Freeze-dried human plasma rich in anti-lipopolysaccharide (anti-LPS) immunoglobulin G was used to treat septic shock (systolic pressure less than or equal to 80 mm Hg, central venous pressure greater than or equal to 6 cm H2O) in obstetric and gynaecological patients. Mortality in conventionally treated patients was 9/19 (47.4%) compared with 1/14 (7.1%) in anti-LPS-treated patients. Anti-LPS caused the mean arterial pressure to rise from 45.1 +/- 7.36 mm Hg to 69.1 +/- 9.07 mm Hg within 75 min of administration. The mean hospital stay of survivors was 28.1 days for controls and 14.2 days for the anti-LPS-treated patients. The development of complications of septic shock was much reduced in the treated group. Anti-LPS thus appears significantly to reduce mortality and morbidity in septicaemia.

A randomised, double-blind, placebo-controlled trial was conducted to evaluate the ability of RIT 4237 live attenuated bovine rotavirus (subgroup 1) vaccine strain to protect against natural rotavirus infection in children. 178 infants aged 8 to 11 months received a single oral dose of RIT 4237 vaccine or placebo and were followed up serologically and clinically during a subgroup 2 rotavirus epidemic. No side-effects attributable to the vaccine were observed. During the 5 months' observation after vaccination 2 of the 86 vaccine recipients and 18 of 92 placebo recipients had rotavirus diarrhoea lasting more than 24 h (p less than 0.001). The vaccine-protection rate was thus 88%. The 2 children in the vaccine group with rotavirus diarrhoea were regarded as primary vaccine failures since they had no detectable serum antibody responses after vaccination. Vaccine prepared from RIT 4237 strain of attenuated bovine rotavirus thus seems to protect children against heterologous subgroup 2 rotavirus diarrhoea.

Newborn infants of Chinese HBeAg-carrier mothers in Hong Kong were randomly assigned to one of four study groups. Group I was treated with 3 micrograms heat-inactivated hepatitis B (HB) vaccine at birth and at 1, 2, and 6 months thereafter, in conjunction with seven monthly HBIg injections; group II was treated according to the same vaccine schedule but received only one HBIg injection at birth; group III received only the vaccine, at months 0, 1, 2, and 6; and group IV received placebos for both vaccine and HBIg. The first set of injections was given within 1 h after birth. Comparisons were made in the 140 children who were at least six months old at the close of the trial (495 days). In all three treatment groups development of the persistent carrier state was significantly (p less than or equal to 0.0001) less frequent than in controls (2.9%, 6.8%, and 21.0% versus 73.2%). Although vaccination alone was significantly less protective than vaccination plus multiple HBIg injections (p = 0.03), the degree of protection was still remarkable. 12 months after the first set of injections 96-100% of the infants in the three treatment groups were anti-HBs positive; the geometric mean titres of anti-HBs in the three groups did not differ significantly. This indicates that even high doses of HBIg do not interfere with the anti-HBs response to the vaccine. Probable intra-uterine HB infections were observed in 3 infants. No serious side-effects were observed from the interventions, even in the babies with intra-uterine infections who had received HBIg and HB-vaccine at birth. To prevent development of the persistent HBsAg carrier state, and thereby the consequent chronic liver disease and/or primary carcinoma of the liver, HB vaccine and HBIg should be administered as soon as possible after birth to all newborn infants at risk of perinatal hepatitis B infection.

Terminally ill cancer patients at a Veterans Administration hospital were randomly assigned to receive hospice or conventional care. The hospice care was provided both in a special inpatient unit and at home. 137 hospice patients and 110 control patients and their familial care givers (FCGs) were followed until the patient's death. No significant differences were noted between the patient groups in measures of pain, symptoms, activities of daily living, or affect. Hospice patients expressed more satisfaction with the care they received; and hospice patients' FCGs showed somewhat more satisfaction and less anxiety than did those of controls. Hospice care was not associated with a reduced use of hospital inpatient days or therapeutic procedures and was at least as expensive as conventional care.

A randomised controlled trial of exchange versus no exchange was conducted to find out whether plasma exchange would be useful in acute inflammatory polyradiculoneuropathy. It was calculated that 15 patients would be required in each group to demonstrate a worthwhile improvement in functional ability 1 month after completion of treatment. Treatment comprised five exchanges in 10 days (55 ml plasma/kg body weight/exchange). Both groups received normal supportive care and were followed up periodically for a year. Overall the treated group showed a slight but not significant benefit (p greater than 0.05); at two weeks' follow-up of patients admitted to the trial within 14 days of onset of neuropathic symptoms, p = 0.07. These results do not provide grounds for recommending plasma exchange for the treatment of severe AIP.

Neutralising antibody responses to six post-exposure regimens of human diploid cell strain rabies vaccine with or without human rabies immune globulin (HRIG) were studied in 98 patients. The total amount of vaccine used was 22-34% of that required by conventional regimens. Vaccine was given at multiple sites intradermally or subcutaneously with or without adjuvant. Antibody was detectable within 7 days of the first dose in all subjects only in the groups given 0.1 ml intradermally at 8 sites. From day 14 onwards all groups showed an excellent antibody response; there was little difference between the various regimens. Suppression of the response to 8-site intradermal vaccination by a large dose of HRIG could be prevented by giving the second dose of vaccine on day 7 rather than day 14.

