软肝巴布剂治疗原发性胆汁性肝硬化的临床研究
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摘要
目的:在中医内病外治理论指导下研制中药软肝巴布剂治疗肝纤维化,探讨软肝巴布剂对原发性胆汁性肝硬化患者TGF-β1、MMP-1、TIMP-1的影响。
     材料与方法:将60例在辽宁中医药大学附属医院风湿免疫科于2009年7月至2011年2月住院的符合诊断标准的肝硬化患者采用随机数字法分为治疗组即西医基础治疗加软肝巴布剂治疗组30例,对照组即西医基础治疗组30例,治疗组30例,男24例,女6例;平均年龄为:(50±2.1)岁,平均病程为:(12±6)个月,疗程一个月,观察治疗前后两组患者的治疗效果及TGFβ-1、MMP-1、TIMP-1的变化。组间比较采用方差分析。TGF-β1、MMP-1、TIMP-1的检测均采用放射免疫法。
     结果:
     1.中医临床疗效评价:对照组:显效4例,有效14例,无效12例,总有效率为:60%。治疗组:显效12例,有效10例,无效8例,总有效率为:73.3%(p<0.05)。
     2.中医量化积分:治疗组:治疗前为:22.9±2.6,治疗后为:10.8±2.4,变化值为:12.1±0.2;对照组:治疗前为:24.0±2.0,治疗后为:23.0±2.0,变化值为:1.0。治疗组优于对照组,有明显差异(p<0.05)。
     3.肝纤维化指标:治疗组肝纤维化指标TGF-β1、MMP-1、TIMP-1的变化值分别为:10.4±2.6,(ng/ml)、-168.3±(-51.6)、60.0±(-2.8);对照组:TGF-β1、MMP-1、TIMP-1的变化值分别为:14.1±4.3、-168.2±(-50.6)、83.8±29.6。两组三项指标差值比较均有统计学意义(p<0.05)。
     结论:软肝巴布剂通过透皮给药,并通过肝胆经在体表的投影穴位的作用使药物的有效成分达到病所,在中医量化积分以及肝纤维化指标改善上,治疗组优于对照组,并且软肝巴布剂没有明显的毒副作用,充分证明了软肝巴布剂是一种治疗肝硬化的安全有效的中医特色外治疗法,值得临床推广与应用,使之能为更多的肝硬化患者解除痛苦,产生新的治疗途径。
Purpose:In Chinese medical theory of disease outside the rule developed under the guidance of traditional Chinese medicine treatment of soft cataplasm liver, liver fibrosis, the liver of soft poultice of primary biliary cirrhosis TGF-β1, MMP-1, TIMP-1 effect.
     Material and method: 60cases in Liaoning University Hospital of Traditional Chinese Medicine Division of Rheumatology in July 2010 to February 2011 met the diagnostic criteria of hospitalization in patients with cirrhosis were randomly divided into treatment by the Western group based therapy plus soft liver cataplasm The treatment group of 30 patients in the control group that is the basis of the treatment group of 30 Western patients, the treatment group of 30 patients, 24 males and 6 females; mean age: (50±2.1) years, mean disease duration: (12±6) months Among them, 4 patients with liver cirrhosis, primary biliary cirrhosis, 25 cases of alcoholic cirrhosis in 1 case. Control group of 30 patients, 23 cases of male patients, 7 were female patients, mean age (45±3) years, mean disease duration (7±3. 2) months, 3 cases of alcoholic cirrhosis, primary biliary cirrhosis 26 cases, hepatitis C cirrhosis in 1 case. Month course of treatment, patients were observed before and after treatment and the therapeutic effect of TGFβ-1, MMP-1, TIMP-1 changes. Groups were compared using analysis of variance. TGF-β1, MMP-1, TIMP-1 detection were by radioimmunoassay.
     Results:1. TCM clinical efficacy evaluation: control group: 4 cases were markedly effective in 14 cases, 12 cases, the total effective rate: 60%. Treatment group: 12 cases markedly effective in 10 cases, 8 cases, total effective rate: 73.3% (p <0.05).
     2. Traditional quantitative points: the treatment group: before treatment: 22.9±2.6, after treatment: 10.8±2.4, change the value: 12.1±0.2; control group: before treatment: 24.0±2.0, after treatment: 23.0±2.0, the change is: 1.0. The treatment group than the control group, were significantly different (p <0.05). 3.Liverfibrosis:treament of liver fibrosis TGF-β1、MMP-1、TIMP-1changes in values were:10.4±2.6(ng/ml), -168.3±(-51.6)、60.0±(-2.8); control group: TGF-β1, MMP-1, TIMP-1 changes in values were: 14.1±4.3, -168.2±(-50.6), 83.8±29.6. Comparison of two groups of three indicators were statistically significant difference (p <0.05).
     Conclusion:Ruangan cataplasm by transdermal delivery, and by the Liver and Gallbladder points in the role of the projection surface so that the active ingredients of drugs to disease are, in Chinese medicine to quantify liver fibrosis score and improvement, the treatment group than the control group And soft cataplasm no significant liver toxicity, demonstrating a soft treatment of liver cirrhosis cataplasm effective security method is worthy of promotion and application, so that it can to relieve pain more sclerosis patients. Generate a new therapeutic approach
引文
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