使用腫瘤壞死因子抑制劑病患其肺結核的預防： 系統性回顧臨床指引

A Systematic Review of Clinical Practice Guidelines on Prophylaxis for Tuberculosis in Patients Receiving anti -TNF agents

徐敦珍(TUN-CHEN HSU)

指導教授 ： 林美香

共同指導教授 ： 曾頌惠

臺北醫學大學/藥學院/生技製藥產業碩士專班/碩士(2014年)

https://doi.org/10.6831/TMU.2014.00024

摘要

台灣因屬結核中度流行區，使用腫瘤壞死因子-alpha（tumor necrosis factor-alpha，簡稱TNF-α）拮抗劑之患者增加肺結核感染之風險，較美國、日本等結核低流行區域顯著。為避免造成國家結核防疫的漏洞，TNF-α拮抗劑使用前的預防措施顯得非常重要。
本研究以系統性回顧(systematic review)進行。文獻搜尋使用的關鍵字及相關字彙(MeSH terms)如 ( adalimumab , etanercept , infliximab , golimumab , certolizumab , guideline )，檢索電子資料庫 ( PubMed ) 及線上指引資料庫2000年1月1日至2013年3月1日期間出版的TNF-α拮抗劑的臨床指引相關英文文獻。最後使用AGREE II工具評讀，滿分為七分。
搜尋結果發現符合納入條件有九篇英文文獻，加上發表於台灣的中文臨床指引一篇共有十篇。AGREE II工具評讀的整體評估結果，沒有一篇獲得滿分。最高分為英國的指引（BTS 2005，6.13分）。此結果顯示這些指引的品質多仍有提升的空間。另對預計使用TNF-α拮抗劑之病患，各國都建議病患須先做胸部X光檢查，篩檢結核的方式則以皮膚結核試驗或丙型干擾素血液測驗為主，但會因國家盛行率及經濟條件而有所不同。台灣的指引只有建議做預防性的篩檢，非強制性做篩檢。潛伏結核感染之治療在多數的指引是建議以口服Isoniazid 九個月為主，並於治療四周後才可以開始使用TNF-α拮抗劑。
藉由本論文的系統性回顧發現各國的指引品質大多不足，還有進步的空間，且指引的發展有賴高品質的證據來支持，指引的建立亦需要定期更新。

關鍵字

腫瘤壞死因子 ； 肺結核 ； 系統性回顧

並列摘要

The patients treated with TNF-α antagonists will increase the chances of tuberculosis infection. Taiwan is a moderately prevalent country of tuberculosis, and the risk of developing tuberculosis while using TNF-α antagonists therapy seems higher than of United States and Japan. In order to avoid loopholes in prevention of tuberculosis, the anti-tuberculosis prophylactic steps before using TNF-α antagonists is extremely important.
We conducted a systematic review of clinical guidelines for tuberculosis screening before initiation of TNF-α- antagonists treatment. The PubMed database and guidelines’ websites were searched for clinical practice guidelines (CPGs) written in English and published between January 2000 and March 2013. The AGREE-II instrument was used for guideline quality appraisal. The highest overall quality score was 7.
There were 9 CPGs in English assessed by the AGREE-II, and one CPG in Taiwan was also included. The scores ranged from 2.78 to 6.13 out of 7, with the highest score published by United Kingdom (BTS 2005, scored 6.13), suggesting most of the CPGs have weaker domains to strengthen for the update of these recommendations. The UK (BTS2005) guideline is also recommended for use in clinical practice. All of the guidelines suggested chest x ray examination before treatment with TNF-α antagonists. Tuberculosis skin test or Interferon-γ release assays were also suggested as the screening methods for tuberculosis, but the usage depended on the tuberculosis prevalence and economic of the country. Taiwan's guidelines recommends screening as prophylaxis. For latent TB treatment, most CPGs recommend taking isoniazid for 9 months, and the TNF-α antagonists were administrated 4 weeks after isoniazid therapy.
In conclusion, all the present CPGs showed various weaker domains to strengthen for update recommendations of this issue.

並列關鍵字

tumor necrosis factor ； systematic review ； tuberculosis

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