目的 評(píng)價(jià)胞磷膽堿鈉片治療急性腦出血的效果及其安全性.方法采用隨機(jī)、雙盲、雙模擬、陽(yáng)性藥物平行對(duì)照的臨床試驗(yàn)
方法 將符合入選標(biāo)準(zhǔn)的患者隨機(jī)分為兩組:試驗(yàn)組18例,口服胞磷膽堿鈉片0.2 g tid及胞磷膽堿鈉模擬膠囊0.2 g tid;對(duì)照組18例,口服胞磷膽堿鈉膠囊0.2 g tid及胞磷膽堿鈉模擬片0.2 g tid.療程均為21天.用美國(guó)國(guó)立衛(wèi)生所卒中量表(NIHSS)和Barthel 指數(shù)(BI)評(píng)價(jià)神經(jīng)功能恢復(fù)狀況.
結(jié)果 兩組受試者治療后的NIHSS量表評(píng)分和Barthel 指數(shù)較治療前均顯著改善(P lt;0.01),改善程度組間比較差異無(wú)統(tǒng)計(jì)學(xué)意義(P gt;0.05).兩組均未發(fā)現(xiàn)明顯不良反應(yīng),治療前后兩組的實(shí)驗(yàn)室指標(biāo)無(wú)顯著變化.
結(jié)論 胞磷膽堿鈉片治療急性腦出血所致的神經(jīng)功能缺損效果及安全性良好,與胞磷膽堿膠囊相比較,兩種劑型療效和安全性基本一致.胞磷膽堿鈉片為急性腦出血患者用藥提供了一種有效且服用方便的選擇.
引用本文： 周沐科,何 俐,孔雙艷,周 東. 胞磷膽堿鈉片治療急性腦出血的隨機(jī)對(duì)照試驗(yàn). 中國(guó)循證醫(yī)學(xué)雜志, 2005, 05(11): 818-821. doi: 復(fù)制
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- 1. 陽(yáng)清偉, 劉鳴. 胞二磷膽堿臨床研究和應(yīng)用的循證評(píng)價(jià)[J]. 中國(guó)循證醫(yī)學(xué)雜志, 2003; 3(1): 68～69.
- 2. 張象麟. 主編. MCDEX藥物臨床信息參考[J]. 第1版. 成都: 四川科學(xué)技術(shù)出版社; 2004. 891～892.
- 3. 楊樹(shù)聲. 藥物的劑型與其療效、藥效及毒副作用的關(guān)系[J]. 實(shí)用醫(yī)技雜志, 1998; 5(6): 385.
- 4. 喻芳芳, 歐陽(yáng)存, 沈利亞, 張曉琴. 胞磷膽堿治療腦出血臨床評(píng)價(jià)[J]. 藥物流行病學(xué)雜志, 2004; 13(4): 178～179.
- 5. Yang QW, Liu M. Evidence-based evaluation on clinical trials and application of citicoline[J]. Chinese Journal of Evidence-Based Medicine, 2003; 3(1): 68-69.
- 6. Zhang XL. Editor-in-Chief. MCDEX clinical drug reference[J]. 1st ed. Chengdu: Sichuan Science & Technology Press; 2004. 891-892.
- 7. Yang SS. The dosage form of drug and its connection with the therapeutic effect, pharmacodynamic action and side effects[J]. Practical Medical Technology Journal, 1998; 5(6): 385.
- 8. Clark W, Gunion-Rinker L, Lessov N, Hazel K. Citicoline Treatment for Experimental Intracerebral Hemorrhage in Mice[J]. Stroke, 1998; 29(10): 2 136-2 140.
- 9. Yu FF, Ou-Yang C, Shen LY, Zhang XQ. Clinical Observation on Effect of Cytosine Dihosphate-choline Injection in Treating Patients with Intercerebral Hemorrhage[J]. Chin J Pharmacoepidemiol, 2004; 13(4): 178-179.