本文選題：臍療 + 功能性便秘��； 參考：《中國中醫(yī)科學院》2017年博士論文

【摘要】：功能性便秘(functional constipation,FC)是臨床常見病證,屬于功能性胃腸病,診斷主要依據(jù)患者的癥狀。臨床表現(xiàn)個體差異大,既包括傳統(tǒng)意義上的便次減少(3次/周),也涵蓋更廣義范疇的排便困難,包括各種伴隨不適,羅馬Ⅲ標準是目前全球用于FC診斷、治療的共識性文件。FC發(fā)病與膳食、體力活動、生活習慣、精神心理問題及濫用瀉劑等因素有關,其病生理機制尚不十分清楚,主要與胃腸排空轉運時間延長、肛門括約肌或盆底肌功能缺失相關。隨著飲食結構的改變和生活節(jié)奏加快,FC在中年、青年人中也日漸多見,60歲以上人群患病率更可達22%。目前西醫(yī)處理功能性便秘主要采用處方或非處方藥物,以各種瀉劑為主,慢傳輸型便秘可配合瀉劑使用促動力藥物,而排便障礙型便秘藥物治療效果不佳,循證醫(yī)學建議給予生物反饋治療(Ⅰ級證據(jù)、A級推薦),國內未普遍開展。因此,西醫(yī)治療便秘的療效和安全性都有待提升。中醫(yī)認為便秘的形成主要在于臟腑功能失調,大腸傳導糟粕和輸布津液功能異常。其病位在大腸,與肺、脾、胃、腎、肝、小腸和魄門相關。中醫(yī)治療便秘有著豐富的治療體系,關注證候特點加以施治,緩解排便困難的同時有效解決多臟腑的整體協(xié)調問題�！白怨帕脊げ粡U外治”,臍療用于治療便秘歷史悠久、價廉易行,藥物透皮吸收,避免有效成分被各種酶類及消化液分解破壞,同時,減輕了胃腸道負擔。近現(xiàn)代有大量文獻報道敷臍治療便秘安全、有效,但臨床未得到很好的推廣。其中原因需要探討,包括臨床使用的可行性、與西醫(yī)藥治療相比的優(yōu)勢與劣勢,能否結合施治等等。為回答這些問題,本研究做了三方面的工作:1、查閱文獻,完成功能性便秘發(fā)病機制和中西醫(yī)治療進展兩篇綜述,深入學習相關知識,了解目前中西醫(yī)治療便秘的現(xiàn)狀和發(fā)展方向;2、完成中藥敷臍干預功能性便秘:隨機對照試驗的系統(tǒng)綜述,深入了解運用敷臍療法治療功能性便秘的臨床科研現(xiàn)狀,發(fā)現(xiàn)在治法治則、療效評價等方面的問題;3、應用隨機、雙盲、安慰劑對照臨床試驗,以功能性便秘中的實秘患者為研究對象,觀察大承氣湯復方敷臍治療實秘的療效,以期為進一步研究奠定基礎,也為臨床使用提供思路和依據(jù)。一、系統(tǒng)綜述目的:系統(tǒng)評價臍療干預功能性便秘的有效性和安全性。方法依據(jù) Cochrane 系統(tǒng)評價方法,檢索 PubMed、Embase、The Cochrane Library、中國生物醫(yī)學文獻數(shù)據(jù)庫、中國知網(wǎng)數(shù)據(jù)庫、萬方數(shù)據(jù)庫、重慶維普數(shù)據(jù)庫和相關文章的參考文獻,納入臍療與安慰劑、空白和常規(guī)西藥比較干預功能性便秘的隨機對照試驗。由兩名研究者獨立進行文獻篩選、數(shù)據(jù)提取和納入研究的質量評價。對同質性研究進行Meta分析,異質性較高的研究僅作定性分析。采用漏斗圖檢測可能的發(fā)表偏倚。應用GRADEpro軟件對納入研究的主要對照組中主要結局指標生成證據(jù)質量匯總表。結果:共納入9項隨機對照臨床試驗,包括945個患者。6項研究報告了隨機化方法,1項研究使用了安慰劑,沒有研究描述結局評價者盲法、樣本量計算和意向性分析。由于異質性較高,僅3項研究納入meta分析。結果發(fā)現(xiàn),臍療與常用西藥(枸櫞酸莫沙必利、大黃碳酸氫鈉片、聚乙二醇4000散)比較,對于功能性便秘的總有效率作用相當(RR 1.10;95%CI 0.99 to 1.22;3 trials,n=120;I2 =37%)。多數(shù)研究支持臍療聯(lián)合基礎治療比單純基礎治療可以更好地改善功能性便秘患者的主要癥狀積分。尚未發(fā)現(xiàn)臍療干預功能性便秘患者存在嚴重不良反應。納入研究的整體方法學質量較低且主要結局指標的證據(jù)質量僅為“中等水平”。結論:現(xiàn)有的臨床證據(jù)表明,臍療干預功能性便秘在總有效率和改善主要癥狀積分方面可能有益,且無嚴重不良反應。然而,由于納入研究的數(shù)量和整體質量有限,且部分研究因異質性較高無法進行合并分析,臍療干預功能性便秘的有效性和安全性尚不能得出肯定結論,還有待更多高質量的臨床研究進行驗證。二、臨床研究目的:證實大承氣湯復方敷臍聯(lián)合西藥治療實秘的療效優(yōu)于單用西藥。方法:以功能性便秘中的實秘患者為研究對象,疾病符合羅馬Ⅲ診斷標準,證侯包括腸胃積熱證和氣機郁滯證。采用隨機、雙盲、安慰劑對照臨床試驗設計,根據(jù)既往研究計算樣本量,募集患者,將符合試驗條件的受試者隨機分為試驗組和對照組。試驗組采用大承氣湯(大黃:芒硝:厚樸:枳實為2:1:4:2)復方敷臍聯(lián)合口服乳果糖治療,對照組采用安慰劑敷臍聯(lián)合口服乳果糖治療,療程14天。主要結局指標選用可量化的客觀指標:排便頻率和首次排便時間,次要指標涵蓋主觀、客觀指標,分別是自評癥狀評分、生存質量滿意度評分、結腸傳輸指標(72小時鋇條存留部位與數(shù)量,結腸傳輸指數(shù))、肛門直腸測壓指標(感覺指標、動力指標)。所有受試者均簽署知情同意書,分別接受培訓,在治療期與觀察期內堅持填寫治療手冊,每周隨訪一次。在治療前依據(jù)證侯標準分出虛秘和實秘,實秘在治療前、后及觀察四周后共進行三次PRO量表評估,治療前、后兩次予以結腸傳輸試驗和高分辨直腸肛管測壓,采集數(shù)據(jù),評估患者治療前后排便頻率、腸道傳輸功能、肛直腸動力及主觀感受的變化,觀察不良反應。臨床試驗按照CONSORT聲明進行報告。嚴格執(zhí)行隨機化和隨機方案的隱藏,試驗過程中,對所有患者、藥師、醫(yī)生、護士、數(shù)據(jù)管理和統(tǒng)計分析人員實施盲法,使已知的偏倚達到最小。結果:(1)符合診斷的66位患者隨機分為試驗組和對照組,試驗組脫落2人,31人納入分析;對照組治療期脫落3人,觀察期剔除2人,30人納入療效分析,28人納入遠期療效分析。(2)基線資料結果顯示,試驗組和對照組在人口特征數(shù)據(jù)和結局指標的基線資料方面差異均無統(tǒng)計學意義,具有可比性;(3)治療后,試驗組主要結局指標排便頻率的改善優(yōu)于對照組(t=-5.39,P0.001,95%CI:-2.28,-1.05);首次排便時間縮短,與對照組比較差異有統(tǒng)計學意義(卡方值=4.86,P=0.0285)。(4)治療后,結局指標的主觀指標得以改善。試驗組排便困難積分和主訴癥狀積分的改善優(yōu)于對照組(t=-4.26,P0.001;t=-2.36,P0.05)。生存質量總滿意度積分優(yōu)于對照組(t=-2.78,P0.05,95%CI:-2.22,-0.36)。(5)治療后,結局指標的客觀指標也得以改善,試驗組72小時直腸、乙狀結腸鋇條存留數(shù)與對照組比較差異有統(tǒng)計學意義(差值:-1.63,95%CI:-3.07,-0.19,P0.05);治療后,便秘的分型構成出現(xiàn)差異,以排便障礙型便秘改善最為明顯。肛管直腸動力學感覺指標FSV、DSV、DTV、MTV在治療后組間比較及治療前后變化值在組間的比較均有顯著差異(P0.001);動力指標中肛管靜息壓、模擬排便時肛門括約肌壓力的變化在治療后組間比較及治療前后變化值在組間的比較差異均有統(tǒng)計學意義(P0.05),矛盾收縮得以緩解。(4)停藥觀察四周后,周排便次數(shù)組間差異有統(tǒng)計學意義(t=-5.15,P0.001,95%CI:-2.22,-0.98),排便困難積分、大便性狀積分、主訴癥狀積分組間差異均有統(tǒng)計學意義(P0.001),試驗組遠期療效好于對照組。(5)試驗組不良反應發(fā)生率低,程度較輕。結論:(1)大承氣湯復方敷臍聯(lián)合西藥治療實秘臨床療效肯定,優(yōu)于單用西藥,能有效緩解排便困難,改善伴隨癥狀,提高患者生存質量滿意度。(2)該法對實秘患者中排便障礙型便秘的改善優(yōu)于其它分型。(3)與西藥乳果糖聯(lián)合使用能增強療效,減少副作用。(4)敷臍療法干預功能性便秘,可以應用主觀PRO量表與客觀的便秘評價指標結合進行療效評價。
