痛瀉要方治療腹瀉型腸易激綜合征的療效觀察及其對(duì)腸道菌群的影響
本文選題:腹瀉型腸易激綜合征 切入點(diǎn):痛瀉要方 出處:《中國(guó)中醫(yī)科學(xué)院》2017年碩士論文 論文類型:學(xué)位論文
【摘要】:目的:1通過(guò)臨床觀察,闡明痛瀉要方治療IBS-D的療效,為IBS-D的治療提供可靠的方法和依據(jù);2運(yùn)用16SrRNA技術(shù)比較痛瀉要方應(yīng)用前、應(yīng)用4周、應(yīng)用8周IBS-D患者腸道菌群結(jié)構(gòu)的改變,為研究腸道菌群結(jié)構(gòu)與中藥復(fù)方之間的作用機(jī)制提供依據(jù)。方法:1根據(jù)納入、排除標(biāo)準(zhǔn)納入IBS-D患者,予痛瀉要方治療,1袋/次,3次/日,療程為8周,以IBS-SSS量表積分、IBS-SSS積分等級(jí)改善、IBS-QOL量表、PRO量表及中醫(yī)癥狀量表為療效評(píng)價(jià)指標(biāo),比較用藥前、用藥4周及用藥8周的積分變化;2根據(jù)納入、排除標(biāo)準(zhǔn)納入IBS-D患者,根據(jù)SOP留取糞便標(biāo)本,應(yīng)用16SrRNA技術(shù)、Illumina平臺(tái)測(cè)序、生物信息學(xué)分析比較應(yīng)用痛瀉要方前、用藥4周、用藥8周IBS-D患者腸道菌群a多樣性、β多樣性及菌群結(jié)構(gòu)顯著性差異的變化。結(jié)果:1痛瀉要方治療IBS-D的療效觀察共納入病例35例,退出3例,其中女性13例,男性19例。年齡最小者24歲,年齡最大者70歲。療效評(píng)價(jià)指標(biāo)包括IBS-SSS量表積分變化、IBS-SSS積分等級(jí)改善變化、IBS-QOL量表積分變化、PRO量表積分變化、中醫(yī)癥狀積分變化。(1)IBS-SSS量表積分變化IBS-D患者應(yīng)用痛瀉要方前、用藥4周、用藥8周IBS-SSS量表積分平均分分別為 213.11±79.01、164.00±76.40、141.57±80.11。經(jīng)比較,用藥 4 周、用藥 8周較用藥前比較均具有統(tǒng)計(jì)學(xué)差異(P0.05)。腹痛程度維度積分平均分用藥前、用藥4周、用藥后分別為29.86±24.99、23.38±21.56、22.59±23.38。經(jīng)比較,無(wú)明顯統(tǒng)計(jì)學(xué)差異(P0.05);腹痛頻率維度積分平均分用藥前、用藥4周、用藥8周分別為31.03±30.73、22.38±26.01、18.45±23.30。經(jīng)比較,無(wú)明顯統(tǒng)計(jì)學(xué)差異(P0.05);腹脹程度維度積分平均分用藥前、用藥 4 周、用藥 8 周分別為 26.09±24.73、14.26±16.24、12.35±15.34。經(jīng)比較,用藥4周、用藥8周較用藥前比較均具有統(tǒng)計(jì)學(xué)差異(P0.05);排便滿意度維度積分平均分用藥前、用藥4周、用藥8周分別為66.43±25.15、52.35±25.48、49.44±25.40。經(jīng)比較,用藥4周、用藥8周較用藥前比較均具有統(tǒng)計(jì)學(xué)差異(P0.05);對(duì)生活的影響維度積分平均分用藥前、用藥4周、用藥8周分別為60.31±27.16、51.88±25.05、45.18±23.67。經(jīng)比較,用藥4周較用藥前無(wú)統(tǒng)計(jì)學(xué)差異(P0.05),用藥8周較用藥前比較具有統(tǒng)計(jì)學(xué)差異(P0.05)。(2)IBS-SSS量表積分等級(jí)改善根據(jù)IBS-SSS病情的分級(jí)標(biāo)準(zhǔn),治療結(jié)束后痊愈8例,顯效3例,有效12例,無(wú)效9例。痊愈率為24.24%,有效率為69.67%。(3)IBS-QOL量表總積分及各維度積分改善IBS-QOL量表總積分用藥前、用藥4周、用藥8周平均分分別為49.31±31.69、40.51±28.09、32.97±24.57。用藥4周較用藥前下降差異無(wú)統(tǒng)計(jì)學(xué)意義(P0.05),用藥8周較用藥前有下降趨勢(shì),差異有統(tǒng)計(jì)學(xué)意義(P0.05)。心境惡劣維度積分用藥前、用藥4周、用藥8周平均分分別為14.60±13.12、10.65±8.13、8.59±7.81,用藥4周較用藥前下降,差異無(wú)統(tǒng)計(jì)學(xué)意義(P0.05),用藥8周較用藥前下降,差異有統(tǒng)計(jì)學(xué)意義(P0.05);行為障礙維度積分用藥前、用藥4周、用藥8周平均分分別為10.20±6.30、9.44±6.35、7.71±6.38,用藥4周較用藥前下降,差異無(wú)統(tǒng)計(jì)學(xué)意義(P0.05),用藥8周較用藥前下降,差異有統(tǒng)計(jì)學(xué)意義(P0.05);自體意象維度積分用藥前、用藥4周、用藥8周平均分分別為3.63±3.49、3.15±2.66、2.91±3.10,用藥4周、用藥8周較用藥前積分下降均無(wú)明顯差異,無(wú)統(tǒng)計(jì)學(xué)意義(P0.05);健康擔(dān)憂維度積分用藥前、用藥4周、用藥8周平均分分別為5.66±3.51、4.56±3.15、3.91±3.24,用藥4周較用藥前下降,差異無(wú)統(tǒng)計(jì)學(xué)意義(P0.05),用藥8周較用藥前下降,差異有統(tǒng)計(jì)學(xué)意義(P0.05);進(jìn)食逃避維度積分用藥前、用藥4周、用藥8周平均分分別為5.40±3.90、5.21±3.22、4.35±3.23,用藥4周、用藥8周較用藥前積分下降無(wú)明顯差異,無(wú)統(tǒng)計(jì)學(xué)意義(P0.05);社會(huì)功能維度積分用藥前、用藥4周、用藥8周平均分分別為4.94±3.93、4.32±3.57、3.71±3.39,用藥4周、用藥8周較用藥前積分下降無(wú)明顯差異,無(wú)統(tǒng)計(jì)學(xué)意義(P0.05);性行為維度積分用藥前、用藥4周、用藥8周平均分分別為1.86±2.57、1.85±2.36、1.09±1.66,用藥4周、用藥8周較用藥前積分下降無(wú)明顯差異,無(wú)統(tǒng)計(jì)學(xué)意義(P0.05);關(guān)系拓展維度積分用藥前、用藥4周、用藥8周平均分分別為3.03±3.14、2.26±2.26、2.00±2.20,用藥4周、用藥8周較用藥前積分下降無(wú)明顯差異,無(wú)統(tǒng)計(jì)學(xué)意義(P0.05)。(4)PRO量表總積分及各維度積分改善PRO量表總積分用藥前、用藥4周、用藥8周平均分分別為57.14±20.45、47.12±20.69、43.09±21.03,用藥4周較用藥前差異無(wú)統(tǒng)計(jì)學(xué)意義(P0.05),用藥8周較用藥前差異有統(tǒng)計(jì)學(xué)意義(P0.05);全身狀態(tài)維度積分用藥前、用藥4周、用藥8周平均分分別為14.83±5.41、11.85±4.96、11.62±5.04,用藥4周及用藥8周均較用藥前降低,差異有統(tǒng)計(jì)學(xué)意義(P0.05);反流維度積分用藥前、用藥4周、用藥8周平均分分別為5.69±4.28、4.21±3.51、4.03±3.52,用藥前后積分變化無(wú)統(tǒng)計(jì)學(xué)差異(P0.05);消化不良維度積分用藥前、用藥4周、用藥8周平均分分別為14.54±7.13、11.38±7.22、11.38±7.30,用藥前后積分變化無(wú)統(tǒng)計(jì)學(xué)差異(P0.05);排便維度積分用藥前、用藥4周、用藥8周平均分分別為12.00±3.31、9.38±4.36、8.91±4.40,用藥4周及用藥8周均較用藥前降低,差異有統(tǒng)計(jì)學(xué)意義(P0.05);心理維度積分用藥前、用藥4周、用藥8周平均分分別為7.71±4.18、5.74±3.29、5.15±3.14,用藥4周較用藥前差異無(wú)統(tǒng)計(jì)學(xué)意義(P0.05),用藥8周較用藥前積分下降,差異有統(tǒng)計(jì)學(xué)意義(P0.05);社會(huì)功能維度積分用藥前、用藥4周、用藥8周平均分分別為2.37±2.33、1.59±1.86、1.41±1.91,用藥前后積分變化無(wú)統(tǒng)計(jì)學(xué)差異(P0.05)。(5)中醫(yī)癥狀量表積分改善情況中醫(yī)癥狀量表積分用藥前、用藥4周、用藥8周分別為12.00±5.81、10.67±5.43、9.23±4.73,用藥4周較用藥前積分下降無(wú)統(tǒng)計(jì)學(xué)差異(P0.05);用藥8周較用藥前下降,差異有統(tǒng)計(jì)學(xué)意義(P0.05)。(2)安全性檢查研究中未發(fā)現(xiàn)明確與臨床試驗(yàn)藥物相關(guān)的、有臨床意義的不良事件。2痛瀉要方對(duì)IBS-D患者腸道菌群的影響共納入病例35例,退出3例。其中,男性19例,女性13例。應(yīng)用痛瀉要方前、用藥4周、用藥8周腸道菌群a多樣性、β多樣性無(wú)明顯差異。門水平上,服用痛瀉要方后較服用前相比,擬桿菌門及變形菌門豐度增加,厚壁菌門豐度減少;屬水平上,變形菌門中產(chǎn)堿菌科、奈瑟氏菌屬數(shù)量均增多,但同屬變形菌門的琥珀酸弧菌屬數(shù)量減少;梭菌門內(nèi)的梭菌屬數(shù)量有所增多;屬于厚壁菌門的Defluviitaleaceae、光崗菌屬數(shù)目均減少,同屬厚壁菌門的芽孢桿菌數(shù)目有所增多;擬桿菌門中一種未知細(xì)菌的數(shù)量減少,纖維粘網(wǎng)菌的數(shù)量增多;屬于酸桿菌門的Bryobacter菌屬增多。結(jié)論:痛瀉要方能夠改善IBS-D患者癥狀,并改善其腸道菌群結(jié)構(gòu)。
[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.
【學(xué)位授予單位】:中國(guó)中醫(yī)科學(xué)院
【學(xué)位級(jí)別】:碩士
【學(xué)位授予年份】:2017
【分類號(hào)】:R259
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