利多卡因贴片治疗中国带状疱疹后神经痛患者疗效和安全性的随机、安慰剂对照、多中心临床研究
Randomized, Placebo-Controlled, Multicenter Clinical Study on the Efficacy and Safety of Lidocaine Patches in Chinese Patients with Postherpetic Neuralgia.
作者信息
Wang Aiping, Li Hang, Xie Zhihong, Li Lingfeng, Jiang Xian, Guo Qing, Hu Fengming, Zhang Jianzhong, Cui Yong, Ding Yangfeng, Fang Hong, Han Xiuping, Guo Shuping, Wang Junlong, Ni Na
机构信息
Dermatology and Venereology Department, Peking University First Hospital, Beijing, China.
Dermatology Department, Beijing Hospital, Beijing, China.
出版信息
Dermatol Ther (Heidelb). 2023 Jul;13(7):1477-1487. doi: 10.1007/s13555-023-00938-8. Epub 2023 Jun 2.
INTRODUCTION
To evaluate the efficacy and safety of lidocaine patches in Chinese patients with postherpetic neuralgia (PHN).
METHODS
Patients were randomized to receive lidocaine patches or placebo every day for 4 weeks. Efficacy endpoints included the decrease of analogue scale score (VAS) value at week 4, 2 and 1 and the percentage of patients that achieved a 30% decrease of VAS value. Safety analyses were conducted as well.
RESULTS
Two hundred forty Chinese patients were randomized. At week 1, lidocaine patch-treated patients had a higher clinical response versus placebo, and at week 4, the mean (SD) decreases of VAS value compared to the baseline were 14.01 (14.35) in the treatment group and 9.36 (12.03) in the placebo group (p = 0.0088). Overall, the safety profile in the treatment group was consistent with that observed in the placebo group [adverse event (AE) incidence rate: 33.33% versus 37.29%, p = 0.5857].
CONCLUSIONS
Lidocaine patches resulted in improved clinical response versus placebo in the treatment of PHN patients and were well tolerated.
引言
评估利多卡因贴片对中国带状疱疹后神经痛（PHN）患者的疗效和安全性。
方法
患者被随机分组，每天接受利多卡因贴片或安慰剂治疗，为期4周。疗效终点包括第4周、第2周和第1周时视觉模拟评分（VAS）值的降低，以及VAS值降低30%的患者百分比。同时进行安全性分析。
结果
240名中国患者被随机分组。在第1周时，利多卡因贴片治疗的患者与安慰剂相比有更高的临床反应，在第4周时，治疗组与基线相比VAS值的平均（标准差）降低为14.01（14.35），安慰剂组为9.36（12.03）（p = 0.0088）。总体而言，治疗组的安全性概况与安慰剂组观察到的一致[不良事件（AE）发生率：33.33%对37.29%，p = 0.5857]。
结论
在治疗PHN患者方面，利多卡因贴片与安慰剂相比可改善临床反应，且耐受性良好。
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