J Int Med Res {1911) 5, 65
A General Practice Assessment of Locabiotal in the Treatment of Upper Respiratory Tract Infections J C Vallé-Jones, MRCS, LRCP, DObst, RCOG, General Practitioner,
Sussex,
England
An open clinical trial of Locabiotal, in which the antibiotic, fusafungine, is presented in a micronized aerosol was performed in general practice. One hundred and ten patients suffering from upper respiratory infections without associated hyperpyrexia or toxic symptoms were treated for 7 days. There was a marked improvement in the symptoms rated during the first 48 hours. After the full course of treatment 37 patients regarded its effect as excellent and 48 us good.
Introduction Locabiotal has enjoyed extensive use on the continent of Europe over the past ten years. It has been the subject of a considerable number of clinical investigations in which it has been used in both upper and lower respira tory infections in Ear, Nose and Throat and Dental Departments (Abruzzi & Cohen 1972, Bagot & Guerin 1964, Black 1972, Chaperon & Maspetiol 1972, Larribaud & Narbonne 1972, Nicougar 1972, Piquet 1964, Piquet, Hequet & Decroix 1969, Therond 1967). Arnstein, Cook and Lacey (1946) first reported on the potential of the active ingredient of Locabiotal, fusafungine. It is a potent antimicrobial and possesses marked anti-inflammatory properties (Larribaud & N a r b o n n e 1971). In Locabiotal, the antibiotic is presented in micronized form with more than 8 0 % of the particles ranging around 1 micron in size. Micronization is believed to allow highly effective dispersal, and measurement by Coulter counter has shown that 350 million particles are delivered in one metered dose. Each pack of Locabiotal contains 200 metered doses.
There is growing concern regarding the abuse of antibiotics (Editorial, Lancet 1974, 1975, Mernstein & Rogers 1974), especially in 'minor red throat' illness (Editorial, British Medical Journal 1974), sore throat occurring in children (Ross, Chisty & Knox 1971), acute sore throat (Royal College of General Practitioners 1975) and pharyngitis (Mernstein & Rogers 1974). The study described was instituted to assess the value of a purely 'topical' approach to the treatment of upper respiratory infections for which general practitioners invariably consider the use of systemic broad spectrum antibiotics. Method Patients suffering from upper respiratory infections without associated hyperpyrexia and toxic symptoms were considered suitable for admission to the study. Bacteriological examinations were not made. All patients over the age of 3 years were eligible for entry into the trial. At first interview patients were examined clinically and a diagnosis made. All symptoms of which each patient complained were noted and these were graded as severe, moderate or slight. A check-list of symptoms
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66
The Journal of International
Medical
was provided and if common symptoms were absent this was noted. The symptoms on the list were: congestion, nasal stuffiness, pharyngeal oedema, pharyngeal pain, pharyngeal 'redness', interference with drainage, headache, hoarseness, cough, sneezing and rhinorrhoea. Patients were then given one aerosol pack with appropriate dosage instructions. Each patient was reassessed after 48 hours with a final assessment after seven days. On completion of the trial, patients were asked to report their opinion on the efficacy of the treatment on the basis of excellent, good, fair and poor responses. Side-effects were noted together with any other observa tions made by the patient on this new form of treatment.
