中药威脑口服液干预亚健康随机双盲安慰剂对照方法临床研究

目的 评价中药制剂威脑口服液干预亚健康的有效性和安全性.方法采用随机双盲安慰剂对照方法,将400例亚健康者随机分为干预组300例,对照组100例,分别予威脑口服液或安慰剂,观察4周.结果 总有效率干预组82.7%,对照组70.0%,P＜0.05.干预组亚健康积分有显著改善(与对照组相比P＜0.01),失眠、多梦、口干咽痛、神疲乏力、心慌心悸、急躁易怒、困倦、胸闷不舒、少气懒言、性欲减退等症状改善显著.在安全性上,干预组和对照组分别有4例和2例出现轻至中度口干、大便干,停药或减少剂量后症状缓解并完成治疗.结论 中药制剂威脑口服液辨证用于干预亚健康状态有较好效果,且用药安全.

Weinao Oral Solution intervening sub-health and dummy control of random double-blind

Objective To evaluate the validity and security of Weinao Oral Solution for intervening sub-health. Method The dummy control of random double-blind was applied to divide 400 sub-healthy cases into the intervening group (n=300) and control group (n=100). Weinao Oral Solution and dummy were given to these two groups respectively and observation was made for 4 weeks. Result The tatal effective rate in the intervening group was 82.7%, and 70.0 % in the control group (P<0.05). The integral of sub-health in the intervening group was improved remarkably (P<0.01 compared with that of the control group). Some symptoms, such as insomnia, dreamful sleep, drymouth, throat pain, fatigue, palpitation, impetuosity, susceptibility to rage, sleepy, thoracic oppression, asthenic breathing, taciturn and hyposexuality, were relieved significantly. On the security there were 4 and 2 cases in two groups respectively with drymouth and constipation in varying degrees, which would be relived after the treatment was stopped or the dose of Weinao Oral Solution was decreased. Conclusion Weinao Oral Solution has a better effect on sub-healthy state and a higher security.