Izmeth M G, Khan S Y, Kumarajeewa D I, Shivanathan S, Veall R M, Wiley Y V
Greaves Hall Hospital, Southport, England.
Pharmatherapeutica. 1988;5(4):217-27.
One hundred and sixteen mentally handicapped patients with behavioural disorders were studied in a double-blind clinical comparison of zuclopenthixol decanoate injection (mean dosage 123 mg/week) and placebo. The study consisted of a 4-week open phase, in which all patients were treated with zuclopenthixol decanoate, followed by a 12-week double-blind phase where approximately half of the patients were changed to placebo. Patients were assessed every 2 weeks using the Clinical Global Impression, the Nurse's Observation Scale for In-patient Evaluation, a specific behaviour rating scale designed for this study and a side-effects check-list. Fourteen patients in the placebo group were withdrawn because of an increase in the frequency and severity of their behavioural disorders compared to only 4 in the zuclopenthixol decanoate group. Analyses of the rating scales of the patients remaining in the study also showed zuclopenthixol decanoate to be superior to placebo in the treatment of mentally handicapped patients with behavioural disorders. Side-effects in general were not a problem and did not affect treatment.
对116名患有行为障碍的智力障碍患者进行了癸酸珠氯噻醇注射液（平均剂量123毫克/周）与安慰剂的双盲临床对照研究。该研究包括一个为期4周的开放期，在此期间所有患者均接受癸酸珠氯噻醇治疗，随后是一个为期12周的双盲期，在此期间约一半患者改用安慰剂。每2周使用临床总体印象量表、护士住院评估观察量表、为本研究设计的特定行为评定量表和副作用检查表对患者进行评估。安慰剂组有14名患者因行为障碍的频率和严重程度增加而退出，而癸酸珠氯噻醇组仅有4名。对研究中剩余患者评定量表的分析也表明，癸酸珠氯噻醇在治疗患有行为障碍的智力障碍患者方面优于安慰剂。总体而言，副作用不是问题，也不影响治疗。
