金龙固本补肺健脾合剂治疗支气管哮喘缓解期多中心随机对照试验研究

Multi-center randomized controlled trials about Jinlong Guben-Bufei Jianpi Heji treating asthma in remission

目的评价金龙固本补肺健脾合剂治疗支气管哮喘缓解期的临床疗效与安全性。方法将239例支气管哮喘缓解期患者随机分为治疗组和对照组,治疗组予金龙固本补肺健脾合剂连续口服4个月,对照组不予药物干预,观察治疗后及随访12个月疾病复发率、国际哮喘控制测试表(ACT)、血嗜酸性粒细胞(EOS)计数等指标。结果疾病复发率:治疗组总有效率为98.29%,对照组总有效率为77.27%,两组间比较差异有显著统计学意义(P<0.01);国际哮喘控制测试表(ACT):两组间比较差异有统计学意义(P<0.01);外周血嗜酸性粒细胞(EOS)计数:两组有明显差异(P<0.01)。结论金龙固本合剂能降低哮喘患者外周血嗜酸性粒细胞水平,明显减少支气管哮喘发作次数,预防支气管哮喘急性发作,并且未发现明显的毒副作用及不良反应,为哮喘缓解期临床用药提供了新的选择。

Objective To observe the effects and security of Jinlong Guben - Bufei Jianpi Heji treating asthma in remission. Methods 239 patients with Asthma in remission stage were randomized to two groups;The treatment group treated with Jinlong Guben- Bufei Jianpi Heji for 4 months ,the control group without treatment. All patients were followed up for 12 months , to observe the recurrence rate,Asthma Control Test （ACT）, Eosinophil count etc. Results The recurrence rate：the treatment group ： the total effective rate is 98.29% ;the control group： the total effective rate is 77.27%, there is very significant difference between the two groups （P 〈 0.01 ） ;there is very significant difference between the two groups in Asthma Control Test （ACT）and Eosinophil count （P 〈 0.01 ）. Conclusion Jinlong Guben -Bufei Jianpi Heji treating asthma in remission is safe and effective.