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Granulocyte‐Colony Stimulating Factor (G‐CSF) as an adjunct to antibiotics in the treatment of pneumonia in adults

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Referencias

References to studies included in this review

Ir a:

Nelson 1998 {published data only}

Nelson S, Belknap SM, Carlson RW, Dale D, DeBoisblanc B, Farkas S, et al. A randomized controlled trial of filgrastim as an adjunct to antibiotics for treatment of hospitalized patients with community‐acquired pneumonia. CAP Study Group. Journal of Infectious Diseases 1998;178(4):1075‐80.

Nelson 2000 {published data only}

Nelson S, Heyder AM, Stone J, Bergeron MG, Daugherty S, Peterson G. A randomized controlled trial of filgrastim for the treatment of hospitalized patients with multilobar pneumonia. Journal of Infectious Diseases 2000;182(3):970‐3.

Root 2003 {published data only}

Root RK, Lodato RF, Patrick W, Cade JF, Fotheringham N, Milwee S, et al. Multicenter, double‐blind, placebo‐controlled study of the use of filgrastim in patients hospitalized with pneumonia and severe sepsis. Critical Care Medicine 2003;31(2):367‐73.

Wunderink 2001 {published data only}

Wunderink R, Leeper K, Schein R, Nelson S, DeBoisblanc B, Fotheringham N, et al. Filgrastim in patients with pneumonia and severe sepsis or septic shock. Chest 2001;119(2):523‐9.

References to studies excluded from this review

Ir a:

Hustinx 1998 {published data only}

Hustinx WN, Van Kessel CP, Heezius E, Burgers S, Lammers JW, Hoepelman IM. Effects of granulocyte colony‐stimulating factor (G‐CSF) treatment on granulocyte function and receptor expression in patients with ventilator‐dependent pneumonia. Clinical and Experimental Immunology 1998;112(2):334‐40.

Meyanci 2001 {published data only}

Meyanci G, Oz H. Combination of granulocyte colony‐stimulating factor and antibacterial drugs for the treatment of ventilatory associated nosocomial pneumonia. Middle Eastern Journal of Anaesthesiology 2001;16(1):91‐101.

References to studies awaiting assessment

Ir a:

Root 2000 {published data only (unpublished sought but not used)}

Root RK, Marrie TJ, Lodato RF. Quoted in "A Randomized Controlled Trial of Filgrastim for the Treatment of Hospitalized Patients with Multilobar Pneumonia". Journal of Infectious Diseases2000.

Annane 2002

Annane D, Sibille C, Charpentier C, Bollaert PE, Francois B, Korach JM, et al. Effect of treatment with low doses of hydrocortisone and fludrocortisone on mortality in patients with septic shock. JAMA 2002;288(7):862‐71.

ATS Guidelines 1996

ATS Guidelines. Hospital‐acquired pneumonia in adults: diagnosis, assessment of severity, initial antimicrobial therapy, and preventive strategies. A consensus statement, American Thoracic Society, November 1995. American Journal of Respiratory and Critical Care Medicine 1996;153(5):1711‐25. [MEDLINE: 10]

Azoulay 2001

Azoulay E, Attalah H, Harf A, Schlemmer B, Delclaux C. Granulocyte colony‐stimulating factor or neutrophil‐induced pulmonary toxicity: myth or reality? Systematic review of clinical case reports and experimental data. Chest 2001;120(5):1695‐1701.

Bartlett 1995

Bartlett JG, Mundy LM. Community‐acquired pneumonia. New England Journal of Medicine 1995;333(24):1618‐24.

Berghmans 2002

Berghmans T, Paesmans M, Lafitte JJ, Mascaux C, Meert AP, Jacquy C, et al. Therapeutic use of granulocyte and granulocyte‐macrophage colony‐ stimulating factors in febrile neutropenic cancer patients. A systematic review of the literature with meta‐analysis. Supportive Care in Cancer 2002;10(3):181‐8.

