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口服甲硝唑与替硝唑治疗细菌性阴道病的随机、双盲、对照研究

Randomized, double-blind, comparative study of oral metronidazole and tinidazole in treatment of bacterial vaginosis.

作者信息

Raja Indu M, Basavareddy Asha, Mukherjee Deepali, Meher Bikash Ranjan

机构信息

Department of Pharmacology, Sri Venkateshwaraa Medical College, Puducherry, India.

Department of Pharmacology, Sri Devaraj Urs Medical College, Tamaka, Kolar, Karnataka, India.

出版信息

Indian J Pharmacol. 2016 Nov-Dec;48(6):654-658. doi: 10.4103/0253-7613.194843.

Abstract

OBJECTIVE

To compare the efficacy and tolerability of oral metronidazole and tinidazole in patients with bacterial vaginosis (BV) using Amsel's criteria.

PATIENTS AND METHODS

This was a randomized double-blind study, conducted by the Departments of Pharmacology and Gynecology of a tertiary care teaching hospital. Patients diagnosed with BV received either tablet metronidazole 500 mg twice daily for 5 days or tablet tinidazole 500 mg once daily + one placebo for 5 days and instructed to come for follow-up at the 1 week and 4 week. They were categorized as cured, partially cured, and not cured based on Amsel's criteria at the end of the study and compared between two groups using Chi-square test.

RESULTS

A total 120 women were enrolled in the study, of which 114 completed the study. The treatment arms were comparable. The cure rate with low-dose tinidazole was significantly more compared to metronidazole at 4 week ( = 0.0013), but not at 1 week ( = 0.242). The adverse drug reactions were less with tinidazole compared to metronidazole.

CONCLUSION

Tinidazole at lower dose offers a better efficacy than metronidazole in long-term cure rates and in preventing relapses with better side effect profile.

摘要

目的

采用阿姆塞尔标准比较口服甲硝唑和替硝唑治疗细菌性阴道病(BV)患者的疗效和耐受性。

患者与方法

这是一项由三级护理教学医院的药理学和妇科部门开展的随机双盲研究。被诊断为BV的患者接受以下治疗:甲硝唑片500毫克,每日两次,共5天;或替硝唑片500毫克,每日一次加一片安慰剂,共5天,并被要求在1周和4周时前来随访。在研究结束时,根据阿姆塞尔标准将她们分为治愈、部分治愈和未治愈,并使用卡方检验在两组之间进行比较。

结果

共有120名女性参与该研究,其中114名完成了研究。各治疗组具有可比性。低剂量替硝唑在4周时的治愈率显著高于甲硝唑(P = 0.0013),但在1周时并非如此(P = 0.242)。与甲硝唑相比,替硝唑的药物不良反应更少。

结论

低剂量替硝唑在长期治愈率和预防复发方面比甲硝唑疗效更好,且副作用更小。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/303a/5155465/0964f6892408/IJPharm-48-654-g001.jpg

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