A Randomized, Double Blind, Double Dummy Parallel Controlled Study in Schizophrenia Treated with Ziprasidone Tablets and Risperidone Orally Disintegrating Tablets
- VernacularTitle:齐拉西酮与利培酮口腔崩解片治疗首发精神分裂症患者随机、双盲、双模拟平行对照研究
- Author:
Juan XU
;
Xiaomei LIU
;
Dahong QIU
;
Dongping CHEN
;
Qunming HUANG
;
Yuansong ZHENG
- Publication Type:Journal Article
- Keywords:
schizophrenia, ziprasidone, risperidone
- From:
Chinese Journal of Rehabilitation Theory and Practice
2009;15(6):556-558
- CountryChina
- Language:Chinese
-
Abstract:
Objective To compare efficacy and safety of ziprasidone tablets and risperidone orally disintegrating tablets in the treatment of schizophrenia.Methods The randomized, double blind, double dummy parallel controlled was designed for this study. All cases were diagnosed as schizophrenia in accordance with the Chinese Classification and Diagnostic Criteria of Mental Disorder-3(CCMD-3) diagnosis standard and randomized into two groups which were treated with ziprasidone tablets or risperidone orally disintegrating tablets for 8 weeks. The initial doses of ziprasidone tablets risperidone and orally disintegrating tablets were 40 mg and 2 mg per day, respectively; and the effective doses range of ziprasidone tablets and risperidone orally disintegrating tablets were 40～160 mg and 2～8 mg per day, respectively. The Positive and Negative Syndrome Scale (PANSS), Clinical Global Impression (CGI) and Treatment Emergent Side-effect Scale (TESS) were used to evaluate efficacy and side effects before and at the ends of 2, 4, 6, 8 weeks treatment，respectively. Results 114 adult schizophrenia patients were recruited in this study, including 55 patients in ziprasidone group and 59 patients in risperidone group. After 8 weeks treatment, the significant efficacy rates of ziprasidone group and risperidone group were 65.5% and 67.8%, respectively. The efficacy rates of ziprasidone group and risperidone group were 92.7% and 93.2%, respectively. There was no significant difference between the two groups (P＞0.05). All of the side effects observed in this study were slight. The incidence rates of side effect were 36.4% and 32.2% of ziprasidone group and risperidone group, respectively. Electrocardiogram (ECG) abnormality was only observed in ziprasidone group (7.3%). Accordingly, the extrapyramidal side syndrome (EPS) incidence rate of risperidone group (11.9%) was higher than ziprasidone group (3.6%). The difference between the two groups was not statistically significant (P＞0.05).Conclusion Both of the two medicines were effective and safe in treatment of schizophrenia.
