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Biomedical subjects

C E Cox

Publications and source records attributed to C E Cox.

At least 19 recordsLinked to original sources

A comparison of the safety and efficacy of lomefloxacin and ciprofloxacin in the treatment of complicated or recurrent urinary tract infections.

The efficacy and safety of two fluoroquinolone antimicrobial agents, lomefloxacin and ciprofloxacin, were compared in a randomized, investigator-blinded, multiple-dose study that enrolled 150 adult outpatients with complicated or recurrent urinary tract infections. A total of 75 patients were treated with 400 mg of lomefloxacin once daily for 10-14 days; an equal number of patients received 500 mg of ciprofloxacin every 12 hours for 10-14 days. Both groups of patients were comparable in terms of demographics and distribution of underlying conditions. The most frequently occurring pathogens in both groups were Escherichia coli and Klebsiella pneumoniae. A total of 142 patients met the criteria for efficacy evaluation, 72 in the lomefloxacin group and 70 in the ciprofloxacin group. Eradication of the initial pathogen (post-treatment culture of less than or equal to 10(4) colony-forming units (CFU)/mL) was noted in 97.2% of patients treated with lomefloxacin and in 95.7% of ciprofloxacin-treated patients. Clinical success (disappearance or amelioration of presenting signs and symptoms) occurred in 98.6% of lomefloxacin-treated patients and in 95.7% of patients treated with ciprofloxacin. The differences in outcome between the two treatment groups were not statistically significant. Both drug regimens were well tolerated. There were no clinically significant changes in clinical laboratory values during treatment. In the lomefloxacin group three patients reported nausea, one nervousness, and one pruritus; in the ciprofloxacin group, two patients reported nausea and three pruritus. Two lomefloxacin-treated patients (3%) and four patients treated with ciprofloxacin (5%) withdrew from treatment because of adverse events. A single daily dose of 400 mg lomefloxacin was comparable to 500 mg ciprofloxacin every 12 hours for the treatment of complicated or recurrent urinary tract infections.

Adult

Argyrophilic nucleolar organizer regions in breast carcinoma. Correlation with DNA flow cytometry, histopathology, and lymph node status.

Argyrophilic nucleolar organizer regions (AgNOR) have been correlated with proliferative activity of neoplasms. Increased AgNOR may reflect increased proliferative activity of cells or ploidy. To explore this hypothesis, 41 breast carcinomas were processed for AgNOR silver staining and DNA flow cytometry. AgNOR counts were expressed as mean AgNOR/nucleus and percentage of tumor cells with more than five AgNOR/nucleus. The first count was designated mean AgNOR or mAgNOR, and the second count was designated AgNOR proliferative index or pAgNOR. Using Mantel-Haensel statistical analysis, carcinomas that exhibited mAgNOR of 2.4 or more had a high likelihood of aneuploidy (P less than 0.0001), an S-phase fraction of more than 5.8% (P less than 0.003), or a diameter greater than 2 cm (P less than 0.007). In addition, tumors with pAgNOR of 8% or more showed a statistically significant correlation with aneuploidy (P less than 0.004), tumor grade (P less than 0.04), and a more significant one with high S-phase fraction (P less than 0.0001). No significant correlation was obtained between pAgNOR and tumor size or lymph node status. These data indicate that AgNOR quantitation reflects changes in DNA ploidy and cell proliferation. They also suggest that the mean AgNOR counts correlate best with the DNA mass or ploidy and that the frequency of cells with higher AgNOR count best reflects proliferative activity or S-phase fraction.

Aneuploidy

Multicenter open-label study of parenteral ofloxacin in treatment of pyelonephritis in adults.

