Efficacy and safety of two methods of administration of granisetron injection for nausea and vomiting induced by chemotherapy for tumors in hematopoietic organs--a randomized crossover comparison between intravenous drip infusion and intravenous bolus injection]

We investigated the efficacy and safety of two methods of granisetron injection to treat nausea and vomiting induced by chemotherapy for tumors in hematopoietic organs. The methods of administration were intravenous drip infusion over 30 minutes, which is the conventional method, and intravenous bolus injection. In this study, 89.5% of patients in both groups (17/19 for each) were free from vomiting. No serious adverse events were observed in either administration group. Abnormal laboratory test values suspected to be related to granisetron were observed in 3 cases in the bolus injection group and in 2 cases in the drip infusion group. but did not pose any clinical problem. These results demonstrated the safety of both methods of administration. In conclusion, it is considered that granisetron intravenous bolus injection can be considered as the method of choice for the prevention of nausea and vomiting induced by chemotherapy for tumors in hematopoietic organs.     

Clinical evaluation of 2 mg granisetron tablet for nausea and vomiting induced by anticancer drugs including cisplatin

1. The clinical efficacy and safety of the 2 mg granisetron tablet were assessed in 32 mainly lung cancer patients who were to receive treatment with anticancer drugs including CDDP. 2. One 2 mg granisetron tablet was administered prophylactically one hour before the start of CDDP administration. 3. Based on the development of nausea and vomiting in 24 hours after the start of CDDP administration, the study medication was judged to be "remarkably effective" or "effective" in 71.0% (22/31) of cases. 4. The study medication was judged to be "safe" in 96.9% (31/32) of cases, without causing any adverse reactions. 5. The above results indicate that the 2 mg granisetron tablet is safe and useful.     

Continuous-infusion granisetron compared to ondansetron for the prevention of nausea and vomiting after high-dose chemotherapy

OBJECTIVES: The main aim was to calculate the prevalence of mental pathology in women between 18 and 70 in a Health District of Pamplona; second, to describe comorbidity and to analyse how mental pathology was recorded in the clinical histories. DESIGN: An observational crossover study with randomised selection. SETTING: A community study in the Txantrea quarter of Pamplona, covering 21,590 inhabitants, with 7605 women between 18 and 70. PATIENTS: Randomised sample, stratified by age, of 237 women between 18 and 70 taken from the 1991 Census. MEASUREMENTS AND RESULTS: In a face-to-face interview at the Health Centre, the DIS Questionnaire, which diagnoses mental illness, was administered to all participants. A check was made to see if mental pathology was recorded in their clinical history. The prevalence of mental illnesses, mainly Phobias and Depression, in the "last year of life" was 33.3% (27.5-39.5), which fell to 24.9% (19.7-30.7) when tobacco abuse was excluded. The most common pathologies were: Depression (17.3%), Tobacco dependency (17.3%), simple Phobia (14.8%), Agoraphobia (13.5%), social Phobia (8.9%) and post-traumatic stress (8.0%). CONCLUSIONS: Understanding the high psychological morbidity in these urban women can contribute to the development of Mental Health Promotion and Prevention Programmes and foment fuller mental health training for Primary Care professionals.     

Prevention of nausea and vomiting in female patients undergoing breast surgery: a comparison with granisetron, droperidol, metoclopramide and placebo

Centromerically located alphoid satellite DNAs are present in all primates. They typically consist of arrays of a 340-bp monomeric unit that is composed of related, but diverged, 170-bp subunits. A unique monomeric unit has recently been described: the alphoid satellite monomers of the neotropical primate Chiropotes satanas (bearded saki) are typically 539 bp in length. In addition, a number of smaller satellite sequences are present in this species. Analysis of two primates closely related to Chiropotes, Pithecia irrorata (saki) and Cacajao melanocephalus (uakari), show that they also contain unique alphoid satellites that are different from those of Chiropotes and different from one another. Southern blot and sequence analyses suggest that an alphoid satellite rearrangement(s) occurred early in the history of the tribe Pitheciini (Chiropotes, Pithecia, Cacajao) and that rearrangements are continuing to occur in this group of primates.     