Results One hundred and ten patients were admitted to the trial. There were 67 males and 43 females with an age range of 4 to 73 years. The initial diagnoses made on admission to the trial are shown in Table 1. The commonest diagnoses were, common cold 32, 'cold' and laryngitis 16, 'cold' and rhinitis 12, and 'cold' and sore throat 10. Table 2 shows the symptoms present initially and their severity. All patients suffered from congestion, nasal stuffiness and rhinorrhoea with the majority also having headache, cough and interference with drain age. These were all rated as moderate or slight with none being severe. Table 3 shows the symptom ratings after 48 hours treatment. Only 12 symptoms were
Table 1 Common cold 32 Rhinitis 7 Laryngitis 9 Sinusitis 2 Pharyngitis 6 Sore throat 1 Cold and laryngitis 16 Cold and sinusitis 3 Cold and swelling 1
Cold and rhinitis Cold and sore throat Cold and cough Cold and pharyngitis Pharyngitis and rhinitis Laryngitis and rhinitis Cold, pharyngitis and sore throat Sinus pain, cold and sore throat
12 10 2 3 1 2 1 2
Table 2
Congestion Nasal stuffiness Laryngeal oedema Interference with drainage Headache Hoarseness Cough Laryngeal pain Sneezing Rhinorrhoea
Total
Severe
Moderate
Slight
Absent
110 110 86 102 106 96 105 83 52 110
0 0 0 0 0 0 0 0 0 0
86 50 11 8 41 16 44 8 8 37
24 60 75 94 65 80 61 75 44 73
0 0 0 0 0 0 0 0 0 0
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Table 3
Congestion Nasal stuffiness Laryngeal oedema Interference with drainage Headache Hoarseness Cough Laryngeal pain Sneezing Rhinorrhoea
Severe
Moderate
Slight
Absent
0 0 0 0 0 0 0 0 0 0
1 1 0 0 5 1 4 0 0 0
99 95 71 77 75 64 72 58 37 48
10 14 15 25 26 31 29 25 45 62
Black W (1972) A propos d'un nouvel antibiotique local en ORL Locabiotal pressurise. Cahiers d'ORL, June suppl., 87 Chaperon Ch & Maspetiol R (1972) Le traitement local des infections ORL en pediatric. Cahiers d'ORL June suppl, 91 Editorial (1974) Antibiotics and respiratory illness. British Medical Journal, Vol 3, 1 Editorial (1974) Antibiotics for disease. Lancet, No. 7888, Vol. 2, 1054 Editorial (1975) Antimicrobial treatment of Chronic Bronchitis. Lancet, No. 7905, Vol. I, 505 Larribaud J & Narbonne Ch (1972) Existe-t-il une Flore Respiratoire 'Physiologique'? Peut-on la respecter par un Antibiotique Local? Cahiers d'ORL, June suppl., 9 Mernstein J Η & Rogers Κ D (1974) Steptococcal Pharyngitis: Early treatment and management by nurse practitioners. Journal of the Conclusion American Medical Association 227, 1278 The results of this trial show quite clearly Nicougar G R (1972) Etude clinique de Taction d'un nouvel anti that the patients symptomatology was much biotique anti-inflammatoirc dans le traitement local des infections nasosinusiennes. Cahiers d'ORL, June improved during the first 48 hours and that suppl. 77 the overall time for recovery was reduced. Piquet J J Locabiotal would seem to be an appropriate (1964) Utilisation en ORL d'un nouvel antibiotique: Le 314S. Vie Medicate, Dec. suppl., 38 therapy for 'minor red t h r o a t ' illness. Piquet J J, Hequet Β & Decroix G (1969) Interct de I'utilisation du Locabiotal pressurise dans la pathologie rhinosinusienne de I'enfant. Gazette Medícale de France, Feb. (No. 6 Suppl.), 47 Ross Ρ W, Chisty S Μ Κ & Knox J D Ε REFERENCES (1971) Sore throat in children: Its causation and Abruzzi W A & Cohen Β Μ incidence. British Medical Journal 2, 624 (1968) Etude comparative d'un aerosol de locabiotal Study by the East Scotland Faculty, Royal College of pressurise et d'un placebo dans le traitment des General Practitioners and Dept of Bacteriology, The infections des voies respiratoires supérieures (méthode University of Dundee de test double aveugle). Medecine Interne 3 (11), 819 (1975) Acute sore throat—diagnosis and treatment Arnstein Η R, Cook A Η & Lacey Μ S in general practice. Journal of Royal College of General (1946) An antibacterial pigment of Fusarium javani- Practitioners 25, 126 cum. Nature 157, 333 Therond C Bagot Ρ & Guérin C (1967) Action therapeutique d'un antibiotique local (1964) Aerosol thérapie en pratique ORL et bron- anti-inflammatoire dans la lutte contre la surinfection chique: Le locabiotal pressurise. Vie Medicate, Dec. des allergies respiratoires des infantiles. Presse .suppl., 40 Medicaids (11), 553 rated as moderate as compared with 309 initially. Six hundred and ninety-five were regarded as slight as opposed to 651 initially and 252 were absent as compared with none initially. After 7 days of treatment, at the time of the final assessment, 23 symptoms were rated as moderate with 209 as slight and 728 absent. In the patients final opinion of the treat ment, 37 regarded it as excellent, 48 as good, 21 as fair and 4 as poor. N o side-effects were reported and patients found the aerosol simple to use and very pleasant in taste and aroma.
