Dhatri-Lauha治疗缺铁性贫血:一项前瞻性开放标签单臂多中心试验。

Ayu Pub Date : 2021-04-01 Epub Date: 2023-03-16 DOI:10.4103/ayu.ayu_379_21
Narayanam Srikanth, Bhogavalli Chandrasekhara Rao, Babita Yadav, Amit Kumar Rai, Sophia Jameela, Rakesh Kumar Rana, Richa Singhal, Shruti Khanduri, Bhagwan Sahai Sharma, Pratap Makhija
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引用次数: 1

摘要

背景:由于口服补铁的耐受性较差,印度的缺铁性贫血(IDA)负担仍然很高。因此,需要更多的注意力来探索传统医学治疗IDA的安全有效的选择。目的:评估Dhatri-Lauha治疗IDA患者的临床安全性和疗效。材料和方法:在12个中心进行了一项开放标签、前瞻性、单臂、多中心的试验,每个研究点的样本量为40名参与者。年龄在18-60岁的IDA患者,血红蛋白水平在6-10gm/dl范围内,平均红细胞体积(MCV)Dhatri-Lauha 500mg胶囊每天两次,餐后用温水给药45天。主要的结果测量是从基线到第45天血红蛋白(Hb%)水平的变化。次要转归指标包括MCV、MCHC、血清铁和铁蛋白水平的变化、不良事件的发生率以及安全性参数(肝肾功能测试)的变化。使用配对样本t检验比较了从基线到第45天的结果测量的平均(统计)变化。结果:在参与该研究的458名参与者中,有400人参与了最终分析。治疗45天后,Hb%、MCV、MCHC、血清铁蛋白和血清铁水平等结果参数存在显著差异(P<0.001)。平均Hb%从基线时的8.46±1.14 g/dl变化到第45天的9.18±1.61 g/dl(P<0.001)。研究期后LFT和KFT均在正常范围内。没有参与者因不良事件退出研究。结论:Dhatri-Lauha是一种安全的干预措施,有望改善IDA患者的血红蛋白水平、红细胞参数和铁储存。未来的随机对照试验,如果样本量更大,以标准护理为对照,随访时间更长,可能会产生更准确可靠的结果。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

<i>Dhatri Lauha</i> in the management of iron deficiency anemia: A prospective open-label single-arm multi-center trial.

Dhatri Lauha in the management of iron deficiency anemia: A prospective open-label single-arm multi-center trial.

Background: The burden of iron-deficiency anemia (IDA) remains persistently high in India due to the poor tolerability of oral iron supplementation. Therefore, more focus is required to explore traditional medicine for safe and effective options for managing IDA.

Aim: To assess the clinical safety and efficacy of Dhatri Lauha in patients with IDA.

Materials and methods: An open-label, prospective, single-arm, multi-center trial was conducted at 12 centers with a sample size of 40 participants per study site. Patients with IDA aged 18-60 years with hemoglobin levels in the range of 6-10gm/dl, mean corpuscular volume (MCV) <80 fl, mean corpuscular hemoglobin concentration (MCHC) <34 μg/dl, serum ferritin <30 μg/dl and serum iron <50 μg/dl were included in the study. Dhatri Lauha 500 mg capsule was administered twice daily with lukewarm water after meals for 45 days. The primary outcome measure was the change in hemoglobin (Hb%) level from baseline to day 45. Secondary outcome measures included the change in MCV, MCHC, serum iron and ferritin levels, incidence of adverse events, and change in safety parameters (liver and kidney function tests). The mean (statistical) change in outcome measures from baseline to day 45 was compared using a paired sample t-test.

Results: Out of 458 participants enrolled in the study, 400 contributed to the final analysis. A significant difference was observed in the outcome parameters such as Hb%, MCV, MCHC, serum ferritin, and serum iron levels (P < 0.001) after 45 days of treatment. Mean Hb% changed from 8.46 ± 1.14 g/dl at baseline to 9.18 ± 1.61 g/dl on day 45 (P < 0.001). LFT and KFT were within the normal limits after the study period. No participant withdrew from the study due to adverse events.

Conclusions: Dhatri Lauha is a safe intervention and can be expected to improve hemoglobin levels, red blood cell parameters, and iron stores in patients with IDA. Future RCTs with a larger sample size, standard care as control and a longer follow-up may produce more accurate and reliable results.

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