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Two different doses of cefaclor advanced formulation (AF), a new sustained-release formulation of cefaclor, were compared with the regular formulation of cefaclor for efficacy and safety in the treatment of uncomplicated cystitis and asymptomatic bacteriuria. A 7-day course of treatment was used, and the trials were double-dummy and double-blind. In one trial, cefaclor AF 500 mg once daily (at night) was compared with cefaclor 250 mg three times a day. Satisfactory clinical and bacteriological responses were found in 179/189 (94.7%) and 160/191 (83.8%) patients, respectively, given cefaclor AF and in 82/87 (94.3%) and 74/90 (82.2%) patients given cefaclor, 5-9 days after the end of treatment. In the other trial, cefaclor AF 375 mg twice daily was compared with cefaclor 250 mg three times a day. Satisfactory clinical and bacteriological responses were obtained in 164/180 (91.1%) and 156/184 (84.8%) patients, respectively, given cefaclor AF, and in 86/92 (93.5%) and 81/93 (87.1%) patients taking cefaclor, 5-9 days after the end of treatment. Very similar results were found in both studies in those patients who were assessable 3-5 weeks later. Only 4.3% and 2.4% of patients treated with cefaclor AF (375 mg and 500 mg, respectively) and 2.2% of cefaclor patients discontinued therapy due to adverse events. The three most commonly reported events were vaginal moniliasis or vaginitis (8.6%), headache (5.0%) and nausea (4.8%). No significant differences were found between clinical efficacy and safety parameters in the different study groups, and it was concluded that cefaclor AF in a twice-daily or once-daily dosage is as effective and as safe as the currently recommened three-times-a-day dosage of cefaclor.
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PMID:Comparative trials of cefaclor AF in uncomplicated cystitis and asymptomatic bacteriuria. 128 20

The purpose of this pilot study was to describe the 3-year experience of ambulatory medical care provided by one family physician in an Army community hospital. Data collected at each outpatient visit included the patient's age, race, gender, problems actively addressed, and procedures. There were 7,895 outpatient visits, representing 3,665 patients and 2,292 families. Of the 13,158 problems recorded, the 10 most frequent were pregnancy care, general medical examination, alcohol and tobacco use, hypertension, depression/anxiety, contraception, otitis media, acute upper respiratory infection, vaginitis, and headache. Further studies should be done to validate this pilot study.
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PMID:The content of outpatient family practice care in an Army community hospital: one physician's three-year experience. 147 Mar 54

The Norplant System consists of 6 capsules each containing 36 mg of crystal line levonorgestrel (LNG), for a total dose of 216 mg LNG. The capsules are inserted subdermally in the mid-upper arm, and LNG diffuses continuously through the capsule walls for 5 years. In the United States the Norplant System was approved in December 1990. The initial rate of hormone delivery is about 85 mcg/day, then decreases over the next 9 months to 5 mcg/day, and over the ensuing 9 months to 35 mcg/day. Thereafter, the diffusion rate levels off for the next 3.5 years, averaging around 30-35 mcg/day. Removal results in a drop in the plasma concentration of levonorgestrel to below contraceptive levels within 24 hours and below the detectable limit of .1 pg/ml at 96 hours. Preliminarily data from 402 users over 5 years show improvements of Norplant produced better efficacy in all weight classes and a lowered cumulative rate of 1.1 pregnancies of 100 users. The pregnancy rate for the first year of use is 02., better than for oral contraceptives. Side effects include headache, nervousness, nausea, dizziness, dermatitis, acne, change of appetite, breast tenderness, minimal weight gain, some change in hair distribution, and adnexal enlargement. Adverse reactions include breast discharge, possible cervicitis, musculoskeletal pain, abdominal discomfort, leukorrhea, and vaginitis. More than the usual number of bleeding days occurred in slightly more than one fourth of the patients, prolonged bleeding in 27.6% spotting in 17.1% and amenorrhea in 9.4% of patients. Hyperlipidemic users should be observed for possible low-density lipoprotein elevations. The cumulative discontinuation rate for pregnancy was 3.9 per 100 users; for bleeding irregularities the rate was 25.1 per 100 users, and for other medical results it was about 22.4 per 100 users. Personal reasons for discontinuation accounted for 38.7 per 100 users, equivalent to a cumulative continuation rate of about 30 per 100 users over the 5-year duration.
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PMID:The NORPLANT system of contraception. 168 4

In a prospective, randomized, double-blind trial, ciprofloxacin (250 mg orally, twice daily) was compared with cinoxacin (500 mg orally, twice daily) in 60 patients with urinary tract infections. Most patients were women with uncomplicated urinary tract infections. Escherichia coli was the most common isolate (36 patients). Clinical and microbiologic cure occurred in 20 of 24 (83 percent) evaluable patients treated with ciprofloxacin, compared with 15 of 21 (71 percent) evaluable patients treated with cinoxacin. Ciprofloxacin was well tolerated and had a low incidence of minor side effects that included Candida vaginitis, headache, and gastrointestinal intolerance. Relapse or failed therapy was not associated with the development of resistance.
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PMID:Ciprofloxacin versus cinoxacin in therapy of urinary tract infections. A randomized, double-blind trial. 355 49

