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

1、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 11-01-27 11:08:00 编辑：studa20 作者：王力宁， 王雪峰， 原晓风， 李燕宁， 高树彬，杨岩姜之炎, 洪丽君 张炜， 胡香玉，刘小凡， 王孟清， 李伟伟， 许尤佳， 李立新， 【摘要】 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

2、、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7 d;肺部啰音明显者加用丹参注射液3 d。总疗程14 d。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(P0.05);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

3、统计学意义(P0.05);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(P0.05)。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(P0.05)。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(P0.05);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(P0.05);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(P0.05)。结论

4、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。 【关键词】 肺炎喘嗽; 风热闭肺证; 痰热闭肺证; 内治法; 外治法; 儿童【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肺炎是小儿时期常见的肺系疾病，好发于婴幼儿，年龄越小发病率越高，病情越重。世

13、界卫生组织(WHO)已将该病列为全球3种重要的儿科疾病之一，中国也将其作为儿科重点防治的4种疾病之一。据WHO报道，小儿肺炎是5岁以下儿童最主要的死亡原因，严重危害小儿的身体健康1。“十五”期间汪受传等2、王雪峰等3分别对儿童肺炎进行多中心的临床研究，结果证实风热闭肺证、痰热闭肺证是儿童肺炎的主要证型。为验证中医不同疗法治疗小儿肺炎的疗效，笔者于200909/201004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成员单位中认真梳理了中医治疗肺炎的诊疗方案，对协作组中共识较为集中的“中医药防治肺炎喘嗽风热闭肺证与痰热闭肺证的诊疗方案”进行了多中心区组随机对照的临床验证工作，现将验证结

14、果报道如下。1 资料与方法1.1 临床资料病例分别来源于200909/201004在广西中医学院第一附属医院、辽宁中医药大学附属医院、吉林省中医研究院、长春中医药大学第一附属医院、厦门市中医院、牡丹江市中医院、湖南中医药大学第一附属医院、平顶山市中医院、南阳市中医院、山东中医药大学附属医院、上海中医药大学附属龙华医院、广东省中医院、成都中医药大学第一附属医院住院患儿，共计640例。按照区组随机方法将纳入验证的病例分为内治组207例、外治组205例、内外合治组228例;风热闭肺证内治组93例，外治组106例，内外合治组104例;痰热闭肺证内治组114例，外治组99例，内外合治组124例。3组患儿

15、年龄分布比较差异有统计学意义(P0.05);3组患儿入组时病情严重程度积分情况比较差异无统计学意义(P0.05);3组中风热闭肺证、痰热闭肺证证型分布与积分比较差异无统计学意义(P0.05);3组风热闭肺证、痰热闭肺证在发热、痰壅、咳嗽、气喘、肺部听诊、胸片等各症状积分比较差异均无统计学意义(P0.05)，具有可比性。见表1。表1 3组患儿一般资料比较1.2 诊断标准1.2.1 疾病诊断标准参照中华中医药学会儿科分会2008年小儿肺炎喘嗽中医诊疗指南4，临床表现为气喘，咳嗽，咯痰痰鸣，发热，肺部闻及中、细湿啰音。X线全胸片可见小片状、斑片状阴影，也可出现不均匀的大片状阴影，或为肺纹理增多、紊乱

16、，肺部透亮度增强或降低。病原学检查细菌培养、病毒学检查等可获得相应的病原学诊断。细菌性肺炎，白细胞总数可升高，中性粒细胞增多;病毒性肺炎，白细胞总数正常或偏低。1.2.2 证候诊断标准参照国家中医药管理局中医病证诊断疗效标准中医儿科病证诊断疗效标准内肺炎喘嗽的风热闭肺、痰热闭肺证候分类标准5。1.3 纳入标准(1)符合中医肺炎喘嗽的诊断标准;(2)中医辨证属风热闭肺证或痰热闭肺证者;(3)年龄17岁;(4)知情同意并签署知情同意书。1.4 排除标准(1)合并有严重营养不良、佝偻病、哮喘及心、肝、肾和造血系统等严重原发疾病、消耗性疾病者;(2)原发性免疫缺陷病、肺发育不良、吞咽功能不全者;(3)根据医生判断，容易造成失访者。1.5 治疗方案1.5.1 中医辨证内治方案按中医辨证属风热闭肺证者用麻杏石甘汤加味，处方：炙麻黄5 g，生石膏20 g，杏仁8 g，甘草6 g，鱼腥草10 g，瓜蒌壳8 g，银花10 g，连翘8 g。发热者加粳