本文選題：參苓白術(shù)散 + 潰瘍性結(jié)腸炎　； 參考：《華北理工大學(xué)》2017年碩士論文

【摘要】：目的利用循證醫(yī)學(xué)方法對參苓白術(shù)散治療潰瘍性結(jié)腸炎(Ulcerative colitis,UC)的臨床療效和安全性進(jìn)行系統(tǒng)評價。方法1文獻(xiàn)納入標(biāo)準(zhǔn):1)研究類型:隨機(jī)對照試驗(RCT),無論是否使用盲法。2)語言類型:語言限于中/英文。3)研究對象:文獻(xiàn)中試驗選擇納入對象符合中華醫(yī)學(xué)會消化病學(xué)分會炎癥性腸病學(xué)組在2012年通過的《炎癥性腸病診斷與治療的共識意見》對UC的診斷標(biāo)準(zhǔn)[1]的患者,性別、年齡、病例來源不限。4)干預(yù)措施:(1)治療組采用參苓白術(shù)散(包括根據(jù)中醫(yī)辯證論治對藥味和藥量的加減),對照組采用安慰劑或西藥或空白對照。(2)治療組在對照組的醫(yī)治手段基礎(chǔ)上加用參苓白術(shù)散加減;對照組給予西藥療法。5)結(jié)局指標(biāo):(1)治療無效人數(shù)(2)Sutherland疾病活動指數(shù)(DAI)評分情況。(3)血清白細(xì)胞介素-17(IL-17)、IL-23、腫瘤壞死因子-α(TNF-α)、C-反應(yīng)蛋白(CRP)水平。(4)復(fù)發(fā)的機(jī)率。(5)藥物是否安全,是否會對人體產(chǎn)生副作用,或者與藥物目的無關(guān)的反應(yīng)。2資料檢索:1)電子檢索范圍:中國知網(wǎng)(CNKI)、維普數(shù)據(jù)庫、萬方數(shù)據(jù)庫、中國生物醫(yī)學(xué)文獻(xiàn)數(shù)據(jù)庫(CBMdisc)及Cochrane Library、PUBMED數(shù)據(jù)庫。2)檢索時間:自建庫以來至2016年6月,所有關(guān)于參苓白術(shù)散治療UC的資料,包括是否公開出版、內(nèi)部資料、正在出版等限制。3)手工檢索:手工搜索有關(guān)資料的引文依據(jù)以及國內(nèi)外重要會議摘要。4)檢索詞和檢索策略(1)中文檢索詞:本文的主題詞或關(guān)鍵詞為潰瘍性結(jié)腸炎、炎癥性腸病;參苓白術(shù)、參苓白術(shù)散、參苓白術(shù)丸、參苓白術(shù)顆粒、參苓白術(shù)膠囊。(2)英文檢索詞:ulcerative colitis、inflammatory bowel disease、Idiopathic Proctocolitis、Colitis Gravis、Shenling Baizhu、Shenling Baizhu powder、Shenling Baizhu San、Shenling Baizhu capsule、Shenling Baizhu pill為關(guān)鍵詞或主題詞。主題詞和關(guān)鍵詞相互結(jié)合為本次檢索主要方式。3文獻(xiàn)篩選:兩名人員根據(jù)制定的入選和排除標(biāo)準(zhǔn)對資料進(jìn)行篩查和選取,若意見不統(tǒng)一時則加入另一成員參與探討,并最終決定是否選擇該項資料。4數(shù)據(jù)提取方法:EXCEL軟件被用來進(jìn)行數(shù)據(jù)的錄入,選取的內(nèi)容包括:資料編號、試驗經(jīng)濟(jì)支持來源、試驗進(jìn)行地點、樣本數(shù)量、受試對象特征(包括判斷疾病標(biāo)準(zhǔn)、納入及排除標(biāo)準(zhǔn)、亞型、年齡、性別、病程、病例總數(shù)、納入分析病例數(shù))、不同的治療措施(名稱、服用方法、用藥量、用藥持續(xù)時間)、結(jié)局指標(biāo)(主要及次要結(jié)局指標(biāo)、評判用藥效果標(biāo)準(zhǔn)、主要結(jié)果、不良事件)、試驗方法特點(包括隨機(jī)分組的方法、隨機(jī)隱藏、盲法、數(shù)據(jù)是否完全、結(jié)局是否有被選擇性報告等)。5采用Cochrane協(xié)作網(wǎng)推薦的“Cochrane風(fēng)險偏倚評估工具”對文獻(xiàn)質(zhì)量評價。其內(nèi)容包括7個方面:(1)隨機(jī)分組方法(2)對干預(yù)措施進(jìn)行的分配方法進(jìn)行隱藏(3)對研究者和受試者隱藏具體干預(yù)措施等信息(4)對結(jié)局評價者隱藏具體信息(5)是否明確報道了中斷試驗的人數(shù)、原因等(6)結(jié)局內(nèi)容是否完全被報道(7)其他可能造成試驗誤差的原因。針對每一項研究結(jié)果,對上述7條作出“低風(fēng)險”、“未知風(fēng)險(相關(guān)信息缺乏或偏倚情況不確定)、“高風(fēng)險”的評判。6系統(tǒng)綜述與meta分析方法:采用Cochrane協(xié)作網(wǎng)提供的Rev Man 5.3統(tǒng)計軟件進(jìn)行Meta分析。計數(shù)資料采用比值比(Odd ratio,OR)來衡量臨床效能統(tǒng)計量。計量資料利用均數(shù)差(Mean difference,MD)來計算。95%可信區(qū)間(CI)來表達(dá)效應(yīng)指標(biāo)。Q統(tǒng)計量和I2統(tǒng)計量被用來判斷各研究資料的性質(zhì)特點是否有差異和不同。當(dāng)P0.10,I250%,說明各資料之間的差異小,屬于同一性質(zhì)資料,賦予固定效應(yīng)模型。如各研究間存在異質(zhì)性(P0.10,I250%),找出產(chǎn)生這種差異的原因,比如分成不同的組別或者改變某一錄入研究來查看效應(yīng)量的變化情況等方法,力求減少或祛除產(chǎn)生來源。若上述做法仍無法解決上述問題,則賦予隨機(jī)效應(yīng)模型來解析。如果差異過大,影響結(jié)果或者合并無實際意義的,則改為一般的統(tǒng)計學(xué)敘述分析。倒漏斗圖分被用來檢測是否有發(fā)表偏倚。結(jié)果1療效結(jié)果:參苓白術(shù)散在降低UC病人無效人數(shù)、炎癥因子IL-17、IL-23、TNF-a水平、復(fù)發(fā)情況方面,及改善UC病人CRP、DAI評分方面優(yōu)于西醫(yī)療法,差異在統(tǒng)計學(xué)上存在意義(P0.05)。2安全性評析:1項研究對參苓白術(shù)散醫(yī)治UC是否安全進(jìn)行了描述。結(jié)果顯示無嚴(yán)重不良反應(yīng)。結(jié)論1參苓白術(shù)散治療UC,和西藥醫(yī)治手段相比,可以降低無效人數(shù)、改進(jìn)DAI評分情況、降低炎癥指標(biāo)CRP、炎癥因子IL-17、IL-23、TNF-a的程度,降低該病的復(fù)發(fā)情況。2由于闡述的研究資料過少,未能明確參苓白術(shù)散醫(yī)治UC的安全性和長期療效。3本SR納入的研究存在偏倚風(fēng)險,質(zhì)量等級不高,影響上述結(jié)論的循證醫(yī)學(xué)證據(jù)強(qiáng)度。日后會隨著更多優(yōu)質(zhì)的多中心、隨機(jī)、雙盲、大樣本的RCT的制作,來進(jìn)一步完善該SR,以期為參苓白術(shù)散治療UC的有效性和安全性提供強(qiáng)度更高的循證醫(yī)學(xué)證據(jù)。
