CLINICAL AND PHARMACOKINETIC STUDY OF PRAZIQUANTEL IN EGYPTIAN SCHISTOSOMIASIS PATIENTS WITH AND WITHOUT LIVER-CELL FAILURE

The pharmacokinetics and therapeutic efficacy of praziquantel (Distoci de(R); Epico, El-Asher-Men-Ramadan City, Egypt) were studied in 40 pat ients with schistosomiasis mansoni and various degrees of hepatic dysf unction. The patients were allocated into four groups: the first inclu ded 10 patients with simple active schistosomiasis while the other thr ee were made up of patients with schistosomiasis associated with liver cirrhosis and splenomegaly according to Child's classification of hep atocellular function. Every patient was treated with 40 mg/kg of prazi quantel as a single oral dose. The efficacy of the drug was evaluated after two months by rectal snip examination. The pharmacokinetic param eters did not differ significantly between patients with simple active schistosomiasis (group 1) and those with hepatosplenomegaly with live r involvement but without ascites and jaundice (group 2). However, as liver cell dysfunction became more evident (groups 3 and 4), pharmacok inetic parameters of praziquantel such as the half-life of elimination , the half-life of absorption, the maximum concentration, the time to maximum concentration, and the area under the concentration-time curve increased proportional to the degree of hepatic insufficiency. Linear correlations were found between each of the these parameters on the o ne hand and hepatic function test results (total bilirubin, direct bil irubin, and serum albumin) on the other. In spite of these pharmacokin etic differences, the cure rates were 70%, 80%, 90%, and 90% in the fo ur groups, respectively. Although the incidence of side effects was hi gh (53%), such effects were transient and mild.