益气活血化浊解毒法治疗缺血性脑卒中的多中心双盲随机对照试验  

Method of Yiqi Huoxue Huazhuo Jiedu in the treatment of cerebral ischemic stroke:A multicenter double-blind randomized controlled trial

作　　者：田军彪[1] 赵见文[2] 张惠利[3] 杨丽静[1] 单婷 刘学飞[1] 王文刚[3] 赵层闪 张希廉 薛秀娟[3] 程丽娜[1] 张颜伟[2] 张培义[2] 石瑞 TIAN Junbiao;ZHAO Jianwen;ZHANG Huili;YANG Lijing;SHAN Ting;LIU Xuefei;WANG Wengang;ZHAO Cengshan;ZHANG Xilian;XUE Xiujuan;CHENG Lina;ZHANG Yanwei;ZHANG Peiyi;SHI Rui(Hebei Hospital of Traditional Chinese Medicine,Shijiazhuang 050011,China;Hebei Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine,Cangzhou 061001,China;Qinhuangdao Hospital of Traditional Chinese Medicine,Qinhuangdao 066000,China;Hengshui Hospital of Traditional Chinese Medicine,Hengshui 053000,China;Wei County People's Hospital,Handan 056800,China)

机构地区：[1]河北省中医院,石家庄050011 [2]河北省沧州中西医结合医院,沧州061001 [3]秦皇岛市中医医院,秦皇岛066000 [4]衡水市中医院,衡水053000 [5]魏县人民医院,邯郸056800

出　　处：《中华中医药杂志》2024年第9期5066-5071,共6页China Journal of Traditional Chinese Medicine and Pharmacy

基　　金：河北省省级科技计划资助(重点研发计划)项目(N o.20377710D);河北省中医药管理局科研计划重点项目(No.Z2022008);河北中医学院科研能力提升重点项目(No.KTZ2019028)。

摘　　要：目的:观察益气活血化浊解毒法对缺血性脑卒中(CIS)患者的临床疗效、安全性及复发率的影响。方法:采用随机、双盲、安慰剂对照、多中心临床试验研究,将120例CIS患者随机分为2组,研究过程中有脱落病例,最终纳入对照组53例,治疗组56例。对照组予以基础治疗及中药颗粒模拟剂口服,治疗组予以基础治疗及益气活血化浊解毒中药颗粒剂口服,分别于治疗前、治疗第21天、治疗第3个月、治疗第6个月观察两组患者美国国立卫生院卒中评分(NIHSS)、中医证候积分、超敏C反应蛋白(hs-CRP)以及血同型半胱氨酸(Hcy)水平的变化,治疗前和治疗第6个月观察两组患者血脂水平的变化,随访两组患者12个月内脑血管病复发率情况。结果:治疗第21天以及第3、6个月,两组患者NIHSS评分、中医证候积分、hs-CRP、Hcy水平均较治疗前显著下降(P<0.05),治疗第3、6个月,治疗组上述指标均显著低于对照组(P<0.05)。两组患者治疗第6个月的血脂水平均较治疗前显著降低(P<0.05),且治疗组显著低于对照组(P<0.05)。随访12个月,治疗组复发率为1.8%(1/56),对照组复发率为5.7%(3/53),差异无统计学意义。结论:益气活血化浊解毒法可明显减轻CIS患者的神经功能缺损程度,改善中医证候,抑制炎症反应,降低Hcy和血脂水平,提高临床疗效,且未发现明显不良反应。Objective:To observe the clinical efficacy,safety and recurrence rate of the method of Yiqi Huoxue Huazhuo Jiedu(YHHJ)in the treatment of cerebral ischemic stroke(CIS).Methods:A randomized,double-blind,placebocontrolled,multicenter clinical trial was conducted.A total of 120 patients with CIS were randomly divided into two groups,during the research process,there were cases of dropouts,53 cases in the control group and 56 cases in the treatment group,finally.The control group was given Chinese medicine granule simulants orally,while the treatment group was given Chinese medicine granule with the efficacy of YHHJ orally.The National Institutes of Health Stroke Scale(NIHSS),traditional Chinese medicine(TCM)syndrome score,high-sensitivity C-reactive protein(hs-CRP)and blood homocysteine(Hcy)in the two groups were observed before treatment,on the 21st day,3rd month and 6th month after treatment.Blood lipid in the two groups were observed before treatment and 6th month after treatment.Both groups were followed up for 12 months to observe the recurrence of cerebrovascular disease.Results:On the 21st day,3rd month and 6th month after treatment,the NIHSS scores,TCM syndrome scores,hs-CRP and Hcy of the two groups were significantly lower than those before treatment(P<0.05).At the 3rd month and 6th month after treatment,the above indexes in the treatment group was significantly lowered than those in the control group(P<0.05).At the 6th month after treatment,the levels of blood lipids in the two groups were lower than those before treatment(P<0.05),and the treatment group was significantly lowered than the control group significantly(P<0.05).After 12 months of follow-up,the recurrence rate was 1.8%(1/56)in the treatment group,while the recurrence rate was 5.7%(3/53)in the control group,there was no statistical significance.Conclusion:The method of YHHJ can significantly reduce NIHSS scores,improve TCM symptoms,lower inflammatory response,reduce Hcy and blood lipid for improving clinical efficacy in CIS patients.It causes n

关 键 词：益气活血化浊解毒法 缺血性脑卒中 气虚血瘀 浊毒内蕴 疗效观察 中风 

分 类 号：R277.7[医药卫生—中医学]