| Objectives 1.To observe the effects on clinical negative symptoms of adjunctive Baicalin in Olanzapine-treated patients with Schizophrenia. 2.To observe the effects on cognitive dysfunction of adjunctive Baicalin in Olanzapine-treated patients with Schizophrenia. 3.To study the effects of Baicalin on the antipsychotic drugs-induced Metabolic disorders in patients with schizophrenia.Methods 1. From June 2014 to June 2015, experimenters who meet Division of Psychiatry were recruited from the department of psychiatry of the First Affiliated Hospital of Zhengzhou University. All patients enrolled that day were obtained detailed history, physical examination and psychiatric examination, clinical data collection. All patients were treated with olanzapine for about 2 weeks.The patients whose negative symptoms had no significant difference after 2 weeks olanzapine treatment were enrolled and randomly divided into two groups, olanzapine monotherapy group(control group), and olanzapine in combination baicalin group(observation group).2. A 24-week open-control study were made, followwing-up four times, namely screening, baseline, 12 weeks and 24 weeks. psychiatric symptoms were assessed by Positive and Negative Symptoms Scale(PANSS).Cognitive function were assessed by MATRICS. Obesity-related metabolic parameters were monitored, To Measure height, weight and then calculate body mass index(BMI). Fasting blood glucose level were measured by the glucose oxidase, serum levels of cholesterol, triglycerides, high density lipoprotein and low density lipoprotein were measured with an enzyme colorimetric determination. Fasting insulin levels were measured by an electrogenerated chemiluminescence method,.The homeostasis model of HOMA2-IR was used to measure insulin resistance namely HOMA2-S%, HOMA2-IR, respectively, insulin sensitivity, insulin resistance index. 3. The statistical software SPSS 22.0 was used to analyze experimental data. Baseline between-group comparisons of continuous variables were performed using t test. Within-group comparisons in continuous variables across different time points were examined using repeated measures analysis of variance(ANOVA). Betweengroup comparisons from baseline to week 24 in continuous variables were performed using analysis of covariance(ANCOVA) with treatment and treatment center as factors, and baseline values as covariate.. Count datas were compared by chi-square test or continued corrected chi-square test. Pearson correlation analysis were used when the datas meet normal distribution, otherwise by Spearman correlation analysis. The values were presented with mean and standard deviation, whereas count datas were reported using frequencies and percentages. A two-tailed P<0.05 indicates significant difference.Results 1. 65 patients were enrolled, those whose negative symptoms significantlly different from baseline were dropped, 5 patients withdrawwed from the study at baseline,57 completed the following-up,there were 27 patients in control group,30 patients in observation group. There were no significant differences between control group and observation group in gender, age, educational level, duration,weight, BMI, PANSS scale, cognitive function, fasting glucose, fasting insulin, insulin resistance index, insulin sensitivity, total cholesterol, triglycerides, high density lipoprotein and low density lipoprotein before treatment( P> 0.05). 2. Within-group comparison, PANSS total score, negative symptoms score, positive symptoms score and general psychopathology points of week 12 and week 24 are lower than that of the baseline in both group( p’s< 0.05).PANSS total score in the control group(58.29±5.47,51.63±5.98,) was significantly higher than that in the observation group(53.60±3.29,46.57±1.27) at 12 weeks and 24 weeks(p=0.024, 0.048); Negative symptoms in the control group(15.50±2.93) at 24 weeks were higher than that in the observation group(9.86±0.38), and the differences between the two groups were statistically significant(p = 0.001). 3. The attention / vigilance T score of cognitive function of the control group((30.73 ± 6.77,48.73. ± 10.87) were significantly lower than that in the observation group(37.20 ± 6.63,60.50 ± 7.79) at 12 weeks and 24 weeks( p <0.001, p = 0.019). There were statistically significant differences in working memory and visual learning between the two groups(p = 0.031,0.011),the working memory(44.80 ± 12.68) and visual learning(48.73 ± 10.87) T score in the control group were lower than that in the observation group(57.30 ± 11.23,60.50 ± 7.79) at 24 weeks. There were no significant differences between the two groups in information processing speed, verbal learning, reasoning and problem solving, social cognition areas of T score during treatment(p’s> 0.05). 4. Changes in glucose in the comparison groups were as follows. There was no significant difference in fasting plasma glucose between the two groups at each time of follow-up( p> 0.05); The fasting insulin levels was statistically higher than that of the observation group at 12 weeks(p = 0.012).The difference of insulin resistance index was statistically significant between the two groups at 12 weeks and 24 weeks(p=0.023,0.003), the insulin resistance index in the control group(2.82 ± 1.14,2.14±1.02)was higher than that in the observation group(1.87 ± 0.89,1.67±0.92). There was no significant difference between the two groups in HOMA2-% S at each time of follow-up(p> 0.05).5. Changes in lipid metabolism in the comparison groups was as follows. There were significant between group differences in body weight, BMI,TCHO, LDL(p <0.05), which of the control group were higher than that of the observation group at 12 weeks and 24 weeks. There were significant between group differences in TG levels(p = 0.005),TG levels of the control group(2.00 ± 0.95) was higher than that of the observation group(1.18 ± 0.70) at 24 weeks; HDL levels of the 24 weeks the control group was significantly lower than that of the observation group at 24 weeks(p = 0.033). 6. Safety measures:There was no significant differences between the two groups in liver injury, serum leves of creatinine, blood urea nitrogen, blood pressure, heart rate and extrapyramidal reactions(p> 0.05).No serious adverse events were seen during treatment in either group.Conclusions 1. The combined use of baicalin could help improve the negative symptoms of schizophrenia. 2. The combined use of baicalin could help improve attention / vigilance, working memory and visual learning of cognitive function field of schizophrenia. 3. Combined with Baicalin could relieve insulin resistance, reduce lipids and body weight in olanzapine-treated patients with schizophrenia, to a certain extent could improve antipsychotic-induced obesity. |
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