Comaty J E, Janicak P G, Rajaratnam J, Sharma R P, Baker D, Davis J M
Illinois State Psychiatric Institute, Chicago 60612.
Psychopharmacol Bull. 1990;26(2):267-70.
The authors designed a three-phase prospective trial in which only those patients who developed an acute, neuroleptic-induced extrapyramidal side effect (EPSE) received benztropine (BZ) at 2 mg i.m. and then 1 mg p.o. b.i.d. for 2 days after their symptoms were rated for severity and type (Preparatory Phase 1). They were then randomly assigned under double-blind conditions to continue BZ or be switched to placebo for 8 days (Experimental Phase 2). Finally in Phase 3 (Followup), all patients continued on placebo in a single-blind design until Day 30. If the patient re-experienced an acute EPSE that was of sufficient severity to require immediate BZ administration, he or she was rated, treated, and then dropped from the study. EPSE scores and dropout rates did not differ in Phase 2 between the placebo- and BZ-treated groups. Implications for the continuation, cessation, or intermittent use of antiparkinsonian (AP) drugs are discussed.
作者设计了一项三期前瞻性试验，在该试验中，只有那些出现急性、抗精神病药物引起的锥体外系副作用（EPSE）的患者，在其症状被评定严重程度和类型后，接受2毫克苯海索肌肉注射，然后口服1毫克，每日两次，持续2天（准备阶段1）。然后，他们在双盲条件下被随机分配，继续服用苯海索或改用安慰剂，持续8天（实验阶段2）。最后在第3阶段（随访），所有患者以单盲设计继续服用安慰剂，直至第30天。如果患者再次出现严重到需要立即注射苯海索的急性EPSE，他或她将被评定、治疗，然后退出研究。在实验阶段2，安慰剂组和苯海索治疗组之间的EPSE评分和退出率没有差异。文中讨论了抗帕金森病（AP）药物持续使用、停药或间歇使用的意义。
