比较胰岛素快速溶解膜与对照组对嗅觉丧失患者改善其健康和社会生活质量的随机临床试验

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL Open Access Journal of Clinical Trials Pub Date : 2022-12-01 DOI:10.2147/oajct.s389489
Soad A Mohamad, S. M. Sayed, A. A. Sadek, A. Badawi
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引用次数: 0

摘要

背景:嗅觉异常是covid -19后疾病中最常见的疾病。尽管推荐了几种不同的治疗策略,但只有15%的患者完成了规定的治疗计划;这对患者的身体、社交和情感健康产生了不利影响。目的:与对照组相比,本研究的目的是批准鼻内速溶胰岛素膜作为嗅觉缺失的首选治疗方法,并根据患者的健康相关生活质量(HRQoL)评估新型治疗方法对covid -19后嗅觉缺失的治疗效果。方法:对40例成人病毒感染后嗅觉丧失患者进行随机临床试验,以进行治疗和评估。被招募的参与者是在2021年10月1日至3月8日之间根据预先确定的标准招募的。一份关于参与者嗅觉、身体和心理结果的有效嗅觉评估问卷被发给他们。纳入的患者随机分为干预组和对照组。干预组采用胰岛素鼻内膜治疗,对照组采用普通膜(安慰剂)治疗。结果:干预组患者连续治疗4周后,身体、情绪、社会健康生活质量较对照组有显著改善(p值<0.0001)。使用GraphPad Prism 9.1.0软件对数据进行统计分析。结论:胰岛素贴片治疗的新冠肺炎后嗅觉丧失患者的HRQoLs最低,显著影响患者的生活质量。建议采用这种新的干预措施(胰岛素膜)作为主要治疗方法,并收集更多的行业数据,以促进其发展和推广。与安慰剂相比,胰岛素干预显著提高了自我卫生、饮食、危险感和情绪满意度方面的问题。
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Randomized Clinical Trial Comparing Insulin Fast Dissolving Films versus Control Group for Anosmic Patients for Improving Their Health and Social Qualities of Life
Background: Olfactory anomalies are the most common diseases among post-COVID-19 disorders. Only 15% of patients completed their prescribed treatment plans, even though several different treatment strategies were recommended;this had a detrimental effect on the patients' physical, social, and emotional wellbeing.Purpose: The aim of this study was approving intranasal fast-dissolving insulin films as the treatment of choice for anosmia in comparison to the control group, and the innovative treatment for anosmic post-COVID-19 is assessed in terms of the patients' health-related quality of life (HRQoL).Methods: For therapy and evaluation, a randomized clinical trial with forty adult anosmic post-viral patients was performed. The recruited participants were recruited between October 1 and March 8 of 2021 based on predetermined criteria. A validated smell assessment questionnaire concerning the participants' olfactory, physical, and psychological outcomes was given to them. Recruited patients were randomly subdivided into two groups: intervention and control group. Intervention was treated with insulin intranasal films, while control group took plain films (placebo).Results: The physical, emotional, and social health quality of life were significantly (p-value <0.0001) improved after 4 consecutive weeks of treatment with the intervention group compared to the control group. The data were analyzed statistically with the aid of GraphPad Prism 9.1.0.Conclusion: The lowest HRQoLs, which significantly impact their quality of life, are found in post-COVID-19 anosmic patients treated with insulin films. It is advised to employ this new intervention (insulin films) as the main therapy approach and to gather additional industry data for its development and dissemination. Problems with self-hygiene, eating, sense of danger and emotional satisfaction were significantly enhanced with insulin intervention versus placebo.
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来源期刊
Open Access Journal of Clinical Trials
Open Access Journal of Clinical Trials MEDICINE, RESEARCH & EXPERIMENTAL-
CiteScore
3.90
自引率
0.00%
发文量
2
审稿时长
16 weeks
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