扶正化瘀胶囊联合熊去氧胆酸胶囊治疗原发性胆汁性肝硬化临床研究

摘要

目的：观察扶正化瘀胶囊联合熊去氧胆酸胶囊对原发性胆汁性肝硬化（PBC）患者症状、血清细胞因子、免疫相关指标的影响。方法选择PBC患者60例，随机分为实验组及对照组各30例。实验组给予扶正化瘀胶囊联合熊去氧胆酸胶囊口服，对照组单用熊去氧胆酸胶囊口服，疗程均为24周。记录并分析治疗12、24周患者中医临床症状、抗线粒体抗体（AMA）、抗线粒体抗体-M2亚型（AMA-M2）、免疫球蛋白G（IgG）、免疫球蛋白M（IgM）、免疫球蛋白A（IgA）、免疫球蛋白B（IgB）、碱性磷酸酶（ALP）、γ-谷氨酰转肽酶（GGT）、ALT、AST、TBil及总胆固醇（CH）、甘油三酯（TG）等各项指标的变化。结果两组患者在治疗12、24周ALT、AST、TBil、ALP、GGT、TG、CH、AMA、AMA-M2、IgM与治疗前组内比较均改善显著，差异均有统计学意义（P均＜0.05）；而IgA、IgB、IgG与治疗前组内比较均无明显改善，差异均无统计学意义（P均＞0.05）。实验组治疗12、24周中医临床症状较前明显改善，而对照组治疗12周中医临床症状无改善，治疗24周中医临床症状略有改善，但治疗前后差异无统计学意义（P ＞0.05）。实验组治疗12、24周中医临床症状、ALP、GGT、ALT、AST、TG、AMA-M2均较对照组明显改善，差异均有统计学意义（P均＜0.05），而实验组治疗12周AMA、IgM及TBil与治疗前比较略有下降，但与对照组比较差异无统计学意义（P均＞0.05）。实验组治疗24周中医临床症状、ALP、GGT、ALT、AST、TG、AMA-M2较对照组均有显著下降，差异有统计学意义（P ＜0.05）。结论熊去氧胆酸胶囊联合扶正化瘀胶囊治疗PBC，在改善中医临床症状、转氨酶及线粒体抗体方面较单纯使用熊去氧胆酸胶囊有明显疗效，但对降低CH、lgA、IgB、IgG无显著作用。%Objective To evaluate effect of observed serum cytokines between Fuzhenghuayu and joint capsule ursodeoxycholic acid capsules for primary biliary cirrhosis (PBC) in patients with symptoms, immune-related indicators. Methods Total of 60 patients with PBC were randomly divided into experimental group (30 cases) and control group (30 cases). Experimental group received capsules combined Fuzhenghuayu ursodeoxycholic acid capsules orally, the control group UDCA capsules orally. Patients in both groups were treated for 24 weeks. Record and analyze treatment 12 weeks and 24 weeks of patients with symptoms of clinical medicine, anti-mitochondrial antibody (AMA), anti-mitochondrial antibody-M2 subtype (AMA-M2), immunoglobulin G (IgG), immunoglobulin M (IgM), immune immunoglobulin A (IgA), immunoglobulin B (IgB), alkaline phosphatase (ALP), γ-glutamyl peptidase (GGT), ALT, AST, TBil and total cholesterol (CH), triglycerides change (TG) and other indicators. Results After 12 weeks and 24 weeks of treatment, two groups of ALT, AST, TBil, ALP, GGT, TG, CH, AMA, AMA-M2, the IgM before treatment group were improved significantly, the differences were statistically significant (P < 0.05); while IgA, IgB, the IgG before treatment group showed no signiifcant improvement, the difference was not statistically signiifcant (P>0.05). In the experimental group therapy TCM clinical symptoms improved signiifcantly in the 12 weeks and 24 weeks, but over the prior 12 weeks of treatment in the control group did not improve symptoms of clinical medicine, Chinese medicine treatment of 24 weeks of clinical symptoms improved slightly, but no signiifcant difference before and after treatment (P>0.05). In the experimental group therapy TCM clinical symptoms, ALP, GGT, ALT, AST, TG, AMA-M2 signiifcant improvement compared with the control group, the differences were statistically signiifcant (P<0.05) in the 12 weeks and 24 weeks, while the experimental group was treated for 12 weeks AMA, IgM and TBil declined slightly compared with before treatment, compared with control group, but the difference was not statistically significant (P > 0.05). When the treatment in the experimental group TCM clinical symptoms, ALP, GGT, ALT, AST, TG, AMA-M2 compared with the control group were signiifcantly decreased, the difference was statistically signiifcant (P<0.05) in the 24 weeks. Conclusions Fuzhenghuayu capsule combined with ursodesoxycholic acid take better effect than single ursodesoxycholic acid to PBC in symptom, ALP, GGT, ALT, AST, TG, AMA, AMA-M2, IgM, TBil, but have no different for the levels of CH, IgA, IgB, IgG.