中醫(yī)藥治療小兒肺炎喘嗽風熱閉肺證、痰熱閉肺證臨床驗證方案的多

1、中醫(yī)藥治療小兒肺炎喘嗽風熱閉肺證、痰熱閉肺證臨床驗證方案的多中心隨機對照研究 11-01-27 11:08:00 編輯：studa20 作者：王力寧， 王雪峰， 原曉風， 李燕寧， 高樹彬，楊巖姜之炎, 洪麗君 張煒， 胡香玉，劉小凡， 王孟清， 李偉偉， 許尤佳， 李立新， 【摘要】 目的 客觀評價中醫(yī)藥治療小兒肺炎喘嗽風熱閉肺證、痰熱閉肺證臨床療效及各治療方案的優(yōu)勢。方法 在國家中醫(yī)藥管理局“十一五”重點中醫(yī)?？苾嚎品窝讌f(xié)作組的13家醫(yī)院中進行中醫(yī)治療小兒肺炎喘嗽診療方案驗證的多中心隨機對照研究。資料完整的病例共640例，均符合風熱閉肺證、痰熱閉肺證，隨機分為內治組207例、外治組205例

2、、內外合治組228例。內治組方案：風熱閉肺證用以麻杏石甘湯加味，痰熱閉肺證用五虎湯合葶藶大棗瀉肺湯加減，內服湯劑或保留灌腸;外治組方案：采用背穴藥物貼敷;內外合治組方案：同時用內治組方案與外治組方案，即內服湯劑(或保留灌腸)+藥物背穴貼敷。各組常規(guī)靜脈滴注中成藥熱毒寧注射液7 d;肺部啰音明顯者加用丹參注射液3 d。總療程14 d。分別記錄治療前與治療后第7，14天的癥候評分并評價療效。結果 3組病例臨床癥候積分在第7，14天時均明顯減少。各組主癥減分率結果比較，第7天內外合治組減分率高于內治組、外治組，差異有統(tǒng)計學意義(P0.05);風熱閉肺證第7天內外合治組減分率高于內治組、外治組，差異有

3、統(tǒng)計學意義(P0.05);痰熱閉肺證第7，14天3組減分率比較差異均無統(tǒng)計學意義(P0.05)。各組發(fā)熱、痰壅、咳嗽、氣喘、肺部啰音的起效時間比較差異均無統(tǒng)計學意義(P0.05)。各組綜合療效比較，第7天內外合治組愈顯率70.2%(160/228)高于內治組59.9%(124/207)、外治組56.6%(116/205)，差異有統(tǒng)計學意義(P0.05);風熱閉肺證第7天內外合治組愈顯率74.0%(77/104)高于內治組58.1%(54/93)、外治組54.7(58/106)，差異有統(tǒng)計學意義(P0.05);風熱閉肺證、痰熱閉肺證第14天各組愈顯率比較差異亦均無統(tǒng)計學意義(P0.05)。結論

4、采用中醫(yī)辨證論治原則的內治法、采用藥物貼療法的外治法與內外合治法治療小兒肺炎喘嗽均有顯著療效;中醫(yī)藥療法治療肺炎早期更具優(yōu)勢;藥物貼敷療法更顯簡單方便，值得借鑒。 【關鍵詞】 肺炎喘嗽; 風熱閉肺證; 痰熱閉肺證; 內治法; 外治法; 兒童【Abstract】 Objective To evaluate the effect superiority of TCM on childrens pneumonia with“wind and heat blocking the lung syndrome”and“phlegmheatobstructingthelung syndrome”object

5、ively.Methods Multicenter,randomized controlled study was done on 640 cases of pneumonia with“wind and heat blocking the lung syndrome”and“phlegmheat obstructing the lung syndrome”in thirteen hospitals by TCM clinical validation scheme.Children with pneumonia were randomly divided into 3 groups.Besi

6、des the basic treatment of Chinese patent drug by intravenous injections,children in group A were treated with TCM decoction according to syndrome;in group B,the patients were treated by external application of Fubei plaster,while the children in group C were treated by internal administration and e

7、xternal application of Fubei plaster.The course of therapy was 14 days for each group.The childrens clinical symptoms were recorded at the 1,7,14 days of admission.To all these groups,the general effect and syndrome score of TCM were analyzed.Results In these three groups,the score of clinical sympt

8、oms obviously decreased after treatment,indicateding that three therapies all let patients condition ameliorate,and the clinical outcome time corresponds with course of childrens pneumonia.On the 7th day,in group C,the score diminishing rates were better than the other groups (P0.05).There was no di

9、fference among the three groups on the symptom in fever,sputum,cough,breathlessness and auscultation on the lung recovered (P0.05).On the 7th day, the effective rates were 59.9% in group A, 56.69% in group B and 70.2% in group C respectively.There was significant difference among the three groups (P

10、0.05), which meant clinical effect of group C was superior than the other groups. At the same points for the “wind and heat blocking the lung syndrome”,the effective rates were 58.1% in group A,54.8% in group B and 74.0% in group C respectively.There was significant difference among the three groups

