巴戟天寡糖胶囊治疗抑郁症的临床疗效及安全性研究

A Control Study on the Efficacy and Safety of Morinda Officinalis Oligose Capsules ersus Escitalopram in Pa-tients with Depression

【目的】探讨巴戟天寡糖胶囊治疗抑郁症的临床疗效及安全性。【方法】选择本院收治的76例抑郁症患者，将其随机分为观察组和对照组，每组各38例。观察组给予300600mg／d巴戟天寡糖胶囊治疗，对照组给予10～20mg／d艾司西酞普兰治疗，两组均治疗6周。采用汉密尔顿抑郁量表-17（HAMD-17）、中医肾虚证量化评分表评价两组临床疗效，记录两组不良反应发生情况。【结果】观察组、对照组在第2、4、6周末HAMD-17评分均显著低于治疗前，差异具有统计学意义（均Pd0．01）；治疗前、治疗第2、4、6周末观察组与对照组HAMD-17评分比较，差异均无统计学意义（P〉O．05）。治疗6周末后观察组HAMD-17减分率为（57．82土16．93）％，对照组为（60．21±15．40）％，差异无统计学意义（t=0．243，p=0．809）。观察组总有效率为26（74．28％）低于对照组的29（78．37％），组间比较差异无统计学意义（P〉0．05）。治疗第6周末，观察组中医肾虚证量化评分总分减分值为（12．59±4．96）分，对照组为（12．03±4．72）分，组间比较差异无统计学意义（t=0．56，P=0．57）。观察组不良事件发生率为25．71％（9／35），对照组为24．32％（9／37），组间比较差异无统计学意义（X2=0．019，p=0．892）。【结论】巴戟天寡糖胶囊治疗抑郁症具有较好的临床疗效，且不良反应较少，安全性好。

[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 De- pression 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 signifi- cant 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 re- duced 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 signifi- cant （ P〈0.876）. The incidence rates of drug-related adverse reactions were 25.71% （9/35） and 24.32% （9/37）, respective- ly. The difference between the two groups was not statistically significant （X2= 0.019, P =0.892）. [Conclusion]Morinda offi- cinalis oligose capsule and escitalopram have equivalent efficacy in the treatment of mild to moderate depression and have mild adverse reactions and good safety.