Bernard 2001

Bernard GR, Vincent JL, Laterre PF, LaRosa SP, Dhainaut JF, Lopez‐Rodriguez A, et al. Efficacy and safety of recombinant human activated protein C for severe sepsis. New England Journal of Medicine 2001;344(10):699‐709.

Bone 1993

Bone RC, Balk RA, Cerra FB, Dellinger RP, Fein AM, Knaus WA, Schein RM, Sibbald WJ. Definitions for sepsis and organ failure and guidelines for the use of innovative therapies in sepsis. The ACCP/SCCM Consensus Conference Committee. Chest 1993 June;101(6):1644‐1655.

BTS 1987

BTS. Community‐acquired pneumonia in adults in British hospitals in 1982‐1983: a survey of aetiology, mortality, prognostic factors and outcome. The British Thoracic Society and the Public Health Laboratory Service. Quarterly Journal of Medicine 1987;62(239):195‐220. [MEDLINE: 12]

Clarke 2002

Clarke M, Oxman AD, editors. Optimal Search Strategy for RCTs. Cochrane Reviewers' Handbook 4.1.5 [Updated April, 2002]. Appendix 5c. The Cochrane Library 2002, Issue 2.

Ewig 1998

Ewig S, Ruiz M, Mensa J, Marcos MA, Martinez JA, Arancibia F. Severe community‐acquired pneumonia. Assessment of severity criteria. American Journal of Respiratory and Critical Care Medicine 1998;158(4):1102‐08. [MEDLINE: 5]

Fagon 1993a

Fagon JY, Chastre J, Hance AJ, Montravers P, Novara A, Gibert C. Nosocomial pneumonia in ventilated patients: a cohort study evaluating attributable mortality and hospital stay. American Journal of Medicine 1993;94(3):281‐8. [MEDLINE: 6]

Fagon 1993b

Fagon JY, Chastre J, Hance AJ, Domart Y, Trouillet JL, Gibert C. Evaluation of clinical judgment in the identification and treatment of nosocomial pneumonia in ventilated patients. Chest 1993;103(2):547‐53. [MEDLINE: 9]

Fine 1997

Fine MJ, Auble TE, Yealy DM, Hanusa BH, Weissfeld LA, Singer DE, et al. A prediction rule to identify low‐risk patients with community‐acquired pneumonia. New England Journal of Medicine 1997;336(4):243‐50. [MEDLINE: 11]

Garner 1988

Garner JS, Jarvis WR, Emori TG, Horan TC, Hughes JM. CDC definitions for nosocomial infections. American Journal of Infection Control 1988;16(3):128‐40. [MEDLINE: 8]

Hartung 1999

Hartung T. Granulocyte colony‐stimulating factor: its potential role in infectious disease. AIDS 1999;13(Suppl 2):3‐9. [MEDLINE: 20061789]

Hebert 1990

Hebert JC, O'Reilly M, Gamelli RL. Protective effect of recombinant human granulocyte colony‐stimulating factor against pneumococcal infections in splenectomized mice. Archives of Surgery 1990;125(8):1075‐8. [MEDLINE: 2]

McKenna 1996

McKenna P, Nelson S, Andresen J. Filgrastim (rHuG‐CSF) enhances ciprofloxacin uptake and bactericidal activity of human neutrophils in vitro [abstract 535, American Thoracic Society meeting, May, 1996]. American Journal of Respiratory and Critical Care Medicine 1996;153:A535.

