Abstract：
BACKGROUND: Dehydration due to reduced intake or increased losses including insensible losses in patients with acute nondiarrheal diseases may lead to fluid, electrolytes, and energy (FEE) deficits. The impact of oral FEE supplementation adjuvant to standard of care (SOC) treatment on recovery in patients with acute nondiarrheal diseases is yet to be evaluated.
OBJECTIVE: To determine the effectiveness of ORSL® variants (ORSL® Apple Drink and ORSL® PLUS Orange Drink), fruit juice-based electrolyte drinks as an adjuvant along with SOC in the restoration of oral FEE in patients with acute nondiarrheal disease with fever and/or general weakness who attended an outpatient department (OPD).
METHODS: This was a prospective, interventional, open-label, multicenter, real-world, study conducted at eight sites across India. Patients with fever and/or general weakness due to an acute nondiarrheal illness were given either ORSL® Apple Drink or ORSL® PLUS Orange Drink as an adjuvant along with SOC treatment per physician\'s discretion. The primary endpoint of the study was to assess improvement from baseline in energy or hydration levels after ORSL® variants consumption at 6, 24, and 48 hours measured by a new aided recovery scale (ARS). Secondary endpoints were to assess the improvement in energy and hydration levels at 20, 40, and 60 minutes, as well as energy levels and hydration levels at 20, 40, and 60 minutes, 6, 24, and 48 hours after the consumption of ORSL® Apple Drink or ORSL® PLUS Orange Drink. The patient\'s consumption of ORSL® variants and treatment experience, physician\'s experience of recommending ORSL® variants, and product safety were evaluated.
RESULTS: In total, 612 patients were enrolled with mean age 38.3 years, of whom 62.9% were male. The mean baseline level of energy and hydration was 1.59 (range 1.0-2.0) on ARS. Statistically significant (p < 0.0001) improvements were observed in energy or hydration 6 hours after first consumption of ORSL formulations. Furthermore, improvement was observed from 40 minutes, and in levels of energy, hydration, and both energy and hydration from 60 minutes. Patients and physicians reported a positive experience with ORSL® variants.
CONCLUSIONS: ORSL® Apple Drink and ORSL® PLUS Orange Drink are clinically proven to provide hydration and/or energy to patients with fever and/or general weakness.
OBJECTIVE: To determine the effectiveness of ORSL® variants (ORSL® Apple Drink and ORSL® PLUS Orange Drink), fruit juice-based electrolyte drinks as an adjuvant along with SOC in the restoration of oral FEE in patients with acute nondiarrheal disease with fever and/or general weakness who attended an outpatient department (OPD).
METHODS: This was a prospective, interventional, open-label, multicenter, real-world, study conducted at eight sites across India. Patients with fever and/or general weakness due to an acute nondiarrheal illness were given either ORSL® Apple Drink or ORSL® PLUS Orange Drink as an adjuvant along with SOC treatment per physician\'s discretion. The primary endpoint of the study was to assess improvement from baseline in energy or hydration levels after ORSL® variants consumption at 6, 24, and 48 hours measured by a new aided recovery scale (ARS). Secondary endpoints were to assess the improvement in energy and hydration levels at 20, 40, and 60 minutes, as well as energy levels and hydration levels at 20, 40, and 60 minutes, 6, 24, and 48 hours after the consumption of ORSL® Apple Drink or ORSL® PLUS Orange Drink. The patient\'s consumption of ORSL® variants and treatment experience, physician\'s experience of recommending ORSL® variants, and product safety were evaluated.
RESULTS: In total, 612 patients were enrolled with mean age 38.3 years, of whom 62.9% were male. The mean baseline level of energy and hydration was 1.59 (range 1.0-2.0) on ARS. Statistically significant (p < 0.0001) improvements were observed in energy or hydration 6 hours after first consumption of ORSL formulations. Furthermore, improvement was observed from 40 minutes, and in levels of energy, hydration, and both energy and hydration from 60 minutes. Patients and physicians reported a positive experience with ORSL® variants.
