| Objective: To observe the efficacy and safety of sertraline combined with probiotics on first-episode adolescent depression,and provide new ideas for the treatment of adolescent depression.Research method: Enrolled from January to December 2020 in the inpatient department of the Mental Health Department of Lanzhou University Second Hospital,the 216 first-episode adolescent depression patients receive firstly antidepressant treatment,aged 13 to 18 years,self-denying history of emotional high,24 Hamilton Depression Scale(24-Hamilton Depression Scale)Depression Rating Scale(HAMD-24)scores ≥20 points.The 216 cases were equally allocated to the treatment group and the control group by the odd and even number method.The treatment group was assigned sertraline combined with Bacillus subtilis live bacteria enteric-coated capsules.The control group was assigned sertraline combined with placebo(starch in Bacillus subtilis live bacteria enteric-coated capsule shell).The course of treatment was 12 weeks,assessing all patients in the scores of HAMD-24 and Hamilton Anxiety Scale(HAMA)before treatment,the second weekend,the fourth weekend,the eighth weekend,and the 12 th weekend,to compare the changes in the condition before and after treatment.In addition,the occurrence of adverse reactions is assessed.The subjects of statistical analysis is Full Analysis Set(FAS)data.Data were analysed using SPSS version 25.0.Differences between treatment and control groups were compared using the T-test and Chi-square test to evaluate the curative effect and the occurrence of adverse reactions.Results: 209 patients(age 15.46±1.73 years,63 men)were included in FAS,103 cases in group A(age 15.36±1.71 years,30 men),and the 106 in group B(age15.36±1.71 years,33 men).The groups did not differ in demographic(age,sex)characteristics and clinical(HAMD-24,HAMA)at baseline.Groups was observed in the scores change of the HAMD and HAMA after treatment,and the following results were obtained: 1.A significant difference in the scores change of the HAMD and HAMA compared with the baseline scores at different observation points(The second weekend,the fourth weekend,the eighth weekend,the twelfth weekend)after treatment(P<0.05).The scores all declined.2.The scores of the HAMD and HAMA in treatment group declined the fastest from the fourth weekend to the eighth weekend after treatment.The scores of HAMD-24 in control group decreased the most from the fourth weekend to the eighth weekend,and the rate of decline slows after period,while the decrease scores of HAMA was basically the same throughout the treatment period.3.It did not differ in gender on the efficacy of depression between the groups at any stage of treatment(P>0.05).4.The treatment group did no statistical difference in the efficacy of different depression and anxiety levels at any stage of treatment(P>0.05).The control group had no statistical difference in the efficacy of different anxiety levels(P>0.05),but did differ in depression levels(P<0.05).Curative effect of mild and moderate depression in patients is better than that of severe patients.5.The groups were no statistical difference in HAMD-24 and HAMA at the second weekend(P>0.05),but the difference was statistically significant(P<0.05),that the scores of the treatment group were lower than those of the control group at the fourth weekend,the eighth weekend,the twelfth weekend.6.The groups were no statistical difference in the effective rate(P>0.05),but it was a statistical difference(P<0.05),that the "clinical cure" rate in treatment group was higher than control group.7.The incidence of adverse reactions between groups were no statistical difference(P>0.05).The groups both occurred mild adverse reactions within 12 weeks of treatment,but the adverse reactions disappeared by close observation or symptomatic treatment(such as sleep aid,laxative,monitoring vital signs,etc.).Conclusion: 1.Sertraline combined with Live Combined Bacillus Subtilis and Enterococcus Faecium Enteric-coated Capsules can control depression and anxiety symptoms faster and more effectively;2.Gender has no effect on the efficacy no matter if it is combined with Live Combined Bacillus Subtilis and Enterococcus Faecium Enteric-coated Capsules;3.Sertraline is more effective for mild to moderate depressive symptoms,and is equally effective for anxiety symptoms.Sertraline combine with Live Combined Bacillus Subtilis and Enterococcus Faecium Enteric-coated Capsules can enhance the efficacy of severe depression;4.Sertraline combination of Live Combined Bacillus Subtilis and Enterococcus Faecium Enteric-coated Capsules will not increase the incidence of adverse reactions. |
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