自拟宁心安神方治疗轻中度广泛性焦虑症的临床疗效观察
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摘要
目的:观察自拟宁心安神方颗粒剂治疗轻中度广泛性焦虑症(血虚肝热证)的临床疗效和安全性。方法:选取符合广泛性焦虑症(血虚肝热证)的患者60例,采用随机、双盲安慰剂对照,疗程为4周,治疗组给予自拟宁心安神方颗粒剂口服,每日1剂,早晚温服。观察汉密尔顿焦虑量表(HAMA)、自拟中医症状量表、副反应量表(TESS)变化。结果:自拟宁心安神方颗粒剂治疗广泛性焦虑症(血虚肝热证)患者,其HAMA评分总有效率为83.33%,显著优于中药安慰剂颗粒组(40%)(P<0.01)。两组治疗第2、4周后同本组治疗前比较,HAMA评分均有显著改善(P<0.05)。在改善中医症状方面,两组治疗第2、4周后较本组治疗前均有显著改善(P<0.05);组间比较,治疗4周后治疗组显著优于同期对照组(P<0.01)。TESS评分两组间差异无统计学意义。结论:自拟宁心安神方能有效改善广泛性焦虑症患者的焦虑状况,且安全有效,不良反应少,依从性好。
Objective: To observe the clinical efficacy and safety of Ningxin Anshen Formula on generalized anxiety disorder with the syndrome of blood-deficient and liver-heat. Methods: Sixty generalized anxiety disorder patients with the syndrome of blood-deficient and liver-heat were selected and treated with a randomized, double-blind placebo control for 4 weeks.The treatment group was treated with Ningxin Anshen Formula orally, one dose a day, warm in the morning and evening. the changes of Hamilton anxiety scale(HAMA), TCM syndromes of self-made scale and side effects scale(TESS) were observed.Results: The total effective rate of the HAMA score of the Ningxin Anshen Formula in treating generalized anxiety disorder patients with syndrome of blood-deficient and liver-heat was 83.33%, which was significantly better than that of placebo granule group(40%)(P<0.01). The HAMA scores of the two groups after 2 and 4 weeks of treatment were significantly different from those before treatment(P<0.05). In terms of improving TCM symptoms, there were significant differences between the two groups after 2 and 4 weeks of treatment compared with before treatment(P<0.05). There were significant differences between the two groups after 4 weeks of treatment(P<0.01). There was no significant difference in TESS score between the two groups.Conclusion: Ningxin Anshen Formula could effectively improve anxiety of patients with generalized anxiety disorder, and it is safe and effective, with low side effects and good compliance.
Objective: To observe the clinical efficacy and safety of Ningxin Anshen Formula on generalized anxiety disorder with the syndrome of blood-deficient and liver-heat. Methods: Sixty generalized anxiety disorder patients with the syndrome of blood-deficient and liver-heat were selected and treated with a randomized, double-blind placebo control for 4 weeks.The treatment group was treated with Ningxin Anshen Formula orally, one dose a day, warm in the morning and evening. the changes of Hamilton anxiety scale(HAMA), TCM syndromes of self-made scale and side effects scale(TESS) were observed.Results: The total effective rate of the HAMA score of the Ningxin Anshen Formula in treating generalized anxiety disorder patients with syndrome of blood-deficient and liver-heat was 83.33%, which was significantly better than that of placebo granule group(40%)(P<0.01). The HAMA scores of the two groups after 2 and 4 weeks of treatment were significantly different from those before treatment(P<0.05). In terms of improving TCM symptoms, there were significant differences between the two groups after 2 and 4 weeks of treatment compared with before treatment(P<0.05). There were significant differences between the two groups after 4 weeks of treatment(P<0.01). There was no significant difference in TESS score between the two groups.Conclusion: Ningxin Anshen Formula could effectively improve anxiety of patients with generalized anxiety disorder, and it is safe and effective, with low side effects and good compliance.
引文
[1]Kessler K C,Chiu W T,Deniler O,et al.Prevalence,severity and comorbidity of 12-mouth DSM-IV disorders in the National Comorbidity Survey Replication.Arch Gen Psychiatry,2005,62(6):617-627
[2]Bunevicius R,Liaugaudaite V,Peceliuniene J,et al.Factors affecting the presence of depression,anxiety disorders,and suicidal ideation in patients at tending primary health care service in Lithuania.Scand J Prim Health Care,2014,32(1):24-29
[3]Zhang X,Norton J,Carriere I,et al.Generalized anxiety in community-dwelling elderly:Prevalence and clinical characteristics.J Affect Disord,2014,172(9):24-29
[4]中华医学会精神科分会.中国精神障碍分类与诊断标准.济南:山东科技出版社,2001:53
[5]中华中医药学会.中医内科常见病诊疗指南.北京:中国中医药出版社,2008:294-296
[6]Peng W H,Hsieh M T,Lee Y S,et al.Anxiolytic effect of seed of Zizphus jujuba in mouse models of anxiety.Ethnopharmacol,2000,72(3):435-441
[7]荣春蕾,代永霞,崔瑛.酸枣仁对阴虚小鼠焦虑行为的影响.中药材,2008,31(11):1703-1705
[8]高桂龙.刺五加注射液配合针灸治疗产后焦虑症的疗效观察.山东医学高等专科学校学报,2013,35(3):239-240
[9]郭晓,郭蓉娟,邢佳,等.自拟宁心安神方调控失眠大鼠Glu/GABA-Gln代谢环路失衡的机制研究.北京中医药大学学报,2017,40(5):413-419
[2]Bunevicius R,Liaugaudaite V,Peceliuniene J,et al.Factors affecting the presence of depression,anxiety disorders,and suicidal ideation in patients at tending primary health care service in Lithuania.Scand J Prim Health Care,2014,32(1):24-29
[3]Zhang X,Norton J,Carriere I,et al.Generalized anxiety in community-dwelling elderly:Prevalence and clinical characteristics.J Affect Disord,2014,172(9):24-29
[4]中华医学会精神科分会.中国精神障碍分类与诊断标准.济南:山东科技出版社,2001:53
[5]中华中医药学会.中医内科常见病诊疗指南.北京:中国中医药出版社,2008:294-296
[6]Peng W H,Hsieh M T,Lee Y S,et al.Anxiolytic effect of seed of Zizphus jujuba in mouse models of anxiety.Ethnopharmacol,2000,72(3):435-441
[7]荣春蕾,代永霞,崔瑛.酸枣仁对阴虚小鼠焦虑行为的影响.中药材,2008,31(11):1703-1705
[8]高桂龙.刺五加注射液配合针灸治疗产后焦虑症的疗效观察.山东医学高等专科学校学报,2013,35(3):239-240
[9]郭晓,郭蓉娟,邢佳,等.自拟宁心安神方调控失眠大鼠Glu/GABA-Gln代谢环路失衡的机制研究.北京中医药大学学报,2017,40(5):413-419