帕利哌酮緩釋片和利培酮片治療首發精神分裂癥的療效和安全性開放性觀察對照研究

王崴等

[摘要] 目的 評價帕利哌酮緩釋片和利培酮片治療首發精神分裂癥的療效和安全性。方法 選取56例首發精神分裂癥患者為觀察對象，并將其分為研究組和對照組各28例。分別給予帕利哌酮緩釋片和利培酮片劑治療，并于治療前和治療后的第1、2、4和8周采用陽性與陰性癥狀量表（PANSS）評定療效，副反應量表（TESS）評定不良反應。 結果 兩組患者治療后陽性和陰性癥狀量表總分及各因子分均較治療前下降，差異有統計學意義（P<0.01）；研究組治療2周末的PANSS總分及2、4、8周的PANSS陰性評分低于對照組，差異有統計學意義（P<0.01）；兩組患者8周末臨床治療總有效率分別為78.6%和71.4%，差異無統計學意義（P>0.05）；兩組患者不良反應發生率差異有統計學意義（P<0.05）。 結論 帕利哌酮緩釋片對精神分裂癥疾病治療效果確定，尤其是在早期顯效和改善陰性癥狀方面優于利培酮，且安全性更好。

[關鍵詞] 帕利哌酮緩釋片；利培酮；首發精神分裂癥

[中圖分類號] R749 [文獻標識碼] A [文章編號] 1674-0742（2014）06（b）-0016-03

[Abstract] Objective To evaluate the efficacy and safety of paliperidone extended-release tablets and risperidone tablets in the treatment of first-episode schizophrenia. Methods 56 cases of first-episode schizophrenia patients were selected as the subjects and divided into study group and the control group with 28 cases in each， and the two groups were given paliperidone extended-release tablets and risperidone tablets treatment， respectively. Positive and Negative Syndrome Scale （PANSS） was used to assess the efficacy before the treatment and at 1， 2， 4， 8 weeks after the treatment； Treatment Emergent Symptom Scale（TESS） was used to evaluate the adverse reactions. Results After treatment， the PANSS total scores and factor scores of both groups of patients were lower than those before treatment， the differences were statistically significant（P<0.01）；the PANSS total score 2 weeks after the treatment and the PANSS negative score 2，4，8 weeks after the treatment of the study group were lower than those of the control group， the differences were statistically significant（P<0.01）； the clinical total effective rate 8 weeks after the treatment of the two groups was 78.6%， 71.4%， respectively， the difference was not statistically significant（P>0.05）； the difference in incidence of adverse reactions between two groups was statistically significant（P<0.05）. Conclusion The effect of paliperidone extended-release tablets for the treatment of schizophrenia disease is definite， and it is better than risperidone especially in taking effect early and improving negative symptoms with better safety.

[Key words] Paliperidone extended-release tablets； Risperidone； First-episode schizophrenia

精神分裂癥作為一種病程遷延、致殘率較高及慢性化的精神疾病，給患者的正常生活及工作帶來嚴重影響。目前臨床上精神分裂癥的治療強調全病程治療，其中藥物治療顯得尤為重要，非典型性抗精神病藥物通常作為首選[1]。帕利哌酮緩釋片作為臨床上一種新型非典型抗精神病藥物，于2009年在我國上市，其主要成分為利培酮的活性代謝產物9—羥基利培酮。考慮到帕利哌酮緩釋片與利培酮片化學結構上的相似性，該研究選取該院2012年8月—2013年6月住院的首發精神分裂癥患者為研究對象，利用利培酮作為對照藥物，評價帕利哌酮緩釋片治療首發精神分裂癥的療效和安全性，現報道如下。endprint