Wang 2017.
| Methods | Prospective, parallel, randomised controlled trial. Blinding not reported. Duration of treatment 26 weeks | |
| Participants | N = 86. Age range: 61 to 83 years. Mean age (years): 70.5 (azithromycin) and 72.4 (placebo) Female: 44.2% (azithromycin) and 37.2 (placebo) 10 cases of cardiac functional grade II, 27 cases of grade III and 6 cases of grade IV (azithromycin) and 11 cases of cardiac functional grade II, 23 cases of grade III and 9 cases of grade IV (placebo) Patients with pulmonary hypertension secondary to COPD. Patients whose mean arterial pressure was detected as not less than 25 mmHg by right cardiac catheterisation in a quiescent condition or as no less than 30 mmHg in a motion state, and patients who had not suffered from acute attack of COPD or acute lung infection. Exclusions: severe cardiac, hepatic, and liver function abnormality, pulmonary thromboembolism, allergic rhinitis, asthma or primary pulmonary hypertension, or were allergic to the drugs used in the study |
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| Interventions | Prophylaxis: 1. Azithromycin 250 mg daily 2. Control group (no antibiotic treatment) |
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| Outcomes | 1. PaO2 2. PaCO2 3. Blood pH 4. FEV1 5. FVC 6. Six minutes walking distance 7. Pulmonary arterial pressure |
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| Notes | Funding: "Grant Support & Financial Disclosures: None". | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "randomly divided into an observation group and a control group using random number table, 43 in each group". |
| Allocation concealment (selection bias) | Unclear risk | Allocation concealment was not described |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | No blinding of participants or personnel described. Assumed open‐label |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | No blinding of outcome assessors described. Assumed open‐label |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Not described |
| Selective reporting (reporting bias) | High risk | No prospective trial registration or protocol identified. Dyspnea grade reported as measured in the abstract and not reported. Not clear currently if FEV1 and FVC variance were SDs or SEs. |
| Other bias | Low risk | No additional bias identified |
BTS: British Thoracic Society; CAT: COPD assessment test; COPD: chronic obstructive pulmonary disease; CRP: C‐reactive protein; CRQ: chronic respiratory disease questionnaire; CYP: cytochrome P450; CXCL8: C‐X‐C motif ligand 8 (interleukin 8); ECG: electrocardiogram; FEV1: forced expiratory volume in 1 second; FVC: forced vital capacity; GOLD: Global Initiative for Chronic Obstructive Lung Disease; HDAC2: histone deacetylase 2; HIV: human immunodeficiency virus; HRQoL: health related quality of life; ICS: inhaled corticosteroid; IgG: immunoglobulin G; IL: interleukin; ITT: intention‐to‐treat; L: litres; LCQ: Leicester Cough Questionnaire; NF‐κB: nuclear factor kappa‐light‐chain‐enhancer of activated B cells; OCS: oral corticosteroids; PaCO2: partial pressure of carbon dioxide; PaO2: partial pressure of oxygen; pH: potential of hydrogen; PI3K: phosphoinositide 3‐kinase; qPCR: quantitative polymerase chain reaction; QTc: Q‐T Corrected (corrected Q‐T interval); QT: Q‐T interval; rRNA: ribosomal ribonucleic acid; R5‐R20: total respiratory system resistance, measured at 5 to 20 Hz; SD: standard deviation; SF‐12/36: Short‐Form 12/36; SGRQ: St George's Respiratory Questionnaire; ULN: upper limit of normal