Sequential methotrexate/5-fluorouracil therapy with 5'-deoxy-5-fluorouridine against advanced gastric cancer: comparison between bolus injection and drip infusion of 5-fluorouracil administration. Hirosaki Cooperative Study Group for Cancer Chemotherapy

Forty-two patients with gastric cancer were entered in this study. Forty-one of them were eligible and administered sequential methotrexate (MTX)/5-fluorouracil (5-FU) with 5'-deoxy-5-fluorouridine (5'-DFUR). 5-FU was administered intravenously by drip infusion for 2 hours in 22 cases (group A), and was infused by bolus injection in 19 cases (group B). The treatment schedules were as follows: MTX 100 mg/m2 was given intravenously (i.v.) followed by 5-FU 600 mg/m2 i.v. 2 hours later and leucovorin 15 mg/body i.v. 8 and 20 hours later. This cycle was repeated once a week. 5'-DFUR 1,200 mg/body/day was given orally on 5 consecutive days per week. Three of 20 cases (15%) in group A showed PR, while 5 of 15 cases (33%) in group B showed PR. Median survival time was 2.8 months in group A and 3.7 months in group B. There was, however, no statistical difference. Gastrointestinal toxicity was commonly observed. Leukocytopenia was more severe in group B. Alopecia was more frequently observed in group B (p < 0.025). These results suggested bolus injection of 5-FU was a promising way of administration in sequential MTX/5-FU therapy.     

A case of renal pelvic cancer with recurrence of liver metastasis showing partial response by injection of methotrexate and intraarterial infusion of cisplatin and pirarubicin

The patient was a 71-year-old man who had been diagnosed as having a left renal pelvic cancer with liver metastasis. We performed total left nephroureterectomy with lymphnode cleaning and partial resection of the liver. Because abdominal CT 5 months after the operation revealed multiple metastasis of the liver, we performed chemotherapy with a regimen consisting of methotrexate 50 mg (intravenous injection), cisplatin 30 mg and pirarubicin 20 mg (intraarterial infusion), and leucovorin 3 mg (intramuscular injection), three times at intervals of 6 hours. Ten days after chemotherapy, CT revealed the disappearance of most of the liver metastatic lesions, and a partial response was obtained. We are now performing the regimen at an interval of a month to a month and one-half to control the metastatic lesions.     

Prevention of nausea and vomiting with granisetron, droperidol and metoclopramide during and after spinal anaesthesia for caesarean section: a randomized, double-blind, placebo-controlled trial

OBJECTIVE: To compare the safety and efficacy of a combination of amoxicillin and clavulanate potassium given orally every 12 hours (amoxicillin, 875 mg; clavulanate, 125 mg) with that given every 8 hours (amoxicillin, 500 mg; clavulanate, 125 mg) for the treatment of patients with acute bacterial maxillary sinusitis. DESIGN: Multicenter double-blind randomized double-dummy controlled trial. SETTING: Physicians' offices and ambulatory care clinics. PATIENTS: One hundred seventy patients at least 18 years of age with acute bacterial maxillary sinusitis who could be treated with an oral antimicrobial agent were randomized, and data from 134 were suitable for evaluation. Four patients were withdrawn from this study because of adverse effects. INTERVENTIONS: Patients received a combination of amoxicillin and clavulanate orally every 12 hours (amoxicillin, 875 mg; clavulanate, 125 mg) or every 8 hours (amoxicillin, 500 mg; clavulanate, 125 mg) for 14 days. MAIN OUTCOME MEASURE: Clinical success at the end of therapy. RESULTS: Clinical success at the end of therapy was similar for the 2 treatment groups, 93% and 88% of patients in the every 12-hour and every 8-hour groups, respectively (P = .76; 95% confidence interval, -4.0% to 15.6%). Clinical success rates at follow-up 2 to 4 weeks after the end of therapy were also similar in the 2 groups. Adverse events related to treatment were reported with similar frequency in the 2 groups. CONCLUSION: Amoxicillin and clavulanate given every 12 hours is as effective and as safe as administration every 8 hours for the treatment of acute bacterial maxillary sinusitis.     

