本文選題：中醫(yī)藥 + 隨機(jī)的臨床對(duì)照試驗(yàn)�。� 參考：《廣州中醫(yī)藥大學(xué)》2016年博士論文

【摘要】：背景功能性消化不良(Functional Dyspepsia,FD)是指具有胃及十二指腸消化道功能上運(yùn)化失常引起的患者不適,然后再經(jīng)過(guò)一些實(shí)驗(yàn)室的檢查排除了一些其它能引起這些癥狀的一些其它的器質(zhì)性及疾病的一組患者為主要臨床表現(xiàn)的病理綜合征。主要癥狀包括：上腹痛、上腹灼熱感、餐后飽脹和早飽,按照羅馬Ⅲ標(biāo)準(zhǔn)分上腹痛綜合征(epigastric pain syndrome,EPS)和餐后不適綜合征(postprandial distress syndrome,PDS)。功能性消化不良是一種臨床常見(jiàn)病,臨床上,據(jù)臨床醫(yī)師反應(yīng),在醫(yī)院門(mén)診就診的許許多多自訴胃腸道不適的的患者,他們?cè)卺t(yī)生的建議下在進(jìn)行了胃內(nèi)窺鏡的檢查以后,如果診斷報(bào)告為慢性淺表性胃炎的患者,其實(shí)大部份都可以收歸于功能性消化不良(FD)的范圍并可進(jìn)行臨床研究的。在歐洲的一項(xiàng)流行病學(xué)研究發(fā)現(xiàn)20.6%的被調(diào)查者在近一年來(lái)有上腹部不適癥狀�，F(xiàn)在隨著生活環(huán)境的變化,本病的發(fā)病率呈現(xiàn)出越來(lái)越高的趨式,而且功能性消化不良的癥狀繁多,不易痊愈,病人需要的治療的時(shí)間長(zhǎng),而且稍不注意就會(huì)很容易反反復(fù)復(fù)發(fā)作,因此本病的特點(diǎn)是病程長(zhǎng),易反復(fù),使得病人的生活質(zhì)量明顯下降,并且對(duì)病人的身心健康均造成了很不好的影響。功能性消化不良目前尚未有根治的藥物。功能性消化不良患者治療目標(biāo)為緩解胃脘脹滿不適、惡心、噯氣及納差等,提高患者生活質(zhì)量。在治療方面,主要采用藥物治療方式。藥物可緩解臨床癥狀,一定程度上控制病情發(fā)展,但因?yàn)榉帟r(shí)間較長(zhǎng),患者的依從性往往會(huì)隨時(shí)間而降低,而且長(zhǎng)期的治療也容易給患者帶來(lái)巨大的精神和經(jīng)濟(jì)壓力。西醫(yī)治療功能性消化不良這種疾病到現(xiàn)在為止都沒(méi)有什么很大的進(jìn)展,也沒(méi)有什么歷史意義的突破,在臨床上我們可以看見(jiàn)很多醫(yī)生在治療功能性消化不良上的主要用藥為多潘立酮或者西沙比利等一些可以促進(jìn)胃腸動(dòng)力藥或者只能采用對(duì)癥治療的方法,但其實(shí)患者對(duì)該病的效果并沒(méi)有什么好的評(píng)價(jià),而且西藥治療副作用較大是醫(yī)生和患者都知道的。但是中醫(yī)藥在治療功能性消化不良這個(gè)疾病上,因?yàn)橹嗅t(yī)存在的時(shí)間長(zhǎng),且本病為常見(jiàn)病,所以從古至今,中醫(yī)師在長(zhǎng)期治療的臨床實(shí)踐中,各代名家積累了豐富的經(jīng)驗(yàn),各家學(xué)說(shuō)百家爭(zhēng)鳴,各個(gè)醫(yī)家都有其獨(dú)特的治療心得,也分享了許許多多有效的方子,治療方法多樣,療效肯定。并且中醫(yī)治病圍繞辨證論治為核心的思想,如果患者的體質(zhì)不同,寒熱虛實(shí)不同,就根據(jù)患者本身的個(gè)體差異來(lái)實(shí)施辨證施治,可以取得滿意的治療效果。近年來(lái)不少學(xué)者采用中醫(yī)中藥治療,初步證明中醫(yī)治療FD有一定的優(yōu)勢(shì),并已取得一定的成績(jī)。近年來(lái),越來(lái)越多臨床研究應(yīng)用隨機(jī)對(duì)照的方法觀察、研究和比較了中醫(yī)治療功能性消化不良的臨床效果,并發(fā)表了大量的文獻(xiàn),但目前評(píng)價(jià)治療性文獻(xiàn)的系統(tǒng)評(píng)價(jià)甚少。如果沒(méi)有很多數(shù)據(jù)的隨機(jī)研究實(shí)驗(yàn)的情況下,該怎么科學(xué)的評(píng)價(jià)現(xiàn)在的中醫(yī)藥對(duì)本病的治療?隨著醫(yī)學(xué)的發(fā)展,有很多醫(yī)學(xué)上的學(xué)者們都開(kāi)始但是議要提出使用一種更科學(xué)的評(píng)價(jià)方法來(lái)解決相關(guān)的問(wèn)題,而循證醫(yī)學(xué)無(wú)可非議就是在當(dāng)今的理論上最適合的這樣一種方法,我們使用循證醫(yī)學(xué)來(lái)解決相關(guān)問(wèn)題,不僅是因?yàn)檠C醫(yī)學(xué)是-個(gè)很好的方法,而且也能因?yàn)樗奶攸c(diǎn),即通過(guò)覆蓋面很廣的去收集全世界所有已發(fā)表的文獻(xiàn),還有一些沒(méi)有發(fā)表的如會(huì)議論文,系統(tǒng)的去收集,去評(píng)價(jià),這樣的學(xué)科,它的發(fā)展可以為臨床上存在的許多有爭(zhēng)議的,不能解決的問(wèn)題提供了很好的解決辦法,因?yàn)橥ㄟ^(guò)這種辦法,基本上所有的臨床研究結(jié)果都被包括在內(nèi),如果我們把符合的、質(zhì)量上乘的文獻(xiàn)選擇出來(lái),然后經(jīng)過(guò)作者的分析,軟件的分析,還有數(shù)據(jù)的分析,筆者認(rèn)為主要還是作者人工的篩選這一步最為關(guān)鍵,再得出到比較可靠的、科學(xué)的結(jié)論。這樣對(duì)于臨床研究的意義無(wú)異是巨大的。現(xiàn)在,在循證醫(yī)學(xué)上,很多人已經(jīng)把它運(yùn)用在很廣泛的領(lǐng)域,并且得到很好的開(kāi)展,例如是在一些對(duì)臨床治療療效的評(píng)價(jià),還有在預(yù)防醫(yī)學(xué)上對(duì)于疾病預(yù)防的調(diào)查評(píng)價(jià),流行病學(xué)上某種疫情流行的規(guī)律特點(diǎn),對(duì)預(yù)防醫(yī)學(xué)也可以進(jìn)行指導(dǎo)。對(duì)一些尚在探討上的,不能確定病因的一些疾病該怎么證明?這些都需要可靠性高并且具有科學(xué)性的系統(tǒng)評(píng)價(jià)來(lái)幫忙完成。于是,此次筆者的研究正是出于此目的,應(yīng)用筆者及團(tuán)隊(duì)所掌握的系統(tǒng)評(píng)價(jià)的方法,對(duì)中醫(yī)在功能性消化不良上的各種療法,如中藥湯劑、中成藥口服或外用,此外還有針灸、推拿等一些中醫(yī)療法,總結(jié)并提取出數(shù)據(jù),得出中醫(yī)藥對(duì)本病療效的綜合評(píng)估,希望借此可對(duì)中醫(yī)藥應(yīng)用于治療功能性消化不良作出科學(xué)的評(píng)價(jià),為廣大的醫(yī)學(xué)同仁提供一些可靠的參考。