[盐酸奥昔布宁乳液(APOHIDE® 20%乳液)作为原发性手掌多汗症新疗法的药理特性和临床研究结果]。

Koji Okawa, Takaaki Terahara
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引用次数: 0

摘要

APOHIDE® 20%乳液是一种治疗原发性掌多汗症的外用制剂,含有活性成分盐酸奥昔布宁。盐酸奥昔布宁具有抗胆碱能作用,通过与肾上腺汗腺中的 M3 受体(毒蕈碱乙酰胆碱受体的一种亚型)结合而抑制出汗。盐酸奥昔布宁治疗的临床反应还涉及奥昔布宁的活性代谢产物 N-去乙基奥昔布宁。一项针对日本原发性手掌多汗症患者的临床研究显示,APOHIDE® 20%乳液的疗效优于安慰剂,即APOHIDE® 20%乳液组的应答者(即汗液量比基线减少≥50%的患者)明显多于安慰剂组(APOHIDE® 20%乳液组:52.8%;安慰剂组:52.8%;APOHIDE® 20%乳液组:52.8%;APOHIDE® 20%乳液组:52.8%):52.8%,安慰剂组:24.3%;治疗差异:28.5%;P < 0.001,费雪精确检验)。该研究和其他临床研究报告了一些与药物抗胆碱能效应相关的不良事件(AEs)和一些涂抹部位的不良事件,但大多数不良事件都很轻微。长期治疗(52 周)后,临床反应并没有降低,只有少数患者(125 例中有 2 例)因 AEs 而中断治疗。综上所述,研究结果表明,APOHIDE® 20%乳液可能是原发性手掌多汗症患者的一种有效、安全的新治疗选择。
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[Pharmacologic properties and results of a clinical study of oxybutynin hydrochloride lotion (APOHIDE® Lotion 20%) as a novel treatment for primary palmar hyperhidrosis].

APOHIDE® Lotion 20% is a topical agent for treating primary palmar hyperhidrosis that contains the active ingredient oxybutynin hydrochloride. Oxybutynin hydrochloride has anticholinergic effects and inhibits sweating by binding to the M3 receptor, a subtype of the muscarinic acetylcholine receptor, in eccrine sweat glands. The clinical response to oxybutynin hydrochloride treatment also involves N-desethyloxybutynin, an active metabolite of oxybutynin. A clinical study in Japanese patients with primary palmar hyperhidrosis showed superiority of APOHIDE® Lotion 20% over placebo, i.e., there were significantly more responders (i.e., patients with a reduction in sweat volume ≥50% from baseline) in the APOHIDE® Lotion 20% group (APOHIDE® Lotion 20% group: 52.8%, placebo group: 24.3%; treatment difference: 28.5%; P < 0.001, Fisher's exact test). This and other clinical studies reported some adverse events (AEs) associated with the drug's anticholinergic effects and some application site AEs, but most of the AEs were mild. Clinical response did not decrease with long-term (52-week) treatment, and only a few patients (2 of 125) discontinued treatment because of AEs. Taken together, study results indicate that APOHIDE® Lotion 20% may be an effective and safe new treatment option for patients with primary palmar hyperhidrosis.

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来源期刊
Folia Pharmacologica Japonica
Folia Pharmacologica Japonica Pharmacology, Toxicology and Pharmaceutics-Pharmacology
CiteScore
0.40
自引率
0.00%
发文量
132
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