11、 (P0.05).Conclusions TCM has marked clinical effect on childrens pneumonia,whether by internal administration of Chinese recipe prescribed according to syndrome differentiation,external application of Fubei plaster,or combining both methods,especially in the early stage of pneumonia.Besides,applicat

12、ion therapy is more handy simpler and more convenient,so we could popularize this method.【Keywords】 pneumonia with dyspnea and cough; wind and heat blocking the lung syndrome; phlegmheat obstructing the lung syndrome; internal therapy; external therapy; children肺炎是小兒時期常見的肺系疾病，好發(fā)于嬰幼兒，年齡越小發(fā)病率越高，病情越重。世

13、界衛(wèi)生組織(WHO)已將該病列為全球3種重要的兒科疾病之一，中國也將其作為兒科重點防治的4種疾病之一。據WHO報道，小兒肺炎是5歲以下兒童最主要的死亡原因，嚴重危害小兒的身體健康1?！笆濉逼陂g汪受傳等2、王雪峰等3分別對兒童肺炎進行多中心的臨床研究，結果證實風熱閉肺證、痰熱閉肺證是兒童肺炎的主要證型。為驗證中醫(yī)不同療法治療小兒肺炎的療效，筆者于200909/201004在國家中醫(yī)藥管理局“十一五”重點中醫(yī)專科兒科肺炎協(xié)作組成員單位中認真梳理了中醫(yī)治療肺炎的診療方案，對協(xié)作組中共識較為集中的“中醫(yī)藥防治肺炎喘嗽風熱閉肺證與痰熱閉肺證的診療方案”進行了多中心區(qū)組隨機對照的臨床驗證工作，現(xiàn)將驗證結

14、果報道如下。1 資料與方法1.1 臨床資料病例分別來源于200909/201004在廣西中醫(yī)學院第一附屬醫(yī)院、遼寧中醫(yī)藥大學附屬醫(yī)院、吉林省中醫(yī)研究院、長春中醫(yī)藥大學第一附屬醫(yī)院、廈門市中醫(yī)院、牡丹江市中醫(yī)院、湖南中醫(yī)藥大學第一附屬醫(yī)院、平頂山市中醫(yī)院、南陽市中醫(yī)院、山東中醫(yī)藥大學附屬醫(yī)院、上海中醫(yī)藥大學附屬龍華醫(yī)院、廣東省中醫(yī)院、成都中醫(yī)藥大學第一附屬醫(yī)院住院患兒，共計640例。按照區(qū)組隨機方法將納入驗證的病例分為內治組207例、外治組205例、內外合治組228例;風熱閉肺證內治組93例，外治組106例，內外合治組104例;痰熱閉肺證內治組114例，外治組99例，內外合治組124例。3組患兒

15、年齡分布比較差異有統(tǒng)計學意義(P0.05);3組患兒入組時病情嚴重程度積分情況比較差異無統(tǒng)計學意義(P0.05);3組中風熱閉肺證、痰熱閉肺證證型分布與積分比較差異無統(tǒng)計學意義(P0.05);3組風熱閉肺證、痰熱閉肺證在發(fā)熱、痰壅、咳嗽、氣喘、肺部聽診、胸片等各癥狀積分比較差異均無統(tǒng)計學意義(P0.05)，具有可比性。見表1。表1 3組患兒一般資料比較1.2 診斷標準參照中華中醫(yī)藥學會兒科分會2008年小兒肺炎喘嗽中醫(yī)診療指南4，臨床表現(xiàn)為氣喘，咳嗽，咯痰痰鳴，發(fā)熱，肺部聞及中、細濕啰音。X線全胸片可見小片狀、斑片狀陰影，也可出現(xiàn)不均勻的大片狀陰影，或為肺紋理增多、紊亂，肺部透亮度增強或降低。

16、病原學檢查細菌培養(yǎng)、病毒學檢查等可獲得相應的病原學診斷。細菌性肺炎，白細胞總數(shù)可升高，中性粒細胞增多;病毒性肺炎，白細胞總數(shù)正?；蚱汀⒄諊抑嗅t(yī)藥管理局中醫(yī)病證診斷療效標準中醫(yī)兒科病證診斷療效標準內肺炎喘嗽的風熱閉肺、痰熱閉肺證候分類標準5。1.3 納入標準(1)符合中醫(yī)肺炎喘嗽的診斷標準;(2)中醫(yī)辨證屬風熱閉肺證或痰熱閉肺證者;(3)年齡17歲;(4)知情同意并簽署知情同意書。1.4 排除標準(1)合并有嚴重營養(yǎng)不良、佝僂病、哮喘及心、肝、腎和造血系統(tǒng)等嚴重原發(fā)疾病、消耗性疾病者;(2)原發(fā)性免疫缺陷病、肺發(fā)育不良、吞咽功能不全者;(3)根據醫(yī)生判斷，容易造成失訪者。1.5 治療方案按中醫(yī)辨證屬風熱閉肺證者用麻杏石甘湯加味，處方：炙麻黃5 g，生石膏20 g，杏仁8 g，甘草6 g，魚腥草10 g，瓜蔞殼8 g，銀花10 g，連翹8 g。發(fā)熱者加粳米或