低劑量 Etoricoxib對照Aceclofenac於治療類風濕性關節炎的療效和安全性評估：單一醫學中心，平行雙組隨機分派的先導性研究

Comparison of Lower Dosage of Etoricoxib versus Aceclofenac in the Treatment of Patients with Rheumatoid Arthritis: A Single-center, Parallel-group, Randomized Controlled Pilot Study

楊凱介(Kai-Jieh Yeo)

指導教授 ： 魏正宗

中山醫學大學/醫學院/醫學研究所/碩士(2016年)

摘要

研究目的：本研究目的是比較低劑量萬克適 (Etoricoxib 60 Mg qd) 和痛停錠(Aceclofenac 100 mg bid) 用於治療類風濕性關節炎 (Rheumatoid arthritis, RA) 之療效和安全性評估。
研究方法及資料：本研究這是一個單一醫學中心、 平行雙組隨機分派、 需服藥時8週的臨床研究。 本研究篩選RA病患40人， 隨機分派至兩組不同治療組別 (Etoricoxib和Aceclofenac)， 每組20人。 過程中除了收集病人的基本資料， 也用客觀的評估工具來評估療效和安全性。 主要終點為ACR20反應指標， 次要終點為ACR 50、70、關節疾病活動度積分 (DAS 28)、 EULAR反應標準、 關節腫與壓痛數目、 醫師對病人的整體評估、 病人整體評估、 病人的疼痛分數和SF-36 健康量表等。 另外， 本研究也同時記錄所有發生的不良反應， 結果都以意圖治療分析法來分析。
研究結果：主要指標為ACR20反應指標， 兩組病人並無顯著差異 (45% vs 25%, p=0.320)， 但在次要指標中除了醫師對病人的整體評估和關節疾病活動度積分（DAS- 28）皆有達標顯著差異外， 其他皆無顯著差異。在EULAR反應指標方面， 研究組有較多患者逹到至少適度反應 (Moderate response) 以上 (45% vs 20%, p=0.0526)。 另外, 所發生的不良反應皆無顯著差異，但研究組的血清肌酸酐 (Serum creatinine) 較高一些。 在次分析所有達到ACR20反應指標的患者時, 其中抗環瓜氨酸抗體 (Anti-cyclic citrullinated peptide Antibody, Anti-CCP) 的患者人數， 兩組皆相同 (n=3, 15% vs n=3, 15%, p= 0.650).

結論與建議：低劑量萬克適和痛停錠用於治療類風濕性關節炎之療效和安全性相當，但前者似乎效果較好一些，但仍需更大型的研究方能釐清和證實較低劑量萬克適在台灣人可否真的有別於其他種族。

關鍵字

類風濕性關節炎 ； 萬克適 ； 痛停錠 ； 療效效果 ； 安全性 ； 台灣民族

並列摘要

Objective：Comparison of lower dosage etoricoxib (60 mg daily) with aceclofenac (100 mg bid) for their efficacy and safety in the treatment of rheumatoid arthritis (RA).

Methods and Materials：This was a single medical center, parallel-group, randomized controlled trial, which conducted for eight weeks. In this study, 40 patients of RA were randomly assigned to two different treatment groups (etoricoxib and aceclofenac), and 20 patients were enrolled for each group. In addition to baseline data collection, objective assessment tools were used to evaluate for efficacy and safety. The primary endpoint was American College of Rheumatology 20% improvement criteria (ACR20) , secondary endpoints were the ACR 50,70, disease activity score 28 (DAS 28), European League Against Rheumatism (EULAR) response criteria, the number of tender and swollen joints, physician's global assessment, patient's global assessment, pain scores, the short form health survey (SF-36) health Questionnaire and etc. In addition, all adverse reactions were recorded and all the results were analyzed in the intention to treat (ITT) manner.

Results：The primary endpoint ACR20 response was not significantly different in between both groups (45% vs 25%, p = 0.320). Yet, there were significant differences in the secondary endpoints such as the physician’s global assessment and DAS- 28, where the remainders were not. In the EULAR response criteria, the study group had more patients achieving at least or more than the moderate response (45% vs 20%, p = 0.0526) comparing to the control group. In addition, no significant differences were observed in the adverse event, but the serum creatinine level was mildly elevated in the study group, but which still clinically insignificant. Subgroup analysis of ACR20 responder, the numbers of patient with positive anti-cyclic citrullinated peptide antibody (ACPA) were similar in both group (n=3, 15% vs n=3, 15%, p= 0.650).

Conclusion and Suggestion：Low-dose etoricoxib and acceclofenac seem to have similar efficacy and safety profiles in the treatment of RA, but the former seems to have better trend. Yet, we still need larger studies in order to clarify and confirm whether there were distinguishing results in the Taiwanese patient comparing with other ethnic groups in the treatment of RA.

並列關鍵字

Rheumatoid arthritis ； etoricoxib ； acceclofenac ； efficacy ； safety ； Taiwanese

參考文獻

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