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.
作者
熊航
郭蓉娟
XIONG Hang;GUO Rong-juan(Encephalopathy Department,Tongzhou Branch,Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine,Beijing101100,China;Dongfang Hospital Affiliated to Beijing University of Chinese Medicine,Beijing100078,China)
出处
《中华中医药杂志》
CAS
CSCD
北大核心
2019年第6期2803-2806,共4页
China Journal of Traditional Chinese Medicine and Pharmacy
基金
北京中医药大学自主选题资助项目(No.2017-JYB-081)~~
关键词
广泛性焦虑症
自拟宁心安神方
安慰剂
临床研究
Generalized anxiety disorder
Ningxin Anshen Formula
Placebo
Clinical research
