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[摘要]
目的 研究多中心常規(guī)方法加銀杏內(nèi)酯注射液治療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)列研究的試驗(yàn)方法,收集各中心2013年8月-2014年12月缺血性腦卒中患者,以銀杏內(nèi)酯注射液加常規(guī)治療的患者為治療組;對(duì)照組患者在常規(guī)治療基礎(chǔ)上可使用其他活血化瘀類(lèi)藥物,治療組354例,對(duì)照組180例;在出院后3、6、12個(gè)月對(duì)兩組患者進(jìn)行電話(huà)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):患者工作恢復(fù)率、成本效果比(CER);以及不良事件發(fā)生率、嚴(yán)重程度,評(píng)估患者不同治療方案的遠(yuǎn)期獲益差異。結(jié)果 出院后3、6、12個(gè)月,治療組的ADL評(píng)分、痊愈率、自理率、工作恢復(fù)率均優(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6、12個(gè)月,治療組的CER均小于對(duì)照組(P<0.05);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)酯注射液治療腦卒中的有效性及經(jīng)濟(jì)性。
[Key word]
[Abstract]
Objective To study the clinical efficacy, safety, and economic efficiency of ginkgolide injection and conventional therapy of patients with cerebral arterial thrombosis in multi center, and to evaluate the economic value of drugs. Methods A prospective cohort study was conducted in this study, patients with ischemic stroke were collected from August 2013 to December 2014. Patients (354 cases) in treatment group were treated with Ginkgolide Injection and routine treatment, and patients (180 cases) in control group could be treated with other drugs for activating blood circulation to dissipate blood stasis on the basis of routine treatment. The patients were telephonefollowed-upvisited 3, 6, and 12 months after discharge for pharmacodynamic indexes: evaluation of activities of daily living (ADL) score, self-care rate, cure rate, recurrence rate, and all-cause mortality; economic indicators: the patient work recovery rate, cost effectiveness ratio (CER), and the incidence, and severity of adverse events, to assess the differences in the long-term benefits of different treatment regimens. Results Follow-up in 3, 6,and 12 months showed that ADL score, cure rate, self-care rate, and work recovery rate of the treatment group were better than those of control group, and the difference was statistically significant. Follow-up in 12 months showed that, recurrence rate and mortality rate in the treatment group was better than that in the control group, with statistical difference.Follow-up in 6 and 12 months showed thatCER of treatment group was smaller than that of the control group. The incidence of adverse reactions was low in the two groups. Conclusion Long term evaluation showed that patients treated with 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 stroke.
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