中西医结合治疗特发性肺间质纤维化的Meta分析

发布时间：2019-01-25 09:27

【摘要】：目的:特发性肺间质纤维化(Idiopathic pulmonary fibrosis,IPF)是一种临床较为常见的疾病,是以普通型间质性肺炎为病理改变的慢性炎症性间质性肺疾病。目前被WHO列为难治性疾病,其发病隐匿,病因尚不清楚,预后不良,确定诊断后,中位生存期仅为2-4年。多数患者表现为缓慢、逐步、可预见的肺功能下降,临床表现为咳嗽、乏力、气短、呼吸困难。目前,西医治疗IPF多采用较大剂量糖皮质激素联合免疫抑制剂、抗纤维化、抗氧化等方法,但是尚无循证医学证据证明某种治疗方法有明确疗效,且治疗过程长,副作用明显,给患者增加了很多身体上的不适和焦虑情绪。近年来,中药治疗本病的临床研究日益增多,具有一定疗效,然而,单纯的中药治疗随机对照研究较少,未广泛应用于临床。中西医结合取长补短,治疗IPF具有很大的优势,但目前缺乏对临床研究证据的系统评价。本研究应用Meta分析方法,系统评价中药制剂的加入相对单纯西医治疗IPF的临床疗效与安全性,为IPF的治疗提供更有效的方法和依据。方法:对数据库进行全面系统检索,包括相关期刊论文(Chinese National Knowledge Infrastructure databases,CNKI)、维普中文科技期刊全文数据库、中国生物医学文献数据库(Chinese Biomedical database,CBM)、万方医学期刊数据库、Pub Med、EMBASE、Cochrane图书馆;检索对象为中西医结合治疗IPF的随机对照试验(randomized controlled trials,RCTs)研究;检索时间从建库到2016年6月30日,不限定语言,由两名评价员依据制定的纳入与排除标准,对文献进行筛选和资料的提取,并依据修改版Jadad量表对纳入的文献进行方法学质量评价,筛选符合要求的随机对照试验纳入本研究,并应用Revman Manager 5.2软件进行Meta分析。结果:本研究最终纳入符合条件的随机对照研究共17项,病例总计1337例,其中治疗组675例,对照组662例,治疗组给予中药与西药联合治疗方法(中西医结合治疗),对照组给予单纯西医药治疗。对数据进行Meta分析,结果显示:1、中西医结合治疗IPF临床疗效优于西医治疗组,两组间的差异具有统计学意义。2、与西医治疗相比,中西医结合治疗能够改善患者的DLCO(一氧化碳弥散量)、FVC(用力肺活量)、VC(肺活量)、FEV1/FVC(第一秒呼出量/用力肺活量)、FEV1(第一秒用力呼气量)和PEF(最高呼气流速)。在改善TLC(肺总量)方面,中西医结合治疗与西医治疗效果相当。3、与西医治疗相比,中西医结合治疗IPF能显著升高动脉氧分压(Pa O2),疗效优于西医治疗组。4、与西医治疗相比,中西医结合治疗IPF能显著降低患者呼吸困难和咳嗽症状的积分值,能有效缓解呼吸困难和咳嗽的症状。5、不良反应:有5项研究报告了不良反应的发生情况,均显示中西医结合治疗组无不良反应发生。结论:与西医治疗相比,中西医结合治疗IPF具有一定的优势,能够提高临床疗效,改善肺功能和临床症状,并可降低西药的不良反应,增加患者对西药治疗的耐受性,进而提高患者生活质量,可在临床上推广。但基于所纳入的研究对不良反应报告率较低,中西医治疗IPF绝对安全这一定论具有局限性,今后还需要更多大样本、高质量、多中心的随机对照研究进一步探讨。
[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.
【学位授予单位】：大连医科大学
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：R563.9

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