生物製劑用於中重度克隆氏症之療效與安全性

Effectiveness and Safety of Biological Therapeutic for Moderate to Severe Crohn's Disease

陳西蕙(Hsi-Hui Chen) ； 謝永宏(Yung-Hung Hsieh)

《臺灣臨床藥學雜誌》 30卷2期 (2022/04) Pp. 117-128

https://doi.org/10.6168/FJCP.202204_30(2).0003

摘要

克隆氏症（Crohn's disease, CD）是一種病因尚未確定的慢性自發性之發炎性腸道疾病（inflammatory bowel disease），侵犯範圍包括整個消化道，疾病嚴重時甚至出現腸道外症狀。發生率和盛行率最高的是北美和歐洲，發生率北美是6.3～23.8/10萬人年，歐洲是0.4～15.4/10萬人年，盛行率北美是96.3～318.5/10萬人，歐洲是1.51～322/10萬人；臺灣的發生率從1988年到2008年增加4.0%，2015年的發生率0.47/10萬人年，盛行率3.9/10萬人。疾病進展的活動性及嚴重度，以克隆氏症疾病活動指數（Crohn's disease activity index, CDAI）來評估，CDAI分數221～450分是中重度活動性CD。生物製劑是治療中重度活動性CD重要的藥物，2018年美國胃腸醫學學院及2019年歐洲克隆氏症及結腸炎組織治療指引，建議先以抗腫瘤壞死因子α藥物（anti-tumor necrosis factor α agents）併用免疫調節劑治療，當反應不佳時可改用證據等級分別是高、中度的ustekinumab或vedolizumab；雖然有多項探討生物製劑的療效與安全性的系統性文獻回顧，但是目前尚無直接比較（head-to-head）的研究，因選擇治療藥物前需考慮治療史、疾病嚴重程度、合併症、療程與投藥途徑遵從性等，建議採用醫病共享決策（shared decision-making, SDM）的流程，由醫療提供者與病人審慎評估個別的風險與效益，共同討論後一起決定適當的治療方案。

關鍵字

中重度克隆氏症 ； 生物製劑 ； 誘導療法 ； 維持療法

並列摘要

Crohn's disease (CD) is a chronic idiopathic inflammatory bowel disease of unknown aetiology, that can affect any segment of the gastrointestinal tract. If severe, CD can exhibit extraintestinal manifestations. North America and Europe report the highest incidence and prevalence worldwide. Notably, the incidence of CD is 6.3-23.8 and 0.4-15.4 per 100,000 person-years, while the prevalence is 96.3-318.5 and 1.51-322 per 100,000 in North America and Europe, respectively. In Taiwan, which has recorded an annual percentage change in CD incidence of +4.0% from 1998 to 2008, the incidence and prevalence of CD were noted as 0.47 per 100,000 person-years and 3.9 per 100,000 in 2015, respectively. The Crohn's Disease Activity Index is frequently employed to describe disease activity and severity. Biological agents are important drugs for treating moderate to severely active CD. According to the clinical guidelines of the 2018 American College of Gastroenterology and the 2019 European Crohn's and Colitis Organisation, combination therapy with anti-tumor necrosis factor-α and immunomodulators may be preferred first-line agents, while ustekinumab or vedolizumab could be employed as the second-line agent. Several systematic reviews have explored efficacy and safety, but head-to-head studies comparing biologics are lacking. Appropriate medical therapy can be tailored to the individual based on treatment history, disease severity, comorbidities, treatment course, and adherence to administration. The risks and benefits of medical therapy must be discussed between physicians and patients, and a shared decision-making process is recommended.

並列關鍵字

Moderate to Severe Crohn's Disease ； Biological Agents ； Induction Therapy ； Maintenance Therapy