Leder Steven B, Acton Lynn M, Kmiecik Joann, Ganz Cindy, Blom Eric D
Yale University School of Medicine, Department of Surgery, New Haven, CT 06520-8041, USA.
Otolaryngol Head Neck Surg. 2005 Nov;133(5):681-4. doi: 10.1016/j.otohns.2005.08.009.
To determine whether the Blom-Singer indwelling Advantage tracheoesophageal voice prosthesis (TEP) extends prosthesis life span significantly in patients with documented premature device failure due to fungal colonization.
Data were collected in a prospective manner on a total of 42 standard indwelling TEP users who exhibited early device failure, that is, between 2 weeks and 6 months, due to fungal colonization of the flap valve despite appropriate use of oral antifungal agents. There were 29 men and 13 women, whose ages ranged from 36 years 10 months to 86 years 8 months.
Baseline data were derived from the average number of days 3 previous standard indwelling prostheses functioned before leaking. An Advantage indwelling TEP was placed after the third change, oral antifungal agents stopped, and routine care implemented, that is, flush and brush the device in situ twice each day. Each participant was assigned to 1 of 3 groups. Group 1 had device failure equal to or less than 2 months (n = 12). Group 2 had device failure between 2 and 4 months (n = 19). Group 3 had device failure between 4 and 6 months (n = 11).
Groups 1 and 2 exhibited significantly longer device life span, that is, 77 and 82 days, respectively (P < 0.01), and group 3 exhibited device life span that was longer but not significantly so, that is, 12 days (P > 0.05), after the change from standard to Advantage TEP. Individual data indicated that the majority of participants, that is, 32 of 42 (76.2%), experienced longer device life span after changing to the Advantage prosthesis. Specifically, 9 of 12 (75.0%) users in group 1, 17 of 19 (89.5%) users in group 2, and 6 of 11 (54.5%) users in group 3 exhibited longer device life span. The combination of using an Advantage TEP, discontinuing oral antifungal agents, and reducing the number of both TEP changes and clinic visits resulted in overall cost benefits for both the user and the health care system. The cost benefit for group 1 was dollar 520.00; group 2, dollar 393.00; and group 3, dollar 204.25.
The Advantage TEP extended device life span significantly for standard indwelling device users with documented premature device failure due to fungal colonization, reduced costs associated with tracheoesophageal voice restoration rehabilitation, and enhanced user satisfaction by eliminating use of oral antifungal agents and reducing clinic visits.
Use of an Advantage indwelling voice prosthesis is warranted from both cost and user satisfaction perspectives when early and repeated device failure occurs as a result of fungal colonization.
B-3.
确定Blom-Singer留置式Advantage气管食管语音假体（TEP）是否能显著延长因真菌定植而出现器械过早失效的患者的假体使用寿命。
前瞻性收集了42例标准留置式TEP使用者的数据，这些使用者尽管适当使用了口服抗真菌药物，但由于瓣阀真菌定植，在2周龄至6个月之间出现了早期器械失效。其中男性29例，女性13例，年龄范围为36岁10个月至86岁8个月。
基线数据来自之前3个标准留置式假体在泄漏前发挥功能的平均天数。在第三次更换后，放置Advantage留置式TEP，停用口服抗真菌药物，并实施常规护理，即每天原位冲洗和刷洗该装置两次。将每位参与者分配到3组中的1组。第1组器械失效时间等于或少于2个月（n = 12）。第2组器械失效时间在2至4个月之间（n = 19）。第3组器械失效时间在4至6个月之间（n = 11）。
从标准TEP更换为Advantage TEP后，第1组和第2组的器械使用寿命显著延长，分别为77天和82天（P < 0.01），第3组的器械使用寿命虽有所延长，但不显著，为12天（P > 0.05）。个体数据表明，大多数参与者，即42人中的32人（76.2%），更换为Advantage假体后器械使用寿命延长。具体而言，第1组12名使用者中的9人（75.0%）、第2组19名使用者中的17人（89.5%）和第3组11名使用者中的6人（54.5%）器械使用寿命延长。使用Advantage TEP、停用口服抗真菌药物以及减少TEP更换次数和门诊就诊次数的综合措施为使用者和医疗保健系统带来了总体成本效益。第1组的成本效益为520.00美元；第2组为393.00美元；第3组为204.25美元。
对于因真菌定植而有器械过早失效记录的标准留置式器械使用者，Advantage TEP显著延长了器械使用寿命，降低了气管食管语音恢复康复相关成本，并通过停用口服抗真菌药物和减少门诊就诊提高了使用者满意度。
当因真菌定植导致早期和反复器械失效时，从成本和使用者满意度角度来看，使用Advantage留置式语音假体是合理的。
B-3