Comparison of single-dose oral granisetron versus intravenous ondansetron in the prevention of nausea and vomiting induced by moderately emetogenic chemotherapy: a multicenter, double-blind, randomized parallel study

PURPOSE: The antiemetic effectiveness and safety of single-dose oral granisetron were compared with intravenous (I.V.) ondansetron in chemotherapy-naive patients who received moderately emetogenic chemotherapy. PATIENTS AND METHODS: In this double-blind, parallel-group study, patients naive to emetogenic chemotherapy (N = 1,085) who were scheduled to receive cyclophosphamide- (500 to 1,200 mg/m2) or carboplatin (> or = 300 mg/m2) based chemotherapy, were randomized to receive either oral granisetron (n = 542) or I.V. ondansetron (n = 543). Efficacy assessments included the proportion of patients in each treatment group with total control over the 24 and 48 hours following chemotherapy initiation, as well as incidence and severity of nausea and emesis and use of antiemetic rescue medication. Prophylactic corticosteroids were allowed. Safety assessment was based on patients' reports of adverse experiences. RESULTS: Approximately 80% of patients received prophylactic corticosteroids. Single-dose oral granisetron (2 mg) and I.V. ondansetron (32 mg) resulted in equivalent levels of total emetic control during the first 48 hours after chemotherapy. The proportion of nausea- and emesis-free patients at 24 and 48 hours were also approximately equivalent. The most commonly reported adverse experiences were headache, asthenia, and constipation. More patients who received ondonsetron than granisetron reported dizziness (9.6% v 5.4%, respectively; P = .011) and abnormal vision (4.2% v 0.6%, respectively; P < .001). CONCLUSION: A single oral dose of granisetron (2 mg) resulted in equivalent levels of antiemetic protection as I.V. ondansetron (32 mg). Both agents were well tolerated, although more dizziness and abnormal vision were reported with ondansetron. Because the two antiemetic regimens exhibited equivalent efficacies, additional factors such as convenience and cost of therapy should be considered.     

A cooperative study on concomitant with low-dose divided administration of cisplatin (CDDP) and sustained drip infusion of 5-fluorouracil (5-FU) for unresectable advanced gastric cancer. Osaka Cisplatin Gastric Cancer Study Group

British Indian Asian men aged <40 years have a twofold to threefold increased risk of death from coronary heart disease (CHD) compared with British whites. Epidemiological studies have suggested an association between glucose intolerance and hyperinsulinemia with premature CHD in Indian Asians. We tested the association of insulin action with myocardial infarction (MI) by using the hyperinsulinemic-euglycemic clamp in 17 MI patients: 8 Punjabi Sikhs (PSMIs), 9 British whites (BWMIs), and 17 control subjects (9 PSCs and 8 BWCs). Metabolic factors associated with insulin resistance were investigated in 51 MI patients (24 PSMIs and 27 BWMIs) and 53 control subjects (28 PSCs and 25 BWCs). Familial aggregation of defective insulin action was examined by studying five pedigrees of Sikh survivors of MI. Sikh survivors of premature MI demonstrated impaired insulin-mediated glucose uptake (P<.001) by use of the clamp technique and nonesterified fatty acid (NEFA) suppression (P<.05) by using both clamp techniques and the oral glucose tolerance test, as compared with Sikh control subjects. White patients had impaired insulin-mediated glucose uptake but normal NEFA suppression. Metabolic factors usually associated with insulin resistance, including increased 2-hour post-oral glucose tolerance test triglycerides, smaller low density lipoprotein particle size, and increased plasminogen activator inhibitor-1, were present in white (all P<.05) but surprisingly absent in Sikh (all P>.05) MI patients compared with respective ethnic control subjects. Fasting glucose and total cholesterol levels did not differ between patients and control subjects. Abdominal obesity, impaired NEFA suppression after oral glucose, and fasting hyperinsulinemia were present in Sikh MI patients and their nondiabetic first-degree relatives compared with Sikh control subjects. PS survivors of premature MI demonstrated impaired insulin-mediated glucose disposal and NEFA suppression compared with ethnic control subjects. BWMI patients showed abnormalities of carbohydrate, but not of NEFA, metabolism compared with white control subjects. Defects of insulin action manifested as abdominal obesity, impaired NEFA suppression, and fasting hyperinsulinemia are present in Sikh MI patients and their asymptomatic, nondiabetic, first-degree relatives. We suggest that these defects may be early metabolic markers that predict risk of premature MI among PSs.     

