摘要
目的观察肠健平方治疗溃疡性结肠炎(UC)脾虚湿盛证的临床疗效。方法选取河南4家医院UC脾虚湿盛证患者163例,采用多中心分层、随机化方法将患者分为治疗组和对照组。治疗组予肠健平方水丸,6 g/次,3次/d,口服;对照组予美沙拉嗪肠溶片,2片/次,3次/d,口服。为保证盲法,2组药物均按每次用量研碎,分装于数量一致的同种肠溶胶囊及药物储存瓶。2组均连续治疗4周。观察2组临床疗效,比较2组治疗前后西医症状评分、中医证候评分,并监测安全性指标。结果共纳入全分析集(FAS)患者163例,符合方案集(PPS)患者137例。FAS治疗组总有效率为95.29%(81/85),对照组为82.05%(64/78),2组比较差异有统计学意义(P<0.05);PPS治疗组总有效率为95.95%(71/74),对照组为79.37%(50/63),2组比较差异有统计学意义(P<0.05)。FAS、PPS治疗组治疗后西医症状评分、中医证候评分均明显低于对照组(P<0.05)。2组治疗过程中均无不良事件发生。结论肠健平方可有效改善UC脾虚湿盛证患者西医症状及中医证候,疗效较好,无明显不良反应。
Objective To evaluate the clinical efficacy of Changjianping Prescription in the treatment of ulcerative colitis(UC)with spleen deficiency and dampness syndrome.Methods Totally 163 cases of UC patients with spleen deficiency and dampness syndrome in 4 hospitals in Henan Province were randomly divided into treatment group and control group through multicenter stratified randomization method.The treatment group was treated with Changjianping Prescription water pill preparations,6 g per time,three times a day,orally;the control group was treated with mesalazine enteric-coated tablets,two tablets per time,three times a day,orally.To ensure blindness,drugs for both groups were ground according to the dosage of each time and sub packed in the same kind of enteric coated capsules and drug storage bottles.The treatment lasted for 4 weeks.The clinical efficacy of both groups was observed.Western medicine symptom scores and TCM syndrome scores before and after the treatment of both group were compared,and safety index was monitored.Results Totally 163 patients in the full analysis set(FAS)and 137 patients in the per-protocol set(PPS)were included.The total effective rate of FAS treatment group was 95.29%(81/85)and that of control group was 82.05%(64/78),with statistical significance(P<0.05);the total effective rate was 95.95%(71/74)in PPS treatment group and 79.37%(50/63)in control group,with statistical significance(P<0.05).The scores of Western medicine symptom and TCM syndrome in FAS and PPS treatment groups were significantly lower than those in the control group (P<0.05). There were no adverse events in both groups. Conclusion Changjianping Prescription can effectively improve Western medicine symptoms and TCM syndromes of UC patients with spleen deficiency and dampness syndrome, with good efficacy and no adverse reactions.
作者
陈淑君
潘慧
常为伟
张东岳
王华胜
陈俊
董倩倩
CHEN Shujun;PAN Hui;CHANG Weiwei;ZHANG Dongyue;WANG Huasheng;CHEN Jun;DONG Qianqian(The First Affiliated Hospital of Henan University of Chinese Medicine,Zhengzhou 450000,China;People’s Hospital of Zhengzhou,Zhengzhou 450000,China;Zhengzhou First People’s Hospital,Zhengzhou 450000,China;Zhoukou Central Hospital,Zhoukou 466000,China)
出处
《中国中医药信息杂志》
CAS
CSCD
2022年第4期121-125,共5页
Chinese Journal of Information on Traditional Chinese Medicine
基金
河南省首批中医药青苗人才培养项目(2018年)。
关键词
溃疡性结肠炎
脾虚湿盛证
肠健平方
临床研究
ulcerative colitis
spleen deficiency and dampness syndrome
Changjianping Prescription
clinical research
