| 摘要: | 研究背景：臺灣過去主要以每天服用一次異煙肼(isoniazid)的9個月療程(簡稱9H療程)作為潛伏性結核感染的治療療程，隨著每週服用一次isoniazid併用利福噴丁(rifapentine)的3個月療程(簡稱3HP療程)在2016年4月引進後，目前已成為新的潛伏性結核感染治療選擇，但臺灣仍未有太多針對兩種療程的療效進行比較，故本研究希望藉由分析某區域教學醫院的案例去探討這兩種療程的療效。
研究目的：評估兩種潛伏性結核感染治療療程在臨床上的療效差異，希望能提供病人使用較合適及安全的治療選擇。
研究方法：本研究為回溯性世代研究，利用某區域教學醫院的病歷資料庫分析自2012年1月1日到2019年12月31日之間所納入的174名9H組病人及37名3HP組病人，以結核病發生率、治療完成率及藥品不良反應發生率作為療效指標，分析兩種療程的療效差異，並探討可能會影響藥品不良反應發生的病人特徵。
統計分析：本研究使用SPSS第18版對病人資料進行統計分析，利用卡方檢定、費雪精確性檢定或獨立樣本t檢定分析兩種療程的療效差異性；另外以羅吉斯迴歸分析可能影響藥品不良反應發生的病人特徵。
研究結果：本研究僅有一名病人在治療期間發生結核病活化，整體結核病發生率為0.6%。9H組的治療完成率與3HP組沒有明顯差異(73.0% vs. 78.4%, p=0.498)。9H組的藥品不良反應發生率顯著低於3HP組(32.2% vs. 51.4%, p=0.027)；9H組的藥品不良反應以肝毒性為主(15.5%)，而3HP組的藥品不良反應則以腸胃道(29.7%)、類流感症狀(24.3%)及神經系統不良反應(21.6%)為主。在次族群藥品不良反應發生率的分析發現，女性在兩種療程中皆比男性有較高的發生率(9H組：37.6% vs. 27.0%；3HP組：63.2% vs. 38.9%)，且3HP組女性的發生率顯著高於9H組女性(63.2% vs. 37.6%, p=0.042)；在體重小於60公斤的病人族群中，3HP組的發生率亦顯著高於9H組(66.7% vs. 32.8%，p=0.01)。在多變量分析中發現女性使用9H療程為增加藥品不良反應發生機率的因子。
結論：研究顯示3HP療程的治療完成率與9H療程沒有顯著差異，但3HP組的藥品不良反應發生率顯著高於9H組約20%，女性或體重小於60公斤的族群使用3HP療程甚至比使用9H療程的相同族群高約30%的發生率。當以上兩個病人族群使用3HP療程時，醫療人員應加強衛教，讓病人能及早察覺藥品不良反應的症狀，同時醫療人員亦需密切關注這兩個族群在治療期間是否發生不良反應，或建議病人改為使用藥品不良反應發生率較低的9H療程。
Background: In the past, treatment for latent tuberculosis infection (LTBI) was daily isoniazid for 9 months (9H) in Taiwan before 2016. After that, the new regimen, weekly isoniazid combined with rifapentine for 3 months (3HP) has been introduced. Nowadays, those two regimens are commonly used to treat LTBI, but the evaluation of efficacy between two regimens still lacking, so the aim of this study is to discuss the efficacy and safety of 9H and 3HP regimen.
Method: In this retrospective cohort study, we screened the data from hospital database, and included 174 patients used 9H regimen and 37 patients used 3HP regimen from 2012/01/01 to 2019/12/31. The incidence rate of tuberculosis, treatment completion rate, incidence rate of adverse drug reaction (ADR) and factors associated with ADR incidence would be analyzed. Chi-squared test, Fisher’s Exact test or independent-samples t test were used to determine the difference of two regimens, logistic regression was used to identify the factors associated with ADR.
Result: In this study, only one patient occurred tuberculosis during therapy, overall incidence rate of tuberculosis was 0.6%. There was no difference between 9H and 3HP regimen in treatment completion rate (73.0% vs. 78.4%, p=0.498). Incidence rate of ADR was significantly lower in 9H group than in 3HP group (32.2% vs. 51.4%, p=0.027), hepatotoxicity was a common ADR in 9H group (15.5%), where gastrointestinal reaction, flu-like symptoms and nervous system reaction were common in 3HP group (29.7%, 24.3% and 21.6%, respectively). Female patients had higher ADR incidence rate than male in both group (9H group: 37.6% vs. 27.0%; 3HP group: 63.2% vs. 38.9%), female patients in 3HP group also had significantly higher ADR incidence rate than in 9H group (63.2% vs. 37.6%, p=0.042). Patients’ body weight lower than 60 kg also had significantly higher ADR incidence rate in 3HP group than in 9H group (66.7% vs. 32.8%, p=0.01). In multivariableanalysis, female sex was associated with risk of ADR occurrence when using 9H regimen.
Conclusion: Treatment completion rate of 3HP group was similar to 9H group, but 3HP group have significantly higher ADR incidence rate, especially in female sex and body weight lower than 60 kg. We suggest that female and patients with body weight lower than 60 kg should closely monitor the ADR occurrence when using 3HP regimen. |
