黄连素治疗精神分裂症患者代谢综合征的临床研究

Clinical study of berberine treatment on metabolic syndrome in patients with schizophrenia

目的评估黄连素对精神分裂症患者代谢综合征的疗效和安全性.方法本研究为8周的开放随机对照试验.采用随机数字表法将同时符合《精神障碍诊断与统计手册（第5版） 》 （ DSM - 5 ）精神分裂症诊断标准以及《中国成人血脂异常防治指南》中代谢综合征诊断标准的70例受试者分为黄连素药物治疗组和生活干预组,黄连素组在原单一稳定剂量抗精神病药物治疗基础上联合黄连素300 mg tid;生活干预组为在原治疗基础上联合本研究设计的干预模式,包括饮食控制、体育锻炼和康复训练.于基线期和治疗8周末测量两组体质量、腰围、臀围、血压,采集两组血液标本,检测空腹血糖（ FBG）、 空腹胰岛素（ Fins）、胆固醇（TC）、甘油三酯（TG）、高密度脂蛋白（ HDL）、低密度脂蛋白（ LDL）和餐后2 小时血糖（2h PPG）并进行PANSS评定,记录研究过程中发生的不良事件.结果①共62例完成研究,其中黄连素组30例,生活干预组32例,数据分析来自完成研究的受试者.②治疗8周末,两组体质量、体质指数（ BMI）、腰围、腰臀比与治疗前比较差异均无统计学意义（t1= -0.614,t2 = -0.268,t3 = -0.430,t4 = -0.529,P1 =0.542, P2 =0.789, P3 =0.667, P4 =0.599）.③治疗 8 周末黄连素组收缩压和舒张压均低于生活干预组,差异均有统计学意义（t1 =-2.511,t2 = -3. 831,P1 =0.015,P2 〈0.01）.④治疗8 周末,黄连素组FBG、2h PPG、Fins、TC、TG、LDL水平均低于生活干预组,差异均有统计学意义（t1 = -3.052,t2=-2.891, t3 = -3.627, t4 = -3. 011,t5 = -2.99%,t6 = -2. 144,P1 =0. 003,P2 =0. 005,P3 =0. 001,P4 =0. 004, P5 =0. 004, P6 =0. 036）. ⑤治疗8周末,黄连素组PANSS阴性症状评分低于生活干预组,差异有统计学意义（t= -2. 397, P =0. 020）.⑥治疗后两组不良反应发生率差异无统计学意义（χ^2 =0. 089,P =0.765）.结论黄连素较生活干预方式更能改善抗精神病药物治疗伴发的代谢综合征各项症状,能辅助改善精神分裂症患者的阴性症状,二者安全性相当.

Objective To evaluate the efficacy and safety of berberine treatment on metabolic syndrome in patients with schizophrenia. Methods An 8 - week open randomized controlled trail was designed for the study. 70 cases of patients with schizophrenia and metabolic syndrome were included in the study, and they were randomized divided into the berberine treatment group and the lifestyle intervention group. All patients remained original single antipsychotic treatment, including olanzapine, clozapine, risperidone and quetiapine. Berberine group was treated with berberine 300 mg tid as the additional treatment and the lifestyle intervention group was treated with intervention model included diet control, exercise and health rehabilitation training. Body weight, waist circumference, hip circumference and blood pressure were measured for patients in two groups before and after the treatment. Blood samples of patients were collected in two groups for testing fasting blood glucose （FBG） , fasting insulin （ Fins） , cholesterol （TC）,triglyceride （ TG） , high density lipoprotein （ HDL） , low density lipoprotein （ LDL） and 2 hour postprandial blood glucose （2h PPG） before and after treatment. PANSS and adverse events were assessed during the study for all patients. Results ①There were 70 subjects participated in the study, 62 subjects finished the study, 30 cases in the berberine group and 32 cases in the life intervention group. The data of the analysis was from the accomplished subjects.②In the 8th week,no significant difference existed between the berberine group and the life intervention group of body weight, BMI, waist and WHR（t1 = -0. 614, t2 - - 0 . 268, t3 = - 0 . 430, t4= -0. 529, P1= 0 . 5 4 2,P 2 = 0 . 7 8 9,P 3 = 0 . 6 6 7,P4 = 0 . 5 9 9 ） . ③In the 8 th w eek ,the berberine group declined more in SBP and DBP levels than the life intervention group（t1 = -2. 511, t2 = - 3. 8 3 1 , P1 = 0 . 015 ,P 2 〈 0. 0 1 ） . ④The berberine group decreased more significantly than the life intervention group of FBG, 2h PPG, Fins, TC, TG and LDL levels after treatment for 8 weeks（t1= - 3 . 052,t2=-2.891,t3= - 3.627, t4= - 3.011,t5 = -2.998 , t6 = -2. 144,P1 = 0 .0 0 3 , P 2 = 0 .0 0 5 , P 3 = 0 .0 0 1,P 4 = 0 . 004 ,P 5 = 0 .004,P6 =0.036 ）.⑤ The PANSS negative subscale score declined more significantly after berberine treatment for 8 weeks than the life intervention group （T= -2. 397, P = 0. 0 2 0 ） . ⑥ There was no statistically significant difference in adverse events between the two groups （χ^2 = 0. 089,P = 0.765） . Conclusion Berberine has better effect in improving the symptoms of metabolic syndrome in schizophrenia patients compared with lifestyle intervention, and berberine can improve the negative symptoms of schizophrenia. Both berberine additionaltreatment and lifestyle intervention are safe.