加味温胆汤联合利培酮治疗精神分裂症的随机对照研究

A Randomized Controlled Trial of Jiawei Wendan Decoction Combined with Risperidone on Patients with Schizophrenia

目的观察加味温胆汤联合利培酮治疗精神分裂症的疗效和安全性。方法采用随机数字表法将患者60例分为观察组和对照组各30例,两组均给予利培酮治疗,观察组在此基础上加用加味温胆汤,对照组加用安慰剂治疗,于治疗前及治疗后6周、12周采用阳性和阴性症状量表(PANSS)观察疗效,并于治疗前及治疗后12周抽验血清脑源性神经营养因子(BDNF)浓度,采用副反应量表(TESS)监测药物副反应。结果治疗6周、12周后,观察组、对照组PANSS评分均较治疗前低(P<0.05)。治疗6周、12周后,两组PANSS评分比较差异有统计学意义(P<0.05)。治疗12周后,两组有效率比较差异有统计学意义(P<0.05)。治疗6周、12周后,两组血清BDNF浓度均较治疗前高(P<0.05)。治疗12周后,观察组血清BDNF浓度高于对照组(P<0.05)。观察组不良反应发生率明显低于对照组(P<0.05)。结论加味温胆汤联合利培酮治疗精神分裂症的疗效优于单独使用利培酮,副作用少。

Objective： To investigate the efficacy and safety of Jiawei Wendan Decoction and risperidone on the patients with schizophrenia. Methods： 60 patients were randomly divided into the experimental group and the control group by random number table,30 cases in each group. The experimental group was treated with Jiawei Wendan Decoction and risperidone. The control group was treated with risperidone and placebo. Before and after six weeks and twelve weeks of the treatment,the Positive and Negative Syndrome Scale（PANSS） scores and Treatment Emergent Symptom Scale（TESS） were used to detect the curative effect. Twelve weeks before and after treatment,blood serum was extracted to measure the levels of brain derived neurotrophic factor（BDNF）. A side reaction scale（TESS） was used to monitor side effects of drugs. Results： Six weeks and twelve weeks after treatment,PANSS scores of the experimental group and the control group both reduced than before（P 〈 0.05）. Six weeks and twelve weeks after treatment,PANSS scores of the two groups had statistically significant difference（P 〈0.05）. After twelve weeks′ treatment,the effective rate of the two groups had statistically significant difference（P 〈0.05）. Six weeks and twelve weeks after treatment,the blood serum concentration of BDNF in both groups were higher than before（P 〈 0.05）. Twelve weeks after treatment,the difference of BDNF concentration between the two groups was statistically significant（P 〈 0.05）. The experimental group had fewer adverse reactions than the control group（P 〈 0.05）. Conclusion： Jiawei Wendan Decoction combined with risperidone is more effective on schizophrenia than risperidone alone,and has fewer side effects.