Bravo-Mehmedbasic Alma
Psychiatric Clinic, Clinical Center University of Sarajevo, Bosnia and Herzegovina.
Med Arh. 2011;65(6):345-7.
Risperidone is a second generation antipsychotic agent, with potent serotonin 5-HT2A and dopamine D2 receptor blocking effects. Specifically, risperidone possesses a unique balance of serotonin and dopamine antagonism, namely that its affinity for 5-HT2A receptors is significantly greater than its affinity for D2 receptors. Risperidone is well-established medication, with the proven effects on positive and negative symptoms of schizophrenia. The aim of research was to establish the effectiveness and safety of risperidone in patients with schizophrenia.
The sample consisted of 60 subjects, age ranged was between 18-60 years, both genders, who met the criteria for the diagnosis various types of schizophrenia, according to ICD-10 (International Statistical Classification of Diseases). They were enrolled in the study as outpatient and inpatient setting. All subjects signed informed consent before entering into this study which had been conducted at the Psychiatric Clinic, University Clinical Center Sarajevo. Study was designed for 8-week, open-label, flexible-dose observational study. The subjects had to have a total score > -40 on Positive and Negative scale -two parts of the Positive and Negative Syndrome Scale (PANSS), and to be able to discontinue current antipsychotic medications. The primary efficacy parameter was the percent of score difference between baseline and week 8 of therapy on two above-mentioned PANSS subscales. The difference was considered as significant improvement if decrease from the baseline was 20% or more. The secondary efficacy parameter was subjective clinical evaluation of efficacy with five possible answers: very good, good, moderate, not satisfactory, not possible to evaluate. It was measured at the end of observational period by the investigator.
All 60 enrolled patients completed the study. After the 8 weeks of treatment, 54/60 patients (90%) had clinically significant improvement of 20% or more decreased total PANSS score (Positive and Negative subscale). In 6/60 patients (10%) clinical improvement was also reported with less of 20% decreased total PANSS score. The side effects were registered in 8/60 patients (13.32%). The mild extrapyramidal symptoms registered in 1/60 (11.66%) patients, whom dose of risperidone was reduced. Increase of prolactine in 7/60 (11.66%), patients, whose dose of risperidone also were reduced. Average weight gain was 0.84 kg.
In this study Risperidone has shown very good effectiveness and safety.
利培酮是一种第二代抗精神病药物，具有强效的5-羟色胺5-HT2A和多巴胺D2受体阻断作用。具体而言，利培酮具有独特的5-羟色胺和多巴胺拮抗平衡，即其对5-HT2A受体的亲和力显著高于对D2受体的亲和力。利培酮是一种成熟的药物，已证实对精神分裂症的阳性和阴性症状均有疗效。本研究的目的是确定利培酮治疗精神分裂症患者的有效性和安全性。
样本包括60名年龄在18至60岁之间的受试者，男女不限，均符合国际疾病分类第十版（ICD-10）中各类精神分裂症的诊断标准。他们以门诊和住院患者的身份参与研究。所有受试者在进入萨拉热窝大学临床中心精神病诊所进行的本研究之前均签署了知情同意书。该研究设计为一项为期8周的开放标签、灵活剂量观察性研究。受试者在阳性与阴性症状量表（PANSS）的阳性和阴性两个分量表上的总分必须大于-40分，并且能够停用当前的抗精神病药物。主要疗效参数是上述两个PANSS分量表在治疗基线与第8周时的得分差异百分比。如果得分较基线下降20%或更多，则认为差异为显著改善。次要疗效参数是对疗效的主观临床评估，有五个可能的答案：非常好、好、中等、不满意、无法评估。由研究者在观察期结束时进行测量。
所有60名入组患者均完成了研究。治疗8周后，54/60名患者（90%）的PANSS总分（阳性和阴性分量表）临床显著改善，下降20%或更多。6/60名患者（10%）也报告有临床改善，PANSS总分下降不到20%。8/60名患者（13.32%）出现了副作用。1/60名患者（11.66%）出现轻度锥体外系症状，对其减少了利培酮剂量。7/60名患者（11.66%）出现催乳素升高，其利培酮剂量也进行了减少。平均体重增加0.84千克。
在本研究中，利培酮显示出非常好的有效性和安全性。
