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As part of a programme of multicentre trials of the tolerance and therapeutic effect of praziquantel, clinical trials were carried out in Brazil in patients with active Schistosoma mansoni infections, each of whom had a minimum geometric mean egg output of 100 eggs per gram of faeces calculated from multiple pretreatment stool examinations.The first stage was a double-blind assessment of tolerance and efficacy of oral doses of 1 x 20, 2 x 20, or 3 x 20 mg of praziquantel per kg of body weight. Subsequently, single-blind trials explored the effects of 3 x 20 mg/kg at 4-hourly intervals, and a single dose of 50 mg/kg.Side effects increased in frequency as dosage increased. Nausea, epigastric pain, headache, dizziness, and drowsiness were all noted but their severity was mild or moderate and they disappeared in 48 hours. In general, monitoring laboratory tests showed little change.Following a stringent parasitological follow-up, 96% of 28 patients followed at 1 year after treatment with either 3 x 20 mg/kg or 1 x 50 mg/kg were cured. Praziquantel seems to be a very promising drug against S. mansoni and further clinical trials should be strongly encouraged.
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PMID:Preliminary trials with praziquantel in human infections due to Schistosoma mansoni. 39 54

Ninety-six patients who had heavy Opisthorchis viverrini infection were studied. Egg count per gram of faeces ranged from 10,800 to 139,000 (mean 26,044.3). Praziquantel 50 mg per kg body weight was given after a morning meal. 68 patients completed the follow up period of 60 days. The cure rate was 97.0%. The side-effects occurred in 61 patients (89.7%). The common side effects were diarrhoea, dizziness, sleepiness, epigastric pain, headache, nausea and anorexia. These side-effects were mild and transient. 62 patients (91.2%) showed clinical improvement, and 20 patients were symptom free on day 60.
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PMID:Studies on the chemotherapy of human opisthorchiasis: effective dose of praziquantel in heavy infection. 390 18

153 patients coming to France from Southeast Asia were treated with Praziquantel for Opisthorchiasis. All these patients, 52 children and 101 adults were examined 30 to 90 day after arrival in France. They came from Laos (118 cases), Vietnam (10 cases) and Cambodia (25 cases), generally via Thailand. 7 heavy (10.000-29.999 Eggs Per Gram of faeces, EPG), 55 moderate (1.000-9.999 EPG) and 91 light infections (1-999 EPG) were detected. Praziquantel was given at a dose of 25 mg/kg body weight, orally, three times on a single day at intervals of 4-6 hours. Clinical tolerability was perfect in 59 patients and pretty good in the 94 remaining cases. We only observed, for one or two days, lassitude, headache, drowsiness, nausea, epigastric pain or arthralgia-myalgia, always of weak or moderate intensity and for 1 or 2 days. The biological tolerability was excellent without any variation of the biological norm values (47 parameters). The therapeutic efficacy was remarkable with 100% cure in all patients, who were followed-up for 40 days. All earlier controls (7th, 20th days) were always negative except for two patients who were completely negative on day 40th and later.
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PMID:[Praziquantel in the treatment of opisthorchiasis in Southeast Asian refugees. Evaluation of 153 cases]. 407 69

Praziquantel (2-cyclohexylcarbonyl-1,2,3,6,7,11b-hexahydro-4H-pyrazino[2,1-a]++ +isoquinolin- 4-one, EMBAY 8440, Biltricide) has been used in 4853 patients with Opisthorchis viverrini infection. 786 patients were treated as inpatients with extensive clinical evaluation and the rest were out-patients. A cure rate (evaluated with 5 faecal samples) of 100% was obtained in groups given 6 X 25 mg/kg on 2 days and 3 X 25 mg/kg on 1 day, while in groups given 2 X 25 mg/kg, 1 X 25 mg/kg and 1 X 40 mg/kg all on 1 day the cure rates were 88, 44 and 91%, respectively. With one sample evaluation the parasitological cure rate was 96% in further 96 patients excreting the geometric mean (GM) of 5394 eggs per gram (EPG) and receiving 1 X 40 mg/kg. Another 68 patients with an egg output of 26044 (GM/EPG) and treated with 1 X 50 mg/kg showed a cure rate of 97% by similar evaluation. Side effects were mild and transient and were more frequent in higher dosage groups. They included anorexia, nausea, vomiting, abdominal pain, epigastric pain, rumbling in the abdomen, diarrhoea, lassitude, myalgia, headache, dizziness, sleeplessness, sleepiness, "hot sensation", shortness of breath, and skin rash in a few cases. Headache (30.7%) was most common in the 6 X 25 mg/kg group. In 53 patients with severe jaundice the side effects were similar. There was no evidence of toxicity. Remarkable was one patient treated with 1 X 50 mg/kg who expelled 5636 O. viverrini worms, most of which were elongated and damaged. When a single dose is prescribed it should be given at bed time to reduce the side effect of sedation.
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PMID:Opisthorchis viverrini: clinical experience with praziquantel in Hospital for Tropical Diseases. 654 86

