Sennosides

最近，被许多网友当作“减肥神器”西梅汁频频陷入争议。为何西梅汁会成为“网红饮料”？靠拉肚子减肥可取吗？　　01  年轻人的“难言之隐”让西梅汁爆红近两年，西梅这款水果风靡饮品市场，背后有一部分原因是抓住了当代年轻人的“难言之隐”——便秘。在小红书上搜索“窜稀”，笔记篇数之多高达3w+。豆瓣小组“排便健康学研究基地”中也有超过1.5万人聚集在一起讨论。　　根据中华医学会消化病学分会胃肠动力学组发布的《中国慢性便秘专家共识意见（2019）》显示，我国成人慢性便秘的患病率为4%至10%。也就是说，我国约有5000万成人正在受到便秘困扰。　　对于西梅汁缓解便秘的作用，科普作家、生物与食品工程专业博士云无心曾发文解释，西梅能有通便甚至腹泻的作用，其实来自于含有的天然成分膳食纤维、果糖和山梨糖醇。但含量与品种、产地甚至生长条件关系很大。比如通便的关键成分山梨糖醇，含量低的西梅中只有1%左右，含量高的可以超过5%。相应地，一批西梅汁与西梅干含有多少山梨糖醇，不确定性也很高。　　此外，人体对于山梨糖醇的耐受性差别很大。有的人吃10克就可能开始“喷射”，而有的人吃到30克以上都还“无感”。所以，西梅的通便作用因人而异。02  “网红西梅汁”被海关总署点名“不要购买”2月26日，海关总署发布消息指出：经核实，在华注册编号为CUSA24092203180057的美国饮料生产企业JERRY&SONS PHARMACEUTICAL INC在申请注册时提供了虚假材料。海关总署根据《中华人民共和国进口食品境外生产企业注册管理规定》有关规定已撤销该企业在华注册资格。海关未发现上述企业的产品报关记录。　　海关提醒消费者，不要购买该美国企业的饮料产品，包括天萁西梅汁（TiQ Prune Juice）。已获得该企业饮料产品的，请停止食用，与原获取渠道联系退货事宜。　　此前，该品牌曾进入包括东方甄选、疯狂小杨哥等头部电商直播间销售。今年1月18日，知名打假人王海在微博发文称，东方甄选带货一款“TiQ天萁西梅汁”的产品，被检出有泻药成分，分别为番泻苷A、番泻苷B。　　2月27日，东方甄选客服回复表示，该产品系外链合作商家产品，已经反馈给相关部门进行处理，正在启动调查程序。如果买到商品担心的话可以支持退货退款，后续是否会继续销售要看选品部门做出的选择。截图自海关总署网站03  靠“拉肚子”减肥不可取通便之外，不少商家更是直接将西梅汁作为减肥利器来营销。“喝4盒掉20斤”“大餐救星”“窜稀神器”等营销话术出现在各大销售西梅汁的电商页面和直播间。　　但事实上，依靠“拉肚子”减肥本身就不可取。对于正常人来说，频繁的腹泻不仅会导致肠胃功能受损，还会出现电解质紊乱、血钾浓度降低等损害人体健康的负面问题。　　另外，近年来，包括前述的天萁西梅汁在列，市场监管部门查处多起宣称”减肥“”通便“的食品中非法添加番泻苷A、番泻苷B。需要提醒的是，如果长期服用番泻苷a和b，结肠会逐渐黑变，便秘会越来越严重。而结肠黑变，还可能增加结肠癌的风险。　　中新健康了解到，番泻苷A、番泻苷B是中药番泻叶中具有导泻药理作用的主要成分，在食品中加入番泻苷容易使消费者产生药物依赖。《中华人民共和国食品安全法》第三十八条规定，生产经营的食品中不得添加药品。　　此前，市场监管总局发文表示，使用药品等非食用物质生产食品一直是市场监管部门持续严厉打击的违法行为之一。此类违法行为有隐蔽性增强、非法添加物质不断翻新的趋势，市场监管部门将继续加大打击力度，对食品中非法添加药品和非食用物质的行为严惩重处，严处违法犯罪分子。来源：中新健康  作者：韦香惠

– Data demonstrates that linaclotide reduces the need for rescue medications in this patient population – – Additional presentations further characterize the efficacy and safety profiles of linaclotide as the only FDA-approved prescription therapy for this patient population – – Functional constipation affects an estimated 6 million children and adolescents ages 6-17 years-old in the U.S.1­ – BOSTON--(BUSINESS WIRE)-- Ironwood Pharmaceuticals, Inc. (Nasdaq: IRWD), a leading global gastrointestinal healthcare company, will present findings during the 2023 North American Society for Pediatric Gastroenterology, Hepatology & Nutrition (NASPGHAN) Annual Meeting demonstrating that linaclotide decreased the use of rescue medications in children and adolescents ages 6-17 years-old with functional constipation. These findings build on previously announced data from the company’s pivotal Phase III trial, which formed the basis of a June 2023 Food and Drug Administration (FDA) approval of linaclotide for the treatment of functional constipation in this pediatric population. Functional constipation in children is defined as a condition with hard, infrequent bowel movements that are often difficult or painful to pass2. The condition affects an estimated 6 million children and adolescents ages 6-17 years-old in the U.S.1 The data, which were part of a post-hoc analysis, will be featured in a poster titled Once-Daily Linaclotide 72 µg Reduces the Need for Rescue Medication Use in Children with Functional Constipation (presentation number 465) on Oct. 6 from 12:30 to 1:30 p.m. PDT in the Sapphire Ballroom presented by Tina Shakhnovich, M.D., pediatric gastroenterologist and Ironwood’s Medical Director of Clinical Development. The analysis found that approximately half of the children enrolled in the trial relied on rescue medications at least once per week for symptom relief. By the end of the 12-week treatment period, the use of rescue medications, which included senna (oral), bisacodyl (oral or rectal) or sodium picosulphate (oral), decreased to 8.7 percent of children receiving linaclotide versus 18.8 percent of children receiving placebo. Over the entire study period, more children treated with linaclotide (61.0 percent) experienced a decrease in rescue