發(fā)布時間：2018-07-09 12:48

  本文選題：調神健脾針法 + 腹瀉型腸易激綜合征��； 參考：《南京中醫(yī)藥大學》2017年博士論文

【摘要】：目的:評價調神健脾針法治療腹瀉型腸易激綜合征(diarrhea-predominant irritable bowel syndrome,IBS-D)的包括腸道癥狀、精神癥狀(焦慮、抑郁、睡眠障礙)的整體療效;同時基于靜息態(tài)功能磁共振(resting state functional magnetic resonance imaging,Rs-fMRI),探討調神健脾針法治療IBS-D的中樞機制。方法:1、調神健脾針法治療IBS-D的臨床療效評價將符合臨床研究招募標準的118例IBS-D患者,采用中央隨機系統(tǒng)按2:1比例隨機分為針刺組(調神健脾針法組)79例和西藥組(匹維溴銨片組)39例。分別給予6周的相應治療,針刺組予調神健脾針法,穴取百會、印堂、太沖、天樞、上巨虛、足三里、三陰交,隔日針刺1次,每周3次,連續(xù)6周;西藥組予匹維溴銨片口服,每次50mg,每日3次,連續(xù)6周。治療前及治療1、2、4、6周對兩組患者的臨床觀察指標包括癥狀嚴重程度積分(IBS-symptom severity score,IBS-SSS)、ZUNG 氏焦慮自測量表(self-rating anxiety scale,SAS)、ZUNG 氏抑郁自測量表(self-rating depression scale,SDS)進行評估;治療前、治療6周結束時對匹茲堡睡眠質量評分(pittsburgh sleep quality index,PSQI)進行評估;6周治療結束后進行療效評價和安全性評價。2、基于Rs-fMRI的調神健脾針法治療IBS-D療效的中樞機制研究一共納入符合磁共振研究招募標準的IBS-D患者組18例和健康對照組21例,予患者組調神健脾針法治療6周(具體操作方法同臨床療效評價部分),健康對照組不干預�；颊呓M于治療前后進行臨床觀察指標(IBS-SSS、SAS、SDS、PSQI)評估和靜息態(tài)功能磁共振數(shù)據(jù)采集。健康對照組入組前進行臨床觀察指標(SAS、SDS、PSQI)的評估,入組后進行靜息態(tài)功能磁共振數(shù)據(jù)采集。運用低頻振幅(amplitude oflowfrequency fluctuation,ALFF)法和局部一致性(regional homogeneity,ReHo)法對兩組的靜息態(tài)功能磁共振數(shù)據(jù)分析,比較治療前患者組與健康對照組的腦功能差異,以及患者組治療前后的腦功能變化,并將治療前后差異腦區(qū)的ALFF、ReHo的變化值和臨床觀察指標的改善值進行相關分析,以確定調神健脾針法作用的靶向腦區(qū)。結果:1、調神健脾針法治療IBS-D的臨床療效評價結果(1)共有9例IBS-D患者脫落,針刺組脫落3例,西藥組脫落6例。故最后共有109例IBS-D患者納入統(tǒng)計分析,針刺組76例,西藥組33例。(2)兩組的一般情況及各項基線評分資料比較沒有統(tǒng)計學差異(P0.05),具有可比性。(3)主要療效評價顯示:針刺組的痊愈率、愈顯率均較西藥組高(P0.05,0.01),總有效率也高于西藥組(P0.05),表明針刺組總體療效更好。(4)次要療效評價顯示:①IBS癥狀嚴重程度積分(IBS-SSS)評價結果IBS-SSS總積分比較:經(jīng)重復測量方差分析顯示,6周治療后,兩組IBS-D患者的IBS-SSS總積分都下降(P=0.0000.01);兩組間整體比較,IBS-SSS總積分沒有表現(xiàn)出有統(tǒng)計學意義的差異(P=0.0800.05),但是P值較小,有出現(xiàn)統(tǒng)計學差異的趨勢,結合數(shù)值看有針刺組的IBS-SSS總積分較西藥組更低的趨勢。兩組間各觀測時點比較,只有第6周時,IBS-SSS總積分的組間比較有統(tǒng)計學差異(P=0.0010.0125),其余時間點(第1、2、4周時),均未出現(xiàn)統(tǒng)計學差異(P=0.339,0.015,0.0310.0125),但第2、4周的P值較小(P=0.015,0.031),說明有出現(xiàn)統(tǒng)計學差異的趨勢,結合數(shù)值看針刺組的IBS-SSS總積分較西藥組更低,且這種差異性有出現(xiàn)在治療的較早期(第2周)的可能性。綜上,針刺組IBS-SSS總積分的改善略優(yōu)于西藥組。IBS-SSS各單項分值比較:在治療后的各觀測時點(第1、2、4、6周),針刺組的腹痛程度、腹痛天數(shù)、腹脹程度、排便滿意度、生活影響五項分值均較治療前降低(P0.0125);在治療后的各觀測時點(第1、2、4、6周),西藥組的腹痛程度、腹痛天數(shù)、排便滿意度三項分值均較治療前降低(P0.0125),而腹脹程度、生活影響兩項分值只在治療后第4周和第6周顯示出降低(P0.0125),前兩周的觀測時點未出現(xiàn)統(tǒng)計學差異(P0.0125)。組間比較,治療2周時,針刺組的生活影響分值較西藥組低(P=0.0120.0125),其余各項分值比較均無統(tǒng)計學意義差異(P0.0125);治療6周時,針刺組的腹痛程度、腹痛天數(shù)、生活影響三項分值較西藥組低(P=0.002,0.003,0.0030.0125),腹脹程度、排便滿意度兩項分值比較均無統(tǒng)計學意義差異(P0.0125);治療1周和4周時,兩組間各單項分值比較,均沒有統(tǒng)計學意義的差異(P0.0125)。②ZUNG氏焦慮自測量表(SAS)的評價結果經(jīng)重復測量方差分析顯示,6周治療后,兩組IBS-D患者的SAS自評分都下降(P=0.0000.01);兩組間整體比較,SAS自評分沒有表現(xiàn)出統(tǒng)計學意義的差異(P=0.0980.05),但是P值較小,有出現(xiàn)統(tǒng)計學差異的趨勢,結合數(shù)值看有針刺組的SAS自評分較西藥組有更低的趨勢。各觀測時點兩組間比較均未出現(xiàn)有統(tǒng)計學意義的差異(P0.0125),但是治療第6周的P值為0.028,值較小,亦有出現(xiàn)針刺組的SAS分值低于西藥組的趨勢。另外,從兩組的各自SAS評分下降趨勢和具體數(shù)值來看,西藥組在最后2周時SAS分值略有波動,針刺組的作用更為平穩(wěn)。③ZUNG氏抑郁自測量表(SDS)的評價結果經(jīng)重復測量方差分析顯示,6周治療后,兩組IBS-D患者的SDS自評分都下降(P=0.0000.01);但兩組SDS分值改善的整體差異不顯著(P0.05),且在各觀測時點進行兩組間SDS分值比較,未發(fā)現(xiàn)SDS分值有統(tǒng)計學意義的差異(P0.0125)。然而,從兩組的各自SDS評分下降趨勢和具體數(shù)值來看,西藥組在最后2周時SDS分值略有波動,針刺組的作用更為平穩(wěn)。④匹茲堡睡眠質量評分(PSQI)的評價結果經(jīng)6周治療后,兩組與各自治療前比較,針刺組患者的PSQI評分下降明顯(P0.01),西藥組患者的PSQI評分變化不明顯(P0.05)。