【作者】 任辉杰；

【导师】 郁晓维；

【作者基本信息】 南京中医药大学 ， 中医儿科学， 2007， 硕士

【摘要】 目的：小儿呼吸道合胞病毒(RSV)肺炎是多发生于婴幼儿的急性下呼吸道病毒感染性疾病，发病率较高，国外研究报道几乎所有儿童在2岁以下感染过RSV~1。病情较重，有一定的死亡率，并且可能给儿童的肺功能带来长期的影响，威胁小儿的生命质量。按照小儿病毒性肺炎痰热闭肺证的病机，制成清肺口服液，用于治疗小儿病毒性肺炎，取得了良好的效果。为进一步评价清肺口服液治疗小儿呼吸道合胞病毒肺炎痰热闭肺证的有效性，我们开展本项随机对照临床试验。资料和方法：南京中医药大学附属医院、中国人民解放军南京军区南京总医院、盐城市中医院按照相关标准共纳入99例RSV肺炎患儿，随机入组。其中试验组52例，使用清肺口服液加用不合抗病毒药物的液体静滴，对照组47例，使用利巴韦林注射液加用清肺口服液安慰剂口服。两组均根据病情和方案采取相应的对症处理措施。依方案规定填写病例报告表，在microsoft access系统中建立数据库，应用SAS9.13进行数据处理，并采用适当的统计分析方法进行统计分析。研究结果：主要症状咳嗽、痰鸣、气喘、肺部听诊的改善方面试验组明显优于对照组，表现在改善时间较早，改善程度较大，或者最终改善结果较好；而发热改善方面，两组无显著差异；次要症状中食欲和舌象等症状体征改善方面，试验组明显优于对照组，其余次要症状多无显著差异。在临床理化检查指标变化方面，X线胸片检查评分组间比较，在治疗前后评分差值方面试验组优于对照组，差别有统计学意义，但最终结果两组无显著性差异。试验组和对照组主症积分组间比较，第二天起差别有高度统计学意义(P＜0.01)；次症积分组间比较，第二天起差别有高度统计学意义(P＜0.01)；总积分组间比较，第二天起差别有高度统计学意义(P＜0.01)，积分减少方面，试验组优于对照组。疗效评定方面，试验组痊愈率为82.69％，对照组痊愈率为31.91％，两组相比差别有高度统计学意义(P＜0.01)，试验组优于对照组；试验组总有效率为100.00％，对照组总有效率为97.87％，两组总有效率相比差别无统计学意义(P＞0.05)，两组无显著性差异；综合疗效两组对比，差别有高度统计学意义(P＜0.01)，试验组优于对照组。结论：清肺口服液是治疗小儿呼吸道合胞病毒肺炎痰热闭肺证的有效药物。更多还原

【Abstract】 Object: Childhood RSV pneumonia is a disease of the lower respiratory infection,which is caused by virus. The mobility of childhood RSV pneumonia was growing. Almost,all of the children have contacted RSV before it was 3 years old. The childhood RSVpneumonia is serious most of the time; some of the patients may die of this disease. It canalso affect their lung functions in the last of life. Previously the scientists of our departmenthave studied in this subject. They found that more than three quarters of RSV pneumoniachildren are of the syndrome of phlegm and heat obstructing lung. Moreover, they product acompound named qingfei oral liquid. It is effective to cure the syndrome of phlegm andheat obstructing the pulmonary of childhood virus pneumonia. To evaluate the effectivenessof qingfei oral liquid for the syndrome of phlegm and heat obstructing the pulmonary ofchildhood RSV pneumonia, we conduct this multi-center randomized controlled clinicaltrial.Data and method: There are 99 subjects in this trial; all of them are inpatients ofaffiliated hospital of Nanjing university of CM, Nanjing general hospital of Nanjingmilitary area and Yancheng hospital of TCM. Fifty-two of the subjects are in the therapyarm, treating with the qingfei oral liquid; and 47 of the last in the control arm, treating withribavirin. After that, the investigators finish the case report forms. The statistical analysissoftware we used is SAS9.13.Result: Qingfei oral liquid group is superior to control group in the improvement of themain symptoms and signs, like cough, rale, and some second symptoms and signs asappetite, and tongue. However, in the improvement of some other symptoms, it is not advanced. In addition, there is little differentiation between the two arms in the X-rayscores before and after the trial. Nevertheless, the integrate effectiveness of qingfei oralliquid is excelled than that of the control group.Conclusion: qingfei oral liquid is an effective compound for the syndrome of phlegmand heat obstructing the pulmonary of childhood RSV pneumonia.更多还原