Fig. 1 Chemical structure of norfioxacin (AM-715)

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Transcription:

Fig. 1 Chemical structure of norfioxacin (AM-715)

Table 1 Serum and biliary concentration of norfloxacin (AM-715)

Table 2 Protocol for clinical evaluation of norfloxacin (AM-715) in the treatment of biliary tract infection 1. Purpose. To evaluate the efficacy and safety of norfloxacin (AM-715) for the treatment of biliary tract infection by an open study 2. Subject: Patients who can take orally the drug and from whose biles bacteria can be isolated and identified are included: 1)patients under percutaneous transhepatic drainage of biliary tract (PTCD) 2)patients who have fistula with obstructive jaundice 3) patients under choledochal drainage 3. Dosage and duration 200mg, t.i.d. after meal (600mg/day), 5 to 7 days 4. Concomitant use of drugs : Patients should not receive any of other chemotherapeutics, anti-inflammatory and antipyretic/analgesic agents 5. Items of observation and examination 1) Subjective symptoms spontaneous pain tenderness 2)Objective findings. WBC count bile findings body temperature 3)Bacteriological examination count of bacteria in bile MIC identification of causative organisms 6. Judgement of efficacy : 1) Effect on symptoms and laboratory findings 2) Effect on bacteria in bile 3)Clinical efficacy evalueted by physician and by the committee

Table 3 Surgical procedure on the biliary tract disease

Table 6 Clinical efficacy on all cases Effect on symptoms and laboratory findings Clinical efficacy evaluated by physician Clinical efficacy classified by type of severity Table 7 Clinical efficacy on group A Effect on symptoms and laboratory findings Effect or. bacteria Clinical efficacy evaluated by physician

Table 8 Clinical efficacy on group A by the type of infection Effect on symptoms and laboratory findings Effect on bacteria Clinical efficacy evaluated physician Table 9 Clinical efficacy evaluated by physician foreach strain

Table 10 Bacteriological effect on isolated strains Table 11 Correlation of MIC and bacteriological response

Table 12 Strains appearing after treatment Table 13 Clinical efficacy on group B Effect on symptoms and laboratory findings Clinical efficacy evaluated by physician

Table 14 Clinical efficacy evaluated by committee Table 15 Clinical efficacy evaluated by the committee (Monomicrobial infection)

Table 16 Clinical efficacy evalueted by the committee ( Polvmicrobial infection)

Fig. 2 Laboratory findings (1)

Fig. 2 Laboratory findings (2)

1) ITO, A; K. HIRAI, M. INOUE, H. KOGA, S. SUZUE, T. IRIKURA & S. MITSUHASHI : In vitro antibacterial activity of AM-715, a new nalidixic acid analog. Antimicr. Agents & Chemoth. 17: 103 `108, 1980

FUNDAMENTAL AND CLINICAL STUDIES OF NORFLOXACIN (AM-715) IN BILIARY TRACT INFECTION HIDEHIKO SHIMURA, HIROSHI YAMAMOTO, HIROTSUNE IGIMI and SUMITAKA ARIMA The First Department of Surgery, Fukuoka University RYUSUKE OHKUMA and YUSUKE KURODA The First Department of Surgery, University of Occupational and Environmental Health AKIO TAIRA, KOICHI OZASA, NOBUAKI SAKAGUCHI and NOBUTOSHI IMAIZUMI Department of Surgery, Hamanomachi Hospital TOHRU MIDORIKAWA, RYOICHI TAMURA and TOSHIKAZU FUKAMURA Department of Surgery, Karatsu Red Cross Hospital TEIJI FURUSAWA Department of Gastroenterology, Koga Hospital Norfloxacin (AM-715), a newly developed oral antibacterial agent, was evaluated with respect to bile concentration and clinical effect for patients with various biliary tract infections, and the following results were obtained. Biliary levels of AM-715 were 2.6 `6.0 Đg/ml at the peak of 3 `4 hours after administration of 400 mg and were 1.4 `2.5 Đg/ml at 6 hours after administration. Biliary levels were 3 `5 times of serum concentrations. 31 patients suspected of the biliary infection after PTCD or choledocho-drainage received 600 mg of AM-715 t. i. d. for 5 `7 days. Clinical efficacy judged by attending physicians was excellent in one, good in 20, fair in 4 and poor in 6 cases, and the effectiveness rate was 67.7% (21/31). Improvement rate of symptoms and laboratory findings was 69.0% (20/29). In 21 cases, that causative organisms in bile were identified, clinical efficacy was evaluated by the committee objectively from macroscopic findings of bile and bacteriological effect. It was excellent in one, moderate in 14 and poor in 6 cases, the effectiveness rate was 71.4%. Bacteriological response was "Eliminated" in 28.6%, and "Eliminated" or "Decreased" in 47. 6% of the cases. Clinical efficacy on monomicrobial infection and polymicrobial infection were 66.7% (6/9) and 75.0% (9/12), respectively. No side effect was observed.

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