Granulocyte transfusions for preventing infections in people with neutropenia or neutrophil dysfunction.
Granulocyte transfusions for preventing infections in people with neutropenia or neutrophil dysfunction.
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DOI：
10.1002/14651858.cd005341.pub3
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发表时间：
2015-06-29
期刊：
影响因子：
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通讯作者：
Massey E
中科院分区：
文献类型：
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作者：
Estcourt LJ;Stanworth S;Doree C;Blanco P;Hopewell S;Trivella M;Massey E
尽管有现代抗微生物药物和支持性治疗，细菌和真菌感染仍然是长期疾病相关或治疗相关中性粒细胞减少症患者的主要并发症。自20世纪90年代末以来，为治疗或预防自身缺乏功能性粒细胞的人的严重感染，捐献粒细胞输注的需求不断增加。这是对2009年首次发表的Cochrane综述的更新。确定预防性粒细胞输注的有效性和安全性，并与未接受这种干预的对照人群进行比较，以预防中性粒细胞减少症或中性粒细胞功能障碍患者的全因死亡率、感染死亡率、感染或任何其他原因引起的感染证据。我们检索了Cochrane中央对照试验注册库（Cochrane图书馆2015年第3期）、MEDLINE（1946年起）、EMBASE（1974年起）、CINAHL（1937年起）、输血证据库（1980年起）和正在进行的试验数据库中的随机对照试验（rct）和准rct。随机对照试验（rct）和准rct比较接受粒细胞输注以预防感染发展的人群与不接受粒细胞输注的对照组。新生儿是另一篇Cochrane综述的主题，并被排除在本综述之外。不受检查结果的限制，但本综述的重点是死亡率、感染死亡率和不良事件。我们采用Cochrane协作网期望的标准方法程序。12项试验符合纳入标准。一项试验仍在进行中，总共有11项试验符合条件，涉及653名参与者。这些试验在1978年至2006年间进行，并从相当相似的患者群体中招募了参与者。没有一项研究包括有中性粒细胞功能障碍的人。10项研究仅包括成人，2项研究包括儿童和成人。其中10项研究包含每个组的单独数据，并且能够进行批判性评估。一项研究将受试者重新随机化，因此无法进行定量分析。总体而言，根据GRADE方法，不同结果的证据质量非常低。这是由于许多研究存在高偏倚风险，而且许多结果估计不精确。9项研究（609名参与者）报告了全因死亡率。接受预防性粒细胞输注者与未接受预防性粒细胞输注者在30天内的全因死亡率没有差异（7项研究，437名受试者；RR 0.92, 95% CI 0.63至1.36，证据质量非常低）。7项研究（398名参与者）报告了感染导致的死亡率。在接受预防性粒细胞输注者和未接受预防性粒细胞输注者之间，30天内感染的死亡率没有差异（6项研究，286名参与者；RR 0.69, 95% CI 0.33至1.44，证据质量非常低）。9项研究（609名参与者）报告了局部或全身性细菌或真菌感染的人数。粒细胞剂量亚组间差异有统计学意义（亚组差异P = 0.01）。在低剂量粒细胞组（每天< 1.0 × 1010个粒细胞）中，接受预防性粒细胞输注的患者和未接受预防性粒细胞输注的患者在30天内感染的人数没有差异（4项研究，204名参与者；RR 0.84, 95% CI 0.58至1.20；证据质量非常低）。在接受预防性粒细胞输注的中剂量粒细胞组（每天1.0 × 1010至4.0 × 1010粒细胞）中，超过30天的感染人数减少（4项研究；293名参与者；RR 0.40, 95% CI 0.26至0.63，低质量证据）。在接受预防性粒细胞输注的受试者中，出现菌血症和真菌血症的受试者数量减少（9项研究，609名受试者；RR 0.45, 95% CI 0.30至0.65，低质量证据）。在接受预防性粒细胞输注的参与者中，局部细菌或真菌感染的参与者数量没有差异（6项研究，296名参与者；RR 0.75, 95% CI 0.50至1.14；证据质量非常低）。严重的不良事件仅报告了接受粒细胞输注的参与者和粒细胞输注者。在因骨髓抑制化疗或造血干细胞移植而导致中性粒细胞减少的患者中，有低等级证据表明预防性粒细胞输注可降低菌血症或真菌血症的风险。有低级证据表明，预防性粒细胞输注的效果可能是剂量依赖性的，每天至少10 × 1010的剂量在降低感染风险方面更有效。没有足够的证据来确定感染死亡率、全因死亡率或严重不良事件的任何差异。
Despite modern antimicrobials and supportive therapy, bacterial and fungal infections are still major complications in people with prolonged disease-related or therapy-related neutropenia. Since the late 1990s there has been increasing demand for donated granulocyte transfusions to treat or prevent severe infections in people who lack their own functional granulocytes. This is an update of a Cochrane review first published in 2009. To determine the effectiveness and safety of prophylactic granulocyte transfusions compared with a control population not receiving this intervention for preventing all-cause mortality, mortality due to infection, and evidence of infection due to infection or due to any other cause in people with neutropenia or disorders of neutrophil function. We searched for randomised controlled trials (RCTs) and quasi-RCTs in the Cochrane Central Register of Controlled Trials (Cochrane Library 2015, Issue 3), MEDLINE (from 1946), EMBASE (from 1974), CINAHL (from 1937), the Transfusion Evidence Library (from 1980) and ongoing trial databases to April 20 2015. Randomised controlled trials (RCTs) and quasi-RCTs comparing people receiving granulocyte transfusions to prevent the development of infection with a control group receiving no granulocyte transfusions. Neonates are the subject of another Cochrane review and were excluded from this review. There was no restriction by outcomes examined, but this review focuses on