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阿苯达唑与安慰剂治疗棘球蚴病的对比研究

Albendazole versus placebo in treatment of echinococcosis.

作者信息

Keshmiri M, Baharvahdat H, Fattahi S H, Davachi B, Dabiri R H, Baradaran H, Rajabzadeh F

机构信息

Department of Pulmonary Disease, Ghaem Hospital, Mashhad University of Medical Sciences, Iran.

出版信息

Trans R Soc Trop Med Hyg. 2001 Mar-Apr;95(2):190-4. doi: 10.1016/s0035-9203(01)90162-2.

Abstract

Echinococcus granulosus infection can have multiorgan involvement, and is common in Third-World countries. Uncontrolled studies show that albendazole can be effective in its treatment, but there are also reports of spontaneous resolutions. We therefore undertook a placebo-controlled double-blind parallel-group randomized study in Iran to evaluate the effect of albendazole on hydatid cysts. Twenty-nine patients with 240 cysts entered the study in 1994-95 and received either albendazole (400 mg twice a day, in 3 cycles of 6 weeks with 2 weeks between cycles) or placebo. At study completion, 172 and 31 cysts in the albendazole and placebo groups, respectively, were evaluable. In the treatment arm, 134 cysts showed improvement or cure compared to 4 in the placebo group (P < 0.001). Eighteen (82%) of 22 patients in the treatment arm showed either cure (8 patients) or improvement (10 patients); in the placebo group only 1 (14%) of 7 showed spontaneous improvement but no cure. Some patients with liver cysts after treatment showed increasing heterogeneity and density suggestive of inactive cysts. Patients with larger cysts and those with pulmonary involvement were better responders. Age and gender had no effect on outcome. The observed results are encouraging, showing albendazole has good effect on hydatid cysts and should be offered to patients before surgical treatment is considered.

摘要

细粒棘球绦虫感染可累及多个器官,在第三世界国家较为常见。非对照研究表明阿苯达唑对其治疗可能有效,但也有自发缓解的报道。因此,我们在伊朗进行了一项安慰剂对照、双盲、平行组随机研究,以评估阿苯达唑对包虫囊肿的疗效。1994 - 1995年,29例患者的240个囊肿进入研究,分别接受阿苯达唑(每日2次,每次400mg,共3个疗程,每个疗程6周,疗程间间隔2周)或安慰剂治疗。研究结束时,阿苯达唑组和安慰剂组分别有172个和31个囊肿可进行评估。治疗组中,134个囊肿显示改善或治愈,而安慰剂组为4个(P < 0.001)。治疗组22例患者中有18例(82%)显示治愈(8例)或改善(10例);安慰剂组7例中只有1例(14%)显示自发改善但未治愈。一些肝囊肿患者治疗后显示异质性和密度增加,提示囊肿无活性。囊肿较大的患者和肺部受累患者反应较好。年龄和性别对结果无影响。观察结果令人鼓舞,表明阿苯达唑对包虫囊肿有良好疗效,在考虑手术治疗前应提供给患者。

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