組間比較,兩組治療前后PSQI評分差值的比較,差異有統(tǒng)計學意義(P0.05),從數(shù)值上看,針刺組患者的PSQI評分下降較西藥組患者更明顯。(5)安全性評價只有1例脫落的西藥組患者服藥后癥狀加重,可能存在藥物不良反應。其余所有納入患者均無針刺或藥物不良反應,亦無肝腎功能異常變化。2、基于Rs-fMRI的調神健脾針法治療IBS-D中樞機制研究結果(1)18例IBS-D患者組中脫落1例,故只有17例患者進入統(tǒng)計分析,健康對照組21例全部進入統(tǒng)計分析。(2)兩組的一般情況比較沒有統(tǒng)計學差異(P0.05),具有可比性;但IIBS-D患者組的焦慮、抑郁、睡眠的基線評分均較健康對照組高(P0.01)。(3)調神健脾針法治療后,IBS-D患者組各項臨床觀察指標均下降,具體為:癥狀嚴重度總積分(IBS-SSS)(P0.01)、腹痛程度(P0.01)、腹脹程度(P0.05)、排便滿意度(P0.01)、焦慮自評分(SAS)(P0.01)、抑郁自評分(SDS)(P0.01)、匹茲堡睡眠質量評分(PSQI)均下降(P0.01),有效率為88.2%,與臨床療效評價部分結果基本一致,適合進行靜息態(tài)功能磁共振研究。(4)調神健脾針法治療前,患者組與健康對照組的腦功能差異:與健康對照組比較,患者組ALFF值降低的腦區(qū)有左側顳上回、顳中回,左側角回;ReHo值降低的腦區(qū)有雙側補充運動區(qū)、額內回、右額上回;未發(fā)現(xiàn)ALFF值和ReHo值升高腦區(qū)。兩個指標降低的腦區(qū)均主要位于新皮層。(5)調神健脾針法治療后,患者組的腦功能變化:與治療前比較,患者組ALFF值升高的有雙側顳葉的顳上回、顳中回、顳橫回,左側腦島,右側海馬,雙側枕葉的距狀裂周圍皮層、舌回;ALFF值降低的有左前扣帶,左殼核;ReHo值升高的有雙側顳葉的顳上回、顳橫回,左側顳中回,左側腦島,雙側枕葉的距狀裂周圍皮層,額內回,雙側補充運動區(qū);ReHo值降低的有雙側前扣帶,左殼核。兩個指標升高的腦區(qū)主要位于新皮層,降低的腦區(qū)主要位于邊緣系統(tǒng)。(6)調神健脾針法作用的靶向腦區(qū):治療前后,左前扣帶的ALFF值的變化和腹脹程度分值的改善有正相關關系(r =0.501,P=0.0400.05),未發(fā)現(xiàn)其他差異腦區(qū)變化和臨床觀察指標改善有相關性。結論:1、調神健脾針法治療IBS-D,在改善IBS-SSS癥狀總積分以及緩解腹痛程度、減少腹痛頻率、改善生活影響、提高睡眠質量方面療效優(yōu)于西藥匹維溴銨片,尤其是改善生活影響方面,在治療的較早期(第2周)即表現(xiàn)出優(yōu)勢;在緩解腹脹、提高排便滿意度、改善焦慮和抑郁情緒方面療效與西藥匹維溴銨片相當,但改善焦慮和抑郁方面的作用較西藥匹維溴銨片平穩(wěn);總體療效優(yōu)于西藥匹維溴銨片。2、基于Rs-fMRI,腹瀉型腸易激綜合征患者和健康受試者的腦功能存在差異,部分新皮層腦區(qū)的低頻振幅和局部一致性降低,可能是IBS-D的重要中樞病理變化。調神健脾針法治療后,IBS-D患者的腦功能變化主要為部分新皮層腦區(qū)的低頻振幅和局部一致性升高,部分邊緣系統(tǒng)腦區(qū)的低頻振幅和局部一致性降低,其中左前扣帶的變化與腹脹改善相關。因此,調神健脾針法治療IBS-D具有腸道和精神癥狀兼治的作用,整體療效更好;其臨床療效的中樞機制之一可能在于對邊緣系統(tǒng)-新皮層相關腦區(qū)的良性調節(jié),使其恢復平衡,涉及協(xié)調內臟痛覺網(wǎng)絡、情緒調控網(wǎng)絡、認知調控網(wǎng)絡內部及網(wǎng)絡間關系,其中左前扣帶可能是其改善內臟感覺的靶向腦區(qū);中樞機制之二可能是對默認模式網(wǎng)絡的良性調節(jié)。
[Abstract]:Objective: To evaluate the overall efficacy of diarrhea-predominant irritable bowel syndrome (IBS-D) in the treatment of diarrhea type irritable bowel syndrome (bowel syndrome, IBS-D), and to explore the effects of mental symptoms (anxiety, depression, sleep disorders), and based on the resting state functional magnetic resonance (resting state functional magnetic resonance imaging, Rs-fMRI). The central mechanism of regulating the spleen and invigorating the spleen method for the treatment of IBS-D. Methods: 1, the evaluation of the clinical efficacy of IBS-D with the method of regulating the spleen and invigorating the spleen will be in line with the recruitment criteria of 118 cases of IBS-D patients. The central random system is randomly divided into 79 cases and 39 cases in the western medicine group (Pinaverium Bromide Tablets group). According to the corresponding treatment, the acupuncture group was given the method of regulating the spleen and invigorating the spleen, taking Baihui, printing hall, Tai Chou, Tianshu, Zusanli, three yin, 1 times a week, 3 times a week for 6 weeks. The western medicine group gave Pinaverium Bromide Tablets oral, each time 50mg, 3 times a day for 6 weeks. The clinical observation indexes of two groups before and after treatment and treatment were serious symptoms including severe symptoms. IBS-symptom severity score (IBS-SSS), ZUNG's anxiety self-test scale (self-rating anxiety scale, SAS), the ZUNG's depression self-measurement