一项前瞻性上市后监测(PMS)研究,旨在监测固定剂量联合盐酸曲普利定2.5 mg和盐酸苯肾上腺素5mg [Recofast片]对上呼吸道感染患者症状缓解的安全性

Sachin Madhukar Kadoo, Preksha Pramod Patil
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引用次数: 0

摘要

上呼吸道感染是人类最常见的疾病。绝大多数急性上呼吸道感染是由病毒引起的。这些会引起各种患者疾病,包括急性支气管炎、普通感冒、流感和呼吸窘迫综合征。这项研究是在上呼吸道感染患者中进行的,以观察药物是否能缓解这些疾病的症状。其他疾病,如过敏性鼻炎和流感,也包括在症状缓解的研究中。这是一项开放标签、多中心、积极的上市后监测(PMS)研究,目的是评估Recofast片(盐酸Triprolidine IP 2.5 mg和盐酸Phenylephrine IP 5 mg)的固定剂量组合的安全性,该研究在来自不同地理区域的150名参与者中进行了评估。然后将结果记录下来。这些地区共有19例(13%)患者记录了轻微不良事件。150例患者中男性95例,女性55例。所有患者年龄在18-80岁之间。在研究过程中没有观察到明显的不良事件,所有地区只有13%的患者记录了轻微的不良事件。因此,这种配方是完全安全有效的上呼吸道感染和过敏的管理。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
A prospective, post-marketing surveillance (PMS) study to monitor the safety of fixed dose combination of Triprolidine Hydrochloride IP 2.5 mg and Phenylephrine Hydrochloride IP 5 mg [Recofast Tablets] for the symptomatic relief in patients with upper respiratory tract infections
Upper Respiratory Tract Infection (URTI) is the most frequent illness in humans. The vast majority of acute upper respiratory tract infections are caused by viruses. These cause a variety of patient diseases including acute bronchitis, common cold, influenza, and respiratory distress syndromes.The study was conducted in patients with upper respiratory tract infections to see if the medication provides symptomatic relief in these conditions. Other conditions like allergic rhinitis and influenza were also included in the study for symptomatic relief.This is an open label, multicentric, active Post Marketing Surveillance (PMS) study with an objective to assess safety of fixed dose combination regarding Recofast tablets (Triprolidine Hydrochloride IP 2.5 mg and Phenylephrine Hydrochloride IP 5 mg) which was evaluated in 150 participants from different geographical regions. And then results were documented. A total of 19 (13%) patients recorded minor adverse event from these regions. Out of 150 patients 95 were male & 55 were female. All the patients were in the range of 18-80 years.No significant adverse events were observed during the course of the study, only 13% patients recorded minor adverse events from all regions. Thus this formulation is completely safe and effective in the management of Upper Respiratory Tract Infections and allergies.
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