目的:观察清肺解毒汤加减治疗儿童大叶性肺炎临床疗效及安全性。方法:采用双中心、随机、对照方法纳入90例确诊为大叶性肺炎住院患儿，治疗组60例，对照组30例（按治疗组与对照组2∶1分组，因考虑临床疗效，可充分显示治疗组的作用又不影响统计学分析）。对照组予基础治疗加安慰剂治疗，治疗组予基础治疗联合清肺解毒汤加减治疗。疗程2周，观察两组在发热、咳嗽、啰音、肺部X线/CT、实验室指标等方面变化及安全性。结果：治疗组愈显率为81.7%，对照组愈显率为66.7%，差异具有统计学意义（P<0.05）；安全性比较，治疗组较对照组更为安全，差异具有统计学意义（P<0.05）。结论:清肺解毒汤加减治疗儿童大叶性肺炎的疗效显著，安全性好。

This study was aimed to investigate the clinical effect and safety of Qing- Fei Jie- Du (QFJD) decoction on treating lobar pneumonia in children. Ninety cases of children diagnosed with lobar pneumonia in hospital were selected by double-centre, random and control method. Cases were divided into the test group (60 cases) and the control group (30 cases. The ratio between the test group and the control group was 2:1. It can fully demonstrate the effect of the test group without any influence on the statistical analysis). Children of the control group were given conventional medicine with placebo, while children of the test group were given conventional medicine with modified QFJD decoction. The treatment course was 2 weeks. The clinical symptoms including fever, cough, lung rale, lung image (X-ray or CT scan), laboratorial index and safety were compared between two groups. The results showed that the recovery rate of the test group was 81.7%; and the recovery rate of the control group was 66.7%. The difference between them was statistically significant (P<0.05). The comparison of safety between two groups indicated that the treatment of the test group was safer than control group with statistical difference (P<0.05). It was concluded that modified QFJD decoction had a significant clinical effect and was very safe in the treatment of children with lobar pneumonia.

国家中医临床研究基地业务建设科研专项课题（JDZX2012105），负责人：宋桂华；河南省重点中医学科（专科）学术带头人培养项目专项课题（2013ZY03020），负责人：宋桂华；史纪全国名老中医药专家传承工作室项目（CZ0008），负责人：宋桂华。