化痰解郁颗粒对轻中度抑郁症(痰热扰心证型)的临床研究
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摘要
目的观察化痰解郁颗粒治疗轻中度抑郁症痰热扰心证型的临床疗效,及对抑郁症合并焦虑症状、睡眠障碍的有效性研究。方法随机、双盲、安慰剂对照。选取诊断为轻中度抑郁症(痰热扰心证型)的患者144例,随机分入试验组、安慰剂对照组。试验组:化痰解郁颗粒,每袋10克,每次1袋,逐日口服3次;安慰剂对照组:化痰解郁颗粒模拟药颗粒,每次1袋,逐日口服3次。两组比例为1:1。疗程共6周。分别在治疗前、治疗3周、治疗6周分组分别进行汉密尔顿抑郁量表、汉密尔顿焦虑量表评分,患者治疗前、后做三大常规、肝肾功、心电图等检查,进行药物的安全性评价。结果化痰解郁颗粒可以明显改善轻中度抑郁症(痰热扰心证型)患者的汉密尔顿抑郁量表和汉密尔顿焦虑量表评分的疗效。化痰解郁颗粒对焦虑躯体化障碍、体重减轻、认知障碍、阻滞障碍及睡眠障碍的相关症状和全身症状的改善有明显疗效。化痰解郁颗粒服用后无明显不良反应。结论化痰解郁颗粒经过本试验发现其在治疗抑郁症痰热扰心证型患者方面疗效显著,能明显降低HAMD及HAMA评分,且无明显毒副作用。
Objective To evaluate the efficacy and safety of The Hua Tan Jie Yu particles in the treatment of the mild to moderate depressive disorder(Syndrome of phlegm heat disturbing heart syndrome) and which Depression with anxiety symptoms and sleep disorders, and to provide a scientific basis for its clinical application. Methods This is a randomized, double-blind, placebo, parallel-group clinical trials. Select144 patients who met the inclusion criteria and randomLy divided into 2 groups. Experimental study for a period of six weeks.Experimental group and the placebo group the number ratio of 1:1.The experimental group was given 10 g Hua Tan Jie Yu particles 3 times daily, the placebo group was given 10 g Hua Tan Jie Yu particles Simulation agent 3 times daily. Treatment for 6 weeks.Before treatment, three weeks, six weeks respectively HAMD and HAMA score.Clinical curative effect and assaying items were observed after one course of treatment. Results(1) HAMD Comparison:Each group were significantly different before and after treatment and the difference was significant(P<0.05).The total effective rate in the treated group(79.16%) was more effective than that in the placebo group(65.27%).The difference was significant(P<0.05).(2) HAMA Comparison :Each group were significantly different before and after treatment and the difference was significant(P<0.05).The total effective rate in the treated group(83.3%) was more effective than that in the placebo group(59.7%).The difference was significant(P<0.05).(3) Two groups of the safety evaluation of no difference. Conclusion The Hua Tan Jie Yu particles can significantly reducing HAMA and HAMD scores and no significant side effects.
Objective To evaluate the efficacy and safety of The Hua Tan Jie Yu particles in the treatment of the mild to moderate depressive disorder(Syndrome of phlegm heat disturbing heart syndrome) and which Depression with anxiety symptoms and sleep disorders, and to provide a scientific basis for its clinical application. Methods This is a randomized, double-blind, placebo, parallel-group clinical trials. Select144 patients who met the inclusion criteria and randomLy divided into 2 groups. Experimental study for a period of six weeks.Experimental group and the placebo group the number ratio of 1:1.The experimental group was given 10 g Hua Tan Jie Yu particles 3 times daily, the placebo group was given 10 g Hua Tan Jie Yu particles Simulation agent 3 times daily. Treatment for 6 weeks.Before treatment, three weeks, six weeks respectively HAMD and HAMA score.Clinical curative effect and assaying items were observed after one course of treatment. Results(1) HAMD Comparison:Each group were significantly different before and after treatment and the difference was significant(P<0.05).The total effective rate in the treated group(79.16%) was more effective than that in the placebo group(65.27%).The difference was significant(P<0.05).(2) HAMA Comparison :Each group were significantly different before and after treatment and the difference was significant(P<0.05).The total effective rate in the treated group(83.3%) was more effective than that in the placebo group(59.7%).The difference was significant(P<0.05).(3) Two groups of the safety evaluation of no difference. Conclusion The Hua Tan Jie Yu particles can significantly reducing HAMA and HAMD scores and no significant side effects.
