[關(guān)鍵詞]
[摘要]
目的 系統(tǒng)評(píng)價(jià)羅匹尼羅治療帕金森病的療效與安全性。方法 計(jì)算機(jī)檢索PubMed、The Cochrane Library、Embase、中國(guó)生物醫(yī)學(xué)文獻(xiàn)數(shù)據(jù)庫(CBM)、中國(guó)學(xué)術(shù)期刊全文數(shù)據(jù)庫(CNKI)、維普中文期刊全文數(shù)據(jù)庫(VIP)和萬方數(shù)據(jù)庫,查找羅匹尼羅治療帕金森的隨機(jī)對(duì)照研究(RCTs),檢索時(shí)限由建庫至2019年12月,由2名評(píng)價(jià)員獨(dú)立篩選文獻(xiàn)、提取資料和評(píng)價(jià)納入研究的偏倚風(fēng)險(xiǎn),采用RevMan 5.3進(jìn)行Meta-分析。結(jié)果 共納入14篇RCTs,帕金森患者4 456例,其中羅匹尼羅組(試驗(yàn)組)2 397例,對(duì)照組2 059例。Meta-分析結(jié)果顯示:UPDRS Ⅲ評(píng)分下降值試驗(yàn)組優(yōu)于對(duì)照組[SMD=-2.06,95% CI(-3.49,-0.64),P=0.005];UPDRS降低30%的病例數(shù)有統(tǒng)計(jì)學(xué)差異[OR=1.72,95% CI(1.04,2.86),P=0.03];臨床總體療效改善率兩組無統(tǒng)計(jì)學(xué)差異[OR=1.32,95% CI(0.90,1.95),P=0.16]。因不良事件退出率無統(tǒng)計(jì)學(xué)差異[OR=1.06,95% CI(0.87,1.29),P=0.58]。試驗(yàn)組引起疼痛、惡心、暈厥、運(yùn)動(dòng)障礙、幻覺的發(fā)生率高于對(duì)照組,引起挫傷的發(fā)生率低于對(duì)照組,差異有統(tǒng)計(jì)學(xué)意義,其余不良反應(yīng)發(fā)生率差異無統(tǒng)計(jì)學(xué)意義。結(jié)論 羅匹尼羅能有效的控制帕金森患者的癥狀,耐受性較好,但增加了疼痛、惡心等不良事件發(fā)生的風(fēng)險(xiǎn);受納入研究的數(shù)量和質(zhì)量限制,上述結(jié)論尚需更多高質(zhì)量、大樣本RCT予以驗(yàn)證。
[Key word]
[Abstract]
Objective This systematic review and Meta-analysis aimed to compare the efficacy and safety of ropinirole in the treatment of Parkinson disease. Methods A thorough search in The Cochrane Library, PubMed, Embase, CBM, CNKI, VIP, and Wanfang Data were conducted for studies published up to December 2019. Randomized controlled trials (RCTs) of ropinirole in the treatment of Parkinson disease. Quality assessment and data extraction were performed by two reviewers independently, and Meta-analysis was performed by using RevMan 5.3 software. Results Fourteen RCTs involving 4 456 patients were included. Experimental group omprised 2 397 and control group had 2 059 patients. The Meta-analysis indicated the superior effect of UPDRS Ⅲ[SMD=-2.06, 95%CI (-3.49,-0.64), P=0.005], 30% responder of UPDRS Ⅲ[OR=1.72, 95%CI (1.04, 2.86), P=0.03]. No significant effects were at improvement rate of CGI[OR=1.32, 95%CI (0.90, 1.95), P=0.16], tolerance[OR=1.06, 95%CI (0.87, 1.29), P=0.58]. The incidence of pain, nausea, syncope, dyskinesia, and hallucinations in the experimental group was higher than that in the control group, and the difference was statistically significant, The incidence of contusion was lower than that of the control group, the difference was statistically significant, and the incidence of other adverse reactions was not statistically significant. Conclusion Ropinirole can effectively control the symptoms of Parkinson's patients, and it is well tolerated, but it increases the risk of adverse events such as pain and nausea. Due to the quantity and quality limitations of the included studies, the above conclusions need more quality, large sample RCT is verified.
[中圖分類號(hào)]
R971
[基金項(xiàng)目]