[Abstract]:Functional constipation (functional constipation, FC) is a common clinical syndrome. It belongs to functional gastrointestinal disease. The diagnosis is based on the symptoms of the patients. The clinical manifestations are very different, including the traditional reduction (3 times per week), and the more broad category of defecation, including all kinds of discomfort. The Rome III standard is the present world. The common understanding document.FC for FC diagnosis is related to diet, physical activity, living habits, mental and psychological problems and abusing laxatives. The physiological mechanism of the disease is not very clear. It is mainly related to the prolongation of the transit time of gastrointestinal emptying, the loss of anal sphincter or pelvic floor muscle power, with the change of diet structure and the rhythm of life. Speed up, FC in middle age, young people are becoming more and more common, the prevalence rate of people over 60 years of age is up to 22%., the current western medical treatment for functional constipation mainly uses prescription or non prescription drugs, mainly with various laxatives, slow transmission constipation can be combined with laxatives for the use of stimulating drugs, and the effect of defecation type constipation is not effective, evidence-based medicine The effect and safety of Western medicine in the treatment of constipation need to be promoted. Therefore, the formation of constipation in western medicine is to be improved. The formation of constipation is mainly due to the dysfunction of the viscera, the large intestine conduction of dross and the transfer of body fluid. The disease is in the large intestine, the lung, spleen, stomach, kidney, liver, small intestine and soul. TCM treatment of constipation has a rich treatment system, pay attention to the syndrome characteristics to treat, alleviate the difficulty of defecation and solve the overall coordination problem of multiple viscera. "Ancient good workers do not waste external treatment". Umbilical therapy is used to treat constipation with a long history, cheap and easy to use, drug transdermal absorption, and avoid the effective components of various enzymes and digestive juice. There is a lot of literature reports on the safety and effectiveness of umbilicus in the treatment of constipation in recent modern times, but it has not been popularized well. The reasons need to be discussed, including the feasibility of clinical use, the advantages and disadvantages compared with the western medicine treatment, the combination of treatment and so on. To answer these questions, this study does this study. Three aspects of the work: 1, consult the literature, complete the pathogenesis of functional constipation and the progress of the treatment of Chinese and Western medicine two reviews, in-depth study of relevant knowledge, to understand the current situation and development direction of constipation in the treatment of Chinese and Western medicine; 2, complete Chinese medicine umbilical intervention functional constipation: a systematic review of randomized controlled trials and in-depth understanding of the application of the rule of law to the rule of law. The clinical research status of functional constipation, found in the treatment of the rule of law, the efficacy of evaluation and other aspects of the problems. 3, the application of random, double blind, placebo controlled clinical trials, functional constipation in the constipation patients as the research object, to observe the effect of Dachengqi Decoction compress umbilicus in the treatment of constipation, in order to lay the foundation for further study, and for clinical cause The purpose of this paper is to provide a systematic review for the purpose of systematic review: to systematically evaluate the effectiveness and safety of umbilical therapy in the intervention of functional constipation. Methods based on the Cochrane system evaluation method, PubMed, Embase, The Cochrane Library, Chinese biomedical literature database, Chinese knowledge network database, Wanfang database, Chongqing VIP database and related data are used. The reference of the article was included in the randomized