目的本次研究意在通過(guò)對(duì)各種文獻(xiàn)上記載的有關(guān)使用中醫(yī)中醫(yī)藥來(lái)治療功能性消化不良的隨機(jī)臨床實(shí)驗(yàn)文獻(xiàn)進(jìn)行評(píng)價(jià)研究,來(lái)達(dá)到以下目的：①系統(tǒng)評(píng)價(jià)中醫(yī)藥治療功能性消化不良的療效及安全性；②對(duì)50多年中醫(yī)藥治療功能性消化不良的方法,一般在臨床上的觀察方法主要包括隨機(jī)的或者半隨機(jī)的。此外,在所涉及的觀察臨床數(shù)據(jù)上,文章中所寫(xiě)的的病例數(shù)必需要多于20例才能被納入,再將符合要求的,質(zhì)量高的文獻(xiàn)進(jìn)行進(jìn)一步的提取,并把所獲得的數(shù)據(jù)錄入進(jìn)建立的數(shù)據(jù)庫(kù)。③系統(tǒng)評(píng)價(jià)與西藥和安慰劑相比,中醫(yī)藥治療功能性消化不良是否具有明顯優(yōu)勢(shì)。方法計(jì)算機(jī)檢索清華同方系列數(shù)據(jù)庫(kù)(CNKI)之中國(guó)期刊全文數(shù)據(jù)庫(kù)；中文科技期刊數(shù)據(jù)庫(kù)；中國(guó)生物醫(yī)學(xué)文獻(xiàn)數(shù)據(jù)庫(kù)；維普資訊網(wǎng)；萬(wàn)方數(shù)據(jù)庫(kù)；PubMed醫(yī)學(xué)文獻(xiàn)檢索服務(wù)系統(tǒng);Cochrane圖書(shū)館中Cochrane系統(tǒng)評(píng)價(jià)數(shù)據(jù)庫(kù)和Cochrane對(duì)照試驗(yàn)核心注冊(cè)數(shù)據(jù)庫(kù)和在臨床試驗(yàn)報(bào)告論文或綜述的參考文獻(xiàn)中追蹤查閱相關(guān)文獻(xiàn)。檢索年限均從建庫(kù)至2015年1月。手工檢索納入研究的參考文獻(xiàn)及相關(guān)雜志、會(huì)議論文集、學(xué)位論文匯編等。并向有關(guān)作者詢問(wèn)是否有未發(fā)表的灰色文獻(xiàn),由兩位本團(tuán)隊(duì)的研究者,分別的,并且在收集病例時(shí)要求他們要獨(dú)立地去分析文獻(xiàn),把認(rèn)為符合條件的、質(zhì)量高的文獻(xiàn),尤其要符合標(biāo)準(zhǔn)的隨機(jī)對(duì)照試驗(yàn)或者是半隨機(jī)對(duì)照試驗(yàn)也可,再對(duì)文獻(xiàn)的數(shù)據(jù)和資料進(jìn)行提取,提取后要雙方再進(jìn)一步的進(jìn)行核對(duì)。如果在文獻(xiàn)納入方法研究者存在有分歧,解決的方法是雙方通過(guò)討論,如果還不能達(dá)成一致,則要咨詢第三方來(lái)解決這個(gè)問(wèn)題。按Cochrane系統(tǒng)評(píng)價(jià)方法篩選試驗(yàn)、評(píng)價(jià)質(zhì)量、提取資料,并用RevMan 5.3軟件進(jìn)行Meta分析。如果遇到二分類(lèi)的變量,計(jì)算的方式采用比值比(odds ratio, OR)的方法還用可信區(qū)間(95%)來(lái)去統(tǒng)計(jì)。如果是連續(xù)變量的文獻(xiàn),按照教材上的要求,應(yīng)該要以教材上所標(biāo)志的方法來(lái)使用的計(jì)算加權(quán)的數(shù)學(xué)算術(shù)均數(shù)差還有它們的可置信的一些區(qū)間來(lái)統(tǒng)計(jì)了。檢索詞“功能性消化不良”；“中醫(yī)、中藥或中醫(yī)藥；“臨床、對(duì)照”等關(guān)鍵詞進(jìn)行檢索,建立數(shù)據(jù)庫(kù)并進(jìn)行分析。本系統(tǒng)評(píng)價(jià)只對(duì)納入試驗(yàn)的臨床癥狀有效率及治療后中醫(yī)癥候的總體積分改善程度來(lái)進(jìn)行評(píng)價(jià)。結(jié)果經(jīng)嚴(yán)格篩選,評(píng)價(jià)及共同討論后共納入10個(gè)隨機(jī)對(duì)照試驗(yàn),1104例患者,其中治療組690例,對(duì)照組414例。納入試驗(yàn)的方法學(xué)質(zhì)量均較高(Jadad計(jì)分≥3分),根據(jù)Cochrane協(xié)作網(wǎng)偏倚風(fēng)險(xiǎn)評(píng)價(jià)標(biāo)準(zhǔn)：10篇文章中有1個(gè)A級(jí),9個(gè)B級(jí)。提取數(shù)據(jù)后用RERIEWMAMAGER軟件來(lái)進(jìn)行meta分析。①在經(jīng)過(guò)2至4個(gè)星期后,文獻(xiàn)上所報(bào)道的各病人的臨床癥狀的好轉(zhuǎn)率、痊愈率和有效率：結(jié)論是：?jiǎn)渭冎嗅t(yī)藥優(yōu)于西藥或安慰劑OR值為6.2,95%可信區(qū)間[(3.45,10.13)],Z=7.28(P0.00001)]、治療2-4周后的臨床癥狀痊愈率：?jiǎn)渭冎嗅t(yī)藥優(yōu)于西藥或安慰劑[0R值2.48,95%置信區(qū)間為(1.73,3.63),Z=7.28(P0.00001)]、中醫(yī)證候積分[WMD=-3.23,[95%CI(-3.46,-3.00),Z=27.12(P0.00001)]。但由于P0.00001,I250%,表明不宜用META分析來(lái)評(píng)價(jià)中醫(yī)癥狀積分,已改為描述性評(píng)價(jià)。②本研究提示所納入的10隨機(jī)對(duì)照比較中醫(yī)藥對(duì)功能性消化不良試驗(yàn)中,在療效方面,中醫(yī)藥較西藥有效,組間比較有顯著性差異；在功能性消化不良的臨床表現(xiàn)上,中醫(yī)藥治療和西藥對(duì)比,中醫(yī)藥治療后患者消化道總體癥狀積分都是較治療前有很大的進(jìn)步的；在改善單個(gè)消化道癥狀積分方面,中醫(yī)藥的治療對(duì)于患者胃脘部脹滿、早飽感、胃脘痛,還有反胃、嘔吐的作用也優(yōu)于西藥治療。結(jié)論現(xiàn)有證據(jù)表明,中醫(yī)藥治療功能性消化不良的療效較西藥如多潘立酮、莫沙比利等相比,療效明顯,具有可推廣性。但由于受納入臨床結(jié)局評(píng)價(jià)指標(biāo)及文獻(xiàn)數(shù)量及質(zhì)量的限制,中醫(yī)藥對(duì)功能性消化不良的療效與安全性的優(yōu)勢(shì)也需更多的臨床試驗(yàn)來(lái)驗(yàn)證,期待有更多的、更高更好的一些更隨機(jī)的臨床研究的文獻(xiàn)或者一些非動(dòng)物試驗(yàn)的研究,對(duì)患者的研究來(lái)評(píng)價(jià)中醫(yī)傳統(tǒng)療法在治療功能性消化不良的療效。
