Latest industry information on the safety profile of levofloxacin in the US.

This paper reviews the safety data for levofloxacin utilizing reports from clinical and post-marketing surveillance trials. The side effect incidence rates are 1.3% for nausea, 0.1% for anxiety, 0.3% for insomnia, and 0.1% for headache. No levofloxacin-related adverse events were reported at a rate higher than 1.3%, and most were lower. Four clinical trials were reported. Levofloxacin achieved superior clinical and microbiological results compared to ceftriaxone/macrolide combination, and was better tolerated. Results comparing IV azithromycin plus ceftriaxone versus 500 mg levofloxacin in hospitalised CAP demonstrated that levofloxacin performed better, with more adverse events associated with the comparators (levofloxacin 5.3%, comparators 9.3%). High-dose levofloxacin (750 mg) was also evaluated and found to be well tolerated. Surveillance data reported low ADR rates for levofloxacin: nausea 0.8%, rash 0.5%, abdominal pain 0.4%, and diarrhoea, dizziness, and vomiting 0.3%. Worldwide and US surveillance data confirmed that tendon rupture occurred in less than 4 per million prescriptions, taste perversion in less than 3 per million, convulsions in 2 per million, and photosensitivity, hepatitis, hepatic failure, QT prolongation, torsade de pointes or empyema all in less than 1 per million.

Validation of a patient-graded instrument for facial nerve paralysis: the FaCE scale.

OBJECTIVE: To develop and validate a patient-based instrument to measure both facial impairment and disability, the Facial Clinimetric Evaluation (FaCE) Scale. STUDY DESIGN: Prospective instrument validation. METHODS: Eighty-six patients with a documented history of facial paralysis completed a preliminary, 51-item instrument (alpha FaCE Scale), as well as the previously developed Facial Disability Index (FDI) and the Medical Outcomes Study Short Form 36 Item Questionnaire (SF-36). Two weeks after completing these instruments, 76 patients again completed the alpha FaCE Scale. Forty-one of the patients were also evaluated using the House-Brackmann Grading System (HBGS) and the Facial Grading System (FGS). RESULTS: Exploratory principal component factor analysis grouped 15 FaCE Scale items into 6 impairment and disability categories (domains), forming the beta FaCE Scale. Overall, the test-retest reliability of the FaCE Scale was high (Spearman's correlation coefficient (r) = 0.88, P <.01), as were the reliability coefficients of the individual domains (r = 0.81-0.92, P <.01). The FaCE Scale domains showed appropriate correlation to global visual analogue scale questions posed on the original alpha FaCE Scale (r = 0.65-0.81, P <.01). Overall, the FaCE Scale showed significant correlation with HBGS and FGS scores (r = -0.55 and 0.57, respectively; P <.01). However, not all FaCE Scale domains correlated with the HBGS and FGS scores. CONCLUSIONS: A reliable and valid patient-based system to measure impairment and disability in facial paralysis has been developed. This system appears to be better than traditional, physician-graded scales for evaluating quality-of-life issues affected by facial disability.

Acute temporal bone trauma: utility of high-resolution computed tomography.

OBJECTIVE: To determine the clinical utility of high-resolution computed tomography (HRCT) for temporal bone trauma evaluation and management. STUDY DESIGN: Retrospective review. SETTING: Level I trauma center. PATIENTS: Patients (n = 105) with evidence of temporal bone trauma. MAIN OUTCOME MEASURES: Statistically significant associations between HRCT, clinical, audiometric, and head CT findings, and management decisions; role of HRCT in management decisions. RESULTS: Statistical analysis demonstrated poor association between specific clinical and HRCT findings, and between HRCT findings and management decisions. The HRCT complemented decision making in 10% of cases and revealed asymptomatic carotid canal fractures in 9% of cases. CONCLUSION: Routine HRCT yields minimal clinical utility. Selective use of HRCT may complement decision making, but patient management is predominantly influenced by other factors. Although angiography was performed in cases of asymptomatic carotid canal fractures, no clinical utility for this practice was demonstrated. An algorithm for temporal bone trauma evaluation and management is presented.

