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在印度南部本地治里,单剂量乙胺嗪(DEC)单独使用或与伊维菌素联合使用清除班氏吴策线虫微丝蚴血症的耐受性和疗效。

Tolerability and efficacy of single dose diethylcarbamazine (DEC) alone or co-administration with Ivermectin in the clearance of Wuchereria bancrofti microfilaraemia in Pondicherry, South India.

作者信息

Pani S P, Reddy G Subramanyam, Vanamail P, Venkatesvarlou N, Das L K, Vijayan A P

机构信息

Vector Control Research Centre (ICMR), Pondicherry.

出版信息

J Commun Dis. 2004 Dec;36(4):240-50.

Abstract

The tolerability and efficacy of single dose DEC (12mg/kg body weight) or co-administration of DEC (6mg/kg body weight) with Ivermectin (200 or 400 mcg/kg of body weight) was studied in 60 asymptomatic W. bancrofti microfilariae (Mf) carriers following a double blind randomized design. The drugs were tolerated well. The incidence of adverse reactions of DEC (85.0%), DEC + Ivermectin 200mcg (95.0%) and DEC + Ivermectin 400mcg (100%) did not vary significantly (P>0.05). The mean score of adverse reaction intensity due to DEC + Ivermectin 200mcg (1.41) was significantly higher compared to DEC (0.61) (P<0.05). However, there was no significant difference between and DEC +Ivermectin 400mcg (0.89) and DEC + Ivermectin 200mcg (1.41) and DEC + Ivermectin 400mcg and DEC. The major adverse reactions were fever, headache and myalgia in all groups. The incidence and intensity of the adverse reactions were maximum between 24 to 48 hours of post therapy. The haematological and biochemical parameters did not vary significantly between pre and 7-day post therapy values in any of the study groups (P>0.05). Efficacy was measured in terms of proportion of cases clearing microfilaraemia completely and reduction in geometric mean parasite density in comparison to pre therapy levels. At the end of one year, DEC with Ivermectin 400mcg group showed significantly higher efficacy in complete clearance of Mf (94.4%) than that of DEC with Ivermectin 200mcg (60.0%) or DEC alone (52.6%) (P<0.05). However, no significant difference was observed in reduction of geometric mean Mf density (99.9%, 99.7%, 99.5% respectively). In all the groups, the tolerability and efficacy of the drugs were independent of host age and gender.

摘要

采用双盲随机设计,对60名无症状的班氏丝虫微丝蚴携带者研究了单剂量乙胺嗪(12mg/kg体重)或乙胺嗪(6mg/kg体重)与伊维菌素(200或400μg/kg体重)联合使用的耐受性和疗效。药物耐受性良好。乙胺嗪(85.0%)、乙胺嗪+200μg伊维菌素(95.0%)和乙胺嗪+400μg伊维菌素(100%)的不良反应发生率无显著差异(P>0.05)。与乙胺嗪(0.61)相比,乙胺嗪+200μg伊维菌素所致不良反应强度的平均评分(1.41)显著更高(P<0.05)。然而,乙胺嗪+400μg伊维菌素(0.89)与乙胺嗪+200μg伊维菌素(1.41)以及乙胺嗪+400μg伊维菌素与乙胺嗪之间无显著差异。所有组的主要不良反应为发热、头痛和肌痛。不良反应的发生率和强度在治疗后24至48小时最高。任何研究组治疗前和治疗后7天的血液学和生化参数均无显著差异(P>0.05)。疗效通过完全清除微丝蚴血症的病例比例以及与治疗前水平相比几何平均寄生虫密度的降低来衡量。一年结束时,乙胺嗪+400μg伊维菌素组在完全清除微丝蚴方面的疗效(94.4%)显著高于乙胺嗪+200μg伊维菌素组(60.0%)或单独使用乙胺嗪组(52.6%)(P<0.05)。然而,在几何平均微丝蚴密度降低方面未观察到显著差异(分别为99.9%、99.7%、99.5%)。在所有组中,药物的耐受性和疗效与宿主年龄和性别无关。

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