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基于心电图参数和血压的利培酮与奥氮平的心血管安全性比较:一项前瞻性开放标签观察性研究。

Comparative cardiovascular safety of risperidone and olanzapine, based on electrocardiographic parameters and blood pressure: a prospective open label observational study.

作者信息

Choure Balwant Kisanrao, Gosavi Devesh, Nanotkar Sanjay

机构信息

Department of Pharmacology, Mahatma Gandhi Institute of Medical Sciences, Sevagram, Wardha, Maharashtra, India.

出版信息

Indian J Pharmacol. 2014 Sep-Oct;46(5):493-7. doi: 10.4103/0253-7613.140579.

Abstract

OBJECTIVE

To assess the cardiovascular safety of two commonly prescribed atypical antipsychotics risperidone (RSP) and olanzapine (OZP) in schizophrenic patients, using electrocardiography (ECG) and Blood Pressure (BP).

MATERIALS AND METHODS

This was a 10-week prospective open label, observational study, carried out in a newly diagnosed 64 schizophrenic patients receiving either RSP or OZP. RSP (n = 32) was started with dose of 2 mg/day and increased to 4 mg/day after 2 weeks, whereas OZP (n = 32) was started at a dose of 5 mg/day and was increased to 10 mg/day after 2 weeks. Heart rate (HR), ECG parameters (PR, RR, QRS, QT intervals and QTc and QTd) and BP (systolic and diastolic in supine and standing position) were recorded at baseline (before drug therapy)) and during follow-up visits at 2(I), 6(II) and 10(III) weeks.

RESULTS

In the RSP group, at II and III follow-ups, a significant increase in the HR (P = 0.018, P = 0.011 respectively) as well as in QTc (P = 0.025, P = 0.015, respectively) was observed when compared to the basal values. In the OZP group, diastolic BP was significantly decreased in standing position at II and III follow-ups (P = 0.045 and P = 0.024, respectively) compared to the basal values. When the two groups were compared with each other, no significant differences were observed in the changes of HR, PR, QRS, QT, RR, QT, QTd and SBP (supine and standing position); and DBP (supine position). However, DBP in standing position showed a significant decrease in the OZP group at II and III follow-up (P = 0.036 and P = 0.016, respectively) compared to the RSP group.

CONCLUSIONS

Patients treated with OZP are at higher risk to develop postural hypotension as compared with RSP; hence RSP could be better tolerated by patients taking antihypertensive drugs as compared with OZP whereas OZP would have a safer cardiac profile.

摘要

目的

采用心电图(ECG)和血压(BP)评估两种常用非典型抗精神病药物利培酮(RSP)和奥氮平(OZP)对精神分裂症患者的心血管安全性。

材料与方法

这是一项为期10周的前瞻性开放标签观察性研究,在64例新诊断的接受RSP或OZP治疗的精神分裂症患者中进行。RSP组(n = 32)起始剂量为2mg/天,2周后增至4mg/天;而OZP组(n = 32)起始剂量为5mg/天,2周后增至10mg/天。在基线(药物治疗前)以及随访的第2周(I)、第6周(II)和第10周(III)记录心率(HR)、ECG参数(PR、RR、QRS、QT间期以及QTc和QTd)和血压(仰卧位和站立位的收缩压和舒张压)。

结果

在RSP组,与基础值相比,在第II和III次随访时,HR(分别为P = 0.018,P = 0.011)以及QTc(分别为P = 0.025,P = 0.015)均显著升高。在OZP组,与基础值相比,在第II和III次随访时,站立位舒张压显著降低(分别为P = 0.045和P = 0.024)。当两组相互比较时,在HR、PR、QRS、QT、RR、QT、QTd和收缩压(仰卧位和站立位)以及舒张压(仰卧位)的变化方面未观察到显著差异。然而,与RSP组相比,OZP组在第II和III次随访时站立位舒张压显著降低(分别为P = 0.036和P = 0.016)。

结论

与RSP相比,接受OZP治疗的患者发生体位性低血压的风险更高;因此,与OZP相比,服用抗高血压药物的患者对RSP的耐受性可能更好,而OZP的心脏安全性更高。

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