【摘要】：目的:特發(fā)性肺間質(zhì)纖維化(Idiopathic pulmonary fibrosis,IPF)是一種臨床較為常見的疾病,是以普通型間質(zhì)性肺炎為病理改變的慢性炎癥性間質(zhì)性肺疾病。目前被WHO列為難治性疾病,其發(fā)病隱匿,病因尚不清楚,預(yù)后不良,確定診斷后,中位生存期僅為2-4年。多數(shù)患者表現(xiàn)為緩慢、逐步、可預(yù)見的肺功能下降,臨床表現(xiàn)為咳嗽、乏力、氣短、呼吸困難。目前,西醫(yī)治療IPF多采用較大劑量糖皮質(zhì)激素聯(lián)合免疫抑制劑、抗纖維化、抗氧化等方法,但是尚無循證醫(yī)學(xué)證據(jù)證明某種治療方法有明確療效,且治療過程長,副作用明顯,給患者增加了很多身體上的不適和焦慮情緒。近年來,中藥治療本病的臨床研究日益增多,具有一定療效,然而,單純的中藥治療隨機(jī)對照研究較少,未廣泛應(yīng)用于臨床。中西醫(yī)結(jié)合取長補(bǔ)短,治療IPF具有很大的優(yōu)勢,但目前缺乏對臨床研究證據(jù)的系統(tǒng)評價(jià)。本研究應(yīng)用Meta分析方法,系統(tǒng)評價(jià)中藥制劑的加入相對單純西醫(yī)治療IPF的臨床療效與安全性,為IPF的治療提供更有效的方法和依據(jù)。方法:對數(shù)據(jù)庫進(jìn)行全面系統(tǒng)檢索,包括相關(guān)期刊論文(Chinese National Knowledge Infrastructure databases,CNKI)、維普中文科技期刊全文數(shù)據(jù)庫、中國生物醫(yī)學(xué)文獻(xiàn)數(shù)據(jù)庫(Chinese Biomedical database,CBM)、萬方醫(yī)學(xué)期刊數(shù)據(jù)庫、Pub Med、EMBASE、Cochrane圖書館;檢索對象為中西醫(yī)結(jié)合治療IPF的隨機(jī)對照試驗(yàn)(randomized controlled trials,RCTs)研究;檢索時(shí)間從建庫到2016年6月30日,不限定語言,由兩名評價(jià)員依據(jù)制定的納入與排除標(biāo)準(zhǔn),對文獻(xiàn)進(jìn)行篩選和資料的提取,并依據(jù)修改版Jadad量表對納入的文獻(xiàn)進(jìn)行方法學(xué)質(zhì)量評價(jià),篩選符合要求的隨機(jī)對照試驗(yàn)納入本研究,并應(yīng)用Revman Manager 5.2軟件進(jìn)行Meta分析。結(jié)果:本研究最終納入符合條件的隨機(jī)對照研究共17項(xiàng),病例總計(jì)1337例,其中治療組675例,對照組662例,治療組給予中藥與西藥聯(lián)合治療方法(中西醫(yī)結(jié)合治療),對照組給予單純西醫(yī)藥治療。對數(shù)據(jù)進(jìn)行Meta分析,結(jié)果顯示:1、中西醫(yī)結(jié)合治療IPF臨床療效優(yōu)于西醫(yī)治療組,兩組間的差異具有統(tǒng)計(jì)學(xué)意義。2、與西醫(yī)治療相比,中西醫(yī)結(jié)合治療能夠改善患者的DLCO(一氧化碳彌散量)、FVC(用力肺活量)、VC(肺活量)、FEV1/FVC(第一秒呼出量/用力肺活量)、FEV1(第一秒用力呼氣量)和PEF(最高呼氣流速)。在改善TLC(肺總量)方面,中西醫(yī)結(jié)合治療與西醫(yī)治療效果相當(dāng)。3、與西醫(yī)治療相比,中西醫(yī)結(jié)合治療IPF能顯著升高動(dòng)脈氧分壓(Pa O2),療效優(yōu)于西醫(yī)治療組。4、與西醫(yī)治療相比,中西醫(yī)結(jié)合治療IPF能顯著降低患者呼吸困難和咳嗽癥狀的積分值,能有效緩解呼吸困難和咳嗽的癥狀。5、不良反應(yīng):有5項(xiàng)研究報(bào)告了不良反應(yīng)的發(fā)生情況,均顯示中西醫(yī)結(jié)合治療組無不良反應(yīng)發(fā)生。結(jié)論:與西醫(yī)治療相比,中西醫(yī)結(jié)合治療IPF具有一定的優(yōu)勢,能夠提高臨床療效,改善肺功能和臨床癥狀,并可降低西藥的不良反應(yīng),增加患者對西藥治療的耐受性,進(jìn)而提高患者生活質(zhì)量,可在臨床上推廣。但基于所納入的研究對不良反應(yīng)報(bào)告率較低,中西醫(yī)治療IPF絕對安全這一定論具有局限性,今后還需要更多大樣本、高質(zhì)量、多中心的隨機(jī)對照研究進(jìn)一步探討。
[Abstract]:Objective: Idiopathic pulmonary fibrosis (IPF) is a more common disease, and is a chronic inflammatory interstitial lung disease which is characterized by common interstitial pneumonia as a pathological change. The current WHO is listed as a refractory disease, its pathogenesis is unknown, the cause of the disease is not clear, the prognosis is poor, and after the diagnosis is determined, the median survival time is only 2-4 years. Most of the patients showed a slow, progressive and predictable decrease in lung function, with the clinical manifestations of cough, weakness, shortness of breath, and difficulty in breathing. At present, western medicine has adopted a large dose of glucocorticoid combined immunosuppressants, anti-fibrosis and anti-oxidation methods in the treatment of IPF, but there is no evidence of evidence-based medical evidence that a certain treatment method has definite curative effect, and the treatment process is long and the side effect is obvious. The patient added a lot of physical discomfort and anxiety. In recent years, the clinical study on the treatment of this disease with traditional Chinese medicine has been increasing, and has a certain curative effect. However, the traditional Chinese medicine for the treatment of this disease is less, and is not widely used in clinical practice. The combination of traditional Chinese and western medicine has a great advantage in the treatment of IPF, but there is a lack of systematic evaluation of the evidence of clinical research. In this study, a Meta-analysis method was used to evaluate the clinical efficacy and safety of the traditional Chinese medicine preparation in the treatment of IPF with the pure western medicine, and to