痛泻要方治疗腹泻型肠易激综合征的疗效观察及其对肠道菌群的影响

发布时间：2018-03-16 21:54

本文选题：腹泻型肠易激综合征　切入点：痛泻要方　出处：《中国中医科学院》2017年硕士论文　论文类型：学位论文

【摘要】：目的:1通过临床观察,阐明痛泻要方治疗IBS-D的疗效,为IBS-D的治疗提供可靠的方法和依据;2运用16SrRNA技术比较痛泻要方应用前、应用4周、应用8周IBS-D患者肠道菌群结构的改变,为研究肠道菌群结构与中药复方之间的作用机制提供依据。方法:1根据纳入、排除标准纳入IBS-D患者,予痛泻要方治疗,1袋/次,3次/日,疗程为8周,以IBS-SSS量表积分、IBS-SSS积分等级改善、IBS-QOL量表、PRO量表及中医症状量表为疗效评价指标,比较用药前、用药4周及用药8周的积分变化;2根据纳入、排除标准纳入IBS-D患者,根据SOP留取粪便标本,应用16SrRNA技术、Illumina平台测序、生物信息学分析比较应用痛泻要方前、用药4周、用药8周IBS-D患者肠道菌群a多样性、β多样性及菌群结构显著性差异的变化。结果:1痛泻要方治疗IBS-D的疗效观察共纳入病例35例,退出3例,其中女性13例,男性19例。年龄最小者24岁,年龄最大者70岁。疗效评价指标包括IBS-SSS量表积分变化、IBS-SSS积分等级改善变化、IBS-QOL量表积分变化、PRO量表积分变化、中医症状积分变化。(1)IBS-SSS量表积分变化IBS-D患者应用痛泻要方前、用药4周、用药8周IBS-SSS量表积分平均分分别为 213.11±79.01、164.00±76.40、141.57±80.11。经比较,用药 4 周、用药 8周较用药前比较均具有统计学差异(P0.05)。腹痛程度维度积分平均分用药前、用药4周、用药后分别为29.86±24.99、23.38±21.56、22.59±23.38。经比较,无明显统计学差异(P0.05);腹痛频率维度积分平均分用药前、用药4周、用药8周分别为31.03±30.73、22.38±26.01、18.45±23.30。经比较,无明显统计学差异(P0.05);腹胀程度维度积分平均分用药前、用药 4 周、用药 8 周分别为 26.09±24.73、14.26±16.24、12.35±15.34。经比较,用药4周、用药8周较用药前比较均具有统计学差异(P0.05);排便满意度维度积分平均分用药前、用药4周、用药8周分别为66.43±25.15、52.35±25.48、49.44±25.40。经比较,用药4周、用药8周较用药前比较均具有统计学差异(P0.05);对生活的影响维度积分平均分用药前、用药4周、用药8周分别为60.31±27.16、51.88±25.05、45.18±23.67。经比较,用药4周较用药前无统计学差异(P0.05),用药8周较用药前比较具有统计学差异(P0.05)。(2)IBS-SSS量表积分等级改善根据IBS-SSS病情的分级标准,治疗结束后痊愈8例,显效3例,有效12例,无效9例。痊愈率为24.24%,有效率为69.67%。(3)IBS-QOL量表总积分及各维度积分改善IBS-QOL量表总积分用药前、用药4周、用药8周平均分分别为49.31±31.69、40.51±28.09、32.97±24.57。用药4周较用药前下降差异无统计学意义(P0.05),用药8周较用药前有下降趋势,差异有统计学意义(P0.05)。心境恶劣维度积分用药前、用药4周、用药8周平均分分别为14.60±13.12、10.65±8.13、8.59±7.81,用药4周较用药前下降,差异无统计学意义(P0.05),用药8周较用药前下降,差异有统计学意义(P0.05);行为障碍维度积分用药前、用药4周、用药8周平均分分别为10.20±6.30、9.44±6.35、7.71±6.38,用药4周较用药前下降,差异无统计学意义(P0.05),用药8周较用药前下降,差异有统计学意义(P0.05);自体意象维度积分用药前、用药4周、用药8周平均分分别为3.63±3.49、3.15±2.66、2.91±3.10,用药4周、用药8周较用药前积分下降均无明显差异,无统计学意义(P0.05);健康担忧维度积分用药前、用药4周、用药8周平均分分别为5.66±3.51、4.56±3.15、3.91±3.24,用药4周较用药前下降,差异无统计学意义(P0.05),用药8周较用药前下降,差异有统计学意义(P0.05);进食逃避维度积分用药前、用药4周、用药8周平均分分别为5.40±3.90、5.21±3.22、4.35±3.23,用药4周、用药8周较用药前积分下降无明显差异,无统计学意义(P0.05);社会功能维度积分用药前、用药4周、用药8周平均分分别为4.94±3.93、4.32±3.57、3.71±3.39,用药4周、用药8周较用药前积分下降无明显差异,无统计学意义(P0.05);性行为维度积分用药前、用药4周、用药8周平均分分别为1.86±2.57、1.85±2.36、1.09±1.66,用药4周、用药8周较用药前积分下降无明显差异,无统计学意义(P0.05);关系拓展维度积分用药前、用药4周、用药8周平均分分别为3.03±3.14、2.26±2.26、2.00±2.20,用药4周、用药8周较用药前积分下降无明显差异,无统计学意义(P0.05)。(4)PRO量表总积分及各维度积分改善PRO量表总积分用药前、用药4周、用药8周平均分分别为57.14±20.45、47.12±20.69、43.09±21.03,用药4周较用药前差异无统计学意义(P0.05),用药8周较用药前差异有统计学意义(P0.05);全身状态维度积分用药前、用药4周、用药8周平均分分别为14.83±5.41、11.85±4.96、11.62±5.04,用药4周及用药8周均较用药前降低,差异有统计学意义(P0.05);反流维度积分用药前、用药4周、用药8周平均分分别为5.69±4.28、4.21±3.51、4.03±3.52,用药前后积分变化无统计学差异(P0.05);消化不良维度积分用药前、用药4周、用药8周平均分分别为14.54±7.13、11.38±7.22、11.38±7.30,用药前后积分变化无统计学差异(P0.05);排便维度积分用药前、用药4周、用药8周平均分分别为12.00±3.31、9.38±4.36、8.91±4.40,用药4周及用药8周均较用药前降低,差异有统计学意义(P0.05);心理维度积分用药前、用药4周、用药8周平均分分别为7.71±4.18、5.74±3.29、5.15±3.14,用药4周较用药前差异无统计学意义(P0.05),用药8周较用药前积分下降,差异有统计学意义(P0.05);社会功能维度积分用药前、用药4周、用药8周平均分分别为2.37±2.33、1.59±1.86、1.41±1.91,用药前后积分变化无统计学差异(P0.05)。(5)中医症状量表积分改善情况中医症状量表积分用药前、用药4周、用药8周分别为12.00±5.81、10.67±5.43、9.23±4.73,用药4周较用药前积分下降无统计学差异(P0.05);用药8周较用药前下降,差异有统计学意义(P0.05)。(2)安全性检查研究中未发现明确与临床试验药物相关的、有临床意义的不良事件。2痛泻要方对IBS-D患者肠道菌群的影响共纳入病例35例,退出3例。其中,男性19例,女性13例。应用痛泻要方前、用药4周、用药8周肠道菌群a多样性、β多样性无明显差异。门水平上,服用痛泻要方后较服用前相比,拟杆菌门及变形菌门丰度增加,厚壁菌门丰度减少;属水平上,变形菌门中产碱菌科、奈瑟氏菌属数量均增多,但同属变形菌门的琥珀酸弧菌属数量减少;梭菌门内的梭菌属数量有所增多;属于厚壁菌门的Defluviitaleaceae、光岗菌属数目均减少,同属厚壁菌门的芽孢杆菌数目有所增多;拟杆菌门中一种未知细菌的数量减少,纤维粘网菌的数量增多;属于酸杆菌门的Bryobacter菌属增多。结论:痛泻要方能够改善IBS-D患者症状,并改善其肠道菌群结构。
