Amoxicillin for non-severe pneumonia in young children
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《英国医生杂志》
EDITOR—The need for newer antibiotics must be addressed, but we disagree with Wrennall's other points. Our study was in a low resource setting to identify strategies for improving child health. Data on the appropriate duration of antibiotic treatment for pneumonia in children are scarce. Inappropriate use of antibiotics and increasing antimicrobial resistance are major public health problems. We believe that our results can be applied to a broader population.
Our indicators of treatment failure were stringent. Cases were classified as failed if pulse oximetry results were < 90% on day 3, even if a patient's respiratory rate was below the age specific cut-off point and they would have been called disease free.1 The sample size estimations were adequate to test equivalence of treatment, and corrections were done for interim analysis.2 While recruiting cases, we recorded a detailed history and examination. We followed up children for up to 14 days, using pulse oximetry to detect hypoxaemia. For brevity we included only relevant sections in the published paper. We assessed and reported caretakers' attitudes, a strength of our work.
Diagnosed asthma was an exclusion criterion. Children with non-severe pneumonia and wheeze were, however, offered conventional treatment. When the results of this study are applied to wider populations no reason exists to believe that there would be unpredictable deaths among people with undiagnosed asthma. We showed equivalence of three and five days of amoxicillin treatment for non-severe pneumonia, as defined by the World Health Organization's standard case management guidelines for poor settings.
Children are indeed vulnerable, and the investigators, mostly paediatricians, ensured that their benefit was paramount throughout. Ethics committees of all the participating institutions approved the work. None of the study patients died. Forty one children in whom the disease became more severe were admitted to hospital; they received injectable antibiotics and oxygen when required. A similar study has been conducted in Pakistan.3
Although we did not use chest radiography to diagnose pneumonia, we followed the WHO's clinical case definition of ambulatory pneumonia for managing pneumonia in countries with an infant mortality of more than 40 per 1000 births.4 Given the extent of pneumonia in communities with low resources, it is impractical and expensive to perform chest radiography in all children with suspected pneumonia. Even if chest radiography were used in all the patients as part of the study, the results could not be generalised to other low resource settings, where pneumonia is not diagnosed by chest radiography. Moreover, chest radiography may not change the outcome of pneumonia in ambulatory patients.5
We compared the five with the three day regimen because the WHO case management guidelines recommend antibiotic treatment for five days.4 Although the British Thoracic Society's guidelines cited by Borja and Rigau recommend seven days' antibiotic therapy, they mention a lack of empirical data for appropriate duration of treatment.
Shally Awasthi, professor of paediatrics
King George Medical University, Lucknow, India sawasthi@sancharnet.in
S K Kabra, Addl professor of paediatrics
All India Institute of Medical Sciences, New Delhi, India
Shamim Qazi, medical officer
Department of Child and Adolescent Health and Development,World Health Organization, Geneva, Switzerland
, for the On behalf of the ISCAP Study Group
Competing interests: None declared.
References
WHO Memorandum. Clinical management of acute respiratory infections in children. Bull WHO 1981;59: 707-16.
O'Brien PC, Fleming TR. A multiple testing procedure for clinical trials. Biometrics 1979;35: 549-56.
MASCOT Group. Clinical efficacy of three days versus five days of oral amoxicillin for the treatment of childhood pneumonia: a multicentre double-blind trial. Lancet 2002;360: 835-41.
World Health Organization. Technical bases for WHO recommendations on the management of pneumonia in children at first level health facilities. Geneva: WHO, 1991. (WHO/ARI/91.20.)
Swingler GH, Hussey GD, Zwarenstein M. Randomised controlled trial of clinical outcome after chest radiograph in ambulatory acute lower-respiratory infection in children. Lancet 1998;351: 404-8.
Our indicators of treatment failure were stringent. Cases were classified as failed if pulse oximetry results were < 90% on day 3, even if a patient's respiratory rate was below the age specific cut-off point and they would have been called disease free.1 The sample size estimations were adequate to test equivalence of treatment, and corrections were done for interim analysis.2 While recruiting cases, we recorded a detailed history and examination. We followed up children for up to 14 days, using pulse oximetry to detect hypoxaemia. For brevity we included only relevant sections in the published paper. We assessed and reported caretakers' attitudes, a strength of our work.
Diagnosed asthma was an exclusion criterion. Children with non-severe pneumonia and wheeze were, however, offered conventional treatment. When the results of this study are applied to wider populations no reason exists to believe that there would be unpredictable deaths among people with undiagnosed asthma. We showed equivalence of three and five days of amoxicillin treatment for non-severe pneumonia, as defined by the World Health Organization's standard case management guidelines for poor settings.
Children are indeed vulnerable, and the investigators, mostly paediatricians, ensured that their benefit was paramount throughout. Ethics committees of all the participating institutions approved the work. None of the study patients died. Forty one children in whom the disease became more severe were admitted to hospital; they received injectable antibiotics and oxygen when required. A similar study has been conducted in Pakistan.3
Although we did not use chest radiography to diagnose pneumonia, we followed the WHO's clinical case definition of ambulatory pneumonia for managing pneumonia in countries with an infant mortality of more than 40 per 1000 births.4 Given the extent of pneumonia in communities with low resources, it is impractical and expensive to perform chest radiography in all children with suspected pneumonia. Even if chest radiography were used in all the patients as part of the study, the results could not be generalised to other low resource settings, where pneumonia is not diagnosed by chest radiography. Moreover, chest radiography may not change the outcome of pneumonia in ambulatory patients.5
We compared the five with the three day regimen because the WHO case management guidelines recommend antibiotic treatment for five days.4 Although the British Thoracic Society's guidelines cited by Borja and Rigau recommend seven days' antibiotic therapy, they mention a lack of empirical data for appropriate duration of treatment.
Shally Awasthi, professor of paediatrics
King George Medical University, Lucknow, India sawasthi@sancharnet.in
S K Kabra, Addl professor of paediatrics
All India Institute of Medical Sciences, New Delhi, India
Shamim Qazi, medical officer
Department of Child and Adolescent Health and Development,World Health Organization, Geneva, Switzerland
, for the On behalf of the ISCAP Study Group
Competing interests: None declared.
References
WHO Memorandum. Clinical management of acute respiratory infections in children. Bull WHO 1981;59: 707-16.
O'Brien PC, Fleming TR. A multiple testing procedure for clinical trials. Biometrics 1979;35: 549-56.
MASCOT Group. Clinical efficacy of three days versus five days of oral amoxicillin for the treatment of childhood pneumonia: a multicentre double-blind trial. Lancet 2002;360: 835-41.
World Health Organization. Technical bases for WHO recommendations on the management of pneumonia in children at first level health facilities. Geneva: WHO, 1991. (WHO/ARI/91.20.)
Swingler GH, Hussey GD, Zwarenstein M. Randomised controlled trial of clinical outcome after chest radiograph in ambulatory acute lower-respiratory infection in children. Lancet 1998;351: 404-8.