慢性心力衰竭中医简化辨证方案研究

Clinical Research on Chronic Heart Failure(CHF)Using Xinyin or Xinyang Tablet

目的:观察慢性心力衰竭患者经本院中成制剂心阴片、心阳片治疗后的返院率、中医临床症状积分、明尼苏达心衰生活质量评分等指标,评价心阴片及心阳片的临床疗效。方法:以目前公认的慢性心力衰竭治疗方案作为基础治疗,开展前瞻性、随机、多中心对照的临床研究,将纳入病例随机分为对照组和治疗组,对照组给予基础治疗,治疗组给予基础治疗加心阴片或心阳片,每次4片,每天3次,疗程12个月。观察治疗前后心衰患者的返院率、中医证候和明尼苏达生存质量量表的变化。结果 :(1)中西医结合治疗组与单纯西医治疗组对比,两组12个月的总返院率无统计学差异(P>0.05),但中西医治疗组的返院率有下降的趋势。(2)明尼苏达量表3次积分的比较,第1次积分比较两组之间未见统计学差异(P>0.05),后两组明尼苏达量表积分比较均显示出显著的统计学差异(P<0.01)。(3)中医证候疗效比较,治疗组总有效率为93.33%,对照组总有效率为83.33%,两组的疗效差别有统计学意义(P<0.05)。结论:本院中成制剂心阴片及心阳片能改善患者心功能、降低中医临床症状积分及明尼苏达心衰生活质量评分,与观察组治疗后比较有统计学差异;治疗组患者返院率与观察组之间未见统计学差异但有下降趋势,提示增大样本量及延长观察时限可能获得统计学差异;同时心阴片及心阳片有良好的安全性和依从性。

Objective：To observe return hospital rate,Chinese medicine clinical symptoms marks and Minnesta in heart failure subjects of patients with CHF treated by Xinyin or Xinyang tablet.Methods：60 patients with CHF were randomly divided into two groups.The control group was treated with standard modern medical therapy and the treatment group was treated with Xinyin or Xinyang tablet besides the same modern medical therapy as control group,for 1 year.Result：（1）Comparing with the control group,there was no significant difference（P〉0.05）on return hospital rate,but experimental group had decreasing tendency.（2）Minnesta in heart failure subjects showed no significant difference in the first follow-up（P〉0.05）,but showed the significant difference in the second and third follow-up（P〈0.01 or P〈0.05）.（3）Comparison of curative effect on TCM Syndroms：the total effective rate was 93.33% in the treatment group and 83.33% in the control group,and there was a statistically significant difference in efficacy between the two groups（P〈0.05）.Conclusion：Xinyin or Xinyang tablet can improve patients heart function,Chinese medicine clinical symptoms marks and Minnesta in heart failure subjects,it shows significant difference between groups;but there is no significant difference between groups on returning hospital rate,which indicates that if more cases to be observed and much longer to observe it might be significantly different.