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Biomedical subjects

J G SanMiguel

Publications and source records attributed to J G SanMiguel.

7 recordsLinked to original sources
PubMed1993

Primary prophylaxis for Pneumocystis carinii pneumonia: a randomized trial comparing cotrimoxazole, aerosolized pentamidine and dapsone plus pyrimethamine.

OBJECTIVE: To compare the efficacy and tolerance of monthly aerosolized pentamidine versus cotrimoxazole versus dapsone plus pyrimethamine to prevent the initial episodes of Pneumocystis carinii pneumonia (PCP) in HIV-infected patients. DESIGN: An open randomized clinical trial. PATIENTS AND METHODS: HIV-infected patients (n = 331) with CD4 cell counts < 200 x 10(6)/l or with AIDS but without a history of PCP or cerebral toxoplasmosis (CT) were randomized to receive pentamidine (300 mg every 4 weeks), cotrimoxazole (160/800 mg 3 days a week) or dapsone plus pyrimethamine (100 and 25 mg weekly). If immunoglobulin G (IgG) antibodies to Toxoplasma were present, patients in the first two groups were randomized further to 25 mg pyrimethamine per week or to no treatment. RESULTS: The mean follow-up was 313 days (range, 30-670 days). The three groups were homogeneous for age, sex, risk group for HIV infection, initial CD4 cell count and mean follow-up. PCP developed in 16 patients, with an estimated cumulative probability of 5.3% at 1 year of follow-up. The PCP rate per year of observation, using an intention-to-treat analysis, was 5.6% [95% confidence interval (CI), 0.9-10.3], 3% (95% CI, 0-6.3) and 8.3% (95% CI, 2.8-13.8) in the groups treated with pentamidine, cotrimoxazole and dapsone plus pyrimethamine, respectively (P > 0.05). Moderate or severe side-effects were observed in one patient on pentamidine, 10 on cotrimoxazole and nine on dapsone plus pyrimethamine (P < 0.05); the study drug had to be discontinued in no, 10 and six patients, respectively (P < 0.05). Neither cotrimoxazole alone nor pyrimethamine combined with dapsone or cotrimoxazole prevented initial episodes of toxoplasmosis among patients with IgG antibodies to Toxoplasma gondii. CONCLUSIONS: Low-dose thrice-weekly cotrimoxazole or weekly dapsone plus pyrimethamine was not significantly worse (differences > 15% would have been detected with 90% certainty) than monthly aerosolized pentamidine in preventing a first episode of PCP in patients at high risk, but aerosolized pentamidine was better tolerated.

AIDS-Related Opportunistic Infections↗
PubMed1987

Univariate and multivariate analyses of risk factors predisposing to auditory toxicity in patients receiving aminoglycosides.

Risk factors predisposing to auditory toxicity of aminoglycosides were analyzed from records of 187 patients enrolled in three prospective randomized trials comparing the toxicity of netilmicin, tobramycin, and amikacin. Patients were eligible if they received three or more days of therapy and at least two serial audiograms were available. The overall auditory toxicity rate was 9.6% (18 of 187). Auditory toxicity was detected in 4.4, 10.8, and 23.5% of patients given netilmicin, tobramycin, and amikacin, respectively (P = 0.05). In the univariate analysis, patients who developed auditory toxicity were significantly older (P = 0.01) and had a significantly higher (P = 0.04) percentage of trough levels of netilmicin or tobramycin above 2 mg/liter or amikacin above 5 mg/liter. In the final logistic regression model, only age was retained as independently influencing the development of auditory toxicity (P less than 0.00001). Conversely, factors that did not add significantly to the prediction of auditory toxicity were aminoglycoside serum levels, total aminoglycoside dose, duration of therapy, sex, peak temperature, presence of bacteremia, shock, liver cirrhosis, dehydration, previous otic pathology or renal failure, and development of renal toxicity. At least in certain populations, age is the most important predisposing factor for the development of auditory toxicity in patients receiving aminoglycosides.

Amikacin↗
PubMed1987

Perioperative cefamandole prophylaxis against infections.

Seven hundred and seventeen patients were included in a prospective randomized double-blind trial comparing the efficacy of five doses of cefamandole (group I, 335 patients) with that of a single preoperative dose (group II, 382 patients) for prophylaxis against sepsis in patients who had an operation using either a Moore prosthesis, Ender or Küntscher nails, a bone plate, or another internal-fixation device. Patients who had an open fracture or total joint replacement were not included in the study. The two groups were similar in terms of mean age, sex ratio, duration of preoperative hospital stay, underlying risk factors, and type of surgical procedure. A wound infection developed in none of the seventy-four patients in group I and in five (6.6 per cent) of the seventy-six in group II (p = 0.03) who required a Moore prosthesis. A wound infection developed in three patients (1 per cent) in group I and in fifteen (5 per cent) in group II (p = 0.006) who required an internal fixation device other than a Moore prosthesis. Staphylococcus aureus, Staphylococcus epidermidis, and gram-negative bacilli were the most common infecting organisms. The rate of mortality was similar in both groups, while the percentage of postoperative urinary-tract infections was lower in group I (p = 0.04). No adverse side effects of the drug were encountered.

Adult↗
PubMed1985

Tobramycin and amikacin nephrotoxicity. Value of serum creatinine versus urinary concentration of beta-2-microglobulin.

108 patients who received tobramycin or amikacin could be evaluated for nephrotoxicity in a prospective randomized trial. Both groups had similar illnesses, and causative agents, concurrent drug administration, ages, sex ratios, initial serum creatinine and aminoglycoside levels and total dose and duration of therapy. Using urinary concentration of beta 2 microglobulin (beta 2m) as a marker, nephrotoxicity was detected in 13 (22.4%) of 58 patients given tobramycin and 13 (26%) of 50 given amikacin (n.s.). Using serum creatinine as a marker, nephrotoxicity was detected in 3 (5.2%) of 58 patients given tobramycin and in 7 (14%) of 50 given amikacin (n.s.). The whole group of 108 patients was used to compare the usefulness of serum creatinine levels versus urinary concentration of beta 2m. An elevation of serum creatinine was detected in 10 of 108 patients (9.3%). In 5 of these 10 patients the beta 2m remained normal, suggesting a functional renal failure. In 21 of the 108 patients (19.4%) the beta 2m increased while the serum creatinine remained normal, suggesting an aminoglycoside nephrotoxicity which would have remained undetected if only serum creatinine had been measured. In the remaining patients (77 of the 108; 71.3%) serum creatinine and urinary concentration of beta 2m both remained normal throughout the treatment. In conclusion no statistically significant differences were found between tobramycin and amikacin nephrotoxicity. Urinary beta 2m is more sensitive than serum creatinine and furthermore it allows one to differentiate aminoglycoside nephrotoxicity from functional renal failure.

Adult↗
PubMed1984

Prospective randomized double-blind comparison of nephrotoxicity and auditory toxicity of tobramycin and netilmicin.

Netilmicin or tobramycin was administered to 197 patients in a prospective randomized double-blind trial. Of these patients, 140 recipients of nine or more doses of netilmicin or tobramycin could be evaluated for nephrotoxicity. Fifty-five patients were able to cooperate in the administration of serial audiograms. Nephrotoxicity of similar severity developed in 7 of 73 (9.6%) recipients of tobramycin and in 7 of 67 (10.4%) recipients of netilmicin (P greater than 0.05). Mild or slight auditory toxicity developed in 5 of 28 (17.8%) recipients of tobramycin and in 2 of 27 (7.4%) recipients of netilmicin (P greater than 0.05).

Adult↗