[Abstract]:Objective: through clinical observation of 1, to clarify the effect of Tongxie Decoction in the treatment of IBS-D, a reliable basis and method for the treatment of IBS-D; 2 16SrRNA was used to compare Tongxieyaofang application before the application for 4 weeks, 8 weeks in patients with IBS-D of intestinal microflora changes, provide the basis for the mechanism of intestinal flora structure and compound Chinese medicine. Methods: 1 according to the inclusion and exclusion criteria included patients with IBS-D treated with Tongxieyaofang treatment, 1 bag / time, 3 times / day, for 8 weeks, IBS-SSS scores, IBS-SSS score levels improve, IBS-QOL scale, PRO scale and TCM symptom table for the evaluation index, compared with before treatment, 4 weeks of medication and medication scores were 8 weeks; 2 according to inclusion, exclusion criteria included patients with IBS-D, according to the SOP collected fecal samples, the application of 16SrRNA technology, Illumina sequencing, bioinformatics analysis and comparison of application of Tongxieyaofang before 4 weeks of medication use. 8 weeks of treatment with IBS-D a intestinal flora diversity, diversity and variation of microbial community structure difference. Results: 1 to observe the curative effect of Tongxie Decoction in the treatment of IBS-D 35 cases were included, out of 3 cases, there were 13 female and 19 male patients. The youngest was 24 years old, maximum age 70 years old. Efficacy evaluation indexes including IBS-SSS scale scores were IBS-SSS, improve the integral level changes, IBS-QOL scale score changes, PRO scale score changes, TCM symptoms integral change. (1) the IBS-SSS scale scores were used in patients with IBS-D pain diarrhea before 4 weeks of medication, medication for 8 weeks IBS-SSS scale integral average score was 213.11 + 79.01164.00 + 76.40141.57 + 80.11. by comparison, medication for 4 weeks, 8 weeks of treatment compared with before treatment were statistically different (P0.05). The average degree of abdominal pain dimensions before medication, medication 4 weeks after treatment were 29.86 + 24.99,23.38 + 21.56,22.59 + 2 3.38., by comparison, no statistically significant difference (P0.05); the average frequency of abdominal pain dimensions before medication, medication for 4 weeks, 8 weeks of treatment were 31.03 + 30.73,22.38 + 26.01,18.45 + 23.30. by comparison, no statistically significant difference (P0.05); the average dimensions of abdominal distension before medication, medication for 4 weeks, 8 weeks of medication were 26.09 + 24.73,14.26 + 16.24,12.35 + 15.34. by comparison, medication for 4 weeks, 8 weeks of treatment compared with before treatment were statistically different (P0.05); the average defecation satisfaction score before treatment, 4 weeks and 8 weeks of medication were 66.43 + 25.15,52.35 + 25.48,49.44 + 25.40. by comparison, 4 weeks of medication, medication 8 weeks after medication, the difference was statistically significant (P0.05); dimensions of life integral average score before treatment, 4 weeks and 8 weeks of medication were 60.31 + 27.16,51.88 + 25.05,45.18 + 23.67. by comparison, 4 weeks after medication, no Statistical difference (P0.05), 8 weeks of treatment compared with before treatment with statistical difference (P0.05). (2) IBS-SSS scores improved grades according to the IBS-SSS classification of the disease, after the end of