| Comparison 2. Single IV antibiotic (with placebo) versus combination IV antibiotic for pulmonary exacerbations with P aeruginosa | ||||||
|---|---|---|---|---|---|---|
| Outcomes | Illustrative comparative risks* (95% CI) | Relative effect (95% CI) | No of Participants (studies) | Quality of the evidence (GRADE) | Comments | |
| Assumed risk | Corresponding risk | |||||
| Combination IV antibiotics | Single IV antibiotic (with placebo) | |||||
| [tobramycin + placebo versus tobramycin + ceftazidime] FEV1 % predicted (absolute change) - Follow-up: 10 days | The mean FEV1% predicted (absolute change) in the tobramycin + ceftazidime group was 12.8 | The mean FEV1 % predicted (absolute change) in the tobramycin + placebo groups was 2.2 lower (6.63 lower to 2.23 higher) | 98 (Master 2001) | ⊕⊕⊝⊝ low1,2 | ||
| [tobramycin + placebo versus piperacillin + tobramycin] FEV1% predicted (relative change) - Follow-up: 2 weeks | The mean FEV1% predicted (relative change) in the piperacillin + tobramycin group was 12.2 | The mean FEV1% predicted (relative change) in the tobramycin + placebo groups was 4.2 lower (26.5 lower to 18.1 higher) | 9 (Macystis fibrosisarlane 1985) | ⊕⊝⊝⊝ very low3,4 | ||
| [tobramycin + placebo versus piperacillin + tobramycin] FEV1% predicted (relative change) - Follow-up: 2 weeks | The mean FEV1% predicted (relative change) in the piperacillin + tobramycin group was 1.8 | The mean FEV1% predicted (relative change) - in the tobramycin + placebo groups was 7.95 higher (8.78 lower to 24.68 higher) | 9 (Macystis fibrosisarlane 1985) | ⊕⊝⊝⊝ very low3,4 | ||
| [tobramycin + placebo versus piperacillin all regimens] Adverse effects - sensitivity reaction - number of participants Follow-up: 2 weeks | 300 per 1000 | 51 per 1000 (3 to 888) | RR 0.17 (0.01 to 2.96) | 18 (Macystis fibrosisarlane 1985) | ⊕⊕⊝⊝ low3,5 | |
| [tobramycin + placebo versus tobramycin + ceftazidime] Adverse effects - Number of hospital admissions due to Tinnitus Follow-up: 2 weeks | 39 per 1000 | 43 per 1000 (6 to 290) | RR 1.09 (0.16 to 7.4) | 98 (Master 2001) | ⊕⊝⊝⊝ very low1,6 | |
| [tobramycin + placebo versus tobramycin + ceftazidime] Adverse effects - serum - Creatinine Follow-up: 2 weeks | The mean serum creatinine in the tobramycin + ceftazidime groups was 0 | The mean serum creatinine in the Tobramycin + placebo groups was 4 lower (9.38 lower to 1.38 higher) | 44 (Master 2001) | ⊕⊝⊝⊝ very low1,6 | ||
| [tobramycin + placebo versus tobramycin + ceftazidime] Adverse effects - serum - NAG Follow-up: 2 weeks | The mean serum NAG in the tobramycin + ceftazidime groups was | The mean serum NAG in the Tobramycin + placebo groups was 2.1 lower (3.46 lower to 0.74 lower) | 44 (Master 2001) | ⊕⊕⊕⊝ moderate1 | ||
The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
Abbreviations: CI: confidence interval; FEV1: forced expiratory volume in 1 second; MD: mean difference; NAG: N-acetyl glucosamine; RR: risk ratio
The quality of the evidence was downgraded by 1 as each participant contributed to multiple treatment episodes.
The quality of the evidence was downgraded by 1 as the 95% CI crossed 1 clinical MID
The quality of the evidence was downgraded by 1 due to attrition bias (2 participants withdrew and did not contribute to analysis) and 1 participant received 2 treatment courses.
The quality of the evidence was downgraded by 2 as the 95% CI crossed 2 clinical MIDs
The quality of the evidence was downgraded by 1 due to very serious imprecision as 95%CI crossed 1 default MIDs
The quality of the evidence was downgraded by 2 as the 95% CI crossed 2 default MIDs
From: 9, Pulmonary monitoring, assessment and management
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