脑心清片治疗缺血性脑卒中恢复期多中心随机双盲对照研究  

Effect of Naoxinqing Tablet in the Treatment of Convalescent Stroke:A Multicenter,Randomized,Double-Blind,Control Trial

作　　者：黄坚红[1] 才鼎[2] 卞金玲 腾秀英 李陈渝[5] 李克东 迟晓玲 杜菊梅[8] 朱瑞增 贺维亚 姚宝农 庄慧魁[12] 王保申 高学敏 孙媛媛 段珊珊 徐运[17] HUANG Jian-hong;CAI Ding;BIAN Jin-Ling;TENG Xiu-ying;LI Chen-yu;LI Ke-dong;CHI Xiao-ling;DU Ju-mei;ZHU Rui-zeng;HE Wei-ya;YAO Bao-nong;ZHUANG Hui-kui;WANG BAO-shen;GAO Xue-min;SUN Yuan-yuan;DUAN Shan-shan;XU Yun(Department of Neurology,Guangzhou Traditional Chinese Medicine Hospital,Guangzhou,510130;Department of Neurology,Qinghai Provincial People's Hospital,Xining,810007;Acupuncture Department,First Teaching Hospital of Tianjin University of Traditional Chinese Medicine,Tianjin,300193;Rehabilitation Department,Second Affiliated Hospital of Heilongjiang University of Traditional Chinese Medicine,Harbin,150001;Department of Neurology,Chongqing Traditional Chinese Medicine Hospital,Chongqing,400021;Department of Integrated Chinese and Western Medicine,Yuncheng Central Hospital of Shanxi Province,Shanxi,044000;Department of Neurology,Harbin Traditional Chinese Medicine Hospital,Harbin,150076;Department of Encephalopathy,The Second Affiliated Hospital of Shaanxi University of Chinese Medicine,Shaanxi,712021;Department of Encephalopathy,Daqing Hospital of Traditional Chinese Medicine,Heilongjiang,163001;Department of Neurology,Huaihe Hospital of Henan University,Henan,475000;Department of Encephalopathy,Qinzhou Hospital of Traditional Chinese Medicine,Guangxi,535000;Department of Neurology,The Second Affiliated Hospital of Shandong University of Traditional Chinese Medicine,Jinan,250001;Department of Encephalopathy,Luohe Hospital of Traditional Chinese Medicine,Henan,462000;China Traditional Chinese Medicine Association Drug Research and Evaluation Technology Center,Beijing,100024;China Traditional Chinese Medicine Association Encephalopathy Medicine Research Committee,Beijing,100024;Beijing Kangpaixing Pharmaceutical Technology Development Co.,Ltd,Beijing,100024;Department of Neurology,Nanjing Drum Tower Hospital,The Affiliated Hospital of Nanjing University Medical School,Nanjing,210008)

机构地区：[1]广州市中医医院神经内科,广州510130 [2]青海省人民医院神经内科,西宁810007 [3]天津中医药大学第一附属医院针灸科,天津300193 [4]黑龙江中医药大学附属第二医院康复科,哈尔滨150001 [5]重庆市中医院神经内科,重庆400021 [6]山西省运城市中心医院中西医结合科,山西044000 [7]哈尔滨市中医院神经内科,哈尔滨150076 [8]陕西中医药大学第二附属医院脑病科,陕西712021 [9]大庆市中医医院脑病科,黑龙江163001 [10]河南大学淮河医院神经内科,河南475000 [11]钦州市中医院脑病科,广西535000 [12]山东中医药大学第二附属医院神经内科,济南250001 [13]漯河市中医院脑病科,河南462000 [14]中国中药协会药物研究评价技术中心,北京100024 [15]中国中药协会脑病药物研究专业委员会,北京100024 [16]北京康派星医药科技开发有限公司,北京100024 [17]南京大学医学院附属鼓楼医院神经内科,南京210008

出　　处：《中国中西医结合杂志》2022年第7期802-810,共9页Chinese Journal of Integrated Traditional and Western Medicine

