Comparative effectiveness and safety of cefdinir and amoxicillin-clavulanate in treatment of acute community-acquired bacterial sinusitis. Cefdinir Sinusitis Study Group

Cefdinir is an extended-spectrum oral cephalosporin that is active against pathogens commonly seen in acute community-acquired bacterial sinusitis (ACABS), including Streptococcus pneumoniae, Haemophilus influenzae, and Moraxella catarrhalis. Two randomized, investigator-blind, multicenter trials (one in the United States and one in Europe) compared two dosage regimens of cefdinir (600 mg once a day for 10 days and 300 mg twice a day for 10 days) to amoxicillin-clavulanate (A-C) (500 mg three times a day for 10 days) for adult and adolescent patients with ACABS. Twelve hundred twenty-nine patients entered the U.S. study, 698 with antral puncture; 569 patients entered the European study, all with antral puncture. Clinical response (cure or improvement) was determined 7 to 14 days and 3 to 5 weeks posttherapy. Microbiologic eradication rates were determined 10 to 30 days posttherapy in a subset of patients who underwent pre- and posttherapy sinus aspirate culture. Rates of adverse events and treatment discontinuations due to adverse events were examined. Cefdinir, given once or twice daily, was as effective clinically (approximately 90% cure rate) as amoxicillin-clavulanate given three times daily in the treatment of ACABS. Microbiologic eradication rates were also similar in the three groups. The major side effect was mild diarrhea, occurring in approximately 20% of each group. Cefdinir caused fewer adverse events requiring treatment discontinuation.     

Cefdinir versus cephalexin for the treatment of skin and skin-structure infections. The Cefdinir Adult Skin Infection Study Group

Because of increasing resistance to older antimicrobial agents, newer drugs need to be evaluated for the treatment of skin and skin-structure infections (SSSIs). This double-masked, randomized, comparative, multicenter study enrolled patients aged 13 years or older with SSSIs to receive either cefdinir 300 mg BID or cephalexin 500 mg QID for 10 days. Nine hundred fifty-two patients (474 in the cefdinir group and 478 in the cephalexin group) took part, primarily white males between 18 and 65 years of age. There were two follow-up visits, with efficacy determined at the test-of-cure visit, 7 to 16 days posttherapy. Many patients were not microbiologically assessable, primarily because of negative cultures at study admission. Patients who required surgical intervention (e.g., incision and drainage) at the site of infection more than 24 hours after the initiation of drug therapy were defined as treatment failures. Significantly more isolated pathogens were resistant to cephalexin than to cefdinir. In the 178 efficacy-assessable cefdinir-treated patients, the rate of pathogen eradication was 93% (200/215), and the rate of successful clinical response was 88% (157/178), compared with 89% (221/247) and 87% (177/204), respectively, in the 204 efficacy-assessable cephalexin-treated patients. Using confidence-interval analysis, the microbiologic and clinical response rates of the cefdinir-treated patients were statistically equivalent to those of the cephalexin-treated patients. At the follow-up visits, patients were questioned about any adverse events occurring since their previous visit. Any untoward symptom occurring during or within 2 days after completion of drug treatment was considered an adverse reaction if the investigator judged it to be definitely, probably, or possibly related to the study drug. One hundred twenty-three (26%) cefdinir-treated patients and 77 (16%) cephalexin-treated patients experienced at least one adverse reaction, a statistically significant difference. Study drug was discontinued for adverse reactions in 20 (4%) cefdinir-treated patients and 13 (3%) cephalexin-treated patients; in the two groups, 10 and 7 patients, respectively, were discontinued for diarrhea. Cefdinir taken BID was as effective as cephalexin taken QID in the treatment of mild-to-moderate SSSIs and was well tolerated by most patients. The increased antibacterial activity of cefdinir must be balanced against the higher rate of diarrhea seen in patients treated with this drug.     

