Hassanzad Maryam, Maleki Mostashari Keyvan, Ghaffaripour Hosseinali, Emami Habib, Rahimi Limouei Samane, Velayati Ali Akbar
Pediatric Respiratory Diseases Research Center (PRDRC), National Research Institute of Tuberculosis and Lung Disease (NRITLD), Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Chronic Respiratory Diseases Research Center (PRDRC), National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Galen Med J. 2019 Jun 28;8:e1350. doi: 10.31661/gmj.v8i0.1350. eCollection 2019.
We examined the efficiency and safety of a specific synbiotic compound, brand name Kidilact, in the treatment of asthma in children 12 years of age or younger.
This double-blinded, randomized, placebo-controlled clinical trial was conducted in Tehran, Iran, from May 22, 2016, to May 21, 2017. One hundred children, 12 years of age or younger, who suffered from mild to moderate asthma were recruited in this study. The subjects were randomly divided into two groups; the experimental group received a sachet of Kidilact, and the control group received a sachet of placebo once a day for six months. Both groups were compared in terms of the frequency of asthma attacks that were severe enough to require administration of fast-acting medications, the number of outpatient visits for asthma-related problems, and the frequency of hospitalization due to exacerbated symptoms of asthma.
There were fewer complaints of drug-induced side effects, e.g., vomiting, headache, stomachache, and diarrhea, exacerbated cough, and constipation in the experimental group than in the control group. Overall, a significantly greater number of participants in the experimental group were satisfied with the therapeutic intervention than those in the control group, as verified by the participants and their parents/guardians self-report. There was no significant difference between both groups in the frequency of asthma attacks and hospitalization due to exacerbated symptoms of asthma. The only significant difference between both groups was the count of outpatient visits. While the control group made 55 outpatient visits to the hospital, participants in the experimental group visited the hospital only 19 times (P=0.001).
Results of our study indicates that synbiotic compound Kidilact generally alleviates the symptoms of asthma in children of 12 years of age or younger, resulting in less frequent outpatient visits to the hospital due to asthma-related problems while rarely causing any side effects. Due to ease of use, the rarity of side effects, and their indirect positive effects on quality of life of asthmatic patients, we recommend that synbiotics be incorporated in regular treatment and management of children with asthma.
我们研究了一种特定的合生元化合物(商品名Kidilact)在治疗12岁及以下儿童哮喘方面的有效性和安全性。
这项双盲、随机、安慰剂对照的临床试验于2016年5月22日至2017年5月21日在伊朗德黑兰进行。本研究招募了100名12岁及以下患有轻至中度哮喘的儿童。受试者被随机分为两组;实验组每天服用一袋Kidilact,对照组每天服用一袋安慰剂,持续六个月。比较两组中严重到需要使用速效药物治疗的哮喘发作频率、因哮喘相关问题的门诊就诊次数以及因哮喘症状加重而住院的频率。
与对照组相比,实验组药物引起的副作用,如呕吐、头痛、胃痛、腹泻、咳嗽加剧和便秘的投诉较少。总体而言,经参与者及其父母/监护人自我报告证实,实验组中对治疗干预满意的参与者数量明显多于对照组。两组在哮喘发作频率和因哮喘症状加重而住院方面没有显著差异。两组之间唯一的显著差异是门诊就诊次数。对照组到医院门诊就诊55次,而实验组的参与者仅就诊19次(P = 0.001)。
我们的研究结果表明,合生元化合物Kidilact通常可缓解12岁及以下儿童的哮喘症状,减少因哮喘相关问题到医院门诊就诊的频率,同时很少引起任何副作用。由于使用方便、副作用少以及对哮喘患者生活质量有间接积极影响,我们建议将合生元纳入儿童哮喘的常规治疗和管理中。