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Objective:To compare the expression levels of candidate genes before and after Shuganjieyu capsule treatment, to analyze their correlation with depression symptoms and cognitive function, and to find and clarify the biomarkers related to the efficacy of Shuganjieyu capsule.Methods:Among 27 patients with mild to moderate depression (MMD), 24 items Hamilton depression rating scale (HAMD-24) was used to assess the severity of depression, Chinese revised Wechsler adult intelligence scale(WAIS-RC) and Chinese revised Wechsler memory scale(WMS) were used to assess cognitive function, and qRT-PCR was used to detect the expression levels of candidate genes in peripheral blood of patients with depression before and after treatment with Shuganjieyu capsule.SPSS 25.0 software was used for statistical analysis, paired t-test, non-parametric test, Spearman correlation analysis and receiver operating characteristic curve were used for data statistics. Results:The symptoms of MMD patients were relieved after Shuganjieyu capsule treatment(HAMD scores: baseline 14.00(9.75, 18.25), 8-week 4.00(2.00, 7.25), Z=-4.462, P<0.01), and the verbal intelligence quotient(VIQ) of WMS was puomoved (VIQ scores: baseline (123.00±10.24), 8-week (128.00±6.77), t=4.372, P<0.01). The level of gene expression brain derived neurotrophic factor(BDNF) (baseline 1.68(0.92, 2.63), 8-week 2.30(1.47, 4.34), Z=-2.781, P=0.005), glial cell derived neurotrophic factor(GDNF) (baseline 0.74(0.31, 1.15), 8-week 0.97(0.50, 1.71), Z=-2.159, P=0.031), 5-hydroxytryptamine receptor 2A(HTR2A) (baseline 0.60(0.39, 1.60), 8-week 0.98(0.44, 2.29), Z=-1.994, P=0.046) and glutamate ionotropic receptor AMPA type subunit 1(GRIA1) (baseline 1.19(0.66, 2.40), 8-week 1.76(0.86, 4.13), Z=-2.756, P=0.006) was up-regulated after treatment.The change rate of BDNF expression were correlated with the score of HAMD-24 ( r=-0.35, P=0.038) and performance intelligence quotient of WMS ( r=0.40, P=0.022). Conclusions:BDNF may be used as a therapeutic marker of Shuganjieyu capsule in the treatment of clinical symptoms and cognitive function of MMD patients, which is used to evaluate the efficacy of antidepressants.
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Objective To study the efficacy and safety of Shuganjieyu capsule alone or in combination with other antidepressants for the treatment of post-stroke depression (PSD).Methods Wanfang database,China National Knowledge Infrastructure (CNKI),Chinese VIP journals database,PubMed,EMbase,Cochrane Library,and Chinese dissertations full text database were retrieved by computers.The randomized controlled trials (RCTs) on Shuganjieyu capsule for the treatment of PSD from January 1995 to September 2017 were collected.After literature screening,data extraction,and methodological quality evaluation,RevMan 5.1 software was used to conduct a Meta-analysis.The bias was evaluated with the Stata 12.0 software using Begg's rank correlation and Egger's linear regression.Results A total of 19 RCTs were included,including 1 814 participants.The Meta-analysis results showed that compared with other antidepressants,there were no significant differences in the effective rate and cure rate of Shuganjieyu capsule (combinedeffects:RR=1.04 [95％ CI0.97-1.11],Z=0.99,P=0.32 and RR =1.06 [95％ CI 0.85-1.32];Z =0.52,P =0.60).Compared with other antidepressants,there were significant differences in the effective rate and cure rate of Shuganjieyu capsule in combination with other antidepressants (combined effects:RR =1.19 [95％ CI 1.13-1.26];Z =6.43,P ＜0.01 and RR =1.54 [95％ CI 1.26-1.88];Z =4.17,P ＜0.01).The incidence of adverse events of Shuganjieyu capsule alone was less than that of other antidepressants (combined effect:RR =0.39 [95％ CI 0.27-0.55];Z =5.30,P ＜ 0.01).The incidence of adverse events of Shuganjieyu capsule in combination with other antidepressants was the same as other antidepressants (combined effect:RR =0.99 [95％ CI 0.77-1.26];Z =0.10,P =0.92).Conclusions Shuganjieyu capsule is effective for post-stroke depression.The efficacy of Shuganjieyu capsule alone is as effective as other antidepressants,however,Shuganjieyu capsule in combination with other antidepressants is superior to other antidepressants,and the safety is better than other antidepressants.