Opportunities for prevention of perinatal group B streptococcal disease: a multistate surveillance analysis. The Neonatal Group B Streptococcal Disease Study Group

OBJECTIVE: To evaluate the potential impact of ACOG and Centers for Disease Control and Prevention (CDC) consensus strategies for the prevention of perinatal group B streptococcal disease. METHODS: We evaluated cases of early-onset group B streptococcal disease identified by active surveillance during 1995, in four areas in North America with an aggregate 186,000 births per year. We reviewed the hospital records of mothers and infants and any prenatal records available on site. Cases were determined to be preventable based on whether group B streptococcal screening could have been performed prenatally, sensitivity of screening, presence of obstetric complications, and opportunity to administer antibiotics. RESULTS: We reviewed records for 245 of 246 infants with early-onset group B streptococcal disease in the surveillance areas. Most of the 53 case-mothers who delivered preterm and 192 who delivered full-term had had at least one prenatal visit (83% and 99%, respectively). Few case-mothers had prenatal group B streptococcal screening cultures, although compliance was high for other prenatal screening tests. Fifty-four percent of case-mothers had a recognized obstetric risk factor for group B streptococcal disease: labor or rupture of membranes at less than 37 weeks, rupture of membranes for 18 hours on longer, or temperature 38C or greater. The estimated preventable portion of early-onset group B streptococcal cases was 78% for the screening-based approach (range 74% to 82% by area), compared with 41% for the risk-based approach (range 39% to 53% by area). CONCLUSION: Comprehensive implementation of either of the recommended prevention strategies could potentially prevent a substantial proportion of early-onset group B streptococcal disease.     

Group A streptococcal bacteremia. A 10-year prospective study

In this paper we present a prospective evaluation of 100 patients with Group A Streptococcal (GAS) bacteremia evaluated in our hospital over a 10-year period. Sixty-two patients were intravenous drug users (IVDU); all but 1 of these had an obvious cutaneous portal of entry related to the injection of illicit drugs. Twenty-seven patients had infectious metastasis, and the presence of septic pulmonary embolism was associated with suppurative phlebitis. Four of these patients had endocarditis. In the non-IVDU group, 24 patients had an underlying disease, and 12 were immunosuppressed. In 14 cases the infection was of hospital acquisition; in 35% infection was related to medical manipulations. Comparing the IVDU and non-IVDU groups, GAS bacteremia in IVDU patients is associated with a more benign outcome, a longer time of evolution before diagnosis, and a lower frequency of septic shock and mortality than in non-IVDU patients. Although in the univariate analysis GAS bacteremia was associated with several variables, in the multivariate analysis only the presence of shock and nosocomial acquisition of the infection were independently associated with a fatal outcome. Fifty-two patients were infected with human immunodeficiency virus (HIV); 5 of these were in the non-IVDU group. During the last 5 years of study, GAS bacteremia in our hospital was 39 times more frequent in HIV-infected patients than in patients without HIV. Nine patients presented clinical criteria corresponding to Streptococcal toxic shock syndrome (STSS), although its incidence was lower in the IVDU group. In the non-IVDU group, STSS was more frequent in patients with a necrotizing portal of entry, an age between 20 and 40 years, women, and when the origin of the infection was the skin or soft tissue. Six patients with STSS died, and death was associated with the presence of necrotizing lesions and lower counts of white cells, platelets, or hemoglobin.     

Multistate case-control study of maternal risk factors for neonatal group B streptococcal disease. The Active Surveillance Study Group

