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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

Two of three members (a 29-year-old man [case 1] and a 26-year-old woman [case 2]) of a tourist party to the tropics (Mali) developed a high fever (less than or equal to 40 degrees C), headache, cough, weight loss (less than or equal to 5 kg) and tiredness 3-4 weeks after returning to Germany. In case 1, acute schistosomiasis was tentatively diagnosed as the cause because he reported an attack of dermatitis after exposure to fresh water in an endemic schistosomiasis region and had marked eosinophilia (2118/microliters; 28%) on admission. Serological tests were positive (ELISA with adult antigen, O.D. 0.65 [normal less than 0.15]; with egg antigen O.D. 1.73 [normal less than 0.30], antibody titre in the immunofluorescence test 1:320 [normal less than 1:80]) supported the diagnosis and it was confirmed by demonstrating the parasite, Schistosoma mansoni, in stool but not urine. Findings in case 2 were similar. The third member of the group [case 3], a 58-year-old woman, was symptom-free, but tests revealed schistosomiasis. All three patients were treated with a single dose of Praziquantel (40 mg/kg). A second course of praziquantel (single dose of 40 mg/kg as well as 20 mg/kg three times daily for 3 days) became necessary in case 1, while in case 3 a further single dose of 40 mg/kg was given to ensure a parasite-free state. A follow-up scheme is suggested: clinical examination with white cell and differential counts 1, 3, 6 and 12 months after treatment; three stool and/or urine examinations 3, 6 and 12 months after treatment.
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PMID:[Acute schistosomiasis in travellers to the tropics]. 160 Aug 68

Twenty-five patients with cerebral cysticercosis admitted to the Bangkok Hospital for Tropical Diseases from March 1987 to November 1989 were studied. The patients had a mean age of 41 +/- 5 years with a mean body weight of 57 +/- 4 kgs. Male to female ratio was 1.5:1. Eight patients (32%) gave a history of having taeniasis with a mean duration of 3.6 years before having symptoms of cerebral cysticercosis. Six patients (24%) also had subcutaneous cysticercosis with a duration of 20 +/- 8 months. The important clinical symptoms were headache, focal seizure, epilepsy and dementia. Fourteen patients (56%) had headache, 12 patients (48%) had focal seizure and four patients (16%) had a mild degree of dementia. Baseline study included routine blood examination, biochemical tests, cerebrospinal fluid for routine examinations and immunological study. Biopsy of subcutaneous cysts, plain films of soft tissue and computerized tomography of brain. Praziquantel was given orally at a dosage of 45 mg/kg/day in 3 divided doses at 4-5 hour interval for 15 days. Patients who were taking anti-epileptic drugs before were permitted to continue their medications. The evaluation of results of treatment was done a year post treatment, ten patients (40%) were asymptomatic, 12 patients (48%) had much clinical improvement, their epileptic attack was controlled by 1-2 tablets of phenobarbital (1/2 g) at bedtime. Two patients (8%) had mild headache. One patient (4%) was not improved. Those patients with dementia were not improved.(ABSTRACT TRUNCATED AT 250 WORDS)
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PMID:The treatment of neurocysticercosis with praziquantel. 182 5

Thirty-three patients with confirmed cysticercosis, with or without cerebral involvement, were treated with praziquantel at a daily dose of 75 mg/kg tid for 3 to 10 consecutive days and evaluated for tolerance and therapeutic effects. For dermal cysticercosis, a daily dose of 75 mg/kg tid for 3 days is effective. The nodules disappeared in one to 12 months after treatment. Twenty out of 33 patients with cysticercosis had cerebral cysticercosis. Among these 20 cases, 13 had epileptic seizures, 6 had a combination of both epileptic seizures and intracranial hypertension, and one had headache. The efficacy of the treatment of cerebral cysticercosis was assessed by the frequency of convulsions before and after treatment, and by the disappearance or decreased densities of the cystic lesions at brain CT scanning (6 months follow up). A daily dose of 75 mg/kg tid for 7 to 10 days (total 525 to 750 mg/kg) seems to be effective for the treatment of cerebral cysticercosis. The concomitant oral administration of dexamethasone during the course of treatment was effective for preventing and minimizing side effects. Praziquantel was very well tolerated.
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PMID:Clinical evaluation of the therapeutic efficacy of praziquantel against human cysticercosis. 248 2

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

We evaluated praziquantel for therapy of active Schistosoma mansoni infection in 15 rural Egyptian males with hepatosplenic schistosomiasis. Criteria for inclusion in this study were two pre-treatment S. mansoni egg counts with a mean of greater than 100 eggs g-1 faeces and an enlarged spleen. Fourteen of 15 patients had hepatomegaly, five had ascites, and six had serum albumin below 3 g dl-1. Schistosoma haematobium infection (less than 10 eggs ml-1 urine) was present in three patients. Praziquantel was administered in a single oral dose of 30 mg kg-1 body weight. Eight of the 15 patients (53%) had mild and transient reactions in the form of fever (usually one day), gastrointestinal symptoms, headache and skin rash. Criteria for parasitological cure were the absence of live eggs in two stool samples and a negative rectal snip biopsy three months after therapy. Ten patients ceased to pass live eggs (cure rate 67%). For the five who were still passing live eggs there was a mean egg reduction of 95%. The three patients with S. haematobium demonstrated parasitological cures. We conclude that praziquantel is an effective and well tolerated drug for treatment of S. mansoni infection in patients with advanced hepatosplenic schistosomiasis, and it is the drug of choice for patients with coexisting S. haematobium infection.
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PMID:Praziquantel for treatment of schistosomiasis in patients with advanced hepatosplenomegaly. 393 36

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

Praziquantel (Embay 8440) was found to be effective in eliminating egg of Opishtorchis viverrini. from the stools of 49 patients. Two regimens were used: Group I patients received 25 mg/kg body weight three times daily after meals for two consecutive days: and Group II patients received 25 mg/kg body weight three times daily after meals for one day. In both groups eggs were not detected in the faeces by day 60 and up to 4-8 months post treatment. Mild transient side effects were present in approximately 80% of patients of Group I, with milder side effects reported in Group II. Severe diarrhoea was present on day 0 in one patient from each group. Side reactions included headache, dizziness, myalgia and lassitude, however, no laboratory evidence of toxicity was detected.
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PMID:Studies on the chemotherapy of human opisthorchiasis in Thailand: I. Clinical trial of praziquantel. 701 95


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