Minerva urologica e nefrologica = The Italian journal of urology and nephrology · 2018
Collagenase clostridium histolyticum: a novel medical treatment for Peyronie's disease.
СтатьяОбзорНазвание и аннотация: Перевод в очереди
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Abdel Raheem Amr, Johnson Mark, Ralph David, Garaffa Giulio
Аннотация
INTRODUCTION: Peyronie's disease (PD) affects up to 9% of the male population. PD causes scarring of the tunica albuginea of the penis which leads to penile deformity making sexual intercourse difficult or impossible. PD also causes significant psychological, emotional and relationship difficulties for both patient and partner. Up until the licencing of Collagenase clostridium histolyticum (CCH) (Xiapex®, Xiaflex®), surgical correction of the penile deformity was the mainstay of treatment. Many conservative treatment options had been previously tried, however, the safety and efficacy of these options has not been demonstrated in large well-designed clinical trials. Intra-lesional CCH is now the gold standard option for the non-surgical management of PD. It is the first and only treatment approved by the Food and Drug Administration and the European Medicines Agency for PD. In this review article, we will discuss the pharmacology, clinical efficacy, safety and future of CCH intralesional injection.
EVIDENCE ACQUISITION: MEDLINE and PubMed search (from 1946). The search terms ("Collagenase Clostridium Histolyticum" OR "Xiapex" OR "Xiaflex") AND "Peyronie's disease" were used.
EVIDENCE SYNTHESIS: The safety and efficacy of intra-lesional CCH in the management of PD has been demonstrated in 2 large-scale multicenter, randomized, double-blind placebo-controlled clinical trials; the investigation for Maximal Peyronie's Reduction Efficacy and Safety Studies I and II (IMPRESS I and IMPRESS II). A new study published by our group suggests a new modified shortened protocol that will reduce the cost and duration of treatment without compromising the safety or efficacy of treatment.
CONCLUSIONS: CCH is the gold standard non-surgical option in the management of PD. The safety and efficacy of CCH has been demonstrated in large well-designed clinical trials. The new modified protocol, developed by our group, reduces the cost and inconvenience to patients whilst maintaining the efficacy. This will allow more men to benefit and will reduce the number of men undergoing surgical correction for their PD.
EVIDENCE ACQUISITION: MEDLINE and PubMed search (from 1946). The search terms ("Collagenase Clostridium Histolyticum" OR "Xiapex" OR "Xiaflex") AND "Peyronie's disease" were used.
EVIDENCE SYNTHESIS: The safety and efficacy of intra-lesional CCH in the management of PD has been demonstrated in 2 large-scale multicenter, randomized, double-blind placebo-controlled clinical trials; the investigation for Maximal Peyronie's Reduction Efficacy and Safety Studies I and II (IMPRESS I and IMPRESS II). A new study published by our group suggests a new modified shortened protocol that will reduce the cost and duration of treatment without compromising the safety or efficacy of treatment.
CONCLUSIONS: CCH is the gold standard non-surgical option in the management of PD. The safety and efficacy of CCH has been demonstrated in large well-designed clinical trials. The new modified protocol, developed by our group, reduces the cost and inconvenience to patients whilst maintaining the efficacy. This will allow more men to benefit and will reduce the number of men undergoing surgical correction for their PD.