Gene/Protein Disease Symptom Drug Enzyme Compound
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Query: UMLS:C0018681 (headache)
 56,091 document(s) hit in 31,850,051 MEDLINE articles (0.00 seconds)

Preparation for bone marrow transplantation (BMT) uses the extremely emetogenic combination of chemotherapy and total body irradiation (TBI). Ondansetron is a selective 5-HT3 antagonist and has clear anti-emetic capabilities. The efficacy of the drug was assessed in 15 children (aged 2-17 years) who received high dose cyclophosphamide (on days -6 and -5) and TBI (days -3 to 0 inclusive). During days -6 to -4 when the emetic effect of cyclophosphamide would be most pronounced, 12 of the 15 patients (80%) had fewer than five emetic episodes during their worst 24-h period, 11 (73%) had fewer than three vomits whilst nine (60%) experienced no vomiting or retching. Eleven patients progressed to TBI and 10 (91%) had fewer than five emetic events in the worst 24-h period (days -3 to +2), six (55%) had no vomiting at all. Of 100 evaluable 'patient-days' 83 (83%) were without any vomiting or retching and a further 10 'patient-days' had only one or two emetic episodes. There were no significant side-effects noted and in particular no extrapyramidal reactions. Headaches and constipation, which have been seen in adult studies, were not reported by patient or parent on any of the study days and transient elevation of liver enzymes were noted in only two patients. Ondansetron has a major role in preparing patients for BMT.
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PMID:Effective emetic control during conditioning of children for bone marrow transplantation using ondansetron, a 5-HT3 antagonist. 183 95

GR 38032F (ondansetron) is a selective serotonin subtype-3 receptor antagonist with reported antiemetic efficacy in patients receiving cisplatin. This study evaluated the safety and efficacy of ondansetron in three consecutive nonrandomized groups of patients who were receiving a 4- or 5-day regimen of cisplatin (20 to 40 mg/m2/d) combination chemotherapy. Thirty-six patients were enrolled. Thirty-five patients were assessable for efficacy. All patients received three daily intravenous doses of 0.15 mg/kg of ondansetron. Twenty-four patients had received no prior chemotherapy. Twelve of these received ondansetron every 2 hours and 12 received ondansetron every 6 hours. Twelve additional patients who had received at least one prior course of chemotherapy were administered ondansetron every 6 hours. All patients were monitored for emetic episodes (vomiting or retching), adverse events, and laboratory safety parameters. Ten patients (29%) had no vomiting or retching throughout the entire study period and 18 patients (51%) experienced two or fewer emetic episodes during the entire study period. The greatest antiemetic efficacy was on day 1 when 27 patients (77%) had no emesis. The chemotherapy-naive patients responded better than the nonnaive patients on all study days. Reported adverse events were minor, with the most common possibly drug-related event being headache (14% of patients). No extrapyramidal symptoms were observed. Transient increases in total SGOT, and SGPT were observed in some patients.
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PMID:Ondansetron: a new antiemetic for patients receiving cisplatin chemotherapy. 213 14

We evaluated, in a multi-center trial, the safety and efficacy of GR 38032F (GR-C507/75), a novel and selective serotonin antagonist, in preventing acute emesis in chemotherapy-naive patients receiving treatment with regimens containing high-dose cisplatin (greater than or equal to 100 mg/m2). Eighty-five patients were randomized to receive GR 38032F, 0.18 mg/kg, either every six or every eight hours for three doses, beginning 30 minutes before cisplatin. Patients were evaluated for emetic episodes (vomiting or retching) over a 24-hour period following cisplatin. All patients were evaluable for toxicity and 83 were evaluable for efficacy. The overall antiemetic response rate was 75% (55% complete response [CR], 20% major response). No difference in antiemetic control between the two administration schedules was noted. Patients with histories of heavy ethanol use had significantly better antiemetic control (74% CR) than modest or non-drinkers (33% CR). Toxicity of GR 38032F was modest and independent of administration schedule. The most common adverse events included mild hepatic transaminase elevations, self-limited diarrhea, dry mouth, headache, and mild sedation. Our data indicate that GR 38032F is a safe and effective agent in the control of acute cisplatin-induced nausea and vomiting. Additional trials exploring dosing, schedule, and comparison to standard antiemetic agents are indicated.
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PMID:GR 38032F (GR-C507/75): a novel compound effective in the prevention of acute cisplatin-induced emesis. 252 57