The efficacy and safety of parenteral ofloxacin were evaluated in an open, multicenter study of hospitalized patients with pyelonephritis. The patients received ofloxacin 400 mg IV as an initial dose followed by ofloxacin 200 mg IV b.i.d. for a minimum of three days. The patients could then continue ofloxacin orally 200 mg b.i.d. for a total of seven to fourteen days. The most common pathogens isolated were Escherichia coli, Enterobacter cloacae, and Klebsiella pneumoniae. Microbiologic eradication was achieved in 65 of 66 evaluable patients (98%), and clinical cure or clinical improvement was noted in all patients. Of 82 patients evaluable for safety, 12 (15%) reported drug-related adverse events, the most frequent of which was pruritus or rash. None of the patients experienced drug-related central nervous system symptoms. Ofloxacin is well tolerated and highly effective in the treatment of pyelonephritis.

Administration, Oral

A physician's guide to smoking cessation.

Claims of the effectiveness of smoking cessation services and products are often misleading. It is important that physicians be well informed in order to make appropriate recommendations to their patients who smoke. In this article smoking cessation products and programs are critically evaluated and issues such as cure rates and validation of self-reported abstinence are discussed. Many commercial products are available to aid in cessation, although none has been proven effective. With the exception of nicotine polacrilex gum and transdermal patches in conjunction with a multicomponent clinic, medications are generally ineffective. Smoking cessation programs range from the provision of self-help materials to multisession groups and clinics. Multicomponent, behavioral-based group programs have been the most successful. Physicians should raise the issue of smoking cessation as frequently as possible with smokers and should recommend the use of smoking cessation products and services as appropriate. Referrals should be made to programs that base their success rates on scientifically accepted standards, including a 1-year follow-up, inclusion of dropouts and nonrespondents in calculating outcome, and biochemical validation of self-reported abstinence. Reports of success rates of 80% to 95% at the end of a 1-year program should be viewed with skepticism. Ideally, whether working independently or through referral, the physician should actively promote smoking cessation for all patients who smoke.

Health Promotion

Oral temafloxacin compared to norfloxacin for the treatment of complicated urinary tract infections.

Temafloxacin is a new oral fluoroquinolone with broad-spectrum antimicrobial activity against gram-negative and gram-positive pathogens. The safety and efficacy of temafloxacin were evaluated in a multicenter, double-blind study of patients with complicated urinary tract infections. Patients were randomized to receive temafloxacin 400 mg (n = 138) or norfloxacin 400 mg (n = 141). Treatment was given orally twice daily for 10-14 days. Clinical response (cure or improvement) occurred in 75 of 78 patients (96%) in the temafloxacin group and in 89 of 91 patients (98%) in the norfloxacin group. Bacteriologic eradication rates in both treatment groups exceeded 95%. Adverse events occurred in a similar, low percentage of patients in both treatment groups and consisted primarily of nausea and dizziness. Temafloxacin appears to be as safe and effective as norfloxacin in the treatment of complicated urinary tract infections.

Administration, Oral

Treatment of chronic bacterial prostatitis with temafloxacin.

In an open multicenter study [corrected], 112 male patients (mean age 47.1 years) with documented symptomatic chronic bacterial prostatitis were treated with oral temafloxacin 400 mg b.i.d. for 28 days. Urine and prostatic secretions were obtained for culture and susceptibility testing, and clinical signs and symptoms were evaluated at day 14 as well as 5-9 days and 26-30 days post-treatment. The most frequently isolated pretreatment pathogens (n = 97) were 36 strains (38%) of Escherichia coli and 16 strains (17%) of Enterococcus. Clinical success (cure plus improvement) was demonstrated in 74 of 81 (91%) patients at visit 4, 5-9 days post-treatment and at visit 5, 26-30 days post-treatment in 61 of 71 (86%) patients. At visit 4, 94% of patients had eradication of pretreatment pathogens. At visit 5, 92% had continued eradication of their original pathogens. Improvement was observed in the severity of signs and symptoms that existed pretreatment at visit 4 (visit 5): dysuria, 92% (93%); perineal pain, 95% (93%); lower abdominal pain, 93% (100%); lower back pain, 88% (93%); scrotal/penile pain, 91% (83%). Digestive system (6.3%) and nervous system (4.5%) adverse events were observed most frequently. Temafloxacin 400 mg b.i.d. administered orally for 28 days represents a safe and effective treatment for chronic bacterial prostatitis.

