【作者】 刘敏；

【导师】 张勤修；

【作者基本信息】 成都中医药大学 ， 中医五官科学， 2010， 硕士

【摘要】 背景慢性鼻-鼻窦炎是耳鼻咽喉科最常见疾病之一。它的特点是鼻及鼻窦黏膜的炎症,症状持续时间在12周以上。在美国每年大约有3100万人口受到该病的困扰；有证据表明,慢性鼻-鼻窦炎的发病率有逐年增加的趋势。根据其流涕、鼻塞、头痛等症状特征,祖国医学将“慢性鼻-鼻窦炎”归为“鼻渊”范畴。功能性鼻窦内窥镜手术(functional endoscopic sinussurgery, FESS)是治疗慢性鼻-鼻窦炎的常用治疗方法。但术后术腔黏膜肿胀、纤毛运动紊乱、分泌物增多、微生物感染及变态反应等因素均影响术腔黏膜的康复。来源于中医理论及多年临床经验的鼻渊舒口服液因其在围手术期具有良好的临床疗效而受到广泛关注。根据目前文献报道,鼻渊舒口服液应用于FESS术后的临床疗效好,但由于目前尚无该药的系统评价研究,故无法为该药的临床使用提供最高强度的证据。目的1、通过评价口服鼻渊舒口服液在慢性鼻-鼻窦炎鼻内窥镜术围手术期的临床疗效及安全性,为该药的临床使用提供一定的参考依据。2、通过系统评价的制作,为今后该药的临床研究提供一定的方法学基础。方法根据系统评价工作者手册的相关要求,检索相关中、英文文献。按纳入、排除标准纳入合格的随机对照研究并对其进行质量评价。不能合并的文献采用描述性分析,临床异质性较小的文献合并后采用RevMan4.2.10软件进行Meta分析,并认真讨论结果。结果1、经过计算机检索和手工检索后阅读题目和摘要,初步筛查出16随机对照研究,认真阅读每一篇研究后剔除不符合要求者,最终纳入10篇研究。共纳入2175例慢性鼻-鼻窦炎患者,其中试验组1121例,对照组1054例。文献质量评价后1篇为高质量,其余为低质量。2、术前术后均用鼻渊舒口服液时：2篇研究显示试验组总有效率高于对照组；1篇研究显示试验组和对照组之间总有效率无差异。1篇研究显示试验组治愈率高于对照组；2篇研究显示试验组和对照组之间,治愈率无差异。术后使用鼻渊舒口服液时：1个meta分析表明试验组总有效率高于对照组；其余4篇研究显示试验组与对照组总有效率无差异。1个meta分析和2篇独立研究显示试验组治愈率高于对照组；其余2篇研究对照组和试验组治愈率无差异。1个meta分析表明试验组头痛、鼻塞、嗅觉减退症状消失率高于对照组；所有研究均表明试验组流脓涕症状消失率高于对照组；1个meta分析显示慢性咳嗽症状消失率两组之间无差异。3、有3篇研究提及不良反应,其中2篇提及未发现不良反应,1篇描述了具体的不良反应,但并未分析是否与口服鼻渊舒口服液有直接联系。结论1、目前研究数据支持慢性鼻-鼻窦炎术后在使用喹诺酮类抗生素、辅舒良喷鼻剂、复方薄荷油的基础上加用口服鼻渊舒口服液较未使用鼻渊舒口服液者综合疗效提高,对缓解头痛、鼻塞、脓鼻涕、嗅觉减退症状有一定的优势。但尚需大样本、高质量的RCT研究。2、术后使用其他方法加用鼻渊舒口服液以及术前术后使用鼻渊舒口服液的疗效不肯定。3、口服鼻渊舒口服液在围手术期的安全性研究证据不充分,不能得出确切结论。更多还原

【Abstract】 BackgroundChronic rhinosinusitis which encompasses a group of disorders characterized by inflammation of the mucosa of nose and sinuses and lasts at least 12 weeks is one of the most common otolaryngologic diseases and a major cause of the upper and lower respiratory complaints and chronic cough. Chronic rhinosinusitis infects about 31 million people in the United States and the incidence is increasing every year. Because of the Symptoms including headache、nasal obstruction、purulent discharge, The chronic rhinosinusitis is similar to "biyuan" in Chinese medicine.Functional endoscopic sinus surgery (FESS) is a commonly used therapy for chronic rhinosinusitis and nasal polyps. The sequelas of FESS such as sinus mucosa swelling, ciliary motility disorder, increased discharge, infection and allergy affect the restoration of sinus mucosa. Therefore, proper use of drugs such as biyuanshu oral solution to promote mucosal restoration arouses wide concern. According to the resent reports in the literature, the Effect and Safety of Biyuanshu Oral Solution in the perioperative period of chronic rhinosinusitis is good but there was no systematic review providing high strength evidence to validate its efficacy and safety.Objective1.To assess the efficacy and safety of Biyuanshu oral solution in the perioperative period of chronic rhinosinusitis.2.To provide certain reference for the use and the research of the Biyuanshu oral solution.Methods1.We performed an electronic search and performed a manual searching for collecting data. We included randomized controlled trials which met the inclusion and exclusion criteria and evaluated the quality of those trials and performed the meta-analysis by RevMan 4.2.10。2. We analyzed the statistical results data, described the meaning and suggestion of the research situation objectively.Evaluate the clinical efficacy and safety of the Biyuanshu oral solution. Then provide certain reference for the future scientific research through analysis the shortage of the present research.Results1. Ten trials were included involving 2175 patients. However, only one of them is high quality; the others were of poor quality.2. Using Biyuanshu at before and after the FESS:tow studies show the total efficiency rate of the treatment group is higher the control group. One study shows the recovery rate of the treatment group is higher the control group. The others show no significant difference between treatment group and control group. Using Biyuanshu at after the FESS:one Meta analysis shows the total efficiency rate of the treatment group is higher the control group.1 Meta analysis and 2 studies shows the recovery rate of the treatment group is higher the control group.1 meta analysis shows the remove rate of the headache、nasal obstruction、hyposmia of the treatment group is higher the control group.All studies show the remove rate of purulent discharge of the treatment group is higher the control group and no significant difference between treatment group and control group in the remove rate of chronic cough.3. There are 3 studies mention the adverse reactions, 2 of them show no adverse reactions and the rest describe the adverse reactions relating the biyuanshu unclearly.ConclusionsBased on the data Collected inadequate evidence shows that the effect and safety of Biyuanshu oral solution in the perioperative period of Chronic rhinosinusitis are marked, due to the poor quantity, poor literature quality and the publish bias of the included trials. High quality RCTs based on the CONSORT is our focus in the future research to provide solid evidence for the clinic.更多还原