中医药治疗小儿肺炎喘嗽风热闭肺证、痰热闭肺证临床验证方案的多中心随机对照研究

Research of TCM clinical validation scheme on children's pneumonia with"wind and heat blocking the lung syndrome" and "phlegm-heat obstructing the lung syndrome" by multi-center randomized controlled study

目的客观评价中医药治疗小儿肺炎喘嗽风热闭肺证、痰热闭肺证临床疗效及各治疗方案的优势。方法在国家中医药管理局"十一五"重点中医专科儿科肺炎协作组的13家医院中进行中医治疗小儿肺炎喘嗽诊疗方案验证的多中心随机对照研究。资料完整的病例共640例,均符合风热闭肺证、痰热闭肺证,随机分为内治组207例、外治组205例、内外合治组228例。内治组方案:风热闭肺证用以麻杏石甘汤加味,痰热闭肺证用五虎汤合葶苈大枣泻肺汤加减,内服汤剂或保留灌肠;外治组方案:采用背穴药物贴敷;内外合治组方案:同时用内治组方案与外治组方案,即内服汤剂(或保留灌肠)+药物背穴贴敷。各组常规静脉滴注中成药热毒宁注射液7d;肺部啰音明显者加用丹参注射液3d。总疗程14d。分别记录治疗前与治疗后第7,14天的症候评分并评价疗效。结果 3组病例临床症候积分在第7,14天时均明显减少。各组主症减分率结果比较,第7天内外合治组减分率高于内治组、外治组,差异有统计学意义(P<0.05);第14天3组减分率比较差异无统计学意义(P>0.05);风热闭肺证第7天内外合治组减分率高于内治组、外治组,差异有统计学意义(P<0.05),第14天3组减分率比较差异无统计学意义(P>0.05);痰热闭肺证第7,14天3组减分率比较差异均无统计学意义(P>0.05)。各组发热、痰壅、咳嗽、气喘、肺部啰音的起效时间比较差异均无统计学意义(P>0.05)。各组综合疗效比较,第7天内外合治组愈显率70.2%(160/228)高于内治组59.9%(124/207)、外治组56.6%(116/205),差异有统计学意义(P<0.05);风热闭肺证第7天内外合治组愈显率74.0%(77/104)高于内治组58.1%(54/93)、外治组54.7(58/106),差异有统计学意义(P<0.05);痰热闭肺证第7天各组愈显率比较差异无统计学意义(P>0.05);风热闭肺证、痰热闭肺证第14天各组愈显率比较差异亦均无统计学意义(P>0.05)。结论采用中医辨证论治原则的内治法、采用药物贴疗法的外治法与内外合治法治疗小儿肺炎喘嗽均有显著疗效;中医药疗法治疗肺炎早期更具优势;药物贴敷疗法更显简单方便,值得借鉴。

Objective To evaluate the effect superiority of TCM on children＇s pneumonia with＂wind and heat blocking the lung syndrome＂and＂phlegm-heat-obstructing-the-lung syndrome＂objectively.Methods Multi-center,randomized controlled study was done on 640 cases of pneumonia with＂wind and heat blocking the lung syndrome＂and＂phlegm-heat obstructing the lung syndrome＂in thirteen hospitals by TCM clinical validation scheme.Children with pneumonia were randomly divided into 3 groups.Besides 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 external application of Fubei plaster.The course of therapy was 14 days for each group.The children＇s 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 symptoms obviously decreased after treatment,indicateding that three therapies all let patients＇ condition ameliorate,and the clinical outcome time corresponds with course of children＇s pneumonia.On the 7th day,in group C,the score diminishing rates were better than the other groups（P0.05）,especially in the group of＂wind and heat blocking the lung syndrome＂.The score diminishing rates in the group of＂phlegm-heat obstructing the lung syndrome＂and on 14th day were of no differences among the three groups（P0.05）.There was no difference 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（P0.05）,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（P0.05）;and for the＂phlegm-heat obstructing the lung syndrome＂on the 14th day,there was no significant difference among the three groups（P0.05）.Conclusions TCM has marked clinical effect on children＇s 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,application therapy is more handy simpler and more convenient,so we could popularize this method.