Adult

Obesity and body fat distribution and breast cancer prognosis.

This study addresses the effect of obesity and body fat distribution on axillary lymph node involvement, tumor size, and estrogen receptor (ER) level in breast cancer patients. Anthropometric measurements were prospectively obtained on 248 consecutively and newly diagnosed women with invasive breast cancer. The anthropometric measurements evaluated were abdomen, thigh, subscapular, and midaxillary skinfolds; weight; and height. Weight and Quetelet Index (kg/m2) were significantly (P = 0.001) associated with lymph node involvement in postmenopausal patients. The abdomen:thigh skinfold ratio was significantly higher in premenopausal patients (P = 0.004) and postmenopausal (P = 0.03) without axillary node involvement compared with women with 4+ axillary node involvement. The abdomen:thigh skinfold was higher (P = 0.05) in women with smaller breast cancers (less than 2.0 cm) and higher ER levels. Weight and Quetelet Index did not affect tumor size or ER level. This study demonstrated that obese postmenopausal women who developed breast cancer tend to have more axillary node involvement than their leaner counterparts. Generalized obesity did not affect tumor size or ER level. Premenopausal and postmenopausal women with upper body fat distribution appear to be a subset of women who have a more favorable prognosis as measured by less lymph node involvement, smaller tumors, and higher levels of ER in their tumors.

Adult

Touch preparation cytology of breast lumpectomy margins with histologic correlation.

Residual microscopic disease after lumpectomy for breast cancer may cause significant local recurrence. We evaluated one hundred fourteen consecutive breast lumpectomy margins in this study by touch preparation cytology. Cytologic preparations were intraoperatively correlated with gross and frozen section results and subsequently with permanent histologic sections of representative margins. Three specimens were cytologically unsatisfactory and 86 yielded benign findings, while material suggestive or diagnostic of malignancy was obtained from 25 specimens. Gross, frozen section, and permanent histologic margins were positive in 10, 17, and 22 cases, respectively. There were three false-positive touch preparation cytologic results, while frozen section specimens were false-negative in five cases. Sensitivity and specificity of touch preparation cytology were 100% and 96.6%, respectively, with a diagnostic accuracy of 97.3%. Touch preparation cytologic examination rapidly and reliably evaluates lumpectomy margins and overcomes sampling errors and artifacts related to frozen section evaluation. This technique currently complements frozen section evaluation of lumpectomy margins as part of a protocol aimed at reducing local recurrence of breast cancer.

Adult

Parenteral ofloxacin in treatment of pyelonephritis.

The interim findings of two studies of intravenous ofloxacin for the treatment of pyelonephritis are presented. The findings are from one center of a multicenter trial. In the first study intravenous (IV) ofloxacin was given to 34 patients with urine-culture-positive pyelonephritis. After three days of intravenous therapy patients could be switched to oral ofloxacin. Microbiologic eradication occurred in 97 percent and clinical cures in 97 percent of the patients treated with ofloxacin. There were three probable drug-related adverse events. In the second comparative study 38 patients with pyelonephritis were randomized to receive IV ofloxacin with the option of switching to oral ofloxacin after three days. IV ceftazidime was given to 30 patients with pyelonephritis with the option of switching to trimethoprim/sulfamethoxazole (TMP/SMX) after three days. Microbiologic cures were experienced by 97 percent of the ofloxacin patients and by 100 percent of the ceftazidime patients. Probable drug-related adverse reactions were experienced by 3/28 ofloxacin patients and by none of the ceftazidime patients. These interim study findings indicate that the intravenous preparation of ofloxacin is efficacious in the treatment of pyelonephritis and that it is safe. In addition, IV ofloxacin is as efficacious as IV ceftazidime for the treatment of pyelonephritis.

Administration, Oral

Review of clinical experience in the United States with cefpodoxime proxetil in adults with uncomplicated urinary tract infections.