CONCLUSIONS: ORSL® Apple Drink and ORSL® PLUS Orange Drink are clinically proven to provide hydration and/or energy to patients with fever and/or general weakness.
摘要：
背景：急性非腹泻病患者由于摄入减少或损失增加（包括感觉不到的损失）而导致脱水，电解质，和能源（FEE）赤字。口服FEE补充剂对标准护理（SOC）治疗对急性非腹泻病患者康复的影响尚待评估。
目的：为了确定ORSL®变种（ORSL®苹果饮料和ORSL®PLUS橙饮料）的有效性，在门诊（OPD）的急性非腹泻病伴发烧和/或全身无力患者中，以果汁为基础的电解质饮料作为辅助药物，并与SOC一起恢复口服FEE。
方法：这是一个前瞻性的，介入,开放标签，多中心，真实世界,在印度的八个地点进行的研究。因急性非腹泻疾病而发热和/或全身无力的患者，根据医生的判断，给予ORSL®苹果饮料或ORSL®PLUSOrange饮料作为辅助治疗，并给予SOC治疗。研究的主要终点是评估通过新的辅助恢复量表（ARS）测量的ORSL®变体在6、24和48小时消耗后能量或水合水平相对于基线的改善。次要终点是评估20、40和60分钟时能量和水合水平的改善，以及20、40和60分钟的能量水平和水合水平，食用ORSL®苹果饮料或ORSL®PLUS橙汁饮料后6、24和48小时。患者对ORSL®变体的消耗和治疗经验，医师推荐ORSL®变体的经验，并对产品安全性进行了评价。
结果：总计，纳入612例患者，平均年龄38.3岁，其中62.9%为男性。ARS的能量和水合的平均基线水平为1.59(范围1.0-2.0)。在首次消耗ORSL制剂后6小时,在能量或水合方面观察到统计学上显著(p<0.0001)的改善。此外，从40分钟开始观察到改善，在能量水平上，水合作用,以及60分钟内的能量和水合作用。患者和医生报告了ORSL®变体的积极经验。
结论：ORSL®AppleDrink和ORSL®PLUSOrangeDrink经临床证明可为发烧和/或全身无力的患者提供水合和/或能量。
目的：为了确定ORSL®变种（ORSL®苹果饮料和ORSL®PLUS橙饮料）的有效性，在门诊（OPD）的急性非腹泻病伴发烧和/或全身无力患者中，以果汁为基础的电解质饮料作为辅助药物，并与SOC一起恢复口服FEE。
方法：这是一个前瞻性的，介入,开放标签，多中心，真实世界,在印度的八个地点进行的研究。因急性非腹泻疾病而发热和/或全身无力的患者，根据医生的判断，给予ORSL®苹果饮料或ORSL®PLUSOrange饮料作为辅助治疗，并给予SOC治疗。研究的主要终点是评估通过新的辅助恢复量表（ARS）测量的ORSL®变体在6、24和48小时消耗后能量或水合水平相对于基线的改善。次要终点是评估20、40和60分钟时能量和水合水平的改善，以及20、40和60分钟的能量水平和水合水平，食用ORSL®苹果饮料或ORSL®PLUS橙汁饮料后6、24和48小时。患者对ORSL®变体的消耗和治疗经验，医师推荐ORSL®变体的经验，并对产品安全性进行了评价。
结果：总计，纳入612例患者，平均年龄38.3岁，其中62.9%为男性。ARS的能量和水合的平均基线水平为1.59(范围1.0-2.0)。在首次消耗ORSL制剂后6小时,在能量或水合方面观察到统计学上显著(p<0.0001)的改善。此外，从40分钟开始观察到改善，在能量水平上，水合作用,以及60分钟内的能量和水合作用。患者和医生报告了ORSL®变体的积极经验。
结论：ORSL®AppleDrink和ORSL®PLUSOrangeDrink经临床证明可为发烧和/或全身无力的患者提供水合和/或能量。