medication use compared to those treated with placebo (48.2 percent), and fewer children treated with linaclotide (15.2 percent) experienced an increase in rescue medication use compared to those treated with placebo (26.2 percent; p=0.0095). “In this clinical trial, participants experiencing an inadequate therapeutic response or exacerbation of symptoms could use rescue medications to alleviate their symptoms,” said Jeffrey S. Hyams, M.D., Head, Division of Digestive Diseases, Hepatology, and Nutrition, Connecticut Children’s Medical Center, Professor of Pediatrics, University of Connecticut School of Medicine. “The decrease we saw in use of rescue medications is additional important evidence supporting the efficacy of linaclotide in this patient population.” Ironwood and its collaborators will present additional data describing the cumulative treatment effect of linaclotide in this patient population. Additionally, Ironwood and its partner AbbVie are sponsoring a medical symposium titled “Managing Pediatric Constipation” on Oct. 6, 2023 from 6:00 to 8:00 p.m. PDT (Room: Indigo AE). The symposium, which is not an official NASPGHAN event/function, will provide meeting attendees with an overview of pediatric functional constipation, presentation/diagnosis and management. “Ironwood is committed to ongoing research and education around our products and the diseases they treat to ensure deeper understanding of their impact,” said Michael Shetzline, M.D., Ph.D., chief medical officer, senior vice president and head of research and drug development at Ironwood Pharmaceuticals. “We’re honored to be at NASPGHAN, reviewing data and information on pediatric functional constipation with the pediatric GI community.” Cumulative Effect of Linaclotide in Children and Adolescents Ages 6-17 Years-Old with Functional Constipation A poster titled Cumulative Treatment Effect of Linaclotide for Pediatric Functional Constipation: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Trial (presentation number 729) will be presented on Oct. 7, 2023 from 12:30 to 1:30 p.m. PDT in the Sapphire Ballroom by Tina Shakhnovich, M.D. The analysis showed that a higher proportion of patients in the linaclotide treatment group versus the placebo consistently achieved improvement at every responder threshold for increase in spontaneous bowel movement frequency and achievement of softer post-baseline stool consistency. A poster titled Cumulative Experience with Diarrhea as an Uncommon Treatment-Emergent Adverse Event in Pediatric Trials of Linaclotide for the Treatment of Functional Constipation (presentation number 727) will be presented on Oct. 7, 2023, from 12:30 to 1:30 p.m. PDT in the Sapphire Ballroom by Julie Khlevner, M.D., Columbia University Vagelos College of Physicians and Surgeons and New York Presbyterian Morgan Stanley Children’s Hospital, New York, NY. The post-hoc analysis demonstrated that in pediatric patients with functional constipation, diarrhea occurred in 7.4 percent of the linaclotide-treated population and 1.5 percent of those receiving placebo. About Linaclotide LINZESS® is the #1 prescribed brand in the U.S. for the treatment of adult patients with irritable bowel syndrome with constipation (“IBS-C”) or chronic idiopathic constipation (“CIC”), based on IQVIA data. LINZESS is a once-daily capsule that helps relieve the abdominal pain, constipation, and overall abdominal symptoms of bloating, discomfort and pain associated with IBS-C, as well as the constipation, infrequent stools, hard stools, straining, and incomplete evacuation associated with CIC. LINZESS relieves constipation in children and adolescents aged 6 to 17 years with functional constipation. The recommended dose is 290 mcg for IBS-C patients and 145 mcg for CIC patients, with a 72 mcg dose approved for use in CIC depending on individual patient presentation or tolerability. In children with functional constipation aged 6 to 17 years, the recommended dose is 72 mcg. LINZESS is not a laxative; it is the first medicine approved by the FDA in a class called GC-C agonists. LINZESS contains a peptide called linaclotide that activates the GC-C receptor in the intestine. Activation of GC-C is thought to result in increased intestinal fluid secretion and accelerated transit and a decrease in the activity of pain-sensing nerves in the intestine. The clinical relevance of the effect on pain fibers, which is based on nonclinical studies, has not been established. In the United States, Ironwood and AbbVie co-develop and co-commercialize LINZESS for the treatment of adults with IBS-C or CIC. In Europe, AbbVie markets linaclotide under the brand name CONSTELLA® for the treatment of adults with moderate to severe IBS-C. In Japan, Ironwood's partner, Astellas, markets linaclotide under the brand name LINZESS for the treatment of adults with IBS-C or CIC. Ironwood also has partnered with AstraZeneca for development and commercialization of LINZESS in China, and with AbbVie for development and commercialization of linaclotide in all other territories worldwide. LINZESS Important Safety Information INDICATIONS AND USAGE LINZESS (linaclotide) is indicated in adults for the treatment of both irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC) and functional constipation (FC) in children and adolescents 6 to 17 years of age. It is not known if LINZESS is safe and effective in children with FC less than 6 years of age or in children with IBS-C less than 18 years of age. IMPORTANT SAFETY INFORMATION WARNING: RISK OF SERIOUS DEHYDRATION IN PEDIATRIC PATIENTS LESS THAN 2 YEARS OF AGE LINZESS is contraindicated in patients less than 2 years of age. In nonclinical studies in neonatal mice, administration of a single, clinically relevant adult oral dose of linaclotide caused deaths due to dehydration. Contraindications LINZESS is contraindicated in patients less than 2 years of age due to the risk of serious dehydration. LINZESS is contraindicated in patients with known or suspected mechanical gastrointestinal obstruction. Warnings and Precautions LINZESS is contraindicated in patients less than 2 years of age. In neonatal mice, linaclotide increased fluid secretion as a consequence of age-dependent elevated guanylate cyclase (GC-C) agonism, which was associated with increased mortality within the first 24 hours due to dehydration. There was no age dependent trend in GC-C intestinal expression in a clinical study of children 2 to less than 18 years of age; however, there are insufficient data available on GC-C intestinal expression in children less than 2 years of age to assess the risk of developing diarrhea and its potentially serious consequences in these patients. Diarrhea In adults, diarrhea was the most common adverse reaction in LINZESS-treated patients in the pooled IBS-C and CIC double-blind placebo-controlled trials. The incidence of diarrhea was similar in the IBS-C and CIC populations. Severe diarrhea was reported in 2% of 145 mcg and 290 mcg LINZESS-treated patients and in <1% of 72 mcg LINZESS-treated CIC patients. In children and adolescents 6 to 17 years of age, diarrhea was the most common adverse reaction in 72 mcg LINZESS-treated patients in the FC double-blind placebo-controlled trial. Severe diarrhea was reported in <1% of 72 mcg LINZESS treated patients. If severe diarrhea occurs, dosing should be suspended and the patient rehydrated. Common Adverse Reactions (incidence ≥2% and greater than placebo) In IBS-C or CIC adult patients: diarrhea, abdominal pain, flatulence, and abdominal distension. In