机构地区:[1]上海中医药大学附属岳阳中西医结合医院呼吸科,上海200437 [2]上海中医药大学附属岳阳中西医结合医院药剂科,上海200437
出 处:《辽宁中医杂志》2016年第3期466-471,共6页Liaoning Journal of Traditional Chinese Medicine
基 金:上海市教育委员会预算内科研项目(2011JW47)
摘 要:目的:参考当代有关仲景经方剂量的研究结果,适当提高支气管扩张症(支扩)稳定方中部分药物剂量,比较与原方的疗效差异。方法:将60例处于支气管扩张症稳定期,中医辨证为气阴两虚夹杂痰热的患者,随机、双盲分为支扩稳定方高剂量组和常规剂量组(各30例)。两组在胸部体位引流的基础上,分别服中药2周。治疗前后比较两组患者中医证候评分、24 h痰量、痰IL-8等的变化及不良反应。结果:治疗2周后,支扩稳定方高剂量组与常规剂量组在中医证候积分、24 h痰量前后自身比较均有明显改善(P<0.01)。但两组组间比较,以上指标与中医证候积分变化率、24痰量变化率均无显著差异(P>0.05)。常规剂量组治疗前、后痰IL-8显著降低(P<0.05),两组痰IL-8变化率有显著差异(P<0.05)。高剂量组发生不良事件11例,其中四级不良事件4例(包括咯血3例,胸痛1例),常规剂量组发生不良事件10例,其中四级不良事件1例(咯血1例),两组不良事件发生率及安全性分级评价无显著差异(P>0.05)。治疗前后,两组肝肾功能、血常规、心电图等均无明显变化,均无严重不良反应。结论:常规剂量与高剂量支扩稳定方皆具有改善支扩稳定期气阴两虚证夹杂痰热患者中医证候、减少痰量的作用,但无循证医学依据证明支扩稳定方高剂量组优于常规剂量组,且高剂量组咯血、胸痛等不良事件有增加的倾向。临床上应根据患者病情、辨证、体质等灵活选用合适剂量,在剂量上注重个体化可能是努力方向。Objective: Referring to the current research results of Zhongjing’ s classic prescriptions,to compare the differences in efficacy of high dose and conventional dose. Methods: A total of 60 patients in stable bronchiectasis with TCM syndrome of deficiency of both qi and Yin were randomly,double blindly divided into high dose group and conventional dose group( 30 cases in each). On the basis of the chest percussion postural drainage,the two groups were given the medicine for 2 weeks,respectively.The changes of TCM syndromes score before and after treatment,24 h sputum and sputum IL- 8 and adverse events were compared between the two groups. Results: After 2 weeks’ treatment,both high dose group and conventional dose group’ s TCM syndrome integral and 24 h sputum volume were significantly improved( P 〈 0. 01). But the two groups’ change of 24 sputum volume,the above indexes and the TCM syndrome integral change had no significant difference( P 〉 0. 05). In the conventional dose group,IL- 8 decreased significantly( P 〈 0. 05) in sputum and its change rate of two groups had significant difference( P 〈0. 05). The adverse events of high dose group occurred in 11 cases,4 of which were class IV( 3 hemoptysis,1 chest pain). The adverse events of conventional dose group occurred in 10 cases,including 1 class IV( 1 hemoptysis). The two groups’ incidence of adverse events was not significantly different( P 〉 0. 05). No liver,kidney,cardiovascular or hematic toxicity was found. No severe adverse event. Conclusion: Both conventional and high dose Bronchiectasis Stabilization Decoction improved the symptoms and reduced the amount of sputum of the patients of stable bronchiectasis with Qi and Yin deficiency syndrome,but no evidence proved that high dose Bronchiectasis Stabilization Decoction could further improve the clinical effect. It is suggested to select the appropriate dose according to different patients’ condition,TCM syndrome differentiation and body constituti
正在载入数据...
正在载入数据...
正在载入数据...
正在载入数据...
正在载入数据...
正在载入数据...
正在载入数据...