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[Quality and efficacy in occupational medicine: relationship between quality, efficacy, and surveillance -- Experience of public and private facilities in Emilia Romagna].

Italian legislation concerning health and safety at work establishes minimal requirements, according to European regulations. On the other side it's compulsory for Employers to set themselves at a level "above minimal requirements" according only to technicalfeasibility. It's a duty of Control Bodies (in Italy National Health Service's Work Environment Prevention Services) to verify the respect of law's preview minimal requirements. Quality standards and application guidelines, on the contrary, require collaboration and consensus among all actors involved in the implementation of health and safety managing systems on workplaces: Control Bodies, Professional Officers (Occupational Physicians, Safety Consultants), public and private Consultant Companies working on the field of health and safety at work. In this document some Emilia Romagna Region Control Bodies guidelines are discussed, and two experiences concerning public and private Consultant Companies are presented.

Humans↗

[Efficacy of a bismuth combination preparation. Efficacy in the treatment of chronic active gastritis and non-ulcerous dyspepsia].

In an open, randomized controlled study, the effect of a combined bismuth preparation, bismuth nitrate and bismuth aluminate on the elimination of Helicobacter pylori, inflammatory activity in the gastric mucosa in chronic type B gastritis, and on the patient's symptoms was investigated. Included in the study were 36 patients with non-ulcerous dyspepsia and chronic gastritis. Twelve patients (Group A) received 4 x 1 tablet a day (800 mg total daily dose), 12 patients (Group B) 2 x 2 tablets a day (800 mg total daily dose), 12 patients (Group C) 2 x 1 tablet (400 mg total daily dose) for a period of 4 weeks. Elimination of Helicobacter pylori was observed in 73% of the patients in Group A, in 87% in Group B, but in only 16% in Group C. Inflammatory activity, measured in terms of polymorphonuclear cell infiltration, regressed noticeably in Group A und B (p less than 0.01), but not in Group C. In all patient groups symptoms regressed significantly (p less than 0.01). Bismuth and methemoglobin concentrations in the serum were within the normal range in all patients on conclusion of treatment.

Adult↗

[A study in the Ivory Coast (1985-1987) of the efficacy and tolerance of ivermectin (Mectizan) in human onchocerciasis. III. The tolerance and efficacy of a single oral dose of 150 mcg/kg in children].

One hundred and three male and female children of 6 to 14 years old with onchocerciasis, having or not ocular involvement and a mean skin microfilariae level of 36.1 mf/mg, received, in October 1986, a single oral dose of 150 mcg/kg ivermectin and controlled at day 4, 3 months, 6 months and 12 months post treatment. After the last control they were retreated with the same dose. The skin microfilariae count fell down to 94% of the initial level at day 4 and to 99% at 3 months. At 6 months the microfilariae count was 2% of the initial level and 5% at 12 months. The percentage of patients having microfilariae in the anterior chamber of the eye which was 33% before treatment fell down to 6% at 12 months. The percentage of patients having microfilariae in the cornea was 39% before treatment and 18% at 12 months. In the cornea and anterior chamber there was a very reduced number of microfilariae still present. 65% of the children had lesions of keratitis before treatment and 34% two months later. Adverse effects (fever, headache, pruritus, oedemas, myalgias, arthralgias) occurred in 64% of children after the first treatment and 50% after the second. They were of weak or moderate intensity and receded rapidly after administration of aspirin and/or anti-histaminic. The administration of ivermectin is an efficient and well tolerated drug in children above 5 years old.

Administration, Oral↗

Safety and efficacy of high-dose rhesus-human reassortant rotavirus vaccines--report of the National Multicenter Trial. United States Rotavirus Vaccine Efficacy Group.

OBJECTIVE: Rotavirus is a leading cause of morbidity and mortality from dehydrating gastroenteritis in infants and young children worldwide. Virtually every child is infected by age 4 years, justifying universal childhood immunization when a safe and effective vaccine is available. We report the results of a multicenter, placebo-controlled field trial in the United States of monovalent serotype 1 and tetravalent (TV) rhesus-human reassortant rotavirus vaccines (RRVs). DESIGN: In this randomized, double-blind trial, 1278 healthy infants ages 5 to 25 weeks received three oral doses of RRV serotype 1, RRV-TV, or a placebo at approximately 2, 4, and 6 months of age. Vaccines contained 4 x 10(5) plaque-forming units of virus. Gastroenteritis episodes were monitored, and severity was graded throughout one rotavirus season. Two stool specimens per episode were tested for rotavirus. RESULTS: The incidence of reactions did not differ among treatment groups during the 5-day, postvaccination safety surveillance period for any of the three doses. Both vaccines significantly reduced the incidence of rotavirus gastroenteritis. Vaccination was most protective against serious rotavirus illness; RRV-TV prevented 49% of rotavirus episodes, 80% of very severe episodes, and 100% of dehydrating rotavirus illness. Reduction of rotavirus disease by RRV-TV resulted in significantly fewer total episodes of gastroenteritis of all causes and an 82% reduction in all cases of dehydrating diarrhea. CONCLUSION: RRV-TV is highly protective against very severe, dehydrating rotavirus gastroenteritis.

Administration, Oral↗