本文選題：烏靈膠囊 + 卒中后抑郁��； 參考：《河南科技大學》2015年碩士論文

【摘要】：目的系統評價烏靈膠囊治療卒中后抑郁(post stroke depression,PSD)的有效性與安全性,為進一步的臨床研究及臨床應用提供證據。方法計算機檢索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),同時手工檢索及向生產廠家索要相關資料,全面收集烏靈膠囊治療PSD的中英文隨機對照試驗(randomized control trials,RCT)。由2位評價者獨立進行篩選文獻、提取資料和文獻質量評價后,采用Rev Man5.3軟件進行Meta分析。結果1.文獻檢索結果初檢出相關文獻113篇,經逐層篩查,最終納入18篇,共1683例患者。其中,3個研究為烏靈膠囊與空白對照進行比較,15個研究為烏靈膠囊聯合其他抗抑郁藥(黛力新、氟西汀、帕羅西汀、西酞普蘭、米氮平、舍曲林)與單用抗抑郁藥進行比較。納入文獻研究質量總體不高。2.Meta分析結果(1)17個RCT(共1623例)在治療前后采用漢密頓抑郁量表(Hamilton Depression Scale,HAMD)評價了抑郁程度,按照干預時間進行亞組分析結果顯示,試驗組4、8、12周的抑郁評分改善優(yōu)于對照組,其差異均有統計學意義[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;總效應量:SMD=-0.9,95%CI(-1.16,-0.63),P0.00001];按照烏靈膠囊聯合抗抑郁藥物類型進行亞組分析結果顯示,聯合治療組較對照組更能降低抑郁評分,其差異有統計學意義;(2)13個RCT(共1181例)在隨訪期末評估了抑郁程度改善的有效率,試驗組的有效率(92.7%)高于對照組(77.2%),其差異有統計學意義[RR=1.20,95%CI(1.14,1.27),P0.00001];(3)3個RCT(共470例)報道了心悸,合成Meta分析發(fā)現試驗組和對照組的心悸發(fā)生率無明顯差異[RR=0.87,95%CI(0.43,1.78),P0.00001]。結論1.對臨床實踐的指導意義當前研究提示,烏靈膠囊能夠改善PSD患者的抑郁狀態(tài)且不良反應較少。但受納入研究數量與質量限制,開展更多高質量的研究予以進一步驗證其療效很有必要。2.對今后研究啟示未來的臨床試驗設計應制定科學合理的研究方案;疾病的診斷最好采用國際公認的診斷標準,對所有研究對象完成隨訪;盡可能采用主要結局指標作為觀察指標,客觀評價其療效。
[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.
【學位授予單位】：河南科技大學
【學位級別】：碩士
【學位授予年份】：2015
【分類號】：R749.13

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本文編號：1879101