立芷雪治疗内科性疾病出血的疗效和安全性系统评价  

Reptilase in the Treatment of Hemorrhages: A Systematic Review

作　　者：吴泰相[1] 谢灵遐[2] 卓奇 

机构地区：[1]四川大学华西医院中国循证医学中心/国际临床流行病学网华西研究与培训中心,成都610041 [2]四川大学华西临床医学院,成都610041

出　　处：《中国循证医学杂志》2005年第10期747-766,共20页Chinese Journal of Evidence-based Medicine

摘　　要：目的评价立芷雪治疗内科性疾病出血的效果和安全性。方法采用Cochrane系统评价方法,检索Cochrane图书馆MEDLINE、VIP、CNKI等电子资料库。由3名评价者共同评价纳入研究质量,对同质研究进行Meta分析。结果共纳入40个研究、2879例各种内科性疾病患者。所有研究均未描述具体的随机方法、分配隐藏和盲法。按疾病种类、测量指标和干预措施进行亚组分析,立芷雪在治疗新生儿颅内出血[RD0.24,95%CI(0.01,0.48)]、高血压颅内出血并发症发生数[RD0.20,95%CI(0.38,0.03)]、咯血24h止血率[RD0.41,95%CI(0.17,0.64)]、上消化道出血24h止血率[RD0.39,95%CI(0.03,0.76)]、新生儿上消化道出血24h止血率[RD0.32,95%CI(0.23,0.41)]等方面均优于对照疗法;纳入研究中仅发现1例过敏者。结论现有研究结果显示,立芷雪是一种有效安全的止血剂,但由于纳入研究存在选择性偏倚和测量性偏倚的高度可能性,势必影响结果的强度,期待将来高质量的随机双盲对照试验提供高质量的证据。Objective To assess the effectiveness and safety of reptilase in the treatment of bleeding due to internal diseases. Methods The Cochrane Library, MEDLINE, VIP, and CNKI were searched. The quality of included studies was evaluated and meta-analysis was performed for the results of homogeneous studies. Results Forty studies involving 2 879 participants related to a variety of internal diseases were included. All included studies were inadquate in reporting randomization, concealment of allocation and blinding. Meta-analysis based on included studies showed that reptilase could better alleviate bleeding compared with the control group in intrecranial encephalic hemorrhage （RD 0. 24, 95 % CI 0. 01 to 0.48）, hypertension induced intrecranbd hemorrhage （RD -0.20, 95% CI -0. 38 to -0. 03）, in hemostasis rate within 24 hours in hemoptysis （RD 0.41, 95% CI 0.17 to 0. 64）, in upper alimentary tract hemorrhage （ RD 0.39, 95% CI 0.03 to 0. 76 ）, in newborn upper alimentary tract hemorrhage （ RD 0.32, 95% CI 0. 23 to 0.41 ）. Only one case of hypersensitivity occured in reptilase group. Conclusions Reptilase is an effective and safe hemostasia remedy for hemorrhage of internal diseases. Due to high risk of selection bias and detection bias of included studies, the evidence is not strong enough to judge whether reptilase is better than other hemostatics. Our results suggest that further and larger-scale trials of the use of reptilase in the treatment of hemorrhages of internal diseases are needed.

关 键 词：立芷雪 内科性疾病出血 治疗 系统评价 

分 类 号：R96[医药卫生—药理学]