益肾养心安神片治疗心血亏虚、肾精不足型失眠症的Ⅲ期临床观察  

A PhaseⅢClinical Observation of Yishen Yangxin Anshen Tablets in Treatment of Insomnia with Deficiency of Heart Blood and Insufficiency of Kidney Essence

作　　者：王伟[1,2] 任君霞 王永争[1] 韩建科 杨立民 汪卫东 连凤梅[3] 艾长山[4] 殷晓莉[5] 王宝亮[6] 孟毅[7] 袁曙光[8] 周德生[9] 高学东[1] WANG Wei;REN Junxia;WANG Yongzheng;HAN Jianke;YANG Limin;WANG Weidong;LIAN Fengmei;AI Changshan;YIN Xiaoli;WANG Baoliang;MENG Yi;YUAN Shuguang;ZHOU Desheng;GAO Xuedong(Yiling Pharmaceutical Co.Ltd.,Shijiazhuang 050035,China;Hebei Yiling Hospital,Shijiazhuang 050091,China;Guang'anmen Hospital,China Academy of Chinese Medical Sciences,Bejing 100053,China;The First Clinical Hospital of Jilin Province Academy of Traditional Chinese Medicine(TCM),Changchun 130117,China;The Second Affiliated Hospital of Liaoning University of TCM,Shenyang 110033,China;The First Affiliated Hospitalof Henan University of Chinese Medicine,Zhengzhou 450000,China;Henan Province Hospital of TCM,Zhengzhou 450002,China;Hebei General Hospital,Shijiazhuang 050051,China;The First Hospital of Hunan University of Chinese Medicine,Changsha 410007,China)

机构地区：[1]石家庄以岭药业股份有限公司,石家庄050035 [2]河北以岭医院,石家庄050091 [3]中国中医科学院广安门医院,北京100053 [4]吉林省中医药科学院第一临床医院,长春130117 [5]辽宁中医药大学附属第二医院,沈阳110033 [6]河南中医药大学第一附属医院,郑州450000 [7]河南省中医院,郑州450002 [8]河北省人民医院,石家庄050051 [9]湖南中医药大学第一附属医院,长沙410007

出　　处：《中国实验方剂学杂志》2023年第4期110-116,共7页Chinese Journal of Experimental Traditional Medical Formulae

摘　　要：目的:确证益肾养心安神片治疗失眠症(心血亏虚、肾精不足证)的临床疗效和安全性。方法:采用区组随机、双盲、安慰剂平行对照、多中心临床试验设计方法,共有7家临床试验机构(中国中医科学院广安门医院、吉林省中医药科学院第一临床医院、辽宁中医药大学附属第二医院、河南中医药大学第一附属医院、河南省中医院、河北省人民医院、湖南中医药大学第一附属医院)参加,纳入480例心血亏虚、肾精不足型失眠患者(治疗组-对照组为3∶1)。两组受试者分别口服益肾养心安神片或模拟剂,4片/次,3次/日,疗程4周,停药后随访4周。比较两组治疗前后睡眠障碍评定量表(SDRS)评分、匹兹堡睡眠质量指数(PSQI)总分、中医证候等疗效指标,并选择4家中心(中国中医科学院广安门医院、河南省中医院、河北省人民医院、湖南中医药大学第一附属医院)进行多导睡眠图(PSG)各项指标客观比较两组疗效。通过一般体检、实验室检查指标、不良事件等观察用药后的安全性。结果:治疗组和对照组基线各项指标差异均无统计学意义,两组具有可比性。与对照组比较,治疗后治疗组的SDRS总分显著降低(P<0.01),可以判断治疗组疗效优于对照组;与治疗结束时比较,停药4周后治疗组组内SDRS总分变化无统计学意义,表明疗效反跳变化不明显。与对照组比较,治疗后治疗组的PSQI总分显著降低(P<0.01);与组内治疗结束时比较,停药4周后治疗组组内PSQI总分变化有统计学意义(P<0.05),但其变化较小,显示疗效反跳变化均不明显。与对照组比较,治疗后治疗组中医证候总有效率显著升高(χ^(2)=137.521,P<0.01);治疗后治疗组入睡困难、睡而易醒、早醒、睡眠时间短、多梦、心悸不安、健忘、头晕、神疲乏力、腰膝酸软等各单项指标消失率显著升高(P<0.01);治疗后治疗组觉醒次数(AT)降低、总睡眠时间(TST)�Objective:To confirm the clinical efficacy and safety of Yishen Yangxin Anshen tablets in the treatment of insomnia(heart-blood deficiency and kidney-essence insufficiency syndrome).Method:A randomized block,double-blind,placebo-controlled,multi-center clinical trial design method was adopted,and a total of 480 patients with insomnia due to deficiency of heart blood and insufficiency of kidney essence(treatment group-control group 3∶1)from seven hospitals(Guang’anmen Hospital,China Academy of Chinese Medical Sciences,The First Clinical Hospital,Jilin Province Academy of Traditional Chinese Medicine(TCM),The Second Affiliated Hospital of Liaoning University of TCM,The First Affiliated Hospital of Henan University of Chinese Medicine,Henan Province Hospital of TCM,Hebei General Hospital,The First Hospital of Hunan University of Chinese Medicine)were enrolled.The treatment group was given Yishen Yangxin Anshen tablets and the control group received placebo tablets(4 tablets/time,3 times/day,4 weeks of administration,4 weeks of follow-up after drug withdrawal).The sleep dysfunction rating scale(SDRS)score,pittsburgh sleep quality index(PSQI)score,TCM,polysomnography(PSG)indicators from four hospital(Guang’anmen Hospital,China Academy of Chinese Medical Sciences,Henan Province Hospital of TCM,Hebei General Hospital,The First Hospital of Hunan University of Chinese Medicine),and other efficacy indicators were compared between the two groups before and after treatment.Through general physical examination,laboratory examination,and observation of adverse events,the safety of the drugs was evaluated.Result:The baseline indexes of the two groups showed no significant difference and thus the two groups were comparable.After treatment,the total score of SDRS in the treatment group was lower than that in the control group(P<0.01).After drug withdrawal for 4 weeks,the total score of SDRS demonstrated no significant change in the treatment group as compared with that at the end of treatment,indicating that the rebound cha

关 键 词：益肾养心安神片 失眠症 随机双盲 安慰剂对照 多中心临床试验 

分 类 号：R22[医药卫生—中医基础理论] R242[医药卫生—中医学] R2-031R287