Downloaded from imr.sagepub.com at MICHIGAN STATE UNIV on April 1, 2015
A General Practice Assessment of Locabiotal in the Treatment of Upper Respiratory Tract Infections J C Vallé-Jones, MRCS, LRCP, DObst, RCOG, General Practitioner,
Sussex,
England
An open clinical trial of Locabiotal, in which the antibiotic, fusafungine, is presented in a micronized aerosol was performed in general practice. One hundred and ten patients suffering from upper respiratory infections without associated hyperpyrexia or toxic symptoms were treated for 7 days. There was a marked improvement in the symptoms rated during the first 48 hours. After the full course of treatment 37 patients regarded its effect as excellent and 48 us good.
Introduction Locabiotal has enjoyed extensive use on the continent of Europe over the past ten years. It has been the subject of a considerable number of clinical investigations in which it has been used in both upper and lower respira tory infections in Ear, Nose and Throat and Dental Departments (Abruzzi & Cohen 1972, Bagot & Guerin 1964, Black 1972, Chaperon & Maspetiol 1972, Larribaud & Narbonne 1972, Nicougar 1972, Piquet 1964, Piquet, Hequet & Decroix 1969, Therond 1967). Arnstein, Cook and Lacey (1946) first reported on the potential of the active ingredient of Locabiotal, fusafungine. It is a potent antimicrobial and possesses marked anti-inflammatory properties (Larribaud & N a r b o n n e 1971). In Locabiotal, the antibiotic is presented in micronized form with more than 8 0 % of the particles ranging around 1 micron in size. Micronization is believed to allow highly effective dispersal, and measurement by Coulter counter has shown that 350 million particles are delivered in one metered dose. Each pack of Locabiotal contains 200 metered doses.
There is growing concern regarding the abuse of antibiotics (Editorial, Lancet 1974, 1975, Mernstein & Rogers 1974), especially in 'minor red throat' illness (Editorial, British Medical Journal 1974), sore throat occurring in children (Ross, Chisty & Knox 1971), acute sore throat (Royal College of General Practitioners 1975) and pharyngitis (Mernstein & Rogers 1974). The study described was instituted to assess the value of a purely 'topical' approach to the treatment of upper respiratory infections for which general practitioners invariably consider the use of systemic broad spectrum antibiotics. Method Patients suffering from upper respiratory infections without associated hyperpyrexia and toxic symptoms were considered suitable for admission to the study. Bacteriological examinations were not made. All patients over the age of 3 years were eligible for entry into the trial. At first interview patients were examined clinically and a diagnosis made. All symptoms of which each patient complained were noted and these were graded as severe, moderate or slight. A check-list of symptoms
Downloaded from imr.sagepub.com at MICHIGAN STATE UNIV on April 1, 2015
66
The Journal of International
Medical
was provided and if common symptoms were absent this was noted. The symptoms on the list were: congestion, nasal stuffiness, pharyngeal oedema, pharyngeal pain, pharyngeal 'redness', interference with drainage, headache, hoarseness, cough, sneezing and rhinorrhoea. Patients were then given one aerosol pack with appropriate dosage instructions. Each patient was reassessed after 48 hours with a final assessment after seven days. On completion of the trial, patients were asked to report their opinion on the efficacy of the treatment on the basis of excellent, good, fair and poor responses. Side-effects were noted together with any other observa tions made by the patient on this new form of treatment.
