| 孙龙龙,吴延海,李叶新,谭陈晨,崔舒,赵菁华.奥氮平口溶膜与肌肉注射氟哌啶醇治疗男性住院精神分裂症患者激越行为的随机对照研究[J].四川精神卫生杂志,2024,37(5):409-413.Sun Longlong,Wu Yanhai,Li Yexin,Tan Chenchen,Cui Shu,Zhao Jinghua,Randomized controlled study of olanzapine oral soluble film versus intramuscular haloperidol against agitated behaviour in male inpatients with schizophrenia[J].SICHUAN MENTAL HEALTH,2024,37(5):409-413 |
| 奥氮平口溶膜与肌肉注射氟哌啶醇治疗男性住院精神分裂症患者激越行为的随机对照研究 |
| Randomized controlled study of olanzapine oral soluble film versus intramuscular haloperidol against agitated behaviour in male inpatients with schizophrenia |
| 投稿时间：2024-04-16 |
| DOI：10.11886/scjsws20240416002 |
| 中文关键词: 奥氮平口溶膜 氟哌啶醇注射液 精神分裂症 激越 |
| 英文关键词:Olanzapine oral soluble film Haloperidol injection Schizophrenia Agitation |
| 基金项目:阜阳市卫生健康委科研立项课题（项目名称：精神分裂症伴代谢障碍的认知功能研究，项目编号：FY2021-147）；安徽省医疗卫生重点专科建设项目（项目编号：皖卫函〔2021〕273） |
|
| 摘要点击次数: |
| 全文下载次数: |
| 中文摘要: |
| 背景 男性精神分裂症患者激越行为对患者自身及社会造成严重影响。非侵入性制剂的给药方式可能有助于快速控制激越行为、改善患者体验，但目前关于奥氮平口溶膜治疗精神分裂症患者激越行为的证据有限。目的 比较奥氮平口溶膜与肌肉注射氟哌啶醇对改善男性精神分裂症患者激越行为的效果和安全性，以期为患者激越行为的改善提供参考。方法 连续纳入2022年5月—2023年7月在阜阳市第三人民医院男性封闭病房住院治疗的、符合《精神障碍诊断与统计手册（第5版）》（DSM-5）诊断标准、伴激越行为的精神分裂症患者（n=44）为研究对象。采用随机数字表法分为研究组和对照组各22例，研究组接受奥氮平口溶膜10 mg/d治疗，对照组接受肌肉注射氟哌啶醇8 mg/d治疗。于治疗前和用药6 h后，使用阳性和阴性症状量表-兴奋因子（PANSS-EC）和激越-镇静评估量表（ACES）评定患者激越行为严重程度，并根据PANSS-EC评分减分率，计算治疗应答率；于用药6 h后，使用锥体外系副反应量表（RSESE）和静坐不能评定量表（BARS）评定药物副反应。结果 用药6 h后，两组PANSS-EC评分和ACES评分比较，差异均无统计学意义（F=0.039、0.082，P均>0.05）；两组治疗应答率比较，差异无统计学意义（χ2=0.419，P=0.517）；研究组不良反应发生率低于对照组，差异有统计学意义（P=0.031）。两组BARS评分比较，差异无统计学意义（t=0.587，P=0.561）；研究组RSESE评分低于对照组，差异有统计学意义（t=-7.367，P<0.01）。结论 奥氮平口溶膜和肌肉注射氟哌啶醇治疗男性精神分裂症患者激越症状的效果相当，且奥氮平口溶膜的安全性优于肌肉注射氟哌啶醇。 |
| 英文摘要: |
| Background Agitated behaviour in male patients with schizophrenia can lead to serious consequences for the individual and the society. Non-invasive drug delivery may help to rapidly control agitation and improve the overall patient satisfaction， but there are limited studies on the efficacy of olanzapine oral soluble film for the treatment of agitated behaviour in patients with schizophrenia.Objective To compare the efficacy and safety profile of olanzapine oral soluble film versus intramuscular haloperidol against agitated behaviour in male patients with schizophrenia， so as to provide a reference for the treatment of agitated behaviour.Methods From May 2022 to July 2023， a consecutive sample of schizophrenic patients （n=44） with agitated behaviour who met the Diagnostic and Statistical Manual of Mental Disorders， fifth edition （DSM-5） were recruited in the male psychiatric closed ward of the Third People's Hospital of Fuyang. Patients were assigned into two groups using the random number table method， each with 22 cases. Study group was treated with olanzapine oral soluble film 10 mg/d， while control group was given intramuscular haloperidol 8 mg/d. The severity of agitated behaviour was determined using Positive and Negative Syndrome Scale-Excited Component （PANSS-EC） and Agitation Calmness Evaluation Scale （ACES） at the baseline and after 6 h of drug administration. The treatment response rate was calculated based on the reduction of PANSS-EC score， and the drug side effects were assessed using Rating Scale for Extrapyramidal Side Effects （RSESE） and Barnes Akathisia Rating Scale （BARS） after 6 h of drug administration.Results After 6 h of drug administration， no statistical difference was reported in PANSS-EC score and ACES score between two groups （F=0.039， 0.082， P>0.05）， and the treatment response rate yielded no statistical difference between two groups （χ2=0.419， P=0.517）， while study group reported a lower incidence rate of adverse reactions compared with control group， with statistically significant difference （P=0.031）. BARS scores noted no statistical significant difference between two groups （t=0.587， P=0.561）， whereas study group scored lower on RSES compared to control group， with a statistical difference （t=-7.367， P<0.01）.Conclusion In the treatment of agitation in male patients with schizophrenia， the efficacy of olanzapine oral soluble film is comparable to that of intramuscular haloperidol， while the safety profile of the former is superior to that of the latter. ［Funded by Scientific Research Project of Fuyang Municipal Health Commission （number， FY2021-147）， Anhui Provincial Medical and Healthcare Key Speciality Construction Project （number， 〔2021〕273）； www.chictr.org.cn number： ChiCTR2200063052］ |
| 查看全文 查看/发表评论 下载PDF阅读器 |
| 关闭 |