In a multicenter, randomized, open, comparative trial, patients with uncomplicated gonorrhea were treated with 400 mg of oral fleroxacin or 250 mg of intramuscular ceftriaxone. A total of 458 men and 447 women were enrolled. Of these, 312 men (68%) and 245 women (55%) were evaluable for efficacy. The treatment groups were demographically similar. Among evaluable men, fleroxacin eradicated 154 of 155 (99%; 95% confidence interval [CI]: 98.1-100%) urethral and 2 of 2 pharyngeal infections, while ceftriaxone eradicated 156 of 156 (95% CI: 99.4-100%) urethral and 5 of 5 pharyngeal infections. Among evaluable women, fleroxacin eradicated 127 of 128 (99%; 95% CI: 97.7-100%) cervical, 20 of 20 anorectal, 16 of 16 urethral, and 7 of 7 pharyngeal infections, while ceftriaxone eradicated 108 of 108 (95% CI: 99.1-100%) cervical, 24 of 24 anorectal, 25 of 25 urethral, and 9 of 9 pharyngeal infections. Adverse events were reported by 68 (16%) of 426 subjects in the fleroxacin group and 20 (5%) of 380 in the ceftriaxone group (p < 0.0001). The most common adverse events reported by the patients who received fleroxacin were nausea (5%), headache (3%), and vaginitis (3%). One patient had severe vomiting, 19 participants had adverse reactions classified as moderate, and 48 patients had mild adverse reactions. Fleroxacin was highly effective in the treatment of uncomplicated gonorrhea and represents an oral alternative to ceftriaxone. Adverse events were more common with fleroxacin than with ceftriaxone.
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PMID:Multicenter trial of fleroxacin versus ceftriaxone in the treatment of uncomplicated gonorrhea. 845 87

Trovafloxacin is a fluoroquinolone antibacterial agent with a broad spectrum of activity. Trovafloxacin has similar or 2-fold lower activity than ciprofloxacin against Enterobacteriaceae and Pseudomonas aeruginosa. Against Haemophilus influenzae and Moraxella catarrhalis, trovafloxacin has similar activity to ciprofloxacin. Other susceptible Gram-negative pathogens include Neisseria gonorrhoeae, Chlamydia trachomatis and mycoplasmas. The drug is active against Gram-positive bacteria and consistently displayed greater activity (2- to 8-fold) than ciprofloxacin against all staphylococci and streptococci tested; activity included methicillin-resistant staphylococci and penicillin-resistant Streptococcus pneumoniae. Trovafloxacin has some activity against vancomycin-resistant enterococci. Anaerobes such as Bacteroides and Clostridium spp. are also susceptible to trovafloxacin. Preliminary clinical data suggest that trovafloxacin is effective in the treatment of patients with upper and lower respiratory tract and uncomplicated urinary tract infections and infections caused by C. trachomatis or N. gonorrhoeae. The most frequently noted adverse event with trovafloxacin is dizziness which is reported in 11% of patients versus 3% of those receiving comparator agents. Other commonly reported events (> 1% of patients) are nausea, headache, vomiting, vaginitis and diarrhoea.
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PMID:Trovafloxacin. 927 5

In a primary care setting, the efficacy and safety of ciprofloxacin (CIP) 500 mg b.i.d. were compared with those of cefuroxime axetil (CA) 250 mg b.i.d., each given for 10 days, in a nationwide, open, prospective, randomized trial of 1414 adults with acute sinusitis. Patients were enrolled if they had clinically documented acute sinusitis (ie, rhinosinusitis) (<4 weeks' duration), based on the 1997 American Academy of Otorhinolaryngology--Head and Neck Surgery criteria of either two major or one major and two minor symptoms. The primary efficacy variable was clinical response (resolution or failure) at the posttherapy assessment on study days 14 through 26. The most common presenting major signs and symptoms of acute rhinosinusitis were facial congestion, nasal drainage/purulence, facial pain/pressure, and nasal obstruction/blockage. The minor symptom, headache, was more common and severe than was nasal obstruction/blockage. A total of 1219 patients were clinically evaluable. Clinical resolution was observed in 559 of 613 (91.2%) CIP-treated patients and 546 of 606 (90. 1%) CA-treated patients. The two regimens were statistically equivalent (95% confidence interval, -2.16% to 4.71%). There were 80 drug-related adverse events reported in the CIP-treated patients and 81 drug-related adverse events reported in the CA-treated patients. The main adverse events were nausea (n = 18) and diarrhea (n = 7) in patients treated with CIP and diarrhea (n = 14), nausea (n = 12), headache (n = 7), and vaginitis (n = 7) in those treated with CA. CIP 500 mg b.i.d. was found to be statistically equivalent to CA 250 mg b.i.d. in the treatment of acute rhinosinusitis.
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PMID:Multicenter comparative trial of ciprofloxacin versus cefuroxime axetil in the treatment of acute rhinosinusitis in a primary care setting. Rhinosinusitis Investigation Group. 982 44

