| BackgroundAnkylosing spondylitis (AS) is characterized by the inflammation in the spine and sacroiliac joints causing initial bone and joint erosion, and ultimately ankylosis and fibrosis. The disease mostly occurs in young people, the age of onset is13-31years old, and the peak of age is20-30years old, after the age of40and onset before the age of8are rare. The onset appear insidiously, and has a high disability rates. Early diagnosis and comprehensive treatment is a necessary condition to improve the prognosis.The disease cannot be cured at present. The treatment target is to relieve the pain, to improve morning stiffness, restore the functional activity,prevention of spinal and joint deformities,jimprove social skills and the ability to work.An integrated treatment of non-drug and drug combination.the physical therapy, movement therapy and health care management are used to treated for AS. such as nonsteroidal antiinflammatorydrugs (NSAIDs) and slow-acting drugs (e.g., Methotrexate, Sulfasalazine, Leflunomide,thalidomide, and Thalidomide) are used to treated for AS too. In recent years the emergence of biological agents applied to the treatment of AS brought a landmark revolution, and represents a better therapeutic regimen for short term. The long-term efficacy and the possible adverse events still require large-scale studies to verify. Many patients with AS are unable to pay for biological agents, which are so expensive. The long-term treatment leads to the great spiritual and pressure on patients and their families.The traditional Chinese medicine(TCM) was effective for AS, and Dialectical treatment had great advantages for the treatment. Pharmacological showed that the TWP and zhengqing fengtongning with anti-inflammatory and anti-allergic effects, which have the effect of treatment of ankylosing spondylitis.Even though lack of large-scale clinical randomized controlled trials, the development of evidence-based medicine provides a good way for clinical dispute resolution. The system review is a new method for comprehensive evaluation of the literatures, collecting all the world’s published and unpublished results of clinical studies, using the clinical epidemiology of strict principles and methods to evaluation the literatures, filtering out literatures those meet quality standards, meta-analysis is conducted with software, and then get the conclusion of comprehensive and reliable. The methods of meta-analysis has been using on medical prevention and treatment, causes of disease, risk of disease, prognosis, diagnosis, and economic analysis widely, which are at the top of the " evidence of the pyramid " launched by the in the Downstate Medical Center of State University of New York, United States.In recent years, there are more and more clinical studies on treatment of ankylosing spondylitis with TriPterygium wilfordii hook and Zhengqingfengtongning, most of which are randomized controlled trials. But there are fewer systematic reviews of them for AS. The purpose of this study is to give an objective evaluation on the overall efficacy and safety of TriPterygium wilfordii hook or Zhengqingfengtongning.ObjectiveTo research the Literature of traditional Chinese medicine in treatment of ankylosing spondylitis, the authors aimed to achieve the following goals:①To systematically evaluate the differences of efficacy and safety of TriPterygium wilfordii hook or Zhengqingfengtongning for ankylosing spondylitis;②Search the random and semi-random treatment studies of Traditional Chinese medicine in30years in domestic:establish the databases of the drugs, and explore the drug characteristics of the disease by frequency analysis.MethodPart One:To evaluate the effects and safety of Tripterygium for ankylosing spondylitis. Having devised the criteria for literature inclusion, exclusion, search strategies, retrieve standard. Such database as PUBMED, EMBASE-ASP,Cochrane Library, OVID, Springer-link, CNKI, VIP, Wanfang and CBM, ect, were searched from the date of their establishment to December2012. Key words for search: AS,ankylosing spondilyties, Tripterygium wilfordii Hook.f, Tripterygium wilfordii, triptolide,TP, TriPterygium wilfordii hook.The quality of included studies was evaluated, and meta-analysis was conducted with RevMan5.1software.Part Two:To evaluate the effects and safety of Zhengqingfengtongning for ankylosing spondylitis. Key words for search:AS,ankylosing spondilyties, Zhengqing Fengtongning、Zhengqingfengtongning Injection、sinomenine. The method and process are the same of part one.Part Three:Search the random and semi-random treatment studies of Traditional Chinese medicine in30years in domestic:establish the databases of the drugs, and explore the drug characteristics of the disease by frequency analysis. Such database asCNKI, VIP, Wanfang and CBM, ect, were searched from the date of their establishment to January2012.ResultsPart One:a Systematic reviews of efficacy and safety of Tripterygium for ankylosing spondylitis. A total of8RCTs involving576patients were included. Meta-analysis showed that there were no significant differences between the Tripterygium and Chinese Herbal Compound groups in the effect on improving the chest movement, the Occiput-Wall distance,the Finger-Ground distance and C-reactive protein. The Chinese Herbal Compound showed more effects in improving the total effective rate, the duration of morning stiffness,the Schober test and reducing C-reactive protein.The Tripterygium may cause to postpone to menstrual period,gastrointestinal adverse reactions,liver dysfunction,and so on.Part Two:a Systematic reviews of Efficacy and safety of Zhengqing fengtongning for ankylosing spondylitis. A total of12RCTs involving1112patients were included. Meta-analysis showed that there were significant differences between the Zhengqingfengtongning and western medicines groups in the effect on improving the total effective[MD=3.07,95%CI(1.88,5.02)],total body pain [MD=-0.43,95%CI(-0.61,-0.24)],spinal pain[MD=-0.31,95%CI(-0.44,-0.19)]。Zhengqing fengtongning Injection would improved the total effective [OR=4.10,95%CI(1.73,9.71)], VAS score [MD=-2.84,95%CI(-3.68,-2.00)]. Zhengqingfeng tongning Injection caused a higher incidence of allergic skin.Part Three:In More than30years, the high frequency of Charaeteristies of drug therapy are, in order, tonics, dispelling rheumatism drugs, dredging blood circulation drugs, tranquilizers and antipyretics, eliminating phlegm drugs, and so on.the high frequency of the single herb for AS are, in order, Paceonia lactiflora Pall, Clematis chinensis Osbeck, Cyathula officinalis Kuan, Aconitum carmichaeli Debx, Aaugellica sinensis(Oliv) Diels, Angelica pubescens Maxim. f. biserrata Shan et Yuan, Eucommia ulmoides Oliv, Cinnamomum cassia Presl, Glycyrrhiza uralensis Fisch, Dipsacus aspercides C.Y.Cheng et T.MAi, Aconitum carmichaeli Debx, Rehmannia glutinosa (Gdertn) Iibosch, and so on.The treatment principles include nourishing kidney essence, warming kidney-yang mainly, expelling wind, cold(heat) and dampness, and dredging channels at the same time, together with dredging blood and alleviating pain.ConclusionThe meta-analysis showed that the traditional Chinese medicine and Zhengqingfengtongning had a higher effective for AS than Tripterygium. the traditional Chinese medicine and Tripterygium showed improvements in the axis functions, ESR, CPR, Use high quality clinical trials to further prove the clinical effects and safety of Tripterygium for AS is necessary promptly.There was some sufficient evidence to support the clinical application of the Zhengqingfengtongning in patients with ankylosing spondylitis currently.Use high quality clinical trials to further prove the clinical effects and safety of Tripterygium for AS is necessary promptly.The treatment principles include nourishing Nourishing Liver and Kidney, Blood-Activating and Collateral-Unblocking,mainly, expelling wind, cold(heat) and dampness, at the same time. Dialectical treatment is the essence of traditional Chinese medicine on the treatment. |
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