Sustained-releasing praziquantel (SRP) tablet was designed for single dose treatment regimen of clonorchiasis. A previous pre-clinical study confirmed its sustained-releasing characteristics and a better cure rate than conventional praziquantel (PZQ). In this clinical study, the pharmacokinetics of this SRP tablet were investigated in human volunteers (phase 1; 12 volunteers), and its curative efficacy was examined in clonorchiasis patients (phase 2; 20 volunteers). In the phase 1 clinical study, blood concentrations of both tablets showed wide individual variation. The AUC(last) of SRP was 497.9+/-519.0 ng.hr/ml (mean+/-SD) and PZQ of 628.6+/-695.5 ng.hr/ml, and the AUC(inf) of SRP was 776.0+/-538.5 ng.hr/ml and of PZQ 658.6+/-709.9 ng.hr/ml. C(max) values of SRP and PZQ were 90.7+/-82.2 ng/ml and 214.9+/-251.9 ng/ml, and T(max) values were 3.42+/-1.43 hr and 1.96+/-1.23 hr, respectively. SRP tablets showed similar AUC values, but lower C(max) and longer T(max) values than PZQ. In the phase 2 study, SRP at 30 mg/kg (single dose) achieved a 60% cure rate and a 95.5% egg reduction rate. The cure rate of a single dose SRP was unsatisfactory compared with that of the conventional PZQ dose, but much better than that achieved by a single dose PZQ.
*Praziquantel/adverse effects/pharmacokinetics/therapeutic use ; Parasite Egg Count ; Male ; Humans ; *Delayed-Action Preparations/pharmacokinetics/therapeutic use ; Clonorchis sinensis/*drug effects/isolation & purification ; Clonorchiasis/*drug therapy ; Area Under Curve ; *Anthelmintics/adverse effects/pharmacokinetics/therapeutic use ; Animals ; Adult

One coastal village in Haenam-gun and two in Yeongam-gun, Jeollanam-do were surveyed for intestinal parasite infections by fecal examination. The egg positive rates of Gymnophalloides seoi were high, 24.1% (14/58) in Haenam-gun and 9.3% (11/118) in Yeongam-gun. The egg positive rates of heterophyids, including Heterophyes nocens, and of Clonorchis sinensis were 10.3% and 6.9% in Haenam-gun, and 14.4% and 8.5% in Yeongam-gun, respectively. After praziquantel treatment and purgation, a total of 37,761 fluke specimens were recovered from 17 patients; 11 in Haenam-gun and 6 in Yeongam-gun. Gymnophalloides seoi was the most commonly recovered species, with 37,489 specimens in total (2,205 per person). Other recovered flukes included Heterophyes nocens, Stictodora fuscata, Heterophyopsis continua, Pygidiopsis summa, and undetermined species. These results indicate that the areas surveyed are new endemic foci of G. seoi.
Trematode Infections/drug therapy/*epidemiology/parasitology ; Trematoda/*classification/drug effects/*isolation & purification ; Prevalence ; Praziquantel/administration & dosage ; Parasite Egg Count/methods ; Middle Aged ; Male ; Korea/epidemiology ; Humans ; Heterophyidae/isolation & purification ; Female ; Feces/parasitology ; Clonorchis sinensis/isolation & purification ; Anthelmintics/administration & dosage ; Animals ; Aged, 80 and over ; Aged ; Adult

Praziquantel is the drug of choice for clonorchiasis. Since clonorchiasis is endemic in most river basins, praziquantel has been widely used for 30 years in Korea. A 54-year-old Korean woman suffered from hypersensitive reactions, such as nausea, dyspnea, rash, and urticaria after taking the first dose of praziquantel to treat clonorchiasis. She ingested one dose again and the same symptoms appeared, and she was treated at a clinic with anti-histamines. She tried one more dose with anti-histamines but found the same symptoms. Later, she was found to pass eggs of Clonorchis sinensis and medicated with flubendazole. The hypersensitive reaction to praziquantel is rare but occurs. This is the 5th case report in the world.
Animals ; Anthelmintics/*administration & dosage/*adverse effects ; Clonorchiasis/*complications/*drug therapy ; Clonorchis sinensis/isolation & purification ; Drug Hypersensitivity/*diagnosis/drug therapy/pathology ; Feces/parasitology ; Female ; Histamine Antagonists/administration & dosage ; Humans ; Mebendazole/administration & dosage/analogs & derivatives ; Middle Aged ; Praziquantel/*administration & dosage/*adverse effects ; Republic of Korea

We describe an unusual presentation of Clonorchis sinensis infection with obstructive jaundice due to duodenal papillitis which was relieved dramatically by endoscopic sphincterotomy. A 26-yr-old male presented with complaints of fatigue, weight loss and painless jaundice. The history was significant for frequent ingestion of raw freshwater fish. The patient underwent endoscopic retrograde cholangiopancreatography for evaluation of obstructive jaundice. The duodenal papilla was markedly edematous with a bulging configuration and hyperemic changes at the orifice. Cholangiography revealed mild bile duct dilatation and irregular wall changes with multiple indentations. However, there were no biliary stricture or stones noted as the cause of obstructive jaundice. We performed an endoscopic sphincterotomy for effective bile drainage through the duodenal papilla. After the sphincterotomy, the patient's jaundice was dramatically improved. Pathology of the duodenal papilla showed eosinophilic infiltration of the mucosa. Parasitic eggs, consistent with the diagnosis of C. sinensis, were found in the bile sample.
Adult ; *Ampulla of Vater ; Animals ; Anthelmintics/therapeutic use ; Bile/parasitology ; Cholangiopancreatography, Endoscopic Retrograde ; Cholangitis/*diagnosis/parasitology/pathology ; Clonorchiasis/*diagnosis ; Clonorchis sinensis/drug effects/isolation & purification ; Duodenum/pathology ; Humans ; Jaundice, Obstructive/*diagnosis/etiology ; Male ; Praziquantel/therapeutic use ; Sphincterotomy, Endoscopic ; Tomography, X-Ray Computed