scale (self-rating depression) was evaluated; the Pittsburgh sleep quality score was evaluated at the end of the treatment and 6 weeks of treatment. After the end, the efficacy evaluation and safety evaluation were.2, and the central mechanism of the treatment of IBS-D based on Rs-fMRI's regulating the spleen and invigorating spleen method was included in 18 cases of IBS-D patients and 21 cases of the healthy control group, which were conformed to the recruitment criteria of magnetic resonance. The clinical observation index (IBS-SSS, SAS, SDS, PSQI) and resting state functional magnetic resonance data were collected before and after the treatment. The clinical observation index (SAS, SDS, PSQI) was evaluated before the healthy control group, and the resting state functional magnetic resonance data were collected after the group entered, and the low frequency amplitude (amplitude oflow) was used. The frequency fluctuation, ALFF) method and local conformance (regional homogeneity, ReHo) method were used to analyze the resting state functional magnetic resonance data of two groups, compared the brain function difference between the patients before treatment and the healthy control group, as well as the changes of brain function before and after the treatment in the patient group, and the changes of ALFF, ReHo in the different brain regions before and after treatment and the clinical value. The improvement value of the observation index was analyzed in order to determine the target brain area of the method of regulating the spleen and invigorating the spleen. Results: 1, the clinical efficacy evaluation results of the treatment of IBS-D by adjusting the spleen and invigorating spleen method (1) there were 9 cases of IBS-D patients falling off, 3 cases in the acupuncture group and 6 cases in the western medicine group. Finally, there were 109 cases of IBS-D patients included in the statistical analysis, 76 cases in needling group and West. There were 33 cases in the medicine group. (2) the general situation of the two groups and the baseline score data were not statistically different (P0.05). (3) the main curative effect evaluation showed that the healing rate of the acupuncture group was higher than the western medicine group (P0.05,0.01), and the total effective rate was higher than that of the western medicine group (P0.05), indicating that the overall effect of the acupuncture group was better. (4) secondary curative effect evaluation. The results were as follows: (1) the total score of the IBS-SSS score of IBS symptom severity score (IBS-SSS) was compared: after 6 weeks of treatment, the total IBS-SSS score of the two groups of IBS-D patients decreased (P=0.0000.01); the total integral of the two groups had no statistical difference (P=0.0800.05), but the P value was small, There was a trend of statistical difference, and the total score of IBS-SSS in the acupuncture group was lower than that of the western medicine group. Compared with the two groups, there was a statistically significant difference between the two groups at the time of sixth weeks (P=0.0010.0125), and the other time points (1,2,4 weeks) were not statistically different (P=0.339,0.015,0.03 10.0125), but the P value of week 2,4 was smaller (P=0.015,0.031), indicating the trend of statistical difference, combined with the value of the acupuncture group, the total integral of IBS-SSS was lower than that of the western medicine group, and this difference had the possibility of the earlier treatment (second weeks). In conclusion, the improvement of the total integral of IBS-SSS in the acupuncture group was slightly better than that of the.IBS-SSS in the western medicine group. Comparison: in each observation point after treatment (week 1,2,4,6), the abdominal pain degree, abdominal pain days, abdominal distention, defecation satisfaction, and life influence five scores were lower than before treatment (P0.0125). In the observation time points after treatment (week 1,2,4,6), the abdominal pain degree, abdominal pain days, and three points of satisfaction of defecation were all compared. Before treatment (P0.0125), the two scores of abdominal distention and life influence were decreased only at fourth and sixth weeks after treatment (P0.0125), and no statistical difference was found in the first two weeks (P0.0125). After 2 weeks of treatment, the life influence of acupuncture group was lower than that of the Western Medicine group (P=0.0120.0125), and the other scores were no more than that of the western medicine group. Statistical significance difference (P0.0125); at 6 weeks, the three scores of abdominal pain, abdominal pain and life influence in the acupuncture group were lower than that of the western medicine group (P=0.002,0.003,0.0030.0125), the degree of abdominal distention, and the two scores of the satisfaction of defecation were not statistically significant (P0.0125). At the time of 1 and 4 weeks of treatment, there was no comparison between the two groups. The difference of study meaning (P0.0125). (2) the evaluation results of ZUNG's anxiety self-test scale (SAS) showed that after 6 weeks of treatment, the SAS self score of two groups of IBS-D patients decreased (P=0.0000.01), and the overall comparison between the two groups showed that SAS self scoring did not show the difference (P=0.0980.05), but the P value was smaller. There was a lower trend in the SAS score of the acupuncture group compared with the western medicine group. There was no statistically significant difference between the two groups of the observation time points (P0.0125), but the value of P in the sixth week treatment was 0.028, and the value of the SAS in the acupuncture group was lower than that in the western medicine group. In addition, from the two groups. The SAS score of the western medicine group was slightly fluctuated at the last 2 weeks and the effect of the acupuncture group was more stable. (3) the evaluation results of the ZUNG depression self measurement scale (SDS) showed that after 6 weeks of treatment, the SDS self score of two groups of IBS-D patients decreased (P=0.0000.01), but the score of SDS in the two groups was improved. The overall difference