Intranasal civamide for the treatment of episodic cluster headaches.
Intranasal civamide for the treatment of episodic cluster headaches.
复制标题
鼻内西维酰胺用于治疗阵发性丛集性头痛。
作者：
J. Saper;J. Klapper;N. Mathew;A. Rapoport;S. Phillips;J. Bernstein
目的
评价发作性丛集性头痛期间鼻内给予辛酰胺溶液预防性治疗的安全性和有效性。
受试者和方法
这是一项多中心、双盲、随机、溶剂对照研究，在美国14家头痛/神经病学中心进行，治疗期为7天，治疗后为20天。28名受试者以2：1的比例随机接受civamide或其载体; 18名接受civamide，10名接受载体。受试者通过滴管接受100 μ L的0.025% civamide（25 μ g）或100 μ L的媒介物至每毫升，每天一次，持续7天。每日总剂量的civamide是50微克。
主要观察指标
对治疗期间和治疗后每周丛集性头痛的数量、疼痛强度、相关症状的存在以及不良事件的发生率进行评估。
结果
在治疗后的第1天到第7天，civamide组的受试者头痛次数从基线到治疗后的百分比下降明显更大（-55.5% vs -25.9%; P = 0.03），并且在第8天至第14天期间有显著性趋势（-66.9% vs -32.3%; P =.07）和第15天至第20天（-70.6% vs -34.9%; P =.07），以及在整个给药后期间（第1天至第20天[P =.054]）与溶剂组相比几乎显著降低。在治疗后期间，治疗组每周头痛次数的减少幅度较大，在治疗后第8天至第14天（-8.6 vs -3.6; P = 0.09）和第15天至第20天（-8.9 vs -3.6; P = 0.07）有显著性趋势。两组在丛集性头痛的疼痛强度、严重头痛的数量或相关症状方面没有显著差异。最常见的不良事件包括鼻灼热（18名接受civamide治疗的受试者中有14名，10名接受溶媒治疗的受试者中有1名; P = 0.001）和流泪（18名接受civamide治疗的受试者中有9名，10名接受溶媒治疗的受试者中有0名; P = 0.01）。
结论
50 μ g剂量的鼻内注射西维因溶液可能对预防性治疗发作性丛集性头痛有一定效果。
OBJECTIVE
To evaluate the safety and efficacy of intranasal civamide solution for preventive treatment during an episodic cluster headache period.
SUBJECTS AND METHODS
This was a multicenter, double-blind, randomized, vehicle-controlled study with a 7-day treatment period and a 20-day posttreatment period performed at 14 headache/neurology centers in the United States. Twenty-eight subjects were randomized to receive civamide or its vehicle in a 2:1 ratio; 18 received civamide and 10 received the vehicle. Subjects received 100 microL of 0.025% civamide (25 microg) or 100 microL of the vehicle to each nostril via dropper once daily for 7 days. The total daily dose of civamide was 50 microg.
MAIN OUTCOME MEASURES
The number of cluster headaches per week during the treatment and posttreatment periods, pain intensity, presence of associated symptoms, and the incidence of adverse events were assessed.
RESULTS
Subjects in the civamide group had a significantly greater percent decrease in the number of headaches from baseline to posttreatment during days 1 through 7 (-55.5% vs -25.9%; P =.03) and a trend toward significance during days 8 through 14 (-66.9% vs -32.3%; P =.07) and days 15 through 20 (-70.6% vs -34.9%; P =.07), as well as a near-significant decrease during the entire posttreatment period (days 1 through 20 [P =.054]) compared with the vehicle group. There were larger decreases in the number of headaches per week during the posttreatment period in the civamide-treated group, with trends toward significance during posttreatment days 8 through 14 (-8.6 vs -3.6; P =.09) and days 15 through 20 (-8.9 vs -3.6; P =.07). There were no significant differences between groups in cluster headache pain intensity, number of severe headaches, or associated symptoms. The most common adverse events included nasal burning (14 of 18 civamide-treated subjects, 1 of 10 vehicle-treated subjects; P =.001) and lacrimation (9 of 18 civamide-treated subjects, 0 of 10 vehicle-treated subjects; P =.01).
CONCLUSION
Intranasal civamide solution at a dose of 50 microg may be modestly effective in the preventive treatment of episodic cluster headache.
影响因子：
3
作者：
Moskowitz,MA;Buzzi,MG;Sakas,DE;Linnik,MD
通讯作者：
Linnik,MD