| Summary: | 碩士 === 長庚大學 === 中醫學系傳統中醫學 === 99 === Systemic Lupus Erythematosus is the autoimmune disease with diverse clinical manifestations. Many studies have been published so far described SLE disease activity and relevance of oxidative stress. Study of oxidative stress will help us to further understand the pathological mechanism of SLE. The clinical Investigation in 2009 demonstrated that “Yin vacuity and damp-heat” is the major pattern of SLE. Combine use of “Liver-Draining Decoction” (long dan xie gan tang) and “Anemarrhena, Phellodendron, and Rehmannia Pill” (zhi bai di huang wan) can nourish Yin vacuity and clear and disinhibit damp-heat. Long dan xie gan tang and zhi bai di huang wan also can reduce oxidative stress and disease activity in SLE animal model.
The study was a double-blinded, placebo-controlled, randomized clinical trial. The endpoint is to evaluate the efficacy of herbal formula LC on the disease activity and oxidative stress of SLE patients. The patients received herbal formula LC for 16 weeks and stop for 8 weeks, evaluations were performed every 4 weeks. We screened Eighty-five patients; twenty-seven patients were enrolled in LC group and twenty-two patients in placebo group. Only the dosage of steroid has significant difference at the baseline(LC group: placebo group=1.83± 1.41:1.07± 0.98，p=0.03 ). We compare the SLEDAI score, anti-dsDNA antibody, C3, C4 and the oxidative stress in two groups by repeated measure ANOVA. There were no significant mean difference in SLEDAI score, anti-dsDNA antibody, C3 and C4 before and after treatment. The steroid dosage demonstrated a significant reduction from baseline (p=0.022).
There was significant mean difference (p=0.033) in Superoxide dismutase (SOD) before and after treatment. The Malondialdehyde (MDA) on LC group decreased when they received LC and rebound after stop drug for 8 weeks. The Nitric oxide (NO) and water-soluble antioxidative capacity (ACW) have no significant difference before and after treatment and between two groups.
The study result demonstrates that SLEDAI, C3, C4 and anti-dsDNA antibody are stable in LC group and placebo group. The herbal formula LC significantly decreases the steroid dosage in SLE patients under the conventional medical treatment. The herbal formula LC and placebo can increase the SOD activity in SLE patients after 12 weeks. Herbal formula LC may decrease the MDA in erythrocytes. The herbal formula LC has its potential to use in SLE patients as a complementary therapy.
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