Ondansetron is a 5-HT3 receptor antagonist which has shown activity in the prevention of nausea and vomiting resulting from cytotoxic therapy. This paper describes the results of studies evaluating the efficacy of oral ondansetron in controlling radiation-induced emesis. Initial non-randomised studies showed that doses of 4 mg q.d.s. or 8 mg t.d.s. of ondansetron achieved complete or major control of vomiting in 77-91% of patients and mild or absence of nausea in 72-77% following single exposure high-dose (8-10 Gy) radiotherapy to the upper abdomen. A subsequent double-blind, prospective, randomised trial compared ondansetron 8 mg t.d.s. with metoclopramide 10 mg t.d.s. in the prevention of emesis following single radiation doses of 8-10 Gy to the upper abdomen. On the day of radiotherapy, ondansetron achieved significantly greater control of vomiting and retching (P less than 0.001) and nausea (P = 0.001) than metoclopramide. An advantage for ondansetron was also seen on days 2 and 3 after irradiation, although this did not reach a statistically significant level. Only two patients, out of 154, in all the studies experienced side effects attributable to ondansetron: one developed headache and the other experienced headache and vertigo. These studies show that ondansetron is a safe drug, with activity in the prevention of radiation-induced emesis and significantly greater efficacy than metoclopramide in the control of nausea and vomiting following single exposure upper abdominal high-dose radiotherapy.
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PMID:Clinical studies with ondansetron in the control of radiation-induced emesis. 253 96

A double-blind randomized crossover study was performed in 56 chemotherapy-naive patients, all receiving non-cisplatin-based chemotherapy, to compare the antiemetic effects of 2 doses of a single administration of methylprednisolone succinate (Solu-Medrol): 250 versus 500 mg. Among the 39 patients who satisfactorily completed both parts of the study, complete and major protection from emesis (0 and 1 emetic episode or only retching) was observed in 79% during the first course and in 69% during the second course. Treatment failure (> or = 6 episodes of vomiting) was observed in 18% during the first course and 21% during the second course. There was no significant difference between the two dose levels neither in terms of antiemetic protection nor in terms of the occurrence of side effects nor in patient preference. Most important side effects were facial flushing (45%), headache (22%) and facial edema (18%). It is concluded that, although a comparison with lower dosages cannot be made, within the dose range studied no clear dose-response relationship could be found.
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PMID:A double-blind randomized crossover study to compare the antiemetic efficacy of 250 mg with 500 mg methylprednisolone succinate (Solu-Medrol) as a single intravenous dose in patients treated with noncisplatin chemotherapy. 849 83

