Geller Elizabeth J, Dumond Julie B, Bowling J Michael, Khandelwal Christine M, Wu Jennifer M, Busby-Whitehead Jan, Kaufer Daniel I
From the *Division of Female Pelvic Medicine and Reconstructive Pelvic Surgery; †Eshelman School of Pharmacy; ‡Gillings School of Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC; §Inpatient Palliative Medicine, WakeMed Medical Center, Raleigh, NC; Divisions of ∥Geriatric Medicine and ¶Neurology, University of North Carolina at Chapel Hill, Chapel Hill, NC.
Female Pelvic Med Reconstr Surg. 2017 Mar/Apr;23(2):118-123. doi: 10.1097/SPV.0000000000000374.
This study aimed to investigate the effect of trospium chloride on cognitive function in postmenopausal women treated for overactive bladder (OAB).
Randomized double-blind placebo-controlled trial conducted from April 2013 to April 2015. Women aged 50 years or older seeking treatment for OAB were randomized to either trospium chloride XR 60 mg daily or placebo. Baseline cognitive function was assessed via Hopkins Verbal Learning Test-Revised (HVLT-R), Mini Mental Status Exam, Mini Mental Status X, Digit Span, Trails A, Trails B, and Epworth Sleepiness Scale. Cognitive function was reassessed at week 1 and week 4. A priori power analysis determined that 21 subjects were needed per group.
Although 59 women were enrolled and randomized (28 trospium and 31 placebo), 45 completed assessment (21 trospium and 24 placebo). Mean age was 68 years, 78% were white, and 44% had previously taken OAB medication. For the primary outcome, there was no difference in HVLT-R total score between trospium and placebo groups at week 4 (P = 0.29). There were also no differences based on the other cognitive tests. There was a correlation between age and the following week-4 tests: HVLT-R total score (r = -0.3, P = 0.02), HVLT-R total recall subscale (r = -0.4, P = 0.007), Trails A (r = 0.4, P = 0.002), and Trails B (r = 0.4, P = 0.004). A linear regression model found that HVLT-R total score decreased by 0.372 points for each increased year of age.
In women aged 50 years and older, there were no changes in cognitive function between those taking trospium and placebo. Cognitive function was correlated with age.
本研究旨在调查氯化托品对治疗膀胱过度活动症(OAB)的绝经后女性认知功能的影响。
2013年4月至2015年4月进行的随机双盲安慰剂对照试验。寻求OAB治疗的50岁及以上女性被随机分为每日服用60毫克缓释氯化托品组或安慰剂组。通过修订的霍普金斯言语学习测试(HVLT-R)、简易精神状态检查、简易精神状态X、数字广度、连线测验A、连线测验B和爱泼华嗜睡量表评估基线认知功能。在第1周和第4周重新评估认知功能。先验功效分析确定每组需要21名受试者。
虽然招募并随机分配了59名女性(28名服用氯化托品,31名服用安慰剂),但45名完成了评估(21名服用氯化托品,24名服用安慰剂)。平均年龄为68岁,78%为白人,44%曾服用过OAB药物。对于主要结局,在第4周时,氯化托品组和安慰剂组的HVLT-R总分无差异(P = 0.29)。基于其他认知测试也没有差异。年龄与以下第4周测试之间存在相关性:HVLT-R总分(r = -0.3,P = 0.02)、HVLT-R总回忆子量表(r = -0.4,P = 0.007)、连线测验A(r = 0.4,P = 0.002)和连线测验B(r = 0.4,P = 0.004)。线性回归模型发现,年龄每增加一岁,HVLT-R总分下降0.372分。
在50岁及以上的女性中,服用氯化托品的女性与服用安慰剂的女性在认知功能上没有变化。认知功能与年龄相关。