马来酸氟伏沙明合并利培酮分散片治疗强迫性障碍临床对照研究

Clinical control research of fluvoxamine maleate combined with risperidone dispersible tablets in the treatment of obsessive compulsive disorder

目的研究马来酸氟伏沙明合并利培酮分散片治疗强迫性障碍的疗效和安全性。方法 86例住院或门诊强迫性障碍患者,随机分为研究组和对照组,各43例。研究组患者使用马来酸氟伏沙明联合利培酮分散片治疗,对照组患者单用马来酸氟伏沙明治疗。在治疗第2、4、6、8周末使用耶鲁·布朗强迫量表(Y-BOCS)和汉密尔顿焦虑量表(HAMA)进行疗效评定,用副反应量表(TESS)评定不良反应,并比较。结果研究组总有效率为72.09%,高于对照组的44.19%,差异具有统计学意义(P<0.05)。两组患者治疗2、4、6、8周末的Y-BOCS和HAMA评分均较治疗前显著下降,差异具有统计学意义(P<0.05);治疗2、4、6、8周末研究组Y-BOCS评分低于对照组,差异具有统计学意义(P<0.05);治疗4、6、8周末研究组HAMA评分低于对照组,差异具有统计学意义(P<0.05)。8周的治疗期间,两组患者TESS评分比较差异均无统计学意义(P>0.05)。结论马来酸氟伏沙明联合利培酮分散片治疗强迫性障碍疗效显著,安全性好,患者依从性高,值得推广。

Objective To research curative effect and safety by fluvoxamine maleate combined with risperidone dispersible tablets in the treatment of obsessive compulsive disorder. Methods A total of 86 hospitalized or outpatient patients with obsessive compulsive disorder were randomly divided into research group and control group, with 43 cases in each group. The research group receveid fluvoxamine maleate combined with risperidone dispersible tablets for treatment, and the control group received single fluvoxamine maleate for treatment. Evaluation of curative effect was made at the end of 2, 4, 6, 8 weeks of treatment by Yale-Brown obsessive compulsive scale（Y-BOCS）and Hamilton anxiety scale（HAMA）, and adverse reactions were evaluated by treatment emergent symptom scale（TESS）for comparison. Results The research group had higher total effective rate as 72.09% than 44.19% in the control group, and the difference had statistical significance（P〈0.05）. Both groups had obviously lower Y-BOCS and HAMA scores at the end of 2, 4, 6, 8 weeks of treatment than those bfore treatment, and their difference had statistical significance（P〈0.05）. The research group had lower Y-BOCS scores at the end of 2, 4, 6, 8 weeks of treatment than the control group, and the difference had statistical significance（P〈0.05）. The research group had lower HAMA scores at the end of 4, 6, 8 weeks of treatment than the control group, and the difference had statistical significance（P〈0.05）. During treatment for 8 weeks, there was no statistically significant difference of TESS scores between the two groups（P〈0.05）. Conclusion Combination of fluvoxamine maleate and risperidone dispersible tablets shows excellent curative effect and good safety in treating obsessive compulsive disorder, along with good compliance in patients. It is worth promoting.