本文關(guān)鍵詞： 過敏性鼻炎-哮喘綜合征 中醫(yī)藥 觀察性研究 病例系列報告　出處：《北京中醫(yī)藥大學(xué)》2017年碩士論文　論文類型：學(xué)位論文

【摘要】：目的過敏性鼻炎-哮喘綜合征(Combined Allergic Rhinitis and Asthma Syndrome,CARAS)是2004年由世界變態(tài)反應(yīng)組織(World Allergy Organization,WAO)提出的醫(yī)學(xué)診斷術(shù)語,其主要表現(xiàn)為同時發(fā)生的上、下呼吸道的慢性炎癥和高反應(yīng)性癥狀,包括鼻癢、噴嚏頻頻、流清鼻涕、鼻塞、咳嗽和喘息等[1]。流行病學(xué)調(diào)查表明,60%～78%的哮喘患者伴有過敏性鼻炎[16],20%～38%的過敏性鼻炎伴有哮喘[25]。目前本病的診斷采用過敏性鼻炎與支氣管哮喘的聯(lián)合診斷,治療則按照相關(guān)指南推薦采取以吸入糖皮質(zhì)激素為主的上、下呼吸道聯(lián)合抗炎治療。然而,臨床實際中,由于未能建立鼻炎與哮喘的聯(lián)合診斷,兩種疾病常分科診治,出現(xiàn)治療重復(fù)和藥物疊加等情況,導(dǎo)致患者經(jīng)濟負擔(dān)加重、依從性和療效差、副反應(yīng)發(fā)生率增加等。因此,尋找安全、有效的中醫(yī)藥治療方案成為當(dāng)務(wù)之急。導(dǎo)師在長期的臨床實踐中發(fā)現(xiàn)成人CARAS具有"肺脾兩虛、風(fēng)痰犯肺、肺失宣降"的病機特點,提出了"益氣溫陽、祛風(fēng)化痰、通竅平喘"的治療大法,以參蛤蒼龍湯為基礎(chǔ)方加減進行分期治療,初步結(jié)果顯示可以改善患者上、下呼吸道的癥狀,減少急性發(fā)作次數(shù)。本研究擬在建立CARAS聯(lián)合診斷模式的基礎(chǔ)上,采用國內(nèi)外公認的觀察性研究的設(shè)計方法和報告規(guī)范,開展益氣溫陽、祛風(fēng)化痰、通竅平喘法治療成人CARAS的臨床觀察性研究,選用國際公認的療效評價指標,初步評價中醫(yī)藥治療本病的臨床療效,探討可能的作用機制,有望為臨床提供一種安全、有效的中醫(yī)藥治療方案,也為下一步開展中醫(yī)治療CRARS的確證性研究提供依據(jù)。方法本研究采用前瞻性觀察性設(shè)計(病例系列報告),選擇2015年6月至2017年3月在東直門醫(yī)院呼吸科門診及耳鼻喉科門診就診的過敏性鼻炎-哮喘綜合征患者(中醫(yī)辨證屬肺脾兩虛、風(fēng)痰犯肺)作為研究對象。對納入研究的受試者予以參蛤蒼龍湯為基礎(chǔ)方加減的中醫(yī)治療方案,12周為一個療程,連續(xù)治療2個療程。觀察治療前和治療后各時點鼻炎和哮喘癥狀評分的變化及相關(guān)實驗室指標檢查結(jié)果的變化(包括療效性指標和安全性指標)。結(jié)果1.受試者納入情況:本研究共篩選45例患者,納入24例,24例中完成全部療程者15例,治療期間脫落者9例。所有患者中,男性7例,女性17例�；颊咧心挲g最大者68歲,最小者17歲,平均年齡43.79±12.29(歲)。鼻炎病程最長者37年,最短者4個月,平均病程141.67±97.88(月)。哮喘病程最長者25年,最短者1個月,平均病程60.92±70.432(月)。間歇性AR4例,持續(xù)性AR20例;輕度AR5例,中-重度AR 19例。哮喘發(fā)作期患者2例,慢性持續(xù)期患者22例;哮喘病情嚴重程度分級屬于間斷狀態(tài)者3例,輕度持續(xù)者10例,中度持續(xù)者11例。2.療效分析本次統(tǒng)計分析共納入病例24例,經(jīng)相關(guān)統(tǒng)計方法處理后發(fā)現(xiàn):本治療方案可以改善CARAS患者的主要療效指標(包括過敏性鼻炎視覺模擬評分、過敏性鼻炎主要癥狀評分、哮喘癥狀評分、哮喘控制測試評分、成人哮喘生存質(zhì)量評分、中醫(yī)證候分級量化積分),同時可使部分合并使用西醫(yī)治療的患者減少西藥用量,但對次要療效指標中所有實驗室指標(包括肺功能指標、血T細胞亞群、血總IgE、血EOS%)則無明顯影響。具體如下:2.1主要療效指標①治療后患者的過敏性鼻炎視覺模擬評分、過敏性鼻炎主要癥狀評分、哮喘癥狀評分、中醫(yī)證候分級量化積分均逐漸下降,且治療后各時點與治療前比較差異有統(tǒng)計學(xué)意義(P0.05)。表明本治療方案可以改善患者的臨床癥狀,包括鼻炎與哮喘的臨床癥狀。②治療后患者的ACT評分與AQLQ評分均較治療前上升,治療后各時點與治療前比較差異有統(tǒng)計學(xué)意義(P0.05)。表明本治療方案可以提高患者的哮喘控制水平,改善患者的生存質(zhì)量。③將所有病例分為純中醫(yī)治療與合并使用西醫(yī)治療兩個亞組分析后發(fā)現(xiàn):治療后各亞組鼻炎與哮喘的各項癥狀評分均逐漸下降,且治療后各時點與治療前比較差異均有統(tǒng)計學(xué)意義(P0.05)。表明使用純中醫(yī)治療與合并使用西醫(yī)治療均可改善患者鼻炎與哮喘的臨床癥狀,提高哮喘的臨床控制,改善患者生存質(zhì)量。2.2次要療效指標①治療方案可使部分合并使用西醫(yī)治療的患者逐步減少西藥的用量。②所有實驗室指標治療前后比較均無顯著差異(P0.05),表明本治療方案對患者的肺功能指標、血T細胞亞群、血總IgE、血EOS%均無明顯影響。3.安全性分析所有受試者在研究期間均未發(fā)生嚴重不良事件,表明本治療方案是安全的。結(jié)論本研究的結(jié)果表明,以參蛤蒼龍湯為主方的中醫(yī)治法"益氣溫陽、祛風(fēng)化痰、通竅平喘"對成人CARAS "肺脾兩虛、風(fēng)痰犯肺"這一證型的臨床治療是安全有效的。中醫(yī)治療方案不僅可以改善患者的鼻炎與哮喘癥狀,提高患者的哮喘控制水平,改善患者生存質(zhì)量,而且可使部分患者減少西藥的用量;所有患者在研究期間均未發(fā)生嚴重不良事件。
