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The clinical effectiveness of a new synthetic pyridoncarboxylic acid derivative, norfloxacin (NFLX: Baccidal) was studied in the urological field. NFLX was given clinically to 50 patients with urogenital tract infections; 40 cases were acute simple cystitis and 10 cases were complicated UTI satisfied the criteria of the UTI committee. Thirty two bacterial strains were isolated from the group of acute simple cystitis and 10 bacterial strains were isolated from the group of complicated UTI. Susceptibility of NFLX by the method of distribution and disk sensitivity was 97% in the former group and 89% in the latter group. The overall clinical efficacy rate estimated by the criteria of the UTI committee in 32 cases with acute simple cystitis was 97% and in 10 cases with complicated UTI was 60%. The incidence of side effect was 8.0% (4/50). All of these side effects which were nausea, abdominal fullness and headache may be attributable to the administration of NFLX. No abnormal laboratory findings were observed except for elevation in GOT and GPT values in 1 case (4.0%), which returned to normal after NFLX treatment. Therefore NFLX is suggested to be a clinically useful and safe drug in the treatment of UTI.
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PMID:[Clinical experience of norfloxacin (Baccidal) in the urological field]. 408 23

We have described a 47-year-old white woman who had spontaneous E coli K1 meningitis after acquiring an E coli K1 urinary tract infection with associated sepsis. The patient's symptoms consisted only of severe headache, fever, and malaise. She had no meningeal or focal neurologic signs, and the CSF did not contain white blood cells. Evidence of meningitis included elevated opening pressure on lumbar puncture, positive CSF culture, and small ventricles on CT scan.
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PMID:Spontaneous Escherichia coli K1 meningitis in an adult. 635 Dec 70

There is little absolute data in the form of prospective studies in patients with specific illnesses who are on oral contraceptives (OCs). Consequently, the clinician must depend on well-founded empiric decisions in prescribing the pill for these patients. The basis for the decision should be a firm understanding of the pathophysiology and laboratory effects of OCs. This needs to be juxtaposed with an understanding of the efficacy and effects of the estrogen and progestational components of the birth control pill and their interactions with maintenance medications. Available evidence is reviewed for the following medical disorders: central nervous system disorders (depression, Wilson's disease, headaches, epilepsy, multiple sclerosis, and the eye); immunologic and connective tissue diseases; diseases of the endocrine system, the gastrointestinal system, the genitourinary system, the memopoietic system; and skin disorders. 7% of women on OCs have increased or newly reported depression. Whether these are primarily psychogenic or metabolically derived is yet to be definitively determined. Wilson's disease can be exacerbated by OCs because of increased plasma ceruloplasmin and increased absorption of copper from the gastrointestinal tract. Headaches can be either a vague or a specific symptom, such as migraines, but 1/3 of these patients will become worse on OCs. There is good evidence that the headaches are caused by falling estrogen levels. There is no good evidence that epilepsy, in general, becomes worse on OCs. OCs have relatively no effect on the longterm prognosis in multiple sclerosis. Increased corneal sensitivity has been observed with OC use, and this has usually presented an intolerance to the use of contact lenses. This is primarily the result of increased edema of the cornea and changing of its contour. By inference, OCs cause some basic universal changes in the immunologic system. OCs have been reported as a cause of a rare form of rheumatoid arthritis, but the Royal College reports a decrease in incidence of cell-mediated immunologic disease, specifically rheumatoid arthritis in its more familiar form. There is no evidence that OCs markedly influence thyroid disease, but they do markedly alter thyroid function testing. OCs do not produce a chronic addisonian state nor do they inhibit the ability of the adrenal-pituitary axis to respond to stress. OCs can be used in thyroid disease but with some caution in hypothyroid states. They should not be used in patients with Cushing's syndrome and are not recommended in patients with adenomas. In general, estrogen works as an irritant to the gastric mucosa, but there is no increase in peptic ulcer diseases associated with OC use, and the incidence of duodenal ulcer disease is decreased. The most striking liver disease seen with OCs is cholelithiasis. The incidence is increased 2-fold. OCs should not be prescribed for patients with chronic renal disease because of the vascular effects as well as the reported increased risk of urinary tract infection. The Royal College report has shown a decreased incidence of iron deficiency anemia in patients on OCs. Various skin changes have been reported in women using OCs. The most common of these is chloasma. In all the diseases studied thus far, the use of OCs has not precipitated a catastrophic change.
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PMID:The use of birth control pills in women with medical disorders. 702 14