[Abstract]:Objective to systematically evaluate the clinical efficacy and safety of Ulcerative colitis (UC) in the treatment of ulcerative colitis (UC) by evidence-based medicine. Methods the literature included standard: 1) study types: randomized controlled trial (RCT), whether or not to use blind.2) language type: language limited to medium / English.3) subjects: the literature test The selected subjects were in conformity with the consensus opinion on the diagnosis and treatment of inflammatory bowel disease, which was passed by the inflammatory bowel disease group of the Chinese Medical Association of Gastroenterology in 2012. The intervention measures for the UC diagnostic standard [1], sex, age, and case origin were not limited to.4): (1) the treatment group adopted Shen Ling Baizhu powder (including the medicinal taste according to the dialectical treatment of traditional Chinese Medicine). The control group was treated with placebo or western medicine or blank control. (2) the treatment group was added with Shen Ling Baizhu powder on the basis of the treatment method in the control group; the control group was given western medicine.5) outcome index: (1) the number of invalid patients (2) Sutherland disease active index (DAI) score. (3) serum interleukin -17 (IL-17), IL-23, Tumor necrosis factor - alpha (TNF- - alpha), C- reactive protein (CRP) level. (4) the probability of recurrence. (5) whether the drug is safe, or whether it will have side effects on the human body, or to retrieve the.2 data that is not related to the purpose of the drug: 1) the scope of electronic retrieval: China (CNKI), VP database, Wanfang database, and the Chinese biomedical literature database (CBMdisc) and Cochrane Library, PUBMED database.2) retrieval time: since the establishment of the library to June 2016, all the information about the treatment of UC by Shen Baizhu powder, including the open publication, the internal data, the publishing and other restrictions on the.3) manual retrieval: the basis for the citation of the relevant information and the domestic and foreign important conference summary.4) retrieval words and retrieval strategies (1 Chinese retrieval words: the subject words or keywords of this article are ulcerative colitis, inflammatory bowel disease, Shen Ling Atractylodes, Shen Ling Baizhu powder, Shen Ling Baizhu pill, sling Baizhu granule, and Shen Ling Baizhu capsule. (2) English retrieval words: ulcerative colitis, inflammatory bowel disease, Idiopathic Proctocolitis, Colitis Gravis, Shenling Baizhu, Shenling Consultants Aizhu powder, Shenling Baizhu San, Shenling Baizhu capsule, Shenling Baizhu pill as key words or subject words. Subject words and keywords are combined to filter the main mode of this retrieval: two people screen and select the data according to the criteria of entry and exclusion, and join another member if the opinion is not unified. Participate in the discussion, and ultimately decide whether to choose the.4 data extraction method of the data: EXCEL software is used for data entry. The contents of the data include: data number, test economic support source, test location, sample size, and sample size, including criteria for disease judgment, inclusion and exclusion criteria, subtypes, age, sex, and disease. The total number of cases, the number of cases included in the analysis of cases), different treatment measures (name, method of use, dosage, duration of medication), outcome indicators (main and secondary outcome indicators, criteria for judging the effect of drugs, major results, adverse events), and the characteristics of the test