Streptococcus pneumoniae Haemophilus influenzae Moraxella catarrhalis S. pneumoniae S. pneumoniae β β H. influenzae S. pneumoniae H. influenzae M. catarrhalis Key words
Otalgia Fever Item Crying,Iritation, anddecreased Appetite Score Table. Symptomsscoring None Description Mild(sometimespainfulbuttolerable) Severe(requiringanalgesics) <. ABT <_.. to. >_. No >_. ABT <_ ABT ABT+<_. ABT+>_. (addpointstoscore) Mild(lessactivethanusualwithslightlydecreasedappetite) Severe(lethargicandoftencryingwithnoappetite) Ifeitherotalgiaorcrying/iritationsobserved,theobservableitem shouldbeassessedandthe scoredoubled. ABT:Averagebodytemperature I
Table. Tympanicmembrane(TM)scoring Otorheaabsent Item BulgingofTM Redness/YelowingofTM Opacification/Cloudiness Score None Mild(portion) Severe(entire) No Mild(inaportion) Severe(entire) No Yes Description Otorheapresentormiddleearfluidobservedbytympanostomy Item Otorhea(middleearefusion) Eardischarge Redness/YelowingofTM Opacification/Cloudiness Score Description SmalamountoffluidpresentsuroundingTM;smal amountdrainedbytympanostomy Moderateamountormore,otorheanotedatexternal auditorycanalentrance;fluidoverflowintympanostomy Serous Mucous,purulent None Mild(portion) Severe(entire) None Yes Symptom Score Tympanic Membrane Score Mild Moderate Severe Fig.. Acuteotitismediaseverity.
Evaluated for clinical efficacy and safety: -mg: -mg: Evaluated for bacteriological efficacy: -mg: -mg: registered Indeterminate bacteriological response: Fig.. Patientsdisposition. Dropouts no visit after first: -mg: -mg: II Gender Age (years) disease Severity Baseline Male Female.to< to< to< to< to< Otitismedia Moderate Severe Table. Patientprofiles Dropouts (novisitafterfirst) No.(%)evaluatedfor safety(clinicaleficacy) (.) (.) (.) (.) (.) (.) (.) () (.) (.) Dailydose (.) (mg/kg) (.) Treatment (days) Meantreatmentduration:.±.days
Tablea. Incidenceofadversedrugreactions(ADRs) Symptom Patients withadr Overal Incidence (%) * Patients withadr -mggroup Incidence (%) * Patients withadr -mggroup Incidence (%) * GIsymptoms Diarhea Vomiting...... Subtotal... Others Rash Tineacruris...... Subtotal...... PatientswithADR * : * : * : Tableb. IncidenceofADRsbyage Age(years) Patients TOTAL(%) </>_ years < (.) / to (.) to (.) to (.) /. to (.) (.)
Tablea. Clinicaleficacybyseverity efective Very Yes Slightly Not patients Eficacy(%) Very+ yes+ slightly/totalcases Patients evaluated.(/) Moderate Severe.(/).(/) Tableb. Clinicaleficacybydoseandseverity Efective Very Yes Slightly Not patients Eficacy(%) Very+ yes+ slightly/totalcases Patients evaluated.(/) -mg.(/) Moderate Severe.(/).(/) -mg.(/) Moderate Severe.(/).(/) Table. Clinicaleficacybyage (years) Very Yes Slightly Not patients Eficacy(%) Very+ yes+ slightly/totalcases to<.(/) to.(/) to.(/) to.(/) to<.(/) Patientsevaluated.(/) Table. Distributionofcausativebacteria Causativebacteria PSSP Middleear(%) (.) Pharynx(%) (.) Streptococcuspneumoniae PISP (.) (.) Haemophilusinfluenzae BLNAR Moraxelacatarhalis Staphylococcusaureusspecies Otherstrains PRSP (.) (.) (.) (.) (.) (.) PRSP:Penicilin(oralpenicilinV) R (μ g/ml) BLNAR:ABPC R (μ g/ml) (.) (.) (.) (.) (.) (.) Streptococcus pneumoniae Haemophilus influenzae Moraxella catarrhalis