Comparison of blast-furnace efficiency with pulverized-coal injection and with anthracite chunks

The use of pulverized coal in steel plants depends on the supply of high-quality coke and iron ore to the blast furnace. In current conditions, it is more economical to use anthracite pieces in place of coke (equivalence ratio 0.8–1.0 kg/kg), in amounts of 70–90 kg/t of hot metal; this technology was developed by researchers at the Ukrainian National Metallurgical Academy, at the Nekrasov Institute of Ferrous Metallurgy, Ukrainian Academy of Sciences, and at Krivorozhstal’. In this technology, considerable economic savings are made possible by the reduction in coke consumption and cost of the hot metal, without additional capital expenditures.     

Comparison of propofol and methohexital continuous infusion techniques for conscious sedation

PURPOSE: Methohexital and propofol have been shown to be effective agents for continuous intravenous infusion to produce conscious sedation during oral surgical procedures. The current study was conducted to compare these techniques for intraoperative cardiopulmonary stability, patient cooperation, amnesia, comfort, recovery time, and postoperative nausea and vomiting. METHODS: Seventy ASA Class I or Class II patients between the ages of 18 and 40 years, scheduled for surgical extraction of impacted third molars, were entered into the study. Thirty-five patients were assigned to group A (methohexital) and 35 were assigned to group B (propofol). Intravenous sedation was accomplished using premedication with 1.5 microg/kg of fentanyl and 0.05 mg/kg of midazolam followed by the continuous infusion of methohexital or propofol at a rate of 50 microg/kg/min. The infusion was then titrated to 100 microg/kg/min to accomplish a level of sedation in which the eyes were closed and the patients were responsive to verbal commands. Subjects were monitored for variability of heart rate, blood pressure, oxygen saturation, amnesia, comfort, cooperation, nausea and vomiting, and recovery time based on cognitive, perceptual, and psychomotor tests. RESULTS: There was no statistical difference between the two medication groups except for heart rate, which was found to increase by 11 beats/min for group A and only three beats/min in group B. CONCLUSION: A continuous infusion technique using either methohexital or propofol (50 to 100 microg/kg/min) was found to be safe and effective, with no clinically significant differences in cooperation, cardiopulmonary stability, recovery time, amnesia, comfort, and the incidence of nausea or vomiting. However, the cost-effectiveness of methohexital is superior to that of propofol.     

Stability and compatibility of granisetron hydrochloride in i.v. solutions and oral liquids and during simulated Y-site injection with selected drugs

