僵直性脊椎炎之中藥方劑輔助治療之先導性試驗

Traditional Chinese medicine as a complementary therapy in patients with ankylosing spondylitis: an open pilot study

僵直性脊椎炎，是一種慢性自體免疫疾病。僵直性脊椎炎的西藥治療因為其藥物順從性、副作用及抗腫瘤壞死因子的昂貴價格，使得部份病人的治療效果，仍未能令人滿意。中藥已有數千年的歷史，國人接受度也高，其中必定有其潛力。為了找出可能具有輔助治療潛力的中藥方劑，我們將34例活性期的僵直性脊椎炎病人，在原本治療之藥物維持3個月不變的條件下，依中醫症型分型後，加上濃縮科學中藥方劑，進行此僵直性脊椎炎中藥方劑輔助治療之先導性試驗。本先導性試驗使用了五種中藥方劑，包括當歸拈痛湯、薏苡仁湯、桂枝芍藥知母湯、黃耆五物湯和羌活勝濕湯。三個月後依ASAS 20 response criteria、病人臨床BASDAI, BASFI, BAS-G量表及血清活性指標 （E.S.R,CRP,和IgA），來評估其效果。中藥方劑輔助治療之效果以意圖治療分析法 （Intention-To-Treat） 分析。結果顯示「黃耆五物湯」組中進入試驗者6人，退出試驗者1人，有效人數為2人。「羌活勝濕湯」組中進入試驗者10人，退出試驗者2人，有效人數為3人。沒有病人因為嚴重副作用或不良反應而退出。本研究中，羌活勝濕湯或許是具輔助治療潛力的中藥方劑，但是必須逐一再以較大規模之隨機雙盲試驗去證實其有效性。

Objectives: Ankylosing spondylitis (AS) is a chronic inflammatory autoimmune disease involving joints, entheses and spine. Therapies for AS are unsatisfying in some patients because of poor efficacy, adverse reactions, and high cost. Traditional Chinese Medicine (TCM) might have the potential to serve as adjuvant therapies in AS. Hence, we conducted this open pilot clinical trial to explore potential TCM formulae for further randomized controlled studies. Methods: Thirty-four patients with AS and stable background medication for 3 months, were enrolled. Patients received an additional TCM formula for 3 months according to their syndrome patterns in relation to traditional Chinese medicine. Five TCM formulae: Dang Gui Lian Tong Tang (A), Yi I Ren Tang (B), Gui Zhi Shao Yao Zhi Mu Tang (C), Huang Qi Wu Wu Tang (D), and Qiang Huo Sheng Shi Tang (E), were chosen for this study. Outcome measurements included ASAS-20 response criteria, Bath AS Disease Activity Index (BASDAI), Functional Index (BASFI), Global Index (BAS-G), IgA, C-reactive protein (CRP), and erythrocyte sedimentation rate (ESR). Intention-To-Treat (ITT) analysis and Wilcoxin Signed Rank Test were used for statistical analyses. Results: Among 34 patients enrolled, 9 patients dropped out, and 9 patients achieved ASAS-20 response criteria. No serious adverse events were reported in this 12-week trial. In patients who received Huang Qi Wu Wu Tang (D), 2 out of 6 (33.3%) reached ASAS-20 response criteria. In 10 patients who received Qiang Huo Sheng Shi Tang (E), 3 (30%) were responders. Conclusions: In this study, Qiang Huo Sheng Shi Tang had potential adjuvant effects in the treatment of AS. Further double blind randomized controlled trials are needed to prove their efficacy.