内消软脉汤2号治疗颈动脉粥样硬化斑块痰瘀互结证的实用性随机对照研究

Neixiao Ruanmai Decoction Ⅱ (内消软脉汤2号, NRD-Ⅱ) in the Treatment of Carotid Atherosclerosis Plaque with Binding of Phlegm and Stasis Syndrome: A Pragmatic Randomized Controlled Trial

目的评价内消软脉汤2号及其联合他汀类药物治疗颈动脉粥样硬化斑块痰瘀互结证的有效性及安全性。方法采用实用性随机对照方法,纳入颈动脉粥样硬化斑块痰瘀互结证患者36例,随机分为治疗组与对照组各18例。治疗组给予内消软脉汤2号颗粒剂,每日1剂分2次冲服;对照组在治疗组的基础上同时给予阿托伐他汀钙片口服,每次20 mg,每日1次。两组均连续治疗24周。治疗前后检测两组患者颈动脉最大斑块的横切厚度、斑块面积,计算颈动脉狭窄率并评价临床疗效;检测血脂[包括总胆固醇(TC)、甘油三酯(TG)、高密度脂蛋白胆固醇(HDL-C)、低密度脂蛋白胆固醇(LDL-C)],检测安全性指标肝功能[包括丙氨酸氨基转移酶(ALT)、门冬氨酸氨基转移酶(AST)]、肾功能[包括血尿素氮(BUN)、血肌酐(Cr)]并记录不良事件发生情况。结果治疗组临床疗效有效率为66.67%(12例/18例),对照组为77.78%(14例/18例),对照组较治疗组提高但两组比较差异无统计学意义(P>0.05)。治疗后两组最大斑块横切厚度均较本组治疗前下降(P<0.05)。两组患者治疗前后颈动脉最大斑块面积、颈动脉狭窄率、LDL-C、TG、TC、HDL-C、ALT、BUN及Cr水平比较差异均无统计学意义(P>0.05);治疗后对照组AST水平较治疗前升高(P<0.05)。两组患者在用药期间均未发生不良事件。结论内消软脉汤2号及其联合他汀类药物治疗均可有效降低颈动脉粥样硬化斑块的厚度,但联合他汀类药物治疗可能会导致AST升高。

Objective To evaluate the effect and safety of Neixiao Ruanmai DecoctionⅡ(内消软脉汤2号,NRD-Ⅱ)and its combination with statins in the treatment of carotid atherosclerotic plaque with binding of phlegm and stasis syndrome.Methods In a pragmatic randomized controlled trial design,36 carotid atherosclerotic plaque patients with binding of phlegm and stasis syndrome were divided into treatment group(18 cases)and control group(18cases).The treatment group was given NRD-Ⅱgranule,1 bag for twice a day,and the control group was additionally given oral atorvastatin calcium tablets,20 mg each time,once a day,both for 24 weeks.The cross-sectional thickness,plaque area,stenosis rate and clinical effect were evaluated before and after treatment.Blood lipid indicators including total cholesterol(TC),triglycerides(TG),high-density lipoprotein cholesterol(HDL-C)and lowdensity lipoprotein cholesterol(LDL-C),the safety-related liver function indicators including alanine aminotransferase(ALT)and aspartate aminotransferase(AST)and kidney function indicators including blood urea nitrogen(BUN)and serum creatinine(Cr)were assessed,and the adverse events were recorded.Results The effective rate was 77.78%(14/18)in the control group,higher than 66.67%(12/18)in the treatment group,but with no significant difference between groups(P>0.05).The cross-sectional thickness significantly decreased in both groups after treatment(P<0.05).The maximum plaque area of the carotid artery,the carotid stenosis rate,the LDL-C,TG,TC,HDL-C,ALT,BUN and Cr levels were not significantly different in both groups after treatment(P>0.05).The AST level in the control group increased after treatment(P<0.05).There were no adverse events in both groups during medication period.Conclusion Both NRD-Ⅱalone and its combination with statins can effectively reduce the thickness of carotid atherosclerotic plaque,but the combination of statins may be associated with the increase of AST level.