu, Qin and Yuan. https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms. |
spellingShingle | Pharmacology Zhang, Fuxun Xiong, Yang Wang, Wei Wu, Changjing Qin, Feng Yuan, Jiuhong The efficacy and safety of intralesional injection of collagenase Clostridium histolyticum for Peyronie’s disease: A meta-analysis of published prospective studies |
title | The efficacy and safety of intralesional injection of collagenase Clostridium histolyticum for Peyronie’s disease: A meta-analysis of published prospective studies |
title_full | The efficacy and safety of intralesional injection of collagenase Clostridium histolyticum for Peyronie’s disease: A meta-analysis of published prospective studies |
title_fullStr | The efficacy and safety of intralesional injection of collagenase Clostridium histolyticum for Peyronie’s disease: A meta-analysis of published prospective studies |
title_full_unstemmed | The efficacy and safety of intralesional injection of collagenase Clostridium histolyticum for Peyronie’s disease: A meta-analysis of published prospective studies |
title_short | The efficacy and safety of intralesional injection of collagenase Clostridium histolyticum for Peyronie’s disease: A meta-analysis of published prospective studies |
title_sort | efficacy and safety of intralesional injection of collagenase clostridium histolyticum for peyronie’s disease: a meta-analysis of published prospective studies |
topic | Pharmacology |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9581257/ https://www.ncbi.nlm.nih.gov/pubmed/36278151 http://dx.doi.org/10.3389/fphar.2022.973394 |
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