methods (including random grouping, random concealment, blindness, data complete, ending) .5 uses the "Cochrane risk bias assessment tool" recommended by the Cochrane collaboration network to evaluate the document quality. The content includes 7 aspects: (1) the random grouping method (2) conceals the distribution method of the intervention measures (3) to hide specific intervention measures for the researchers and subjects (4) on the outcome evaluation. The price holder concealed specific information (5) whether the number of interruption tests was clearly reported, the cause and so on (6) whether the content of the outcome was completely reported (7) other possible causes of the test error. For each study, the above 7 were "low risk", "unknown risk (lack of information or bias), and" high risk ". The.6 system review and the meta analysis method are evaluated by using the Rev Man 5.3 statistical software provided by the Cochrane collaboration network for the Meta analysis. The counting data uses the ratio Ratio (Odd ratio, OR) to measure the clinical effectiveness statistics. The measurement data uses the mean number difference (Mean difference, MD) to calculate the confidence interval to express the effect index and the statistics. Statistics are used to determine whether the characteristics of the research data are different and different. When P0.10, I250%, indicating that the differences between the data are small, belong to the same nature data, give the fixed effect model. For example, the heterogeneity (P0.10, I250%) among the various studies, to find out the reasons for this difference, such as a different group or a change of a certain group. If the above problem is still unable to solve the above problem, a random effect model is given to analyze it. If the difference is too large, the result or the combination without practical significance is changed to a kind of statistical narrative analysis. The inverted funnel map is used to be used. Whether there is a publication bias. Results 1 Results: Shen Baizhu powder in reducing the number of invalid UC patients, inflammatory factors IL-17, IL-23, TNF-a level, recurrence, and improving CRP, DAI score in UC patients is superior to western medicine, the difference is statistically significant (P0.05).2 security assessment: 1 studies on Shen Ling Baizhu powder treatment UC. The results showed no serious adverse reaction. Conclusion 1 Shen Ling Baizhu powder treatment UC, compared with western medicine treatment, can reduce the number of invalid, improve the DAI score, reduce the inflammation index CRP, the degree of inflammatory factor IL-17, IL-23, TNF-a, reduce the recurrence of the disease.2 because of the lack of research data explained, the too few, the lack of research data, the failure To clarify the safety and long-term efficacy of Shen Ling Baizhu powder in treating UC.3 this study has a bias risk and the quality grade is not high, which affects the evidence-based medical evidence intensity of the above conclusion. In the future, the SR will be further perfected with more quality multicenter, random, double blind, large sample RCT, in order to treat UC for Shen Ling Baizhu powder. Its effectiveness and safety provide evidences of evidence-based medicine with higher intensity.

【學(xué)位授予單位】：華北理工大學(xué)
【學(xué)位級別】：碩士
【學(xué)位授予年份】：2017
【分類號】：R259

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本文編號：1822293