Splenectomy in patients with AIDS and AIDS-related complex.

OBJECTIVE: To study the effect of splenectomy in HIV-infected patients. DESIGN: A retrospective chart review of patients admitted to St Vincent's Hospital who had splenectomies and were HIV-positive. SETTING: All patients were treated at St Vincent's Hospital, New York City, New York, USA. PATIENTS: Only patients who were HIV-positive and who had had a splenectomy at St Vincent's Hospital were included. INTERVENTION: All patients had a splenectomy. MAIN OUTCOME MEASURES: The effect of the splenectomy in these HIV-positive patients was studied with respect to their operative morbidity and mortality, platelet counts, overall survival and the development of new opportunistic infections. RESULTS: All patients who did not have AIDS but did have thrombocytopenia responded to splenectomy in terms of their thrombocytopenia. None of them had an accelerated progression to AIDS. Most patients with AIDS and thrombocytopenia responded to splenectomy in terms of correcting their thrombocytopenia. CONCLUSIONS: Splenectomy as a treatment for thrombocytopenia is successful not only in HIV-positive patients without AIDS, but also in AIDS patients. However, in patients with disseminated Kaposi's sarcoma or Mycobacterium avium intracellulare, splenectomy may not be a factor for survival.

Comparison of the efficacy and safety of ketorolac and meperidine in the relief of dental pain.

A single-dose, randomized, double-blind study of parallel design was conducted to determine the analgesic efficacy and safety of ketorolac tromethamine in patients who experience moderate or severe pain after the surgical removal of three or more third molars, one of which was a bony-impacted mandibular molar. Meperidine hydrochloride was used as the control analgesic. In this 8-hour study, assessments were made of pain intensity, pain relief, and overall rating of the medication in 145 patients, each of whom had received an intramuscular injection of 10 mg, 30 mg, or 90 mg of ketorolac, or 50 mg or 100 mg of meperidine. The summed pain intensity and total pain relief scores showed that, at 3 and 8 hours, the effectiveness of 30 mg of ketorolac was similar to that of 90 mg ketorolac and that both of these doses were significantly more efficacious than 10-mg ketorolac, 50-mg meperidine, or 100-mg meperidine. Patients who received 30 mg or 90 mg of ketorolac gave the study medication significantly higher ratings overall than did patients who received 50 mg or 100 mg of meperidine. Significantly fewer patients treated with ketorolac reported adverse events in comparison with those treated with meperidine (17% and 59%, respectively), which suggests that it possesses a better therapeutic index than meperidine. Thus, ketorolac appears to represent an important advance in analgesic therapy.

Comparison of long-term safety of ketorolac tromethamine and aspirin in the treatment of chronic pain.

A double-blind, randomized trail was conducted in 823 patients who required long-term analgesic therapy for chronic pain such as that caused by osteoarthritis, fibromyopathies or fibromyalgias, other nonarticular chronic soft tissue pain syndromes, or headaches. The safety and analgesic efficacy of ketorolac tromethamine 10 mg 4 times a day as needed was compared with that of aspirin 650 mg 4 times a day as needed. The primary emphasis of this 52-week study was on evaluating the safety of the drugs. Patients returned to the clinics at 2, 5, 10, 15, 20, 28, 36, 44, and 52 weeks for assessments of safety and efficacy. Both patients' and investigators' evaluations of overall efficacy and safety favored ketorolac over aspirin. The probability of early withdrawal from the study was significantly higher with aspirin than with ketorolac, primarily because of lack of efficacy. Early withdrawal for safety-related reasons alone was similar for those taking aspirin and ketorolac.

Efficacy and safety of single doses of intramuscular ketorolac tromethamine compared with meperidine for postoperative pain.

Ketorolac tromethamine, a potent nonnarcotic prostaglandin synthetase-inhibiting analgesic, was compared with meperidine for relief of moderate to severe postoperative pain. In a double-blind, randomized study, 125 patients received single intramuscular doses of ketorolac 30 or 90 mg or meperidine 50 or 100 mg. The degree of pain and pain relief were quantified verbally and with visual analog scales at baseline and 30 minutes, then hourly for 6 hours. Ketorolac 30 and 90 mg were significantly superior to meperidine 50 mg in six of nine efficacy measures. The onset of and peak analgesic effect of both doses of ketorolac and of meperidine were equivalent. Compared with both doses of meperidine, the two doses of ketorolac exhibited significantly longer duration of analgesic effect, as measured by the percentage of patients who terminated the study because of inadequate pain relief. The frequency of side effects was not significantly different between the drugs. The prolonged efficacy of intramuscular ketorolac combined with the reduced risk of respiratory depression suggest an important use of this drug for the relief of postoperative pain.

Absorption of naproxen controlled-release tablets in fasting and postprandial volunteers.

