目的 探讨丹栀逍遥片治疗抗精神病药物所致月经紊乱的临床效果及其安全性,分析月经紊乱与血清泌乳素(Prolactin,PRL)水平的关系.方法 纳入符合DSM-5诊断标准的70例稳定期精神分裂症女性患者,且近三个月有明显的月经紊乱,按随机数字表法分为试验组45例(37例完成)、对照组45例(40例完成).两组患者分别在基线期以及治疗3月后完成血常规、生化、血清PRL、阳性与阴性症状量表(Positive and Negative Syndrome Scale,PANSS)及月经状况评估.结果 两组患者基线时在月经状况、血清PRL水平及月经状况评估方面的差异无统计学意义(P＞0.05).治疗3月后,试验组患者月经恢复的有效率(62.2％)与对照组(7.5％)相比差异有统计学意义(P＜0.05);试验组患者血清PRL水平明显低于对照组及干预组,差异有统计学意义(P＜0.05).血清PRL水平与月经有无恢复呈明显的正相关(P=0.001).血清PRL水平预测抗精神病药物所致月经紊乱患者月经恢复情况的曲线下面积为0.786(95％CI为0.681-0.891,P＜0.05),血清PRL水平为53.875μg.L-1时其预测抗精神病药物所致月经紊乱是否恢复的敏感度为73.1％,特异度为76.5％,其约登指数为0.496.干预3月后,试验组患者血清胆固醇(Cholesterol,CHO)、低密度脂蛋白胆固醇(Low density lipoprotein cholesterol,LDL-C)及PANSS量表评分水平与对照组比较,差异有统计学意义(P＜0.05);干预后,试验组患者血清CHO、LDL-C、尿酸(Uric acid,UA)和PANSS评分与基线相比差异均存在统计学意义(P＜0.05).结论 丹栀逍遥片能改善抗精神病药物所致月经紊乱,且无不良反应,而血清PRL水平可预测其月经状况.
Effect of Danzhi Xiaoyao Tablet on Menstrual Disorders Caused by Antipsychotic Drugs
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 num-ber 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 PRL,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(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％)(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(P＜0.05).The serum PRL level was positively correlated with the recovery of menstruation(P=0.001).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 53.875 μg,the sensitivity,specificity and Yoden index of the drug to predict the recovery of menstrual disorder caused by antipsy-chotic drugs were 73.1％,76.5％and 0.496 respectively.After 3 months of intervention,the levels of CHO、LDL-C and PANSS scores between the test group and the control group(P＜0.05).After intervention,there were significant differences compared with the baseline in serum CHO,LDL-C,UA and PANSS scores of patients in the test group(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.
NETL
NSTL
万方数据
