OBJECTIVE: To compare the therapeutic efficacy and safety of domestic vs. imported aripiprazole in the treatment of schizophrenia. METHODS: 72 schizophrenia patients were randomly divided into domestic aripiprazole group and imported aripiprazole group. Two groups were given domestic Aripiprazole tablets or imported Aripiprazole tablets for 8 weeks. The therapeutic efficacies of two groups were evaluated using Positive and Negative Symptoms Scale (PANSS) before treatment and 2, 4, 6, 8 weeks after treatment. Treatment Emergent Symptom Scale (TESS), electrocardiogram and biochemical index were used to evaluate the safety of treatment before treatment and at the end of trial. RESULTS: The effective rates of domestic aripiprazole group and imported aripiprazole group were 73.5％ and 74.2％ (P＞0.05). Compared with before treatment, positive symptom score, negative symptom score, pathological symptom score and PANSS scores of two groups at eighth weekend decreased significantly (P＜ 0.01). No severe ADR was found in two groups during treatment. The incidence of side effect of two groups were 41.2％ and 38.7％ (P＞0.05). CONCLUSION: The therapeutic efficacy of domestic aripiprazole is similar to that of imported aripiprazole in the treatment schizophrenia with good safety.%目的:比较国产与进口阿立哌唑治疗精神分裂症的疗效及安全性.方法:72例精神分裂症患者随机分为国产组与进口组,分别给予国产阿立哌唑片、进口阿立哌唑片治疗,观察疗程为8周.入组时和治疗后第2、4、6、8周,采用阳性和阴性症状量表(PANSS)进行疗效评估;在治疗前和试验结束时,用副反应量表(TESS)、心电图、实验室检查等进行安全性评估.结果:国产组与进口组的有效率分别为73.5%、74.2%(P>0.05).与治疗前比较,治疗第8周末2组的阳性量表分、阴性量表分、一般精神病理症状量表分、PANSS总分均显著下降(P＜0.01).治疗期间2组均未发生严重不良事件,国产组与进口组副反应总发生率分别为41.2%、38.7%(P>0.05).结论:国产阿立哌唑治疗精神分裂症的疗效与进口阿立哌唑相当,安全性良好.
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