The absorption of naproxen in a new controlled-release (CR) formulation (1000 mg tablet) was studied in fasting and postprandial volunteers. The total area under the plasma concentration-time curve averaged 2221 micrograms.hr/mL in fasting participants and 2111 micrograms.hr/mL in postprandial participants; whereas the difference was statistically significant (P = .025), the 95% confidence intervals indicated equivalent values. The peak plasma concentration was lower in the fasting state (63.1 micrograms/mL) than in the fed state (86.1 micrograms/mL) (P = .0001). There were no statistically significant differences between fasting versus postprandial values for the mean absorption time (9.7 hr vs. 7.7 hr) or plasma half-life (17.3 hr vs. 17.6 hr). Hence, the rate and extent of absorption of CR naproxen was not substantially altered by the ingestion of food.

A multiple-dose pharmacokinetic comparison of naproxen as a once-daily controlled-release tablet and a twice-daily conventional tablet.

The bioequivalence and absorption kinetics of naproxen in a new controlled-release tablet (750 mg or 1,000 mg naproxen) administered once daily were determined relative to an equivalent dose of the conventional naproxen tablet (375 mg or 500 mg naproxen) administered q12h. Naproxen was well absorbed from the controlled-release tablet (about 90%) compared with the conventional tablet. Absorption was dependent on drug release from the tablet matrix. The mean absorption time of naproxen averaged 8.4 hours for the 750-mg controlled-release tablet and 9.2 hours for the 1,000-mg controlled-release tablet. Once-daily administration of the controlled-release tablet resulted in equivalent trough concentrations of naproxen, and steady-state plasma concentrations were maintained within narrower limits than with twice-daily naproxen.

Comparison of intramuscular ketorolac tromethamine and morphine sulfate for analgesia of pain after major surgery.

Ketorolac tromethamine is a new injectable nonnarcotic analgesic. In a parallel, double-blind study, the analgesic efficacies of single intramuscular doses of ketorolac 10, 30 and 90 mg were compared with those of morphine sulfate 6 and 12 mg. Two hundred forty-one patients were categorized according to type of surgical procedure and severity of pain. Pain intensity and pain relief were assessed for 6 hours by scoring standard verbal and visual analog scales. Patients receiving ketorolac 10, 30 or 90 mg or morphine (MS) 12 mg all had significantly better pain relief in almost all measurements performed than those receiving MS 6 mg (p less than 0.05). Ketorolac 10 and 30 mg were as effective as morphine 12 mg during the entire 6-hour observation period, and ketorolac 90 mg was more effective than morphine 12 mg during the entire 6 hours. Patients with pain related to major surgery (e.g., cholecystectomy and abdominal hysterectomy) were better able to distinguish analgesic potency of morphine than those having less traumatic procedures (e.g., tendon and ligament repairs).

Ketorolac versus aspirin for postpartum uterine pain.

Ketorolac tromethamine, a new nonsteroidal antiinflammatory analgesic, was evaluated for relative efficacy, safety and time course of analgesia in a stratified, randomized, parallel, double-blind trial. The study involved 120 hospitalized women (4 groups of 30) with moderate or severe postpartum uterine pain treated with single oral doses of ketorolac 5 mg and 10 mg, aspirin 650 mg or placebo. At regular interviews for 6 hours patients rated pain intensity, pain relief and side effects. Significant differences (p less than or equal to 0.05, two-tailed) occurred among the 4 treatments for various measurements of summed and peak analgesia. Ketorolac 10 mg was significantly superior to placebo in 5 of 5 major efficacy measurements, and aspirin was significantly superior in 3 of 5. Ketorolac 10 mg gave the highest mean rating for summed pain intensity differences (13.6, p = 0.0002 versus placebo), followed by aspirin (11.9, p = 0.012), ketorolac 5 mg (10.9, p = 0.072) and placebo (8.6). With ketorolac 10 mg and 5 mg and aspirin, analgesia lasted 6 hours, with peak efficacy at 3 hours. Side effects were not significant. Our results suggested a positive dose-response relationship for ketorolac. Compared to aspirin, ketorolac 10 mg induced equal or more analgesia, whereas ketorolac 5 mg was near the minimum effective dose and seemed less effective than aspirin.

Kinetics of glutaraldehyde fixation of erythrocytes: size, deformability, form, osmotic and hemolytic properties.

Red blood cells interact with glutaraldehyde (GA) in a complex kinetic pattern of events. At a given GA concentration in phosphate buffered saline (PBS), the sequence of cell 'volume' response, as measured by resistive pulse spectroscopy (RPS), includes: an immediate response to the overall solution osmolality; a constant volume, latent phase; a rapid swelling phase; an intermediate constant volume phase; and a shrinkage phase to a final steady state volume. The final volume depends on fixative solution osmolality; for GA concentrations between 0.05% and 0.25% w/v, fixative osmolalities of less than 355 mosM, including 'isotonic', or greater than 355 mosM, lead to final cell volumes greater or less than native, respectively. Cell-membrane deformability decreases continuously and monotonically with time, as assessed by RPS. The rate of fixation is a direct function of GA concentration, in accordance with a derived empirical expression. The measured kinetic responses are related to considerations of cell size, deformability, and form, and to mechanisms involved in abrupt osmotic hemolysis.