养心汤联合氯氮平治疗难治性精神分裂症安全性的随机对照研究

Safety Observation of Yangxin Decoction with Clozapine in Treating Recurrent Schizophrenia

目的:探讨养心汤联合氯氮平治疗难治性精神分裂症的安全性。方法:选取住院的难治性精神分裂症患者60例,按照随机数字表法分为实验组和对照组各30例。实验组给予养心汤联合氯氮平治疗,对照组给予单纯氯氮平治疗。治疗4周后观察2组安全性,安全性评价采用TESS量表,并监测白细胞、谷丙转氨酶(ALT)、心电图结果,检测血浆中多巴胺D1受体和五羟色胺(5-HT)受体水平。结果:对照组22例既往不良反应改善,实验组24例既往不良反应改善,实验组在兴奋或激越、失眠、视力模糊、便秘的改善方面优于对照组;实验组1例在基线期白细胞降低者在4周末恢复,ALT 4周末无异常。实验组心电图无异常。2组多巴胺D1受体水平在基线及4周末时,2组与健康组之间没有显著差异。5-HT受体水平在四周末阳性症状组与阴性症状组均低于健康对照,其中阴性症状组在4周末5-HT水平最低。结论:养心汤和氯氮平通过不同的机制治疗难治性精神分裂症,发挥了协同作用,实验组药物安全性高,值得临床推广应用。

Objective： To observe the safety of Yangxin decoction and clozapine in the treatment of re-current schizophrenia.Methods： Sixty patients were recruited and randomly divided into 2 groups. The experimental group was treated by Yangxin decoction and clozapine and the control group by clozapine. The safety of the drug was observed after 4 weeks of treatment. TESS scale is used for safety evaluation. White blood cells,liver function,glutamic-pyruvic transaminase（ ALT）,electrocardiogram were monitored. Besides,dopamine D1 receptors and 5-HT receptor level in plasma were detected. Results： Twenty-two cases of adverse reaction from control group has improved and 24 cases of adverse reaction from the experimental group got better. The improvement of the experimental group is better than that of the control group in excitement or agitation,insomnia,blurred vision,and constipation. One case from experimental group recovered after 4 weeks of lower of white cells in baseline period. ALT had no abnormal conditions after 4 weeks. Electrocardiogram had no abnormal conditions. There were no significant differences at baseline,and after 4 weeks,there is no difference among the health group and the experimental group treatment group. The dopamine D1 receptor levels,5-HT receptor levels of the negative group and positive group in four weekend were lower than that of healthy controls,and5-HT receptor levels of negative symptoms group were lowest after 4 weeks of treatment. Conclusion： Yangxin decoction and clozapine can effectively improve the symptoms of recurrent Schizophrenia,especially for negative symptoms,and has great curative effect.