Risk factors for early onset disease (EOD) caused by Group B streptococci (GBS) that are the foundation of prevention guidelines were identified in studies conducted in a few hospital centers. We investigated cases of EOD identified through laboratory-based active surveillance during 1991 and 1992 in a multistate population of 17 million. Ninety-nine cases were compared with 253 controls matched for hospital, date of birth and birth weight. Prematurity (< 37 weeks of gestation) was present in 28% of cases; 53% of case mothers had rupture of membranes > 12 hours; and 48% reported intrapartum fever. The incidence of EOD in each surveillance area was higher among blacks. By multivariate analysis, case mothers were more likely than controls to have rupture of membranes before labor onset (adjusted odds ratio 8.7, P < 0.001), intrapartum fever (adjusted odds ratio 11.9, P < 0.001), and history of urinary infection during pregnancy (adjusted odds ratio 4.3, P < 0.05). Young maternal age was also associated with risk of disease. Three-fourths of case mothers had intrapartum fever, < 37 weeks of gestation and/or prolonged rupture of membranes, indicators previously used to select high risk women for intrapartum chemoprophylaxis. Our findings extend data from single hospitals and suggest prenatal screening and selective intrapartum chemoprophylaxis of high-risk mothers could potentially prevent the majority of EOD in the United States.     

Group treatment for child sexual abuse.

Describes a 12-wk group therapy program used with more than 50 preadolescent children (aged 7–12 yrs) who have experienced intrafamilial sexual abuse. A cotherapy model is used. 90-min group sessions consist of 4 parts: circle time, focused activities, diary time, and snack. Activities are designed to highlight (1) development of trust, cohesiveness, and safety; (2) identification and labeling of feelings; (3) discussion of family relationships and family changes; and (4) exploration of issues associated with the offender. Sessions also examine legal issues and concerns and focus on self-esteem enhancement, social skills development, sex education, prevention of future abuse, and termination issues. (French abstract) (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

The effect of a rapid kit for detection of streptococcal pharyngitis on the accuracy of the physicians' diagnoses

BACKGROUND: In the last decade, the accuracy of rapid tests for detection of group A streptococcal antigen was evaluated in laboratory and clinical settings, and the tests were suggested as an alternative to the traditional throat culture. METHODS: We evaluated 19 patients with a preliminary diagnosis of nonstreptococcal pharyngitis and 13 patients with a preliminary diagnosis of streptococcal pharyngitis. The physician performed a rapid latex agglutination test (Detect A Strep), took throat culture from all of the patients, reconsidered the preliminary diagnosis, and made a working diagnosis. A clinical score was calculated for each patient during data analysis. The accuracy of the physicians' preliminary diagnoses was compared with the accuracy of the scoring system, with the accuracy of the latex agglutination test, and with the accuracy of the physicians' working diagnoses. RESULTS: The scoring system, the physicians' preliminary diagnoses, the latex agglutination test, and the physicians' working diagnoses correlated significantly with throat culture results (p < or = 0.05). The efficiency of the physicians' preliminary diagnoses was 75% compared with an efficiency of 69% of the clinical scoring system, an efficiency of 66% of the latex agglutination test, and an efficiency of 69% of the physicians' working diagnoses. The physician changed the preliminary diagnosis only for two patients as a result of the latex agglutination test results; ironically, however, the preliminary diagnosis was correct in both of these cases. CONCLUSION: The use of a rapid test for the diagnosis of group A streptococcal antigen under normal working conditions did not improve the accuracy of the physician's diagnosis, so the use of the latex agglutination test in this study was not cost-effective.     

A multicenter trial of ropinirole as adjunct treatment for Parkinson's disease. Ropinirole Study Group

OBJECTIVE: To evaluate the nonergot dopamine agonist ropinirole as an adjunct to L-dopa in a randomized, double-blind trial in PD patients with motor fluctuations. BACKGROUND: L-dopa in the treatment of PD is associated with motor fluctuations, dyskinesia, and other adverse effects. The use of dopamine agonists in the treatment of PD delays recourse to L-dopa and thus delays the possibility of adverse effect onset. METHODS: Ropinirole (n = 95) or placebo (n = 54) was added to L-dopa, and L-dopa was then reduced in a planned manner during the 6-month trial. RESULTS: A significantly greater number of ropinirole patients were able to achieve a 20% or greater reduction in both L-dopa dose and in percent time spent "off" compared with placebo (35.0% versus 13.0%; p = 0.003). The mean daily L-dopa dose was reduced significantly with ropinirole treatment (242 mg versus 51 mg; p < 0.001) as was the percent awake time spent "off" (11.7% versus 5.1%; p = 0.039). There was no difference in the percent of patients who withdrew because of adverse effects (15.8% on ropinirole versus 16.7% on placebo). CONCLUSIONS: Ropinirole permits a reduction in L-dopa dose with enhanced clinical benefit for PD patients with motor fluctuations.     

