應用新的診斷標準作華人纖維肌痛症治療之臨床研究

Clinical Trial of Pregabalin in Chinese Patients with Fibromyalgia under New Diagnostic Criteria

研究目的：本研究之目的，在評估本院疼痛科門診纖維肌痛症之長期華人病患，使用 Pregabalin作治療時的止痛效果及安全性。方法：本研究選擇了22位有慢性嚴重疼痛且長期規律性於本院疼痛門診治療之病患，以開放標記方式使用Pregabalin治療作臨床試驗。所有病患均須符合美國風濕病醫學會纖維肌痛症診斷標準更新版（Wolfe et al，2011）的要求。在研究前的評估後（訪查1），病患均以Pregabalin 150，300及450mg/d的劑量作三階段依每週增加一個劑量之方式，調整至病患有效止痛為止，然後按有效之劑量繼續治療至完成為期三週時間之研究。療效之評估是分別依使用Pregabalin的第一週（訪查2）、第二週（訪查3）及第三週（訪查4）結束時 進行。評估內容包括：疼痛嚴重程度評估（NRS）（0-10分）；睡眠品質量表（0-10分）；病患 整體改善量表（PGIC）（1-7分）及的纖維肌痛症綜合問卷（FIQR-2009）（0-100分）。同時，我 們還評估其治療之滿意度（0-4分）及副作用等。所得之數據以平均值±標準差表示，並以paired Student's t-tes作統計分析，p value小於0.05為統計上有顯著之差異。結果：在給予Pregabalin治療的22位有效病患中，除其中2位因嚴重暈眩至無法繼續進行研究外；在其他20位有效的個案中，15位為女性、5位為男性，平均年齡為48.7±77歲；廣泛分佈性疼痛指標（WPI分數）為8.2±1.7，症狀嚴重度（SS分數）為7.8±2.1；至於其發病時間長短為10.8±74年。最常見之疼痛性質為抽痛、敏感過度及酸痛；最常出現疼痛之部位 為上背、肩部及下背；過去最常使用之藥物為消炎劑、鴉片類及骨骼肌鬆強劑。其他於治療前、後之數據包括：壓痛點數目為17.5±11.7 vs10.9±9.6，疼痛分數為8.5±1.4 vs 3.7±1.6，睡眠品質分數為8.8±1.7vs3.8±2.2，纖維肌痛症綜合問卷（FIQR-2009）分數為 65.4±20.4vs38.1±17.2。而病患整體改善量表（PGIC）得分為2.6±0.6，亦即整體症狀部份獲得改善。病人的滿意度分數為3.1士0.5，表示達到滿意的程度。至於不良副作用則以暈眩（40%）、體重增加（20%）及嗜睡（15%）為主。同時所有治療前後之比較均有統計上明顯的差異（p<0.001 ）。結論：Pregabalin可有效地緩解大部分纖維肌痛症的慢性頑固性疼痛，同時可改善病人的睡眠及生活品質；但其暈眩、體重增加及嗜睡等副作用則為其最大的治療障礙。

Objective: The purpose of this study was to assess the efficacy and safety of Pregabalin on Chinese patients with long-term Fibromyalgia in our pain clinic. Methods: This open-label, 3 week clinical trial of Pregabalin was done on 22 patients with Fibromyalgia who underwent long-term treatment for chronic intractable pain. Their symptoms met the modified American College of Rheumatology diagnostic criteria for Fibromyalgia by Wolfe et al 2011. After a pre-study patient assessment Key Words: (visit 1), we titrated Pregabalin at doses of 150, 300, and 450 mg/d, increasing weekly, Fibromyalgia, until effective for pain relief without intolerable adverse effects. Then we maintained Pregabalin, the effective dose for the remainder of the 3-week treatment course. Patients were Chinese, assessed at the end of each week (visit 2,3,4). Outcome Measures included a verbal Efficacy, ranking scale for pain intensity (NRS) (0-10), quality of sleep (0-10), Patient Global Safety. Impression of Change (PGIC) (1-7), and the Revised Fibromyalgia Impact Questionnaire (FIQR-2009)(0-100). We also recorded patient satisfaction (0-4) and adverse effects. Results: Twenty of the 22 patients enrolled in this study reported effective pain relief, and two withdrew due to experiencing intolerable dizziness. Among the 20 effective cases, 15 were female and 5 were male, with average age of 48.7±7.7 years. Widespread Pain Index was 8.2±1.7; Symptom Severity Score was 7.8±2.1 and the duration of FM was 10.8±7.4 years. The major pain characters were throbbing, hyperalgesia and soreness; the most frequent locations of tender points were upper back, shoulder and lower back; the most common medications used prior to this study were NSAID's, opioids and skeletal muscle relaxants. All data presended, before and after treatment, included number of tender point 17.5±11.7 vs 10.9±9.6, pain score 8.5±1.4 vs 3.7±1.6, quality of sleep 8.8±1.7 vs 3.8±2.2, and FIQR-2009 score 65.4±20.4 vs 38.1±17.2 respectively. The PGIC score was 2.6±0.6 and the overall satisfaction was 3.1±0.5. The common adverse effects were dizziness (40%), weight gain (20%) and somnolence (15%). All data compared before and after treatment was shown as statistically significant (p<0.001). Conclusions: Pregabalin is found to effectively relieve chronic intractable pain of Fibromyalgia. It can also improve the quality of sleep and life, but its adverse effects, such as dizziness, weight gain and somnolence, may be intolerable for some patients.