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目的评价小儿牛黄清心散治疗毛细支气管炎的安全性及临床疗效。方法采用前瞻性、多中心、随机、对照的临床研究方法 ,在4个中心纳入800例毛细支气管炎住院患儿,按照随机分类方法分为两组,治疗组400例采用口服小儿牛黄清心散联合西医抗病毒治疗;对照组400例采用西医抗病毒治疗。以临床疗效、咳嗽消失时间、憋喘消失时间、热退时间、住院时间为主要指标,动态评估病情变化,评价不同干预措施的临床疗效。结果治疗组总有效率96.25%,明显高于对照组的83.75%(P<0.05);治疗组的咳嗽、憋喘、肺部啰音等体征消失时间及其退热、住院时间分别为(5.1±2.4)d、(4.2±0.8)d、(4.1±1.1)d、(1.5±0.4)d、(5.1±1.4)d,均明显优于对照组的(5.7±2.8)d、(4.4±1.2)d、(5.5±1.6)d、(2.8±0.5)d、(6.4±1.8)d(P<0.05)。结论小儿牛黄清心散治疗毛细支气管炎的临床疗效确切,并不增加临床不良反应。
Objective To evaluate the safety and clinical efficacy of Beihuang Qingxin San in the treatment of bronchiolitis. Methods A prospective, multicenter, randomized, controlled clinical study was conducted in 800 children with bronchiolitis admitted in 4 centers. According to the randomized classification, the patients were divided into two groups. The treatment group received oral combined with bezoar, Western medicine antiviral therapy; 400 cases of control group using Western antiviral therapy. The clinical curative effect, cough disappear time, disappear time of asthma, recuperation time and length of hospital stay were taken as the main indexes to evaluate the changes of the disease dynamically and evaluate the clinical curative effect of different interventions. Results The total effective rate in the treatment group was 96.25%, which was significantly higher than that in the control group (83.75%, P <0.05). The disappearance time of the cough, asthma, (4.2 ± 0.8) d, (4.1 ± 1.1) d, (1.5 ± 0.4) d and (5.1 ± 1.4) d were significantly higher than those in control group 1.2) d, (5.5 ± 1.6) d, (2.8 ± 0.5) d, (6.4 ± 1.8) d respectively (P <0.05). Conclusion Pediatric bezoar Qingxisan treatment of bronchiolitis clinical efficacy is exact, does not increase the clinical adverse reactions.