Nosocomial streptococcal blood stream infections in the SCOPE Program: species occurrence and antimicrobial resistance. The SCOPE Hospital Study Group

OBJECTIVE: To observe the effects of anti-idiotypic monoclonal antibody 6B11 against ovarian carcinoma SKOV3 on immunocompetent mice BCF1 both in vivo and in vitro, so as to investigate the possibility of using it as a tumor vaccine. METHODS: After immunization with 6B11 and normal mice (NM) IgG respectively on 2 groups of BCF1, blood, lymphocytes and tumor tissues were taken every other day. Ab3 was tested from blood samples. Subpopulations of lymphocytes were examined by FCM. The lymphocytes from immunized BCF1 were also cultured with SKOV3 to observe the chemotaxis and killing effects. Serial tissue sections were taken from BCF1 after immunization by SRCA implantation of SKOV3. TIL and visible cancer cells were examined carefully and compared with those in the controls. RESULTS: Ab3 rose quickly after immunization with 6B11 but lowered down gradually till the 9th week. The CD4+/ CD8+ ratio of BCF1 changed markedly after immunization with 6B11. The immunized lymphocytes showed a beautiful chemotaxis with and killing effect on SKOV3. During in vivo examinations, TIL were found significantly earlier in the immunized BCF1 than in the controls and reached the peak earlier in the former (on the 6th day) than in the latter, while the viability of tumor cells was vice versa between the two groups. CONCLUSION: 6B11 may be used as a vaccine for not only active immunization but also prevention of ovarian carcinoma.     

Oral sildenafil in the treatment of erectile dysfunction. Sildenafil Study Group

BACKGROUND: Sildenafil is a potent inhibitor of cyclic guanosine monophosphate hydrolysis [corrected] in the corpus cavernosum and therefore increases the penile response to sexual stimulation. We evaluated the efficacy and safety of sildenafil, administered as needed in two sequential double-blind studies of men with erectile dysfunction of organic, psychogenic, and mixed causes. METHODS: In a 24-week dose-response study, 532 men were treated with oral sildenafil (25, 50, or 100 mg) or placebo. In a 12-week, flexible dose-escalation study, 329 different men were treated with sildenafil or placebo, with dose escalation to 100 mg based on efficacy and tolerance. After this dose-escalation study, 225 of the 329 men entered a 32-week, open-label extension study. We assessed efficacy according to the International Index of Erectile Function, a patient log, and a global-efficacy question. RESULTS: In the dose-response study, increasing doses of sildenafil were associated with improved erectile function (P values for increases in scores for questions about achieving and maintaining erections were <0.001). For the men receiving 100 mg of sildenafil, the mean score for the question about achieving erections was 100 percent higher after treatment than at base line (4.0 vs. 2.0 of a possible score of 5). In the last four weeks of treatment in the dose-escalation study, 69 percent of all attempts at sexual intercourse were successful for the men receiving sildenafil, as compared with 22 percent for those receiving placebo (P<0.001). The mean numbers of successful attempts per month were 5.9 for the men receiving sildenafil and 1.5 for those receiving placebo (P<0.001). Headache, flushing, and dyspepsia were the most common adverse effects in the dose-escalation study, occurring in 6 percent to 18 percent of the men. Ninety-two percent of the men completed the 32-week extension study. CONCLUSIONS: Oral sildenafil is an effective, well-tolerated treatment for men with erectile dysfunction.     