108 patients coming to France from Southeast Asia were treated with praziquantel (2-cyclohexylcarbonyl-1,2,3,6,7,11b-hexahydro-4H-pyrazino[2,1-a] isoquinolin-4-one, EMBAY 8440, Biltricide) for opisthorchiasis. All patients, 31 children and 77 adults, were examined at the Department of Parasitic Diseases 30 to 90 days after arrival in France. They came from Laos (79 cases), Viet Nam (4 cases) and Cambodia (25 cases), generally via Thailand. 6 heavy (10 000-19 999 eggs per gram of faeces, EPG), 23 moderate (1000-9999 EPG) and 79 light infections (1-999 EPG) were detected. Praziquantel was given at a dose of 25 mg/kg body weight, three times on a single day at intervals of 4 h. The biological tolerability was excellent without any variation of the biological norm values (47 parameters). Clinical tolerability was perfect in 48 patients and pretty good in the 60 remaining cases. We only observed, for one or two days, lassitude, headache, drowsiness, nausea, epigastric pain or arthralgia-myalgia always of weak or moderate intensity. The therapeutic efficacy is remarkable with 100% cure in all patients who were followed-up for 90 days. All earlier controls (7th, 20th, 40th days) were always negative except for one child with a light infection still weakly positive at the 7th, 20th and 40th day controls but negative, too, after 90 days.
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PMID:Therapeutic results in opisthorchiasis with praziquantel in a reinfection-free environment in France. 654 88

Six species of Paragonimus have been reported in Thailand: P. siamensis in cat, bandicoot and rat; P. bangkokensis in mongoose; P. harinasutai in cat and dog (experiment); P. macrochis in bandicoot and rat; P. westermani in tiger and P. heterotremus in cat, dog and man. It is interesting to note that in 1965 two immature P. heterotremus worms were recovered for the first time in man, namely in subcutaneous swellings in a boy; in 1981 nine mature P. heterotremus worms were expectorated after praziquantel treatment. P. heterotremus has been postulated to be the main cause of human paragonimiasis in Thailand. The clinical manifestation of paragonimiasis heterotremus is similar to paragonimiasis westermani. In the 1960's and 1970's bithionol was used to treat paragonimiasis, the cure rate was only 50-60%, and side effects including urticaria, rash, abdominal pain, nausea, vomiting, diarrhoea and dizziness were common. In the past 4 years, niclofolan and praziquantel (2-cyclohexyl-carbonyl-1,2,3,6,7,11b-hexahydro - 4H - pyrazino [2,1-a]isoquinolin-4-one, EMBAY 8440, Biltricide) have been used. A single dose of 2 mg/kg body weight of niclofolan yielded 100% cure rate. Praziquantel at dosages of 3 X 25 mg/kg body weight daily for one day and two days gave 80% and 100% cure rates, respectively. The eggs disappeared in 2-3 weeks with improvement of symptoms and signs, but radiologically lesions took a few months or more to clear, depending on size and severity. Side effects in the niclofolan group were higher; in the praziquantel group side effects were minimal and no toxic effects were detected.
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PMID:Paragonimus heterotremus and other Paragonimus spp. in Thailand: pathogenesis, clinic and treatment. 654 91

Among 810 parasitologically examined persons (1981) 277 (34%) showed positive findings. The high percentage of parasitisation in foreigners (86%) is to be explained by the in most cases aimed transfer of these patients (215 of the 810 persons). Affection with Schistosoma was recognized in 51 patients at the age of 17-47 years (means = 21.86), without Africans, and stood in the 3rd place of the distribution of frequency of the heterogeneous parasitoses. 49 of these patients came from Mozambique, 1 from Namibia and 1 from Zambia. In 51% S. haematobium was diagnosed, in 22% S. mansoni and in 27% a double infestation with the two forms of parasites. While 80% of the patients with affection of S. haematobium showed clinical symptoms (macrohaematuria, cystitis complaints), there were only 44% among the S. mansoni group. 47 patients were treated with Niridazole (Ambilhar, 25 mg/kg, 5-7 days), 2 patients with Praziquantel (Biltricide, 40 mg/kg, 1 day) and 2 other patients with Praziquantel after unsuccessful Niridazole therapy. Follow-up examinations were performed after 1, 3, 6 and 12 months. In 17% of the patients treated with Niridazole the primary treatment did not lead to cure; side effects (abdominal pain, nausea, vertigo) were observed in 55%. Praziquantel was tolerated very well. During a control period of 1 year living eggs of Schistosoma were no more proved.
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PMID:[Clinical aspects and therapy of schistosomiasis]. 661 96

