Davis A, Biles J E, Ulrich A M
Bull World Health Organ. 1979;57(5):773-9.
Initial studies of the tolerance and efficacy of praziquantel in the treatment of human infections due to Schistosoma haematobium were conducted at the WHO Tropical Diseases Research Centre, Ndola, Zambia. The first stage of the trial was a double-blind assessment against placebo of the tolerance and efficacy of oral doses of 1x20, 2x20, or 3x20 mg/kg in patients with a minimum schistosome egg excretion of 50 per random 10-ml sample of urine. Later a single-blind trial was carried out of the efficacy of three oral doses, each of 20 mg/kg, given at 4-hour intervals, or of a single oral dose of 50 mg/kg.In 79 young Zambians with S. haematobium infections (and often other parasitic infections), patient tolerance to the drug was very good, only minor post-treatment symptoms of intermittent epigastric pain, anorexia, and headache being noted, all of short duration.No changes of clinical relevance were detected in the results of a battery of haematological and biochemical tests. Post-treatment eosinophilia occurred in 42% of drug-treated patients but also in 30% of those given placebo. Serial electrocardiograms revealed no changes of significance.At six months after treatment, of 73 patients followed up, only 1 case of parasitological failure was detected. At one year, 66 (83.5%) of 79 patients with S. haematobium infection were followed up and 2 (2.5%) parasitological failures were detected.Two years after treatment, 45 (57%) of 79 patients with S. haematobium showed negative urines, 7 (9%) had positive hatching tests, and 27 (34%) were absent.
关于吡喹酮治疗埃及血吸虫所致人体感染的耐受性和疗效的初步研究在世卫组织赞比亚恩多拉热带病研究中心开展。试验的第一阶段是针对安慰剂进行双盲评估,观察口服剂量为1×20、2×20或3×20毫克/千克的吡喹酮对每随机10毫升尿液中血吸虫卵排泄量最少为50个的患者的耐受性和疗效。后来又进行了一项单盲试验,观察每4小时间隔服用3次、每次20毫克/千克的口服剂量,或单次口服50毫克/千克的疗效。在79名感染埃及血吸虫(且常伴有其他寄生虫感染)的赞比亚年轻人中,患者对该药的耐受性非常好,仅出现轻微的治疗后症状,如间歇性上腹部疼痛、食欲不振和头痛,且持续时间均较短。一系列血液学和生化检查结果未发现具有临床意义的变化。42%接受药物治疗的患者治疗后出现嗜酸性粒细胞增多,但服用安慰剂的患者中这一比例也为30%。连续心电图检查未发现有意义的变化。治疗6个月后,在接受随访的73名患者中,仅检测到1例寄生虫学治疗失败病例。1年后,在79名感染埃及血吸虫的患者中,66名(83.5%)接受了随访,检测到2例(2.5%)寄生虫学治疗失败病例。治疗2年后,79名感染埃及血吸虫的患者中,45名(57%)尿液检测呈阴性,7名(9%)孵化试验呈阳性,27名(34%)失访。