中医辨证治疗功能性消化不良的随机对照研究  

Treatment of Functional Dyspepsia by Chinese Medical Syndrome Typing: a Randomized Control Research

作　　者：范一宏[1] 蔡利军[1] 徐国萍[1] 冯雯[1] 金曼[1] 吕宾[1] 姜宁[1] 乔樵[1] 

机构地区：[1]浙江中医药大学附属第一医院消化科,杭州310006

出　　处：《中国中西医结合杂志》2012年第12期1592-1597,共6页Chinese Journal of Integrated Traditional and Western Medicine

基　　金：浙江省中医药科技计划单病种诊疗规范项目(No.2008GA004)

摘　　要：目的评价中药辨证治疗功能性消化不良(FD)的近远期疗效和安全性。方法采用随机、阳性药平行对照临床研究方法。纳入FD患者170例,按4∶1的比例随机分为中药组(136例)和西药组(34例)。中药组根据中医辨证分型给予不同的方药,西药组根据罗马Ⅲ分型给予多潘立酮片或埃索美拉唑片。于治疗期第1、2、4周观察疗效:(1)临床症状评分;(2)SF-36生活质量量表评分;(3)安全性;(4)依从性;(5)满意度;(6)复发率;(7)成本—效果(C/E)比值及停药后第1、3、6个月进行随访。结果中药组136例,脱落16例;西药组34例,脱落4例,两组脱落率均为11.76%,差异无统计学意义(P>0.05)。中药组临床症状评分从治疗前的(5.62±2.30)分下降到治疗4周后的(1.41±1.22)分,治疗前后比较,差异有统计学意义(P<0.01),与西药组同期比较差异无统计学意义(P>0.05)。中药组痊愈率、总有效率治疗4周时分别为38.24%、86.76%;停药6个月时分别为60.00%、65.00%;西药组分别为41.18%、79.41%;46.67%、50.00%,两组比较,差异均无统计学意义(P>0.05)。两组躯体生理健康总评分(PCS)和精神心理健康总评分(MCS)于治疗4周后均有所上升,但与治疗前比较,差异无统计学意义(P>0.05);停药后6个月PCS、MCS评分与治疗前比较,差异有统计学意义(P<0.05);而两组间比较,差异无统计学意义(P>0.05)。两组均未发现明显的不良反应。服药4周时中药组和西药组治疗的依从性和满意度分别为95.59%和91.91%,94.12%和91.18%,两组比较,差异无统计学意义(P>0.05)。停药后1、3、6个月复发率中药组分别为10.29%、19.12%、29.41%,均较同期西药组(分别为17.65%、23.53%、35.29%)低,但差异无统计学意义。在C/E上,治疗4周时中药组∶西药组为15.59∶16.53,停药6个月时为22.27∶28.28,进一步的增量成本—增量效果比值分析显示中药组在远期比值降低,由5.44降至2.35。结论中医辨证治疗FD4周方案近、远期疗�Objective To assess the short-and long-term efficacy and safety of treating functional dyspepsia （FD） by Chinese medical syndrome typing （CMST）. Methods A randomized, positive-drug parallel controlled study was conducted. Recruited were 170 FD patients who were randomly assigned to the test group （ 136 cases, treated by Chinese herbs） and the control group （34 cases, treated by Western medicine） in the ratio of 4： 1. Different recipes were administered to patients in the test group according to CMST at the 1 st, 2nd, and 4th week, respectively, while those in the control group took Domperidone or Esomeprazole Magnesium Enteric-coa- ted Tablet according to Roma III Criteria. The therapeutic efficacy was observed at the 1st, 2nd, and 4th week of the treatment, including （1） clinical symptom score; （2） the score of SF-36 quality of life scale; （3） safety; （4） compliance; （5） satisfaction; （6） the relapse rate; （7） cost-effectiveness ratio （C/E）. The follow-ups were performed at the 1st, 3rd, and 6th month. Results Sixteen patients fell off in the test group and 4 fell off in the control group, and the expulsion rate being 11.76% in the two groups, showing no statistical difference （ P 〉0.05）. The clinical symptom scores in the test group decreased from 5.62 ±2.30 before treatment to 1.41 ± 1.22 after 4-week treatment, showing statistical difference （ P 〈 0.01 ）, but with no statistical difference when compared with the control group at the same time point （P〉0.05）. The healing rate and the total effective rate at week 4 were 38.24% and 86.76% respectively in the test group, and they were 60. 00% and 65.00% at 6- month withdrawal. They were 41.18%, 79.41%, 46.67%, and 50.00%, respectively, in the control group. There was no statistical difference between the two groups （P 〉0.05）. The scores of physical component-summary （PCS） and mental component-summary （MCS） both increased after 4-week treatment in the two groups, showing no statist

关 键 词：功能性消化不良 药物治疗 SF-36生活质量量表 中医辨证 

分 类 号：R259[医药卫生—中西医结合]