Sodium Bicarbonate

So far this year, drugmakers have been forced to yank their products over labeling issues, potency issues, contamination scares and more. So far in August, the FDA has announced two separate drug recalls on its website: one related to particulate concerns and the other thanks to high endotoxin levels.While neither recall has resulted in any safety flags or side effect reports so far, the issues stemming from the faulty products could be severe, the drugmakers have warned.First up, German drug and devicemaker B. Braun Medical is yanking two lots of injectable 0.9% sodium chloride to the consumer level in the U.S. The company blamed the product pull on the potential for particulate matter and fluid leakage from the product’s “E3 containers.” The solution is used in both kids and adults as a source of electrolytes and water for hydration. The product is specifically approved for extracellular fluid replacement, treatment of metabolic alkalosis with fluid loss and mild sodium depletion. The product is also used as a priming solution for hemodialysis procedures and may be used to kick-start and terminate blood transfusions without hemolyzing red blood cells.The German firm says it mistakenly released the affected batches to domestic distributors across the U.S. before completing required acceptance activities for embedded particulate matter.While the company hadn’t received any safety reports as of Aug. 8, there is a risk of patients suffering embolic issues like stroke or ischemia/infarction to other organs, plus possible infection, if the particulates in the product aren’t sterile, B. Braun warned.Separately, Baxter International is voluntarily withdrawing a single lot of heparin sodium in 0.9% sodium chloride injection due to the potential for elevated endotoxin levels.The injection is used as an anticoagulant to maintain catheter patency—or the state of being open or unobstructed. Baxter says it shipped the suspect batch to U.S. healthcare facilities, wholesalers and distributors between March 12 and Aug. 24.Using heparin with excess endotoxin levels could lead to serious health consequences for patients such as toxic shock, organ failure and death, the company warned.As of Aug. 6, the company hadn’t received any adverse event reports tied to the product pull.Over the last year, drugmakers have been forced to yank their products over labeling issues, potency issues, contamination scares and more. Most recently, Endo USA—a unit of Endo Pharmaceuticals—recalled a single lot of clonazepam tablets in July thanks to a labeling issue that resulted in an incorrect strength being printed on the product cartons.Endo blamed the issue on a third-party packager.As for the risk of particulate matter turning up in drugs, Pfizer’s Hospira in October recalled three lots of sodium bicarbonate and lidocaine HCI injectables due to the possible presence of glass particles in vials. 

研究结果表明，水果和蔬菜饮食组以及NaHCO3治疗组都改善了肾脏健康，但只有水果和蔬菜饮食组降低了血压并改善了心血管疾病风险指数。 近日，德克萨斯大学奥斯汀分校的研究人员在 The American Journal of Medicine 期刊发表了题为：Kidney and Cardiovascular Protection Using Dietary Acid Reduction in Primary Hypertension: A Five-Year, Interventional, Randomized, Control Trial 的研究论文。 这项为期五年的干预性随机对照临床试验结果显示，富含水果和蔬菜的饮食具有减酸作用，可以降低血压，减少心血管风险，并改善肾脏健康。 该研究的首席研究员Donald E. Wesson，医学博士，工商管理硕士，戴尔医学院-德克萨斯大学奥斯汀分校内科学系，说:“作为一名肾科医生(肾脏医生)，我的酸碱实验室研究肾脏从血液中去除酸并将其放入尿液的方法。 研究团队多年前的动物实验显示，如果长期暴露在产酸饮食中，肾脏用来清除血液中的酸的机制可能会导致肾脏损伤。而他们在人类中发现了类似的结果——产酸饮食（肉类含量较高）对肾脏有害，而产碱饮食（水果和蔬菜含量较高）对肾脏有益。此外，还有其他研究显示，富含水果和蔬菜的饮食还有益于心脏健康。 研究团队推测，水果和蔬菜对肾脏和心脏有益，是因为这种饮食模式减少了饮食中的酸，从而减轻了肾脏除酸的负担。 为了验证这一假设，研究团队设计了一项临床试验，选择了高血压（非糖尿病）和尿白蛋白排泄水平非常高（大量白蛋白尿）的参与者，大量蛋白尿患者患有慢性肾脏疾病，随着时间的推移肾脏疾病恶化的风险很高，随后发生心血管疾病的风险也很高。 在这项为期5年的随机对照试验中，研究团队将153名高血压患者分为三组： 1、参与者在日常饮食基础上增加2-4杯水果和蔬菜； 2、参与者使用NaHCO3片剂（用于减酸的碳酸氢钠，即常见的小苏打），每日两次，每次4-5片（每片650毫克）； 3、参与者接受初级保健医师的标准治疗，作为对照组。 研究结果表明，水果和蔬菜饮食组以及NaHCO3治疗组都改善了肾脏健康，但只有水果和蔬菜饮食组降低了血压并改善了心血管疾病风险指数。 水果和蔬菜饮食组以及NaHCO3治疗组都改善了肾脏健康 水果和蔬菜饮食组降低了血压 水果和蔬菜饮食组改善了心血管疾病风险指数 研究团队表示，这项研究表明，人们可以从水果和蔬菜或NaHCO3中获得肾脏健康益处，但还可以通过水果和蔬菜降进一步获得降低血压和降低心血管疾病风险的健康益处，这是NaHCO3不具备的。因此，研究团队建议，水果和蔬菜应该作为高血压患者的“基础”治疗，可以通过多吃水果和蔬菜实现所有三个目标——肾脏健康、降低血压和降低心血管疾病风险。