[Abstract]:The purpose of allergic rhinitis and asthma syndrome (Combined Allergic Rhinitis and Asthma Syndrome, CARAS) is 2004 by the World Allergy Organization (World Allergy Organization, WAO) medical diagnostic terminology proposed, its main performance is to occur at the same time, chronic inflammation of the lower respiratory tract and hyperresponsiveness symptoms, including nasal itching, sneezing frequently, runny nose, stuffy nose, cough and wheezing [1]. survey of epidemiology, 60% ~ 78% of the patients with allergic rhinitis and asthma [16], 20% ~ 38% of the allergic rhinitis associated with asthma [25]. at diagnosis of the disease diagnosis with combined allergic rhinitis and bronchial asthma, the treatment is recommended in accordance with the relevant guidelines to take inhaled glucocorticoids. Corticosteroids based on lower respiratory tract with anti inflammation treatment. However, in clinical practice, because the combined diagnosis failed to establish rhinitis and asthma, two diseases often branch out treatment. The treatment of repetition and drug superposition, resulting in increased economic burden of the patients, compliance and curative effect, side reaction rate increased. Therefore, looking for safe and effective treatment of traditional Chinese medicine has become a pressing matter of the moment. The tutor in the long-term clinical practice found in adult CARAS with lung and spleen two deficiency, wind phlegm invading lung the pathogenesis, characteristics of lung dispersing and descending function ", put forward" Yiqiwenyang, dispelling wind and expelling phlegm, relieving asthma treatment method, Tongqiao "to ShenHa dragon soup based Decoction for staging treatment, preliminary results show that can improve the patients, lower respiratory tract symptoms, reduce the frequency of acute attack. This study based on the establishment of CARAS diagnosis model, the recognized at home and abroad observational study design methods and standards for reporting, carry out Yiqiwenyang, expelling wind and phlegm, relieving asthma clinical observational study of Tongqiao treatment of adult CARAS, using internationally accepted therapy Effect evaluation index, preliminary clinical efficacy evaluation of TCM treatment of this disease, to explore the possible mechanism of action, is expected to provide a safe and effective treatment for clinical medicine, also provides the basis for the research of Chinese medicine treatment of CRARS confirmed the next step. The design method was adopted in this study with prospective observational (series report from June 2015 to March 2017), the cases in Dongzhimen hospital outpatient department of respiration and Department of ENT outpatient treatment of allergic rhinitis and asthma syndrome patients (TCM is two lung spleen deficiency, wind phlegm invading the lung) as the research object. The TCM treatment plan of subjects included in the study of ShenHa dragon soup based decoction. 12 weeks for a course of treatment, continuous treatment of 2 courses. To observe the changes before and after treatment changes at each time point of rhinitis and asthma symptom score and laboratory indexes of examination results (including the effect 鎬ф寚鏍囧拰瀹夊叏鎬ф寚鏍，

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