不同证型中药颗粒剂辨证治疗腹泻型肠易激综合征的临床疗效观察

发布时间：2018-01-20 03:06

本文关键词： 腹泻型肠易激综合征中药颗粒剂马来酸曲美布汀临床试验　出处：《湖北中医药大学》2017年硕士论文　论文类型：学位论文

【摘要】：目的本研究旨在通过观察不同证型中药颗粒剂辨证治疗腹泻型肠易激综合征的治疗效果,并与安慰剂及阳性药物作比较,从而客观评价中药颗粒剂治疗腹泻型肠易激综合征的临床疗效及安全性,并通过对血清5-HT、D-木糖含量的测定,探讨中药颗粒剂治疗腹泻型肠易激综合征的科学性。方法从2014年9月至2016年11月期间从武汉市一医院收集符合IBS-D纳入标准的患者72例。根据随机、双盲分组原则划分3组,分别为试验组(36例),对照组一(18例),对照组二(18例),入组前每位受试者必须有近6个月内的肠镜检查结果,无者另行肠镜检查。治疗前后每位受试者各行一次安全性检查(三大常规、肝肾功能、心电图),以及血清5-HT和D-木糖含量的检测。试验组根据肝郁脾虚证、脾虚湿盛证、脾肾阳虚证分别给予腹泻I号方、腹泻II号方、腹泻III号方及马来酸曲美布汀胶囊安慰剂,对照组一受试者给予中药颗粒剂安慰剂和马来酸曲美布汀胶囊安慰剂,对照组二受试者给予马来酸曲美布汀胶囊和中药颗粒剂安慰剂,疗程均为8周,药物治疗结束后符合要求者进入为期8周的随访。根据肠易激综合征症状严重度分数(IBS-SSS)量表积分、肠易激综合征生存质量(IBS-QOL)量表积分、PRO量表积分、中医症状积分的统计结果来评价中药颗粒剂的治疗效果,根据随访情况比较,评价中药颗粒剂的远期治疗效果,并通过检测血浆5-HT、D-木糖的含量探讨中药颗粒剂治疗腹泻型肠易激综合征的科学性。结果1、总体疗效比较:试验组总有效率达73.53%;对照组一总有效率达37.50%;对照组二总有效率达70.59%。试验组和对照组二总体有效率比较,无统计学差异(P0.05),对照组一与其余两组的总体有效率比较,有统计学差异(P0.05)。2、治疗后试验组和对照二IBS症状严重程度积分与治疗前相比均有所下降,差异均有统计学意义(P0.05,P0.05),两组组间作比较,没有统计学差异(P0.05)。对照组一治疗后积分与治疗前无明显变化,无显著性差异(P0.05),与其余两组比较有统计学差异(p0.05,p0.05)。3、治疗后试验组及对照组二ibs-qol量表积分与治疗前相比均有所下降,差异有统计学意义(p0.05,p0.05),两组组间作比较,没有统计学差异(p0.05),对照组一与治疗前相比无明显变化,无显著性差异(p0.05),与其余两组比较,有显著性差异(p0.05,p0.05)。4、治疗后试验组及对照组二pro量表积分与治疗前相比均有所下降,差异有统计学意义(p0.05,p0.05),两组组间作比较,没有统计学差异(p0.05),对照组一与治疗前相比无明显变化,差异无统计学意义(p0.05),与其余两组比较,有显著性差异(p0.05,p0.05)。5、治疗后试验组及对照组二中医症状积分与治疗前相比均有所下降,差异有统计学意义(p0.05,p0.05),两组组间作比较,试验组下降程度高于对照组二,差异具有统计学意义(p0.05),对照组一与治疗前相比中医症状积分无明显变化,差异无统计学意义(p0.05),与其余两组比较有统计学差异(p0.05,p0.05)。6、试验组及对照组二治疗后血清5-ht含量较治疗前降低,差异具有统计学意义(p0.05,p0.05),两组组间作比较,没有统计学差异(p0.05),对照组一治疗后血清5-ht含量无明显降低,差异无统计学意义(p0.05),与其余两组比较有极显著的统计学差异(p0.01,p0.01)。试验组及对照组二治疗后血清d-木糖含量较治疗前升高,差异具有统计学意义(p0.05,p0.05),两组组间作比较,有极显著的统计学差异(p0.01),试验组血清d-木糖升高程度明显的高于对照组二,对照组一治疗后d-木糖含量无明显变化,差异无统计学意义(p0.05),与其余两组比较有极显著的统计学差异(p0.01,p0.01)。7、治疗后复发情况比较:8周随访,试验组复发率为28.0%低于对照组二的66.7%,两者有显著性差异(p0.05)。结论本研究显示中药颗粒剂和马来酸曲美布汀胶囊对ibs-d均有治疗作用,且治疗效果没有明显差别。中药颗粒剂和马来酸曲美布汀胶囊均可降低患者ibs-sss、ibs-qol、pro量表积分,提高患者生存质量,改善ibs-d相关伴随症状,中药颗粒剂和马来酸曲美布汀胶囊均可降低患者中医症状积分,但中药颗粒剂在改善中医症状方面优于马来酸曲美布汀胶囊,中药颗粒剂和马来酸曲美布汀胶囊均可降低血清5-HT的含量,两者作用效果相当,中药颗粒剂和马来酸曲美布汀胶囊均可明显升高1h血清D-木糖含量,改善肠道吸收,但中药颗粒剂效果明显优于马来酸曲美布汀胶囊。中药颗粒剂治疗IBS-D随访期复发率低于马来酸曲美布汀胶囊,远期治疗效果较好。
[Abstract]:The purpose of this study is to observe the different syndromes of traditional Chinese medicine granules treatment of diarrhea type irritable bowel syndrome treatment, compared with placebo and positive drug, and objective evaluation of Chinese medicine granules for treating diarrhea predominant clinical efficacy and safety of irritable bowel syndrome, and the serum 5-HT, D- determination of xylose content and the scientific study of Chinese medicine granules for treating diarrhea type of irritable bowel syndrome. Methods from September 2014 to November 2016 during the period from a hospital in Wuhan city to collect with IBS-D included 72 cases of patients with standard. According to the randomized, double-blind group is divided into 3 groups, respectively as the experimental group (36 cases), control group (18 cases two), control group (18 cases), before entering the group participants must have colonoscopy results within the past 6 months, no separate colonoscopy before and after treatment. All subjects were all a security check (three conventional, liver and kidney function Can, ECG), and serum levels of 5-HT and D-. The xylose content in experimental group according to the liver stagnation and spleen deficiency, spleen deficiency dampness, spleen kidney yang deficiency syndrome were treated with I, diarrhea, diarrhea, diarrhea, II, III and Trimebutine Maleate Capsules a placebo control group participants were given the Chinese medicine granule placebo and Trimebutine Maleate Capsules placebo. The control group of two subjects for Trimebutine Maleate Capsules and Chinese medicine granule placebo treatment for 8 weeks, after the end of treatment to meet the requirements to enter the 8 week follow-up. According to the IBS symptom severity score (IBS-SSS) scores, irritable bowel syndrome, quality of life (IBS-QOL) scale scores, PRO scores, statistical results of TCM symptom score to evaluate the therapeutic effect of traditional Chinese medicine granules, according to follow-up, the long-term curative effect evaluation of traditional Chinese medicine granules, and Through the detection of plasma 5-HT, D- content of xylose in scientific research on Chinese medicine granule in treating diarrhea type of irritable bowel syndrome. Results 1. The overall curative effect comparison: the experimental group total effective rate was 73.53%; the control group total effective rate was 37.50%; two in the control group the total effective rate was 70.59%. the test group and the control group total effective rate two comparison, no