巴戟天寡糖胶囊治疗抑郁症的临床疗效及安全性研究

[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300~600mg/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P<0.01);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>0.05).治疗6周末后观察组hAMD-17减分率为(57.82±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(χ2=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.

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

[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(χ2= 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.