Depot pipotiazine palmitate and undecylenate for schizophrenia

 

Abstract

Background

Antipsychotic drugs are usually given orally but compliance may be problematic. The development of depot injections in the 1960s gave rise to their extensive use as a means of long-term maintenance treatment. Pipotiazine palmitate is a depot from the phenothiazine family of antipsychotic drugs.

Objectives

To assess the clinical, social and economic effects of depot pipotiazine palmitate and undecylenate compared with placebo, oral antipsychotics and other depot antipsychotic preparations for people with schizophrenia.

Search methods

For this update we searched the Cochrane Schizophrenia Group's Register (June 2003). We also inspected references of all identified trials for more studies and contacted relevant industries.

Selection criteria

We included all randomised clinical trials comparing depot pipotiazine palmitate and undecylenate to oral antipsychotics or other depot preparations for people with schizophrenia.

Data collection and analysis

We reliably selected, quality rated and independently extracted data from relevant studies. We calculated the random effects relative risk (RR), the 95% confidence intervals (CI) and, where possible the number needed to treat (NNT) on an intention-to-treat basis. For continuous data, we calculated weighted mean differences (WMD). We only presented scale data for those tools that had attained pre-specified levels of quality.

Main results

When pipotiazine palmitate was compared with 'standard' oral antipsychotic no differences were found for outcomes of global impression (n=53, 1 RCT, RR 2.57, CI 0.8 to 8.6), relapse (n=124, 1 RCT, RR 1.55 CI 0.76 to 3.2), study attrition (n=219, 3 RCTs, RR 1.37 CI 0.8 to 2.4) and behaviour (n=124, 1 RCT, WMD 4.65, CI -1.1 to 10.4). There was also no reported difference in adverse effects such as tardive dyskinesia or the need for anticholinergic drugs.

Sixteen studies compared pipotiazine palmitate with other depot preparations (n=1123). Pipotiazine palmitate was consistently equivalent to other depots in terms of a range of outcomes, including global impression (n=217, 4 RCTs, RR not improved 0.99 CI 0.91 to 1.07), relapse (n=239, 5 RCTs, RR relapse by 1 year 0.98 CI 0.55 to 1.75), and adverse effects (n=337, 5 RCTs, RR needing anticholinergic medication 0.98 CI 0.84 to 1.15).

Authors' conclusions

Although well-conducted and reported randomised trials are still needed to fully inform practice (no trial data exists reporting hospital and services outcomes, satisfaction with care and economics) pipotiazine palmitate is a viable choice for both clinician and recipient of care.

 

Plain language summary

Depot pipotiazine palmitate and undecylenate for schizophrenia

We undertook this review to determine the effects of pipotiazine palmitate for schizophrenia in comparison to placebo, other oral antipsychotics and other depot antipsychotics. We included results of 12 medium term trials, two long term trials, three short term trials and one trial that looked at immediate effects. We found that depot pipotiazine is effective for the treatment of schizophrenia, but overall was similar in effect to other depots and oral typical antipsychotic drugs.

 

摘要

背景

Depot pipotiazine palmitate 及 undecylenate 用於精神分裂症的治療

抗精神病藥物通常是口服的形式，但藥物順從性可能會有問題。注射給藥(Depot injections)的發展在1960年代開始了它們在長期維持治療的廣泛使用。Pipotiazine palmitate 是一個從phenothiazine 家族抗精神病藥而來的注射藥劑

目標

為了評估比較pipotiazine palmitate和undecylenate注射型藥劑 與安慰劑、口服抗精神病藥物和其他抗精神病藥注射型藥劑用於精神分裂症患者，臨床、社會和經濟方面的影響

搜尋策略

對於此更新，我們搜查了Cochrane Schizophrenia Group's Register (2003年6月)。我們也審查所有相關研究的文獻以得到更多資料 並且接觸相關產業

選擇標準

我們包括所有比較pipotiazine palmitate和undecylenate注射型藥劑與口服抗精神病藥物和其他抗精神病藥注射型藥劑用於精神分裂症患者的隨機臨床試驗

資料收集與分析

我們從相關的研究中謹慎地選擇，品質評估和獨立提取數據。我們計算了隨機效應相對風險率(RR)， 95 ％置信區間(CI)並在可能的情況下在意向處理分析(ITT)的基礎計算益需治數(NNT)。為了連續的數據，我們計算加權平均差異(weighted mean differences (WMD)) 。我們只提出了這些工具的尺度數據已經達到了預先指定的質量水平

主要結論

當pipotiazine palmitate 比較‘標準’口服抗精神病藥, 在結果的總體印象沒有差異，(53例， 1個隨機對照試驗，其RR 2.57 ，CI 0.8 ～ 8.6) ，復發(124例， 1個隨機對照試驗，其RR 1.55, CI 0.76 3.2) ，研究損耗(219例， 3個隨機對照試驗，其RR 1.37, CI 0.8至2.4)和行為(124例， 1個隨機對照試驗，WMD 4.65 ，CI −1.1至10.4)。在副作用方現如遲發性運動障礙，或抗膽鹼藥物的需要相比,也無差異。16個研究比較pipotiazine palmitate 與其他depot製劑(n = 1123) 。以一定範圍的結果相比，Pipotiazine palmitate 是一致地於其他注射型藥劑相當,其中包括總體印象(217例， 4隨機對照試驗，RR沒有得到改善0.99, CI 0.91至1.07) ，復發(239例， 5個隨機對照試驗，一年內復發的相對危險率0.98, CI 0.55至1.75) ，和副作用(337例， 5個隨機對照試驗，需要抗膽鹼藥物 RR 0.98, CI 0.84至1.15)

作者結論

雖然仍需要有良好進行並報告的隨機試驗來充分地告知如何應用沒有存在試驗數據報告醫院和服務的結果，護理和經濟上的滿意程度)。對臨床醫師和照顧的接受者來講, pipotiazine palmitate 是一種可行的選擇

翻譯人

本摘要由彰化基督教醫院廖慈凰翻譯

此翻譯計畫由臺灣國家衛生研究院(National Health Research Institutes, Taiwan)統籌

總結

我們進行了這一文獻回顧，以確定pipotiazine palmitate和安慰劑，其他口服抗精神病藥物和其他抗精神病藥注射型藥劑相比,在精神分裂症的效用。我們列入12個中期試驗的結果，兩個長期試驗，三個短期試驗和一個著眼於立即效果的試驗。我們發現，pipotiazine注射型藥劑治療精神分裂症是有效的，但總體影響與其他注射型藥劑depot和口服典型抗精神病藥是相似的