The stability and compatibility of granisetron hydrochloride in common i.v. fluids and oral liquids and during simulated Y-site injection with selected drugs were studied. One milliliter of solution containing granisetron 1 mg (as the hydrochloride salt) was added to 50 mL of 5% dextrose injection, 5% dextrose and 0.9% sodium chloride injection, 5% dextrose and 0.45% sodium chloride injection, or 0.9% sodium chloride injection in polyvinyl chloride (PVC) bags and to 5 mL of 5% dextrose injection, 0.9% sodium chloride injection, or bacteriostatic water for injection in polypropylene syringes and stored at room temperature (20 degrees C) for 24 hours. One milliliter of the granisetron hydrochloride injection was added to 50 mL of apple juice, orange juice, cola, or an electrolyte replacement solution and stored for 60 minutes at room temperature. Twenty-nine drugs were mixed with the granisetron hydrochloride injection in 0.9% sodium chloride injection in volumes simulating Y-site injection and stored at room temperature. Finally, dexamethasone sodium phosphate injection 0.5 mL and 1 mL of the granisetron hydrochloride injection were added to 50 mL of 0.9% sodium chloride injection in a PVC bag and stored for 60 minutes. Drug concentrations were determined by high-performance liquid chromatography, and color, clarity, and pH were evaluated. Granisetron hydrochloride was stable in and compatible with all the i.v. solutions and oral liquids. Neither granisetron nor any of the drugs it was tested with during simulated Y-site injection showed any physical changes except for a slight Tyndall effect in the granisetron hydrochloride-doxorubicin hydrochloride combination; all the drugs retained at least 96% of initial concentrations. Granisetron and dexamethasone sodium phosphate were stable and compatible in the admixture. Granisetron 1 mg (as the hydrochloride salt) was stable for 24 hours in four i.v. infusion fluids in PVC bags and in 5% dextrose injection, 0.9% sodium chloride injection, and bacteriostatic water for injection in polypropylene syringes; for 1 hour in four oral liquids; for 4 hours in the presence of each of 29 drugs during simulated Y-site injection; and for 1 hour when mixed with dexamethasone sodium phosphate in 0.9% sodium chloride injection in a PVC bag.     

Comparison between extradural infusion of ropivacaine or bupivacaine for the prevention of postoperative pain after total knee arthroplasty

We have compared the analgesia and motor block produced by extradural infusions of ropivacaine and bupivacaine after total knee arthroplasty. Fifty-two patients received 8 ml h1 of either 0.2% ropivacaine or 0.2% bupivacaine by extradural infusion for 24 h after operation. Analgesia was assessed by postoperative visual analogue scale (VAS) and morphine consumption. At rest these were low in both groups; median VAS was 0-13.3 mm for the ropivacaine group and 0-0.5 mm for the bupivacaine group. Over the 24 h of the infusion, the estimated (ropivacaine bupivacaine) difference in wound pain at rest was 5.6 mm (P = 0.017) and on passive movement 11.6 mm (P = 0.016). Median morphine consumption was 30.7 mg in the ropivacaine group and 20.5 mg in the bupivacaine group. In the ropivacaine group, 50% of patients compared with 19% in the bupivacaine group had no motor block 2 h after operation, increasing to 88% for ropivacaine and 56% for bupivacaine by 24 h. Bupivacaine produced significantly more frequent and intense motor block over the 24 h (P = 0.015).     

Postoperative hypoxaemia: continuous extradural infusion of bupivacaine and morphine vs patient-controlled analgesia with intravenous morphine

We carried out a randomized prospective study in 60 patients who had undergone major abdominal surgery for cancer. For postoperative pain control, 30 patients received continuous extradural infusion of 0.125% bupivacaine 12.5 mg h-1 and morphine 0.25 mg h-1 (EXI group) and 30 received patient-controlled analgesia (PCA) with intravenous morphine (1 mg bolus, 5-min lock-out and maximum dose 20 mg 4h-1). Both groups had general anaesthesia. The two groups were compared for postoperative pain scores, satisfaction, sedation and oxygen saturation. Oxygen saturation was recorded continuously the night before surgery and for two consecutive postoperative nights. Episodes of moderate desaturation (90% > SpO2 85%) were more frequent in the EXI group than in the PCA group (P < 0.05). Pain scores were lower in the EXI group compared with the PCA group at rest and while coughing (P < 0.05). No significant difference was found for patient sedation and satisfaction.     

单喷颗粒镁脱硫与镁基复合喷吹脱硫喷吹系统的区别

单喷颗粒镁脱硫和镁基铁水脱硫是最常见的铁水脱硫技术,对单喷颗粒镁脱硫与镁基复合喷吹脱硫喷吹系统进行了比较,主要区别在于:单喷镁脱硫系统要求的镁颗粒较大,球形度好,采用机械给料的方式精确给料,料罐容积小,利于实现设备的小型化,但是喷枪需要设置气化室,结构复杂;复合喷吹铁水脱硫通过调节动力学参数来调节镁粉喷吹速率。     

Phase II study of continuous infusion carmustine and cisplatin followed by cranial irradiation in adults with newly diagnosed high-grade astrocytoma

