Table_2_Zinc Supplementation Promotes a Th1 Response and Improves Clinical Symptoms in Fewer Hours in Children With Pneumonia Younger Than 5 Years Old. A Randomized Controlled Clinical Trial.docx

Background: Pneumonia caused 704,000 deaths in children younger than 5 years in 2015. Zinc is an important micronutrient due to its role in immune function. Since 2004, WHO recommends zinc supplementation for children with diarrhea to shorten the duration and decrease severity. Zinc supplementation for children with pneumonia is controversial.
Methods: A randomized controlled clinical trial was conducted, and 103 children 1 month to 5 years old with pneumonia were included. Zinc or placebo was given during hospitalization. Clinical symptoms were recorded, and a blood draw was obtained to determine serum zinc levels, lymphoproliferation, and cytokines at hospitalization and at discharge of the patient; a nasal wash was obtained to detect viral or bacterial pathogens by multiplex RT-PCR.
Results: Zinc supplementation improved in fewer hours the clinical status (76 ± 7 vs. 105 ± 8, p = 0.01), the respiratory rate (37 ± 6 vs. 57 ± 7, p = 0.04), and the oxygen saturation (53 ± 7 vs. 87 ± 9, p = 0.007) compared to the placebo group. An increase in IFNγ and IL-2 after treatment in the zinc group was observed.
Conclusions: Zinc supplementation improved some clinical symptoms in children with pneumonia in fewer hours and induced a cellular immune response.
Clinical Trial Registration: The trial was retrospectively registered in ClinicalTrials.gov, identifier NCT03690583, URL https://clinicaltrials.gov/ct2/show/NCT03690583?term=zinc+children&cond=Pneumonia&draw=2&rank=1.

背景：2015年，肺炎导致全球5岁以下儿童死亡70.4万例。锌作为重要的微量营养素，在机体免疫功能中发挥关键作用。自2004年起，世界卫生组织（WHO）推荐腹泻患儿补充锌剂以缩短病程、减轻症状严重程度。但针对肺炎患儿补充锌剂的临床价值仍存在争议。
方法：本研究开展了一项随机对照临床试验，共纳入103名月龄1个月至5岁的肺炎患儿。患儿住院期间分别给予锌剂或安慰剂对照。研究记录了患儿的临床症状，并分别于住院时及出院时采集血液样本，检测血清锌水平、淋巴细胞增殖情况及细胞因子水平；同时采集鼻腔冲洗液，通过多重逆转录聚合酶链反应（multiplex RT-PCR）检测病毒或细菌病原体。
结果：与安慰剂组相比，锌剂补充组患儿的临床状态改善所需时长更短（76±7 vs. 105±8，p=0.01），呼吸频率（37±6 vs. 57±7，p=0.04）及血氧饱和度（53±7 vs. 87±9，p=0.007）均得到改善。此外，锌剂组患儿治疗后外周血干扰素γ（IFNγ）与白细胞介素2（IL-2）水平均出现升高。
结论：针对肺炎患儿补充锌剂可缩短临床症状改善所需时长，并可诱导机体产生细胞免疫应答。
临床试验注册：本试验于ClinicalTrials.gov平台进行回溯性注册，注册编号为NCT03690583，注册网址为https://clinicaltrials.gov/ct2/show/NCT03690583?term=zinc+children&cond=Pneumonia&draw=2&rank=1。