Staphylococcus aureus species, Moraxella catarrhalis, Other strains, PSSP, Moraxella catarrhalis, Staphylococcus aureus species, Other strains, PSSP, BLNAR, Streptococcus pneumoniae, Haemophilus influenzae, PISP, PRSP, BLNAR, Streptococcus pneumoniae, Haemophilus influenzae, PISP, PRSP, Fig.. Distributionofcausativebacteria(middleear)(%). Fig.. Distributionofcausativebacteria(pharynx)(%). Table. Susceptibilityofmajormiddle-earcausativebacteriatoCFPN-PIandCVA/AMPC CFPN-PI Drugconcentration <_.... >_ strains PSSP PISP+ PRSP H.influenzae includingblnar M.catarhalis strains CVA/AMPC Drugconcentration <_.... >_ strains PSSP PISP+ PRSP H.influenzae includingblnar M.catarhalis strains strains CFPN-PI CVA/AMPC.... Drug concentration (mcg/ml) Fig.. Susceptibilityofmiddle-earbacteria(PISP+PRSP)forCFPN-PIandCVA/AMPC. S. pneumoniae S. pneumoniae S. pneumoniae H. influ-
strains.... Drug concentration (mcg/ml) CFPN-PI CVA/AMPC Fig.. Susceptibilityofmeddle-earbacteria(H.influenzaeincludingBLNAR)forCFPN- PIandCVA/AMPC. strains CFPN-PI CVA/AMPC.... Drug concentration (mcg/ml) Fig.. Susceptibilityofmiddle-earofbacteria(M.catarhalis)forCFPN-PIand CVA/AMPC. enzae M. catarrhalis S. pneumoniae H. influenzae M. catarrhalis µ H. influenzae M. catarrhalis S. pneumoniae H. influenzae M. catarrhalis S. pneumoniae H. influenzae M. catarrhalis S. pneumoniae H. influenzae M. catarrhalis III
Table. SingleandmixedInfection Isolatedbeforetreatment Middleear Pharynx PSSP PISP PRSP H.influenzae Single BLNAR M.catarhalis S.aureus(includingMRSA) Other Sub-total PSSP+ H.influenzae PSSP+ BLNAR PSSP+ M.catarhalis PSSP+ Others PISP+ H.influenzae PISP+ BLNAR PISP+ M.catarhalis Mixed (species) PISP+ Others PRSP+ H.influenzae PRSP+ BLNAR PRSP+ M.catarhalis PRSP+ Others H.influenzae+ M.catarhalis H.influenzae+ Others BLNAR+ M.catarhalis Others Sub- PSSP+ H.influenzae+ M.catarhalis PSSP+ BLNAR+ M.catarhalis PISP+ H.influenzae+ M.catarhalis Mixed (>_ species) PISP+ H.influenzae+ M.catarhalis+ S.aureus PISP+ BLNAR+ M.catarhalis PRSP+ H.influenzae+ M.catarhalis Others Sub- patients (strains) patients (strains) S. pneumoniae H. influenzae M. catarrhalis
Bacteria PSSP Table. Distributionofbacteria Middleear (strainsevaluated) Eradication Reducted Replacement Nochange Bacteriological eficacy * (%).(/) S.pneumoniae(S.p.) PISP.(/) S.p.() S.p.(resistant) H.influenzae BLNAR M.catarhalis S.aureusspecies Other PRSP PSSP+ PISP+ PRSP PISP+ PRSP (/).(/).(/).(/).(/).(/).(/).(/).(/) * :Calculatedbysubtractingthenumberofstrainswithindeterminatebacteriologicalresponsefrom thenumberofcausativebacterial strainsisolated * :Eradication/numberofstrainsevaluated(Eradication+ Reduction+ Replacement+ Nochange)
Streptococcus pneumoniae Haemophilus influenzae Moraxella catarrhalis Penicillin-intermediate S. pneumoniae penicillin-resistant S. pneumoniae β lactamase-negative ABPC-resistant H. influenzae S. pneumoniae H. influenzae M. catarrhalis