A multicenter, investigator-blinded, randomized comparison of oral levofloxacin and oral clarithromycin in the treatment of acute bacterial sinusitis.

A multicenter, investigator-blinded, randomized, parallel-group study was conducted to compare oral levofloxacin 500 mg once/day for 14 days with clarithromycin 500 mg twice/day for 14 days in the treatment of acute bacterial sinusitis. Of 216 adult outpatients randomized to treatment, 190 were evaluable for efficacy. The primary efficacy measure was clinical response, based on resolution of signs and symptoms 2-5 days after therapy. A secondary efficacy measure was relapse rate 1 month after therapy. Among evaluable patients, clinical success rates (cured or improved) were 96.0% and 93.3% for levofloxacin (L) and clarithromycin (C), respectively (95% CI -9.2%, 3.7%). The confidence interval (CI) for treatment difference (C-L) included zero and its upper limit was less than 15%, indicating that levofloxacin was as effective as clarithromycin. In all, 4.1% of patients receiving levofloxacin and 7.2% receiving clarithromycin had a relapse of symptoms 1 month after therapy (95% CI-12.2%, 3.2%). Long-term success (initial success, absence of relapse at 1 month, no further antibacterial therapy 2-5 days after therapy) was 79.2% in the levofloxacin group and 76.4% in the clarithromycin group (95% CI -14.7%, 9.0%). Based on investigator-assessed treatment-emergent adverse events, overall tolerability of the drugs was similar, except for a higher frequency of taste perversion and diarrhea in the clarithromycin group. Levofloxacin had an advantage over clarithromycin based on two quality-of-life (QOL) parameters: number of times taking other drugs for targeted medical conditions and mean total cost of these drugs. No statistical significance was found in other QOL variables. These findings suggest that the efficacy and tolerability of levofloxacin 500 mg once/day are comparable with those of clarithromycin 500 mg twice/day in the treatment of acute bacterial sinusitis.

Ofloxacin versus standard therapy in treatment of community-acquired pneumonia requiring hospitalization. Pneumonia Study Group.

Community-acquired pneumonia occurs 3 to 4 million times per year in the United States, accounting for about 500,000 hospitalizations annually. Empiric treatment is usually instituted because of a lack of early organism-specific diagnostic tests. This study compared empiric therapy with ofloxacin to standard antibiotic regimens (usually a beta-lactam with or without a macrolide) for patients hospitalized for community-acquired pneumonia. Therapy was administered to 298 patients (146 receiving ofloxacin and 152 receiving standard therapy); 227 patients (ofloxacin, 109; standard treatment, 118) were evaluable for treatment efficacy. The most common pyogenic respiratory pathogens were Haemophilus influenzae (30 isolates) and Streptococcus pneumoniae (24 isolates). There was evidence of infection with either Mycoplasma pneumoniae (38 patients), Chlamydia pneumoniae (40 patients), or a Legionella sp. (8 patients) in a total of 79 patients (35%). The clinical success rates were similar in both groups among evaluable patients (92%, ofloxacin; 87%, standard therapy) and among patients with atypical respiratory pathogens (88%, ofloxacin; 81%, standard therapy). The mean numbers (+/- the standard deviations) of intravenous doses of antibiotics were 7.5 +/- 8.0 in the ofloxacin group and 18.4 +/- 18.5 in the standard therapy group (P < 0.001); the mean number of oral doses of ofloxacin per patient was 19.7 +/- 11.2, compared with 30.2 +/- 16.0 oral antibiotic doses in the standard therapy group (P < 0.001). All treatments were well tolerated and associated with no significant clinical or laboratory abnormalities. The findings of this study indicate that ofloxacin is active against traditional bacterial pathogens as well as the major atypical respiratory pathogens. When given as monotherapy for the empiric treatment of community-acquired pneumonia, ofloxacin is as effective as standard antimicrobial therapy.

Firearm violence in California. Information and ideas for creating change.

