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Biomedical subjects

R H Rousell

Publications and source records attributed to R H Rousell.

16 recordsLinked to original sources
PubMed1991

Prospective study on the hepatitis safety of intravenous immunoglobulin, pH 4.25.

Recent reports of transmission by intravenous gamma-globulin preparations of non-A non-B hepatitis (NANBH), including several cases that progressed to severe liver damage and death, have raised concerns about the safety of intravenous gamma-globulin. However, the problem does not seem to be widespread. To assess this issue, we previously reported the results of liver function tests monitored in 41 patients with primary immunodeficiency treated with intravenous immunoglobulin (IGIV), pH 4.25 over periods ranging from 6 to 15 months. Eighteen of these patients at two of the three centers have now had serial serum glutamic pyruvic transaminase (SGPT) levels performed regularly at intervals of 1-5 weeks while continuing monthly intravenous infusions of nonmodified IGIV, pH 4.25 for an additional 14-26 months. The standard dosage was 400 mg per kg body weight IGIV, pH 4.25. Six lots of IGIV, pH 4.25 were used. Transient minor SGPT elevations were observed in 5 of the patients on a total of 8 occasions. None of the elevations was considered indicative of NANBH or of any chronic hepatic disease. All patients remained negative for hepatitis B surface antigen throughout the study.

Adult↗
PubMed1989

Anticomplementary activity and the safety of intravenous immunoglobulin.

Quality assurance release levels for anti-complementary (AC) activity of a non-modified intravenous immunoglobulin (IGIV, pH 4.25) were reviewed over a period of one year and nine months in an attempt to correlate the incidence of complement-mediated-type adverse reactions with the AC level. Over 200 lots and ten possible complement-mediated side effects were evaluated. No correlation was found. A similar evaluation was made of a prospective study in which three lots of IGIV, pH 4.25 (one with a low, one with a mid-range, and one with a high AC activity) were used; again no correlation was found. Finally, a comparison was made between the AC activity assay used to release IGIV, pH 4.25 and an alternative AC activity assay designed for a highly modified IGIV preparation. It was demonstrated that the AC activity assay designed for the modified preparation and its assay limits were unsuitable in attempting to define AC activity of the nonmodified preparation.

Complement Inactivator Proteins↗
PubMed1988

Clinical safety of intravenous immune globulin and freedom from transmission of viral disease.

Although rare, side-effects have been associated with the administration of iv immune globulins (IVIG). While the clinical presentation may be similar, several different mechanisms account for these adverse reactions. There are those effects in the hypogammaglobulinaemic patient which are probably due to antigen-antibody interaction (so-called inflammatory reactions), those due to spontaneous activation of the complement system (possibly caused by IgG aggregates), those due to true hypersensitivity (for example, hypersensitivity to IgA), and those due to possible contaminants or even stabilizers or preservatives which might have been used. The incidence and nature of clinical side-effects seen in 37 patients who were treated with a native IVIG is shown. In addition, data are provided which support the absence of transmission of human immune deficiency virus in idiopathic thrombocytopenia (ITP) patients, and the agents of non-A, non-B hepatitis in 41 immune-deficient patients having periods of follow-up ranging up to 18 months. Finally, evidence of the inactivation of human immunodeficiency virus during the manufacturing procedure is provided.

Antibodies, Viral↗
PubMed1988

Non-A non-B hepatitis and the safety of intravenous immune globulin, pH 4.2: a retrospective survey. Preliminary communication.

Evidence for transmission of non-A non-B hepatitis (NANB) was sought in 41 patients with primary immune deficiency who were receiving human intravenous immune globulin (IGIV) over periods ranging from 6 to 15 months at a monthly dosage of 400 mg/kg body weight. One lot of a reduced and alkylated IGIV and three lots of a nonmodified preparation stabilized at pH 4.2 were used. No evidence of NANB was found, although transient elevations in serum glutamic pyruvic transaminase (alanine aminotransferase) were found in 6 of the patients. The possible causes of the elevated levels in these 6 patients are discussed.

Adolescent↗
PubMed1987

A new intravenous immunoglobulin in adult and childhood idiopathic thrombocytopenic purpura: a review.

This is a review of the work leading to the generalized use of intravenous immunoglobulins (IVIgG) in the treatment of idiopathic thrombocytopenic purpura. Much of the work performed using a reduced and alkylated IVIgG is discussed. Finally, preliminary data on the results being achieved with a new non-modified IVIgG in idiopathic thrombocytopenic purpura (ITP) is dealt with in two studies involving a total of 42 patients.

Adult↗
PubMed1984

Antibody levels in reduced/alkylated intravenous immune globulin.

Antibody titers, found in representative lots of a reduced and alkylated intravenous immune globulin, against a variety of common microorganisms are presented. With the more frequently occurring pathogens the specific antibody level does not vary significantly between lots. Depending upon the type of assay used, antibody titers per se may or may not reflect the therapeutic activity of the preparation against a specific microorganism.

Antibodies↗
PubMed1984

Comparison of high-dose and low-dose intravenous immunoglobulin therapy in patients with primary immunodeficiency diseases.