An interdisciplinary group of researchers developed a conceptual and methodological framework to determine the extent of the problem of reproductive morbidity at the community level in Middle Eastern society and then, in turn, to improve reproductive health conditions in women. It conducted an exploratory study in a family planning clinic in Cairo, Egypt; a medical workshop on clarification of the symptomatology of reproductive morbidity; and a focus group in a village in Giza, Egypt, to ensure that the reproductive morbidity questions of interview questionnaires were appropriate and complete. The group tested the accuracy of the questionnaires in 2 villages in rural Giza (509 women). Field workers went to the women's homes to administer the questionnaire on characteristics of the household during the first visit. During the second visit, they administered the questionnaire on reproductive morbidity, and then the social researcher went with the women to the health center so the women could undergo a gynecological examination. 50% of the women had reproductive tract infections, especially vaginitis. 56% had prolapse, and prevalence increased significantly with age. 63% had anemia, especially 14-19 year olds (76%). Just 24 women (5%) had no reproductive morbidity. About 50% had at least 3 reproductive conditions. The leading problems reported by the women were vaginal discharge (77%), dysmenorrhea (71%), perceived delay in conception (48%), stress incontinence (37%), and pain during intercourse (36%). Feeling of heaviness below, probably indicating prolapse, was the only symptom which increased with age (p = .03). 41% had been pregnant in the last 2 years. 77% delivered at home. Leading conditions during pregnancy were headache (59%) and discharge (45%), and those after delivery were fever and discharge/inflammation (30% for both). The interdisciplinary group proposed 3 mechanisms which are of utmost importance to policy: conducting similar research in other communities, expansion of reproductive health services at the community level, and implementing changes in the education and training programs of health professionals and social scientists.
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PMID:Concepts and measures of reproductive morbidity. 1014 96

(1) The reference treatment for uterine leiomyoma with major symptoms is surgery. (2) Leuprorelin and triptorelin, two Gn-RH analogues, are the first drugs to be licensed in France for preoperative treatment of uterine leiomyoma associated with anaemia, when a reduction in the size of the leiomyoma is necessary to facilitate or modify the surgical technique. (3) A double-blind placebo-controlled trial of leuprorelin in nearly 300 anaemic women showed no advantage in terms of the need for non autologous transfusion. (4) Three double-blind placebo-controlled trials have shown that leuprorelin reduces the volume of uterine leiomyomas, but whether or not this facilitates or modifies the surgical technique is not known. An unblinded trial versus lynestrenol in non anaemic women showed a superior effect of leuprorelin on the size of the leiomyoma, but again there were no data on a possible effect on the choice of surgical technique. (5) In the absence of comparative double-blind trials, the observed effects of triptorelin on the choice of surgical technique are uninterpretable. (6) The adverse effects of leuprorelin are mainly linked to its hormone effect, i.e. flushing, headache, vaginitis and vaginal dryness. There are no recent reviews of the adverse effects of triptorelin in this setting. (7) In practice, for anaemic women with leiomyomas requiring surgery, there is no proof that leuprorelin and triptorelin have any tangible clinical advantages.
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PMID:Leuprorelin and triptorelin: new indication. Preoperative treatment of uterine leiomyoma: no proven value. 1171 67

Results of a large multicentered clinical trial of a new contraceptive vaginal ring show that the new ring may be about as effective as oral contraceptives but with fewer side effects. The ring, which is a little smaller than a 75 mm diaphragm and has a Silastic inner core and outer tubing, is avilable in 2 sizes (50 mm or 58 mm) and contains a middle layer with a steroid mixture of estrogen and progestin. Both types of ring contain about 100 mg levonorgestrel and 50 mg estradiol. Ovulation is suppressed by the steroids in the ring. The ring is placed in the vagina for about 3 weeks and then removed for 1 week. Withdrawal bleeding occurs when the ring is removed. Comparative studies of the effectiveness of the ring and a pill (Nordette, which contains 150 mcg levonorgestrel and 30 mcg estradiol) show that after a year's use, both type of contraceptives had a pregnancy rate of about 3 pregnancies per 100 users. Ring users had higher continuation rates than pill users (50/100 women for the ring vs. 30/100 for the pill). Reasons for discontinuation for the ring include occurrence of vaginal discharge, vaginitis, and menstrual problems. Ring users had lesser incidence of nausea and headache compared to pill users; they also did not experience an increase in angiotensinogen levels or blood pressure. Another advantage of the ring is its once-a-month administration. Investigators are still testing the best method for using the ring. However, as testing is not yet complete, application for approval by the Food and Drug Administration may take quite some time.
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PMID:Trials point to effectiveness of new vaginal ring. 1227 58


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