中医药治疗功能性消化不良的系统评价

发布时间：2018-05-11 05:29

  本文选题：中医药 + 随机的临床对照试验　； 参考：《广州中医药大学》2016年博士论文

【摘要】：背景功能性消化不良(Functional Dyspepsia,FD)是指具有胃及十二指肠消化道功能上运化失常引起的患者不适,然后再经过一些实验室的检查排除了一些其它能引起这些症状的一些其它的器质性及疾病的一组患者为主要临床表现的病理综合征。主要症状包括：上腹痛、上腹灼热感、餐后饱胀和早饱,按照罗马Ⅲ标准分上腹痛综合征(epigastric pain syndrome,EPS)和餐后不适综合征(postprandial distress syndrome,PDS)。功能性消化不良是一种临床常见病,临床上,据临床医师反应,在医院门诊就诊的许许多多自诉胃肠道不适的的患者,他们在医生的建议下在进行了胃内窥镜的检查以后,如果诊断报告为慢性浅表性胃炎的患者,其实大部份都可以收归于功能性消化不良(FD)的范围并可进行临床研究的。在欧洲的一项流行病学研究发现20.6%的被调查者在近一年来有上腹部不适症状。现在随着生活环境的变化,本病的发病率呈现出越来越高的趋式,而且功能性消化不良的症状繁多,不易痊愈,病人需要的治疗的时间长,而且稍不注意就会很容易反反复复发作,因此本病的特点是病程长,易反复,使得病人的生活质量明显下降,并且对病人的身心健康均造成了很不好的影响。功能性消化不良目前尚未有根治的药物。功能性消化不良患者治疗目标为缓解胃脘胀满不适、恶心、嗳气及纳差等,提高患者生活质量。在治疗方面,主要采用药物治疗方式。药物可缓解临床症状,一定程度上控制病情发展,但因为服药时间较长,患者的依从性往往会随时间而降低,而且长期的治疗也容易给患者带来巨大的精神和经济压力。西医治疗功能性消化不良这种疾病到现在为止都没有什么很大的进展,也没有什么历史意义的突破,在临床上我们可以看见很多医生在治疗功能性消化不良上的主要用药为多潘立酮或者西沙比利等一些可以促进胃肠动力药或者只能采用对症治疗的方法,但其实患者对该病的效果并没有什么好的评价,而且西药治疗副作用较大是医生和患者都知道的。但是中医药在治疗功能性消化不良这个疾病上,因为中医存在的时间长,且本病为常见病,所以从古至今,中医师在长期治疗的临床实践中,各代名家积累了丰富的经验,各家学说百家争鸣,各个医家都有其独特的治疗心得,也分享了许许多多有效的方子,治疗方法多样,疗效肯定。并且中医治病围绕辨证论治为核心的思想,如果患者的体质不同,寒热虚实不同,就根据患者本身的个体差异来实施辨证施治,可以取得满意的治疗效果。近年来不少学者采用中医中药治疗,初步证明中医治疗FD有一定的优势,并已取得一定的成绩。近年来,越来越多临床研究应用随机对照的方法观察、研究和比较了中医治疗功能性消化不良的临床效果,并发表了大量的文献,但目前评价治疗性文献的系统评价甚少。如果没有很多数据的随机研究实验的情况下,该怎么科学的评价现在的中医药对本病的治疗?随着医学的发展,有很多医学上的学者们都开始但是议要提出使用一种更科学的评价方法来解决相关的问题,而循证医学无可非议就是在当今的理论上最适合的这样一种方法,我们使用循证医学来解决相关问题,不仅是因为循证医学是-个很好的方法,而且也能因为它的特点,即通过覆盖面很广的去收集全世界所有已发表的文献,还有一些没有发表的如会议论文,系统的去收集,去评价,这样的学科,它的发展可以为临床上存在的许多有争议的,不能解决的问题提供了很好的解决办法,因为通过这种办法,基本上所有的临床研究结果都被包括在内,如果我们把符合的、质量上乘的文献选择出来,然后经过作者的分析,软件的分析,还有数据的分析,笔者认为主要还是作者人工的筛选这一步最为关键,再得出到比较可靠的、科学的结论。这样对于临床研究的意义无异是巨大的。现在,在循证医学上,很多人已经把它运用在很广泛的领域,并且得到很好的开展,例如是在一些对临床治疗疗效的评价,还有在预防医学上对于疾病预防的调查评价,流行病学上某种疫情流行的规律特点,对预防医学也可以进行指导。对一些尚在探讨上的,不能确定病因的一些疾病该怎么证明?这些都需要可靠性高并且具有科学性的系统评价来帮忙完成。于是,此次笔者的研究正是出于此目的,应用笔者及团队所掌握的系统评价的方法,对中医在功能性消化不良上的各种疗法,如中药汤剂、中成药口服或外用,此外还有针灸、推拿等一些中医疗法,总结并提取出数据,得出中医药对本病疗效的综合评估,希望借此可对中医药应用于治疗功能性消化不良作出科学的评价,为广大的医学同仁提供一些可靠的参考。