Intervention Review

D-penicillamine for primary sclerosing cholangitis

  1. Sarah Louise Klingenberg1,*,
  2. Wendong Chen2

Editorial Group: Cochrane Hepato-Biliary Group

Published Online: 21 JAN 2009

Assessed as up-to-date: 14 SEP 2005

DOI: 10.1002/14651858.CD004182.pub3

Database Title

Additional Information

How to Cite

Klingenberg SL, Chen W. D-penicillamine for primary sclerosing cholangitis. Cochrane Database of Systematic Reviews 2006, Issue 1. Art. No.: CD004182. DOI: 10.1002/14651858.CD004182.pub3.

Author Information

  1. 1

    Copenhagen Trial Unit, Centre for Clinical Intervention Research, Department 3344, Rigshospitalet, Copenhagen University Hospital, Cochrane Hepato-Biliary Group, Copenhagen, Denmark

  2. 2

    Toronto Health Economics and Technology Assessment Collaborative (THETA), University of Toronto, Departments of Health Policy Management and Evaluation, and Pharmacy, Toronto, Ontario, Canada

*Sarah Louise Klingenberg, Cochrane Hepato-Biliary Group, Copenhagen Trial Unit, Centre for Clinical Intervention Research, Department 3344, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, Copenhagen, DK-2100, Denmark. slk@ctu.rh.dk.

Publication History

  1. Publication Status: Edited (no change to conclusions)
  2. Published Online: 21 JAN 2009

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Abstract

  1. Top of page
  2. Abstract
  3. Plain language summary
  4. 摘要

Background

Primary sclerosing cholangitis is a cholestatic disease. D-penicillamine is suggested as a treatment option due to its copper reducing and immunomodulatory potential.

Objectives

To evaluate the beneficial and harmful effects of D-penicillamine for patients with primary sclerosing cholangitis.

Search methods

Eligible trials were identified through searches of The Cochrane Hepato-Biliary Group Controlled Trials Register (August 2005), The Cochrane Central Register of Controlled Trials in The Cochrane Library (Issue 3, 2005), MEDLINE (1950 to August 2005), EMBASE (1980 to August 2005), Science Citation Index EXPANDED (1945 to August 2005), and reference lists of relevant articles. Authors of trials and pharmaceutical companies known to produce D-penicillamine were also contacted.

Selection criteria

Randomised clinical trials comparing D-penicillamine in any dose, duration, and route of administration versus placebo, no intervention, or other intervention(s). Trials were included irrespective of publication status, year of publication, language, or blinding.

Data collection and analysis

Both authors selected the trials, extracted data, and evaluated the methodological quality of the trials with respect to the generation of allocation sequence, allocation concealment, blinding, and follow-up. The results were reported by intention-to-treat analysis. The outcomes were presented as relative risk (RR) or weighted mean difference (WMD), both with 95% confidence intervals (CI).

Main results

One randomised trial was identified and included in the review. It was of low methodological quality. The trial compared D-penicillamine versus placebo in 70 patients with primary sclerosing cholangitis. Compared with placebo, D-penicillamine therapy had no significant effect on mortality (RR 1.14, 95% CI 0.49 to 2.64), liver transplantation (RR 1.11, 95% CI 0.39 to 3.17), hepatic histologic progression (RR 1.17, 95% CI 0.79 to 1.74), or cholangiographic deterioration (RR 0.87, 95% CI 0.43 to 1.79). D-penicillamine led to a significant improvement in the serum aspartate aminotransferase (WMD -23.00 U/L; 95% CI -30.66 to -15.34), but not in serum bilirubin level (WMD 0.40 mg/L; 95% CI -0.19 to 0.99) and serum alkaline phosphatases activity (WMD 44.00 U/L; 95% CI -37.89 to 125.89). There were significantly more adverse events in patients receiving D-penicillamine (P = 0.013).

Authors' conclusions

There is not sufficient evidence to support or refute the use of D-penicillamine for patients with primary sclerosing cholangitis. We do not recommend the use of D-penicillamine for patients with primary sclerosing cholangitis outside randomised trials.

