Randomized Controlled Trial of Oxybutynin Extended Release Versus Placebo for Urinary Symptoms During Intravesical Bacillus Calmette-Guerin Treatment
Randomized Controlled Trial of Oxybutynin Extended Release Versus Placebo for Urinary Symptoms During Intravesical Bacillus Calmette-Guerin Treatment
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DOI：
10.1016/j.juro.2012.10.070
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发表时间：
2013-04-01
影响因子：
6.6
通讯作者：
Kibel, Adam S.
中科院分区：
文献类型：
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作者：
Johnson, Michael H.;Nepple, Kenneth G.;Kibel, Adam S.
目的：卡介苗膀胱灌注治疗非肌层浸润性尿路上皮癌可降低复发率。尿路刺激症状是治疗的常见副作用，经常限制治疗耐受性。虽然抗胆碱能药物可用于症状的预防，据我们所知，他们还没有被评估在一个随机对照trial.Materials和方法：共50卡介苗初治患者被随机分配到10毫克延长释放奥昔布宁每日或安慰剂开始前一天6周卡介苗治疗。在整个治疗过程中，每天记录一份评估泌尿系统症状（频率、排尿时烧灼感、尿急、膀胱疼痛、血尿）、全身症状（流感样症状、发热、关节痛）和药物副作用（便秘、视力模糊、口干）的问卷。线性混合重复测量模型测试每个点和基线scores.Results之间的差异：治疗组有一个更大的增加与安慰剂相比，排尿频率和燃烧（P = 0.004和P = 0.04，分别）。两组间其他泌尿系统症状无显著差异，卡介苗接种后严重程度增加，但两组均恢复至基线水平。与安慰剂相比，治疗组经历了发热、流感样症状、口干和便秘的增加（分别为p < 0.0001、p = 0.0008、p = 0.045和p = 0.001）。有其他非泌尿系统症状或药物的不良反应没有显着差异。结论：奥昔布宁增加排尿频率和燃烧相比，安慰剂在接受膀胱内卡介苗治疗的患者排尿。我们的研究结果不支持常规使用奥昔布宁预防卡介苗治疗期间的泌尿系统症状。
Purpose: Intravesical bacillus Calmette-Guerin is used to decrease recurrence rates of nonmuscle invasive urothelial carcinoma. Irritative urinary symptoms are a common side effect of treatment and frequently limit treatment tolerance. While anticholinergic medications may be used for symptom prophylaxis, to our knowledge they have not been evaluated in a randomized controlled trial.Materials and Methods: A total of 50 bacillus Calmette-Guerin naive patients were randomized to 10 mg extended release oxybutynin daily or placebo starting the day before 6 weekly bacillus Calmette-Guerin treatments. A questionnaire assessing urinary symptoms (frequency, burning on urination, urgency, bladder pain, hematuria), systemic symptoms (flu-like symptoms, fever, arthralgia) and medication side effects (constipation, blurred vision, dry mouth) was recorded daily throughout the therapeutic course. A linear mixed repeated measures model tested the differences between each point and baseline score.Results: The treatment group had a greater increase in urinary frequency and burning on urination compared to placebo (p = 0.004 and p = 0.04, respectively). There were no significant differences between groups for other urinary symptoms, which increased in severity after bacillus Calmette-Guerin but concomitantly returned to baseline in both groups. The treatment group experienced increases in fever, flu-like symptoms, dry mouth and constipation compared to placebo (p < 0.0001, p = 0.0008, p = 0.045 and p = 0.001, respectively). There were otherwise no significant differences in nonurinary symptoms or medication adverse reactions.Conclusions: Oxybutynin increased urinary frequency and burning on urination compared to placebo in patients receiving intravesical bacillus Calmette-Guerin treatment. Our results do not support the routine use of oxybutynin as prophylaxis against urinary symptoms during bacillus Calmette-Guerin therapy.