treatment, 8 cases were cured, 3 cases were cured, 12 cases effective, 9 cases ineffective. The cure rate is 24.24%, the effective rate was 69.67%. (3) IBS-QOL Scale total score and each dimension scores of IBS-QOL Scale total score before treatment, 4 weeks of medication, medication for 8 weeks in average were 49.31 + 31.69,40.51 + 28.09,32.97 + 24.57. was significantly decreased after 4 weeks, there was no statistically significant difference (P0.05), 8 weeks of treatment than before treatment decreased the difference was statistically significant (P0.05). Dysthymic dimensions before medication, medication for 4 weeks, 8 weeks of treatment, the average scores of 14.60 + 13.12,10.65 + 8.13,8.59 + 7.81, 4 weeks of treatment was significantly decreased, the difference was not statistically significant (P0.05), 8 weeks of treatment was significantly decreased, the difference was statistically Statistically significant (P0.05); behavior disorder dimensions before medication, medication for 4 weeks, 8 weeks of treatment, the average scores of 10.20 + 6.30,9.44 + 6.35,7.71 + 6.38, 4 weeks of treatment was significantly decreased, the difference was not statistically significant (P0.05), 8 weeks of treatment was significantly decreased, the difference was statistically significant (P0.05); autologous image dimensions before medication, medication for 4 weeks, 8 weeks of treatment, the average scores of 3.63 + 3.49,3.15 + 2.66,2.91 + 3.10, 4 weeks, 8 weeks of treatment compared with before treatment score decreased had no difference, no statistical significance (P0.05); health anxiety points before treatment, 4 weeks of medication, medication the 8 week average were 5.66 + 3.51,4.56 + 3.15,3.91 + 3.24, 4 weeks of treatment was significantly decreased, the difference was not statistically significant (P0.05), 8 weeks of treatment was significantly decreased, the difference was statistically significant (P0.05); avoid eating dimension points before treatment, 4 weeks of medication, medication 8 weeks average respectively. 5.4 0 + 3.90,5.21 + 3.22,4.35 + 3.23, 4 weeks, 8 weeks of treatment compared with before treatment score decreased no difference, no statistical significance (P0.05); social function dimension score before treatment, 4 weeks of medication, medication for 8 weeks in average were 4.94 + 3.93,4.32 + 3.57,3.71 + 3.39, 4 weeks of medication, medication for 8 weeks the integral decreased compared with that before treatment had no significant difference, no statistical significance (P0.05); sexual behavior dimensions before medication, medication for 4 weeks, 8 weeks of treatment, the average scores of 1.86 + 2.57,1.85 + 2.36,1.09 + 1.66, 4 weeks, 8 weeks of treatment compared with before treatment score decreased no difference, no statistical significance (P0.05) the relationship between development dimension; integral before medication, medication for 4 weeks, 8 weeks of treatment, the average scores of 3.03 + 3.14,2.26 + 2.26,2.00 + 2.20, 4 weeks, 8 weeks of treatment compared with before treatment score decreased no difference, no statistical significance (P0.05). (4) PRO Scale total score and each dimension scores of PRO scale The total score before treatment, 4 weeks of medication, medication for 8 weeks in average were 57.14 + 20.45,47.12 + 20.69,43.09 + 21.03, 4 weeks of treatment compared with before treatment there was no statistically significant