A prospective, randomized placebo-controlled study was undertaken to compare the effects on heart rate and blood pressure during surgery and on the incidence of nausea, vomiting and headache after surgery of i.m. prochlorperazine 0.2 mg.kg-1, i.v. prochlorperazine 0.1 mg.kg-1 and i.v. ondansetron 0.06 mg.kg-1 given at induction of general anaesthesia to patients undergoing septorhinoplasty. The effects of the test drugs after administration on heart rate and blood pressure were similar, as were the incidences of retching and vomiting in the recovery ward after each test drug. Postoperatively, compared with placebo (7%), nausea per se was most frequent in those given i.v. prochlorperazine (25%, P < 0.01), and less frequent in those given i.m. prochlorperazine (2%) and i.v. ondansetron (15%). Vomiting per se was reduced from 24% to 7% (P < 0.025) by i.v. prochlorperazine and to 4% (P < 0.0005) by i.v. ondansetron. The incidence of nausea with vomiting was reduced from 35% to 15% (P < 0.025). 16% (P < 0.05) and 11% (P < 0.005) by i.m. prochlorperazine, i.v. prochlorperazine and i.v. ondansetron respectively. I.m. prochlorperazine and i.v. ondansetron increased the frequency (from 35% to 64%, P < 0.0005 and to 71%, P < 0.0005, respectively) of those experiencing no PONV and delayed the onset of PONV, but only i.m. prochlorperazine reduced the severity of postoperative vomiting. Headache was frequent in the control (69%), i.v. prochlorperazine (62%) and i.v. ondansetron (69%) groups, and least frequent after i.m. prochlorperazine (53%; P < 0.05 versus i.v. ondansetron). It is concluded that these drugs have no adverse cardiovascular effects within 10 minutes of administration, i.m. prochlorperazine and i.v. ondansetron reduce PONV more effectively than i.v. prochlorperazine and postoperative headache after septorhinoplasty occurs less frequently in those given i.m. prochlorperazine than in those given i.v. ondansetron.
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PMID:The prophylactic antiemetic efficacy of prochlorperazine and ondansetron in nasal septal surgery: a randomized double-blind comparison. 890 62

The purpose of this study was to evaluate the efficacy and safety of four different doses of granisetron when administered as a single intravenous (i.v.) dose for prophylaxis of cisplatin-induced emesis in a multicenter, randomized, parallel-group, double-blind investigation. A total of 353 chemotherapy-naive patients were enrolled, stratified according to cisplatin dose (moderate dose: 50-80 mg/m2, n = 169; high dose: 81-120 mg/m2, n = 184) and randomized to one of four granisetron doses: 5, 10, 20, or 40 micrograms/kg. Control of emesis was evaluated by the percentages of patients attaining complete response (no vomiting or retching, and no rescue medication) and major response (< or = 2 episodes of vomiting or retching, and no rescue medication). Patients were assessed on an inpatient basis for 18-24 h. Safety analyses consisted of adverse events and laboratory parameter changes. Complete response rates over 24 h after chemotherapy were 23%, 48%, 48%, and 44% for granisetron doses of 5, 10, 20, and 40 micrograms/kg, respectively, in the combined patient population (P = 0.011 for linear trend); 29%, 56%, 58%, and 41%, respectively, in the moderate-dose cisplatin stratum (P = 0.278 for linear trend); and 18%, 41%, 40%, and 47%, respectively, in the high-dose cisplatin stratum (P = 0.011 for linear trend). Transient headache was the most frequently reported adverse event (19%). There was no evidence of association between increased dose and headache. A single 10-, 20- or 40-micrograms/kg dose of granisetron is comparably effective in controlling nausea and vomiting associated with moderate or high-dose cisplatin chemotherapy. Granisetron was safe and well tolerated at all doses.
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PMID:Efficacy and safety of different doses of granisetron for the prophylaxis of cisplatin-induced emesis. 901 Sep 81

Women undergoing general anesthesia for breast surgery are at particular risk of postoperative nausea and vomiting. In a randomized, double-blinded, placebo-controlled trial, 90 patients scheduled for breast surgery, aged 33-63 years, received intravenously placebo, 3 mg granisetron, or 0.3 mg ramosetron (n = 30 of each) at the end of surgical procedure. A standard general anesthetic technique and postoperative analgesia were used. Emetic episodes and safety assessment were performed during 0-24 hours and 24-48 hours after anesthesia. The rate of patients experiencing emetic symptoms (nausea, retching, vomiting) 0-24 hours after anesthesia was 17% with granisetron (P = 0.013) and 10% with ramosetron (P = 0.002) compared with placebo (47%); the corresponding rate 24-48 hours after anesthesia was 27% (P = 0.032) and 7% (P = 0.001), compared with placebo (53%). In the 24-48 hours after anesthesia, there were fewer emetic episodes in patients who had received ramosetron than in those who had received granisetron (P = 0.039). The severity of nausea was less in patients receiving ramosetron than in those receiving granisetron (P = 0.044). Zero to 24 hours after anesthesia, no difference in the rate of patients having emetic symptoms and the severity of nausea was observed between the granisetron and ramosetron groups. The most common reported adverse events were headache and dizziness, and there were no difference in the incidence of adverse events due to the study drug among the 3 groups. In conclusion, prophylactic therapy with ramosetron is more effective than that with granisetron for the long-term prevention of postoperative nausea and vomiting in women undergoing general anesthesia for breast surgery.
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PMID:Benefits and risks of granisetron versus ramosetron for nausea and vomiting after breast surgery: a randomized, double-blinded, placebo-controlled trial. 1526 19

