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Prospective, randomized, double-blind study of prophylactic antibiotics in axillary lymph node dissection.

BACKGROUND: Antibiotic prophylaxis is controversial in patients undergoing axillary lymph node dissection (ALND). We determined whether preoperative antibiotics decreased incidence or treatment cost of infectious complications following ALND. METHODS: Two hundred patients entered this prospective, randomized, double-blind trial. Patients received either placebo or cefonicid preoperatively. Loco-regional signs of infection were monitored for 4 weeks postoperatively. RESULTS: There was a trend toward fewer infections in the prophylactic group (placebo 13% versus cefonicid 6%; P = 0.080). Cefonicid significantly decreased severe infections requiring hospitalization (placebo 8% versus cefonicid 1%; P = 0.033). Cefonicid also decreased the treatment cost of infection per patient ($49.80 versus $364.87). CONCLUSIONS: We demonstrated a trend toward fewer overall infections and significantly fewer severe infections in patients given prophylactic antibiotics, which translated into a decrease in the cost of treatment for infectious complications. These findings support antibiotic prophylaxis for patients undergoing ALND.

Adult↗

In-vitro interaction of cephalosporin and the immune system.

In this study we have evaluated the effects of an antibiotic, such as cefonicid, on some immune reactivities in vitro. The following immune parameters have been analyzed: i) interferon-gamma and interleukin-2 production and ii) lymphocyte proliferation following mitogen stimulation in the presence of cefonicid concentrations ranging from 50 to 500 microg/ml. No. decrease in lymphokine production in the presence of cefonicid concentrations up to 250 microg/ml was observed between untreated or antibiotic-treated lymphocyte cultures. When lymphocyte proliferation upon Con A stimulation, as evaluated by 3H-dHtd incorporation, was measured in the presence of cefonicid, no differences were observed with untreated controls. These results demonstrate that the in vitro interaction of cefonicid with the immune system does not lead to a decrease of the immune response.

Cefonicid↗

Influencing prescribing behavior by adapting computerized order-entry pathways.

A program is described in which informational text was inserted into a computerized drug order-entry pathway to alter prescribing patterns and contain costs. In April 1986 the pharmacy and therapeutics committee at a 700-bed teaching hospital recommended that cefonicid be used instead of cefuroxime to treat adult patients with community-acquired pneumonia in which infection with Haemophilus influenzae or gram-negative enteric rods was suspected; substantial cost savings were projected. A paragraph recommending cefonicid was inserted into the cefuroxime order-entry screen in November 1986. In February 1987 the screen was further modified to allow the physician to select the cefonicid alternative without returning to the drug index. A final change was made in November 1987 to allow the physician to select ampicillin or erythromycin directly from the cefuroxime screen as well. The cost and relative use of cefonicid and cefuroxime were examined in specific patients with pneumonia--those assigned to diagnosis-related group 89--for whom either drug was prescribed. From January 1986 to December 1987, the percentage of these patients who were prescribed cefuroxime decreased from 100% to 22%, while the percentage of patients receiving cefonicid increased from 0% to 78%. The average acquisition cost of the two antibiotics per patient decreased from $123 to $48. Although other variables may have affected prescribing patterns and this method of drug therapy intervention has some disadvantages, such as the need for physician cooperation, the concept warrants further attention. Adaptation of computerized order-entry pathways may increase the ability of pharmacy to influence prescribing behavior and control costs.

Cefonicid↗

In vitro activity of second and third generation cephalosporins against ampicillin susceptible and resistant haemophilus influenzae.

One hundred seventy-five clinical isolates of Haemophilus influenzae (including 74 beta-lactamase-producing strains) were examined for susceptibility to ampicillin, cefonicid, cefamandole, cefuroxime and cefotaxime. Cefonicid and cefamandole exhibited similar activity against ampicillin-susceptible strains (MIC90 = 0.2 mg/l for both antibiotics); cefuroxime was slightly less active (MIC90 = 0.01 mg/l). However, cefonicid, cefuroxime and cefotaxime were all more active against beta-lactamase-producing H. influenzae than cefamandole (MIC90 = 1.0 mg/l for cefonicid, MIC90 = 2.0 mg/l for cefuroxime, MIC90 = 0.01 mg/l for cefotaxime, MIC90 = 5.0 mg/l for cefamandole). One hundred twenty-five of the 175 isolates were also tested for susceptibility to cefonicid and cefamandole by disc diffusion technique and a plot of zone diameter vs. MIC was analyzed for the beta-lactamase-producing strains.

