| アブストラクト | BACKGROUND: Corporal rupture and severe penile injury are established complications of collagenase clostridium histolyticum (CCH) treatment for Peyronie's disease. How spontaneous reports jointly encode injury, management, hospitalization, timing, and procedural or product-use details remains unclear. METHODS: We analyzed quarterly FDA Adverse Event Reporting System files from 2014Q1 through 2025Q4. We retained the latest, deletion-list-aware report version when CCH was the primary suspect for a strict Peyronie's disease indication. We compared a fracture-coded phenotype (F1) with a mutually exclusive non-fracture local-injury phenotype (I1). Raw report proportions with exact confidence intervals were the primary descriptive results. Firth models provided secondary control for reporting period, healthcare professional reporter, and manufacturer origin. Analyses also considered surgery/repair (M1), hospitalization, a heterogeneous procedural/product-use summary (P1), and a report-level therapy-start-to-event interval. RESULTS: Of 3,750 latest-version strict reports, 3,658 named CCH as the sole primary suspect. The active comparison included 445 F1 and 834 I1 reports. M1 was recorded in 194/445 F1 and 30/834 I1 reports. Hospitalization was recorded in 2.5% of I1 reports without M1, 8.0% of F1 reports without M1, and 26.3% of F1 reports with M1. P1 was recorded in 57/445 F1 reports (12.8%, exact 95% CI: 9.8%-16.3%) and 171/834 I1 reports (20.5%, 17.8%-23.4%); the crude odds ratio was 0.57 (exact 95% CI: 0.40-0.80), and the adjusted reporting odds ratio was 0.50 (95% CI: 0.35-0.71). The subdomains were directionally discordant. After 20 P1-negative F1 reports were reclassified, the balanced adjusted 95% CI included 1; reclassification of 35 reports equalized the crude proportions. A therapy-start-to-event interval was available for 91/445 F1 reports (median 14 days, IQR 1-27), and entry into this date-complete subset was non-random. CONCLUSION: Fracture-coded FAERS reports after CCH form a clinically coherent but heterogeneous phenotype, often accompanied by surgery/repair or hospitalization codes. P1 is a reporting-process summary rather than a unitary clinical construct: its inverse aggregate association concealed discordant components, was sensitive to modest differential under-recording, and does not indicate protection. The study refines the reporting phenotype of a known serious risk without estimating incidence, comparative safety, or causation. |
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| 投稿者 | Qian, Xin; Ran, Can; Gong, Yangyang; Cai, Xiang; Xiang, Linlin; Jiang, Mingdong; Tian, Hui; Feng, Yougang; Liu, Hongjian |
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