CAJ | 학술논문

目的：综合分析乌司他丁（ulinastatin， UTI）、胸腺肽α1（thymosin α1， Tα1）联合或单独治疗严重脓毒症的安全性和有效性。方法检索PubMed、Embase和Cochrane Library数据库中收录的有关UTI、Tα1联合或单独治疗严重脓毒症的相关文献，依据Cochrane 系统评价手册5.1．0版推荐的质量评价标准对随机对照试验（ randomized controlled trial ， RCT ）进行评价，使用Review Manager 5．3统计学软件进行数据分析和综合，并绘制森林图和漏斗图。结果共纳入10篇文献，12项研究。试验组和对照组比较的亚组分析结果显示：①UTI联合Tα1亚组中，28 d死亡率差异有统计学意义[RR＝0．67，95％CI（0．57，0．80）， P＜0．00001]，90 d死亡率差异有统计学意义[ RR＝0．74，95％ CI （0．64，0．85）， P＜0．0001]，机械性通气时间差异有统计学意义[MD＝－1．51，95％ CI（－2．93，－0．09）， P＝0．04]，28 d APACHEⅡ评分差异有统计学意义[MD＝－3．39，95％CI（－5．89，－0．90）， P＝0．008]。②UTI亚组中，机械性通气时间差异有统计学意义[MD＝－4．40，95％CI（－7．55，－1．25）， P＝0．006]。③ Tα1亚组中，28 d死亡率差异有统计学意义[RR＝0．72，95％CI （0．55，0．93）， P＝0．01]，抗生素使用时间差异有统计学意义[MD＝－6．00，95％ CI（－8．14，－3．86）， P＜0．00001]。结论依据目前的资料，UTI联合Tα1能够降低严重脓毒症患者28 d死亡率、90 d死亡率、机械性通气时间和28 d APACHEⅡ评分，UTI能够降低机械性通气时间，Tα1能够降低28 d死亡率和抗生素使用时间，但各亚组纳入研究较少，次要结局指标间异质性较大，进一步的结论有待更多高质量的RCT进行验证。
목적：종합분석오사타정（ulinastatin， UTI）、흉선태α1（thymosin α1， Tα1）연합혹단독치료엄중농독증적안전성화유효성。방법검색PubMed、Embase화Cochrane Library수거고중수록적유관UTI、Tα1연합혹단독치료엄중농독증적상관문헌，의거Cochrane 계통평개수책5.1．0판추천적질량평개표준대수궤대조시험（ randomized controlled trial ， RCT ）진행평개，사용Review Manager 5．3통계학연건진행수거분석화종합，병회제삼림도화루두도。결과공납입10편문헌，12항연구。시험조화대조조비교적아조분석결과현시：①UTI연합Tα1아조중，28 d사망솔차이유통계학의의[RR＝0．67，95％CI（0．57，0．80）， P＜0．00001]，90 d사망솔차이유통계학의의[ RR＝0．74，95％ CI （0．64，0．85）， P＜0．0001]，궤계성통기시간차이유통계학의의[MD＝－1．51，95％ CI（－2．93，－0．09）， P＝0．04]，28 d APACHEⅡ평분차이유통계학의의[MD＝－3．39，95％CI（－5．89，－0．90）， P＝0．008]。②UTI아조중，궤계성통기시간차이유통계학의의[MD＝－4．40，95％CI（－7．55，－1．25）， P＝0．006]。③ Tα1아조중，28 d사망솔차이유통계학의의[RR＝0．72，95％CI （0．55，0．93）， P＝0．01]，항생소사용시간차이유통계학의의[MD＝－6．00，95％ CI（－8．14，－3．86）， P＜0．00001]。결론의거목전적자료，UTI연합Tα1능구강저엄중농독증환자28 d사망솔、90 d사망솔、궤계성통기시간화28 d APACHEⅡ평분，UTI능구강저궤계성통기시간，Tα1능구강저28 d사망솔화항생소사용시간，단각아조납입연구교소，차요결국지표간이질성교대，진일보적결론유대경다고질량적RCT진행험증。
Objcetive To analyze the safety and effectiveness of ulinastatin ( UTI ) and thymosin α1 (Tα1) combined therapy or monotherapy for severe sepsis .Mtehods PubMed, Embase and Cochrane Library were searched for the literature which was about UTI and /or Tα1 for severe sepsis . Randomized controlled trial ( RCT) was evaluated by the Cochrane handbook 5.1.0 .Analyses and syntheses of data were performed and forest plot and funnel plot were drawn by the Review Manager 5.3 statistics software.Results 10 articles and 12 studies were taken into meta -analysis.The statistical analysis results between experimental group and control group in subgroups were as follows : ①In the subgroup of UTI and Tα1, there were significant differences in 28-day mortality [RR=0.67, 95%CI (0.57, 0.80), P<0.00001]; there were significant differences in 90-day mortality [RR=0.74, 95%CI (0.64, 0.85), P <0.0001]; there were significant differences in length of mechanical ventilation [MD=-1.51, 95%CI (-2.93 , -0.09), P=0.04];there were significant differences in 28-day APACHEⅡscores [MD=-3.39, 95% CI ( -5.89, -0.90), P=0.008].②In the subgroup of UTI , there were significant differences in length of mechanical ventilation [ MD=-4.40, 95%CI (-7.55, -1.25), P=0.006].③In the subgroup of Tα1, there were significant differences in 28 -day mortality [RR =0.72, 95% CI (0.55, 0.93), P =0.01]; there were significant differences in length of antibiotics use [MD=-6.00, 95% CI ( -8.14, -3.86), P<0.00001]. Conclusion According to the current data , UTI and Tα1 combined therapy for severe sepsis can reduce 28-day mortality, 90 -day mortality, length of mechanical ventilation and 28 -day APACHEⅡscores.UTI can reduce length of mechanical ventilation .Tα1 can reduce 28-day mortality and length of antibiotics use.However, there are a small number of studies in each subgroup and the heterogeneity in secondary outcomes is obvious , and the further conclusion needs to be validated by more high quality RCTs.