was not significant (P0.05), and the SDS score of two groups was compared at every point of observation. The difference of SDS score was not found statistically significant (P0.0125). However, in the last 2 weeks, the value of SDS in the western medicine group fluctuated slightly and the role of the acupuncture group was more stable in the last 2 weeks of the two groups. After 6 weeks of treatment, the results of the evaluation of sleep quality score (PSQI) were compared with the two groups before the treatment. The PSQI score of the patients in the acupuncture group decreased significantly (P0.01), and the PSQI score of the western medicine group was not significant (P0.05). The difference between the two groups before and after the treatment was statistically significant (P0.05). The PSQI score of the patients in the group was more obvious than those in the western medicine group. (5) only 1 cases of the western medicine group had more symptoms and had adverse drug reactions. The rest of the patients had no acupuncture or adverse drug reactions, and there was no abnormal.2 in the liver and kidney function, and the treatment of IBS-D based on Rs-fMRI's regulating the spleen and invigorating the spleen. The results of the central mechanism study (1) 18 cases of IBS-D patients were dropped out of 1 cases, so only 17 patients entered the statistical analysis, and 21 cases in the healthy control group were all entered into statistical analysis. (2) the general situation of the two groups was not statistically different (P0.05), but the baseline score of anxiety, depression and sleep in the IIBS-D group was higher than that of the healthy control group. (P0.01) (3) after the therapy of regulating the spleen and strengthening the spleen, the clinical observation indexes of IBS-D patients were all decreased, specifically: the total score of symptom score (IBS-SSS) (P0.01), abdominal pain (P0.01), abdominal distention (P0.05), defecation satisfaction (P0.01), self rating anxiety (SAS) (P0.01), depression (SDS) (P0.01), and Pittsburgh sleep quality score (PSQI) decreased (P0.01) the effective rate was 88.2%, which was basically consistent with the results of the clinical efficacy evaluation. (4) the difference of brain function between the patient group and the healthy control group before the therapy of adjusting the spleen and invigorating spleen: compared with the healthy control group, the brain area of the patient group with lower ALFF value had the left temporal gyrus, the middle temporal gyrus, the left angular gyrus, and the ReHo value. There were bilateral supplementary motor areas, frontal gyrus, right frontal gyrus, and no ALFF and ReHo value increased in the brain area. The brain areas of the two indexes were mainly located in the neocortex. (5) the brain function of the patient group was changed after the therapy of regulating the spleen and invigorating the spleen: compared with the pre treatment, the ALFF value of the patients was increased with bilateral temporal lobe temporal gyrus, middle temporal gyrus, and temporomandibular. Transverse gyrus, left