Group A streptococcal necrotizing fasciitis. Diagnosing and treating the "flesh-eating bacteria syndrome"

Current research has still not clarified the biological role of soluble interleukin(IL)-2 receptor (sIL-2R) and the significance of its increase in the serum of colon cancer patients compared to healthy subjects. To address these questions at the immunological level in a group of patients and healthy subjects, we determined the sIL-2R level in the serum and its release from peripheral blood mononuclear cells (PBMC) as a function of tumour necrosis factor (TNF) alpha, IL-1 alpha, IL-1 beta, IL-2, interferon (IFN) gamma, IL-4, IL-6 and IL-10 levels in the serum and PBMC production; and PBMC proliferative responses to IL-2, IL-4 and anti-CD3 monoclonal antibody (CD3), variously combined. The level of sIL-2R in patients' serum was higher than in healthy subjects and correlated with the stage of advancement. Moreover, while in healthy subjects the serum level of sIL-2R was not significantly correlated with other parameters, in patients it was positively related to IL-4, IL-6 and IL-10 serum levels, PBMC IL-4 production and to the PBMC proliferative response to CD3 and CD3 + IL-2; it was negatively correlated to IL-2 serum level and IL-1 beta PBMC release. A negative connection between IFN gamma serum level and the PBMC production of sIL-2R was also found. This suggests that the increase of sIL-2R in the serum of patients, compared to healthy subjects, is involved in the inappropriate expansion of the T helper (TH2) suppressive immune response, which we previously reported. The multivariate statistical method supported the above suggestions and we also found that, in healthy subjects, the up- and down-regulation of sIL-2R in the serum within the physiological ranges seems to have a regulating role in the relationships between TNF alpha, IFN gamma and IL-4, IL-6, contributing to the operation of the cytokine network between TH1 and TH2 cells. However, in patients compared to healthy subjects the increased sIL-2R serum level seems to direct the immune response towards a suppressive type, which may be due to an alteration in the above-mentioned physiological regulating role.     

Group treatment for abusive men: Process and outcome.

Describes the Men's Educational Workshop Program, a 6-wk behaviorally based psychoeducational group for abusive men. Outcome criteria and follow-up data are reported for 11 males (mean age 25.5 yrs); results show that there was an elimination rather than a reduction of violence, and nonviolence was maintained for at least 6 mo postgroup. Findings support the utility of this program in controlling relationship violence. (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

Group B streptococcal bacteremia in adults. Five years' experience and a review of the literature

The importance of group B streptococcus (GBS) as a cause of serious infectious disease among adults is not widely appreciated. In adults, the modes of acquisition and transmission are unknown. Since most hospital-based studies of GBS bacteremia in adults consist of small numbers of patients, the clinical spectrum of disease is not well described. Our retrospective study reviews the clinical features, antimicrobial therapy, and risk factors for mortality of 32 adult patients (18 women and 14 men) with GBS bacteremia and compares the proportion of isolates from the different beta-hemolytic streptococci sero-groups. We found that 39% of isolates from adult blood cultures were group B, a frequency nearly identical to that of group A streptococcal bacteremia. Most (66%) adult patients were more than 50 years old. Primary bacteremia was the most frequent clinical diagnosis, occurring in 7 (22%) of 32 patients. Nonhematologic cancer was the most frequently associated condition (25%). Nineteen percent of the patients had diabetes mellitus. The overall mortality rate was 31% and was significantly associated with increasing age. Our results are compared to those obtained by a review of all 5 previous comparable studies and demonstrate that GBS bacteremia is a serious infection in adults with increased mortality related to advancing age.     

Ropinirole for the treatment of early Parkinson disease: a 12-month experience. Ropinirole Study Group

