辛开苦降法治疗功能性消化不良的效果与安全性评价  

Evaluation on the efficacy and safety of pungent-opening and bitter-descending method in the treatment of functional dyspepsia

作　　者：王蓓[1] 苏晓兰[2] 张晓红[2] 牛然 魏玮[2] 

机构地区：[1]中国中医科学院望京医院ICU,北京100102 [2]中国中医科学院望京医院脾胃病科,北京100102

出　　处：《中国医药导报》2016年第25期112-117,共6页China Medical Herald

基　　金：北京市科技计划“首都临床特色应用研究”专项课题(Z141107002514163)

摘　　要：目的 评价辛开苦降法治疗功能性消化不良（FD）寒热错杂证的效果和安全性。方法 选择2015年3月~2016年2月中国中医科学院望京医院消化内科门诊及内镜中心收治的FD患者105例,采用随机、双盲、安慰剂对照的方法按2∶1原则将其分为治疗组70例和对照组35例,分别给予胃康宁方以及安慰剂治疗,疗程均为4周。在治疗前、治疗2周、治疗4周时记录患者的中医证候积分、西医症状积分等情况。治疗前后均行血尿便常规、肝肾功、心电图、血沉等安全性检查。结果 共收集病例102例,其中治疗组无脱落,对照组因疗效不理想脱落病例3例。（1）中医证候疗效评价：治疗组有效率为97.1%,对照组为81.3%,差异有统计学意义（P〈0.05）。治疗2周及4周时,两组中医证候总积分均较治疗前显著降低,且治疗组中医证候总积分低于对照组,差异有统计学意义（P〈0.05）。治疗2周时,治疗组胃脘或脘腹胀满、嗳气呃逆单项证候评分低于对照组,治疗4周时,治疗组胃脘或脘腹胀满、嗳气呃逆、胃脘疼痛、饮食减少、恶心呕吐、胃中嘈杂、失眠多梦、善太息、反酸单项证候评分低于对照组,差异有统计学意义（P〈0.05）。（2）西医症状疗效评价：治疗组有效率为94.3%,对照组为68.8%,差异有统计学意义（P〈0.05）。治疗2周及4周时,两组西医症状总积分均较治疗前显著降低,且治疗组西医症状总积分低于对照组,差异有统计学意义（P〈0.05）。治疗2周时,治疗组餐后饱胀、早饱、上腹烧灼的症状积分均低于对照组,治疗4周时治疗组餐后饱胀、早饱、上腹烧灼、上腹痛单项症状积分均显著低于对照组,差异有统计学意义（P〈0.05）。（3）安全性评价：治疗过程中两组均未出现不良反应。结论 以胃康宁方为代表的辛开苦降法治疗寒热错杂型FD有效且安全。Objective To evaluate the efficacy and safety of pungent-opening and bitter-descending method in the treatment of functional dyspepsia （FD） with syndrome of intermingled heat and cold. Methods One hundred and five patients with FD admitted to Outpatient Department of Gastroenterology and Endoscopy Center in Wangjing Hospital, China Academy of Chinese Medical Sciences from March 2015 to February 2016 were selected, they were divided into 70 cases of treatment group and 35 cases of control group based on the principle of 2：1 by randomized, double-blind, placebo-controlled method, the two groups were given Weikangning Prescription and placebo respectively, the course of both groups was 4 weeks. The TCM syndrome scores and western medicine symptom scores before treatment and after treatment for 2, 4 weeks were recorded, the blood routine examination, routine urine test, stool test, liver and kidney function, electrocardiogram and erythrocyte sedimentation rate before and after treatment were taken examination. Resuits One hundred and two patients were enrolled finally, no cases fell off in the treatment group, 3 cases fell off in the control group because of poor curative effect. （1）Evaluation for the efficacy of TCM symptoms： the effective rate was 97. 1% in the treatment group and 81.3% in the control group, there was a statistically significant difference （P 〈 0.05）. After treatment for 2, 4 weeks, the total scores of TCM symptoms of the two groups were all significantly lower than those before treatment, and the total score of TCM symptoms of treatment group was lower than that of control group, the differences were statistically significant （P 〈0.05）. Afler treatment for 2 weeks, the single syndrome scores of abdominal fullness and distention, belching and hiccup of treatment group were lower than those of control group, after treatment for 4 weeks, the single syndrome scores of abdominal fullness and distention, belclling and hiccup, gastric cavity pain, less diet, nausea and wmliting, g

关 键 词：功能性消化不良 辛开苦降 胃康宁 寒热错杂证 

分 类 号：R57[医药卫生—消化系统]