Niederman 1993

Niederman MS, Bass JB, Jr, Campbell GD, Fein AM, Grossman RF, Mandell LA, et al. Guidelines for the initial management of adults with community‐acquired pneumonia: diagnosis, assessment of severity, and initial antimicrobial therapy. American Thoracic Society. Medical Section of the American Lung Association. American Review of Respiratory Disease 1993;148(5):1418‐26. [MEDLINE: 4]

Sanchez‐Nieto 1998

Sanchez‐Nieto JM, Torres A, Garcia‐Cordoba F, El Ebiary M, Carrillo A, Ruiz J, et al. Impact of invasive and noninvasive quantitative culture sampling on outcome of ventilator‐associated pneumonia: a pilot study. American Journal of Respiratory and Critical Care Medicine 1998;157(2):371‐6. [MEDLINE: 7]

Smith 1995

Smith WS, Sumnicht GE, Sharpe RW, Samuelson D, Millard FE. Granulocyte colony‐stimulating factor versus placebo in addition to penicillin G in a randomized blinded study of gram‐negative pneumonia sepsis: analysis of survival and multisystem organ failure. Blood 15‐8‐1995;86(4):1301‐9. [MEDLINE: 3]

Stephens 2002

Stephens DP, Fisher DA, Currie BJ. An audit of the use of granulocyte colony‐stimulating factor in septic shock. Internal Medicine Journal 2002;32(4):143‐8. [MEDLINE: 1]

Weiss 1999

Weiss M, Moldawer LL, Schneider EM. Granulocyte colony‐stimulating factor to prevent the progression of systemic nonresponsiveness in systemic inflammatory response syndrome and sepsis. Blood 1999;93(2):425‐39.

Welte 1996

Welte K, Gabrilove J, Bronchud MH, Platzer E, Morstyn G. Filgrastim (r‐metHuG‐CSF): the first 10 years. Blood 1996;88(6):1907‐29.

Characteristics of studies

Characteristics of included studies [ordered by study ID]

Ir a:

Nelson 1998

Methods

Multicentre, double blinded RCT

Participants

Community‐acquired pneumonia in hospitalized adults.

Interventions

G‐CSF 300mcg/d for 10 days vs placebo

Outcomes

Time to resolution of morbidity, 28 day mortality, time to ICU and hospital discharge, adverse events including organ dysfunction.

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Low risk

A ‐ Adequate
Nelson 2000

Methods

Multicentre, double blinded RCT

Participants

Community acquired multilobar pneumonia in hospitalized adults

Interventions

G‐CSF 300mcg/d for 10 days vs placebo
Placebo

Outcomes

28 day mortality, therapeutic failure, adverse events including organ dysfunction
No difference in organ dysfunction

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Low risk

A ‐ Adequate
Root 2003

Methods

Multicentre, double blinded RCT

Participants

Confirmed hospital acquired or community acquired pneumonia with severe sepsis

Interventions

G‐CSF 300mcg/day for 5 days vs placebo

Outcomes

28 day mortality, time to ICU discharge, adverse events

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Low risk

A ‐ Adequate
Wunderink 2001

Methods

Double blinded RCT in 3 centres in US

Participants

Confirmed hospital acquired or community acquired pneumonia with severe sepsis

Interventions

G‐CSF 300mcg/d for 5 days vs placebo

Outcomes

Non‐significant reduction in mortality. No difference in organ dysfunction

Notes

Small study. heterogenous population.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment (selection bias)

Low risk

A ‐ Adequate

Characteristics of excluded studies [ordered by study ID]

Ir a:

Study

Reason for exclusion

Hustinx 1998

Not a randomized controlled trial

Meyanci 2001

Clinical endpoints, such as mortality or rates of organ dysfunction, were not reported.

Data and analyses

Open in table viewer
Comparison 1. Mortality

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 28 day mortality Show forest plot

4

1955

Odds Ratio (M‐H, Fixed, 95% CI)

0.99 [0.77, 1.29]
Analysis 1.1
Comparison 1 Mortality, Outcome 1 28 day mortality.

Comparison 1 Mortality, Outcome 1 28 day mortality.
Open in table viewer
Comparison 2. Adverse events

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Any adverse event (including organ dysfunction) Show forest plot

4

1955

Odds Ratio (M‐H, Fixed, 95% CI)

0.91 [0.73, 1.14]
Analysis 2.1
Comparison 2 Adverse events, Outcome 1 Any adverse event (including organ dysfunction).

