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加拿大男性衰老研究协会:对加拿大卫生部关于睾酮治疗立场文件的回应。

Canadian Society for the Study of the Aging Male: response to health Canada's position paper on testosterone treatment.

作者信息

Bain Jerald, Brock Gerald, Kuzmarov Irwin

机构信息

Department of Medicine, Division of Endocrinology and Metabolism, Mount Sinai Hospital, University of Toronto, Toronto, Ontario, Canada;.

Department of Surgery, Division of Urology, St. Joseph's Health Center, University of Western Ontario, London, Ontario, Canada.

出版信息

J Sex Med. 2007 May;4(3):558-566. doi: 10.1111/j.1743-6109.2007.00488.x.

DOI:10.1111/j.1743-6109.2007.00488.x
PMID:17498097
Abstract

INTRODUCTION

Testosterone treatment of older symptomatic men with reduced testosterone availability is increasing. There is an expanding body of literature to support such treatment in a large subset of aging men, but there has not yet been a long-term placebo-controlled double-blind study of several thousand men to confirm the efficacy and safety of this treatment as indicated by shorter-term studies. The absence of a long-term study has been used by governmental agencies as a limiting factor in providing full access and payment for this treatment in government-sponsored health care plans. Health Canada issued a testosterone analysis document to the pharmaceutical industry, the implications of which may make it more difficult for appropriate patients to receive such treatment. The Canadian Society for the Study of the Aging Male (CSSAM) believed it had an obligation to advocate on behalf of men requiring this treatment.

AIM

To provide an international consensus on the use of testosterone treatment in appropriately selected hypogonadal men.

MAIN OUTCOME MEASURE

To determine whether the literature supports the use of testosterone treatment in a selected population of hypogonadal men, to achieve consensus on this point among an international consulting group, and to transmit this view to health care workers and insuring and governmental agencies.

METHODS

Email communication among the consulting group to prepare a response to Health Canada, followed by a review of appropriate literature and international practice guidelines, incorporating the literature and guidelines together with the CSSAM letter and Health Canada's response.

RESULT

The literature and international guidelines support the initiation of testosterone therapy in symptomatic hypogonadal men, recognizing that there is no universal agreement on the criteria for the diagnosis of hypogonadism in each suspected case. The need for careful monitoring of such men is stressed.

CONCLUSION

CSSAM acted as an advocate for hypogonadal men who may benefit from treatment with testosterone. Short-term studies and 60 years of experience with testosterone therapy attest to its efficacy. Long-term studies are desirable, but it may take many years before results could be forthcoming. There is no evidence to suggest that testosterone treatment increases the risk of prostate cancer or cardiovascular disease. Current evidence suggests, in fact, that testosterone treatment may be cardioprotective. It is important to bring this information to the attention of governments and insuring agencies through the collaboration of groups devoted to the diagnosis and treatment of hypogonadal men.

摘要

引言

对睾酮水平降低的老年有症状男性进行睾酮治疗的情况正在增加。有越来越多的文献支持在很大一部分老年男性中进行这种治疗,但尚未有针对数千名男性的长期安慰剂对照双盲研究来证实短期研究所表明的这种治疗的疗效和安全性。政府机构将缺乏长期研究作为在政府资助的医疗保健计划中全面提供和支付这种治疗的限制因素。加拿大卫生部向制药行业发布了一份睾酮分析文件,其影响可能使合适的患者更难接受这种治疗。加拿大男性衰老研究协会(CSSAM)认为有义务代表需要这种治疗的男性进行倡导。

目的

就睾酮治疗在适当选择的性腺功能减退男性中的应用达成国际共识。

主要观察指标

确定文献是否支持在选定的性腺功能减退男性人群中使用睾酮治疗,在国际咨询小组中就此达成共识,并将这一观点传达给医护人员、保险机构和政府机构。

方法

咨询小组通过电子邮件交流准备对加拿大卫生部的回复,随后对相关文献和国际实践指南进行审查,将文献、指南与CSSAM的信件以及加拿大卫生部的回复整合在一起。

结果

文献和国际指南支持对有症状的性腺功能减退男性开始进行睾酮治疗,同时认识到对于每例疑似性腺功能减退病例的诊断标准尚无普遍共识。强调了对这类男性进行仔细监测的必要性。

结论

CSSAM为可能从睾酮治疗中受益的性腺功能减退男性进行了倡导。短期研究和60年的睾酮治疗经验证明了其疗效。长期研究是可取的,但可能需要很多年才能得出结果。没有证据表明睾酮治疗会增加前列腺癌或心血管疾病的风险。事实上,目前的证据表明睾酮治疗可能具有心脏保护作用。通过致力于性腺功能减退男性诊断和治疗的团体之间的合作,将这些信息告知政府和保险机构非常重要。

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