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评价
发布时间：2018-07-18 09:49
【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。
[Abstract]:Background
Chronic rhinosinusitis is one of the most common diseases in the throat department of the ear . It is characterized by inflammation of nasal and nasal sinuses mucosa , and the duration of symptoms is over 12 weeks . About 31 million people in the United States suffer from the disease every year .
There is evidence that the incidence of chronic rhinosinusitis is increasing year by year . According to the characteristics of nasal discharge , nasal obstruction , headache and other symptoms , the traditional Chinese medicine classifies " chronic rhinosinusitis " into the category of " rhinorrhea " .
Functional endoscopic sinussurgery ( FESS ) is commonly used in the treatment of chronic nose - sinusitis .
According to the current literature report , the clinical curative effect of Jingyuan shu oral liquid in the operation of FESS is good , but because there is no systematic evaluation study of the drug at present , it is impossible to provide evidence of the highest intensity for clinical use of the drug .
Purpose
1 . By evaluating the clinical curative effect and safety of the oral nasal endoscope in the perioperative period of nasal endoscopic sinus surgery , some references are provided for the clinical use of the medicine .
2 . Through systematic evaluation , it provides a theoretical basis for the clinical research of the drug in the future .
method
According to the relevant requirements of the system evaluation worker ' s manual , the relevant Chinese and English literatures were searched . According to the inclusion , the exclusion criteria were included in the qualified randomized controlled study and the quality evaluation was conducted . The literature which cannot be combined was analyzed by descriptive analysis and the literature with less clinical heterogeneity was combined , Meta - analysis was conducted with RevMan4.2 . 10 software , and the results were carefully discussed .
Results
1 . After computer retrieval and manual retrieval , the subjects and abstracts were read out . A total of 16 randomized controlled studies were screened out . After careful reading of each study , the subjects were excluded from those who did not meet the requirements and were eventually included in 10 studies . Among them , 2175 patients with chronic rhinosinusitis were enrolled , including 1121 in the trial group and 1054 in the control group . One after the quality of the literature was high quality , the rest was low quality .
2 . The total effective rate of the test group was higher than that of the control group .
One study showed no difference in the total effective rate between the test group and the control group . One study showed that the cure rate of the test group was higher than that of the control group ;
Two studies showed no difference in cure rate between the test group and the control group .
1 meta - analysis showed that the total effective rate of the test group was higher than that of the control group .
The remaining 4 studies showed no difference in the total effective rate between the test group and the control group . One meta - analysis and two independent studies showed that the cure rate of the test group was higher than that of the control group ;
There were no difference in the cure rate of the remaining two study groups and test group . One meta - analysis showed that the disappearance rate of headache , nasal obstruction and olfactory decreased in the test group was higher than that of the control group ;
All the studies indicated that the disappearance rate of rhinorrhea in the test group was higher than that in the control group .
One meta - analysis showed no difference between the two groups of symptoms of chronic cough symptoms .
3 . There were 3 studies referring to adverse reactions , 2 of which mentioned no adverse reactions , 1 described specific adverse reactions , but did not analyze whether there was a direct contact with the oral administration of Nasobuchi oral liquid .
Conclusion
1 . At present , the study data supports the improvement of the comprehensive curative effect of the oral nasal buchi oral liquid on the basis of the use of the quinolone antibiotics , the auxiliary Shu Liangliang nasal spray and the compound peppermint oil after the operation of the chronic nose - sinusitis , and has certain advantages in relieving headache , nasal obstruction , pus and nasal discharge , and olfaction symptoms . However , large sample and high quality RCT study are still needed .
2 . The use of other methods to add the oral liquid before operation and the use of the nasal buyuan shu oral liquid before operation is not sure .
3 . There is insufficient evidence of safety of oral administration of the oral liquid in the perioperative period , and the exact conclusion cannot be reached .
