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吡喹酮治疗日本血吸虫病患者的剂量探索性双盲临床试验。

Dose finding double-blind clinical trial with praziquantel in schistosomiasis japonica patients.

作者信息

Chen M G, Hua X J, Wang M J, Xu R J, Yu C B, Jiang S B

出版信息

Southeast Asian J Trop Med Public Health. 1985 Jun;16(2):228-33.

PMID:3934764
Abstract

A double-blind clinical trial with praziquantel was carried out. A total of 400 cases was treated with four different dosages, namely, 60, 50, 40 and 30 mg/kg body weight of praziquantel. The drug was given in one day divided into two doses. Identical placebo tablets were used to make up a total of 60 mg/kg. Tolerance was good in all with the exception of one case suffering from asthmatic attack with papule rashes over large area of the body surface. 394 patients were able to be followed up parasitologically six months post-treatment. 79.8%, 71.7%, 78.8% and 70.1% of the patients were negative in the groups with the total dose of 60, 50, 40 and 30 mg/kg respectively. The cure rates as well as the side effects were similar for the four groups. The efficacy was lower than that reported by other authors and the possibility of reinfection was incriminated. In villages with few snails the negative hatching rates in aforementioned four groups were 89.1%, 91.1%, 88.9% and 81.8%, while in villages with abundant snails the rates were 68.2%, 46.5%, 66.7% and 54.8%. The difference between the two areas was statistically significant. Higher efficacy was observed in adults with an average cure rate of 80.0% than in children under 15 years of age, the average cure rate being 57.1%.(ABSTRACT TRUNCATED AT 250 WORDS)

摘要

开展了一项关于吡喹酮的双盲临床试验。总共400例患者接受了四种不同剂量的治疗,即每公斤体重60、50、40和30毫克的吡喹酮。药物在一天内分两次服用。使用相同的安慰剂片以凑成总共每公斤体重60毫克的剂量。除1例出现哮喘发作并伴有大面积体表丘疹性皮疹的病例外,所有患者耐受性良好。394例患者在治疗后6个月能够接受寄生虫学随访。总剂量为每公斤体重60、50、40和30毫克的组中分别有79.8%、71.7%、78.8%和70.1%的患者检测为阴性。四组的治愈率和副作用相似。疗效低于其他作者报道的情况,且怀疑有再次感染的可能性。在钉螺数量少的村庄,上述四组的阴性孵化率分别为89.1%、91.1%、88.9%和81.8%,而在钉螺数量多的村庄,这些比率分别为68.2%、46.5%、66.7%和54.8%。两个地区之间的差异具有统计学意义。观察到成年人的疗效较高,平均治愈率为80.0%,高于15岁以下儿童,其平均治愈率为57.1%。(摘要截选至250字)

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