喹硫平联合丙戊酸镁治疗男性双相情感障碍的临床疗效及安全性评价

Clinical Effect and Safety Evaluation of Quetiapine Combined with Magnesium Valproate Sustained Release Tablets on Male with Bipolar Disorder

目的探讨喹硫平联合丙戊酸镁治疗男性双相情感障碍的临床疗效及安全性,为临床用药提供理论依据。方法选择2012年4月至2014年4月收治的男性双相情感障碍患者60例,采用随机数字表法分为对照组和观察组各30例。对照组给予氯硝西泮片及丙戊酸镁缓释片,观察组给予富马酸喹硫平片及丙戊酸镁缓释片治疗,采用躁狂量表(BRMS)、汉密尔顿抑郁量表-21项(HAMD-21)、生活质量综合评定问卷(GQOLI-74)、临床疗效总评量表(CGI)及副反应量表(TESS)评价临床疗效及安全性。结果治疗前,观察组患者BRMS评分、HAMD-21评分与对照组相似,差异无统计学意义(P>0.05);治疗后1周、2周、4周、6周及8周,两组患者BRMS评分、HAMD-21评分较本组治疗前均下降,差异有统计学意义(P<0.05),但是观察组较对照组下降幅度更大,差异有统计学意义(P<0.05)。治疗前,观察组患者GQOLI-74评分与对照组相似,差异无统计学意义(P>0.05);治疗8周,两组患者GQOLI-74评分较本组治疗前均升高,差异有统计学意义(P<0.05),但是观察组较对照组升高幅度更大,差异有统计学意义(P<0.05)。观察组患者临床治愈17例、显著进步6例、进步4例及无效3例;对照组临床治愈9例、显著进步8例、进步7例及无效6例,两组间差异有统计学意义(P>0.05)。治疗期间,观察组患者不良反应发生率为30.00%,对照组不良反应发生率为23.33%,差异无统计学意义(P>0.05);治疗2周、4周、8周,两组患者TESS评分相似,差异无统计学意义(P<0.05)。结论喹硫平联合丙戊酸镁治疗男性双相情感障碍起效快、效果好,既可有效控制躁狂发作又可有效改善抑郁症状,提高患者生活质量。

Objective To explore the clinical effect and safety evaluation of quetiapine combined with magnesium valproate sustained release tablets on male with bipolar disorder and provide theoretical basis for clinical application. Methods From April 2012 to April 2014,60 men with bipolar disorder according with selection criteria were divided into control group and observation group of 30 cases each by the random number table. The control group was given clonazepam tablets and magnesium valproate sustained release tablets,while the observation group was given quetiapine fumarate andmagnesium valproate sustained release tablets. The Bech-Rafaelsenmainiarating Scale（BRMS）,Hamilton depression scale-21 items（HAMD-21）,general quality of life inventory（GQOLI-74）,clinical global impression scale（CGI）and treatment emergent symptom scale（TESS）were used to evaluate the clinical efficacy and safety. Results Before the treatment,the BRMS scores and HAMD-21 scoresof the observation group and control group were similar and there was no statistically significant difference（P〉0. 05）;1 week,2 weeks,4 weeks,6 weeks and 8 weeks after treatment, the BRMS scores and HAMD-21 scores decreased in both groups, which had significant difference （P〈0. 05）,but the observation group had a bigger drop than the control group,which had significantdifference（P〈0. 05）. Before the treatment,the GQOLI-74 scores of the observation and control group were similar and there was no statistically significant difference（P〉0. 05）;After treatment for 8 weeks,the GQOLI-74 scores increased in both group,which had significant difference （P〈0. 05）,but the observation group had a larger rise than the control group,which had significant difference（P〈0. 05）. There were 17 cases of clinical cure,6 cases of remarkable progress,4 cases of progress and 3 cases of inefficacy in the observation group,while there were 9 cases of clinical cure,8 cases of remarkable progress,7 cases of progress and 6 cases of inefficacy in the control group and the difference was statistically significant（P〈0. 05）. During the treatment,the incidence of adverse reactionsnbsp;was30. 00% in the observation group while the incidence of adverse reactions was 23. 33% in the control group,and there was no statistically significant difference（P〉0. 05）;After 2 weeks,4 weeks,8 weeks of treatment,the TESS scores of two groups were similar,and there was no statistically significant difference（P〉0. 05）. Conclusion Combination of quetiapine and magnesium valproate sustained release tablets has quickly and good effect on male with bipolar disorder by effectively controlling the manic,im-proving depressive symptoms and improving patients’ quality of life.