In a randomised, coordinated six-centre study 163 patients with serious systemic infections received treatment with either imipenem (N-formimidoyl thienamycin) plus cilastatin, an inhibitor of its renal metabolism (77, I/C group) or gentamicin and clindamycin (86, G/C group); 56 and 62, respectively, were evaluable. Significantly more G/C than I/C patients failed to respond to treatment (9 vs 2) and 1 G/C patient died of infection. The frequency of elimination of causative pathogens was higher in the I/C group (88% vs 77%). Clinical and biochemical adverse reactions were less common in the I/C than the G/C group. Treatment had to be discontinued because of adverse reactions in 3 I/C patients and in 7 G/C patients. Clinical superinfections were noted in 1 I/C and in 2 G/C patients. Thrombophlebitis was significantly more common in the I/C group. In terms of clinical and bacteriological efficacy and safety, the I/C combination was superior to gentamicin/clindamycin.

A 10-year study of the management of rheumatoid arthritis was conducted to compare a programme consisting of rest and anti-inflammatory and antirheumatic drugs with one consisting of maintenance of activity, anti-inflammatory and antirheumatic drugs, and systemic steroids where necessary. During this period subjects who did not respond to the treatment allocated went on to a combined treatment programme of rest, anti-inflammatory and antirheumatic drugs, and steroids. Among those who remained in the trial for the 10 years, there was little difference between the two groups in morning stiffness, number of inflamed joints, functional capacity, grip strength, number of American Rheumatism Association criteria present, and whether they remained on their original treatment programme or switched to the combined programme. However, in those who started in the steroid group, the condition of several joints tended to be better clinically and radiologically than in those of the other group during and at the end of 10 years of the original treatment programme, at time of transfer to the combined programme, and at the completion of the combined programme. Both groups had as many complications of disease and treatment, and adverse effects attributable to steroids seemed to be restricted to those with severe disease who had not responded to their original programme. A policy of maintaining physical activity plus the judicious use of steroids where required produces, in the long term, results as good as or probably better than a regimen of bed rest and no steroids.

To determine whether moderate restriction of dietary sodium content or supplementation of potassium intake reduces blood-pressure in patients with mild essential hypertension, twelve patients were put on three different diets--a control diet (180 mmol sodium/day), a sodium restricted diet (80 mmol/day). Each diet was taken for at least 4 weeks and the sequence of the regimens was randomised. At the completion of each regimen intra-arterial pressure was recorded continuously, and vasoactive hormones were measured hourly, for 24 h, under standardised conditions, in hospital. Compared with the control diet, sodium restriction was associated with lower blood-pressure readings in seven patients, higher levels in five, and an overall reduction in mean pressures of only 4.0/3.0 mm Hg (not significant). Individual differences in blood-pressure between these two diets correlated closely with concomitant differences in plasma renin activity (r = 0.75). Potassium supplementation also resulted in variable changes in arterial pressure, and the mean difference in pressure recordings (0.1/0.8 mm Hg) was insignificant. The results show that moderate restriction of sodium intake or supplementation of dietary potassium has variable effects on arterial pressure in individuals with mild essential hypertension, and that overall the blood-pressure changes induced are very small. Responsiveness of the renin-angiotensin system may limit the fall in blood-pressure induced by sodium restriction.

The efficacy of live attenuated cold-adapted (ca) reassortant influenza virus vaccine against experimental challenge with homologous wild-type virus 5 to 8 weeks after vaccination was compared with that of licensed inactivated vaccine in 81 seronegative (haemagglutination-inhibition antibody titre less than or equal to 1:8) college students. At a dose of 10(7.5) 50% tissue culture infectious dose (TCID50) (70 HID50, human 50% infectious doses) the live virus vaccine, given intranasally, completely protected against illness caused by wild-type virus, whereas the inactivated vaccine, administered intramuscularly, provided 72% protection. Wild-type virus was recovered from only 13% of live virus vaccinees (10(7.5) TCID50 dose of ca virus) compared with 63% of inactivated virus vaccinees and the few infected live virus vaccinees shed 1000 times less wild-type virus than did infected inactivated virus vaccinees or unvaccinated controls. This striking reduction in virus shedding suggests that influenza transmission may be more efficiently interrupted with live than with inactivated virus vaccination.

The value of pulsed electromagnetic fields (PEMF) for the treatment of persistent rotator cuff tendinitis was tested in a double-blind controlled study in 29 patients whose symptoms were refractory to steroid injection and other conventional conservative measures. The treated group (15 patients) had a significant benefit compared with the control group (14 patients) during the first 4 weeks of the study, when the control group received a placebo. In the second 4 weeks, when all patients were on active coils, no significant differences were noted between the groups. This lack of difference persisted over the third phase, when neither group received any treatment for 8 weeks. At the end of the study 19 (65%) of the 29 patients were symptomless and 5 others much improved. PEMF therapy may thus be useful in the treatment of severe and persistent rotator cuff and possibly other chronic tendon lesions.

In addition to their usual diet, 17 lactovegetarian college students consumed 400 kcal of test foods per day containing one extra-large egg for three weeks and similar isocaloric eggless foods for an additional three weeks in a randomised double-blind crossover trial. Ingestion of the egg increased dietary cholesterol from 97 to 418 mg per day. Mean plasma low density lipoprotein (LDL) cholesterol was 12% higher (p = 0.005) and mean plasma apolipoprotein B was 9% higher (p = 0.007) when eggs were being consumed than during the eggless period. Mean plasma high density lipoprotein cholesterol, apolipoproteins A-I and A-II, very low density lipoprotein cholesterol, and total triglycerides did not change significantly. Thus, ingestion of egg seems selectively to raise cholesterol and protein in LDL particles in the plasma of free-living normal people. Plasma LDL may be more sensitive to cholesterol at low intakes than at moderate to high intakes.