乌灵胶囊治疗卒中后抑郁疗效与安全性的系统评价

发布时间：2018-05-12 15:14

本文选题：乌灵胶囊 + 卒中后抑郁　；参考：《河南科技大学》2015年硕士论文

【摘要】：目的系统评价乌灵胶囊治疗卒中后抑郁(post stroke depression,PSD)的有效性与安全性,为进一步的临床研究及临床应用提供证据。方法计算机检索Pub Med(1966~2013.11)、The Cochrane Library(2013年第4期)、EMBASE(1966~2013.11)、CBM(1978~2013.11)、CNKI(1994~2013.11)、VIP(1989~2013.11)和Wan Fang(1998~2013.11),同时手工检索及向生产厂家索要相关资料,全面收集乌灵胶囊治疗PSD的中英文随机对照试验(randomized control trials,RCT)。由2位评价者独立进行筛选文献、提取资料和文献质量评价后,采用Rev Man5.3软件进行Meta分析。结果1.文献检索结果初检出相关文献113篇,经逐层筛查,最终纳入18篇,共1683例患者。其中,3个研究为乌灵胶囊与空白对照进行比较,15个研究为乌灵胶囊联合其他抗抑郁药(黛力新、氟西汀、帕罗西汀、西酞普兰、米氮平、舍曲林)与单用抗抑郁药进行比较。纳入文献研究质量总体不高。2.Meta分析结果(1)17个RCT(共1623例)在治疗前后采用汉密顿抑郁量表(Hamilton Depression Scale,HAMD)评价了抑郁程度,按照干预时间进行亚组分析结果显示,试验组4、8、12周的抑郁评分改善优于对照组,其差异均有统计学意义[4周:SMD=-0.87,95%CI(-1.25,-0.5),P0.00001;8周:SMD=-1.22,95%CI(-1.86,-0.59),P=0.0002;12周;SMD=-0.62,95%CI(-1.09,-0.15),P=0.01;总效应量:SMD=-0.9,95%CI(-1.16,-0.63),P0.00001];按照乌灵胶囊联合抗抑郁药物类型进行亚组分析结果显示,联合治疗组较对照组更能降低抑郁评分,其差异有统计学意义;(2)13个RCT(共1181例)在随访期末评估了抑郁程度改善的有效率,试验组的有效率(92.7%)高于对照组(77.2%),其差异有统计学意义[RR=1.20,95%CI(1.14,1.27),P0.00001];(3)3个RCT(共470例)报道了心悸,合成Meta分析发现试验组和对照组的心悸发生率无明显差异[RR=0.87,95%CI(0.43,1.78),P0.00001]。结论1.对临床实践的指导意义当前研究提示,乌灵胶囊能够改善PSD患者的抑郁状态且不良反应较少。但受纳入研究数量与质量限制,开展更多高质量的研究予以进一步验证其疗效很有必要。2.对今后研究启示未来的临床试验设计应制定科学合理的研究方案;疾病的诊断最好采用国际公认的诊断标准,对所有研究对象完成随访;尽可能采用主要结局指标作为观察指标,客观评价其疗效。
[Abstract]:Objective to evaluate the efficacy and safety of Wuling capsule in the treatment of post stroke depression after stroke, and to provide evidence for further clinical research and clinical application. Methods the Cochrane Library was searched by computer in Pub Medi (No. 4, 2013) and Wan Fang199813 / 11 / 11 / 2013. The randomized control trialsrctronic trials in Chinese and English were carried out in Wuling capsule for the treatment of PSD in a randomized control trialsrctronic trial in both Chinese and English. The results were as follows: (1) in this paper, the data were collected by computer and compared with those of the Chinese and English randomized controlled trials of Wuling capsule therapy in the Chinese and English languages. The results were compared with those obtained from the Chinese and English randomized controlled trials of Wuling capsule therapy in both Chinese and English. The results were compared with those obtained from the Chinese and English randomized controlled trials of Wuling capsule therapy in the Chinese and English languages. The literature was screened by two evaluators, and the data were extracted and evaluated. The Meta analysis was carried out by Rev Man5.3 software. Result 1. The results of literature retrieval showed that there were 113related articles, and 18 articles were included after screening. 1683 patients were included. Three of the studies were compared with blank control, and 15 were compared with antidepressants alone (Delixine, fluoxetine, paroxetine, citalopram, mirtazapine, sertraline) and other antidepressants (Delixine, fluoxetine, paroxetine, sertraline). Results of Meta-analysis) 17 RCTs (1623 cases) were evaluated by Hamilton Depression scale before and after treatment. The results of subgroup analysis according to the intervention time showed that 17 RCTs (1623 cases) were evaluated by Hamilton Depression scale before and after treatment. The depression score of the trial group at 12 weeks was better than that of the control group, and the difference was statistically significant [4: SMD-0.8795 CI-1.25- 0.5 P0.00001w: SMD-1.2295CI-1.86h-0.59P0.000212-week SMD-0.62CI-95CI-1.09C -0.15P0.01; Total effect dose: SMD-0.995CI-1.995CI-1.16C1-0.63P0.00001; according to the type of Wuling capsule combined with antidepressant drugs, the results showed that The depression scores in the combined treatment group were significantly lower than those in the control group. The difference was statistically significant. Thirteen RCTs (1181 cases) were evaluated for the effective rate of depression improvement at the end of follow-up. The effective rate of the trial group was higher than that of the control group, and the difference was statistically significant. Three RCTs (470 cases) were reported. There was no significant difference in the incidence of palpitation between the test group and the control group (RRRR0.8795CIT 0.431.78 / P0.00001). Conclusion 1. The guiding significance of clinical practice suggests that Wuling capsule can improve the depressive state of PSD patients with less adverse reactions. However, due to the limitation of quantity and quality, it is necessary to carry out more high quality studies to further verify its efficacy. Scientific and reasonable research plan should be made for the future clinical trial design, the diagnosis of disease should adopt the internationally accepted diagnostic standard, and all the subjects should be followed-up. As far as possible, the main outcome index was used as the observation index to evaluate the curative effect objectively.
【学位授予单位】：河南科技大学
【学位级别】：硕士
【学位授予年份】：2015
【分类号】：R749.13

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