To assess safety and efficacy of high-dose intravenous immunoglobulin therapy in patients with primary immunodeficiency syndromes we treated a group of 19 patients with a monthly dose of 400 mg/kg of reduced and alkylated, maltose-containing immunoglobulin (Gamimune, Cutter Biological, Berkeley, California) and compared their responses with a group of 16 patients receiving 100 mg/kg per month intravenously. Side effects observed were mild to moderately severe and similar in both groups. In one adult patient receiving the high dose a severe enough reaction developed during the first infusion to exclude her from the study. Serum IgG levels of patients receiving high-dose immunoglobulin showed a stepwise increase in both trough and peak values until a new plateau was reached after four to six infusions. None of the patients receiving the low dose showed such a stepwise increase. On average, serum IgG levels rose by approximately 250 mg/dl for each 100 mg/kg immunoglobulin infused. The mean catabolic rate of the infused IgG was estimated to be 26 days in patients receiving high-dose immunoglobulin infusions. We demonstrated that 400 mg/kg immunoglobulin given intravenously every four weeks to patients with immunodeficiency results in a substantial increase in serum IgG during the postinfusion period, suggesting persistence of specific antibody throughout the interval between infusions.

Adult↗
PubMed1980

Safety and patient acceptability of intravenous immune globulin in 10% maltose.

The safety and patient acceptance of two preparations of modified (reduced and alkylated) immune globulin for intravenous use were evaluated; one preparation was formulated as a 5% solution in 10% maltose (IGIV-maltose), the other did not contain maltose (IGIV). In this double-blind trial each of 29 immunodeficient patients received three consecutive monthly infusions (100 or 150 mg/kg immune globulin) of one preparation before being crossed over to the other. Only 3 of 29 patients had adverse reactions when on IGIV-maltose, compared with 22 who had side-effects during infusions of IGIV (p < 0.001). Adverse reactions were recorded during 3 of 87 IGIV-maltose infusions and during 51 infusions with the maltose-free IGIV (p < 0.001). 27 patients expressed preference for IGIV-maltose. IGIV-maltose seems safe and will permit rapid infusion of large doses of immune globulin, thus improving the management of patients with antibody deficiency diseases.

Clinical Trials as Topic↗
PubMed1976

Streptokinase in acute myocardial infarction: a controlled multicentre study in the United Kingdom.

In a multicentre trial of streptokinase in acute myocardial infarction 302 patients received an intravenous infusion of 2 500 000 IU of streptokinase over 24 hours, while 293 patients served as controls. Neither group received anticoagulants unless indicated by thromboembolic complications. No significant difference in mortality was evident during inpatient treatment nor at six-week or six-month follow-up. The inpatient death rate was 12-6% in the streptokinase group and 13-7% among controls. There was no significant difference in the peak levels or pattern of enzyme increase. The incidence of cardiac failure and reinfarction was similar in the two groups, but major arrhythmias were less common in those on streptokinase (P less than 0-05). In the streptokinase group there were 36 minor and six more serious haemorrhagic complications. Gastrointestinal haemorrhage may have contributed to the death of one patient in each group. There were 18 thromboembolic complications in the streptokinase group and 38 among the controls. Pathological examination of the hearts of 25 patients who had taken streptokinase and 24 controls showed no striking differences between the groups, but haemorrhagic infarcts were found in three patients who had received streptokinase. An infusion of streptokinase within 24 hours of the onset of acute myocardial infarction does not significantly affect the mortality or course of the illness up to six months.

Aged↗
PubMedDate not supplied

The pharmacology of a new pasteurized antihemophilic factor concentrate derived from human blood plasma.

The pharmacology of a new pasteurized factor VIII (FVIII) concentrate derived from human blood plasma was studied in 23 adults with hemophilia A. In Part 1 of the study involving six nonbleeding subjects, the mean increase in FVIII activity was 1.43 +/- 0.34 U per ml 10 minutes after an intravenous dose of 50 U per kg. The intravascular survival kinetics in these six patients showed a biphasic decay curve with an initial mean half-life of 5.1 +/- 1.2 hours probably representing early redistribution, and a late half-life of 13.3 +/- 4.9 hours. In Part 2 of the study, the activity at 10 minutes was measured in another 17 patients, as well as in one patient already studied in Part 1. The mean increase in activity with the 24 observations was 1.13 +/- 0.37 U per ml with a mean FVIII dosage of 51.0 +/- 2.6 U per kg of body weight. Only one patient had an allergic reaction, which did not recur when the patient was given a second lot.

Adult↗
PubMedDate not supplied

Determination of serum progesterone levels using a direct 125I-radioimmunoassay.

A new conventional simple and direct 125I-radioimmunoassay (RIA) for serum progesterone is described. In comparison with the classical tritiated assays which are preceded by extraction, the assay is more simple, less time-consuming, less subject to error and hence less expensive. In normal cycling females the serum progesterone range during the follicular phase was 0.9 to 5.5 ng/ml (mean 2.5 ng/ml). Levels above 12 ng/ml occurring during the luteal phase are indicative of adequate luteal function. The actual progesterone levels assayed with this method are significantly greater than those found using the classical tritiated technique, and the reasons for this discrepancy are discussed. The assay is also capable of being used to assess the response to treatment for infertility, thus indicating that, in spite of the higher values obtained, there is no impairment in diagnostic sensitivity.

Female↗