insula, right hippocampal, bilateral occipital lobe peri cortex, lingual gyrus, left anterior cingulate and left putamen with lower ALFF value, bilateral temporal gyrus, left temporal gyrus, left temporal gyrus, left lateral insula, bilateral occipital lobe peri cortex, frontal gyrus, bilateral supplemental motor area, and bilateral ReHo value decreased in ReHo value. The two indexes of the brain were mainly located in the neocortex and the lower brain area was mainly located in the marginal system. (6) the target brain area of the function of regulating the spleen and invigorating the spleen: the changes of the ALFF value of the left anterior cingulate and the improvement of the degree of abdominal distention were positively correlated (R =0.501, P=0.0400.05) before and after treatment, and there was no other difference in the brain region. Conclusion: 1, the treatment of IBS-D is better than the western medicine Pinaverium Bromide Tablets in improving the total integral of IBS-SSS symptoms, reducing the degree of abdominal pain, reducing the frequency of abdominal pain, improving the life influence and improving the quality of sleep, especially in the improvement of the life effect, in the early period of treatment (second weeks) that is, It showed advantages in alleviating abdominal distention, improving satisfaction of defecation, improving anxiety and depression, compared with western medicine Pinaverium Bromide Tablets, but the effect of improving anxiety and depression was more stable than that of Western medicine Pinaverium Bromide Tablets; the overall effect was better than the western medicine Pinaverium Bromide Tablets.2, Rs-fMRI based, diarrhea type irritable bowel syndrome and healthy subjects The low frequency amplitude and local consistency of the part of the neocortex were reduced, which may be the important central pathological changes of IBS-D. After the therapy of regulating the spleen and invigorating the spleen, the changes in the brain function of the IBS-D patients were mainly the low frequency amplitude and local consistency of the part of the neocortex and the low frequency amplitude of the part of the marginal system brain region. The change of the left anterior cingulate is related to the improvement of abdominal distention. Therefore, the therapy of regulating the spleen and invigorating the spleen for the treatment of IBS-D has the effect of both intestinal and mental symptoms, and the overall effect is better. One of the central mechanisms of its clinical effect may be the benign regulation of the marginal system - the neocortex related brain area, which involves the recovery of balance, involving the recovery of the balance. Coordination of visceral pain network, emotional regulation network, cognitive regulation network internal and inter network relations, the left anterior cingulate may be its target brain area to improve the visceral sense; the two of the central mechanism may be a benign regulation of the default mode network.
【學位授予單位】：南京中醫(yī)藥大學
【學位級別】：博士
【學位授予年份】：2017
【分類號】：R246.1

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