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脂质体阿苯达唑与片剂阿苯达唑治疗肝囊性棘球蚴病的比较评价:一项非随机临床试验。

Comparative Evaluation of Liposomal Albendazole and Tablet-Albendazole Against Hepatic Cystic Echinococcosis: A Non-Randomized Clinical Trial.

作者信息

Li Haitao, Song Tao, Shao Yingmei, Aili Tuergan, Ahan Ayifuhan, Wen Hao

机构信息

From the State Key Lab Incubation Base of Xinjiang Major Diseases Research (2010DS890294) and Xinjiang Key Laboratory of Echinococcosis (HL, TS, YS, TA, AA, HW); Hepatobiliary & Hydatid Department, Digestive and Vascular Surgery Centre (HT, TA, AA, HW); and Department of Ultrasonography, First Affiliated Hospital, Xinjiang Medical University, Urumqi, China (TS, YS).

出版信息

Medicine (Baltimore). 2016 Jan;95(4):e2237. doi: 10.1097/MD.0000000000002237.

Abstract

In this study, we aimed to compare the clinical efficacy of liposomal albendazole (L-ABZ) and tablet-albendazole (T-ABZ) for the treatment of human hepatic cystic echinococcosis (CE). Sixty patients with single cyst (CE1) or daughter cyst (CE2) were included in this study and were nonrandomly divided into the L-ABZ group (n = 30, 10  mg/kg per day, p.o., b.i.d.) and T-ABZ group (n = 30, 12-20 mg/kg per day, p.o., b.i.d.), respectively. The treatment duration lasted for 6 months, during which dynamic follow-up was carried out to evaluate the clinical efficacy through calculating the total effective rates (TERs). Measurement data and numerous data were analyzed by the chi-square test. Two-sided tests were performed for all the statistical tests. In our study, 2 patients were lost in the follow-up in the L-ABZ group. One patient was lost in the follow-up in the T-ABZ group, and 1 patient was withdrawal from the study due to receiving surgery. Significant difference was identified in the 3-month TERs of L-ABZ group and T-ABZ group (33.3% vs 76.7%, P < 0.05). Also, remarkable difference was noted in the 6-month TERs in the L-ABZ group and T-ABZ group (66.7% vs 93.3%, P = 0.01). No statistical difference was noticed in the incidence rate of adverse reactions in both groups (P > 0.05). Based on our study, both T-ABZ and L-ABZ are effective for treating human CE. The TER in the L-ABZ group is superior to that of T-ABZ.

摘要

在本研究中,我们旨在比较脂质体阿苯达唑(L-ABZ)和片剂阿苯达唑(T-ABZ)治疗人体肝囊型包虫病(CE)的临床疗效。本研究纳入了60例患有单囊(CE1)或子囊(CE2)的患者,他们被非随机分为L-ABZ组(n = 30,每天10 mg/kg,口服,每日两次)和T-ABZ组(n = 30,每天12 - 20 mg/kg,口服,每日两次)。治疗持续6个月,在此期间进行动态随访,通过计算总有效率(TERs)来评估临床疗效。计量资料和计数资料采用卡方检验进行分析。所有统计检验均进行双侧检验。在我们的研究中,L-ABZ组有2例患者在随访中失访。T-ABZ组有1例患者在随访中失访,1例患者因接受手术退出研究。L-ABZ组和T-ABZ组3个月时的TERs存在显著差异(33.3%对76.7%,P < 0.05)。此外,L-ABZ组和T-ABZ组6个月时的TERs也有显著差异(66.7%对93.3%,P = 0.01)。两组不良反应发生率无统计学差异(P > 0.05)。基于我们的研究,T-ABZ和L-ABZ治疗人体CE均有效。L-ABZ组的TER优于T-ABZ组。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c224/5291548/44c1b41afb5d/medi-95-e2237-g001.jpg

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