目的 評(píng)價(jià)天麻素注射液治療眩暈的療效及安全性.方法 采用多中心隨機(jī)單盲對(duì)照試驗(yàn)設(shè)計(jì),將240例眩暈住院患者隨機(jī)分為治療組和對(duì)照組(n=120),分別予天麻素注射液600 mg和鹽酸倍他司汀注射液30 mg,靜滴,每日1次,療程7 d.統(tǒng)計(jì)分析采用SAS統(tǒng)計(jì)軟件,治療前兩組的基礎(chǔ)數(shù)據(jù)比較采用非參數(shù)檢驗(yàn)或t檢驗(yàn);治療后兩組臨床療效比較采用考慮中心效應(yīng)的CMH方法.結(jié)果?、傺?意向治療(ITT)分析表明,治療組(n=117)與對(duì)照組(n=120)療程結(jié)束時(shí)眩暈癥狀臨床控制率分別為71.19%和54.17%,有效率分別為90.60%和77.50%,兩組間比較其差異有統(tǒng)計(jì)學(xué)意義(P= 0.005和P= 0.004),治療組優(yōu)于對(duì)照組.符合方案數(shù)據(jù)分析(PP)結(jié)果顯示:治療組(n=116)與對(duì)照組(n=117)療程結(jié)束時(shí)的眩暈癥狀臨床控制率分別為72.41%和54.70%,有效率分別為91.38%和77.78%,兩組間也有統(tǒng)計(jì)學(xué)差異(P= 0.005和P= 0.004),治療組優(yōu)于對(duì)照組.ITT與PP分析結(jié)果一致.②前庭功能:治療組(n=53)與對(duì)照組(n=58)療程結(jié)束時(shí)前庭功能臨床控制率分別為62.26%和42.37%,有效率分別為81.13%和76.27%,臨床控制率兩組間有統(tǒng)計(jì)學(xué)差異(P= 0.029),治療組優(yōu)于對(duì)照組,有效率兩組間無(wú)統(tǒng)計(jì)學(xué)差異(P= 0.504),ITT與PP分析結(jié)果相同.③安全性分析結(jié)果表明:治療組(n=120)與對(duì)照組(n=120)的不良反應(yīng)發(fā)生率分別為8.33%和10.83%,兩組間無(wú)統(tǒng)計(jì)學(xué)差異(P= 0.538).結(jié)論 天麻素注射液與倍他司汀注射液均為治療眩暈的有效藥物,天麻素注射液治療眩暈癥狀有效率和前庭功能下降的臨床控制率優(yōu)于倍他司汀注射液.昆明制藥集團(tuán)股份有限公司生產(chǎn)的天麻素注射液治療眩暈臨床療效確切,不良反應(yīng)少,患者耐受性好.
【摘要】 目的 研究天麻素注射液治療椎-基底動(dòng)脈供血不足（vertebrobasilar insufficiency，VBI）的療效和安全性?！》椒āz索CBM、CNKI、VIP、萬(wàn)方數(shù)據(jù)庫(kù)，檢索時(shí)間為各數(shù)據(jù)庫(kù)建庫(kù)至2010年5月，納入天麻素注射液對(duì)比其他藥物治療VBI的隨機(jī)對(duì)照試驗(yàn)（RCT），對(duì)納入研究進(jìn)行方法學(xué)質(zhì)量評(píng)價(jià)后，采用RevMan 5.0軟件進(jìn)行Meta分析?！〗Y(jié)果 納入8個(gè)RCT，涉及受試者648例，均為C級(jí)文獻(xiàn)，Meta分析結(jié)果顯示:天麻素注射液對(duì)比丹參注射液治療VBI，顯效率和總有效率差異均有統(tǒng)計(jì)學(xué)意義[RR=1.63，95%CI （1.37，1.95）和RR=1.21，95%CI （1.12，1.30）]?！〗Y(jié)論 基于當(dāng)前證據(jù)，臨床治療VBI，天麻素注射液療效優(yōu)于丹參注射液，且安全性較好?！続bstract】 Objective To study the effectiveness and safety of gastrodine injection for vertebrobasilar insufficiency (VBI). Methods Databases of CBM, CNKI, VIP and Wanfang were searched from the time of the establishment till May 2010 and randomized controlled trials (RCT) of gastrodine injection compared with other positive drugs for VBI were included. Quality evaluation and meta-analysis by using RevMan 5.0 were performed. Results A total of 8 grade-C RCTs including 648 cases were gathered. The results of meta-analysis showed that the difference of excellent and effective rates between danshen injection and gastrodine injection for VBI were significant: RR=1.63, 95%CI (1.37, 1.95) and RR=1.21, 95%CI (1.12, 1.30). Conclusion Based on current evidence, compared with danshen injection, gastrodine injection is better and safer for VBI.