difference (P0.05), 8 weeks of treatment compared with before treatment was statistically significant (P0.05); systemic state dimensions scores before treatment, 4 weeks of medication, medication the 8 week average were 14.83 + 5.41,11.85 + 4.96,11.62 + 5.04, 4 weeks and 8 weeks of medication decreased, the difference was statistically significant (P0.05); reflux dimensions before medication, medication for 4 weeks, 8 weeks of treatment, the average scores of 5.69 + 4.28,4.21 + 3.51,4.03 + 3.52, no significant difference integral change before and after treatment (P0.05); dyspepsia dimensions before medication, medication for 4 weeks, 8 weeks of treatment, the average scores of 14.54 + 7.13,11.38 + 7.22,11.38 + 7.30, there was no significant difference in score change before and after treatment (P0.05); defecation dimensions before medication, medication for 4 weeks, 8 weeks of medication The average score was 12 + 3.31,9.38 + 4.36,8.91 + 4.40, 4 weeks and 8 weeks of medication decreased, the difference was statistically significant (P0.05); psychological dimensions before medication, medication for 4 weeks, 8 weeks of treatment, the average scores of 7.71 + 4.18,5.74 + 3.29,5.15 + 3.14, 4 weeks of treatment compared with before treatment there was no statistically significant difference (P0.05), 8 weeks of treatment compared with before treatment score decreased, the difference was statistically significant (P0.05); social function dimension score before treatment, 4 weeks of medication, medication for 8 weeks in average were 2.37 + 2.33,1.59 + 1.86,1.41 + 1.91, there was no significant difference in score change before and after treatment (P0.05). (5) TCM Symptom Scale scores of TCM symptom scores before treatment, 4 weeks and 8 weeks of medication were 12 + 5.81,10.67 + 5.43,9.23 + 4.73, 4 weeks of treatment compared with before treatment there was no significant difference in score decreased (P0.05); with 8 weeks of treatment was significantly decreased, with statistical difference Significance (P0.05). (2) found no clear clinical trials of drug related research and safety inspection, clinically significant adverse events in the.2 IBS-D effect of Tongxieyaofang on intestinal flora in patients with a total of 35 cases of patients, 3 cases of exit. Among them, 19 cases of male, female 13 cases. Tongxieyaofang before 4 weeks of medication, medication for 8 weeks a of intestinal flora diversity, no significant difference of beta diversity. The gate level, taking Tongxieyaofang compared with before taking, Bacteroidetes and Proteobacteria increased abundance of Firmicutes decreased abundance at the genus level, deformation; bacterial alkaline bacteria, middle, Neisseria number increased, but belong to the proteobacteria succinivibrio to reduce the number of inside; Clostridium Clostridium number increased; belong to Firmicutes Defluviitaleaceae, mitsuokella number were reduced, the number of Bacillus belong to Firmicutes increased; Bacteroidetes The number of unknown bacteria decreased, the number of fibronoplastic bacteria increased, and the number of Bryobacter bacteria belonging to the acid bacilli increased. Conclusion: Tong Xie Yao Fang can improve the symptoms of IBS-D patients and improve their intestinal flora structure.

【学位授予单位】：中国中医科学院
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：R259

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