[Abstract]:Background functional dyspepsia (Functional Dyspepsia, FD) is a patient discomfort caused by dysfunction of the digestive tract of the stomach and duodenum, and then through some laboratory tests to exclude some of the other groups of other organic and diseases that can cause these symptoms to be the main clinical manifestation. The main symptoms include: upper abdominal pain, upper abdominal burning, postprandial fullness and early satiety, according to Rome III standard epigastric pain syndrome, EPS) and postprandial discomfort syndrome (postprandial distress syndrome, PDS). Functional dyspepsia is a clinical common disease, clinical, according to the clinician reaction, in the hospital door Many of the patients who have been diagnosed with gastrointestinal discomfort have been diagnosed with a gastroscope examination under the doctor's advice. If the diagnosis is a chronic superficial gastritis, most of them can be attributed to the range of functional dyspepsia (FD) and can be clinically studied. An epidemic in Europe. The study found that 20.6% of the respondents had abdominal discomfort for nearly a year. With changes in the living environment, the incidence of the disease is becoming more and more high, and the symptoms of functional dyspepsia are numerous and are not easy to heal. The patients need a long time to treat them, and a little attention will be easy to relapse. Therefore, the disease is characterized by a long course of disease, easy to repeat, a significant decline in the quality of life of the patient, and a bad effect on the physical and mental health of the patients. Functional dyspepsia has not yet been cured. The target of functional dyspepsia is to relieve stomach distention, nausea, belching and nausea, and so on. Patient quality of life. In the treatment, the main use of drug treatment. Drugs can alleviate the clinical symptoms, to a certain extent control the development of the disease, but because of longer medication time, patient compliance tends to decrease with time, and long-term treatment is also easy to bring great mental and economic pressure to the patient. Western medicine treatment function Dyspepsia has not made much progress so far, and there are no historic breakthroughs. Clinically, we can see that many of the major medications in the treatment of functional dyspepsia are domperidone or cisapride, which can promote gastrointestinal motility drugs or can only be treated with symptomatic treatment. Methods, but in fact, the patients have no good evaluation of the effect of the disease, and the side effects of Western medicine are well known by doctors and patients. However, traditional Chinese medicine is in the treatment of functional dyspepsia, because the existence of traditional Chinese medicine is long, and the disease is common disease, so from ancient times, Chinese medicine teachers in the long-term treatment of clinical In practice, various generations of famous people have accumulated rich experience, each family theory is contending, each doctor has its own unique therapeutic