巴戟天寡糖胶囊治疗抑郁症的临床疗效及安全性研究

doi:10.3969/j.issn.1671-7171.2017.09.016

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Abstract 【Objective】To compare the efficacy and safety between Morinda officinalis oligose capsule and Escitalopram in the patients with depression.【Methods】An open-label controlled clinical trial was conducted. A total of 76 cases of outpatients with depression were randomly divided into a study group (Morinda officinalis oligose capsule) with 38 cases and a control group (Escitalopram) with 38 cases. The dose of study group was 300mg or 600mg/d of morinda officinalis oligose capsule, while the control group received 10mg or 20mg/d of escitalopram. The treatment in both groups lasted 6 weeks. Hamilton Depression Rating Scale 17-Item (HAMD-17), TCM Kidney Deficiency Quantitative Score Form and Clinical Global Impression Scale (CGI) were used to evaluate the efficacy, and the assessment of adverse events, physical examination, laboratory tests and ECG were evaluated to determine safety.【Results】A total of 35 cases had completed a 6-week treatment observation in the study group, while 34 cases did so in the control group. The scores of HAMD-17 in the observation group and the control group at the 2nd,4th and 6th week were significantly lower than those before treatment (all P＜0.01). There was no significant difference in the HAMD-17 scores between the observation group and the control group at the 2nd,4th and 6th week after treatment (P＞0.05). The total score of HAMD-17 in the observation group and the control group were both significantly reduced at the end of 6 weeks, and score-reducing rate was (57.82 ± 16.93) % and (60.21 ± 15.40) %, respectively. The difference was not statistically significant (t=0.243,P=0.809). The clinical total response rates of two groups were 71.42% (25/35) and 78.37% (29/37), respectively. The difference was not statistically significant; TCM symptoms effective rates of the observation group and the control group were 68.57% and 70.27%, respectively. The difference was not statistically significant (P=0.876). The incidence rates of drug-related adverse reactions were 25.71% (9/35) and 24.32% (9/37), respectively. The difference between the two groups was not statistically significant (χ²= 0.019,P=0.892).【Conclusion】Morinda officinalis oligose capsule and escitalopram have equivalent efficacy in the treatment of mild to moderate depression and have mild adverse reactions and good safety.

Key words： MORINDA OFFICINALIS/TU Depressive Disorder/ZH CAPSULES△ Citalopram/TU

Received: 05 May 2017

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R749.42

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	CHEN Jing-yu
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CHEN Jing-yu,ZHANG Tao,LI Ying, et al. A Control Study on the Efficacy and Safety of Morinda Officinalis Oligose Capsules ersus Escitalopram in Patients with Depression[J]. JOURNAL OF CLINICAL RESEARCH, 2017, 34(9): 1717-1719,1723.

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http://www.jcr.net.cn/EN/10.3969/j.issn.1671-7171.2017.09.016 OR http://www.jcr.net.cn/EN/Y2017/V34/I9/1717

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