發(fā)布時間：2018-07-18 09:49

【摘要】：背景 慢性鼻-鼻竇炎是耳鼻咽喉科最常見疾病之一。它的特點(diǎn)是鼻及鼻竇黏膜的炎癥,癥狀持續(xù)時間在12周以上。在美國每年大約有3100萬人口受到該病的困擾；有證據(jù)表明,慢性鼻-鼻竇炎的發(fā)病率有逐年增加的趨勢。根據(jù)其流涕、鼻塞、頭痛等癥狀特征,祖國醫(yī)學(xué)將“慢性鼻-鼻竇炎”歸為“鼻淵”范疇。 功能性鼻竇內(nèi)窺鏡手術(shù)(functional endoscopic sinussurgery, FESS)是治療慢性鼻-鼻竇炎的常用治療方法。但術(shù)后術(shù)腔黏膜腫脹、纖毛運(yùn)動紊亂、分泌物增多、微生物感染及變態(tài)反應(yīng)等因素均影響術(shù)腔黏膜的康復(fù)。來源于中醫(yī)理論及多年臨床經(jīng)驗(yàn)的鼻淵舒口服液因其在圍手術(shù)期具有良好的臨床療效而受到廣泛關(guān)注。 根據(jù)目前文獻(xiàn)報(bào)道,鼻淵舒口服液應(yīng)用于FESS術(shù)后的臨床療效好,但由于目前尚無該藥的系統(tǒng)評價研究,故無法為該藥的臨床使用提供最高強(qiáng)度的證據(jù)。 目的 1、通過評價口服鼻淵舒口服液在慢性鼻-鼻竇炎鼻內(nèi)窺鏡術(shù)圍手術(shù)期的臨床療效及安全性,為該藥的臨床使用提供一定的參考依據(jù)。 2、通過系統(tǒng)評價的制作,為今后該藥的臨床研究提供一定的方法學(xué)基礎(chǔ)。 方法 根據(jù)系統(tǒng)評價工作者手冊的相關(guān)要求,檢索相關(guān)中、英文文獻(xiàn)。按納入、排除標(biāo)準(zhǔn)納入合格的隨機(jī)對照研究并對其進(jìn)行質(zhì)量評價。不能合并的文獻(xiàn)采用描述性分析,臨床異質(zhì)性較小的文獻(xiàn)合并后采用RevMan4.2.10軟件進(jìn)行Meta分析,并認(rèn)真討論結(jié)果。 結(jié)果 1、經(jīng)過計(jì)算機(jī)檢索和手工檢索后閱讀題目和摘要,初步篩查出16隨機(jī)對照研究,認(rèn)真閱讀每一篇研究后剔除不符合要求者,最終納入10篇研究。共納入2175例慢性鼻-鼻竇炎患者,其中試驗(yàn)組1121例,對照組1054例。文獻(xiàn)質(zhì)量評價后1篇為高質(zhì)量,其余為低質(zhì)量。 2、術(shù)前術(shù)后均用鼻淵舒口服液時：2篇研究顯示試驗(yàn)組總有效率高于對照組；1篇研究顯示試驗(yàn)組和對照組之間總有效率無差異。1篇研究顯示試驗(yàn)組治愈率高于對照組；2篇研究顯示試驗(yàn)組和對照組之間,治愈率無差異。 術(shù)后使用鼻淵舒口服液時：1個meta分析表明試驗(yàn)組總有效率高于對照組；其余4篇研究顯示試驗(yàn)組與對照組總有效率無差異。1個meta分析和2篇獨(dú)立研究顯示試驗(yàn)組治愈率高于對照組；其余2篇研究對照組和試驗(yàn)組治愈率無差異。1個meta分析表明試驗(yàn)組頭痛、鼻塞、嗅覺減退癥狀消失率高于對照組；所有研究均表明試驗(yàn)組流膿涕癥狀消失率高于對照組；1個meta分析顯示慢性咳嗽癥狀消失率兩組之間無差異。 3、有3篇研究提及不良反應(yīng),其中2篇提及未發(fā)現(xiàn)不良反應(yīng),1篇描述了具體的不良反應(yīng),但并未分析是否與口服鼻淵舒口服液有直接聯(lián)系。 結(jié)論 1、目前研究數(shù)據(jù)支持慢性鼻-鼻竇炎術(shù)后在使用喹諾酮類抗生素、輔舒良噴鼻劑、復(fù)方薄荷油的基礎(chǔ)上加用口服鼻淵舒口服液較未使用鼻淵舒口服液者綜合療效提高,對緩解頭痛、鼻塞、膿鼻涕、嗅覺減退癥狀有一定的優(yōu)勢。但尚需大樣本、高質(zhì)量的RCT研究。 2、術(shù)后使用其他方法加用鼻淵舒口服液以及術(shù)前術(shù)后使用鼻淵舒口服液的療效不肯定。 3、口服鼻淵舒口服液在圍手術(shù)期的安全性研究證據(jù)不充分,不能得出確切結(jié)論。
[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 .
【學(xué)位授予單位】：成都中醫(yī)藥大學(xué)
【學(xué)位級別】：碩士
【學(xué)位授予年份】：2010
【分類號】：R765.9

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本文編號：2131529