【学位授予单位】：成都中医药大学
【学位级别】：硕士
【学位授予年份】：2010
【分类号】：R765.9
本文编号：2131529
[Abstract]:Background
Chronic rhinosinusitis is one of the most common diseases in the throat department of the ear . It is characterized by inflammation of nasal and nasal sinuses mucosa , and the duration of symptoms is over 12 weeks . About 31 million people in the United States suffer from the disease every year .
There is evidence that the incidence of chronic rhinosinusitis is increasing year by year . According to the characteristics of nasal discharge , nasal obstruction , headache and other symptoms , the traditional Chinese medicine classifies " chronic rhinosinusitis " into the category of " rhinorrhea " .
Functional endoscopic sinussurgery ( FESS ) is commonly used in the treatment of chronic nose - sinusitis .
According to the current literature report , the clinical curative effect of Jingyuan shu oral liquid in the operation of FESS is good , but because there is no systematic evaluation study of the drug at present , it is impossible to provide evidence of the highest intensity for clinical use of the drug .
Purpose
1 . By evaluating the clinical curative effect and safety of the oral nasal endoscope in the perioperative period of nasal endoscopic sinus surgery , some references are provided for the clinical use of the medicine .
2 . Through systematic evaluation , it provides a theoretical basis for the clinical research of the drug in the future .
method
According to the relevant requirements of the system evaluation worker ' s manual , the relevant Chinese and English literatures were searched . According to the inclusion , the exclusion criteria were included in the qualified randomized controlled study and the quality evaluation was conducted . The literature which cannot be combined was analyzed by descriptive analysis and the literature with less clinical heterogeneity was combined , Meta - analysis was conducted with RevMan4.2 . 10 software , and the results were carefully discussed .
Results
1 . After computer retrieval and manual retrieval , the subjects and abstracts were read out . A total of 16 randomized controlled studies were screened out . After careful reading of each study , the subjects were excluded from those who did not meet the requirements and were eventually included in 10 studies . Among them , 2175 patients with chronic rhinosinusitis were enrolled , including 1121 in the trial group and 1054 in the control group . One after the quality of the literature was high quality , the rest was low quality .
2 . The total effective rate of the test group was higher than that of the control group .
One study showed no difference in the total effective rate between the test group and the control group . One study showed that the cure rate of the test group was higher than that of the control group ;
Two studies showed no difference in cure rate between the test group and the control group .
1 meta - analysis showed that the total effective rate of the test group was higher than that of the control group .
The remaining 4 studies showed no difference in the total effective rate between the test group and the control group . One meta - analysis and two independent studies showed that the cure rate of the test group was higher than that of the control group ;
There were no difference in the cure rate of the remaining two study groups and test group . One meta - analysis showed that the disappearance rate of headache , nasal obstruction and olfactory decreased in the test group was higher than that of the control group ;
All the studies indicated that the disappearance rate of rhinorrhea in the test group was higher than that in the control group .
One meta - analysis showed no difference between the two groups of symptoms of chronic cough symptoms .
3 . There were 3 studies referring to adverse reactions , 2 of which mentioned no adverse reactions , 1 described specific adverse reactions , but did not analyze whether there was a direct contact with the oral administration of Nasobuchi oral liquid .
Conclusion
1 . At present , the study data supports the improvement of the comprehensive curative effect of the oral nasal buchi oral liquid on the basis of the use of the quinolone antibiotics , the auxiliary Shu Liangliang nasal spray and the compound peppermint oil after the operation of the chronic nose - sinusitis , and has certain advantages in relieving headache , nasal obstruction , pus and nasal discharge , and olfaction symptoms . However , large sample and high quality RCT study are still needed .
2 . The use of other methods to add the oral liquid before operation and the use of the nasal buyuan shu oral liquid before operation is not sure .
3 . There is insufficient evidence of safety of oral administration of the oral liquid in the perioperative period , and the exact conclusion cannot be reached .
【学位授予单位】：成都中医药大学
【学位级别】：硕士
【学位授予年份】：2010
【分类号】：R765.9
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，本文编号：2131529
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