中西医结合治疗慢性肝衰竭多地域、多中心、随机、对照研究

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目的观察中西医结合治疗方案对慢性肝衰竭患者病死率、并发症发生率以及中医症状改善率的影响。方法采用随机对照设计,将纳入对象随机分配入试验组和对照组,分别给予中西医结合和内科综合治疗。结果经χ2检验,在治疗第8周、第12周、第24周和第48周,2组病死率差异无统计学意义,生存分析表明试验组的生存率略低于对照组,但经Log-rank检验,2组生存曲线差异无统计学意义;治疗第5周、第6周、第7周及第24周4个时间点试验组腹水发生率低于对照组(P<0.05),在治疗第48周试验组的肝性脑病发生率低于对照组(P<0.05);在改善乏力、腹胀、水肿等中医临床症状方面试验组优于对照组。结论个体化复杂干预的中西医结合治疗方案与单纯西医治疗比较,在降低慢性肝衰竭病死率方面未显示出优势,但在控制腹水、肝性脑病等并发症方面有一定作用,特别是在改善中医症状方面具有明显优势。 Objective To observe the treatment of traditional Chinese and western medicine on patients with chronic liver failure mortality, the incidence of complications and improvement of Chinese medicine symptoms. Methods A randomized controlled design was adopted. The subjects were randomly assigned to the experimental group and the control group, and were given integrative medicine and comprehensive medical treatment respectively. Results There was no significant difference in mortality between the two groups at the 8th week, the 12th week, the 24th week and the 48th week after the χ2 test. Survival analysis showed that the survival rate of the experimental group was slightly lower than that of the control group. However, -rank test, there was no significant difference in survival curves between the two groups. The incidence of ascites in the test group was lower than that of the control group at the 4th, 5th, 6th, 7th, and 24th weeks after treatment (P <0.05) The incidence of hepatic encephalopathy in the experimental group was lower than that in the control group (P <0.05) in the 48th week of treatment. The experimental group was superior to the control group in improving clinical symptoms of Chinese medicine such as fatigue, bloating and edema. Conclusion The combination of TCM and WM treatment with individualized and complex interventions has no advantage in reducing the mortality of chronic liver failure compared with western medicine alone. However, it has some effects in the control of complications such as ascites and hepatic encephalopathy, especially in improving TCM symptoms have obvious advantages.
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