Comparison 2 Adverse events, Outcome 1 Any adverse event (including organ dysfunction).

2 Adult respiratory distress syndrome Show forest plot

3

1254

Odds Ratio (M‐H, Fixed, 95% CI)

0.91 [0.54, 1.54]
Analysis 2.2
Comparison 2 Adverse events, Outcome 2 Adult respiratory distress syndrome.

Comparison 2 Adverse events, Outcome 2 Adult respiratory distress syndrome.

3 Disseminated intravascular coagulation Show forest plot

3

1254

Odds Ratio (M‐H, Fixed, 95% CI)

0.43 [0.15, 1.22]
Analysis 2.3
Comparison 2 Adverse events, Outcome 3 Disseminated intravascular coagulation.

Comparison 2 Adverse events, Outcome 3 Disseminated intravascular coagulation.

4 Acute renal failure Show forest plot

3

1254

Odds Ratio (M‐H, Fixed, 95% CI)

0.66 [0.27, 1.63]
Analysis 2.4
Comparison 2 Adverse events, Outcome 4 Acute renal failure.

Comparison 2 Adverse events, Outcome 4 Acute renal failure.

5 Septic shock Show forest plot

2

1236

Odds Ratio (M‐H, Fixed, 95% CI)

0.60 [0.34, 1.08]
Analysis 2.5
Comparison 2 Adverse events, Outcome 5 Septic shock.

Comparison 2 Adverse events, Outcome 5 Septic shock.

Comparison 1 Mortality, Outcome 1 28 day mortality.
Figuras y tablas -
Analysis 1.1

Comparison 1 Mortality, Outcome 1 28 day mortality.

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Comparison 2 Adverse events, Outcome 1 Any adverse event (including organ dysfunction).
Figuras y tablas -
Analysis 2.1

Comparison 2 Adverse events, Outcome 1 Any adverse event (including organ dysfunction).

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Comparison 2 Adverse events, Outcome 2 Adult respiratory distress syndrome.
Figuras y tablas -
Analysis 2.2

Comparison 2 Adverse events, Outcome 2 Adult respiratory distress syndrome.

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Comparison 2 Adverse events, Outcome 3 Disseminated intravascular coagulation.
Figuras y tablas -
Analysis 2.3

Comparison 2 Adverse events, Outcome 3 Disseminated intravascular coagulation.

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Comparison 2 Adverse events, Outcome 4 Acute renal failure.
Figuras y tablas -
Analysis 2.4

Comparison 2 Adverse events, Outcome 4 Acute renal failure.

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Comparison 2 Adverse events, Outcome 5 Septic shock.
Figuras y tablas -
Analysis 2.5

Comparison 2 Adverse events, Outcome 5 Septic shock.

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Comparison 1. Mortality

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 28 day mortality Show forest plot

4

1955

Odds Ratio (M‐H, Fixed, 95% CI)

0.99 [0.77, 1.29]
Figuras y tablas -
Comparison 1. Mortality
Ir a la tabla de la revisión
Comparison 2. Adverse events

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Any adverse event (including organ dysfunction) Show forest plot

4

1955

Odds Ratio (M‐H, Fixed, 95% CI)

0.91 [0.73, 1.14]

2 Adult respiratory distress syndrome Show forest plot

3

1254

Odds Ratio (M‐H, Fixed, 95% CI)

0.91 [0.54, 1.54]

3 Disseminated intravascular coagulation Show forest plot

3

1254

Odds Ratio (M‐H, Fixed, 95% CI)

0.43 [0.15, 1.22]

4 Acute renal failure Show forest plot

3

1254

Odds Ratio (M‐H, Fixed, 95% CI)

0.66 [0.27, 1.63]

5 Septic shock Show forest plot

2

1236

Odds Ratio (M‐H, Fixed, 95% CI)

0.60 [0.34, 1.08]
Figuras y tablas -
Comparison 2. Adverse events
Ir a la tabla de la revisión