理肠方治疗腹泻型肠易激综合征肝郁脾虚湿热证的临床研究

发布时间：2018-11-09 14:06

【摘要】：目的:采用随机对照试验的设计方案,通过观察理肠方对腹泻型肠易激综合征(IBS-D)肝郁脾虚湿热证患者临床症状、中医证候积分等有效性指标及安全性指标的改变情况,评价"理肠方"的有效性及安全性,以期为本方广泛应用于临床提供有益参考。方法:采取随机对照的研究方法,共纳入符合入组标准的IBS-D患者72例,并随机分为治疗组与对照组各36例。治疗组予中药"理肠方"治疗,对照组予西药"匹维溴铵+枯草杆菌二联活菌肠溶胶囊"治疗,两组均以4周为一疗程。观察患者的临床症状、中医证候积分和生活质量评分表以及血常规、肝肾功能、心电图等安全性指标的改变,并进行统计学分析,评价理肠方的有效性及安全性。结果:1.本研究共纳入72例患者,其中有65例病人完成了临床观察,观察组脱落3例,对照组脱落4例,总脱落率为9.72%。2.观察组与对照组均能明显改善患者临床症状,而观察组在腹泻、腹痛、急躁易怒、喜叹息、泄下急迫或不爽等几方面的证候积分及IBS-QOL专用量表评分分值变化均明显优于对照组,两组相比有非常显著性差异(P0.05,P0.01);在改善中医证候方面,观察组总有效率为90.9%,明显优于对照组68.8%(P0.01)。3.治疗过程中,所有受试者均未出现不良事件,且血常规、肝肾功及心电图检查等指标均未见明显异常变化。结论:1.理肠方治疗IBS-D肝郁脾虚湿热证疗效确切。2.理肠方无明显不良反应,具有良好安全性。
[Abstract]:Objective: to observe the effect of Lichang recipe on the clinical symptoms of patients with diarrhea type irritable bowel syndrome (IBS-D) such as liver stagnation and spleen deficiency dampness heat syndrome, TCM syndromes integral and safety index. To evaluate the efficacy and safety of Lichang recipe and to provide useful reference for its wide application in clinical practice. Methods: a randomized controlled study was conducted in 72 IBS-D patients who met the criteria of admission, and were randomly divided into treatment group (n = 36) and control group (n = 36). The treatment group was treated with traditional Chinese medicine "Lichang prescription", the control group was treated with the western medicine "pivimoammonium bromide bacilli combined with Bacillus subtilis enteric-coated capsule", both groups were treated with 4 weeks as a course of treatment. To observe the changes of clinical symptoms, score of TCM syndromes and quality of life, blood routine, liver and kidney function, electrocardiogram, and to evaluate the efficacy and safety of Lichang prescription. The result is 1: 1. A total of 72 patients were included in this study, 65 of whom completed the clinical observation. 3 cases in the observation group and 4 cases in the control group, the total abscission rate was 9.72%. 2. Both the observation group and the control group could significantly improve the clinical symptoms of the patients, while in the observation group, diarrhea, abdominal pain, irritability and irritability, sighing, The changes of symptom score and IBS-QOL scale score were obviously superior to those of the control group, and there was a significant difference between the two groups (P0.05, P0.01). In improving TCM syndromes, the total effective rate of the observation group was 90.9, which was significantly better than that of the control group (68.8%, P0.01). In the course of treatment, no adverse events occurred in all subjects, and there were no obvious abnormal changes in blood routine, liver and kidney function and electrocardiogram examination. Conclusion: 1. The curative effect of Lichang prescription on IBS-D liver stagnation and spleen deficiency dampness and heat syndrome is definite. 2. Lichang prescription has no obvious adverse reaction and has good safety.
【学位授予单位】：福建中医药大学
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：R259

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