A phase II multicenter, double-blind, randomized, placebo-controlled study of three dosages of an immunomodulator (PGG-glucan) in high-risk surgical patients.

OBJECTIVE: To examine the safety and efficacy of multiple doses of PGG-glucan (poly-[1-6]-B-D-glucopyranosyl-[1-3]-B-D-glucopyranose) in high-risk patients undergoing major thoracic or abdominal surgery. DESIGN: An interventional, multicenter, double-blind, randomized, placebo-controlled study. SETTING: Four university-affiliated medical centers. PATIENTS: Sixty-seven high-risk patients undergoing major thoracic or abdominal surgery. INTERVENTION: Patients were randomized in a 1:1:1:1 ratio to receive saline placebo or PGG-glucan at a dose of 0.1 mg/kg, 0.5 mg/kg, and 1.0 mg/kg or 2.0 mg/kg. One dose was administered before surgery and three doses were administered after surgery. MAIN OUTCOME MEASURES: To examine the safety and efficacy of PGG-glucan infusion and to identify potentially important factors for a planned phase III study. RESULTS: A dose-response trend with regard to infection incidence among patients who received PGG-glucan was observed. Serious infections occurred in four patients who received placebo and in three patients who received PGG-glucan at a dose of 0.1 mg/kg. However, only one patient who received PGG-glucan at a high dose had a serious infection. The incidence and severity of adverse events was comparable in all groups. CONCLUSIONS: PGG-glucan was generally safe and well tolerated, may decrease postoperative infection rates, and warrants further investigation in a planned phase III trial.

Human immunodeficiency virus (HIV)-associated myopathy: immunocytochemical identification of an HIV antigen (gp 41) in muscle macrophages.

In a patient with acquired immunodeficiency disease syndrome (AIDS) and muscle weakness, a muscle biopsy specimen disclosed degeneration of muscle fibers, regeneration, and focal endomysial mononuclear inflammation. A conspicuous feature was the presence of perivascular macrophages within the endomysium that showed positive immunostaining for human immunodeficiency virus (HIV) (gp 41) antigen. HIV was not detected within myofibers. Our findings suggest an important role for the HIV-infected macrophage in the pathogenesis of this myopathy.

Comparison of the safety and efficacy of parenteral ticarcillin/clavulanate and clindamycin/gentamicin in serious intra-abdominal infections.

One hundred and twelve patients with proven or suspected serious intra-abdominal infections were randomized for treatment with either ticarcillin/clavulanate (3.1 g every 4 h) or gentamicin (dosage schedule adjusted according to serum concentrations) plus clindamycin (in most cases 900 mg every 8 h). Positive intraperitoneal and/or blood cultures were available in 47 cases. Considering only fully evaluable cases, 15/20 (75%) were clinically cured or improved in the ticarcillin/clavulanate group and 16/25 (64%) in the gentamicin/clindamycin group, the difference not being significant (P greater than 0.05). Bacteraemia was documented in nine of 45 fully evaluable cases. During the course of the study, the serum creatinine concentration increased by more than 5 mg/l in only one patient (ticarcillin/clavulanate group). Two patients (one in each group) had apparent allergic reactions. No other drug-related adverse effects were noted. In-vitro sensitivity testing of anaerobic isolates revealed that, of those tested, 5/38, 1/38 and 2/37 were resistant to ticarcillin, ticarcillin/clavulanate and clindamycin, respectively. Among aerobic Gram-negative isolates, 34/78, 6/78 and 4/78 were resistant to ticarcillin, ticarcillin/clavulanate, and gentamicin, respectively. Among aerobic Gram-positive isolates, 2/32, 2/32, and 5/14 were resistant to ticarcillin, ticarcillin/clavulanate, and clindamycin, respectively. We conclude that ticarcillin/clavulanate is a safe and efficacious preparation for treating serious intra-abdominal infections.

Viral diarrhea.

Viral diarrhea is a frequent, self-limited illness that may occur sporadically or in epidemic fashion. Nosocomial outbreaks have been reported. Rotavirus and Norwalk virus are the two most important agents causing this disease. Clinical illness is usually mild but may be quite severe in selected infants or elderly or debilitated persons. Specific diagnosis has been advanced by the use of immunoassays. Treatment is supportive, and most patients recover completely. Good hygienic measures are effective in preventing the transmission of the infection. Rotavirus vaccine trials are under way.

Iatrogenic hand injuries in outpatients.

Potentially serious iatrogenic hand injuries occurred in three patients in a general medicine practice. All resulted from technologic advances in patient care. Each resulted in substantial economic and emotional costs. One patient sustained a serious residual disability. Such injuries have rarely been reported in the past, but advances in medical technology and changes in reimbursement patterns may make outpatient iatrogenic hand injuries increasingly common. Physicians must be alert to such injuries.