日本化学療法学会雑誌第55巻第S-1号
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1 µ µ Key words Streptococcus pneu- moniae S. pneumoniae
2 µ µ I γ
3 H H C HN F F O N O CO H H C SO H H O Fig.. ChemicalstructureofGRNX. γ γ II
4 Haemophilus influenzae Pseudomonas aeruginosa Streptococcus intermedius Klebsiella oxytoca K. oxytoca P. aeruginosa K. oxytoca Table. Evaluationcriteriaofclinicaleficacyatthethdayof post-treatment Evaluation Efective Poor Unevaluable Criteria antibiotictherapyrequired Additionalantibiotictherapyrequired Clinicalresponsenotevaluable.Anotherantimicrobialagentwasusedintherapyforconcurrentinfectiousdisease. K. oxytoca P. aeruginosa H. influenzae γ γ µ µ III
5 Registered patients mg: mg: Safety analysis set Clinical efficacy analysis set mg: mg: mg: mg: Bacteriological efficacy analysis set mg: mg: Fig.. Subjectdisposition. Gender Age(yr) Bodyweight(kg) Item Male Female < < < < < < < < < < < Unknown Table. Backgroundofpatientswithpneumonia Bacterial pneumonia mg Mycoplasma pneumonia/ Chlamydia pneumonia Bacterial pneumonia mg Mycoplasma pneumonia/ Chlamydia pneumonia In In/outpatients Out In Out/Out In Mild Severityofinfection Moderate Severe Underlyingdiseaseand/or complication Medicalhistory Antimicrobial agent just beforethestudy Concomitantdrug Unknown
6 Table. Backgroundofpatientswithunderlyingrespiratorydisorder Item Underlyingdisorder Gender Age(yr) Bodyweight(kg) Category Chronicbronchitis Difusebronchiolitis Bronchiectasis Pulmonaryemphysema Pulmonaryfibrosis Bronchialasthma Oldinactivepulmonarytuberculosis Other Male Female < < < < < < < < < < < Unknown mg mg In In/outpatient Out In Out/Out In Mild Severityofinfection Moderate Severe Underlyingdiseaseand/ orcomplication Medicalhistory Antimicrobialagentjust beforethestudy Concomitantdrug Unknown
7 Diagnosis Alcasesofrespiratory infection Table. Clinicaleficacyclassifiedbydisorder Dosage (mg) Cases Clinicaleficacy * Efective Poor Eficacy rate(%).... % Confidence Interval casesofpneumonia Bacterialpneumonia... Mycoplasmapneumonia, Chlamydiapneumonia Secondaryinfectionof chronicrespiratory disorder * Attheendoftreatment. [/] [/] [/] Diagnosis Alcasesofrespiratory infection Table. Clinicaleficacyclassifiedbydisorder Dosage (mg) Cases Efective Clinicaleficacy * Poor Unableto determine Eficacy rate(%).. % Confidence Interval casesofpneumonia Bacterialpneumonia. Mycoplasmapneumonia, Chlamydiapneumonia Secondaryinfectionof chronicrespiratory disorder * Atthethdayofpost-treatment [/] [/] [/].... µ µ µ µ
8 detaci detaci user user detaci detaci detsisre detsisre derae derae mrete mrete Table. Bacteriologicalefectclassifiedbydisorder Diagnosis Dose (mg) Cases E dar Bacteriologicalefect * P m de E dar P R pae p Unba el ot d nie Eradicated rate(%) % Confidence interval Alcasesofrespiratory infection casesof pneumonia [/]... Bacterialpneumonia [/]. Mycoplasmapneumonia, Chlamydiapneumonia [/] [/] Secondaryinfectionof chronicrespiratory disorder * Attheendoftreatment Table. Bacteriologicalefectclassifiedbyeachdisorder Diagnosis Dose (mg) Cases E dar Bacteriologicalefect * P m de E dar P R pae p Unba el ot d nie Eradicated rate(%) % Confidence interval Alcasesof respiratoryinfection caseofpneumonia [/].. Bacterialpneumonia [/]. Mycoplasmapneumonia, Chlamydiapneumonia Secondaryinfectionof chronicrespiratory disorder [/] [/]... * Atthethdayofpost-treatment in vitro S.pneumoniae
9 Table. Bacteriologicalprognosisbycausativeorganism Organism Dose (mg) Gram-positive bacteria S.aureus MSSA S.pneumoniae PISP PSSP S.intermedius S.constelatus Subtotal Eradicatedrate * (%) [/] [/] [/] [/] [/] [/] [/] [/] [/] Gram-negative bacteria K.pneumoniae [/] K.oxytoca P.aeruginosa H.influenzae BLNAR M.(B.)catarhalis Subtotal Mycoplasmapneumoniae Chlamydiapneumoniae [/] [/] [/] [/] [/] [/] [/] [/] /(.) [/] /() /(.) * Eradicatedrate(%)= Eradicatedstrains/detectedstrains
10 Plasma concentrationg/ml mg mg Time (h) Fig.. Plasmaconcentrationofgarenoxacin. Table. Summarystatisticsoftroughplasmaconcentration Dose(mg) Cases Avg SD Median Mini Max Effective mg mg Clinical efficacy Poor Trough concentration ( g/ml) Fig.. Relationshipbetweenclinicaleficacyandtroughplasmaconcentration.
11 µ µ
日本化学療法学会雑誌第57巻第6号
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