参松养心胶囊对氯氮平所致难治性精神分裂症患者心电图和心肌酶改变的影响

目的：探讨参松养心胶囊对氯氮平所致难治性精神分裂症患者心电图和心肌酶改变的影响.方法对102例心电图和心肌酶正常的难治性精神分裂症患者进行研究，随机分为氯氮平联合参松养心胶囊治疗的观察组(52例)和氯氮平单独治疗的对照组(50例)，分别于治疗前和治疗8周后评估阳性与阴性症状量表(PANSS)评分、检测心电图和心肌酶变化，包括肌酸激酶(CK)和肌酸激酶同工酶MB 亚型(CK－MB).结果(1)两组患者疗效和严重不良事件比较差异均无统计学意义(P ＞0．05)；(2)两组患者共出现33例心电图异常，对照组21例(42．0％)，观察组12例(23．1％)，差异有统计学意义(P ＜0．05)，其中窦性心动过速最常见，分别出现16例(32．0％)和8例(15．4％)，差异有统计学意义(P ＜0．05)，心电图异常的发生与疗效无相关性；(3)与治疗前相比，两组患者治疗后均出现 CK 和 CK－MB升高(P ＜0．05)，且观察组低于对照组，差异均有统计学意义(P ＜0．05).结论参松养心胶囊能够减轻氯氮平所致的难治性精神分裂症患者心电图异常和心肌酶升高.

Effects of Shensong Yangxin capsule on the changes of electrocardiogram and myocardial enzyme in patients with refractory schizophrenia treated with clozapine

Objective To investigate the effects of Shensong Yangxin capsule on the changes of electrocardiogram(ECG)and myocardial enzyme in patients with refractory schizophrenia treated with clozapine.Methods The 102 refractory schizophrenia patients with normal ECG and serum myocardial enzyme level were recruited in this study,which were randomly divided into control group (n = 50)and observation group (n = 52).The control group was only treated by clozapine,while the observation group was treated by clozapine combined with Shensong Yangxin capsule.The PANSS score,ECG and serum levels of CK and CK - MB were detected at base - line and the 8th weeks of treatment. Results (1)There was no statistical difference of drug efficacy and serious adverse event between control group and observation group (P > 0.05),(2)The total incidence for abnormal ECG was 21 (42.0%)in control group and 12 (23.1%)in observation group,the difference was statistically significant between the two groups (P < 0.05).Sinus tachycardia was the most common abnormal ECG,the incidence was 1 6 (32.0%)in control group and 8(1 5.4%)in observation group,the difference was statistically signifi-cant between the two groups (P < 0.05).There was no correlation between the abnormal ECG and effi-cacy.(3)The serum levels of CK and CK- MB were elevated after treatment (P < 0.05),and were more lower in the observation group (P < 0.05).Conclusions Shensong Yangxin capsule could alleviate abnormal ECG and myocardial enzyme in patients with refractory schizophrenia treated with clozapine.