| 王朔,董晓杰,江涛,等.巴戟天寡糖胶囊治疗抑郁症 60例疗效观察及安全性评价[J].安徽医药,2021,25(6):1232-1235. |
| 巴戟天寡糖胶囊治疗抑郁症 60例疗效观察及安全性评价 |
| Clinical observation and safety evaluation of Bajitian oligosaccharide capsules in the treatment of 60 cases with depressive disorder |
| |
| DOI：10.3969/j.issn.1009-6469.2021.06.042 |
| 中文关键词: 抑郁症 巴戟天寡糖胶囊 艾司西酞普兰 疗效 不良反应 |
| 英文关键词: Depressive disorder Bajitian oligosaccharide capsules Escitalopram Efficacy Adverse reactions |
| 基金项目: |
|
| 摘要点击次数: 2896 |
| 全文下载次数: 879 |
| 中文摘要: |
| 目的对巴戟天寡糖胶囊治疗抑郁障碍进行临床疗效观察及安全性评价。方法采取随机对照研究方法，将 2019年 1—6月武汉市精神卫生中心 119例符合 DSM-5抑郁障碍诊断标准的病人按随机数字表法分为巴戟组(n=60)和艾司组(n=59)，两组病人分别接受巴戟天寡糖胶囊 600~1 200 mg∕d、艾司西酞普兰 10~20 mg∕d治疗。进行为期 8周的治疗观察。在基线时、治疗 4、8周末评定临床疗效总评量表( CGI)、汉密尔顿抑郁量表( HAMD)评价临床疗效；评定席汉残疾量表( SDS)评价社会功能状况；评定药物不良反应量表( TESS)评价安全性。结果巴戟组与艾司组的有效率分别为 83.33％( 50/60)和 83.05％( 49/59)(P>0.05)。基线时两组 HAMD评分差异无统计学意义( P>0.05)，治疗 4、8周末评分较治疗前差异有统计学意义( P<0.001)同一时点两组间比较差异无统计学意义(P>0.05)。基线时两组 SDS评分比较差异无统计学意义( P>0.05)治疗 4、8周末两组，SDS评分较治疗前均显著改善(均 P<0.001)4、8周末两组间比较差异有统计学意义(均 P<0.001)。在安全性，方面两组均未发生严重不良事件，巴戟组不良事件发生率 25.0，0%(15/60，95例次)低于艾司组 42.37%(25/59，132例次)(P<0.05)。心电图和实验室检查结果异常少见。结论巴戟天寡糖胶囊治疗抑郁障碍在安全性、有效性方面不劣于艾司西酞普兰，同时药物副反应少，对社会功能恢复起到积极作用。 |
| 英文摘要: |
| Objective To observe the clinical efficacy and safety of Bajitian oligosaccharide capsules in the treatment of depressive disorder.Methods A hundred and nineteen patients with depressive disorder diagnosed by DSM-5 diagnostic criteria at Wuhan Mental Health Center from January 2019 to June 2019 were randomly assigned into Bajitian oligosaccharide capsules group (n=60) and Escitalopram group (n=59). Patients in the two groups took Bajitian oligosaccharide capsules (600~1 200 mg/d) and escitalopram (10~20mg/d) respectively and observations were made for 8 weeks. At baseline, 4 and 8 weeks after treatment, the clinical efficacy was assessed by Clinical Global Impression (CGI) and Hamilton Depression Scale (HAMD), the social function was assessed by Sheehan Disability Scale (SDS), and the safety was assessed by Treatment Emergent Symptom Scale (TESS).Results The effective rates of Bajitian oligosaccharide capsules group and Escitalopram group were 83.33% (50/60) and 83.05% (49/59) (P>0.05). There was no significant difference in HAMD score between the two groups at baseline (P>0.05). There was significant difference in HAMD score between thetwo groups at 4 and 8 weeks after treatment in comparison with pretreatment (P<0.001), and there was no significant difference between the two groups at the same time point (P >0.05). At baseline, there was no significant difference in SDS score between the two group and escitalopram group (P>0.05). At the end of 4, 8 weeks of treatment, SDS scores of both groups were significantly improved compared with that before treatment (both P<0.001). There was significant difference between the two groups at the end of 4, 8 weeks (both P<0.001). In terms of safety, there were no serious adverse events between the two groups. The incidence of adverse events in Bajitian oligosaccharide capsules group was 25.00% (15/60, 95 times), which was lower than 42.37% in Escitalopram group (25/59, 132 times;P<0.05). Abnormal ECG and laboratory results were rare.Conclusion Bajitian oligosaccharide capsules are not inferior to escitalopram in terms of safety and effectiveness in the treatment of depressive disorder and have fewer side effects, which play a positive rolein the recovery of social function. |
|
查看全文
查看/发表评论 下载PDF阅读器 |
| 关闭 |
