Trial of ZMapp for Ebola Virus Infection.
Trial of ZMapp for Ebola Virus Infection.
复制标题
ZMapp 针对埃博拉病毒感染的试验。
DOI：
10.1056/nejmc1614625
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发表时间：
2017
期刊：
影响因子：
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通讯作者：
PrevailIIStudyTeam
中科院分区：
文献类型：
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作者：
DaveyJr,RichardT;Nordwall,Jacquie;Proschan,MichaelA;PrevailIIStudyTeam
致编辑：Davey和他的同事们（10月13日），我在充满挑战的环境下完成了ZMapp的试验，值得赞扬。然而，为了确定ZMapp是否代表了研究组之间的唯一差异，应该为组间比较提供更多的细节。ZMapp输注方案描述了在早期剂量增加期间每15至30分钟监测一次1；然而，没有对接受标准治疗的患者进行类似监测的描述。对接受ZMapp治疗的患者进行频繁监测可能会导致更早地发现严重不良事件，并改善护理服务，这在其他涉及类似环境下严重疾病的试验中也观察到。2基线肌酐水平升高与埃博拉病毒病死亡率相关。3,4在JIKI试验中，基线肌酐水平升高对几乎所有入组患者（97%）都是致命的，且病毒周期阈值较低（< 20）。在ZMapp试验中，接受标准治疗的患者的基线肌酐水平似乎略高；未报道组间是否有显著差异。可以想象，研究组之间的这种差异有助于提高ZMapp干预的生存趋势。
To the Editor: Davey and colleagues (Oct. 13 issue) 1 are to be commended for completing the ZMapp trial under challenging circumstances. However, in order to determine whether ZMapp represented the only difference across study groups, more detail should have been provided for the between-group comparisons. The ZMapp infusion protocol describes monitoring every 15 to 30 minutes during early dose escalation1; however, no description exists for similar monitoring of the patients who received the standard of care. Frequent monitoring of patients receiving ZMapp may have resulted in earlier identification of serious adverse events and improved care delivery, an effect observed in other trials involving severe illness in similar settings. 2 Elevated baseline creatinine levels are associated with Ebola virus disease mortality. 3, 4 In the JIKI trial, the elevated baseline creatinine level was lethal in virtually all enrolled patients (97%) with a low cycle-threshold value for the virus (< 20). 5 In the ZMapp trial, patients receiving the standard of care appear to have had slightly higher baseline creatinine levels; it was not reported whether there was a significant between-group difference. It is conceivable that such differences between study groups contributed to the improved survival trend attributed to the ZMapp intervention.