中西医结合方案与西医方案治疗儿童社区获得性肺炎轻症疗效比较的前瞻性队列研究

Comparative Study of Integrated Traditional Chinese and Western Medicine versus Western Medicine for Children’s Community-acquired Pneumonia:A Prospective Cohort

目的比较中西医结合方案与西医方案治疗儿童社区获得性肺炎(CAP)的临床疗效及安全性。方法采用前瞻性队列研究方法,收集国内13家三级甲等儿科专科医院及中医药大学附属医院儿科就诊的CAP患者,根据患儿应用治疗方案不同分为西医组及中西医结合组,采用倾向性评分匹配(PSM)的方法计算基线资料中两组比较有统计学意义的变量和混杂因素分值,按照1∶1最近邻近匹配法进行匹配,共424例病例匹配成功,每组212例。采用重复测量方差分析、Kaplan-Meier生存分析、Log Rank检验等方法评价两组治疗方案的疾病痊愈率、疾病积分下降趋势、症状/体征消失率和消失时间、住院费用和住院时间等的差异。结果国内大型医院治疗CAP时中西医结合方案实际应用比率为77.4%;西医机构应用中西医结合治疗方案时多使用中成药,中成药使用占比74.3%。中西医结合组治疗CAP第7天痊愈率为54.72%优于西医组的44.34%(P<0.05),但14天内疾病积分下降趋势组间比较差异无统计学意义(P>0.05);第7天主要症状与体征消失率及消失时间比较,两组患儿在咯痰症状、肺部湿啰音方面差异有统计学意义(P<0.05),中西医结合组听诊湿啰音的消失率更高且消失时间更短,而西医组咯痰的消失率与消失时间更优。两组患儿住院时间差异无统计学意义(P>0.05);中西医结合组不良反应发生率较西医组更低(P<0.05);中西医结合组在真实世界的经济成本较西医组更低(P<0.05)。结论中西医结合治疗方案能更快速、有效地改善患儿肺部湿啰音体征,且安全性与经济性均优于西医治疗方案。

ObjectiveTo compare the clinical effect and safety of integrated traditional Chinese and western medicine versus western medicine alone in the treatment of children’s community-acquired pneumonia(CAP).Methods A prospective cohort study was conducted in 13 domestic tertiary first-class pediatric hospitals and the pediatirc department of affiliated hospitals of the university of traditional Chinese medicine(TCM).Children with CAP were included,and were naturally divided into western medicine group and integrated traditional Chinese and western medicine group according to the treatment they were given.The propensity score matching(PSM)method was used to calculate the scores of baseline variables and confounding factors that were statistically significant between the two groups,and were matched with 1∶1 nearest neighbor matching.A total of 424 cases were successfully matched,with212 cases in each group.Repeated measures analysis of variance,Kaplan-Meier survival analysis,Log Rank test and other methods were used to analyze and compare the overall recovery rate of disease,the decreasing trend of disease score,the disappearance rate and disappearance time of symptoms or syndrome,hospitalization cost and length of stay between groups.Results The utilization rate of integrated traditional Chinese and western medicine in large hospitals in domestic China was 77.4%.Western medicine institutions mostly used Chinese patent medicines when applying integrated treatment,accounting for 74.3%of the total.The 7-day recovery rate of the integrated treatment group was 54.72%,significantly higher than 44.34%of the western medicine group(P<0.05),but there was no difference in the decreasing trend of disease score within 14 days between the groups(P>0.05).There was significant difference between groups in the disappearance rate and disappearance time of cough,expectoration,and auscultation rales on the 7th day(P<0.05),which was in favor of the integrated group.The disappearance rate of auscultation wet rales was higher and the disappearance time was shorter in the integrated group,while the disappearance rate the disappearance time of expectoration were better in the western medicine group.There was no significant difference in length of stay between the two groups(P>0.05).The integrated group had lower rate of adverse reactions(P<0.05),and lower hospitalization cost(P<0.05).Conclusion sThe integrated traditional Chinese and western medicine can improve the symptoms of pulmonary wet rales in children with CAP more quickly and effectively,and is superior to western medicine alone in terms of the safety and cost.