目的本次研究意在通过对各种文献上记载的有关使用中医中医药来治疗功能性消化不良的随机临床实验文献进行评价研究,来达到以下目的：①系统评价中医药治疗功能性消化不良的疗效及安全性；②对50多年中医药治疗功能性消化不良的方法,一般在临床上的观察方法主要包括随机的或者半随机的。此外,在所涉及的观察临床数据上,文章中所写的的病例数必需要多于20例才能被纳入,再将符合要求的,质量高的文献进行进一步的提取,并把所获得的数据录入进建立的数据库。③系统评价与西药和安慰剂相比,中医药治疗功能性消化不良是否具有明显优势。方法计算机检索清华同方系列数据库(CNKI)之中国期刊全文数据库；中文科技期刊数据库；中国生物医学文献数据库；维普资讯网；万方数据库；PubMed医学文献检索服务系统;Cochrane图书馆中Cochrane系统评价数据库和Cochrane对照试验核心注册数据库和在临床试验报告论文或综述的参考文献中追踪查阅相关文献。检索年限均从建库至2015年1月。手工检索纳入研究的参考文献及相关杂志、会议论文集、学位论文汇编等。并向有关作者询问是否有未发表的灰色文献,由两位本团队的研究者,分别的,并且在收集病例时要求他们要独立地去分析文献,把认为符合条件的、质量高的文献,尤其要符合标准的随机对照试验或者是半随机对照试验也可,再对文献的数据和资料进行提取,提取后要双方再进一步的进行核对。如果在文献纳入方法研究者存在有分歧,解决的方法是双方通过讨论,如果还不能达成一致,则要咨询第三方来解决这个问题。按Cochrane系统评价方法筛选试验、评价质量、提取资料,并用RevMan 5.3软件进行Meta分析。如果遇到二分类的变量,计算的方式采用比值比(odds ratio, OR)的方法还用可信区间(95%)来去统计。如果是连续变量的文献,按照教材上的要求,应该要以教材上所标志的方法来使用的计算加权的数学算术均数差还有它们的可置信的一些区间来统计了。检索词“功能性消化不良”；“中医、中药或中医药；“临床、对照”等关键词进行检索,建立数据库并进行分析。本系统评价只对纳入试验的临床症状有效率及治疗后中医症候的总体积分改善程度来进行评价。结果经严格筛选,评价及共同讨论后共纳入10个随机对照试验,1104例患者,其中治疗组690例,对照组414例。纳入试验的方法学质量均较高(Jadad计分≥3分),根据Cochrane协作网偏倚风险评价标准：10篇文章中有1个A级,9个B级。提取数据后用RERIEWMAMAGER软件来进行meta分析。①在经过2至4个星期后,文献上所报道的各病人的临床症状的好转率、痊愈率和有效率：结论是：单纯中医药优于西药或安慰剂OR值为6.2,95%可信区间[(3.45,10.13)],Z=7.28(P0.00001)]、治疗2-4周后的临床症状痊愈率：单纯中医药优于西药或安慰剂[0R值2.48,95%置信区间为(1.73,3.63),Z=7.28(P0.00001)]、中医证候积分[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分析来评价中医症状积分,已改为描述性评价。②本研究提示所纳入的10随机对照比较中医药对功能性消化不良试验中,在疗效方面,中医药较西药有效,组间比较有显著性差异；在功能性消化不良的临床表现上,中医药治疗和西药对比,中医药治疗后患者消化道总体症状积分都是较治疗前有很大的进步的；在改善单个消化道症状积分方面,中医药的治疗对于患者胃脘部胀满、早饱感、胃脘痛,还有反胃、呕吐的作用也优于西药治疗。结论现有证据表明,中医药治疗功能性消化不良的疗效较西药如多潘立酮、莫沙比利等相比,疗效明显,具有可推广性。但由于受纳入临床结局评价指标及文献数量及质量的限制,中医药对功能性消化不良的疗效与安全性的优势也需更多的临床试验来验证,期待有更多的、更高更好的一些更随机的临床研究的文献或者一些非动物试验的研究,对患者的研究来评价中医传统疗法在治疗功能性消化不良的疗效。
[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.

【学位授予单位】：广州中医药大学
【学位级别】：博士
【学位授予年份】：2016
【分类号】：R259

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5 周慧敏,黄春凤;功能性疾病与中医辨证浅识[J];中医药学刊;2004年07期

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