OBJECTIVE: To evaluate ropinirole hydrochloride as dopaminergic monotherapy in patients with early Parkinson disease. DESIGN: A 6-month extension of a double-blind, placebo-controlled study. SETTING: Ambulatory care at 22 different sites in the United States. PATIENTS: Patients who successfully completed the initial 6-month study could enter the 6-month extension study (ropinirole, n = 70; placebo, n = 77). INTERVENTION: Use of ropinirole or placebo therapy. MAIN OUTCOME MEASURES: The efficacy variables were the number of patients who successfully completed the 12-month study and did not require supplemental levodopa, the number of patients requiring supplemental levodopa, and the proportion of patients having an insufficient therapeutic response. RESULTS: Significantly fewer ropinirole-treated patients met criteria for insufficient therapeutic response (23 [19.8%] of 116) or required the initiation of levodopa therapy (22 [19%] of 116) compared with placebo-treated patients (60 [48%] of 125 patients for insufficient therapeutic response; 57 [45.6%] of 125 patients for additional levodopa). Significantly more ropinirole-treated patients (51 [44.0%] of 116) successfully completed the 12-month study and did not require supplemental levodopa compared with placebo-treated patients (28 [22.4%] of 125). The incidence of adverse experiences and patient withdrawals was low. CONCLUSION: Ropinirole was effective and well tolerated as monotherapy for 12 months in patients with early Parkinson disease.     

Group treatment for dually diagnosed clients

Group treatment is a widely practiced intervention for persons with dual diagnoses. This chapter reviews the rationale for group treatment and discusses four different approaches to group intervention: twelve-step, educational-supportive, social skills, and stagewise treatment.     

Tamsulosin and chlormadinone for the treatment of benign prostatic hyperplasia. The Kobe University YM617 Study Group

The recent introduction of selective alpha-adrenoceptor blockers adds a further therapeutic option for the treatment of benign prostatic hyperplasia (BPH). Tamsulosin, a selective alpha 1-blocker, has proved effective in relieving irritative and obstructive symptoms caused by BPH. To investigate whether the combination of tamsulosin with the anti-androgenic drug chlormadinone is of further therapeutic benefit, 80 patients randomly received tamsulosin 0.2 mg daily, chlormadinone 50 mg daily or a combination of tamsulosin 0.2 mg and chlormadinone 50 mg daily for 16 weeks. Greater improvement in subjective symptoms of BPH was obtained with either tamsulosin alone or in combination with chlormadinone than with chlormadinone alone. However, the greatest improvement in objective uroflowmetric data was obtained with chlormadinone in combination with tamsulosin. Thus, the combination of tamsulosin with chlormadinone appears to be more beneficial than either of these agents used as monotherapy. Further investigation is required to fully evaluate the therapeutic effects of this combination. After the trial period one-third of the chlormadinone and tamsulosin/chlormadinone-treated patients needed no further treatment due to the satisfactory relief of symptoms. At 12 months follow-up, however, one-fourth of the patients had undergone transurethral resection of the prostate (TUR-P) regardless of medication. This suggests a limitation of the medical treatment of BPH.     

Cardiac and glycemic benefits of troglitazone treatment in NIDDM. The Troglitazone Study Group

Troglitazone is a thiazolidinedione under development for the treatment of NIDDM and potentially other insulin-resistant disease states. Treatment with troglitazone is associated with an improvement in hyperglycemia, hyperinsulinemia, and insulin-mediated glucose disposal. No significant side effects have been observed in humans. Because of reported cardiac changes in animals treated with drugs of this class, this multicenter 48-week study was conducted to evaluate whether NIDDM patients treated with troglitazone develop any cardiac mass increase or functional impairment. A total of 154 NIDDM patients were randomized to receive troglitazone 800 mg q.d. or glyburide titrated to achieve glycemic control (< or =20 mg b.i.d. or q.d.). Two-dimensional echocardiography and pulsed Doppler were used to measure left ventricular mass index (LVMI), cardiac index (CI), and stroke volume index (SVI). All echocardiograms were performed at each center (baseline, 12, 24, 36, and 48 weeks), recorded on videotape, and forwarded to a blinded central echocardiographic interpreter for analysis. The results showed that LVMI of patients treated with troglitazone was not statistically or clinically different from baseline after 24 or 48 weeks. Statistically significant increases in SVI and CI and a statistically significant decrease in diastolic pressure and estimated peripheral resistance were observed in troglitazone-treated patients. These results were not sex-specific. Glycemic benefits of troglitazone treatment were observed as evidenced by long-term improvement of HbA1c and C-peptide levels. Furthermore, triglycerides were significantly lower, and HDL was significantly higher at weeks 24 and 48. In conclusion, NIDDM patients treated with troglitazone do not show any cardiac mass increase or cardiac function impairment. Conversely, patients on troglitazone benefited from enhanced cardiac output and stroke volume, possibly as a result of decreased peripheral resistance. Treatment with troglitazone appears to have a favorable impact on known cardiovascular risk factors and could potentially lower cardiovascular morbidity in NIDDM patients.     

