摘要:

In order to verify the efficacy and safety of a single intravenous dose of ondansetron in the prevention of postoperative nausea and vomiting (PONV), 928 patients undergoing ophthalmic, gynaecological, abdominal and urological procedures under general anaesthesia were enrolled in a single-blind multicentre placebo-controlled study. Patients were randomly allocated to receive either a single intravenous dose of ondansetron 4mg or placebo before the induction of general anaesthesia. General anaesthesia was induced with thiopental sodium and maintained with fentanyl, nitrous oxide and isoflurane in oxygen. Postoperative analgesia was provided with the administration of morphine and/or ketoprofen, with similar total amounts being administered to both groups. The percentage of patients experiencing PONV was significantly higher in the placebo group (80vs20%; p < 0.001). 69 episodes were reported in the group treated with ondansetron compared with 227 episodes in the group receiving placebo. In a subgroup of patients with a previous history of PONV, ondansetron administration produced relief from emetic symptoms in 75% of the patients, while only 25% of patients administered placebo were symptom-free during the 24 hours of the study. No differences were observed in the incidence of adverse events between the 2 groups of patients. The results of this study demonstrate that ondansetron is effective and safe in the prevention of PONV in patients undergoing a variety of surgical procedures under general anaesthesia.

ISSN:0114-2402    

出版商:ADIS    

年代:1994

数据来源: ADIS

摘要:

Suspected adverse drug reactions for digoxin from Australia, France, Germany, Sweden, the UK and the US, which were reported to the World Health Organization (WHO) Collaborating Centre for International Drug Monitoring since 1968, were examined for qualitative and quantitative differences between countries. Intercontinental Medical Statistics (IMS) data on drug utilisation and demographic information were used to explain a much higher reporting of suspected reactions from Australia and a later peak of occurrence with age in France. Australia has a greater number of elderly patient visits to doctors resulting in a prescription, but it is unclear whether this is due to a greater number of patients taking digoxin or to more frequent prescriptions. In France, doctors used higher doses of digoxin in the over 80 years age group than in other countries, which may account for more dose-related effects.

ISSN:0114-2402    

出版商:ADIS    

年代:1994

数据来源: ADIS

摘要:

Minoxidil overdose occurs infrequently and little toxicity data are available. This study examines the epidemiology and clinical toxicity of minoxidil exposures to both tablets and topical solutions. All cases reported to the American Association of Poison Control Centers (AAPCC) Data Collection System from 1985 to 1991 were reviewed with respect to patient age, reason for and route of exposure, dosage form, co-ingestion, healthcare facility (HCF) referral/admission, treatment and medical outcome. 285 cases were reviewed. 145 (51%) occurred in children less than 6 years of age. 273 (96%) exposures were acute, 239 (84%) were accidental, 224 (79%) occurred via ingestion and 61 (21%) involved co-ingestion. 130 (46%) patients were referred to an HCF and 32 (11%) were admitted. The outcomes were: minor/no effect 59%, moderate 4.2%, major 1.8%, and 1 death. All topical exposures resulted in minor to no effects. Of 224 ingestions, 16 (7.1%) developed significant toxicity defined as moderate/major effects [AAPCC criteria] or death (one case involving tablets). In these 16 cases, 69% were intentional and 13 (81%) involved co-ingestion; the most frequent effects were hypotension (69%), tachycardia (38%) and lethargy (31%); 44% received intravenous fluids and vasopressors. Only 2 cases of hypotension were attributable to minoxidil alone (no history of co-ingested drugs); both responded to intravenous fluids and dopamine. The only death was a suicide, with co-ingestion of hydralazine, prazosin and paracetamol; terminal symptoms were intractable hypotension, coma and pulmonary oedema. It is concluded that significant toxicity after minoxidil exposure, regardless of formulation, is associated with oral administration, intentional exposure and co-ingestion of other agents.

ISSN:0114-2402    

出版商:ADIS    

年代:1994

数据来源: ADIS

摘要:

The effect of the oral administration of BN 50730, a specific synthetic platelet-activating factor (PAF) receptor antagonist, on 2 recognised PAF-induced reactions (ex vivoplatelet aggregation and immediate cutaneous responses), was assessed through 3 double-blind placebo-controlled studies in healthy, non-allergic male volunteers. Platelet aggregation showed a peak level of inhibition 4 hours following the single administration of either a 10, 20 or 40mg dose. A doseresponse relationship was observed regarding the duration of the effect; while lasting less than 12 hours for the 10mg dose, inhibition was still evident 16 hours after administration of the 40mg dose. Wheal and flare reactions to intradermal PAF (400ng) were significantly inhibited following single dose administration of either 10, 20 or 40mg of BN 50730. The 40mg dose inhibited the flare reaction by more than 90% at 8 hours post-treatment. Treatment with either 20 or 40mg of BN 50730 twice daily for 7 days resulted in a reduction in the cutaneous responses to PAF after the last dose by at least 80% compared with placebo in both treatment groups, the 2 doses being almost equally effective. The results indicate that BN 50730 is a potent PAF antagonist and provide interesting information for testing the product at 40 or 80mg dose levels in twice-daily phase II clinical studies.

ISSN:0114-2402    

出版商:ADIS    

年代:1994

数据来源: ADIS

摘要:

Ondansetron was compared with conventional-dose metoclopramide in a randomised trial for emesis control in 56 patients with lymphoma and leukaemia receiving commonly used chemotherapeutic regimens that are moderately emetogenic. Emetogenic chemotherapeutic agents were administered on day 1 to lymphoma patients and on days 1 to 5 to leukaemia patients. Ondansetron was superior to metoclopramide in the complete control of acute emesis (75vs43%, p = 0.03). Control of delayed emesis in lymphoma patients was marginally better with ondansetron on days 2 (89vs64%, p = 0.140) and 3 (94vs68%, p = 0.054). Continuous control of emesis for leukaemia patients on daily chemotherapy was better with ondansetron on days 3 (80vs17%, p = 0.035) and 4 (90vs33%, p = 0.036). Furthermore, significantly more patients on ondansetron enjoyed normal food intake on day 1 (71vs14%, p = 0.000). Both antiemetic regimens were well tolerated. No extrapyramidal reactions were observed.

ISSN:0114-2402    

出版商:ADIS    

年代:1994

数据来源: ADIS

摘要:

The effectiveness of ciprofloxacin was compared with that of cotrimoxazole in the treatment of acute bacterial exacerbations of chronic obstructive pulmonary disease. 65 patients were eligible for efficacy analysis and the cure rate (comprised of both complete and partial success responses) was 97.4% for ciprofloxacin-treated patients and 92.6% for patients treated with cotrimoxazole. 261 causative organisms were isolated from 216 patients valid for safety analysis, of which 4 (from 4 patients) were resistant to ciprofloxacin and 70 (from 55 patients) were resistant to cotrimoxazole.Adverse events occurred with an almost identical frequency in the ciprofloxacin- and cotrimoxazole-treated groups (22.3 and 23.9%, respectively). Ciprofloxacin is a well tolerated and effective antibiotic in patients with acute bacterial exacerbations of chronic obstructive lung disease. Causative bacterial pathogens are rarely resistant to ciprofloxacin but commonly resistant to cotrimoxazole.

ISSN:0114-2402    

出版商:ADIS    

年代:1994

数据来源: ADIS

ISSN:0114-2402    

出版商:ADIS    

年代:1994

数据来源: ADIS

ISSN:0114-2402    

出版商:ADIS    

年代:1994

数据来源: ADIS