内消软脉汤治疗颈动脉粥样硬化斑块的随机、双盲、安慰剂平行对照研究  

Neixiao Ruanmai Decoction in treating carotid atherosclerotic plaque:A randomized,double-blind,placebo parallel controlled trial

作　　者：苏文全 武荣荣[1] 高树彪[1] 李贺 杜雅薇[1] 吴圣贤[1] SU Wen-quan;WU Rong-rong;GAO Shu-biao;LI He;DU Ya-wei;WU Sheng-xian(Dongzhimen Hospital,Beijing University of Chinese Medicine,Beijing 100700,China)

机构地区：[1]北京中医药大学东直门医院,北京100700

出　　处：《中华中医药杂志》2021年第10期6233-6237,共5页China Journal of Traditional Chinese Medicine and Pharmacy

基　　金：北京中医药大学基本科研业务费项目(No.2017-JYB-XS-104)。

摘　　要：目的:在不降低低密度脂蛋白胆固醇(LDL-C)的情况下,评价内消软脉汤治疗颈动脉粥样硬化斑块的有效性与安全性。方法:采用随机、双盲、安慰剂平行对照的方法,纳入患有颈动脉粥样硬化斑块且未服用降脂药物的患者36例,随机分为治疗组与对照组,每组18例。治疗组给予内消软脉汤颗粒剂,对照组给予安慰剂,两组连续治疗12周。观察两组患者治疗前后的颈动脉粥样硬化斑块Crouse积分、总斑块面积、总内中膜厚度(IMT)、最大斑块厚度和面积、血脂,并评价两组患者的斑块逆转有效率、中医证候疗效及安全性。结果:与治疗前比较,治疗组治疗后的颈动脉粥样硬化斑块Crouse积分、总斑块面积、总IMT、最大斑块厚度及面积均显著下降(P<0.01,P<0.05)。治疗组的斑块逆转有效率为61.11%(11/18),显著高于对照组的11.11%(2/18,P<0.01)。治疗组的中医证候疗效有效率为94.44%(17/18),优于对照组的55.56%(10/18,P<0.05)。两组患者的血脂水平治疗前后及组间比较差异均无统计学意义。未见严重不良事件,治疗前后肝肾功能无明显异常变化。结论:在不降低LDL-C的情况下,内消软脉汤在逆转颈动脉粥样硬化斑块和改善临床症状中显示出了良好的疗效和安全性。Objective:To evaluate the efficacy and safety of Neixiao Ruanmai Decoction in treating carotid atherosclerotic plaque without reducing LDL-C.Methods:A randomized,double-blind,placebo-controlled parallel method was used in 36 patients with carotid atherosclerotic plaques who did not take lipid-lowering drugs.The treatment group was given Neixiao Ruanmai Decoction,the control group was given placebo,the two groups were treated for 12 weeks.The Crouse score,total plaque area,IMT,maximum plaque thickness and area,blood lipid,plaque reversion rate,TCM syndrome efficacy and safety of the two groups were observed before and after treatment.Results:After treatment,the Crouse score,total plaque area,IMT,maximum plaque thickness and area of carotid plaque in the treatment group were significantly decreased compared with before treatment(P<0.01,P<0.05).The plaque reversion rate in the treatment group was 61.11%(11/18),which was significantly higher than that in the control group[11.11%(2/18),P<0.01].The effective rate of TCM syndrome in the treatment group was 94.44%(17/18),which was superior to 55.56%in the control group(10/18,P<0.05).There was no significant difference in blood lipid level between the two groups before and after treatment.There was no serious adverse event and no significant abnormal change of liver and kidney function before and after treatment.Conclusion:With no decrease of LDL-C,Neixiao Ruanmai Decoction shows good efficacy and safety in reversing carotid atherosclerotic plaque and improving clinical symptoms.

关 键 词：内消软脉汤 化痰散结法 脉生痰核 动脉粥样硬化斑块 随机对照试验 

分 类 号：R259[医药卫生—中西医结合]