Sinclair David, Abba Katharine, Grobler Liesl, Sudarsanam Thambu D
International Health Group, Liverpool School of Tropical Medicine, Liverpool, UK.
Cochrane Database Syst Rev. 2011 Nov 9(11):CD006086. doi: 10.1002/14651858.CD006086.pub3.
Tuberculosis and malnutrition are linked in a complex relationship. The infection may cause undernutrition through increased metabolic demands and decreased intake, and nutritional deficiencies may worsen the disease, or delay recovery by depressing important immune functions. At present, there are no evidence-based nutritional guidance for adults and children being treated for tuberculosis.
To assess the effects of oral nutritional supplements (food, protein/energy supplements or micronutrients) on tuberculosis treatment outcomes and recovery in people on antituberculous drug therapy for active tuberculosis.
We searched the Cochrane Infectious Disease Group Specialized Register, CENTRAL (The Cochrane Library), MEDLINE, EMBASE, LILACS, mRCT, and the Indian Journal of Tuberculosis to July 2011, and checked the reference lists of all included studies.
Randomized controlled trials comparing any oral nutritional supplement given for at least four weeks with no nutritional intervention, placebo, or dietary advice only for people being treated for active tuberculosis.
Two authors independently selected trials, extracted data, and assessed the risk of bias. Results are presented as risk ratios (RR) for dichotomous variables, and mean differences (MD) for continuous variables, with 95% confidence intervals (CI). Where appropriate, data from trials with similar interventions and outcomes have been pooled. The quality of evidence was assessed using the GRADE methods.
Twenty-three trials, with 6842 participants, were included. Macronutrient supplementation Five trials assessed the provision of free food, or high energy supplements, although none were shown to provide a total daily kilocalorie intake above the current daily recommended intake for the non-infected population.The available trials were too small to reliably prove or exclude clinically important benefits on mortality, cure, or treatment completion. One small trial from India did find a statistically significant benefit on treatment completion, and clearance of the bacteria from the sputum, but these findings have not been confirmed in larger trials elsewhere (VERY LOW quality evidence).The provision of free food or high-energy nutritional products probably does produce a modest increase in weight gain during treatment for active tuberculosis (MODERATE quality evidence). Two small studies provide some evidence that physical function and quality of life may also be improved but the trials were too small to have much confidence in the result (LOW quality evidence). These effects were not seen in the one trial which included only human immunodeficiency virus (HIV)-positive patients.Micronutrient supplementation Five trials assessed multi-micronutrient supplementation in doses up to ten times the dietary reference intake, and 12 trials assessed single or dual micronutrient supplementation.There is insufficient evidence to judge whether multi-micronutrients have a beneficial effect on mortality in HIV- negative patients with tuberculosis (VERY LOW quality evidence), but the available studies show that multi-micronutrients probably have little or no effect on mortality in HIV-positive patients with tuberculosis (MODERATE quality evidence). No studies have assessed the effects of multi-micronutrients on cure, or treatment completion.Multi-micronutrient supplements may have little or no effect on the proportion of tuberculosis patients remaining sputum positive during the first eight weeks (LOW quality evidence), and probably have no effect on weight gain during treatment (MODERATE quality evidence). No studies have assessed quality of life.Plasma levels of vitamin A appear to increase following initiation of tuberculosis treatment regardless of supplementation. In contrast, plasma levels of zinc, vitamin D and E, and selenium may be improved by supplementation during the early stages of tuberculosis treatment, but a consistent benefit on tuberculosis treatment outcomes or nutritional recovery has not been demonstrated.
AUTHORS' CONCLUSIONS: There is insufficient research to know whether routinely providing free food or energy supplements results in better tuberculosis treatment outcomes, or improved quality of life. Further trials, particularly from food insecure settings, should have adequate sample sizes to identify, or exclude, clinically important benefits.Although blood levels of some vitamins may be low in patients starting treatment for active tuberculosis, there is currently no reliable evidence that routinely supplementing at or above recommended daily amounts has clinical benefits.
结核病与营养不良存在复杂的关联。感染可能通过增加代谢需求和减少摄入量导致营养不足,而营养缺乏可能会使病情恶化,或因抑制重要免疫功能而延迟康复。目前,对于正在接受结核病治疗的成人和儿童,尚无基于证据的营养指导。
评估口服营养补充剂(食物、蛋白质/能量补充剂或微量营养素)对正在接受抗结核药物治疗的活动性结核病患者的治疗效果和康复情况的影响。
我们检索了Cochrane传染病专业组专门注册库、CENTRAL(Cochrane图书馆)、MEDLINE、EMBASE、LILACS、mRCT以及《印度结核病杂志》,检索截至2011年7月,并查阅了所有纳入研究的参考文献列表。
随机对照试验,比较至少四周给予任何口服营养补充剂与未进行营养干预、安慰剂或仅给予饮食建议的情况,研究对象为正在接受活动性结核病治疗的患者。
两位作者独立选择试验、提取数据并评估偏倚风险。结果以二分类变量的风险比(RR)和连续变量的均值差(MD)表示,并给出95%置信区间(CI)。在适当情况下,对具有相似干预措施和结果的试验数据进行了合并。使用GRADE方法评估证据质量。
纳入了23项试验,共6842名参与者。宏量营养素补充:五项试验评估了提供免费食物或高能量补充剂的情况,尽管没有一项试验显示每日总千卡摄入量高于非感染人群目前的每日推荐摄入量。现有试验规模太小,无法可靠地证明或排除对死亡率、治愈或治疗完成情况的临床重要益处。印度的一项小型试验确实发现对治疗完成情况以及痰液中细菌清除有统计学显著益处,但其他地方的大型试验尚未证实这些发现(极低质量证据)。提供免费食物或高能量营养产品可能确实会使活动性结核病治疗期间的体重增加略有增加(中等质量证据)。两项小型研究提供了一些证据表明身体功能和生活质量也可能得到改善,但试验规模太小,对结果缺乏足够信心(低质量证据)。在仅纳入人类免疫缺陷病毒(HIV)阳性患者的一项试验中未观察到这些效果。微量营养素补充:五项试验评估了剂量高达膳食参考摄入量十倍的多种微量营养素补充情况,12项试验评估了单一或两种微量营养素补充情况。没有足够的证据判断多种微量营养素对HIV阴性结核病患者的死亡率是否有有益影响(极低质量证据),但现有研究表明多种微量营养素对HIV阳性结核病患者的死亡率可能几乎没有影响(中等质量证据)。没有研究评估多种微量营养素对治愈或治疗完成情况的影响。多种微量营养素补充剂可能对结核病患者在前八周内痰液仍呈阳性的比例几乎没有影响(低质量证据),并且可能对治疗期间的体重增加没有影响(中等质量证据)。没有研究评估生活质量。无论是否补充,结核病治疗开始后血浆维生素A水平似乎都会升高。相比之下,结核病治疗早期补充可能会改善血浆锌、维生素D和E以及硒的水平,但尚未证明对结核病治疗结果或营养恢复有一致的益处。
没有足够的研究来确定常规提供免费食物或能量补充剂是否会带来更好的结核病治疗结果或改善生活质量。进一步的试验,特别是来自粮食不安全地区的试验,应有足够的样本量来确定或排除临床重要益处。虽然开始接受活动性结核病治疗的患者某些维生素的血液水平可能较低,但目前没有可靠证据表明按或高于推荐每日量常规补充有临床益处。