PURPOSE: To evaluate the activity and toxicity of carmustine (BCNU) and cisplatin administered as a 72-hour continuous intravenous infusion before radiation in adults with newly diagnosed high-grade astrocytomas. PATIENTS AND METHODS: Fifty-two patients with a Karnofsky performance status greater than 60 and no prior antineoplastic therapy entered this protocol. The median age of the patients was 55 years. Eighty-eight percent had glioblastoma multiforme and 12% had anaplastic astrocytomas. BCNU (40 mg/m2/d) and cisplatin (40 mg/m2/d) were administered concurrently as a 72-hour infusion every 3 to 4 weeks. Radiation was begun 4 weeks after the third cycle of chemotherapy or earlier for progressive disease. Responses required a > or = 50% reduction in contrast-enhancing volume. RESULTS: Forty patients (77%) completed three chemotherapy infusions, five (10%) received two infusions, and seven (13%) received only one. Fifty-one patients completed radiation. Seventeen (42%) patients with measurable disease had a partial response (PR) to chemotherapy, 23 (53%) had stable disease (SD), and two (4%) had progressive disease (PD) on chemotherapy. The median survival time for all patients was 13 months. Survival rates at 1, 2, 3, and 5 years were 62%, 19%, 12%, and 5%, respectively. Grade III to IV leukopenia occurred in 32% of patients; 63% received platelet transfusions and 58% required RBCs. Neutropenic fevers were rare and no intracranial hemorrhages or treatment-related deaths were noted. Nausea, vomiting, peripheral neuropathy, hearing loss, and thromboembolic events were relatively common. CONCLUSION: This chemotherapy regimen appears to have significant activity and may prolong survival in adults with newly diagnosed high-grade astrocytoma.     

Continuous arterial infusion of protease inhibitor with supplementary therapy for the patients with severe acute pancreatitis--clinical effect of arterial injection of ulinastatin

We treated five patients with severe acute pancreatitis by continuous arterial infusion (CAI) of protease inhibitor, nafamostat mesilate. Arterial injection (AI) of ulinastatin was performed in four cases and AI of antibiotics (IPM/CS) was done in one case, as supplemental therapies of CAI. Abdominal pain disappeared in 7.9 hours on the average, abdominal tenderness disappeared in 5.0 days and laboratory data lately recovered. All five cases treated by these therapies were cured without hemodialysis or surgical treatment in acute phase. AI of ulinastatin through arterial infusion catheter is pharmacokinetically more effective, because it yields a relatively high concentration of the drug at the acting site when compared with that of intravenous injection. Furthermore ulinastatin inhibits different types of protease from nafamostat mesilate. Therefore the clinical effect of CAI of nafamostat mesilate is enhanced by the combined therapy with AI of ulinastatin. It is also suggested that arterial injection of ulinastatin might be effective for the control of abdominal pain and that arterial injection of antibiotics might have an advantage on prevention of infectious pancreatic necrosis.     

Tropisetron or ondansetron compared with placebo for prevention of postoperative nausea and vomiting

In a prospective, randomized, double-blind, placebo-controlled, multicentre study, the efficacy of prophylactic tropisetron (2 mg) or ondansetron (4 mg) for the prevention of post-operative nausea and vomiting after abdominal or non-abdominal surgery with general balanced anaesthesia was studied in 842 ASA I-III patients. In patients undergoing abdominal surgery, ondansetron and tropisetron reduced the frequency of emetic episodes compared with the placebo (29%, 30% vs. 42% respectively). In men, neither tropisetron nor ondansetron had an effect different from the placebo, whereas in women both drugs led to lower rates of emetic episodes and nausea. In comparison with abdominal surgery, fewer patients in the non-abdominal surgery subgroup had emetic episodes (42% vs. 23% in the placebo group). However, neither tropisetron nor ondansetron was significantly different from the placebo in this patient subgroup. In conclusion, for patients at increased risk of post-operative nausea and vomiting, a prophylactic therapy at the lowest effective dose with tropisetron or ondansetron may be useful.