Opioids for the management of breakthrough (episodic) pain in cancer patients

 

Abstract

Background

Breakthrough pain is a transient increase in pain intensity over background pain. It is a common and distinct component of cancer pain that can have a negative impact for both patient and carers' quality of life. Breakthrough pain's usually related to background pain and is typically of rapid onset, severe in intensity, and generally self-limiting with an average duration of 30 minutes. At present current management to breakthrough pain is using supplemental analgesia (also known as rescue medication) at a dose proportional to the total around-the-clock (ATC) opioid dose.

Objectives

To explore and assess evidence for the use of opioids in the management of breakthrough pain in patients with cancer.

Search methods

MEDLINE, EMBASE, CancerLit, CINAHL and Cochrane databases were searched in January 2005. There was no language restriction.

Selection criteria

Randomized controlled trials (RCTs) of opioids used as rescue medication against active or placebo comparator in patients with cancer pain were included. Outcome measures sought were reduction in pain intensity measured by an appropriate scale, adverse effects, attrition, patient satisfaction and quality of life. There were no language restrictions.

Data collection and analysis

Eligible studies were selected and examined independently by the two reviewers. Full text was retrieved if any uncertainty about eligibility remained. Non-English texts were screened. Quality assessment and data extraction were conducted using standardised data forms. Drug and placebo dose, titration, route and formulation were compared and detail of all outcome measures (if available) recorded.

Main results

Four studies (393 participants) met the inclusion criteria, all were concerned with the use of oral transmucosal fentanyl citrate (OTFC) in the management of breakthrough pain. Two studies examined the titration of OTFC, one study compared OTFC to normal release morphine and one study compared OTFC to placebo.

OTFC was shown to be an effective treatment for breakthrough pain. When compared to placebo and morphine, participants gave lower pain intensity scores and higher pain relief scores for OTFC at all time points. Global assessment scores also favoured OTFC.

Authors' conclusions

There is evidence that OTFC is an effective treatment in the management of breakthrough pain. The randomised trial literature for the management of breakthrough pain is small and no trials were found for other opioids. Given the importance of this subject, more trials need to be undertaken

 

Plain language summary

Opioids for the management of breakthrough (episodic) pain in cancer patients

Oral transmucosal fentanyl citrate (OTFC) is an opioid and is effective in the management of breakthrough pain. Breakthrough pain is a common and debilitating component of pain in patients with cancer. Clinical trial evidence was sought to determine the effectiveness of opioids in relieving breakthrough pain and the incidence of side effects in these cancer patients. Four trials were identified and included 393 participants; the studies identified examined the use of OTFC in breakthrough pain in cancer patients taking regularly scheduled opioids. All four studies used similar outcome measures. Available data suggest that OTFC is safe and effective (compared to both placebo and morphine) in relieving breakthrough pain. The side effect profile of OTFC is similar to other opioids. Recommendations are made about future clinical trials.

 

摘要

背景

使用鴉片類藥物來處理癌症病人之突發性(偶發)疼痛問題

突發性疼痛是指在原有的疼痛中，暫時性的疼痛強度增加。這種常見又特別由癌症造成的疼痛會使病人和照顧者的生活品質變差。突發性疼痛通常與原有的疼痛有關，會迅速發生，強度相當強，持續時間一般不超過30分鐘。現行治療突發性疼痛的方式是使用額外的止痛藥物(也稱為救援藥物)，其劑量是病患平日按時服用之鴉片類藥物總劑量(ATC)的一定比例。

目標

本回溯分析探討和評估癌症病人使用鴉片類藥物來處理突發性疼痛之證據。

搜尋策略

我們搜尋2005年1月以前的資料庫包括MEDLINE(1966年至2005年), EMBASE(1980年至2005年), CancerLit(1993年至2005年), CINAHL(1982年至2005年)和Cochrane databases。並人工檢索醫學期刊和主要教科書之參考資料並詢問製藥公司未公佈的數據，本搜尋並沒有語言限制。

選擇標準

納入使用鴉片類藥物來治療突發性癌症疼痛之隨機對照試驗,對照組包括別種有效止痛藥物或安慰劑。所評估的結果包括使用適當的量表測量疼痛減少程度、副作用，藥物用量、病人滿意度和生活品質，本搜尋有沒有語言限制。

資料收集與分析

選擇符合條件的研究，並由兩個獨立審查者來檢驗，如果有不清楚是否符合資格時，會參酌全文來判定；也篩選非英語的文章。使用標準的數據形式評估研究的品質和資料分析。比較藥物和安慰劑劑量、調幅，給藥路徑和配方並詳細的記錄所有可參考的結果。

主要結論

有四項研究(393參與者)符合納入標準，都是使用芬太尼透黏膜口含劑(OTFC)來治療突發性疼痛。兩份研究探討OTFC所需之濃度，其中一項研究比較OTFC和正常釋放型嗎啡。另一個研究比較 OTFC和安慰劑的差異。OTFC被證明在治療突發性疼痛是有效的。與安慰劑和嗎啡相比，受試者在各個時間點的疼痛強度的分數降低，且減輕疼痛的分數增加。綜觀評估分數也傾向支持OTFC。

作者結論

目前證據顯示，OTFC可以有效減輕突發性疼痛。現今隨機試驗針對突發性疼痛治療的受試者都不多，且尚無其他鴉片類藥物有臨床試驗。有鑑於此，仍需要進行更多的臨床試驗來探討此議題。

翻譯人

本摘要由三軍總醫院吳宜穎翻譯。

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

總結

芬太尼透黏膜口含劑(OTFC)是鴉片類藥物，可以有效的減輕突發性疼痛。突發性疼痛常發生於癌症患者會使病人虛弱，並產生疼痛。本回溯性分析搜尋臨床試驗探討鴉片類藥物針對癌症病人突發性疼痛治療之療效與發生副作用的機率，分析4個臨床試驗，共393人參加研究，報告中顯示使用OTFC治療定期服用鴉片類藥物癌症病人所產生的突發性疼痛，4項研究使用了類似的方法來評估療效。分析現有的結果顯示OTFC對於突發性疼痛之緩解和安慰劑、嗎啡相比是安全有效的，OTFC的副作用和其他鴉片類藥物相似，未來應有更大型臨床試驗來證實此結論。