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Objective To study effects of shuganjieyu capsule of plasma glucose and lipid metabolism and sleep and body weight in patients with depression.Methods 90 patients of depression who received therapy from July 2013 to July 2016 in our hospital were selected.According to random number table, those patients were divided into the observation group ( n =45 ) and the control group ( n =45 ) .The control group was treated with citalopram, while the observation group was treated with shuganjieyu capsule, then glucose and lipid metabolism, sleep, weight and clinical curative effect were compared.Results After treatment, the fasting blood glucose (FBG), postprandial 2h blood glucose (2 hPG), triacylglycerol (TG), total cholesterol (TC) in the observation group were lower than the control group(all P<0.05), the sleep state self rating scale (SRSS) and the Pittsburgh sleep quality index ( PSQI) in the observation group were lower than the control group ( all P <0.05 ) .The body weight and body mass index in the observation group were lower than the control group (all P<0.05).The total effective rate in the observation group 95.56% (43/45)was higher than the control group 77.78% (35/45) (P<0.05); the incidence of adverse reactions in observation group 20.00% (9/45) was lower the control group 46.67% (21/45) ( P <0.05).Conclusion Shuganjieyu capsule is well for depression, which can conducive to maintaining glucose and lipid metabolism, weight stability, and improve sleep quality and clinical symptoms, and high security,it's worthy of application and promotion.
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Objective To explore the efficacy and safety of double dosage of SHUGANJIEYU capsule on mod?erate depression. Methods The study was conducted by a multicenter, random, double-blind and parallel-controlled trial. Trial group received SHUGANJIEYU capsules 4# twice a day. Control group got two SHUGANJIEYU capsules and two simulated ones twice a day. The study lasted 56 days (8 weeks) for both groups. Primary efficacies were evalu? ated by the total score and score changed rate of Hamilton depression scale-17 (HAMD-17)and Hamilton anxiety scale (HAMA) as well safety by reported adverse events and laboratory tests for patients. Results One hundred twenty patients were recruited in trial group and 120 patients in control group. After a 8-week treatment, the remission ratio was 84.2% and 63.3% for the trial group and the control group, respectively according to the HAMD-17. The differ?ence in the remission ratio was significant (P0.05). Conclusion SHUGANJIEYU capsule ex?hibits a good therapeutic effect on the depressive symptoms and anxiety symptoms in patients with moderate depres?sion. Double doses of SHUGANJIEYU capsule can increase the effect of SHUGANJIEYU and accelerates SHUGAN?JIEYU-induced improvement of depression symptoms with an acceptable safety.
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Objective To compare the effect and safety of venlafaxine sustained-release tablet combined with Shuganjieyu capsule and venlafaxine sustained-release tablet used singlely in the treatment of moderate to severe poststroke depression.Methods 70 patients suffered from moderate to severe post-stroke depression were randomly divided into two groups,35 cases in each group.The patients in the control group were only treated with venlafaxine sustained-release tablet,and the patients in the study group were treated by venlafaxine sustained-release tablet combined with Shuganjieyu capsule.The treatment lasted 6 weeks.The therapeutic effect and safety were evaluated by the positive and negative syndrome scale of HAMD (17 items),and treatment emergent symptom scale of TESS.Results After treatment for 6 weeks,the total effective rate of the study group was 88.57％,which was significantly higher than 65.71％ of the control group (x2 =5.19,P ＜ 0.05).The HAM D score of the study group w.as (16.42 ± 6.07) points,and the HAMD score of the control group was(10.54 ± 5.23) points after 6 weeks.The difference was statistically significant between the two groups (t =4.34,P ＜ 0.01).The difference of TESS score between two groups was not significant(t =0.18,P ＞ 0.05).Conclusion Venlafaxine sustained-release tablet combined with Shuganjieyu capsule is effective and safe in the treatment of moderate to severe post-stroke depression.