provide a more effective method and basis for the treatment of the IPF. Methods: The database was comprehensively retrieved, including the full-text database of Chinese journal (Chinese National Knowledge Infrastructure database, CNKI), full-text database of Chinese sci-tech periodicals, Chinese Biomedical Database (CBM), Wanfang Medical Journal Database, Pub Med, EMBASE and Cochrane Library. The search object is a randomized controlled trial (RCTs) for the treatment of IPF with the combination of the traditional Chinese and western medicine; the retrieval time is from the building library to 30 June 2016, and the language is not limited, and the two evaluators are used for screening and extracting the documents according to the development of the inclusion and exclusion criteria, According to the revised Jadad scale, the included literature was evaluated by methodological quality, the selected randomized controlled trials were included in this study and the Revman Manager 5.2 software was used for Meta-analysis. Results: 17 cases were included in the study. The total number of the cases was 1337. In the treatment group, 675 cases were treated with the control group and 662 cases in the control group. The treatment group was treated with the combination of the traditional Chinese medicine and the western medicine (the combination of the traditional Chinese and western medicine), and the control group was treated with the pure western medicine. The results of the meta-analysis of data show that the combination of traditional Chinese and western medicine in the treatment of IPF is superior to that of western medicine, and the difference between the two groups is of statistical significance. FVC (forced vital capacity), VC (vital capacity), FEV1/ FVC (first-second expiratory volume/ forced vital capacity), FEV1 (first-second forced expiratory volume), and PEF (highest expiratory flow rate). in that aspect of improve TLC (total lung volume), the combination of traditional Chinese and western medicine is comparable to that of western medicine. 3. Compared with western medicine, the combination of traditional Chinese and western medicine can significantly increase the oxygen partial pressure of the artery (PaO2), and the curative effect is superior to that of the western medicine treatment group. 4, compared with the western medicine treatment, The combination of traditional Chinese and western medicine in the treatment of IPF can significantly reduce the integral value of dyspnea and cough in the patients, and can effectively relieve the symptoms of dyspnea and cough. 5. Adverse reaction: 5 studies report the occurrence of adverse reaction, and all shows that no adverse reaction occurs in the combination treatment group of the traditional Chinese and western medicine. Conclusion: Compared with western medicine, the traditional Chinese and western medicine combined with the treatment of the IPF has certain advantages, can improve the clinical curative effect, improve the lung function and the clinical symptom, can reduce the adverse reaction of the western medicine, increase the tolerance of the patients to the western medicine treatment, and further improve the quality of life of the patients, can be popularized clinically. However, on the basis of the study, the report rate of adverse reaction is low, and the theory of absolute safety of the traditional Chinese and western medicine for the treatment of the absolute safety of the IPF has the limitation, and the more large sample, high quality and multi-center randomized controlled study will be further discussed in the future.
【學(xué)位授予單位】：大連醫(yī)科大學(xué)
【學(xué)位級別】：碩士
【學(xué)位授予年份】：2017
【分類號】：R563.9

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