| Abstract |
Objective To investigate the clinical effect and safety of Danzhi Xiaoyao Tablet in the treatment of menstruation disorder caused by antipsychotic drugs, and analyze the relationship between menstruation disorder and serum prolactin level. Methods 70 female patients with stable schizophrenia who met the diagnostic criteria of DSM-5 were included and had obvious menstrual disorder in the past three months, according to the method of random number table, they were divided into 45 cases in the test group (37 cases completed) and 45 cases in the control group (40 cases completed). Patients in the two groups completed blood routine examination, biochemistry, pituitary prolactin, PANSS scale, and menstruation assessment respectively at baseline and 3 months after treatment. Results There was no significant difference in baseline menstrual status, serum PRL level and menstrual status assessment between the two groups (all P>0.05). After 3 months of treatment, the effective rate of menstruation recovery in the test group (62.2%) was significantly higher than that in the control group (7.5%) (χ2=0.577, P＜0.05) .The serum PRL level in the test group was significantly lower than that in the control group and before the intervention, with a statistically significant difference (all P<0.05). The serum PRL level was positively correlated with the recovery of menstruation (r=0.382, P=0.001). The ROC curve analysis showed that the area under the curve that the serum PRL level predicted the menstruation recovery of patients with antipsychotic drug induced menstrual disorder was 0.786 (95%CI: 0.681-0.891, P<0.05), At the time of the serum PRL level was 53.875μg, the sensitivity, specificity and Yoden index of the drug to predict the recovery of menstrual disorder caused by antipsychotic drugs were 73.1%, 76.5% and 0.496 respectively. After 3 months of intervention, the levels of WBC, RBC, Hb, Plt, ALT, AST, TG, HDL-C, SCR, UA and Glu in serum of patients in the test group were not significantly different from those in the control group (all P>0.05), there was no significant difference in serum CHO, LDL-C and PANSS scores between the test group and the control group (all P>0.05). After intervention, the levels of WBC, RBC, Hb, Plt, ALT, AST, TG, HDL-C, SCR and Glu in serum of patients in the test group had no significant difference compared with the baseline (all P>0.05), there were significant differences in serum TCHO, LDL-C, UA and PANSS scores of patients in the test group (all P<0.05). Conclusion Danzhi Xiaoyao Tablet can improve the menstrual disorder caused by taking antipsychotic drugs without adverse reactions, and the level of serum prolactin can predict the menstrual status.
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