Two controlled United States trials compared the safety and efficacy of cefpodoxime proxetil (100mg twice daily) with either cefaclor (250mg 3 times daily) or amoxicillin (250mg 3 times daily) in patients with uncomplicated urinary tract infections. Treatment duration was 7 days. 307 of 762 patients treated with cefpodoxime proxetil, 99 of 190 treated with cefaclor, and 57 of 185 treated with amoxicillin were evaluable for efficacy. 311, 99 and 59 pathogens were isolated from cefpodoxime proxetil, cefaclor and amoxicillin patients, respectively, the most common pathogens being Escherichia coli, Klebsiella spp., Proteus mirabilis, and Staphylococcus saprophyticus. Bacteriological cure rates were 80% (247/307), 82% (81/99) and 70% (40/57) for cefpodoxime proxetil, cefaclor and amoxicillin, respectively. Respective clinical cure rates were 79% (242/307), 79% (78/99) and 72% (41/57). Cefpodoxime proxetil was well tolerated, and there was no significant difference between the groups in the overall incidence of adverse experiences. Thus, cefpodoxime proxetil is efficacious and safe in the treatment of patients with uncomplicated urinary tract infections and compares favourably with cefaclor and amoxicillin.

Adolescent

Abdominal obesity and breast cancer risk.

STUDY OBJECTIVE: To determine if body fat distribution affects breast cancer risk. DESIGN: Prospective case-control study. PATIENTS: The anthropometric measurements of 216 consecutively and newly diagnosed women with invasive carcinoma of the breast were compared with those of 432 age-matched controls. The anthropometric measurements taken were abdomen, thigh, suprailiac, biceps, triceps, subscapular, and midaxillary skinfolds; waist and hip circumference; and weight and height. Women between 25 and 83 years of age were included in the study. RESULTS: Patients with breast cancer had a significantly greater waist:hip circumference ratio than controls (P less than 0.001) and a significantly greater suprailiac:thigh skinfold ratio (P less than 0.001). The relative risk for breast cancer increased with increasing waist:hip circumference ratio (less than 0.73 = 1.00; 0.73 to 76 = 1.90; 0.77 to 0.80 = 2.83; greater than 0.80 = 6.46) and with suprailiac:thigh skinfold ratio (less than 0.42 = 1.00; 0.42 to 0.56 = 1.85; 0.57 to 0.71 = 2.25; greater than 0.71 = 5.85). At other sites of upper body obesity, such as the biceps and triceps, skinfolds were significantly greater in patients with breast cancer. CONCLUSION: Although obese women are at slightly higher risk for developing breast cancer, women with android obesity are a segment of obese women who appear to be at a significantly higher risk for developing breast cancer.

Adipose Tissue

Immunologic and steroid binding properties of the GCDFP-24 protein isolated from human breast gross cystic disease fluid.

A major protein of human breast cyst fluid, termed GCDFP-24, has the property of specifically binding progestins. The purified glycoprotein, of 24,000 apparent molecular weight, bound pregnenolone and progesterone with highest affinity. The association constant for binding of progesterone was 1 X 10(6)L/mol by Scatchard analysis, and there was one binding site per molecule. Changes to the progesterone structure at C-17, C-20, or C-21 interfered with binding. The pH optimum for binding was 4-4.5. The purified protein was highly stable and was not irreversibly denatured by 50% methanol or 3M guanidine. However, dithiothreitol reversibly interfered with progesterone binding. Rabbit antiserum produced against the glycoprotein recognized an immunologically identical component in normal human sera, and partially cross-reacting components in normal monkey and baboon sera. The component in human sera was present in Cohn fractions IV and VI.

Animals

Ofloxacin in the management of complicated urinary tract infections, including prostatitis.