experience, and also shares a lot of effective prescription, the treatment method is diverse, the curative effect is affirmative. And the idea that the TCM treatment is centered around the syndrome differentiation theory, if the patient's physique is different, the cold and heat are different, it is based on In recent years, many scholars have adopted traditional Chinese medicine treatment, which have proved that the treatment of FD has certain advantages and has made certain achievements. In recent years, more and more clinical studies have been used to observe and compare the treatment of traditional Chinese medicine with traditional Chinese medicine. The clinical effects of functional dyspepsia have been published and a large number of literature have been published, but there are few systematic reviews of the evaluation of the therapeutic literature. If there is no random study of the data, how should we scientifically evaluate the current treatment of the disease in traditional Chinese medicine? With the development of Medicine, many medical scholars have opened it. However, it is necessary to propose to use a more scientific evaluation method to solve the related problems, and evidence-based medicine is the most suitable method in today's theory, we use evidence-based medicine to solve the related problems, not only because evidence-based medicine is a good method, but also because of its characteristics, that is, Through the extensive coverage of all published literature around the world, and some unpublished papers such as conference papers, systematic collection, and evaluation, the development of such a subject can provide a good solution to many disputed and unresolved problems in the clinic, as this is basically the way. All the results of the clinical study are included. If we choose the suitable and high quality literature, then through the analysis of the author, the analysis of the software, and the analysis of the data, the author thinks that it is the most important step for the author to screen this step, and then to a more reliable and scientific conclusion. The significance of bed research is great. Now, in evidence-based medicine, many people have used it in a wide range of fields, and have been well carried out, for example, in the evaluation of some clinical therapeutic effects, the evaluation of preventive medicine on the prevention of disease, the epidemiological characteristics of some epidemic situation, and the characteristics of the epidemiological characteristics of the epidemic. Prophylactic medicine can also be guided. How do some of the diseases that are still being discussed and not determine the cause of the disease should be proven? These all require high reliability and scientific systematic evaluation to help. Traditional Chinese medicine in the functional dyspepsia, such as Chinese medicine soup, Chinese medicine oral or external use, in addition to acupuncture, massage and some other traditional Chinese medicine, summarize and extract the data, draw a comprehensive evaluation of the curative effect of traditional