不同半衰期帕利哌酮治疗精神分裂症依从性、疗效和安全性的比较

Comparison of compliance,efficacy and safety of paliperidone with different half-life in the treatment of schizophrenia

目的比较3种不同半衰期帕利哌酮治疗精神分裂症的依从性、疗效和安全性。方法采用方便抽样法,选取2019年8月至2020年8月在河北医科大学第一医院精神科及邯郸市中心医院心理科住院或门诊治疗的187例精神分裂症患者为研究对象。按照患者和医生的意愿分为帕利哌酮缓释片组(Pali-ER,n=65)、棕榈酸帕利哌酮注射液组(PP1M,n=67)和棕榈帕利哌酮酯注射液组(PP3M,n=55),并进行为期12个月的治疗。分别于治疗前及治疗第3、6、9、12个月采用阳性与阴性症状量表(PANSS)比较不同时间点3组患者的临床症状,比较3组患者的持续治疗时间、不良反应发生情况。结果研究过程中,Pali-ER组共有27例患者退出研究,其中21例停止治疗,4例更换药物,2例住院;PP1M组共17例患者退出,其中9例停止治疗,4例更换药物,4例住院;PP3M组共6例患者退出,其中5例停止治疗,1例更换药物。Pali-ER组的持续治疗时间为(9.169±0.506)个月(95%CI:8.178~10.161),短于PP1M组的(10.254±0.425)个月和PP3M组的(11.455±0.219)个月(95%CI:11.024~11.885),3组比较差异有统计学意义(P<0.05)。3组患者不同时间点的PANSS得分比较,差异无统计学意义(P>0.05)。3组患者锥体外系反应和不良反应总发生情况比较,差异有统计学意义(P<0.05)。结论不同半衰期的帕利哌酮疗效相当,使用半衰期更长的帕利哌酮治疗的患者,其依从性更好,安全性更高。

Objective To compare the compliance,efficacy and safety of three different half-lives of paliperidone in the treatment of schizophrenia.Methods A total of 187 schizophrenic patients who were hospitalized or outpatient treated in the Department of Psychology in the First Hospital of Heber Medical University and Department of Psychiatry in Handan Central Hospital from August 2019 to August 2020 were selected as the study subjects by convenience sampling method.All the patients were assigned to paliperidone sustained-release tablets(Pali-ER,n=65),one-month paliperidone palmitate(PP1M,n=67),and 3-month paliperidone palmitate(PP3M,n=55)according to wills of patients and physician,and underwent a 12 months'treatment.Patients were assessed with the Positive and Negative Symptom Scale(PANSS)at baseline,3,6,9,and 12 months,and adverse events and duration of treatment.Results During the study,a total of 27 patients in the Pali-ER group withdrew from the study,of which 21 stopped treatment,4 changed medication,and 2 were hospitalized;17 patients in the PP1M group withdrew from the study,of which 9 stopped treatment,4 changed medication,and 4 were hospitalized;6 patients in the PP3M group withdrew from the study,of which 5 stopped treatment and 1 changed medication.The mean duration of treatment in Pali-ER group was(9.169±0.506)months(95%CI=8.178-10.161),which was shorter than that of PP1M group[(10.254±0.425)months,95%CI=9.421-11.087]and PP3M group[(11.455±0.219)months,95%CI=11.024-11.885],and the differences among the 3 groups were statistically significant(P<0.05).There was no significant difference in PANSS scores among the three groups at different time periods(P>0.05).There were statistically significant differences in the occurrence of extrapyramidal reactions and adverse reactions among three groups of patients(P<0.05).Conclusions Paliperidone with different half-life has the same efficacy.Patients treated with paliperidone with longer half-life have better compliance and higher safety.