Ampicillin↗

Comparison of single-dose antibiotic prophylaxis in uncomplicated transurethral resection of the prostate.

We evaluated the necessity for antibiotic prophylaxis in uncomplicated transurethral resection of the prostate. A total of 107 patients was entered into a double-blind, prospective, placebo-controlled, randomized trial. Only 7 patients were excluded because they had positive preoperative urine cultures. All patients received a single dose of either 1 gm. cefonicid or saline placebo intramuscularly before surgery. No further antibiotics were administered. Urine cultures were obtained intraoperatively, daily while hospitalized, and at 2 and 4 weeks postoperatively. A growth of 10(4) organisms constituted a positive urine culture. Postoperative infection rates were statistically significant with 12% (6 of 51) in the cefonicid group and 37% (18 of 49) in the placebo group (p = 0.003). During the initial 2 days postoperatively there were no infections in the cefonicid treated patients as opposed to 8 in the placebo group (p = 0.003). Our study demonstrated the need for antibiotic prophylaxis to prevent infection after uncomplicated transurethral resection of the prostate. This can be accomplished by using a single dose, broad-spectrum cephalosporin (cefonicid). This procedure simplifies the implementation and decreases the cost of prophylaxis for transurethral resection of the prostate.

Aged↗

Perioperative antibiotic prophylaxis for herniorrhaphy and breast surgery.

We assessed the efficacy of perioperative antibiotic prophylaxis for surgery in a randomized, double-blind trial of 1218 patients undergoing herniorrhaphy or surgery involving the breast, including excision of a breast mass, mastectomy, reduction mammoplasty, and axillary-node dissection. The prophylactic regimen was a single dose of cefonicid (1 g intravenously) administered approximately half an hour before surgery. The patients were followed up for four to six weeks after surgery. Blinding was maintained until the last patient completed the follow-up and all diagnoses of infection had been made. The patients who received prophylaxis had 48 percent fewer probable or definite infections than those who did not (Mantel-Haenszel risk ratio, 0.52; 95 percent confidence interval, 0.32 to 0.84; P = 0.01). For patients undergoing a procedure involving the breast, infection occurred in 6.6 percent of the cefonicid recipients (20 of 303) and 12.2 percent of the placebo recipients (37 of 303); for those undergoing herniorrhaphy, infection occurred in 2.3 percent of the cefonicid recipients (7 of 301) and 4.2 percent of the placebo recipients (13 of 311). There were comparable reductions in the numbers of definite wound infections (Mantel-Haenszel risk ratio, 0.49), wounds that drained pus (risk ratio, 0.43), Staphylococcus aureus wound isolates (risk ratio, 0.49), and urinary tract infections (risk ratio, 0.40). There were also comparable reductions in the need for postoperative antibiotic therapy, non-routine visits to a physician for problems involving wound healing, incision and drainage procedures, and readmission because of problems with wound healing. We conclude that perioperative antibiotic prophylaxis with cefonicid is useful for herniorrhaphy and certain types of breast surgery.

Bacterial Infections↗

Comparison of once-daily cephalosporin regimens for community-acquired lower respiratory tract infections in patients with chronic lung disease.

The efficacy of cefonicid and of ceftriaxone, administered once daily for the treatment of lower respiratory tract bacterial infections (pneumonia or bronchitis), was evaluated and compared in 118 patients with chronic lung disease. The patients were randomly assigned to receive 1 gm of either drug, intravenously or intramuscularly, daily for three to 11 days (mean, seven days). Pathogenic bacteria were isolated from sputum in 59% of patients; Haemophilus influenzae and Streptococcus pneumoniae predominated. Clinical cure or improvement was noted in 95% and 93% of patients treated with cefonicid and ceftriaxone, respectively, and bacteriologic cure or improvement in 69% and 81% (the differences were not significant). Side effects were infrequent and similar in the two treatment groups, except that diarrhea was more common in the ceftriaxone group (11%, versus 4.4% in the cefonicid group). It is concluded that patients with chronic lung disease who experience acute exacerbations associated with infection caused by H influenzae or S pneumoniae, or other susceptible organisms, can be effectively treated with once-daily administration of either cefonicid or ceftriaxone.

Adult↗