通降颗粒干预非糜烂性反流病肝胃不和证疗效观察

Tongjiang Granule Intervened Non-erosive Reflux Disease Patients of Gan-Wei Incoordination Syndrome: a Curative Effect Observation

目的观察通降颗粒干预非糜烂性反流病(non-erosive reflux disease,NERD)肝胃不和证疗效。方法选择128例2009年2月—2010年11月中国中医科学院西苑医院消化科门诊及住院NERD肝胃不和证患者。采用区组随机的方法,按1∶1将患者随机分为试验组及对照组,每组64例。试验组予以通降颗粒10g/次,3次/日;对照组予以奥美拉唑肠溶片20mg,2次/日;疗程均为4周。观察指标采用症状量表和SF-36生活质量量表。结果试验完成病例114例。两组治疗前胃脘嘈杂、咽部异物感、腹部胀满或腹痛、大便积分比较,差异有统计学意义(P<0.05),其余各指标比较,差异无统计学意义(P>0.05)。与本组治疗前比较,两组各症状积分及症状总积分均有改善(P<0.01,P<0.05)。试验组除精神健康评分无统计学差异(P>0.05)外,其余各维度评分比较,差异均有统计学意义(P<0.01,P<0.05),对照组除生理功能评分无统计学差异(P>0.05)外,其余各维度评分比较,差异均有统计学意义(P<0.01,P<0.05)。两组治疗后反酸、情志烦躁和抑郁积分、身体疼痛、情感职能评分比较,差异有统计学意义(P<0.01,P<0.05)。试验组总有效率高于对照组,差异无统计学意义(P>0.05)。结论通降颗粒治疗NERD肝胃不和证疗效确切,同时可以提高患者的生活质量,未见明显不良反应。

Objective To assess the effectiveness of Tongjiang Granule （TJG） in treating non-e- rosive reflux disease （NERD） of Gan-Wei incoordination syndrome （GWlS）. Methods Totally 128 NERD patients of GWlS were recruited from outpatients or inpatients at Department of Digestive Disease, Xiyuan Hospital, China Academy of Chinese Medical Sciences from February 2009 to November 2010. They were randomly assigned to two groups using the block group in the ratio of 1 ： 1,64 cases in each group. Patients in the experiment group were treated with TJG, 10 g each time, three times a day, while those in the con- trol group were treated with Omeprazole Tablet, 20 mg each time, two times a day. The treatment course of both groups was 4 weeks. The symptoms questionnaires and SF-36 quality of life scale were observed. Re- sults Finally 114 patients completed the trial. There was statistical difference in epigastric upset, pharyn- geal foreign body sensation, abdominal swelling or abdominal pain, and integral of excrement between the two groups before treatment （P 〈0.05）. However, there was no statistical difference in the rest indices be- tween the two groups （P 〉0.05）. Compared with before treatment in the same group, the scores of each symptom or the total symptoms were somewhat improved in the two groups （P 〈0.01, P 〈0.05）. There was statistical difference in the rest scores （P 〉0.05） except the score of mental health in the experiment group （P 〈0.01 ,P 〈0.05）. There was statistical difference in the rest scores （P 〉0.05） except the score of physical function in the control group （P 〈0.01, P 〈0.05）. There was statistical difference in post-treatment acid reflux, irritability, depression, body pain, roles of emotions （P 〈0.01, m 〈0.05~）. The total effective rate was higher in the experimental group, showing no statistical difference when compared with that of the control group （P 〉0.05）. Conclusions TJG had confirmative efficacy in treating NERD patients of GWlS. Meanwhile, it could improve their quality of life, with no obvious adverse reaction.