胶原酶溶组织梭菌在治疗 Peyronie 病中的应用——文献回顾和新的改良方案。
Collagenase Clostridium histolyticum in the Treatment of Peyronie's Disease-A Review of the Literature and a New Modified Protocol.
机构信息
Andrology Department, The Institute of Urology and University College London Hospital, London, UK; Andrology Department, Cairo University Hospital, Cairo, Egypt.
Andrology Department, The Institute of Urology and University College London Hospital, London, UK.
出版信息
Sex Med Rev. 2017 Oct;5(4):529-535. doi: 10.1016/j.sxmr.2017.07.005. Epub 2017 Sep 2.
INTRODUCTION
Peyronie's disease (PD) is a common condition that results in penile deformity, which makes sexual intercourse difficult or impossible, and causes psychological, emotional, and relationship difficulties for the man affected and his partner. Collagenase Clostridium histolyticum (CCH; Xiapex, Xiaflex) is the first licensed non-surgical treatment option for PD. The safety and efficacy have been demonstrated in two large phase III randomized controlled trials (IMPRESS I and IMPRESS II).
AIM
To review the safety and efficacy of CCH and to introduce a new shortened modified protocol for CCH that was developed by the authors to decrease the cost and duration of treatment.
METHODS
A review of the medical literature on CCH for inclusion in this review was obtained by searching the PubMed (from 1946) and Medline (from 1946) medical databases and from the screening of relevant bibliographies. The search terms Xiapex, Xiaflex, collagenase Clostridial histolyticum, and Peyronie's disease were used. Clinical trials in men with PD and scientific articles relating to pharmacologic data were included in the review. When possible, large, randomized, and well-designed trials were selected.
MAIN OUTCOME MEASURES
Changes in the angle of penile curvature and in the Peyronie's Disease Questionnaire domains.
RESULTS
The clinical trials demonstrate the safety and efficacy of CCH in the treatment of PD. The new modified protocol developed by the authors is as safe and effective as the protocol used in the clinical trials.
CONCLUSION
CCH is the first licensed non-surgical treatment for PD. Its safety and efficacy have been demonstrated in large well-designed clinical trials. The new shortened modified protocol decreases the cost and duration of the treatment without compromising the safety and efficacy of the drug. This alteration will allow more patients to benefit from CCH. Abdel Raheem A, Johnson M, Abdel-Raheem T, et al. Collagenase Clostridium histolyticum in the Treatment of Peyronie's Disease-A Review of the Literature and a New Modified Protocol. Sex Med Rev 2017;5:529-535.
简介
佩罗尼氏病（PD）是一种常见病症，会导致阴茎畸形，使性交变得困难或不可能，并给受影响的男性及其伴侣带来心理、情感和关系上的困难。胶原酶溶组织梭菌（CCH；Xiapex，Xiaflex）是第一种获准用于 PD 的非手术治疗选择。两项大型 III 期随机对照试验（IMPRESS I 和 IMPRESS II）已经证明了其安全性和有效性。
目的
回顾 CCH 的安全性和有效性，并介绍作者开发的一种新的缩短改良方案，以降低治疗的成本和持续时间。
方法
通过搜索 PubMed（自 1946 年）和 Medline（自 1946 年）医学数据库以及相关文献的筛选，获得了纳入本综述的关于 CCH 的医学文献综述。使用了 Xiapex、Xiaflex、胶原酶溶组织梭菌和佩罗尼氏病等检索词。综述中包括了患有 PD 的男性的临床试验和与药理学数据相关的科学文章。在可能的情况下，选择了大型、随机和精心设计的试验。
主要观察指标
阴茎弯曲角度和佩罗尼氏病问卷各领域的变化。
结果
临床试验证明了 CCH 在治疗 PD 中的安全性和有效性。作者开发的新改良方案与临床试验中使用的方案一样安全有效。
结论
CCH 是 PD 的第一种获准的非手术治疗方法。其安全性和有效性已在大型精心设计的临床试验中得到证实。新的缩短改良方案降低了治疗的成本和持续时间，同时不影响药物的安全性和有效性。这种改变将使更多的患者受益于 CCH。Abdel Raheem A、Johnson M、Abdel-Raheem T 等人。胶原酶溶组织梭菌治疗佩罗尼氏病的文献综述及新改良方案。性医学评论 2017；5：529-535。
Zotero 插件