柴朴颗粒联合常规疗法治疗难治性哮喘临床观察

作者	单位
于农	山东潍坊哮喘病医院医学部
温明春	山东潍坊哮喘病医院医学部
魏春华	山东潍坊哮喘病医院医学部
刘艳红	山东潍坊哮喘病医院医学部
李国华	山东潍坊哮喘病医院医学部

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中文摘要:

目的评价柴朴颗粒联合常规疗法对难治性哮喘的治疗作用。方法 60例难治性哮喘患者随机双盲分为治疗组和对照组,每组30例,两组均采用常规治疗(规律吸入沙美特罗替卡松(50/250μg)、按需吸入沙丁胺醇异丙托溴胺雾化液),治疗组加用柴朴颗粒,每天6袋,分2次冲服。对照组加用外观与柴朴颗粒一致的安慰剂,每天6袋,分2次冲服,两组均治疗24周。分别于治疗前、治疗4周、12周、24周观察哮喘控制测试(asthma control test,ACT)评分、肺功能检测一秒用力呼气容积(forced expiratory volume in one second,FEV1)、峰流速(peak expiratory flow,PEF)监测、记录哮喘日记、记录激素使用、撤停反应及不良反应。分别于治疗前及治疗24周测定血皮质醇(Cor)、总IgE、细胞因子(IL-4、IL-5、IL-13及IFN-γ)。结果两组患者经过治疗其症状及肺功能均有明显改善,但治疗组患者在各时间点均优于对照组,两组比较差异有统计学意义(P<0.05);经过24周治疗两组患者血IL-5、IL-13、总IgE下降,IFN-γ、Cor增高,与治疗前比较差异有统计学意义(P<0.01,P<0.05),但治疗组改善更明显,两组比较差异有统计学意义(P<0.05);从两组患者激素撤停情况来看,治疗组患者全部撤停激素时间均值为(14.6±5.1)天,激素撤停全身反应发生率为20%,且较轻微,对照组全部撤停激素时间均值为(22.1±6.8)天,激素撤停全身反应发生率为36.7%,其中1例因为哮喘大发作退出治疗,两组比较差异有统计学意义。从不良反应看,治疗组患者除3例发生轻微腹胀外,未发现明显与治疗相关的不良反应。结论柴朴颗粒能有效改善难治性哮喘患者的临床症状及肺功能;调节Th1/Th2平衡,改善患者肾上腺皮质的分泌功能,提示柴朴颗粒是一种治疗难治性哮喘的安全、有效的中药制剂。

英文摘要:

Objective To evaluate the therapeutic effect of Chaipo Granule (CPG) combined with routine treatment on refractory asthma. Methods Sixty patient with refractory asthma were assigned equally in a double-blind,randomized way to the treatment group and the control group. Routine treatment (including regular inhalation of salmeterol and fluticasone propionate 50/250 μg,and if necessary,inhalation of salbutamol+ ipratropium bromide) were given to all patients. CPG (3 pouches every time,twice a day) were administered to the treatment group in addition,while to the control group,placebo with similar appearance in equal volume was given. The therapeutic course for all was 24 weeks. Asthma control test (ACT) scoring and lung function tests (FEV1 and PEF) were performed before treatment and at the end of the 4th,12th and 24th week; daily records of asthma,dose of hormone used,withdrawal reaction and adverse reaction occurred were monitored,and serum levels of cortisol,total IgE and cytokines (IL-4,IL-5,IL-13 and IFN-γ) were measured before treatment and at terminating the 24-week treatment. Results Symptoms and lung function were significantly improved after treatment in both groups,but the improvements were better in the treatment group than the control group at all time points,the difference between groups was statistically significant(P<0.05). Levels of IL-5,IL-13,total IgE decreased,IFN-γ and Cor increased in all patients after 24-week treatment,but the improvements in the treatment group was more significant,with statistical difference between groups (P<0.05); the mean hormone withdrawal time in the treatment group was (14.6±5.1) days,with the incidence of systemic withdrawal reactions of 20%,while those in the control group was (22.1±6.8) days and 36.7% correspondingly,the difference between groups was statistically significant (P<0.05). However,one patient in the treatment group quit the trial due to a severe seizure of asthma. No obvious treatment-related side effects appeared in the treatment group,except that 3 patients suffered from slight abdominal pain. Conclusions CPG could improve the clinical symptoms and lung function,facilitate to Th1/Th2 balance and enhance the secretion of adrenal cortex. It is an effective and safe Chinese herbal remedy for treatment of refractory asthma.

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