Studies of ofloxacin pharmacokinetics and pathogen susceptibilities suggested that this new fluoroquinolone might be particularly well suited to the treatment of urinary tract infections and prostatitis. Compared with carbenicillin and trimethoprim/sulfamethoxazole in separate studies of complicated urinary tract infection, ofloxacin achieved a significantly higher rate (p = 0.048) of microbiologic cures and more clinical cures than carbenicillin, while essentially matching the efficacy of the trimethoprim/sulfamethoxazole combination. Most common organisms were Pseudomonas aeruginosa in the first study and Escherichia coli in the second. In preliminary data from the prostatitis study comparing ofloxacin 300 mg given twice daily with carbenicillin 764 mg given every six hours, microbiologic cure rates were 100 percent with both medications. However, clinical cure rates were significantly higher (p = 0.048) with ofloxacin. Throughout these trials, ofloxacin has shown excellent safety and tolerability, with a lower incidence of nausea and diarrhea than with carbenicillin, and less nausea and rash than with trimethoprim/sulfamethoxazole. In all treatment groups, clinically significant laboratory abnormalities were uncommon and unrelated to the medications. Overall, these studies indicate that in complicated urinary tract infection the efficacy of ofloxacin is comparable with that of trimethoprim/sulfamethoxazole and superior to that of carbenicillin. In chronic bacterial prostatitis, results to date suggest that ofloxacin may be more effective clinically and as effective microbiologically as carbenicillin.

Administration, Oral

Comparison of intravenous ciprofloxacin and intravenous cefotaxime for antimicrobial prophylaxis in transurethral surgery.

Intravenous ciprofloxacin has been investigated in the treatment of serious infections, including those of the urinary tract. In this double-blind, randomized study, its effectiveness as a prophylactic agent in men undergoing transurethral surgical procedures was compared with that of another intravenous agent, cefotaxime. One hundred six men with genitourinary tract obstruction were enrolled in the study. The 102 men evaluable for determination of efficacy (53 in the ciprofloxacin group and 49 in the cefotaxime group) received a single intravenous infusion of either 300 mg ciprofloxacin or 1,000 mg of cefotaxime prior to resection of the prostate for benign prostatic hypertrophy and prostatic carcinoma or internal urethrotomy for urethral stricture. A mean of 32.1 and 40.3 minutes for the ciprofloxacin and cefotaxime groups, respectively, elapsed between the end of the intravenous infusion and the onset of surgery; all but one patient in the ciprofloxacin group underwent catheterization after surgery, of which the mean duration was 3.7 days for both groups. At the time of hospital discharge, patients were evaluated clinically; 50 patients in the ciprofloxacin group (94 percent) and 45 in the cefotaxime group (92 percent) had no bacteriologic evidence of genitourinary tract infection. At follow-up two to six weeks after surgery for the patients with no bacteriologic evidence of genitourinary tract infection, fewer patients in the ciprofloxacin group (8 percent) than in the cefotaxime group (16 percent) remained without evidence of infection. Both drugs were well tolerated. This study demonstrated that a single intravenous dose of ciprofloxacin was as effective as a single dose of cefotaxime in reducing the incidence of infection following transurethral surgical procedures.

Adult

Cefixime versus trimethoprim/sulfamethoxazole in treatment of patients with acute, uncomplicated lower urinary tract infections.

One hundred six patients with acute, uncomplicated lower urinary tract infections participated in a randomized study that compared cefixime (one 400-mg tablet once daily) with trimethoprim (160 mg)/sulfamethoxazole (800 mg) (one tablet every 12 hours). Two cefixime recipients and 3 patients given trimethoprim/sulfamethoxazole had courses that were not evaluable for efficacy. At five to nine days post-therapy, 98 percent of the patients in each treatment group had clinical cure and bacteriologic eradication. At four to six weeks post-therapy, 87 percent (34/39) of the cefixime-treated patients and 83 percent (33/40) of those given trimethoprim/sulfamethoxazole had clinical cure and 90 percent (35/39) and 93 percent (37/40) of the patients in the respective treatment groups had bacteriologic eradication. Adverse clinical experiences or changes in the results of laboratory tests were few. Thus, a once-daily dose of cefixime was as safe and as effective as a twice-daily regimen of trimethoprim/sulfamethoxazole.

Anti-Infective Agents, Urinary