Lambertz Colleen K, Johnson Christopher J, Montgomery Paul G, Maxwell James R, Fry Stefanie J
Radiation Oncology, St. Luke's Mountain States Tumor and Medical Research Institute, United States of America.
J Anaesthesiol Clin Pharmacol. 2012 Apr;28(2):200-4. doi: 10.4103/0970-9185.94859.
We measured the effect of 30 milliliters (mL) of 4% lidocaine gel on the breasts and chest wall of healthy women covered for 1 h on plasma concentrations of lidocaine and its principal metabolite, monoethylglycinexylidide (MEGX), electrocardiogram (EKG) results, and adverse events.
This institutional review board-approved, prospective, open-label study complied with the Health Insurance Portability and Accountability Act (HIPAA). The study evaluated 10 healthy women aged 42-75 years with 30 mL of 4% lidocaine gel on the skin of the breasts and chest wall covered for 1 h. Cardiac and neurological assessments were performed and blood was drawn for lidocaine and MEGX levels at baseline and 1/2, 1, 2, 3, 4, 6, and 8 h after application. EKGs were performed before application and at 3 h. Subjects provided informed written consent. Primary and secondary outcomes were plasma concentrations of lidocaine and MEGX and frequency of adverse events, respectively. Statistical analysis included paired t-tests for EKGs and repeated measures regression for vital signs.
No lidocaine was detected in the blood of 9 of 10 subjects. One subject had low plasma concentrations of lidocaine just above the level of detection the first 4 h after application only. No MEGX was detected. Mean decrease in heart rate was likely multifactorial.
Thirty mL of 4% lidocaine gel on the breasts and chest wall covered for 1 h in healthy women resulted in plasma concentrations of lidocaine and MEGX well below therapeutic or toxic levels and no clinically significant adverse events.
我们测量了30毫升4%利多卡因凝胶覆盖健康女性乳房和胸壁1小时后，利多卡因及其主要代谢产物单乙基甘氨酰二甲苯胺（MEGX）的血浆浓度、心电图（EKG）结果及不良事件的影响。
本研究经机构审查委员会批准，为前瞻性、开放标签研究，符合《健康保险流通与责任法案》（HIPAA）。该研究评估了10名年龄在42 - 75岁的健康女性，在其乳房和胸壁皮肤涂抹30毫升4%利多卡因凝胶并覆盖1小时。进行了心脏和神经学评估，并在基线以及用药后1/2、1、2、3、4、6和8小时采集血液检测利多卡因和MEGX水平。在用药前和3小时进行心电图检查。受试者提供了知情书面同意书。主要和次要结局分别为利多卡因和MEGX的血浆浓度以及不良事件的发生频率。统计分析包括对心电图进行配对t检验，对生命体征进行重复测量回归分析。
10名受试者中有9名血液中未检测到利多卡因。仅1名受试者在用药后的前4小时血浆利多卡因浓度略高于检测水平。未检测到MEGX。心率的平均下降可能是多因素导致的。
健康女性乳房和胸壁涂抹30毫升4%利多卡因凝胶并覆盖1小时后，利多卡因和MEGX的血浆浓度远低于治疗或中毒水平，且未出现具有临床意义的不良事件。