statistically significant difference (P0.05), the control group and the other two groups overall efficiency comparison, there were significant differences (P0.05.2), compared to the experimental group after treatment and control two IBS symptom severity score before treatment were decreased, the differences were statistically significant (P0.05, P0.05), compared two groups between groups, no statistically significant difference (P0.05). The control group after treatment score before treatment had no obvious change, no significant difference (P0.05), there was significant difference compared with the other two groups (P0.05, P0.05).3, the test group after treatment and control group two IBS-QOL Score compared with before treatment were decreased, the difference was statistically significant (P0.05, P0.05), were compared between the two groups, no statistically significant difference (P0.05), a control group compared with before treatment had no obvious change, no significant difference (P0.05), and the other two groups, there was significant difference (P0.05, P0.05.4), the test group and the control group two Pro scores compared with before treatment were decreased, the difference was statistically significant (P0.05, P0.05), were compared between the two groups, no statistically significant difference (P0.05), a control group compared with before treatment had no obvious change, no significant difference meaning (P0.05), and the other two groups, there was significant difference (P0.05, P0.05).5, the test group and the control group of two TCM symptoms score and treatment were all lower than before, the difference was statistically significant (P0.05, P0.05), were compared between the two groups, the experimental group decreased significantly higher than that of control group two , the difference was statistically significant (P0.05), a control group compared with before treatment, TCM symptom scores did not change significantly, the difference was not statistically significant (P0.05), there was significant difference compared with the other two groups (P0.05, P0.05).6, the experimental group and the control group two after treatment, serum 5-HT content decreased, with statistical significant differences (P0.05, P0.05), were compared between the two groups, no statistically significant difference (P0.05), the control group did not significantly reduce the content of serum 5-HT after treatment, there was no statistically significant difference (P0.05), there was significant difference compared with the other two groups (P0.01, P0.01). The experimental group and the control group two after treatment, serum d- xylose content higher than that before treatment, the difference was statistically significant (P0.05, P0.05), were compared between the two groups, there were significant differences (P0.01), the serum d- xylose increased was significantly higher than that of control group two, control group treatment D- xylose content after treatment had no obvious change, the difference was not statistically significant (P0.05), there was significant difference compared with the other two groups (P0.01, P0.01).7, comparing the recurrence after treatment: 8 weeks of follow-up, the recurrence rate of experimental group than the control group was 28%, two of the 66.7%, there was significant difference between them (P0.05). Conclusion this study shows that traditional Chinese medicine granules and Trimebutine Maleate Capsules on the therapy of IBS-D had no significant difference. And the therapeutic effect of traditional Chinese medicine granules and Trimebutine Maleate Capsules can be reduced in patients with IBS-SSS, IBS-QOL, pro scale score, improve the quality of life of patients, improve the IBS-D related symptoms of traditional Chinese medicine granules and Trimebutine Maleate Capsules can reduce the patients with symptoms of TCM, but Chinese medicine granule in improving TCM symptoms is better than Trimebutine Maleate Capsules, and Trimebutine Maleate Capsules are traditional Chinese medicine granules Reduce the content of serum 5-HT, the effect of traditional Chinese medicine granules quite, and Trimebutine Maleate Capsules can be significantly elevated 1H serum D- xylose content, improve intestinal absorption, but Chinese medicine granule is better than Trimebutine Maleate Capsules. Traditional Chinese medicine granules for the treatment of IBS-D follow-up recurrence rate was lower than that of Trimebutine Maleate Capsules, a better long-term therapeutic effect.

【学位授予单位】：湖北中医药大学
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：R259

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