應用丹七六位合方於紅斑性狼瘡患者以協助類固醇之遞減並預防疾病之復發

陳忠仁
長庚大學
全身性紅斑性狼瘡(Systemic lupus Erythematosus)是一項嚴重的慢性全身性自體免疫疾病,好發於生育期的女性(15~45歲) 。雖然目前的十年存活率已提昇至80~90%，然而本病罕能根治，絕大部份的病人常須終生治療，而其中約70-80%的病人需長期的類固醇治療。而且本病平均每兩年有一次復發之機率，因此如何能減少類固醇之用藥，並防止本病之復發，是一值得深思之課題。 目前在現代醫學裡，雖然有抗瘧藥及免疫抑制劑之應用，以協助上述問題之解決，然而效果仍是有限，而且又有一定之副作用，因此如何自傳統中草藥裏，找尋良方，和現代醫療相配合，以造福病患，使其長保安康，乃是患者、家屬及醫療人員的共同夢想。 本研究群集合了免疫學、中醫學與藥學三方的專家，共同擬定了丹七六味合方，期盼本方能有效協助類固醇用量之遞減，減少紅斑性狼瘡的復發。此研究為一雙盲隨機分組之對照研究，預計將收錄160名輕中度(SLEDAI 2分~12分)之患者，區分為安慰劑組(n=80)與實驗組(n=80)，經六個月治療後，評估比較類固醇之遞減量與疾病復發率。而收錄之單位共有兩處，其一為高雄長庚醫院風濕過敏免疫科(西醫窗口)，另一為高雄醫學大學中和紀念醫院中醫部(中醫窗口)。 預期本研究之完成，將能有效協助SLE患者減少類固醇劑量及減少復發。
關鍵字：全身性紅斑性狼瘡；類固醇；復發；丹七六味合方

Application of Dan-Chi-Liu-Wei combination in SLE patients to taper steroid and to prevent disease flare

Chung-Jen Cheng
Chang Gung University
Systemic lupus erythematosus (SLE) is a severe chronic systemic autoimmune disease predominantly involving child-baering woman (15-45 years old). Though the ten years survival rate in SLE patients has been improved up to 80%-90%, there is rare cure. Most patients of SLE need long-term treatment of steroids and may suffer from disease flare about once every other year. Therefore, to taperthe dosage of steroid and to prevent disease flare is a critical issue to date. To date, antimalarial drugs and immunosuppressive agents have been used to resolve the above problems, but with limited effect and a lot of toxicity and complications. Therefore, we try to find a good way from traditional Chinese medicine (TCM) to help patients to get long-term health (including less steroid and less disease flare). Our research team including Immunologists, TCM expert and Pharmacy specialist to design the Dan-Chi-Liu-Wei combination, which is expected to be beneficial to taper steroid and to decrease the disease flare of SLE. This study is a randominzed-double blinded controlled trial. In total 160 SLE patients with mild to moderate activity (SLEDAI 2-12) will be recruited. They will be divided into experimental group taking Dan-Chi-Liu-Wei combination and control group.
關鍵字：SLE；steroid；flare；Dan-Chi-Liu-Wei combination