Homicides have been on the rise in California in recent years, almost entirely as a result of increased firearm activity, resulting in one of the highest homicide rates in the country. With increasing morbidity and mortality from guns, health care professionals have called the situation an epidemic. In the past decade, attention from the health care profession has resulted in a new focus on the public health issues surrounding firearms. There is considerable confusion among policy makers regarding what should be done to stem firearm violence. I discuss morbidity and mortality trends, academic research, and legal issues surrounding firearm violence, affording insight into the seriousness and complexity of this rapidly growing problem and providing policy ideas for addressing the role of firearms. Such policy ideas include removal of the California Legislature's preemptive authority on firearms licensing and registration; the formation of an information and advisory body within the California Department of Health; increased liability for manufacturers, distributors, dealers, and owners; and a statewide registration system.

Malignant eccrine neoplasms of the foot.

Eccrine cancers are uncommon, but potentially recurrent, metastatic and fatal. Rarely, they are primary foot lesions. The literature records 46 foot cases, with age and sex given for 41. Various eccrine cancer types (most on the sole), affected all races, males predominating. Average age at diagnosis was approximately 55. A podiatric facility recorded eight cases among approximately 30,000 skin biopsies, during 15 years. Seven arose in women. Five arose in the great toe area. Three are porocarcinomas. Five are "adenocarcinomas" varying in degree of differentiation. None of the eight patients presented recurrence or metastasis during follow-up 0.5-13.4 years. Of the combined 49 literature and podiatric cases, 28 (57.1%) arose in men, mostly between ages 41 and 70. Most were slow growing, long standing, and mildly symptomatic. No clinical features distinguished eccrine cancers from other pedal tumors.

A case of Weil's disease requiring steroid therapy for thrombocytopenia and bleeding.

A young New Hampshire man was recently treated for severe Weil's disease caused by serologically diagnosed Leptospira icterohemorrhagiae. In addition to severe renal failure and hepatic disease, his case featured marked thrombocytopenia with multiple evidences of bleeding. A course of steroid therapy was associated with improved platelet counts and amelioration of his hemorrhagic diathesis.

The impact of recent changes in therapeutic abortion laws.

PIP: This report summarizes the current status of abortion legislation as of January 1, 1971. Data are presented from several sources to characterize the population receiving abortion services in terms of age, race, marital status, and indications for pregnancy termination. A special section details the abortion scene in New York City, especially insofar as it pertains to the availability of abortion services to out-of state women. Certain conclusions are drawn. The practice of legal abortion is increasing dramatically. From January to June 1970, there were 34,143 abortions in 9 selected states. It was estimated that no more than 8000 legal abortions per year were done as recently as 1965. It is apparent that the status of a given law regulating the performance of abortions does not necessarily dictate the actual number performed. While it is true that the complexity or liberalism of the worded law may be instrumental in guiding physicians to the greater performance of legal abortions, it is just as clear that the intention of the practicing physician or hospital to comply with the spirit of the law may, in fact, be more critical. A disproportionate number of abortions reported as a given statewide experience are still being done by a limited number of institutions in that state. States like California and Oregon are defined as "liberal performance states". They do more abortions for mental health indications and more abortions on women who are young and unmarried. Based on the abortion data in this report, it is obvious that race-specific abortion ratios do not correspond to race-specific live birth rates. In Jefferson County, Alabama, and in the State of California, black women have obtained hospital abortions at a rate nearly equal to that of white women, but in Georgia and South Carolina, there is a lower abortion ratio among black women than among white women. It has yet to be determined if this variability is the result of a negative patient attitude or a policy of willful or accidental physical and hospital discrimination. New York City is now providing abortion services for the entire country. The highly significant rise in the citywide abortion ratio between prelaw 1968 and the first postlaw reporting period of 1970 was almost 4 times greater for private than for ward patients. A large influx of out-of-state women was documented and may help to account for this disparity in current abortion ratios. It is concluded that there is an unmet need for more accessible abortion services in these women's home states.^ieng