Group cognitive-behavioral treatment for the nonpurging bulimic: An initial evaluation.

This study tested the initial effects of cognitive-behavioral therapy for binge eating in Ss who do not purge. Forty-four female binge eaters were randomized to either cognitive-behavioral treatment (CB) or a waiting-list (WL) control. Treatment was administered in small groups that met for 10 weekly sessions. At posttreatment a significant difference was found, with 79% of CB Ss reporting abstinence from binge eating and a 94% decrease in binge eating compared with a nonsignificant reduction (9%) in binge eating and zero abstinence rate in WL Ss. Following the posttest assessment, WL Ss were treated and evidenced an 85% reduction in binge episodes and a 73% abstinence rate. Binge eating significantly increased at 10-week follow-up for initially treated Ss; however, the frequency remained significantly improved compared with baseline levels. (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

Comparison of single-dose oral grepafloxacin with cefixime for treatment of uncomplicated gonorrhea in men. The STD Study Group

In a randomized open study, 351 male patients with uncomplicated gonorrhea were given single oral doses of grepafloxacin (400 mg) or cefixime (400 mg). In the 299 microbiologically evaluable patients, urethral infections were cured in 99% (147 of 149) of those receiving grepafloxacin and 97% (145 of 150) of those given cefixime. Eradication rates for both regimens were 100% in the 16% (47 of 299) of participants who were infected with penicillin-resistant Neisseria gonorrhoeae and 97% in the 21% (62 of 299) of participants infected with tetracycline-resistant strains. Grepafloxacin is a well-tolerated alternative to cefixime for treatment of uncomplicated gonorrhea in males.     

Low-dose intravenous calcitriol treatment of secondary hyperparathyroidism in hemodialysis patients. Italian Group for the Study of Intravenous Calcitriol

Intravenous calcitriol is known to directly suppress PTH secretion and release. We evaluated the effect of four months of treatment with low-dose intravenous calcitriol on PTH levels in 83 hemodialysis patients. The criteria for including patients in the study were a serum PTH levels at least four times the normal limit, a serum total calcium less than 10 mg/dl and good control of the serum phosphorus level. All patients underwent standard bicarbonate or acetate dialysis; dialysate calcium level was maintained at the usual 3.5 mEq/liter concentration. Initial calcitriol dose was 0.87 +/- 0.02 (SEM) micrograms (0.015 micrograms/kg body wt) thrice weekly at the end of dialysis, and it was reduced in case of hypercalcemia or elevated calcium-phosphate product. Seven out of 83 patients dropped out during treatment. Among the 76 patients who completed the study, 58 (76%) showed a highly significant decrease of intact PTH levels (average reduction 48%) and of alkaline phosphatase levels after four months of therapy. Total serum calcium increased slightly but significantly in the responder group but remained unchanged in the non-responders. No significant changes in ionized calcium levels could be detected, even in responders. Treatment was well tolerated by patients, but 60% of them had transient episodes of hyperphosphatemia. Mean serum phosphate was 4.95 mg/dl at the beginning of the study. It increased significantly after four months of treatment in patients who showed a decrease of PTH levels, although it remained within acceptable limits, below 5.5 mg/dl. Twenty-eight of 76 patients (37%) reduced the dose of calcitriol because their calcium-phosphate products exceeded 60.(ABSTRACT TRUNCATED AT 250 WORDS)