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目的 探讨生脉胶囊对中高剂量氨磺必利治疗精神分裂症致心率变异性(HRV)的影响.方法 将100例精神分裂症患者随机分为研究组(氨磺必利联用生脉胶囊治疗)和对照组(单用氨磺必利治疗),每组50例.在治疗前及12周疗程结束后分别收集HRV时域指标(SDNN、SDANN index、SDNN index、RMSSD、pNN50)、潘氏阳性与阴性症状量表评分及心血管不良反应发生率进行对比分析.结果 对照组SDNN、SDNN index、RMSSD和pNN50指标均高于研究组(P＜0.05);对照组患者疗程结束后,其SDNN、SDNN index、RMSSD和pNN50指标均高于治疗前(P＜0.05),对照组心血管不良反应发生率高于研究组(P＜0.05),2组患者临床疗效无统计学差异.结论 中、高剂量氨磺必利可使患者HRV增高,影响心脏自主神经功能,导致心血管不良反应发生率增高;联用生脉胶囊可明显降低上述风险.“,”OBJECTIVE To explore the effect of Shengmai Capsule(SMC) on heart rate variability in patients with schizophrenia who administered with megadose amisulpride.METHODS 100 patients with schizophrenia were randomly divided into the experimental group (50 cases medicated with amisulpride and SMC) and the control group (50 cases medicated only with amisulpride).Time domain analyses including SDNN,SDANN index,SDNN index,RMSSD and pNN50 were adopted to assess differences in HRV before and after 12 week of treatment between the two groups.The positive and negative symptom scale (PANSS) was used in evaluating the clinical efficacy of different groups.The incidence rate of cardiovascular adverse reactions of two groups after treatment was also calculated.RESULTS The SDNN,SDNN index,RMSSD and pNN50 of control group were higher than experimental group (P＜0.05).Patients in control group exhibited an increase at SDNN,SDNN index,RMSSD and pNN50 in comparison with pre-treatment (P＜0.05).The total incidence rate of cardiovascular adverse reactions in control group was higher than control group after treatment (P＜0.05).The clinical efficacy of both two groups had no statistical significance.CONCLUSION The use of megadose amisulpride can increase patients' HRV and result in dysfunction of the cardiac autonomic nervous system.The plus of SMC would obviously reduce those risks.