Chinese medicine on this disease, hoping to make a scientific evaluation of the application of traditional Chinese medicine to the treatment of functional dyspepsia. The aim of this study is to evaluate the efficacy and safety of Chinese medicine in the treatment of functional dyspepsia through systematic evaluation of the randomized clinical literature on the treatment of functional dyspepsia by using traditional Chinese medicine and traditional Chinese medicine. For more than 50 years of traditional Chinese medicine for the treatment of functional dyspepsia, the general methods of clinical observation mainly include random or semi random methods. In addition, the number of cases written in the article is required to be more than 20 cases to be included in the observed clinical data. One step is extracted, and the obtained data are entered into the established database. (3) whether the traditional Chinese medicine has obvious advantages in the treatment of functional dyspepsia compared with western medicine and placebo. Methods the Chinese periodical full text database of CNKI, Chinese sci-tech journal database, Chinese sci-tech journal database, Chinese Journal Database and Chinese students are evaluated. The medical literature database; VP information network; Wanfang database; PubMed medical literature retrieval service system; the Cochrane system evaluation database in the Cochrane library and the core registration database of the Cochrane control test and the reference literature in the clinical trial report papers or the references. The retrieval years are from the establishment of the library. By January 2015. The manual retrieval of the references and related magazines, the collection of papers, the compilation of the dissertations, and so on. And asking the authors whether there are unpublished grey literature, by two team researchers, and in the collection of cases, to require them to analyze the literature independently, and to take the quality as qualified. A high volume of literature, especially a standard randomized controlled trial or a semi randomized controlled trial, can be used to extract the data and data from the literature, and then the two sides will be further checked. If there are differences in the literature, the solution is that the two sides can not reach one. The third party should be consulted to solve the problem. According to the Cochrane system evaluation method, the test is screened, the quality is evaluated, the data is extracted, and the Meta analysis is carried out with the RevMan 5.3 software. If the variables of the two classification are encountered, the formula of the ratio Ratio (odds ratio, OR) is also used to count with the confidence interval (95%). If it is a continuous variable, the method is a continuous variable. The literature, according to the requirements of the textbook, should be counted by the calculation weighted arithmetical average number difference and some confidence intervals used in the teaching materials. The retrieval word "functional dyspepsia", "Chinese medicine, Chinese medicine or