芍药甘草汤加味治疗氨磺必利所致高催乳素血症的效果观察

Effect of modified Shaoyao Gancao decoction on hyperprolactinemia caused by amisulpride

目的探讨芍药甘草汤加味治疗氨磺必利所致高催乳素血症的临床效果及安全性。方法选取嘉兴市康慈医院2018年6月至2019年10月收治的氨磺必利所致高催乳素血症患者90例为研究对象,采用随机数字表法分为安慰剂对照组、对照组、观察组各30例,安慰剂对照组予类似口味、颜色的汤剂口服(不含药物成分),对照组予芍药甘草汤治疗,观察组予芍药甘草汤加味治疗,三组疗程均为8周。比较三组临床疗效、治疗前后血清催乳素(PRL)变化、治疗前后阳性和阴性症状量表(PANSS)评分、治疗8周副反应量表(TESS)评分、治疗前后糖脂代谢及肝肾功能的变化。结果安慰剂对照组、对照组、观察组有效率分别为90.0%(27/30)、96.7%(29/30)、100.0%(30/30),三组差异有统计学意义(χ2=7.027,P<0.05);治疗8周,观察组血清PRL[(48.2±15.7)μg/L]明显低于对照组[(52.5±13.7)μg/L]和安慰剂对照组[(57.7±16.9)μg/L](t=7.134、7.034,均P<0.05);治疗后,观察组PANSS评分[(51.02±3.98)分]明显低于对照组[(54.07±4.19)分]和安慰剂对照组[(58.13±4.24)分](t=5.813、6.317,均P<0.05);治疗8周,观察组TESS评分[(5.2±1.3)分]明显高于对照组[(4.9±1.4)分]和安慰剂对照组[(4.4±1.2)分](t=7.011、7.231,均P<0.05);治疗后,观察组血糖、低密度脂蛋白胆固醇、甘油三酯、总胆固醇、丙氨酸氨基转移酶、天门冬氨酸氨基转移酶水平均明显低于安慰剂对照组、对照组,高密度脂蛋白胆固醇明显高于安慰剂对照组、对照组(均P<0.05)。结论芍药甘草汤加味治疗氨磺必利引起的高催乳素血症有较好的临床效果,可降低PRL水平,且具有较好的安全性。

Objective To investigate the clinical efficacy and safety of modified Shaoyao Gancao decoction in the treatment of hyperprolactinemia caused by amisulpride.Methods Ninety patients with hyperprolactinemia caused by amisulpride who received treatment in Kangci Hospital from June 2018 to October 2019 were included in this study.They were randomly divided into the placebo control,control and observation groups(n=30/group).The placebo control group was treated with the decoction with the taste and color(without drug ingredients)similar to that of modified Shaoyao Gancao decoction.The control group was treated with Shaoyao Gancao decoction.The observation group was treated with modified Shaoyao Gancao decoction.All patients were treated for 8 weeks.Clinical efficacy,serum prolactin level and Positive and Negative Syndrome Scale score before and after treatment,Treatment Emergent Symptom Scale score after treatment,glucose and lipid metabolism,liver and kidney function before and after treatment were compared among the three groups.Results The effective rate in the placebo control,control and observation groups was 90.0%(27/30),96.7%(29/30)and 100.0%(30/30),respectively,and the difference among the three groups was statistically significant(χ2=7.027,P<0.05).After treatment,serum prolactin level in the observation group[(48.2±15.7)μg/L]was significantly lower than that in the control group[(52.5±13.7)μg/L]and placebo control group[(57.7±16.9)μg/L,t=7.134,7.034,both P<0.05].After treatment,Positive and Negative Syndrome Scale score in the observation group[(51.02±3.98)points]was significantly lower than that in the control group[(54.07±4.19)points]and placebo control group[(58.13±4.24)points,t=5.813,6.317,both P<0.05].After treatment,Treatment Emergent Symptom Scale score in the observation group[(5.2±1.3)points]was significantly higher than that in the control group[(4.9±1.4)points]and placebo control group[(4.4±1.2)points,t=7.011,7.231,both P<0.05].After treatment,blood glucose,low-density lipoprotein cholesterol,triglyceride,total cholesterol,alanine aminotransferase,aspartate aminotransferase levels in the observation group were significantly lower than those in the placebo control and control groups(all P<0.05).Serum level of high-density lipoprotein cholesterol in the observation group was significantly higher than that in the placebo control and control groups(both P<0.05).Conclusion Modified Shaoyao Gancao decoction is highly effective in the treatment of hyperprolactinemia caused by amisulpride.It can reduce serum prolactin level and has good safety.