Results One hundred and ten patients were admitted to the trial. There were 67 males and 43 females with an age range of 4 to 73 years. The initial diagnoses made on admission to the trial are shown in Table 1. The commonest diagnoses were, common cold 32, 'cold' and laryngitis 16, 'cold' and rhinitis 12, and 'cold' and sore throat 10. Table 2 shows the symptoms present initially and their severity. All patients suffered from congestion, nasal stuffiness and rhinorrhoea with the majority also having headache, cough and interference with drain age. These were all rated as moderate or slight with none being severe. Table 3 shows the symptom ratings after 48 hours treatment. Only 12 symptoms were
Table 1 Common cold 32 Rhinitis 7 Laryngitis 9 Sinusitis 2 Pharyngitis 6 Sore throat 1 Cold and laryngitis 16 Cold and sinusitis 3 Cold and swelling 1
Cold and rhinitis Cold and sore throat Cold and cough Cold and pharyngitis Pharyngitis and rhinitis Laryngitis and rhinitis Cold, pharyngitis and sore throat Sinus pain, cold and sore throat
12 10 2 3 1 2 1 2
Table 2
Congestion Nasal stuffiness Laryngeal oedema Interference with drainage Headache Hoarseness Cough Laryngeal pain Sneezing Rhinorrhoea
Total
Severe
Moderate
Slight
Absent
110 110 86 102 106 96 105 83 52 110
0 0 0 0 0 0 0 0 0 0
86 50 11 8 41 16 44 8 8 37
24 60 75 94 65 80 61 75 44 73
0 0 0 0 0 0 0 0 0 0
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Vallé-Jones
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Table 3
Congestion Nasal stuffiness Laryngeal oedema Interference with drainage Headache Hoarseness Cough Laryngeal pain Sneezing Rhinorrhoea
Severe
Moderate
Slight
Absent
0 0 0 0 0 0 0 0 0 0
1 1 0 0 5 1 4 0 0 0
99 95 71 77 75 64 72 58 37 48
10 14 15 25 26 31 29 25 45 62
Black W (1972) A propos d'un nouvel antibiotique local en ORL Locabiotal pressurise. Cahiers d'ORL, June suppl., 87 Chaperon Ch & Maspetiol R (1972) Le traitement local des infections ORL en pediatric. Cahiers d'ORL June suppl, 91 Editorial (1974) Antibiotics and respiratory illness. British Medical Journal, Vol 3, 1 Editorial (1974) Antibiotics for disease. Lancet, No. 7888, Vol. 2, 1054 Editorial (1975) Antimicrobial treatment of Chronic Bronchitis. Lancet, No. 7905, Vol. I, 505 Larribaud J & Narbonne Ch (1972) Existe-t-il une Flore Respiratoire 'Physiologique'? Peut-on la respecter par un Antibiotique Local? Cahiers d'ORL, June suppl., 9 Mernstein J Η & Rogers Κ D (1974) Steptococcal Pharyngitis: Early treatment and management by nurse practitioners. Journal of the Conclusion American Medical Association 227, 1278 The results of this trial show quite clearly Nicougar G R (1972) Etude clinique de Taction d'un nouvel anti that the patients symptomatology was much biotique anti-inflammatoirc dans le traitement local des infections nasosinusiennes. Cahiers d'ORL, June improved during the first 48 hours and that suppl. 77 the overall time for recovery was reduced. Piquet J J Locabiotal would seem to be an appropriate (1964) Utilisation en ORL d'un nouvel antibiotique: Le 314S. Vie Medicate, Dec. suppl., 38 therapy for 'minor red t h r o a t ' illness. Piquet J J, Hequet Β & Decroix G (1969) Interct de I'utilisation du Locabiotal pressurise dans la pathologie rhinosinusienne de I'enfant. Gazette Medícale de France, Feb. (No. 6 Suppl.), 47 Ross Ρ W, Chisty S Μ Κ & Knox J D Ε REFERENCES (1971) Sore throat in children: Its causation and Abruzzi W A & Cohen Β Μ incidence. British Medical Journal 2, 624 (1968) Etude comparative d'un aerosol de locabiotal Study by the East Scotland Faculty, Royal College of pressurise et d'un placebo dans le traitment des General Practitioners and Dept of Bacteriology, The infections des voies respiratoires supérieures (méthode University of Dundee de test double aveugle). Medecine Interne 3 (11), 819 (1975) Acute sore throat—diagnosis and treatment Arnstein Η R, Cook A Η & Lacey Μ S in general practice. Journal of Royal College of General (1946) An antibacterial pigment of Fusarium javani- Practitioners 25, 126 cum. Nature 157, 333 Therond C Bagot Ρ & Guérin C (1967) Action therapeutique d'un antibiotique local (1964) Aerosol thérapie en pratique ORL et bron- anti-inflammatoire dans la lutte contre la surinfection chique: Le locabiotal pressurise. Vie Medicate, Dec. des allergies respiratoires des infantiles. Presse .suppl., 40 Medicaids (11), 553 rated as moderate as compared with 309 initially. Six hundred and ninety-five were regarded as slight as opposed to 651 initially and 252 were absent as compared with none initially. After 7 days of treatment, at the time of the final assessment, 23 symptoms were rated as moderate with 209 as slight and 728 absent. In the patients final opinion of the treat ment, 37 regarded it as excellent, 48 as good, 21 as fair and 4 as poor. N o side-effects were reported and patients found the aerosol simple to use and very pleasant in taste and aroma.
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