controlled trial of umbilical therapy and placebo, blank and conventional western medicine to intervene in functional constipation. Two researchers were selected independently for literature screening, data extraction and quality evaluation. Meta analysis of homogeneity study was carried out. The high heterogeneity study was only qualitative analysis. Funnel graph examination was used. The possible publication bias was measured. The GRADEpro software was used to generate the evidence quality summary of the main outcome indicators in the main control group. Results: 9 randomized controlled clinical trials were included in 945 patients, including the randomization method, 1 studies used comfortant, and no study described the outcome evaluator blindness. This quantity calculation and intentionality analysis. Due to high heterogeneity, only 3 studies were included in meta analysis. The results showed that umbilical therapy and common western medicine (mosapride citrate, rhubarb Sodium Bicarbonate Tablets, polyethylene glycol 4000 powder) were more effective for functional constipation (RR 1.10; 95%CI 0.99 to 1.22; 3 trials, n=120; I2 =37%). The conclusion is that umbilical therapy combined with basic therapy can better improve the main symptom score of patients with functional constipation. There is no serious adverse reaction in patients with functional constipation in umbilical therapy. The quality of the integrated methodology in the study is low and the quality of the main outcome indicators is only "moderate". Existing clinical evidence suggests that umbilical therapy intervention in functional constipation may be beneficial in terms of total efficiency and improvement of the main symptom score, and there is no serious adverse reaction. However, the effectiveness of umbilical therapy to interfere with functional constipation may be due to the limited number of studies and the limited overall quality of the study. The safety still can not draw the positive conclusion, still need more high quality clinical research to carry on the verification. Two, the clinical research aim: it is proved that the curative effect of Dachengqi Decoction compress the umbilicus combined with western medicine is superior to the western medicine alone. Method: the patients in the constipation of functional constipation are the research object, the disease conforms to the Rome III diagnostic standard, the syndrome includes the syndromes including A randomized, double blind, placebo controlled clinical trial was designed with a randomized, double-blind, placebo-controlled clinical trial. According to the previous study, the patients were collected and the subjects were randomly divided into the experimental group and the control group. The experimental group was treated with Dachengqi Decoction (rhubarb: Magnolia: Magnolia: Fructus aurantii 2:1:4:2) combined navel combined oral milk fruit. The control group was treated with a placebo and oral lactulose combined with oral lactulose for 14 days. The main outcome indexes were quantifiable objective indicators: the frequency of defecation and the first defecation time, the subjective index, the objective index, the self-evaluation symptom score, the quality of life satisfaction score, and the colon transmission index (72 hours barium strip retention). Position and quantity, colon transmission index), anorectal manometry index (sensory index, dynamic index). All subjects signed informed consent, received training separately, followed up the treatment manual during the treatment and observation period, followed up once a week. Before treatment, the constipation and constipation were divided according to the standard of syndrome. Before and after the treatment, the constipation was observed and observed. Three PRO scales were carried out after four weeks. Before and after treatment, the colonic transmission test and high