棕榈酸帕利哌酮与利培酮治疗精神分裂症患者有效性与安全性的开放、随机、对照研究

目的:探讨棕榈酸帕利哌酮治疗精神分裂症的疗效、社会功能及安全性。方法:选择精神分裂症患者68例,根据随机数字方法分为观察组34例和对照组34例。观察组患者予以棕榈酸帕利哌酮注射液,对照组予以利培酮片治疗。分别于治疗前和治疗第4、8、16、24、32和48周采用阳性症状与阴性症状量表(PANSS)、依从性评定量表(MARS)、个人和社会功能量表(PSP)评价受试者相关指标,同时对患者进行安全性分析。结果:57例患者完成48周临床治疗,有11例患者脱落。1PANSS量表结果显示,与治疗前基线相比,两组患者从治疗4周至治疗48周的PANSS总分差异有统计学意义(P均0.05),同时观察组患者在治疗24周和治疗32周的PANSS总分显著低于对照组患者(P均0.05);2PSP量表结果显示,与治疗前相比,两组患者从治疗4周至治疗48周的PSP评分均显著提高(P0.05),同时观察组从治疗4周至治疗48周的PSP评分均显著高于对照组(P0.05);3MARS量表结果显示,与对照组相比,观察组患者从治疗4周至48周的MARS评分均显著提高(P0.05)。两组患者在实验过程中均无严重不良事件发生,组间不良反应发生率比较差异无统计学意义(P0.05)。结论:棕榈酸帕利哌酮治疗精神分裂症效果明显,尤其是其较高的治疗依从性和安全性,有利于促进患者康复和恢复患者的社会功能。

Efficacy and safety of PaliPeridone Palmitate and risPeridone in treatment of schizoPhrenia:an oPen,randomized,controlled study

ObJective:To explore the efficacy,social function and safety of paliperidone palmitate in treatment of schizophrenia. Method:A total of 68 patients with schizophrenia in our hospital were divided in-to observation group(n = 34)and control group(n = 34)randomly. paliperidone palmitate were applied in ob-servation group,and risperidone tablets therapy were applied in control group. Positive and negative syndrome scale(PANSS),personal and social performance scale(PSP),medication adherence report scale(MARS)and side effects were adminstered at baseline,4th,8th,16th,24th,32th and 48th weekend. Results:Fifty-seven patients completed 48 weeks of treatment and 11 patients dropped out. ①The result of PANSS showed that the total scores in the two groups were all significantly lower than the baseline level at the 4th week(P ﹤ 0. 05), and continued to the 48th week,and the total scores in the observation group were significantly lower than those in the control group(P ﹤ 0. 05). ②The result of PSP showed that the scores in the two groups were all signifi-cantly higher than the baseline level at the 4th week(P ﹤ 0. 05),and continued to the 48th week,and the scores in the observation group were significantly higher than those in the control group(P ﹤ 0. 05). ③The re-sult of MARS showed that the total scores in the observation group were significantly higher than those in the control group(P ﹤ 0. 05). In addition,there were no severe adverse reactions in the two groups,and no statisti-cal significance was found on adverse reactions between the two groups(P ﹥ 0. 05). Conclusion:Paliperi-done palmitate therapy have a significant curative effect for schizophrenia,and can improve treatment adherence and social function.