Randomized, Placebo-Controlled, Multicenter Clinical Study on the Efficacy and Safety of Lidocaine Patches in Chinese Patients with Postherpetic Neuralgia

被引:2
作者
Wang, Aiping [1 ]
Li, Hang [1 ]
Xie, Zhihong [2 ]
Li, Lingfeng [3 ]
Jiang, Xian [4 ]
Guo, Qing [5 ]
Hu, Fengming [6 ]
Zhang, Jianzhong [7 ]
Cui, Yong [8 ]
Ding, Yangfeng [9 ]
Fang, Hong [10 ]
Han, Xiuping [11 ]
Guo, Shuping [12 ]
Wang, Junlong [13 ]
Ni, Na [13 ]
机构
[1] Peking Univ First Hosp, Dermatol & Venereol Dept, Beijing, Peoples R China
[2] Beijing Hosp, Dermatol Dept, Beijing, Peoples R China
[3] Capital Med Univ, Beijing Friendship Hosp, Dermatol & Venereol Dept, Beijing, Peoples R China
[4] Sichuan Univ, West China Hosp, Dermatol & Venereol Dept, Chengdu, Peoples R China
[5] Sun Yat Sen Univ, Sun Yat Sen Mem Hosp, Dermatol Dept, Guangzhou, Peoples R China
[6] Dermatol Hosp Jiangxi Prov, Dept Integrated Chinese & Western Med, Nanchang, Peoples R China
[7] Peking Univ Peoples Hosp, Dermatol Dept, Beijing, Peoples R China
[8] China Japan Friendship Hosp, Dermatol Dept, Beijing, Peoples R China
[9] Shanghai Skin Dis Hosp, Dermatol Dept, Shanghai, Peoples R China
[10] Zhejiang Univ, Affiliated Hosp 1, Sch Med, Dermatol Dept, Hangzhou, Peoples R China
[11] China Med Univ, Shengjing Hosp, Dermatol Dept, Shenyang, Peoples R China
[12] Shanxi Med Univ, Hosp 1, Dermatol Dept, Taiyuan, Peoples R China
[13] China State Inst Pharmaceut Ind, Clin Res Ctr, Shanghai, Peoples R China
关键词
Lidocaine patch; Postherpetic neuralgia; Clinical study; Efficacy; Safety; LOCALIZED NEUROPATHIC PAIN; MEDICATED PLASTER;
D O I
10.1007/s13555-023-00938-8
中图分类号
R75 [皮肤病学与性病学];
学科分类号
100206 ;
摘要
IntroductionTo evaluate the efficacy and safety of lidocaine patches in Chinese patients with postherpetic neuralgia (PHN).MethodsPatients 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.ResultsTwo 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].ConclusionsLidocaine patches resulted in improved clinical response versus placebo in the treatment of PHN patients and were well tolerated.
引用
收藏
页码:1477 / 1487
页数:11
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