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[摘要]
目的 研究多中心銀杏內(nèi)酯注射液治療重癥缺血性腦卒中的臨床療效、經(jīng)濟(jì)性、安全性,評(píng)價(jià)藥物經(jīng)濟(jì)價(jià)值。方法 采用前瞻性隊(duì)列研究方法,納入了2013年8月-2013年12月各中心重癥缺血性腦卒中患者共119例,以銀杏內(nèi)酯注射液加常規(guī)治療的患者為治療組,共78例;對(duì)照組41例,患者在常規(guī)治療基礎(chǔ)上可使用其他活血化瘀類藥物。在出院后3、6、12個(gè)月對(duì)兩組患者進(jìn)行電話隨訪,獲取藥效指標(biāo):日常生活活動(dòng)能力評(píng)價(jià)(ADL)評(píng)分、生活自理患者比例、痊愈率、復(fù)發(fā)率、全因死亡率;經(jīng)濟(jì)學(xué)指標(biāo):成本效果比(CER);以及不良事件發(fā)生情況,評(píng)估患者采用不同治療方案的遠(yuǎn)期獲益差異。結(jié)果 出院后3、6、12個(gè)月,治療組ADL評(píng)分、痊愈率和自理率均優(yōu)于對(duì)照組,且差異顯著(P<0.05);出院后6個(gè)月,治療組復(fù)發(fā)率優(yōu)于對(duì)照組,且差異顯著(P<0.05);出院后12個(gè)月,治療組復(fù)發(fā)率和死亡率優(yōu)于對(duì)照組,且差異顯著(P<0.05);出院后3、6、12個(gè)月,治療組的CER均明顯小于對(duì)照組;兩組不良反應(yīng)發(fā)生率均較低。結(jié)論 遠(yuǎn)期評(píng)估發(fā)現(xiàn),經(jīng)銀杏內(nèi)酯注射液治療患者較未接受其治療患者臨床效果更佳,CER更優(yōu),證明了銀杏內(nèi)酯注射液治療重癥腦卒中的有效性及經(jīng)濟(jì)性。
[Key word]
[Abstract]
Objective To study the clinical efficacy, economical efficiency, and security of Ginkgolide Injection in the treatment of severe ischemic stroke in multicenter, and evaluate the economic value of drugs.Methods A prospective cohort study was conducted in this study, a total of 119 patients with severe ischemic stroke were collected from August 2013 to December 2013. In the treatment group, 78 patients were treated with Ginkgolide Injection and routine treatment; In the control group, 41 patients were treated with routine treatment (other blood stasis drugs can be used). The patients were telephone followed-up visited 3, 6, and 12 months after discharge for pharmacodynamic indexes (ADL score, self-care rate, recovery rate, recurrence rate, and all-cause mortality), economic indicators (cost effectiveness ratio, CER), and adverse events, so as to assess the patients with long-term benefit differences after different treatments.Results Follow-up in 3, 6, and 12 months after discharge showed that ADL score, recovery rate and self-care rate of treatment group were better than control group, and the difference was significant (P < 0.05). In the 6 months after discharge, the recurrence rate of treatment group was superior to control group, and the difference was significant (P < 0.05). In the 12 months after discharge, the recurrence rate and death rate of the treatment group were superior to the control group, and the difference was significant (P < 0.05). In the 3, 6 and 12 months after discharge, the CER of the treatment group was less than the control group (P < 0.05). The incidence of adverse reactions was lower in both groups.Conclusions Long-term assessment found that Ginkgolide Injection had better clinical outcomes and better CER than those without it, which proved the effectiveness and economic efficacy of Ginkgolide Injection in the treatment of severe ischemic stroke.
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