摘　　要：目的 观察脑心清片治疗缺血性脑卒中恢复期的有效性及安全性。方法 本研究方案在中国临床试验中心注册(No.ChiCTR-TRC-13003968)。筛选721例受试者,选择缺血性脑卒中发病2周~3个月瘀血阻络证患者654例,采用随机对照方法,使用SAS软件区组随机分为试验组、对照组和安慰剂组,各218例,在西医常规治疗基础上,分别给予脑心清片+银杏叶片模拟剂(试验组)、脑心清片模拟剂+银杏叶片(对照组)和脑心清片模拟剂+银杏叶片模拟剂(安慰剂组),三组用法用量均为3片/次,3次/日,疗程12周。观察美国国立卫生研究院卒中量表NIHSS评分、卒中专门生命质量SSQOL量表评分、改良Rankin评分、日常生活能力Barthel指数、中医证候评分及不良反应发生率。结果 本研究共纳入分析654例,各组均为218例。治疗6周及12周后,试验组在改善NIHSS评分、SSQOL评分、改良Rankin量表评分、Barthel指数方面与对照组疗效相当(P>0.0167),但均优于安慰剂组(P<0.0167)。治疗12周后试验组中医证候有效率高于对照组、安慰剂组(P<0.0167);在治疗6周及12周后对失眠多梦的有效率试验组高于对照组(P<0.0167);在治疗12周后对下肢不遂、上肢不遂、口唇紫暗的有效率试验组高于安慰剂组(P<0.0167)。治疗12周后三组患者凝血四项(PT,APTT,TT,FIB)、血脂四项(TC,TG, LDL-C,HDL-C)、血糖及血液流变学指标疗后差值,组间差异均无统计学意义(P>0.05)。不良事件试验组9例(4.13%),对照组3例(1.38%),安慰剂组8例(3.67%,P=0.2021),不良反应安慰剂组1例,其他两组未发生不良反应。结论 脑心清片能改善缺血性脑卒中恢复期患者的神经功能缺损症状,提高患者生活质量和生活能力,降低致残率,改善中医证候,其疗效与银杏叶片相当,且安全性良好。Objective To observe the efficacy and safety of Naoxinqing Tablet(NXQT)on convalescent ischemic stroke. Methods The protocol was registered in Chinese Clinical Trial Registry(No.ChiCTR-TRC-13003968). A total of 721 patients were screened,654 patients with ischemic stroke for 2 weeks to 3 months were randomly allocated to the trial group(218 cases),control group(218 cases)and placebo group(218cases)by SAS software. All patients received conventional treatment. Patients in trial group took NXQT+GLTS(Ginkgo leaf Tablets simulant),patients in control group took NXQTS(NXQT simulant)+GLT(Ginkgo leaf Tablets),and patients in placebo group took NXQTS+GLTS. The therapeutic course for all was 12 weeks and the usage and dosage were 3 tablets,3 times daily. The NIHSS score,SSQOL score,modified Rankin Scale score,Barthel index,Chinese medicine(CM)syndrome score and the incidence of adverse reactions were observed.Results A total of 654 cases were included in this study for analysis, with 218 cases in each group. After 6 and 12 weeks of treatment,compared with the control group,the trial group showed a similar effect in improving NIHSS score,SSQOL score,modified Rankin Scale score and Barthel index(P>0.0167),but all were superior to the placebo group(P<0.0167). After 12 weeks of treatment,the effective rate of CM syndrome in the trial group was higher than that in the control group and the placebo group(P<0.0167);After 6 and 12 weeks of treatment,the effective rate of insomnia and dreamful sleep in the trial group was higher than that in control group(P<0.0167). For uper and lower limbs failure and dark-purplish lip, after 12 weeks of treatment, the effective rate of the experimental group was significantly higher than that of the placebo group(P<0.0167). After 12 weeks of treatment,there was no statistical difference in levels of coagulation(PT,APTT,TT,and FIB),blood lipids(TC,TG,LDL-C and HDL-C),fasting blood glucose and hemorheology among the three groups(P>0.05). Adverse events occurred in 9 cases(4.13%)in the trial group,

关 键 词：脑心清片 缺血性脑卒中 生活质量 中成药 

分 类 号：R277.7[医药卫生—中医学]