Mast Cell Stabilizer (Ketotifen) in Fibromyalgia: Phase 1 Randomized Controlled Clinical Trial.
Mast Cell Stabilizer (Ketotifen) in Fibromyalgia: Phase 1 Randomized Controlled Clinical Trial.
复制标题
DOI：
10.1097/ajp.0000000000000169
复制
发表时间：
2015-09
期刊：
影响因子：
--
通讯作者：
Stump T
中科院分区：
文献类型：
--
作者：
Ang DC;Hilligoss J;Stump T
与健康对照者相比，纤维肌痛 (FM) 患者的皮肤中有更多的肥大细胞。肥大细胞是否参与 FM 的发病机制尚不清楚。我们试图确定肥大细胞稳定剂（酮替芬）对 FM 症状的影响。 51 名 FM 受试者被随机分为每日口服酮替芬 2 mg BID (n=24) 组，持续 8 周或安慰剂组 (N=27)。受试者的平均年龄为 51.2 岁（标准差/SD 8.4）； 88%为女性，88%为白人； 22% 的人同时服用阿片类药物；平均压痛敏感度（范围 0-20）为 10.0 (0.4)。研究开始时，每周平均疼痛强度为 6.4 (1.1)，修订版纤维肌痛影响问卷 (FIQR) 的平均评分为 66.8 (14.0)。我们发现治疗组在两个主要指标上与基线相比没有统计学上显着的差异：每周平均疼痛强度[酮替芬-1.3（1.9）与安慰剂-1.5（1.9），p=0.7]；和 FIQR 分数 [−12.1 (19.5) 对比 -12.2 (18.1)，p=0.9]。次要结果指标（BPI 疼痛强度和压痛敏感性）没有达到统计显着性；意向治疗分析和完整分析的结果没有差异。除了短暂镇静 [6 例 (28.6%) 对比 1 例 (4.0%)] 外，酮替芬的耐受性良好。研究结果质疑皮肤肥大细胞是否在 FM 的发病机制中发挥主要作用。然而，考虑到肥大细胞在外周和中枢伤害感受中的作用，以及酮替芬的副作用最小，可能需要进行一项使用增加酮替芬剂量的随机临床试验。
Compared to healthy controls, patients with fibromyalgia (FM) have more mast cells in the skin. Whether mast cells are involved in the pathogenesis of FM is unclear. We sought to determine the effects of a mast cell stabilizer (ketotifen) on FM symptoms. Fifty-one FM subjects were randomized to daily oral ketotifen 2 mg BID (n=24) for 8 weeks or placebo (N=27). Mean age of subjects was 51.2 years (standard deviation/SD 8.4); 88% were female and 88% were white; 22% were taking concomitant opiates; and mean pressure pain sensitivity (range 0-20) was 10.0 (0.4). At study entry, the weekly average pain intensity was 6.4 (1.1) and the mean score on the Revised Fibromyalgia Impact Questionnaire (FIQR) was 66.8 (14.0). We found no statistically significant treatment group differences from baseline in either group for the two primary measures: weekly average pain intensity [ketotifen −1.3 (1.9) vs. placebo −1.5 (1.9), p=0.7]; and FIQR score [−12.1 (19.5) vs. −12.2 (18.1), p=0.9]. No secondary outcome measures (BPI pain intensity, and pressure pain sensitivity) reached statistical significance; results did not differ in the intent-to-treat and completer analyses. Other than transient sedation [6 (28.6%) vs. 1 (4.0%)], ketotifen was well tolerated. The study results question whether skin mast cells play a major role in the pathogenesis of FM. However, given the role of mast cells in peripheral and central nociception, and the minimal side effects of ketotifen, a randomized clinical trial using increasing doses of ketotifen may be warranted.