引文
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[7]张丽玲,张刚,张丽萍.张志钧从痰瘀论治中风的经验[J].中华中医药杂志(原中国医药学报),2006,21(4):229-230
[8]Greco T, Eckert G, Kroenke K. The outcome of physical symptoms with treatment of depression[J]. J Gen Intern Med,2004,19(8):813-8.
[9]Conradi HJ, Ornlel J, de Jonge P. Presence of individual(residual)symptoms during depressive episodes and periods of remission:a 3-year prospective study[J]. Psychol Med,2011,41(6):1165-74.
[10]Nierenberg AA, Husain MM, Trivedi MH, et al. Residual symptoms after remission of major depressive disorder with citalopram and risk of relapse:a STAR*D report[J]. Psychol Med,2010,40(1):41-50.
[11]张久亮,柳翼,王君.对缺血性脑卒中病位、病机及治疗方法的新见解[J].中华中医药杂志(原中国医药学报),2008,23(8):709-711.
[12]国家中医药管理局脑病急症协作组.中风病诊断与疗效评定标准(试行).
[13]胡国恒,祝美珍.活血化瘀法防治脑缺血损伤的理论探讨[J].中华中医药杂志(原中国医药学报),2008,23(6):513-515.
[2]陈文垲,周玲,梅晓云,等.从临床流行病学调查探讨抑郁症中医病机规律[J].南京中医药大学学报,2005,21(5):273-276.
[3]郑开梅,武成,薛蕾,等.抑郁症中医证候学临床流行病学调查[J].天津中医药大学学报,2006,25(3):170-171.
[4]张海男,胡随瑜,陈泽奇,等.抑郁症常见中医证候类型第一轮专家问卷分析[J].湖南医科大学学报,2002,27(6):519-521.
[5]张良栋.情感性精神障碍的中医分型及治疗[J].上海精神医学,1990,2(1):7.
[6]陈华昌,韩锡江,腾秀英.中西医结合治疗抑郁症35例[J].陕西中医,1998,19(5):210.
[7]张丽玲,张刚,张丽萍.张志钧从痰瘀论治中风的经验[J].中华中医药杂志(原中国医药学报),2006,21(4):229-230
[8]Greco T, Eckert G, Kroenke K. The outcome of physical symptoms with treatment of depression[J]. J Gen Intern Med,2004,19(8):813-8.
[9]Conradi HJ, Ornlel J, de Jonge P. Presence of individual(residual)symptoms during depressive episodes and periods of remission:a 3-year prospective study[J]. Psychol Med,2011,41(6):1165-74.
[10]Nierenberg AA, Husain MM, Trivedi MH, et al. Residual symptoms after remission of major depressive disorder with citalopram and risk of relapse:a STAR*D report[J]. Psychol Med,2010,40(1):41-50.
[11]张久亮,柳翼,王君.对缺血性脑卒中病位、病机及治疗方法的新见解[J].中华中医药杂志(原中国医药学报),2008,23(8):709-711.
[12]国家中医药管理局脑病急症协作组.中风病诊断与疗效评定标准(试行).
[13]胡国恒,祝美珍.活血化瘀法防治脑缺血损伤的理论探讨[J].中华中医药杂志(原中国医药学报),2008,23(6):513-515.
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