Klimke A, Klieser E, Lehmann E, Miele L
Psychiatric Department, Heinrich-Heine-University Düsseldorf, Germany.
Pharmacopsychiatry. 1993 Jan;26(1):25-9. doi: 10.1055/s-2007-1014337.
Several investigators have found that the initial improvement of acute schizophrenia after some days of neuroleptic treatment is correlated in a statistically significant way to the outcome after four weeks. In all these studies the question arises as to whether the correlation between early response and subsequent outcome is due to a specific response to a certain neuroleptic, or whether patients who respond early simply have a better prognosis. In order to isolate the specific drug effect from prognostic influences we performed a controlled double-blind study in 50 newly admitted schizophrenic inpatients. All patients were treated over three days with 15 mg haloperidol i.v., following which they were classified as 'early responders (ER)' (markedly improved or improved) or as 'early nonresponders (EN)' and then randomly assigned to group 1 (3 x 5 mg haloperidol p.o./d) or to group 2 (3 x 100 mg perazin p.o./d). If there was a specific drug effect on the correlation between early response and subsequent outcome a therapeutic superiority of perazin in EN and no superiority in ER was expected. Independently of the treatment condition the mean BPRS score had decreased from 61.2 (Sx = 12.1) to 38.1 (Sx = 13.9) at the end of the study. ER and EN were evenly distributed in the haloperidol and perazin group. The analysis of variance revealed no significant interactions of the factors 'treatment condition' x 'duration' x 'early response' (p = 0.27) and 'treatment condition' x 'early response' (p = 0.88) on the outcome (BPRS, CGI). This means that the initial hypothesis of this study has to be rejected.(ABSTRACT TRUNCATED AT 250 WORDS)
几位研究者发现,在使用抗精神病药物治疗几天后,急性精神分裂症患者的初期改善情况与四周后的治疗结果在统计学上具有显著相关性。在所有这些研究中,都出现了这样一个问题:早期反应与后续治疗结果之间的相关性,是由于对某种特定抗精神病药物的特异性反应,还是仅仅因为早期有反应的患者预后更好。为了将特定药物效应与预后影响因素区分开来,我们对50名新入院的精神分裂症住院患者进行了一项对照双盲研究。所有患者静脉注射15毫克氟哌啶醇,持续三天,之后将他们分为“早期反应者(ER)”(显著改善或有所改善)或“早期无反应者(EN)”,然后随机分配到第1组(口服3×5毫克氟哌啶醇/天)或第2组(口服3×100毫克奋乃静/天)。如果对于早期反应与后续治疗结果之间的相关性存在特定药物效应,那么预计奋乃静对EN有治疗优势,而对ER则无优势。与治疗条件无关,在研究结束时,平均简明精神病评定量表(BPRS)评分从61.2(标准差Sx = 12.1)降至38.1(标准差Sx = 13.9)。ER和EN在氟哌啶醇组和奋乃静组中分布均匀。方差分析显示,“治疗条件”ד疗程”ד早期反应”因素(p = 0.27)以及“治疗条件”ד早期反应”因素(p = 0.88)对治疗结果(BPRS、临床总体印象量表CGI)均无显著交互作用。这意味着本研究的初始假设必须被否定。(摘要截选至250字)