This is the first international, multi-centre, double-blind, randomised, parallel group study to directly compare the efficacy and safety profile of a single intravenous dose of ondansetron (8 or 32 mg) with granisetron (3 mg) in the control of cisplatin-induced acute emesis. A total of 496 patients were randomised to receive one of three anti-emetic treatments prior to cisplatin chemotherapy (≥50 mg/m2). Of these, 165 and 162 patients received 8 and 32 mg of ondansetron, respectively, and 169 patients received 3 mg of granisetron. Complete control of emesis (0 emetic episodes) over 24 h was reported in 59% of patients in the 8-mg ondansetron group, 51% of patients in the 32-mg ondansetron group and 56% of patients in the granisetron group. Complete or major control (≤2 emetic episodes) was achieved in 76 and 74% of patients in the 8- and 32-mg ondansetron group, respectively, compared with 78% of patients in the granisetron group. Nausea graded none or mild 24 h after the start of cisplatin infusion was reported in 71 and 69% of patients in the 8- and 32-mg ondansetron groups, respectively, and in 73% of patients in the granisetron group. There were no significant differences between the treatment groups when global satisfaction scores were compared. Logistic regression models were fitted to assess any interaction between treatments and prognostic factors (age, gender, alcohol use, cisplatin dose or concomitant chemotherapy) on complete or major response, but there was no evidence of interaction for any factor. All three anti-emetic treatments were well tolerated and no severe or unexpected drug-related adverse events were observed with ondansetron or granisetron. Headache, the most reported drug-related adverse event for all three treatment groups, occurred in 9% of all patients. In summary, no significant difference was observed between any of the treatment groups with respect to emesis, nausea or drug-related adverse events.
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BackgroundPostoperative nausea and vomiting (PONV) is common after tonsillectomy in children. There is evidence that perioperative acupuncture at the pericardium 6 (P6) point is effective for preventing PONV in adults. Our goal was to determine if intraoperative acupuncture at the P6 point, in addition to usual antiemetics, is more effective than antiemetics alone in preventing PONV in children.MethodsIn a randomized double‐blind trial, 161 children age 3 through 9 years undergoing tonsillectomy with or without adenoidectomy were randomized to either bilateral acupuncture at P6 plus antiemetics (n = 86) or antiemetics only (n = 75). All participants received ondansetron 0.15 mg/kg and dexamethasone 0.25 mg/kg, up to 10 mg. The presence of nausea, retching, emesis and administration of additional antiemetics were recorded during phases I and II of PACU recovery. Follow‐up calls occurred on postoperative day 1 (POD 1).ResultDuring phase I and II recovery, the incidence of PONV was significantly less with acupuncture than without (7.0% vs 34.7%, RR: 0.2, 95% CI: 0.09‐0.46; P < 0.001). The difference in PONV was driven by less nausea in the acupuncture group (5.0% vs 24.0%), with no difference in vomiting between the two groups. In the first 24 hours, PONV occurred in 36.1% with acupuncture and 49.3% without; these values did not differ significantly (P = 0.09).ConclusionsChildren receiving acupuncture plus antiemetic therapy had less risk of developing nausea during phase I and II recovery, but there was no difference in PONV on POD 1. Acupuncture may reduce nausea in the PACU, even when combined with antiemetics.
The Special Programme for Research and Training in Tropical Diseases (TDR) co-sponsored by UNICEF, UNDP, World Bank and WHO has been supporting research capacity strengthening in low- and middle-income countries for over 40 years. In order to assess and continuously optimize its capacity strengthening approaches, an evaluation of the influence of TDR training grants on research career development was undertaken. The assessment was part of a larger evaluation conducted by the European Science Foundation. A comprehensive survey questionnaire was developed and sent to a group of 117 trainees supported by TDR who had completed their degree (masters or PhD) between 2000 and 2012; of these, seventy seven (77) responded. Most of the respondents (80%) rated TDR support as a very important factor that influenced their professional career achievements. The “brain drain” phenomenon towards high-income countries was particularly low amongst TDR grantees: the rate of return to their region of origin upon completion of their degree was 96%. A vast majority of respondents are still working in research (89%), with 81% of respondents having participated in multidisciplinary research activities; women engaged in multidisciplinary collaboration to a higher extent than men. However, only a minority of all have engaged in intersectoral collaboration, an aspect that would require further study. The post-degree career choices made by the respondents were strongly influenced by academic considerations. At the time of the survey, 92% of all respondents hold full-time positions, mainly in the public sector. Almost 25% of the respondents reported that they had influenced policy and practice changes. Some of the challenges and opportunities faced by trainees at various stages of their research career have been identified. Modalities to overcome these will require further investigation. The survey evidenced how TDR’s research capacity grant programmes made a difference on researchers’ career development and on south-south collaborations, by strengthening and localizing research capacity in lower income regions, and also showed there is more that needs to be done. The factors involved, challenges and lessons learnt may help donors and policy makers improve their future interventions with regard to designing capacity strengthening programmes and setting funding priorities.
Although the risk/benefit ratio is favourable for sunitinib, all health care professionals must be aware of the risk of such adverse events. When genital lesions are observed, dose adjustment is recommended. Thorough clinical examination and patient interviews are necessary to detect these effects.
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