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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

Praziquantel and oxamniquine were evaluated under operational conditions for use in mass-treatment campaigns in the Rusizi Plain, Burundi. After 6 weeks, the cure rates for oxamniquine at 20, 30 and 40 mg/kg in children (less than 20 years) were respectively 47%, 67% and 86%; in adults they were 86%, 97% and 97%. The egg reduction rates were over 98% in all groups. For praziquantel at 20, 30 and 40 mg/kg the cure rates in children were respectively 58%, 63% and 78%; in adults, 55%, 87% and 91%. The egg reduction rates were respectively 92%, 96%, 98% and 91%, 98%, 98%. These results were largely confirmed by a follow-up 3 months after treatment. Oxamniquine frequently caused important dizziness and drowsiness, and in 2 cases epileptiform seizures. The side effects of praziquantel were mainly mild transient colics and diarrhoea. The cost of oxamniquine (in Burundi) was twice to three times the cost of praziquantel. Because of its better acceptability and its lower cost, with only slightly less good parasitological results, praziquantel, at 40 mg/kg in a single dose, has been selected as the drug of choice for mass-treatment campaigns in Burundi.
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PMID:Field trials of praziquantel and oxamniquine for the treatment of schistosomiasis mansoni in Burundi. 312 65

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

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

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

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

Stool examination was performed on 2,083 Thai children from orphanages and primary schools. Hymenolepis nana infection was found only in children from orphanages with a prevalence of 13.12 per cent. Males had a statistically significant higher prevalence of infection than females. Most infected children were asymptomatic. In symptomatic infected children, the symptoms were mild and non-specific such as pruritus ani, abdominal pain, diarrhea, anorexia, headache, and dizziness. Praziquantel in a single oral dose of 25 mg/kg body weight was effective and well tolerated in Hymenolepis nana infected Thai children.
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PMID:Hymenolepis nana infection in Thai children. 1107 70

Praziquantel(Distocide), the Korean product, was tested for its safety and efficacy in treatment of Clonorchis sinensis infection during the period from April to September, 1983 in Korea. A total of 55 egg positive cases were selected and treated with the regimen of 25 mg/kg t.i.d. for 1 day (total 75 mg/kg). The follow-up stool examination was done in 47 cases by cellophane think smear and Stoll's egg counting techniques. The 8 uncured cases were treated again with the same regimen. The laboratory tests for blood picture and liver function were done in 27 cases and compared before and after the treatment. The results obtained are as follows: After single course treatment, the cure and egg reduction rates were 83.0% and 99.1% respectively. With the second treatment, excellent results of 100% in both rates were obtained. Several kinds of side effects such as dizziness, headache, etc. were complained by 29 cases (61.7%), however, those were so mild and transient that no special treatment was necessary. No significant chang in laboratory findings was recognizable before and after the treatment. From the above results, it is concluded that Distocide is as effective and safe as Biltricide(R) and highly recommendable in treatment of C. sinensis infection.
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PMID:Praziquantel(Distocide(R)) In Treatment Of Clonorchis Sinensis Infection. 1290 55

The present study was undertaken to determine the acceptablility, tolerance and effectiveness of praziquantel in a rural population infected with Clonorchis sinensis and to suggest the suitable dosages of praziquantel for the field use on a large scale. A total of 121 patients with proven C. sinensis infection were treated by two dosages with praziquantel at a single dose of 40 mg/kg bwt and 2 doses of 30 mg/kg bwt in a single day. A single dose of 40 mg/kg bwt were given to 60 patients and 2 x 30mg/kg bwt were given to 61 patients. Follow-up examinations were carried out at about 30 and 60 days after treatment. Two months after therapy, 13(21.7%) of 60 patients who received a single dose of 40 mg/kg bwt were cured completely. Among these cured patients, 9(75.0%) out of 12 cases of light and only 4 out of 48 cases of moderate or heavy infection groups were cured. But in the non-cured cases the overall egg reduction rate was 89.1%. On the other hand, 36(59.0%) out of 61 patients treated with 2 x 30 mg/kg bwt were cured at 60 days after treatment. Among these cured patients, all of the 13 cases of light infection and 18(69.2%) out of 26 cases of moderate and 5(23.8%) out of 21 cases of heavy infection groups were cured completely at 60 days after therapy. However the overall egg reduction rate was 95.2% in the non-cured cases. Praziquantel is well tolerated and side effects consist particularly of mild and transient headache, dizziness and abdominal discomfort, etc. However there was no difference in regard to frequency and intensity of untoward side effects between the two dosage groups. The results obtained in this study suggest that a single dose of 40 mg/kg bwt for light infection, 2 x 30 mg/kg bwt for moderate infection and 3 x 25 mg/kg bwt for heavy infection groups will be recommended for the field use on a large scale.
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PMID:Therapeutic field trial with praziquantel (Biltricide(R)) in a rural population infected with Clonorchis sinensis. 1290 92

A total of 52 paragonimiasis patients was treated with praziquantel at three dose levels: 21 patients received 3 x 25.0 mg/kg bwt on a single day, 21 patients were treated with 3 x 25.0 mg/kg for 2 consecutive days and 10 patients were treated with the same dose for 3 consecutive days. Follow-up examination were carried out at monthly up to 4 months (120 days) after treatment. Fifteen (71.4%) out of 21 patients who received the drug 3 x 25.0 mg/kg bwt on a single day were parasitologically cured. Eighteen (85.7%) out of 21 patients who received 3 x 25.0 mg/kg bwt for 2 consecutive days were also cured. Six and 3 of uncured cases in each above groups were treated again with doses of 3 x 25.0 mg/kg bwt for 2 or 3 consecutive days. Two (consisting each one in each group ) of nine retreated cases were failed in parasitological cure. Therefore the overall cure rates of 95.2 % (20 out of 21 cases) in each group were finally obtained. On the other hand, in 10 patients who received 3 x 25.0 mg/kg bwt for 3 consecutive days, complete cure was obtained at 4 months follow-up examinations. Praziquantel is well tolerated and side effects consist particularly of mild and transient headache and dizziness. There was no great difference between the three dosage groups. Extended hematological and biochemical tests, and urinalysis, revealed no abnormal findings which could be related to the compound after therapy. The disappearance of precipitating bands of immunoelectrophoresis together with the disappearance of abnormal shawdows in chest X-ray after treatment gave a potent proof on assuring the cure of paragonimiasis.
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PMID:Clinical Evaluation Of Praziquantel(Embay 8440; Biltricide(R)) In The Treatment Of Paragonimus Westermani. 1290 16


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