Nikvarz Naemeh, Vahedian Mostafa, Khalili Navid
Herbal and Traditional Medicines Research Center, Faculty of Pharmacy and Pharmaceutical Sciences, Kerman University of Medical Sciences, Haft Bagh Square, Kerman, Iran, 7616911319.
Cochrane Database Syst Rev. 2017 Sep 23;9(9):CD011831. doi: 10.1002/14651858.CD011831.pub2.
The efficacy of chlorpromazine, a benchmark antipsychotic, has not been fully assessed in direct comparison with different individual antipsychotics. Penfluridol is another old antipsychotic with a long half-life so one oral dose may last up to one week. This could confer advantage.
To assess the clinical effects of chlorpromazine compared with penfluridol for adults with schizophrenia.
On 31 March 2017, we searched the Cochrane Schizophrenia Group's Study-Based Register of Trials which is based on regular searches of CINAHL, BIOSIS, AMED, Embase, PubMed, MEDLINE, PsycINFO, and registries of clinical trials. There are no language, date, document type, or publication status limitations for inclusion of records in the register.
We included all randomised clinical trials focusing on chlorpromazine versus penfluridol for adults with schizophrenia or related disorders. Outcomes of interest were death, service utilisation, global state, mental state, adverse effects and leaving the study early. We included trials meeting our selection criteria and reporting useable data.
We extracted data independently. For binary outcomes, we calculated risk ratio (RR) and its 95% confidence interval (CI), on an intention-to-treat basis. For continuous data, we planned to estimate the mean difference (MD) between groups and its 95% CI. We employed a fixed-effect model for analyses. We assessed risk of bias for included studies and created a 'Summary of findings' table using GRADE.
The review includes three studies with a total of 130 participants. Short-term results for hospital admissions showed no clear difference between chlorpromazine and penfluridol (1 RCT, n = 29, RR 0.19, 95% CI 0.01 to 3.60, low-quality evidence). No clear difference in the incidence of akathisia was found at medium term (2 RCTs, n = 85, RR 0.19, 95% CI 0.04 to 1.06, low-quality evidence), and similar numbers of participants - nearly half - from each treatment group left the study early (3 RCTs, n = 130, RR 1.21, 95% CI 0.83 to 1.77, low-quality evidence). The risk of needing additional antiparkinsonian medication was less in the chlorpromazine group (2 RCTs, n = 74, RR 0.70, 95% CI 0.51 to 0.95). No useable data reported clinically important change in global or mental state. No data were reported for relapse. No deaths were reported by the trials.
AUTHORS' CONCLUSIONS: Only three small studies provided data and the quality of reporting and evidence is low. Limited data indicate the efficacy and adverse effects profiles of chlorpromazine and penfluridol are generally similar. Penfluridol, however, may confer advantage by needing to be given only once per week. Firm conclusions are not possible without good-quality trials, and where these treatments are used, such trials are justified.
作为一种基准抗精神病药物,氯丙嗪的疗效尚未与不同的个体抗精神病药物进行直接比较而得到充分评估。五氟利多是另一种半衰期长的老一代抗精神病药物,一次口服剂量可持续长达一周。这可能带来优势。
评估氯丙嗪与五氟利多对成人精神分裂症患者的临床效果。
2017年3月31日,我们检索了Cochrane精神分裂症研究组基于试验的研究注册库,该注册库基于对CINAHL、BIOSIS、AMED、Embase、PubMed、MEDLINE、PsycINFO以及临床试验注册库的定期检索。纳入注册库记录时没有语言、日期、文献类型或出版状态限制。
我们纳入了所有针对氯丙嗪与五氟利多治疗成人精神分裂症或相关疾病的随机临床试验。感兴趣的结局包括死亡、服务利用、总体状态、精神状态、不良反应以及提前退出研究。我们纳入了符合我们选择标准并报告可用数据的试验。
我们独立提取数据。对于二分类结局,我们基于意向性分析计算风险比(RR)及其95%置信区间(CI)。对于连续性数据,我们计划估计组间平均差(MD)及其95%CI。我们采用固定效应模型进行分析。我们评估纳入研究的偏倚风险,并使用GRADE创建了一个“结果总结”表。
该综述纳入了三项研究,共130名参与者。住院的短期结果显示氯丙嗪和五氟利多之间没有明显差异(1项随机对照试验,n = 29, RR 0.19, 95% CI 0.01至3.60,低质量证据)。中期未发现静坐不能发生率有明显差异(2项随机对照试验,n = 85, RR 0.19, 95% CI 0.04至1.06,低质量证据),并且每个治疗组中提前退出研究的参与者数量相近——接近一半(3项随机对照试验,n = 130, RR 1.21, 95% CI 0.83至1.77,低质量证据)。氯丙嗪组需要额外使用抗帕金森药物的风险较低(2项随机对照试验,n = 74, RR 0.70, 95% CI 0.51至0.95)。没有报告关于总体或精神状态临床重要变化的可用数据。没有报告复发数据。试验中未报告死亡情况。
仅有三项小型研究提供了数据,报告质量和证据质量较低。有限的数据表明氯丙嗪和五氟利多的疗效和不良反应概况总体相似。然而,五氟利多可能具有优势,因为它每周只需给药一次。没有高质量试验就无法得出确凿结论,在使用这些治疗方法时,进行此类试验是合理的。