补肾活血膏方对强直性脊柱炎疾病活动影响研究

目的:观察补肾活血膏方对强直性脊柱炎疾病活动影响。方法:采用多中心、前瞻性、队列研究,纳入上海中医药大学附属龙华医院、岳阳中西医结合医院、光华中西医结合医院三家单位的风湿科门诊及病房住院AS患者,共计167例,将是否自愿接受补肾活血中药或膏方作为暴露因素进行分组,分为西医常规治疗加补肾活血中药及补肾活血膏方治疗的高暴露组、西医常规治疗加补肾活血中药治疗的暴露组,及西医常规治疗的非暴露组,进行为期2年的跟踪观察。主要疗效指标ASDAS-CRP、次要疗效指标中医证候积分。统计分析采用T检验、多元方差分析、非参数检验。结果:在24个月治疗期间,三组ASDAS-CRP及中医证候积分组间比较有统计学意义。高暴露组、暴露组改善明显优于非暴露组(P<0.01),高暴露组改善明显优于暴露组(P<0.01)。补肾活血膏方服用期间无明显不良反应。结论:补肾活血膏方能明显降低AS患者的病情活动度,改善临床症状,无明显不良反应。

Effect of Bushen Huoxue Herbal Paste on Activity of AS

Objective:To observe the effect of Bushen Huoxue(Kidney-tonifying and blood-activating)Herbal Paste on the activity of ankylosing spondylitis(AS).Methods:A multicenter prospective cohort study was used.Whether to accept Bushen Huoxue Decoction or Bushen Huoxue Herbal Paste was taken as the exposure factor.167 patients with AS were randomly divided into the highly-exposed group treated by routine western medicine plus Bushen Huoxue Decoction and Bushen Huoxue Herbal Paste,the exposed group treated by routine western medicine plus Bushen Huoxue Decoction,and the non-exposed group treated by routine western medicine,with an observation course of two years.The main therapeutic index was ASDAS-CRP and the secondary therapeutic index was the Chinese medicine syndrome score.T test,multivariate analysis of variance and nonparametric test were used for statistical analysis.Results:During the 24-month treatment period,the comparison of ASDAS-CRP and TCM syndrome points was statistically significant among the three groups;the improvements were more significant in the highly-exposed group and the exposed group than those in the non-exposed group(P<0.01);the improvements in the highly-exposed group were more significant than those of the exposed group(P<0.01).There were no obvious adverse reactions during the administration of Bushen Huoxue Herbal Paste.Conclusion:Bushen Huoxue Herbal Paste can obviously reduce the disease activity of AS patients and improve clinical symptoms without obvious adverse reactions.