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Treatment of respiratory tract infections with erythromycin acistrate and two formulations of erythromycin base. 1988

E Wuolijoki, and U Flygare, and M Hildén, and J Hurme, and H Järvinen, and J Leskinen, and S Pynnönen, and A Riikonen, and V Salomaa, and M Seuri
Research Center, Orion Pharmaceutica, Espoo, Finland.

Erythromycin acistrate (EA)--a new ester of erythromycin--was compared with erythromycin base as enterocoated pellets in capsules (EB enterocapsules) and enterocoated tablets of erythromycin base (EB enterotablets) in the treatment of respiratory tract infections. The present double-blind, multicentre study, conducted in eight occupational health centres, included 474 patients; 236 treated with EA, 117 with EB enterocapsules and 121 with EB enterotablets. The diagnoses included tonsillitis, sinusitis, otitis media, bronchitis and pneumonia. The patients were examined on admission and at the end of the treatment. The dosage of EA was 400 mg tid and that of the two erythromycin base preparations 500 mg tid. The treatment was given for seven to 14 days. In the EA-group, 97% of patients were clinically cured by the end of the treatment, while the cure rates for EB enterocapsules and EB enterotablets were 95% and 94%, respectively. Gastrointestinal side effects were reported by 36% of the patients on EA, 54% on EB enterocapsules and 50% on EB enterotablets. Discontinuations due to adverse effects occurred in 8% in the EA, in 21% in the EB enterocapsule and in 12% in the EB enterotablet groups. All three preparations were thus equally effective, but EA caused statistically significantly less gastrointestinal side effects overall (P less than 0.01), especially nausea (P less than 0.01) and abdominal pain (P less than 0.05), than the two formulations containing erythromycin base. Also discontinuations due to side effects occurred statistically significantly less frequently in the EA-group.

UI MeSH Term Description Entries
D008099 Liver A large lobed glandular organ in the abdomen of vertebrates that is responsible for detoxification, metabolism, synthesis and storage of various substances. Livers
D008297 Male Males
D008875 Middle Aged An adult aged 45 - 64 years. Middle Age
D011897 Random Allocation A process involving chance used in therapeutic trials or other research endeavor for allocating experimental subjects, human or animal, between treatment and control groups, or among treatment groups. It may also apply to experiments on inanimate objects. Randomization,Allocation, Random
D012141 Respiratory Tract Infections Invasion of the host RESPIRATORY SYSTEM by microorganisms, usually leading to pathological processes or diseases. Respiratory System Infections,Upper Respiratory Tract Infection,Upper Respiratory Tract Infections,Infections, Respiratory,Infections, Respiratory Tract,Infections, Upper Respiratory,Infections, Upper Respiratory Tract,Respiratory Infections,Upper Respiratory Infections,Infection, Respiratory System,Infection, Respiratory Tract,Respiratory Infection, Upper,Respiratory System Infection,Respiratory Tract Infection
D004311 Double-Blind Method A method of studying a drug or procedure in which both the subjects and investigators are kept unaware of who is actually getting which specific treatment. Double-Masked Study,Double-Blind Study,Double-Masked Method,Double Blind Method,Double Blind Study,Double Masked Method,Double Masked Study,Double-Blind Methods,Double-Blind Studies,Double-Masked Methods,Double-Masked Studies,Method, Double-Blind,Method, Double-Masked,Methods, Double-Blind,Methods, Double-Masked,Studies, Double-Blind,Studies, Double-Masked,Study, Double-Blind,Study, Double-Masked
D004917 Erythromycin A bacteriostatic antibiotic macrolide produced by Streptomyces erythreus. Erythromycin A is considered its major active component. In sensitive organisms, it inhibits protein synthesis by binding to 50S ribosomal subunits. This binding process inhibits peptidyl transferase activity and interferes with translocation of amino acids during translation and assembly of proteins. Erycette,Erymax,Erythromycin A,Erythromycin C,Erythromycin Lactate,Erythromycin Phosphate,Ilotycin,T-Stat,Lactate, Erythromycin,Phosphate, Erythromycin,T Stat,TStat
D005260 Female Females
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000293 Adolescent A person 13 to 18 years of age. Adolescence,Youth,Adolescents,Adolescents, Female,Adolescents, Male,Teenagers,Teens,Adolescent, Female,Adolescent, Male,Female Adolescent,Female Adolescents,Male Adolescent,Male Adolescents,Teen,Teenager,Youths

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