[Objectives]To explore the antidepressant effect of Shenwei Ningyu Tablet,a new antidepressant traditional Chinese medicine,on rat chronic stress depression model and mouse tail suspension models.[Methods]Rat chronic ...[Objectives]To explore the antidepressant effect of Shenwei Ningyu Tablet,a new antidepressant traditional Chinese medicine,on rat chronic stress depression model and mouse tail suspension models.[Methods]Rat chronic stress model:except for the normal group,the rats in other groups were given corresponding chronic stress,and administered by gavage 1 h before modeling,for a total of 21 d.The changes of each indicator before and after the experiment were observed through the body weight change,the sugar water test,and open field test.The relevant hormone levels were detected by radioimmunoassay.Mouse tail suspension depression model:after continuous administration for 7 d,the activity times was recorded with the mouse automatic recorder,and the mouse immobility time was recorded after tail suspension,to explore the effects of each administration group on the tail suspension immobility time of mice.[Results]Chronic stress depression model:21 d after modeling,compared with the normal group,rats in the model group exhibited significantly reduced body weight,sucrose preference index,and horizontal and vertical movement scores(P<0.05).Compared with the model group,the low-dose Shenwei Ningyu Tablets group had significant differences in the sugar water test,horizontal and vertical movement scores(P<0.05).In addition,all three dose groups of Shenwei Ningyu Tablets could effectively reduce the content of CRF in chronic stress model rats,and the low dose group could significantly reduce the ACTH level in model rats(P<0.05).Mouse tail suspension depression model:the immobility time after tail suspension in each administration group was significantly different from that in the model group(P<0.05).[Conclusions]Shenwei Ningyu Tablets has a certain anti-depression effect on both the rat chronic stress depression model and the mouse tail suspension depression model.展开更多
目的:评估参郁宁神片(宁郁异形片)治疗轻度至中度抑郁症患者的临床疗效和安全性。方法:采用多中心、随机、双盲双模拟设计,纳入572例符合中国精神障碍分类方案与诊断标准(The Chinese Classification of Mental Disorders, Third Editio...目的:评估参郁宁神片(宁郁异形片)治疗轻度至中度抑郁症患者的临床疗效和安全性。方法:采用多中心、随机、双盲双模拟设计,纳入572例符合中国精神障碍分类方案与诊断标准(The Chinese Classification of Mental Disorders, Third Edition, CCMD-3)且基线汉密尔顿抑郁量表(Hamilton Depression Rating Scale, HAMD)-17评分为14~24分的受试者,随机分为3组:参郁宁神片组(2.4 g,tid,n=344)、盐酸氟西汀组(10 mg·d^(-1)首周,20 mg·d^(-1)后续7周,n=115)及安慰剂组(n=113),持续治疗8周。主要终点为HAMD-17评分自基线至第8周的组间差异,采用改良意向治疗分析集,与阳性药组进行非劣效性检验(非劣效界值=2.5),与安慰剂进行差异性检验。结果:治疗8周后,参郁宁神片组HAMD-17评分较基线降低(10.50±4.46)分,显著优于安慰剂组[(7.03±5.07),P<0.05],与盐酸氟西汀组(10.13±3.94)的组间差异为-0.25(95%CI[-1.18,0.68]),达到非劣效标准。安全性分析显示,参郁宁神片组未报告药物相关不良事件(0%vs盐酸氟西汀组8.8%)。结论:参郁宁神片在改善轻中度抑郁症状方面呈现与盐酸氟西汀相当的临床疗效,且具有更优的安全性特征。该结果为参郁宁神片在抑郁症治疗领域的应用提供了高级别循证医学证据。展开更多
基金National Major Scientific and Technological Special Project for"Significant New Drugs Development"(2019ZX09301-005).
文摘[Objectives]To explore the antidepressant effect of Shenwei Ningyu Tablet,a new antidepressant traditional Chinese medicine,on rat chronic stress depression model and mouse tail suspension models.[Methods]Rat chronic stress model:except for the normal group,the rats in other groups were given corresponding chronic stress,and administered by gavage 1 h before modeling,for a total of 21 d.The changes of each indicator before and after the experiment were observed through the body weight change,the sugar water test,and open field test.The relevant hormone levels were detected by radioimmunoassay.Mouse tail suspension depression model:after continuous administration for 7 d,the activity times was recorded with the mouse automatic recorder,and the mouse immobility time was recorded after tail suspension,to explore the effects of each administration group on the tail suspension immobility time of mice.[Results]Chronic stress depression model:21 d after modeling,compared with the normal group,rats in the model group exhibited significantly reduced body weight,sucrose preference index,and horizontal and vertical movement scores(P<0.05).Compared with the model group,the low-dose Shenwei Ningyu Tablets group had significant differences in the sugar water test,horizontal and vertical movement scores(P<0.05).In addition,all three dose groups of Shenwei Ningyu Tablets could effectively reduce the content of CRF in chronic stress model rats,and the low dose group could significantly reduce the ACTH level in model rats(P<0.05).Mouse tail suspension depression model:the immobility time after tail suspension in each administration group was significantly different from that in the model group(P<0.05).[Conclusions]Shenwei Ningyu Tablets has a certain anti-depression effect on both the rat chronic stress depression model and the mouse tail suspension depression model.
