背景:海绵体内注射疗法(ICI)是男性勃起功能障碍的一种公认的治疗策略。执行ICI时,并发症通常与患者错误有关。
目的:本研究的目的是检查已建立的ICI患者培训计划中的患者错误,并确定可预测重大错误的因素。
方法:参加ICI项目的患者接受技术方面的培训,开始剂量滴定。患者在训练中得到明确的指示,口头和书面形式。对使用ICI≥6个月的男性进行记录审查。多变量分析用于定义主要错误的预测因子。
结果:错误被列为次要错误(零响应注入,阴茎瘀伤,过期药物)和主要(可能导致阴茎异常勃起的错误:剂量自滴定,双重注射)。
结果:总体而言,1368例患者符合纳入标准并纳入分析。患者平均年龄为66±22(范围29-91)岁。关于教育,41%的患者接受过研究生教育,48%的人受过大学教育,和11%的高中教育。平均随访时间为3.2±7.6(范围0.5-12)年。使用的药物是三混物(62%),Bimix(35%),罂粟碱(2%),和前列腺素E1单药治疗(1%)。42%的患者在自我给药期间至少发生了1次错误。错误包括由于技术错误(8%的患者)对药物的零反应,阴茎瘀伤(34%),使用过期的瓶子(18%),自滴定(5%),和双重注射(4%的患者);12%的男性在计划期间犯了≥1个错误。在多变量分析中,重大错误发生的独立预测因素包括:年龄小,研究生教育,和<12个月的注射使用。
结论:据我们所知,这是首次报道的调查ICI错误和危险因素的研究.识别预测主要错误的因素允许在该患者子集中进行更量身定制和强化的训练。
■这项研究的优势包括大量患者(1386名男性),并有相当长的随访时间。此外,严格的训练,教育,以及对参与者的监控,以及形式化定义的使用,提高了结果的准确性和可靠性。尽管这项研究的优势,召回偏差可能是一个限制问题。
结论:大多数患者没有错误,大多数错误本质上是次要的。主要错误发生在<10%的患者中。年龄更小,研究生教育,和较少的ICI经验是重大错误的独立预测因素。
BACKGROUND: Intracavernosal injection therapy (ICI) is a well-established therapeutic strategy for men with erectile dysfunction. Complications are often related to patient error when performong ICI.
OBJECTIVE: The objective of this study was to examine patient errors in an established patient training program for performing ICI and identify factors that could predict major errors.
METHODS: Patients enrolled in our ICI program are trained on technical aspects, and dose titration is begun. Patients are given explicit instructions during training, both verbally and in written form. Records were reviewed for men using ICI for ≥6 months. Multivariable analysis was used to define predictors of major errors.
RESULTS: Errors were listed as minor (zero-response injection, penile bruising, expired medication) and major (errors potentially leading to priapism: dose self-titration, double injecting).
RESULTS: Overall, 1368 patients met the inclusion criteria and were included in the analysis. The mean patient age was 66 ± 22 (range 29-91) years. Regarding education, 41% of patients had graduate-level education, 48% had college education, and 11% high school education. Mean follow-up was 3.2 ± 7.6 (range 0.5-12) years. The agents used were trimix (62%), bimix (35%), papaverine (2%), and prostaglandin E1 monotherapy (1%). At least 1 error occurred during self-administration in 42% of patients during their time in the program. Errors included zero response to medication due to technical error (8% of patients), penile bruising (34%), use of an expired bottle (18%), self-titration (5%), and double injecting (4% of patients); 12% of men committed ≥1 error during their time in the program. On multivariable analysis, independent predictors of the occurrence of a major error included: young age, graduate-level education, and <12 months of injection use.
CONCLUSIONS: To the best of our knowledge, this is the first reported study to investigate ICI errors and risk factors. The identification of factors predictive of major errors allows for more tailored and intensive training in this subset of patients.
UNASSIGNED: Strengths of this study include a large patient population (1386 men) with a considerable follow-up time. Additionally, the rigorous training, education, and monitoring of the participants, as well as the use of formal definitions, enhances the accuracy and reliability of the results. Despite the strengths of the study, recall bias may be a limitation concern.
CONCLUSIONS: The majority of patients were error free, and the majority of the errors were minor in nature. Major errors occurred in <10% of patients. Younger age, graduate-level education, and less experience with ICI were independent predictors of major errors.