2026-11-092026-11-09https://scholars.csmu.edu.tw/handle/123456789/37796Ankylosing spondylitis (AS) is a chronic inflammatory disease characterized by axial skeletal ankylosis, inflammation at the insertions of tendons (enthesitis), and occasionally, peripheral arthritis. Studies have demonstrated the efficacy of anti-TNF-(alpha) agents for the treatment of AS and other inflammatory arthritides.No therapy has been shown to slow the progression of axial disease in patients with ankylosing spondylitis. Objective To evaluate the efficacy of herbs in the treatment of ankylosing spondylitis (AS). Study design The study was a randomized, double blind placebo-controlled (DBPC) of12 weeks' duration. Before this, a12weeks？HHH？HHH？HHH？HHH open label pilot of 5 traditional Chinese herbs formulas were tested to find out the most suitable formula to enter the DBPC trial. Patients population Inclusion criteria: Patients fulfilling the 1984 modified New York criteria for AS were recruited after written informed consent was obtained. Other defined criteria for inclusion were 1) BloodESR more than 10 mm/hr2) BASDAI index more than 3 cm of a 10 cm scale. Exclusion criteria: Patients who had abnormal liver (ASP>40), renal(Creatinine > 1.5 mg/dl), pregnant, and a change in the background medication , such as antirheumatic treatment during the preceding three months, were excluded. Number of Subjects 75 patients for the stage 1 pilot study？HHH？HHH？HHH？HHH100 patietns for the stage 2 DBPC trial？HHH？HHH？HHH？HHHtotally 175 patients. Study Duration Screening period of up to 12 weeks, stage 1 pilot treatment for 12 weeks, and stage 2 DBPC trial for 12 weeks. Study Observations Clinical assessments were performed at baseline and after 4, 8, 12 weeks, by the same investigator. The primary criteria were patient-reported global pain intensity over the past 7 days (recorded using a 100-mm VAS) and patient-reported activity and functional impairment (according to the Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] and Bath Ankylosing Spondylitis Functional Index [BASFI]), Schober test, ASAS response criteria.Laboratory assessment include complete blood count (CBC), liver and renal function, erythrocyte sedimentation rate (ESR), C-reactive protein (CRP) and immunoglobulin A (IgA) were monitored at each visit of clinical assessments. Safety profiles monitering.僵直性脊椎炎(Ankylosing spondylitis，簡稱AS)，是一種與基因有關的自體免疫疾病，主要侵犯脊椎與週邊大關節的滑膜與肌腱接骨點。僵直性脊椎炎好發於16至40歲的成年人，95%病人具有HLA-B27基因，估計台灣的僵直性脊椎炎盛行率為0.2 %，病人總數約兩萬人。主要症狀為下背痛、脊椎僵硬及運動範圍受限，X光有兩側薦腸關節炎(sacroiliitis)為其特徵。 目前治療僵直性脊椎炎的原則為運動、非類固醇消炎止痛藥(NSAID)及必要時使用疾病修飾抗風濕藥物(DMARD)。目前證實有效的疾病修飾抗風濕藥物，有sulfasalazine, methotrexate兩種，但效果不甚理想，約有30%患者仍無法控制病情。Thalidomide對sulfasalazine及methotrexate無效的僵直性脊椎炎病人，有80%得到顯著的的療效，但是有致畸胎、頭昏、口乾等副作用。近年來，生物製劑anti-tumor necrosis factor，如Infliximab及etanercept，已證實對90的AS病人有效，但藥價昂貴及免疫力降低副作用為其缺點。 僵直性脊椎炎屬於中醫骨痹範疇，治療原則是辨證施治，以滋補肝腎?本，兼顧清熱、活血、祛寒、止痛。綜合文獻及專家意見，獨活、黃?、白芍、桂枝、狗脊、葛根、雷公藤、薏苡仁、青風藤、大棗、當歸、羌活等中藥為組成的方劑曾有初步報告有效。這些過去的研究顯示，中藥治療僵直性脊椎炎，可能有其可取之處。但共同的缺點是研究設計不夠嚴謹，療效評估等未有統一的標準，數據有誇大之嫌，以至尚無在國際期刊發表。因此，本研究希望經由嚴謹的研究設計，國際可接受的療效評估標準，及客觀的實驗室證據，找出可能對僵直性脊椎炎有效的方劑。 本研究計畫分兩個階段。第一階段為前驅型研究(open pilot study)。收集75例活性期的僵直性脊椎炎病人，隨機分成5組，每組15人，經由文獻搜尋與專家諮詢，先選定5種知名的骨痹風濕腫痛方劑：桂枝芍藥知母湯、薏苡仁湯、黃耆五物湯、當歸拈痛湯、羌活勝濕湯等5種固有成方科學中藥的治療，三個月後比較病人臨床及血清活性指標，並用流式細胞儀評估周邊血液單核球中的CD14＋的單核球含量、蝕骨細胞(osteoclast)表面分子TRAP+, VNR+的表現量，且比較治療前後是否有不同。藉此選擇療效最佳者進入第二階段之隨機雙盲安慰劑控制研究。第二階段計畫收集100例活性期的僵直性脊椎炎病人，隨機分成兩組，每組50人，雙盲接受固有成方科學中藥膠囊或安慰劑，三個月後比較病人臨床及血清活性指標，以評估其療效及副作用的差異。僵直性脊椎炎中藥療效評估ankylosing spondyltiisherbsclinical trialtraditional Chinese medicineProject