急性期氨磺必利疗效欠佳且伴高催乳素血症的精神分裂症患者合并阿立哌唑治疗后的疗效及安全性

Efficacy and safety of amisulpride combined with aripiprazole in treatment of schizophrenic patients with poor efficacy of amisulpride and concomitant hyperprolactinemia in acute phase

目的探讨经氨磺必利治疗疗效欠佳且伴高催乳素血症的精神分裂症患者合并阿立哌唑治疗后的疗效和安全性。方法将使用氨磺必利治疗8周后疗效欠佳且催乳素升高的72例患者随机分成对照组和研究组各36例,对照组患者继续使用氨磺必利(400~1200 mg·d^(-1))治疗,研究组在氨磺必利基础上合并使用阿立哌唑(起始剂量5 mg·d^(-1),可增加至10~30 mg·d^(-1)),均再治疗8周。比较2组患者入组时和治疗不同时间点阳性和阴性症状量表(PANSS)、副反应量表(TESS)评分和血清催乳素水平。结果每组均脱落2例,各完成34例。研究组治疗有效率在第2、4、8周末均显著高于对照组(P<0.05)。治疗4、8周末,研究组PANSS总分显著低于对照组(P<0.01),且较入组时显著下降(P<0.01)。治疗结束时,研究组PANSS总分、阳性量表、精神病理量表的减分值均显著高于对照组(P<0.01)。研究组催乳素水平在治疗4、8周末显著低于对照组(P<0.01),与入组时相比也显著下降(P<0.01);研究组女性患者使用氨磺必利治疗8周后血清催乳素升高值显著高于男性患者(P<0.01),合并阿立哌唑治疗后,女性患者血清催乳素下降值也显著高于男性(P<0.01)。2组TESS评分和不良反应发生率均无显著差异(P>0.05)。结论氨磺必利治疗效果不佳且血清催乳素升高的精神分裂症患者合并阿立哌唑治疗,可以增加疗效,有效降低血清催乳素水平,女性患者获益更加明显,且不良反应未见明显增加。

AIM To investigate the efficacy and safety of amisulpride combined with aripiprazole in schizophrenic patients with poor efficacy of amisulpride and concomitant hyperprolactinemia in acute phase.METHODS A total of 72 patients who had poor efficacy and increased prolactin levels after a 8-week treatment of amisulpride were randomly divided into control group and study group,with 36 patients in each group.The patients in the control group continued to be treated with amisulpride(400-1200mg·d^(-1)),while the patients in the study group received aripiprazole(the initial dose was 5 mg·d^(-1),which could be increased to 10-30mg·d^(-1))on the basis of amsulpride,for an additional 8 weeks of treatment.The scores of Positive and Negative Syndrome Scale(PANSS)and Treatment Emergent Symptom Scale(TESS)and the levels of serum prolactin were compared between the two groups at the time of enrollment and dfferent time points of treatment.RESULTS Two cases were dropped out in each group and 34 cases were completed in each group.The effective rate of the study group was significantly higher than that of the control group at the 2nd,4th,and 8th weekend of treatment(P<0.05).At the end of 4 and 8 weeks,the total PANSS score in the study group was significantly lower than that in the control group(P<0.01),and significantly decreased compared with that at the time of enrollment(P<0.01).At the end of treatment,the reduction of PANSS total score,positive score,and psychopathology score of the study group were significantly higher than those of the control group(P<0.01).The prolactin levels in the study group was significantly lower than that in the control group at the 4th and 8th weekend of treatment(P<0.01),and was also significantly lower than that at the time of enrollment(P<0.01).The increase of serum prolactin in female patients in the study group was more significant than that in male patients(P<0.01)after 8 weeks of treatment with amisulpride,and the decrease of serum prolactin in female patients was also more significant than that in male patients(P<0.01)after treatment combined with aripiprazole.There were no significant difference in TESS score and incidence rate of adverse reactions between the two groups(P>0.05).CONCLUSION After combined with aripiprazole in schizophrenic patients with poor efficacy of amisulpride and elevated serum prolactin,the therapeutic effect can be increased,the serum prolactin level can be reduced,and the benefits are more obvious in female patients,with no significant increase in adverse reactions.