Lambertz Colleen K, Johnson Christopher J, Montgomery Paul G, Maxwell James R
St Luke's Mountain States Tumor Institute, 100 E Idaho St, Boise, ID 83712, USA.
Radiology. 2008 Sep;248(3):765-72. doi: 10.1148/radiol.2482071490. Epub 2008 Jul 22.
To test the hypothesis that premedication with acetaminophen, ibuprofen, and/or 4% lidocaine gel would decrease discomfort and improve satisfaction with screening mammography in women who expect a higher level of discomfort.
In this HIPAA-compliant, institutional review board-approved, prospective, double-blinded, placebo-controlled clinical trial, 418 women aged 32-89 years who expected substantial discomfort with screening mammography were randomly divided to receive premedication with acetaminophen, ibuprofen, and/or 4% lidocaine gel. Subjects provided informed written consent. The primary outcome was discomfort. Secondary outcomes were satisfaction and plans for future mammography on the basis of discomfort. Subjects completed structured questionnaires with visual analog scales to measure discomfort and satisfaction. A generalized linear mixed-models framework was used to assess the effect of medications on discomfort during mammography, and satisfaction with technologist and machine combinations was included as a random effect. The "plans for mammography next year" outcome was modeled by using a binary distribution and logit link function.
Discomfort was significantly lower in the lidocaine gel group (P = .01). Satisfaction was significantly negatively correlated with discomfort (P < .001). Satisfaction and whether or not the subject had delayed her mammography because of fear of discomfort had significant effects on plans to undergo mammography next year (P < .001 for both). There were significant differences in discomfort between different combinations of technologists and machines.
Premedication with 4% lidocaine gel significantly reduced discomfort during screening mammography, and reduced discomfort may improve the likelihood of future mammographic screening and early detection of breast cancer.
验证以下假设，即对于预计会有较高不适程度的女性，使用对乙酰氨基酚、布洛芬和/或4%利多卡因凝胶进行预处理可减轻不适并提高乳腺钼靶筛查的满意度。
在这项符合健康保险流通与责任法案（HIPAA）、经机构审查委员会批准的前瞻性、双盲、安慰剂对照临床试验中，将418名年龄在32 - 89岁、预计乳腺钼靶筛查会有明显不适的女性随机分组，分别接受对乙酰氨基酚、布洛芬和/或4%利多卡因凝胶预处理。受试者提供了知情书面同意书。主要结局为不适程度。次要结局为满意度以及基于不适程度的未来乳腺钼靶检查计划。受试者完成了带有视觉模拟量表的结构化问卷，以测量不适程度和满意度。采用广义线性混合模型框架来评估药物对乳腺钼靶检查期间不适的影响，并将对技术人员和机器组合的满意度作为随机效应纳入。“明年乳腺钼靶检查计划”这一结局采用二项分布和对数链接函数进行建模。
利多卡因凝胶组的不适程度显著更低（P = 0.01）。满意度与不适程度显著负相关（P < 0.001）。满意度以及受试者是否因害怕不适而推迟乳腺钼靶检查对明年进行乳腺钼靶检查的计划有显著影响（两者P均 < 0.001）。不同技术人员和机器组合之间的不适程度存在显著差异。
4%利多卡因凝胶预处理可显著减轻乳腺钼靶筛查期间的不适，减轻不适可能会提高未来乳腺钼靶筛查和早期发现乳腺癌的可能性。
