丙戊酸镁缓释片与碳酸锂对躁狂发作的疗效及生存质量的对照研究

Therapeutic effects of magnesium valproate sustained release tablets and lithium carbonas on manic episode and their effects on quality of life in patients with this disorder: a control study

目的比较丙戊酸镁缓释片与碳酸锂治疗对躁狂发作患者的疗效及对生存质量的影响。方法采用入院顺序分层随机法,将120例躁狂发作患者平均分为研究组(丙戊酸镁)和对照组(碳酸锂),在治疗前,治疗后1、3、6、12月末分别用Bech-Rafaelsen躁狂量表(BRMS)和临床疗效总评量表(CGI)及不良反应表(TESS)评定疗效和副作用,用世界卫生组织生存质量测定量表(WHOQOL-BREF)评估患者的生存质量,分析量表中各领域的计分。结果两组BRMS总分在治疗后与治疗前比较有显著性差异(P<0.01),及各因子分比治疗前明显降低(P<0.01),研究组有效率96.7%,显效率70%;对照组有效率93.3%,显效率66.7%。两组间疗效无显著性差异(P>0.05),研究组副作用比对照组少。经12个月治疗,研究组与对照组两组生存质量各分指标均较治疗前有显著改善(P<0.01),在心理领域、社会关系和环境领域三方面,丙戊酸镁优于碳酸锂(P<0.01)。结论丙戊酸镁缓释片和碳酸锂对治疗躁狂发作均有效。丙戊酸镁缓释片由于副作用小,对生存质量的改善更彻底,而优于碳酸锂。

Objective To observe the efficacy and the quality of life of magnesium valproate sustained release tablets and lithium carbonas in the treatment of manic episode. Methods One hundred and twentv patients with manic episode were randomly administered with magnesium valproates （study group） or lithium earbonas （control group）. The therapeutics effects and side effects were assessed with Bech-Rafaelsen Measuring Seale（BRMS）, Clinical Global lmpression Scale （CGI） and Treatment Emergent Symptom Scale （TESS） 1 , 3, 6 and 12 months later. The World Health Organization Quality of Life （WHOQOL） -BREF was used to evaluate the patients＇quality of life before and after treatment. Results The total BRMS scores and various factors scores in the two groups were significantly reduced after treatment （P 〈0.01 ）. There were not statistical differences in the total efficaey rate on manic episode hetween the two groups, but the incidence of side effects in the study group was lower than the control group （30.4% vs 61.7% ; P 〈0. 01 ）. After treatment for 12 months, the patients＇quality of life in the two groups was greatly improved. The WHOQOL-BREF showed that the scores in the domains of psychologieal health, social relationship and environment of the study group were significantly higher than those in the control group （P 〈 0. 01 ）. Conclusions Both magnesium valproate sustained release tablets and lithium carbonas were effective in the treatment of manic episode. The former, however, appear to be superior to the latter due to less side effects and high efficacy in the improvement of patients＇quality of life.