中医内外合治综合方案改善小儿病毒性肺炎中医证候的多中心随机对照研究

Multicentre randomized controlled study on the improvement of TCM syndromes of pediatric viral pneumonia by comprehensive internal and external treatment of Chinese medicine

目的:评价中医内外合治综合方案治疗小儿病毒性肺炎风热闭肺证和痰热闭肺证的临床疗效和安全性。方法:采用多中心、分层区组、随机对照的临床试验设计方法,分6个中心,将450例病毒性肺炎住院患儿以2∶1比例随机分为治疗组和对照组。治疗组予喜炎平注射液静脉滴注,风热闭肺证予小儿清肺合剂加止咳散口服,痰热闭肺证予小儿清肺合剂加化痰散口服,两证型患儿背部均外用敷胸散,对照组予利巴韦林注射液静脉滴注,愈酚甲麻那敏糖浆口服。疗程均10d。观察两组患儿治疗后中医证候总体疗效及每日疾病积分、风热闭肺证及痰热闭肺证患儿每日证候积分及安全性评价。结果:合格病例421例,其中,治疗组290例,对照组131例。治疗后,治疗组中医证候总体疗效优于对照组(P<0.05),第3、4天治疗组疾病积分变化与对照组比较,显著降低(P<0.05)。痰热闭肺证在第3、4、5天的证候积分改善情况优于对照组(P<0.05),而风热闭肺证患儿每日证候积分变化与对照组比较差异无统计学意义。两组均未发现不良反应。结论:中医内外合治综合方案治疗小儿病毒性肺炎痰热闭肺证具有一定的临床疗效和较高的安全性。

Objective: To investigate the clinical effect and safety of traditional Chinese medicine internal-external combined therapy on children viral pneumonia with wind-heat blocking the lung syndrome and phlegm-heat obstructing the lung syndrome. Methods: A total of 450 patients with viral pneumonia were randomly divided into treatment group and control group at 2∶1 ratio by using the multi-center, stratified group and randomized controlled clinical trial design. The treatment group was given Xiyanping Injection Intravenous infusion. The wind-heat blocking lung syndrome was given children Qingfei Mixture plus Qingfei Powder orally, and phlegm-heat obstructing lung syndrome was given children Qingfei Mixture plus Huatan Powder orally, with Fuxiong Powder for external use on the back. The control group was given Ribavirin Injection intravenous infusion combined with Guaifenesm Methylephedrinc and Chlorphenamine Syrup orally, lasting for 10 days. The overall curative effect of TCM syndrome, the daily disease score, the daily syndrome score of children with wind-heat blocking lung syndrome, the daily syndrome score and the safety evaluation of children with phlegm-heat obstructing lung syndrome were observed. Results: A total of 421 cases were qualified cases, of which 290 cases were in treatment group and 131 cases in the control group. After treatment, the overall efficacy of traditional Chinese medicine syndrome in the treatment group was better than that in the control group(P<0.05). Compared with the control group, the changes of disease scores in the treatment group was significant on the 3 rd, 4 th day(P<0.05), and the improvement of syndrome score of phlegm-heat obstructing lung syndrome on the 3 rd, 4 th, 5 th day was better than those in the control group(P<0.05). There was no significant difference in the daily syndrome score between wind-heat blocking lung syndrome group and the control group. No adverse reactions were found in both groups. Conclusion: Comprehensive treatment of internal-external combined therapy of traditional Chinese medicine on children viral pneumonia with wind-heat blocking the lung syndrome and phlegm-heat obstructing the lung syndrome has a certain clinical efficacy and high safety.