mortality, mortality due to infection and adverse events. We used standard methodological procedures expected by The Cochrane Collaboration. Twelve trials met the inclusion criteria. One trial is still ongoing, leaving a total of 11 trials eligible involving 653 participants. These trials were conducted between 1978 and 2006 and enrolled participants from fairly comparable patient populations. None of the studies included people with neutrophil dysfunction. Ten studies included only adults, and two studies included children and adults. Ten of these studies contained separate data for each arm and were able to be critically appraised. One study re-randomised people and therefore quantitative analysis was unable to be performed. Overall, the quality of the evidence was very low to low across different outcomes according to GRADE methodology. This was due to many of the studies being at high risk of bias, and many of the outcome estimates being imprecise. All-cause mortality was reported for nine studies (609 participants). There was no difference in all-cause mortality over 30 days between people receiving prophylactic granulocyte transfusions and those that did not (seven studies; 437 participants; RR 0.92, 95% CI 0.63 to 1.36, very low-quality evidence). Mortality due to infection was reported for seven studies (398 participants). There was no difference in mortality due to infection over 30 days between people receiving prophylactic granulocyte transfusions and those that did not (six studies; 286 participants; RR 0.69, 95% CI 0.33 to 1.44, very low-quality evidence). The number of people with localised or systemic bacterial or fungal infections was reported for nine studies (609 participants). There were differences between the granulocyte dose subgroups (test for subgroup differences P = 0.01). There was no difference in the number of people with infections over 30 days between people receiving prophylactic granulocyte transfusions and those that did not in the low-dose granulocyte group (< 1.0 × 1010 granulocytes per day) (four studies, 204 participants; RR 0.84, 95% CI 0.58 to 1.20; very low-quality evidence). There was a decreased number of people with infections over 30 days in the people receiving prophylactic granulocyte transfusions in the intermediate-dose granulocyte group (1.0 × 1010 to 4.0 × 1010 granulocytes per day) (4 studies; 293 participants; RR 0.40, 95% CI 0.26 to 0.63, low-quality evidence). There was a decreased number of participants with bacteraemia and fungaemia in the participants receiving prophylactic granulocyte transfusions (nine studies; 609 participants; RR 0.45, 95% CI 0.30 to 0.65, low-quality evidence). There was no difference in the number of participants with localised bacterial or fungal infection in the participants receiving prophylactic granulocyte transfusions (six studies; 296 participants; RR 0.75, 95% CI 0.50 to 1.14; very low-quality evidence). Serious adverse events were only reported for participants receiving granulocyte transfusions and donors of granulocyte transfusions. In people who are neutropenic due to myelosuppressive chemotherapy or a haematopoietic stem cell transplant, there is low-grade evidence that prophylactic granulocyte transfusions decrease the risk of bacteraemia or fungaemia. There is low-grade evidence that the effect of prophylactic granulocyte transfusions may be dose-dependent, a dose of at least 10 × 1010 per day being more effective at decreasing the risk of infection. There is insufficient evidence to determine any difference in mortality rates due to infection, all-cause mortality, or serious adverse events.