resolution anorectal manometry were performed two times. The data were collected to assess the frequency of defecation, intestinal transmission function, anorectal motility and subjective feelings before and after treatment. The clinical trials were reported in accordance with the CONSORT statement. In the course of randomization and randomization, all patients, pharmacists, doctors, nurses, data management and statistical analysts were carried out blind method to minimize the known bias. Results: (1) the 66 patients who were diagnosed were randomly divided into the experimental group and the control group, the test group dropped 2 people, 31 people were analyzed, and the control group dropped 3 during the treatment period. In the observation period, 2 people were eliminated, 30 were included in the curative effect analysis, and 28 people were included in the long-term effect analysis. (2) the baseline data showed that there was no statistical difference between the experimental group and the control group in the baseline data of the demographic data and the outcome indicators. (3) the improvement of the frequency of the defecation of the main outcome indicators of the experimental group was better than that of the control group after treatment. Group (t=-5.39, P0.001,95%CI:-2.28, -1.05), the first defecation time shortened, compared with the control group, the difference was statistically significant (chi square value =4.86, P=0.0285). (4) after treatment, the subjective indicators of the outcome index were improved. The improvement of the difficulty score of the test group and the symptom score of the main complaint was better than that of the control group (t=-4.26, P0.001; t=-2.36, P0.05). The total satisfaction score was better than that of the control group (t=-2.78, P0.05,95%CI:-2.22, -0.36). (5) the objective index of the outcome index was also improved after treatment. The 72 hour rectum in the test group and the barium strip in the sigmoid colon were significantly different from the control group (the difference: -1.63,95%CI:-3.07, -0.19, P0.05). After treatment, the subtypes of constipation were poor. The anorectal motility index FSV, DSV, DTV, and MTV were significantly different between groups after treatment and before and after treatment (P0.001); the dynamic index of anal canal resting pressure and the changes of anal sphincter pressure during the simulated defecation were compared and treated after treatment. There were statistically significant differences between the pre and post changes in the group (P0.05), and the contractions were relieved. (4) there were statistical significance (t=-5.15, P0.001,95%CI:-2.22, -0.98), the integral of defecation difficulties, the integral of stool characters, and the statistical significance (P0.001). The long-term effect of the test group was better than that of the control group. (5) the incidence of adverse reactions in the experimental group was low and the degree was lighter. Conclusion: (1) the clinical efficacy of Dachengqi decoction combined with the combination of umbilical cord and Western medicine in the treatment of constipation is affirmative, which is superior to the western medicine alone. It can effectively relieve the difficulty of defecation, improve the accompanying symptoms and improve the satisfaction of the patient's quality of life. (2) the method has a barrier of defecation in the patients with constipation. The improvement of hinder constipation is better than that of other types. (3) combined use of lactulose with western medicine can enhance the curative effect and reduce side effects. (4) applying umbilical therapy to intervene functional constipation, we can use the subjective PRO scale and objective constipation evaluation index to evaluate the curative effect.
【學位授予單位】：中國中醫(yī)科學院
【學位級別】：博士
【學位授予年份】：2017
【分類號】：R246.1

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