traditional Chinese medicine;" clinical, control "and other key words were retrieved and established. According to the library and analysis, the system evaluation only evaluated the clinical symptoms and the overall improvement of TCM syndrome after the trial. Results after strict screening, evaluation and joint discussion, 10 randomized controlled trials were included in 1104 patients, including 690 cases in the treatment group and 414 in the control group. The quality of the study was higher (Jadad score > 3), according to the Cochrane collaboration network bias risk assessment standard: 10 articles had 1 A and 9 B levels. After extracting the data, the RERIEWMAMAGER software was used to carry out meta analysis. (1) the improvement rate, recovery rate and efficiency of the clinical symptoms of all the patients reported in the literature after 2 to 4 weeks were concluded. The simple Chinese medicine is superior to the western medicine or the placebo OR value 6.2,95% confidence interval [(3.45,10.13)], Z=7.28 (P0.00001)], the cure rate of the clinical symptoms after 2-4 weeks of treatment: the pure Chinese medicine is superior to the western medicine or the placebo [0R value 2.48,95% confidence interval (1.73,3.63), Z=7.28 (P0.00001)], the TCM syndrome integration [WMD=-3.23, [95%CI (P0.00001), [95%CI. 12 (P0.00001)]. But because of P0.00001, I250%, it is not suitable to use META analysis to evaluate the TCM symptom score, and it has been changed to descriptive evaluation. 2. This study suggests that in the functional dyspepsia test, Chinese medicine is more effective than western medicine in the effect of traditional Chinese Medicine, and there is a significant difference in the group between the Chinese medicine and the western medicine. In the poor clinical manifestation, Chinese medicine treatment and Western medicine contrast, the overall symptom score of the digestive tract of the patients after the treatment of traditional Chinese medicine had great progress. In improving the symptom score of the single digestive tract, the effect of traditional Chinese medicine on gastric epigastric fullness, early satiety, epigastralgia, nausea and vomiting was also superior to that of the patients. Conclusion the existing evidence shows that the curative effect of traditional Chinese medicine on functional dyspepsia is obvious compared with western medicine such as domperidone, Mosa Billy and so on. The curative effect is obvious and can be popularized. However, the effect and safety of traditional Chinese medicine on functional dyspepsia are better due to the evaluation index of the clinical outcome and the limitation of the quantity and quality of the literature. More clinical trials are needed to verify that there are more, more and better literature on more randomized clinical studies, or some non animal studies, to evaluate the efficacy of traditional Chinese medicine therapy in the treatment of functional dyspepsia.

【學(xué)位授予單位】：廣州中醫(yī)藥大學(xué)
【學(xué)位級(jí)別】：博士
【學(xué)位授予年份】：2016
【分類(lèi)號(hào)】：R259

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