Nausea and vomiting remain important clinical problems occuring in 25 to 50% of patients receiving chemotherapy for cancer. Clinical trials comparing a new antiemetic drug, ondansetron, to metoclopramide have suggested improved control of nausea and vomiting but studies disagree on the magnitude of the treatment effect and its statistical significance. We combined evidence from randomized controlled trials in a meta-analysis of the efficacy and safety of ondansetron compared to metoclopramide in the prevention of acute (less-than-or-equal-to 24 hours) nausea and emesis associated with chemotherapy. Literature search identified six randomised controlled trials of ondansetron versus metoclopramide in an adult population. Study outcomes were the observed incidence of emesis (vomiting or retching) and patient-reponed grades of nausea after chemotherapy. For meta-analysis of each outcome we defined therapeutic success as complete protection (ie. zero episodes during 24 hours following chemotherapy). The relative odds of success (ondansetron/metoclopramide) was calculated for each trial and all trials combined. Results were expressed as a relative risk (RR) for zero emesis or nausea at 24 hours. The six trials reported on 705 patients (median age range 53-59 years; 57% female). Relative odds for complete control of emesis was greater than one in all trials but was nonsignificant (p>0.05) in two trials, including the largest trial. When trials were combined, summary odds ratios for control of emesis and nausea were greater than one (p<0.05). RR of zero emesis with ondansetron was 1.72 (95% CI 1.45 to 1.97) and was similar for nausea (RR= 1.78, 95% CI 1.39 to 2.13). In trials using high-dose cisplatin chemotherapy, higher rates of extrapyramidal affects and diarrhea were associated with metoclopramide (p<0.05) while headache was frequently associated with ondansetron (p<0.05). Combined clinical trial evidence supports the conclusion. that, relative to metoclopramide, ondansetron places patients at a much lower risk of nausea and emesis following chemotherapy with moderately or highly emetogenic regimens.
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PMID:Ondansetron versus metoclopramide in the prevention of chemotherapy-induced nausea and vomiting - a metaanalysis. 2158 65

Decompressive craniotomies are being increasingly used in the treatment of raised intracranial pressure due to a variety of reasons like large infarcts, hypertensive hemorrhages and contusions. Though effective in decreasing raised intracranial pressure, they have certain complications like the sinking scalp flap syndrome that is caused by cortical dysfunction of the area below the craniotomy which is exposed to the effects of atmospheric pressure. We describe a 60-year-old patient who underwent decompressive craniotomy for acute subdural hematoma and after an initial uneventful postoperative period developed incontinence, irrelevant verbalization and ataxia. He was found to have hydrocephalus and underwent a ventriculo-peritoneal shunt with resolution of his symptoms. Three weeks later his flap had sunk in deeply and the skin was non-pinchable and he was noted to have headaches, vomiting and retching when he sat up. In addition he became aphasic when seated and the symptoms subsided on lying down. A diagnosis of focal cortical dysfunction due to sinking scalp flap syndrome was made. We highlight the incidence and pathophysiology of this unusual complication of decompressive craniotomy and stress the need to be aware of this entity particularly in patients who do not show an initial improvement after decompressive craniotomy as the cause of their poor neurological status may not be explained by any other mechanism.
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PMID:Posture-dependent aphasia: Focal cortical dysfunction in the sinking scalp flap syndrome. 2588 85


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