2-Cyclohexylcarbonyl-1,2,3,6,7,11b-hexahydro-4H-pyrazino [2,1-a]isoquinolin-4-one (praziquantel, EMBAY 8440, Biltricide) was administered to 78 patients aged from 6 to 18 years. They were divided into 3 groups, receiving single doses of 30 mg and 40 mg/kg b.w. and 2 doses of 20 mg/kg b.w. (at an interval of 6 h), respectively. Tolerance examinations showed that 65% of the patients treated did not complain of any side effects. The remaining patients mentioned abdominal pain, headache and/or nausea. All these symptoms disappeared within a few hours without special treatment. Compared with pretreatment results, clinical examinations after treatment did not reveal any significant changes of haematocrit, haemoglobin, transaminases and bilirubin. Follow-up urine examinations were carried out 6 months after treatment in 71 children, of whom 68 were found to be no longer excreting viable eggs of Schistosoma. This corresponds to a parasitological cure rate of 95.8%. In the three patients who were not cured the number of eggs excreted was reduced by 89.2%. No statistically significant difference in efficacy was recorded between the three doses administered. Praziquantel appears to be an effective, well tolerated and easily administrable schistosomicide and thus a favourable contribution to the control of urinary schistosomiasis.
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PMID:[Trial of praziquantel in the treatment of urinary schistosomiasis in Senegal]. 719 48

In case of nonspecific, not constantly occurring abdominal symptoms the investigator should be aware of invermination, especially when immigrants or tourists returning from far regions complain about diarrheal tendency, stomach ache, nausea or hepatic and biliary symptoms. Intestinal helminthism is spread all over the world. Some of these diseases are limited to warm regions, but they are more and more often seen in our gastroenterological outpatient departments. Nematodes are found most frequently, with a predominance of Ascaris, Trichuris, and Enterobius. But Ancylostoma and Strongyloides are not seldom, too. Concerning Cestodes, Taenia and Vampirolepis are predominant. Trematodes = Fasciola, Echinostoma, Schistosoma are less frequent. Larva migrans, Acanthocephala and Dipylidium sometimes cause considerable diagnostive problems. Classification of macroscopic and microscopic findings is decisive for the therapeutic strategy. For nematodiasis Mebendazole (Vermox, Surfont), Pyrantelembonate (Helmex), Pyrviniumembonate (Molevac, Pyrcon) are effective. Albendazole (Eskazole) is approved for strongyloidiasis. For cestodiasis Niclosamid (Yomesan) and Praziquantel (Cesol) are suited. Higher doses of Praziquantel (Biltricide) are recommended for trematodiasis. During pregnancy and lactation period absorbable anthelmintics have to be avoided.
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PMID:[Intestinal helminthiasis--general practice problem of the gastroenterologist]. 897 89

Neurocysticercosis, the most common parasitic disease of the central nervous system, was treated surgically for a long time. Praziquantel (an isoquinolone) and albendazole (an imidazole) are anticysticercal drugs that are currently being used for the treatment of neurocysticercosis. Both have been reported to eliminate or markedly reduce the number and size of cysticerci. Albendazole is less expensive than praziquantel, and is as effective when given for 8 days as compared to longer periods. In a small number of comparative trials, albendazole appeared to be slightly more effective than praziquantel for the treatment of parenchymal cysticercosis. Albendazole has also been found effective in ventricular, subarachnoidal and racemose forms of the disease. However, the response to treatment is not universal. Treatment with these drugs has been associated with a high frequency of adverse reactions, probably due to the host's inflammatory reaction to the dying parasites. Headache, nausea and seizures are common but usually transient. Steroids appear to ameliorate these effects and their concomitant administration has been advocated. However, no data are available to support this view. The rationale of medical therapy in spinal cysticercosis is presently based on the reported efficacy of anticysticercal drugs in cerebral cysticercosis. A marked improvement in an associated seizure disorder following anticysticercal therapy has been observed. Though seizure control is better, the total duration of anti-epileptic drug therapy has not been determined. Some single enhancing computed tomography lesions in patients of epilepsy may be benign forms of neurocysticercosis. The spontaneous resolution of a majority of these lesions has led to doubts of them being merely infective in aetiology. Also, a controlled trial could not demonstrate any beneficial effect of albendazole on such lesions. Hence, most authors recommend that these patients should be treated with anti-epileptic drugs only. Doubts persist about the efficacy of anticysticercal drugs in altering the natural course of the disease and the reported tendency of cysticercus lesions to resolve.
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PMID:Drug treatment of neurocysticercosis. 932 40


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