参苓白术散治疗溃疡性结肠炎的系统评价

发布时间：2018-04-30 00:37

本文选题：参苓白术散 + 溃疡性结肠炎　；参考：《华北理工大学》2017年硕士论文

【摘要】：目的利用循证医学方法对参苓白术散治疗溃疡性结肠炎(Ulcerative colitis,UC)的临床疗效和安全性进行系统评价。方法1文献纳入标准:1)研究类型:随机对照试验(RCT),无论是否使用盲法。2)语言类型:语言限于中/英文。3)研究对象:文献中试验选择纳入对象符合中华医学会消化病学分会炎症性肠病学组在2012年通过的《炎症性肠病诊断与治疗的共识意见》对UC的诊断标准[1]的患者,性别、年龄、病例来源不限。4)干预措施:(1)治疗组采用参苓白术散(包括根据中医辩证论治对药味和药量的加减),对照组采用安慰剂或西药或空白对照。(2)治疗组在对照组的医治手段基础上加用参苓白术散加减;对照组给予西药疗法。5)结局指标:(1)治疗无效人数(2)Sutherland疾病活动指数(DAI)评分情况。(3)血清白细胞介素-17(IL-17)、IL-23、肿瘤坏死因子-α(TNF-α)、C-反应蛋白(CRP)水平。(4)复发的机率。(5)药物是否安全,是否会对人体产生副作用,或者与药物目的无关的反应。2资料检索:1)电子检索范围:中国知网(CNKI)、维普数据库、万方数据库、中国生物医学文献数据库(CBMdisc)及Cochrane Library、PUBMED数据库。2)检索时间:自建库以来至2016年6月,所有关于参苓白术散治疗UC的资料,包括是否公开出版、内部资料、正在出版等限制。3)手工检索:手工搜索有关资料的引文依据以及国内外重要会议摘要。4)检索词和检索策略(1)中文检索词:本文的主题词或关键词为溃疡性结肠炎、炎症性肠病;参苓白术、参苓白术散、参苓白术丸、参苓白术颗粒、参苓白术胶囊。(2)英文检索词:ulcerative colitis、inflammatory bowel disease、Idiopathic Proctocolitis、Colitis Gravis、Shenling Baizhu、Shenling Baizhu powder、Shenling Baizhu San、Shenling Baizhu capsule、Shenling Baizhu pill为关键词或主题词。主题词和关键词相互结合为本次检索主要方式。3文献筛选:两名人员根据制定的入选和排除标准对资料进行筛查和选取,若意见不统一时则加入另一成员参与探讨,并最终决定是否选择该项资料。4数据提取方法:EXCEL软件被用来进行数据的录入,选取的内容包括:资料编号、试验经济支持来源、试验进行地点、样本数量、受试对象特征(包括判断疾病标准、纳入及排除标准、亚型、年龄、性别、病程、病例总数、纳入分析病例数)、不同的治疗措施(名称、服用方法、用药量、用药持续时间)、结局指标(主要及次要结局指标、评判用药效果标准、主要结果、不良事件)、试验方法特点(包括随机分组的方法、随机隐藏、盲法、数据是否完全、结局是否有被选择性报告等)。5采用Cochrane协作网推荐的“Cochrane风险偏倚评估工具”对文献质量评价。其内容包括7个方面:(1)随机分组方法(2)对干预措施进行的分配方法进行隐藏(3)对研究者和受试者隐藏具体干预措施等信息(4)对结局评价者隐藏具体信息(5)是否明确报道了中断试验的人数、原因等(6)结局内容是否完全被报道(7)其他可能造成试验误差的原因。针对每一项研究结果,对上述7条作出“低风险”、“未知风险(相关信息缺乏或偏倚情况不确定)、“高风险”的评判。6系统综述与meta分析方法:采用Cochrane协作网提供的Rev Man 5.3统计软件进行Meta分析。计数资料采用比值比(Odd ratio,OR)来衡量临床效能统计量。计量资料利用均数差(Mean difference,MD)来计算。95%可信区间(CI)来表达效应指标。Q统计量和I2统计量被用来判断各研究资料的性质特点是否有差异和不同。当P0.10,I250%,说明各资料之间的差异小,属于同一性质资料,赋予固定效应模型。如各研究间存在异质性(P0.10,I250%),找出产生这种差异的原因,比如分成不同的组别或者改变某一录入研究来查看效应量的变化情况等方法,力求减少或祛除产生来源。若上述做法仍无法解决上述问题,则赋予随机效应模型来解析。如果差异过大,影响结果或者合并无实际意义的,则改为一般的统计学叙述分析。倒漏斗图分被用来检测是否有发表偏倚。结果1疗效结果:参苓白术散在降低UC病人无效人数、炎症因子IL-17、IL-23、TNF-a水平、复发情况方面,及改善UC病人CRP、DAI评分方面优于西医疗法,差异在统计学上存在意义(P0.05)。2安全性评析:1项研究对参苓白术散医治UC是否安全进行了描述。结果显示无严重不良反应。结论1参苓白术散治疗UC,和西药医治手段相比,可以降低无效人数、改进DAI评分情况、降低炎症指标CRP、炎症因子IL-17、IL-23、TNF-a的程度,降低该病的复发情况。2由于阐述的研究资料过少,未能明确参苓白术散医治UC的安全性和长期疗效。3本SR纳入的研究存在偏倚风险,质量等级不高,影响上述结论的循证医学证据强度。日后会随着更多优质的多中心、随机、双盲、大样本的RCT的制作,来进一步完善该SR,以期为参苓白术散治疗UC的有效性和安全性提供强度更高的循证医学证据。
[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.

【学位授予单位】：华北理工大学
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：R259

【参考文献】