1. Clinical pharmacology The pharmacological studies on tobramycin (TOB) were studied in clinical patients. The peak serum levels following intravenous drip infusion (i.v.d.) administration of TOB 60 mg were 4.62 mcg/ml in 0.5 hour and 4.09 mcg/ml in 1 hour respectively which achieved at the discontinuance of the drug. In 1 case, the concentration in serum and urinary recovery were determined when 60 mg of TOB was given twice a day in i.v.d. at an interval of 5 hours. The peak serum level was 4.11 mcg/ml at the first administration, and 4.96 mcg/ml at the second. No significant accumulation of the drug was observed. The urinary recovery of TOB during 0 approximately 11.5 hours was 44%. 2. Clinical results Tobramycin was administered in a dose of 60 approximately 120 mg once or twice a day by i.v.d. against 18 cases of chronic complicated UTI. The duration of treatment varied but generally 5 days. An overall excellent or moderate effect was seen in 81%. 3. Clinical chemistry The clinical abnormal values from laboratory tests of renal, hepatic function and peripheral hematology in patients treated with TOB were observed in 2 cases. In 1 case BUN increase (17.6 leads to 23 mg/dl) and in the other GOT and GPT elevations (GOT 24.1 leads to 66.7 u, GPT 26.2 u leads to 68.8 u). The abnormal values, however, returned to normal within 2 weeks after the discontinuance of the drug. 4. Clinical tolerance Adverse reactions were encountered in 2 cases. The 1 case yielded skin rash with itching in the second day after therapy. The other case complained of general itching with mild headache 2 days after starting therapy. In the above cases TOB treatment was discontinued, soon after appearing these symptoms. The complete recovery was recognized within 2 days in each case. 5. Summary Based on the clinical pharmacology and clinical studies, intravenous drip infusion administration of tobramycin can be given safely and effectively in treatment of chronic complicated UTI.
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PMID:[Clinical evaluations of tobramycin in treatment of chronic complicated urinary tract infections by intravenous drip infusion administration (author's transl)]. 708 77

We discuss the case of a 24-year-old black woman at 33--34 weeks gestation, who after intravenous injection of Talwin presented with the following symptom complex: pyrexia, nausea, vomiting, shaking, chills, headache, myalgias, polyarthralgias, severe abdominal pain and "contractions." This symptomatology presents a complex diagnostic problem. Systematic laboratory evaluation eliminated more common etiologies, i.e., sub-acute bacterial endocarditis, HAA + hepatitis, placental abruption, chorioamnionitis, and urinary tract infection. The Talwin had been filtered through cotton ball. History plus exclusion of other etiologies led to the diagnosis of "cotton fever." The available literature is reviewed, and the importance of recognizing this entity when servicing a pregnant population with a high rate of drug abuse is discussed.
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PMID:Cotton fever and pregnancy. A confusing clinical problem. 721 12

A 26-year-old woman had had a lumbar subarachnoid-ureteral shunt established at the age of 10 weeks for hydrocephalus. She developed normally and had no trouble until meningitis developed because of reflux from a urinary tract infection. The meningitis responded to antibiotic treatment, and the shunt was removed from the subarachnoid space. Subsequently, the patient deteriorated clinically, with ictal episodes of altered consciousness, headache, and signs of midbrain dysfunction. Despite normal size ventricles on serial computed tomographic scans, her intracranial pressure was markedly elevated, which was shown by spinal puncture pressure. A diversionary lumboperitoneal shunt was inserted. An immediate, sustained recovery followed. The recognition of increased intracranial pressure in the absence of ventriculomegaly led to management that averted a disastrous outcome.
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PMID:Delayed complication of Matson operation for hydrocephalus: case report. 730 Oct 73

Since infection develops in significant numbers of hospitalized patients, the problem of resistance to third-generation cephalosporins is of increasing concern. We evaluated the efficacy of cefepime 1 g bd as treatment for acute, moderately severe bacterial infection in 239 hospitalized patients (mean age 60 years). Of these patients, 204 were evaluated clinically for urinary tract infection (UTI) (n = 90), lower respiratory tract infection (LRTI) (n = 70), skin and soft tissue infection (S/STI) (n = 12) and bacteraemia which was associated with either UTI or LRTI (n = 32) but not included in the previously mentioned UTI and LRTI groups. Amongst the pathogens isolated (36 Gram-positive, 150 Gram-negative), the most predominant species were Escherichia coli in UTI and bacteraemia (n = 81), Streptococcus pneumoniae in LRTI and bacteraemia (n = 23), Haemophilus influenzae in LRTI (n = 16), Pseudomonas aeruginosa (n = 4) and Enterobacter cloacae (n = 2) in S/STI. The mean duration of treatment was 8.5 days and was the same for the 204 clinically evaluable patients. Overall, the clinical cure rate for cefepime was 94% (191/204). Pathogen eradication was achieved in 93% (185/199) of infections. Of the patients with associated bacteraemia, the clinical cure rate was 97% (31/32) and 94% (16/17) of the pathogens were eradicated. Cefepime therapy was well-tolerated. Treatment was discontinued in eight patients (3%) because of local intolerance and in five patients (2%) because of drug-related adverse events (rash, headache and pruritus). Cefepime 1 g bd is as safe and effective as other parenteral cephalosporins for the treatment of acute bacterial UTI, LRTI and S/STI, including those cases with associated bacteraemia. The bd dosing schedule and reported lack of cross-resistance with other cephalosporins against some species of aerobic Gram-negative bacilli make cefepime an attractive treatment option in hospitalized patients.
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PMID:Low-dosage cefepime as treatment for serious bacterial infections. 815 Jul 55

