Pande A C, Davidson J R, Jefferson J W, Janney C A, Katzelnick D J, Weisler R H, Greist J H, Sutherland S M
Parke-Davis Pharmaceutical Research, Division of Warner-Lambert Company, Ann Arbor, Michigan 48105, USA.
J Clin Psychopharmacol. 1999 Aug;19(4):341-8. doi: 10.1097/00004714-199908000-00010.
A randomized, double-blind, placebo-controlled, parallel-group study was conducted to evaluate the efficacy and safety of gabapentin in relieving the symptoms of social phobia. Sixty-nine patients were randomly assigned to receive double-blind treatment with either gabapentin (dosed flexibly between 900 and 3,600 mg daily in three divided doses) or placebo for 14 weeks. A significant reduction (p < 0.05) in the symptoms of social phobia was observed among patients on gabapentin compared with those on placebo as evaluated by clinician- and patient-rated scales. Results were similar for the intent-to-treat and week-2 completer populations. Adverse events were consistent with the known side effect profile of gabapentin. Dizziness (p = 0.05), dry mouth (p = 0.05), somnolence, nausea, flatulence, and decreased libido occurred at a higher frequency among patients receiving gabapentin than among those receiving placebo. No serious adverse events or deaths were reported. On the basis of these limited data, it seems that gabapentin offers a favorable risk-benefit ratio for the treatment of patients with social phobia. Further studies are required to confirm this effect and to determine whether a dose-response relationship exists.
开展了一项随机、双盲、安慰剂对照、平行组研究，以评估加巴喷丁缓解社交恐惧症症状的疗效和安全性。69名患者被随机分配接受双盲治疗，分别服用加巴喷丁（每日剂量900至3600毫克，分三次服用，剂量灵活调整）或安慰剂，为期14周。根据临床医生和患者评定量表评估，与服用安慰剂的患者相比，服用加巴喷丁的患者社交恐惧症症状有显著减轻（p<0.05）。意向性治疗人群和第2周完成治疗人群的结果相似。不良事件与加巴喷丁已知的副作用特征一致。与服用安慰剂的患者相比，服用加巴喷丁的患者出现头晕（p=0.05）、口干（p=0.05）、嗜睡、恶心、肠胃胀气和性欲减退的频率更高。未报告严重不良事件或死亡。基于这些有限的数据，加巴喷丁似乎为社交恐惧症患者的治疗提供了良好的风险效益比。需要进一步研究以证实这种效果，并确定是否存在剂量反应关系。
