齐拉西酮治疗首次发病的蒙古族与汉族精神分裂症患者的疗效、安全性及血药浓度比较

Comparison of clinical efficacy,safety and plasma concentration of ziprasidone in treatment of first-episode Mongolian and Han patients with schizophrenia

目的：探讨蒙古（蒙）族和汉族精神分裂症患者应用齐拉西酮治疗的剂量、疗效、安全性及血药浓度差异。方法：72例首次发病的精神分裂症患者根据民族分为蒙族组（34例）和汉族组（38例）,均给予齐拉西酮80~160 mg/d治疗6周。治疗前和治疗第2、4、6周进行阳性和阴性症状量表（PANSS）和治疗中出现症状量表（TESS）评估;治疗前后进行体质量、血脂、血糖水平及心电图检查;治疗6周末应用反相高效液相色谱法于测定齐拉西酮血药浓度。结果：治疗6周末蒙族组齐拉西酮剂量[（151.18±12.25）mg/d]显著高于汉族组[（135.79±16.21）mg/d]（F=4.316,P=0.041）;蒙族组总有效率（76.5%）及血药浓度[（94.30±16.65）ng/ml]与汉族组[73.7%,（99.63±15.54）ng/ml]相比差异无统计学意义;两组间TESS评分、治疗前后体质量、血脂、血糖水平及Q-Tc间期变化值比较差异无统计学意义;两组治疗后Q-Tc间期较治疗前明显延长（P均〈0.01）。结论：齐拉西酮对蒙族及汉族精神分裂症患者具有相同的疗效,但蒙族患者需要较高的剂量。

Objective： To explore the ziprasidone dosage,clinical efficacy, safety and plasma concentration in Mongolian and Han patients with schizophrenia. Method：Seventy two first-episode schizophrenia pa- tients were enrolled in this study, 34 Mongolian peoples （Mongolian guoup） and 38 Han people （Han group）. All patients were treated with ziprasidone （the dose from 80 to 160 mg/d） for 6 weeks. Clinical efficacy and side effects were evaluated by positive and negative syndrome scale （PANSS） and treatment emergent symptoms scale （TESS） at baseline,2,4 and 6 weeks after treatment. The body weight, the levels of fasting blood glucose （ FBG）, blood lipid were detected before and after ziprasidone treatment. The ziprasidone plasma concentration was detected by high performance liquid chromatography at end of the 6th week of ziprasidone treatment. Results： After treatment, the ziprasidone dosage taken in Mongolian group [ （ 151.18 ±12.25） mg/d ] was significantly higher than Han group [ （ 135.79 ± 16.21 ） mg/d] （ F =4. 316 ,P =0.041 ） ;but no significant differences were found in total effective rates（76.5% vs. 73.7% ） and ziprasidone plasma concentration [ （94.30± 16.65） ng/ml vs. （99.63 ± 15.54）ng/ml] between the two groups. The two groups showed no significant differences in TESS total scores, the change in value of body weight, the levels of FBG and blood lipid, Q-Tc interval; but Q-Tc interval were significantly longer than before treatment in the two group （all P 〈 0.01 ）. Conclusion： The clinical efficacy and safety of ziprasidone are similar in both Mongolian and Han patients with schizophrenia, but Mongolian patients require higher dosage.