After the development of monophasic combined oral contraceptives (COCs), containing a fixed dose of estrogen and progestogen, biphasic and triphasic COCs were introduced in the 1980s; in these the dose of ethinyl estradiol and progestogen changes during the pill cycle. In the so-called every day pills, the 21 pills of active steroid combination are followed by 7 inactive pills containing starch, iron, or bran. Method failures of OCs are among the lowest ranging from 0.2-1/100 woman-years. User failures can be as high as 6.2/100 women-years. The individual difference in peak plasma levels of estrogens in women taking identical OCs can be 10-fold. Conditions that affect the bioavailability of contraceptive steroids are: 1) drug interaction (vitamin C, drugs that induce liver enzymes, and antibiotics); 2) vomiting; 3) vegetarianism; 4) missing pills; and 5) malabsorption. Metabolic effects of COCs pertain to carbohydrate metabolism, lipid metabolism, hemostasis, and vitamins. Prescribing of COCs involves counseling clients about contraindications to COCs, starting routines, and the pill-free interval, as well as follow-up and monitoring, the problem of missing pills, and selection criteria for OC use. Medical conditions in which COC use requires special consideration are sickle cell disease, trophoblastic disease, HIV disease, gallstones, epilepsy, valvular heart disease, oligomenorrhea/amenorrhea, inflammatory bowel disease, and surgery. Side effects of COCs may include depression, nausea, vomiting, headaches, urinary tract infection, and lower genital tract infections. 6 months after stopping the OC 1% of users become amenorrheic. Many of the common causes of amenorrhea, such as weight loss amenorrhea and polycystic ovarian disease, may be treated with the COC until the couple desires to have a baby. The new progestogens desogestrel, norgestimate, and gestodene are highly selective compared to first and second generation progestogens.
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PMID:Combined oral contraceptives: acceptability and effective use. 832 4

Patients were entered in a double-blind, placebo-controlled, multicenter study to compare low- and high-dose fleroxacin with norfloxacin for the treatment of complicated urinary tract infection (UTI). A total of 296 patients were enrolled; 102, 97, and 97 patients were randomized to receive 200 mg of fleroxacin (low-dose), 400 mg of fleroxacin (high-dose), both once daily, or 400 mg of norfloxacin twice daily, respectively, for 10 days. Of these patients, 101, 94, and 95 were included in the safety analysis, and 71, 61, and 58 in the efficacy analysis. The main reason for exclusion from the efficacy analysis was failure to isolate a pathogen at baseline. The groups were comparable with respect to demographics. In the low-dose fleroxacin group, 68 (96%) of 71 patients had bacteriologic cures (eight with superinfection), compared with 56 (92%) of 61 in the high-dose fleroxacin group (two with superinfection) and 52 (90%) of 58 in the norfloxacin group (four with superinfection). Escherichia coli was the most frequent isolate in all groups. In the low-dose fleroxacin group, clinical cure was recorded in 61 (86%) of 71, improvement in six, and failure in four. In the high-dose group, clinical cure was noted in 58 (95%) of 61 patients, improvement in two, and failure in one. In the norfloxacin group, 50 (86%) of 58 patients were clinically cured, four were improved, and four failed. Clinical adverse events were reported by 22 (22%) of 101, 36 (38%) of 94, and 19 (20%) of 95 patients in the low-dose fleroxacin, high-dose fleroxacin, and norfloxacin groups, respectively. Insomnia and nausea were reported most frequently in the fleroxacin groups, and nausea and headache were most common in the norfloxacin group. The efficacy and safety of low-dose fleroxacin are comparable to those of norfloxacin for treatment of complicated UTI.
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PMID:Randomized double-blind trial of high- and low-dose fleroxacin versus norfloxacin for complicated urinary tract infection. 845 63

Fleroxacin, 400 mg once daily, and norfloxacin, 400 mg twice daily, both administered orally, were compared for the treatment of serious urinary tract infections (UTIs). In total, 301 patients from multiple centers who had serious UTIs were randomized to receive fleroxacin or norfloxacin in a double-blind study. The demographic parameters of the two groups were similar. A total of 190 patients were evaluable for efficacy, 94 in the fleroxacin group and 96 in the norfloxacin group. The reasons for exclusion from the efficacy analysis were not significantly different in the two groups, but more patients receiving fleroxacin were prematurely withdrawn from the study. The majority (134) of the diagnoses were complicated UTI, and the pathogens were primarily Enterobacteriaceae. The clinical responses were cure or improvement in 98% of the fleroxacin group and 92% of the norfloxacin group and failure in 2% of the fleroxacin group and 7% of the norfloxacin group. The bacteriologic results by infection were cure in 98% of the fleroxacin group and 89% of the norfloxacin group (including cure with superinfection in 4% of the fleroxacin group and 5% of the norfloxacin group) and failure in 2% of the fleroxacin group and 11% of the norfloxacin group. Adverse events were more common in the fleroxacin group and were mostly nausea, insomnia, and headache. Fleroxacin, 400 mg once daily, was as effective as norfloxacin, 400 mg twice daily, in eradicating UTIs but was associated with more adverse events.
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PMID:Fleroxacin versus norfloxacin for oral treatment of serious urinary tract infections. 845 64


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