【作者】 任献国；

【导师】 韩新民；

【作者基本信息】 南京中医药大学 ， 中医儿科学， 2004， 硕士

【摘要】 目的 应用清肺口服液治疗小儿病毒性肺炎的主要证型痰热闭肺证，并以利巴韦林注射液为对照进行临床研究，从而评价清肺口服液的有效性和安全性，揭示开肺化痰解毒法治疗小儿病毒性肺炎痰热闭肺证的科学性。 方法 遵循盲法、分层区组随机、平行对照的原则，在南京军区南京总医院住院病例中，选择符合西医小儿病毒性肺炎和中医小儿肺炎喘嗽痰热闭肺证证候珍断标准的患儿90例，按电脑随机化2：1分为试验组(Ⅰ组)和对照组(Ⅱ组)，建立随机密码表。填写统一的病历报告表，进行治疗前后对照比较观察研究。Ⅰ组为试验组，口服具有开肺化痰解毒功用的清肺口服液，加用不含抗病毒抗菌药物的澄清静滴液；Ⅱ组为对照组，用利巴韦林注射液静脉滴注，加用不含药物成分的口服液安慰剂。观察疗程为10天。 结果 研究前的一般资料、主症、次症和理化检查结果，除性别、舌质两项外，两组间均无显著性差异，说明两组具有可比性。研究结束后，符合方案集试验组58例、对照组29例，两组痊愈、显效、进步、无效例数分别为：50、5、3、0，15、14、0、0。经秩和检验，Z=4.63，P＜0.0001，试验组疗效非常显著优于对照组。症状、体征、理化检查结果：咳嗽、鼻煽，肺部湿啰音，紫绀、恶心呕吐、小便、四肢，X线全胸片等指标好转情况，试验组均优于对照组；发热、痰鸣(咯痰)、气促、恶寒、面色、精神、出汗、口渴、大便，血常规，鼻咽部分泌物呼吸道病毒学检查，两组疗效无显著性差异。临床安全性指标研究结果，清肺口服液未显示对于重要脏器有毒副作用。 结论 清肺口服液治疗小儿病毒性肺炎痰热闭肺证是安全有效的，开肺化痰解毒法治疗小儿病毒性肺炎痰热闭肺证具有科学性和实用性。更多还原

【Abstract】 ObjectiveTo study on the treatment of accumulation of phlegm-heat in lung syndrome of children’s virus pneumonia with Qing Fei oral liquid, controlled by ribavirin injection. To assess the efficacy and safty of Qing Fei oral liquid and to discover that the therapy of clearing lung to resolve phlegm and removing toxical material in treating accumulation of phlegm-heat syndrome of children’s virus pneumonia is scientific. MethodsAccording to the rule of stratified randomization, equal control, blind, multicent clinical study, in Nanjing Military Area Central Hospital, 90 cases had been carefully chosen as study subjects according to the western medicine s diagnostic criterion of children’s virus pneumonia and the TCM diagnostic criterion of accumulation of phlegm-heat syndrome of children’s virus pneumonia. According to the rule of randomization, all subjects were divided into two groups, test group(group I ) and controlled group(group II ).The ration was 2:1.The randomized code form was also created by computer. The unified lists about cases were filled to study the difference between the status before cases being cured and after cases being cured.Group I was given Qingfei oral liquid, which has the function to resolve phlegm and removing toxical material, and infusion liquid without any antivirus and antibiotics. Group II was infusedribavirin injection and oral placebo. The observing course was 10 days.ResultsThere are, prior to the study, no significant differences between the two groups general information, the leading symptoms and signs, secondary symptoms and signs and physical examinations and laboratory tests except for the sex and texture of tongue. It means that the two groups can be compared. 58 cases of test group and 29 cases of controlled group accorded with the project. The cured, significant effective, improved and ineffective cases of group I were 50, 5, 3, 0. The cured, significant effective, improved and ineffective cases of group II were 15, 14, 0, 0. With rank sum test ,it showed that Z=4.63 , P< 0.0001 .The effect of test group was much better than of the controlled group. Compared with the controlled group, the indexes of test group of the symptoms, signs, physical examinations and laboratory tests including cough, flaring of nares, auscultation on lung, cyanopathy, urine, limb, X-ray of chest were much better. There are no significant differences between the two groups in treating fever, sputum, short breath, aversion to cold, feces, vitality, sweating, thirst, nausea, blood routine test and the virus test of the secretion of nose and throat. The study of clinical safety showed that Qingfei oral liquid had not any harms and side effects on important organs.Conclusions:T therapy of clearing lung to resolve phlegm and removing toxical material herapy of clearing lung to resolve phlegm and removing toxical material is effective in treating accumulation of phlegm-heat syndrome of children’s virus pneumonia.更多还原