 

Plain language summary

  1. Top of page
  2. Abstract
  3. Plain language summary
  4. 摘要

There is insufficient evidence to support or refute D-penicillamine for patients with primary sclerosing cholangitis

D-penicillamine has been considered for patients with primary sclerosing cholangitis due to its copper reducing and immunomodulatory potential. The only identified randomised clinical trial did not demonstrate any beneficial effect of D-penicillamine on the course, complications, and survival of patients with primary sclerosing cholangitis. In addition, its use was associated with a number of adverse events. Therefore, we cannot recommend the use of D-penicillamine outside randomised trials.

 

摘要

  1. Top of page
  2. Abstract
  3. Plain language summary
  4. 摘要

背景

D青黴胺(Dpenicillamine用於治療原發性硬化性膽管炎

原發性硬化性膽管炎是一種膽汁淤積性疾病。由於 D青黴胺(Dpenicillamine)具有降低肝臟的銅和免疫調節的潛能，有人建議其用來治療原發性硬化性膽管炎。

目標

評估原發性硬化性膽管炎病人使用D青黴胺(Dpenicillamine)的利弊。

搜尋策略

透過電子搜索The Cochrane HepatoBiliary Group Controlled Trials Register(2005年，8月), The Cochrane HepatoBiliary Group Controlled Trials Register (CENTRAL) (2005年第3期)，MEDLINE (1950年 2005年8月), EMBASE (1980年 2005年8月), Science Citation Index EXPANDED (1945年 2005年8月)以及相關文章的參考列表，我們確定合格的試驗。 同時我們聯繫了試驗作者和生產D青黴胺(Dpenicillamine)的製藥公司。

選擇標準

包括比較安慰劑, 無干預法或其他干預法和以任意劑量，任意持續期和任意用藥路徑的D青黴胺(Dpenicillamine)的隨機臨床試驗。不受語言，發表年份和發表狀態的限制。

資料收集與分析

兩位作者選擇試驗，提取資料，從分配順序、分配方案的隱藏、盲法和隨訪等方面，評估試驗的方法學品質。我們採用意向性分析記錄結果。 結果表示為相對風險度(RR)或加權平均差 (WMD),均以95% 信賴區間 (CI)表現。

主要結論

本次綜述確定並收錄一項隨機試驗。方法學品質品質不高。 該試驗比較原發性硬化性膽管炎70位病人使用. D青黴胺(Dpenicillamine)和安慰劑的效果。比較安慰劑, D青黴胺(Dpenicillamine)療法對於死亡率 (RR 1.14, 95% CI 0.49 – 2.64), 肝移植(RR 1.11, 95% CI 0.39 – 3.17), 肝病理進展(RR 1.17, 95% CI 0.79 1.74)或膽道造影的退化(RR 0.87, 95% CI 0.43 – 1.79)沒有顯著作用。 D青黴胺(Dpenicillamine)可以明顯改善血清中的天門冬氨酸氨基轉移?(WMD −23.00 U/L; 95% CI −30.66 15.34), 但是不能改善血清中的膽紅素值(WMD 0.40 mg/L; 95% CI −0.19 0.99)和血清的鹼性磷酸?活性(WMD 44.00 U/L; 95% CI −37.89 125.89)。服用D青黴胺(Dpenicillamine)(P = 0.013)的病人沒有出現顯著較多的不良事件。

作者結論

沒有足夠的證據支持或反對原發性硬化性膽管炎病人使用D青黴胺(Dpenicillamine)。 我們不建議原發性硬化性膽管炎病人在隨機試驗以外的領域使用D青黴胺(Dpenicillamine)。

翻譯人

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

總結

沒有足夠的證據支持或發對原發性硬化性膽管炎病人使用D青黴胺(Dpenicillamine)。 由於具有降低肝臟的銅和免疫調節的潛能， D青黴胺(Dpenicillamine)被考慮用於治療原發性硬化性膽管炎。 唯一一個隨機臨床試驗顯示 D青黴胺(Dpenicillamine)在原發性硬化性膽管炎病人的療程，併發症和存活率方面，並無效益。 另外，考慮該藥物的不良反應。我們不建議在隨機試驗以外的領域使用D青黴胺(Dpenicillamine)。

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