Nygaard H A, Bakke K, Brudvik E, Elgen K, Lien G K
Fyllingsdalen sykehjem, Bergen, Norway.
Curr Med Res Opin. 1994;13(4):222-32. doi: 10.1185/03007999409110487.
A double-blind controlled trial was carried out in 73 hospitalized elderly patients to evaluate the effect of different low doses of the neuroleptic, zuclopenthixol, on behavioural disorders associated with dementia. Patients were randomized into four groups and received treatment for 4 weeks with fixed daily doses of 2 mg, 4 mg or 6 mg zuclopenthixol, or with a dose which could be increased from 4 mg to 20 mg daily. The dose could also be reduced if necessary. Fifty-four of the patients remained on the same daily dose throughout the study. The results of symptom assessments showed that there was a significant improvement from baseline scores in all of the dose groups and, with the exception of patients on 2 mg daily, this was evident after only 1 week of treatment. Although improvement was noted in all the symptoms evaluated, the best effect was achieved on aggressive behaviour, restlessness/agitation, sleep disorders, and shouts/torments others. Only a few, relatively mild side-effects were recorded and there was no increase in frequency with increasing doses. There was significant correlation between the serum concentration and the dose of zuclopenthixol used but not in connection to age and clinical efficacy.
对73名住院老年患者进行了一项双盲对照试验，以评估不同低剂量的抗精神病药物珠氯噻醇对与痴呆相关的行为障碍的影响。患者被随机分为四组，接受为期4周的治疗，每日固定剂量分别为2毫克、4毫克或6毫克珠氯噻醇，或剂量可从每日4毫克增加至20毫克的治疗方案。如有必要，剂量也可减少。54名患者在整个研究过程中每日剂量保持不变。症状评估结果显示，所有剂量组的基线评分均有显著改善，除每日服用2毫克的患者外，仅治疗1周后就有明显改善。尽管在评估的所有症状中均有改善，但对攻击行为、烦躁不安/激动、睡眠障碍以及大喊大叫/折磨他人等症状的效果最佳。仅记录到少数相对轻微的副作用，且未随剂量增加而增多。所用珠氯噻醇的血清浓度与剂量之间存在显著相关性，但与年龄和临床疗效无关。