FC pediatric patients: diarrhea. Please see full Prescribing Information including Boxed Warning: LINZESS® and CONSTELLA® are registered trademarks of Ironwood Pharmaceuticals, Inc. Any other trademarks referred to in this press release are the property of their respective owners. All rights reserved. About Ironwood Pharmaceuticals Ironwood Pharmaceuticals (Nasdaq: IRWD), an S&P SmallCap 600® company, is a leading global gastrointestinal (GI) healthcare company on a mission to advance the treatment of GI diseases and redefine the standard of care for GI patients. We are pioneers in the development of LINZESS® (linaclotide), the U.S. branded prescription market leader for adults with irritable bowel syndrome with constipation (IBS-C) or chronic idiopathic constipation (CIC). LINZESS is also approved for the treatment of functional constipation in pediatric patients ages 6-17 years-old. Ironwood is also advancing apraglutide, a next-generation, long-acting synthetic GLP-2 analog being developed for rare gastrointestinal diseases, including short bowel syndrome with intestinal failure (SBS-IF) as well as several earlier stage assets. Building upon our history of GI innovation, we keep patients at the heart of our R&D and commercialization efforts to reduce the burden of GI diseases and address significant unmet needs. Founded in 1998, Ironwood Pharmaceuticals is headquartered in Boston, Massachusetts, and has additional operations in Basel, Switzerland. We routinely post information that may be important to investors on our website at . In addition, follow us on Twitter and on LinkedIn. Forward-Looking Statements This press release contains forward-looking statements. Investors are cautioned not to place undue reliance on these forward-looking statements, including statements about the potential of linaclotide for children and adolescents ages 6-17 years-old with functional constipation; the efficacy and safety profiles of linaclotide in this pediatric patient population; the size of the pediatric population affected by functional constipation. These forward-looking statements speak only as of the date of this press release, and Ironwood undertakes no obligation to update these forward-looking statements. Each forward-looking statement is subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statement. Applicable risks and uncertainties include those related to the effectiveness of development and commercialization efforts by us and our partners; preclinical and clinical development, manufacturing and formulation development of linaclotide and our product candidates; the risk that clinical programs and studies may not progress or develop as anticipated, including that studies are delayed or discontinued for any reason, such as safety, tolerability, enrollment, manufacturing, economic or other reasons; the risk that findings from our completed nonclinical and clinical studies may not be replicated in later studies; the risk that we or our partners are unable to obtain, maintain or manufacture sufficient LINZESS or our product candidates, or otherwise experience difficulties with respect to supply or manufacturing; the efficacy, safety and tolerability of linaclotide and our product candidates; the risk that the therapeutic opportunities for LINZESS or our product candidates are not as we expect; decisions by regulatory and judicial authorities; the risk we may never get additional patent protection for linaclotide and other product candidates, that patents for linaclotide or other products may not provide adequate protection from competition, or that we are not able to successfully protect such patents; outcomes in legal proceedings to protect or enforce the patents relating to our products and product candidates, including abbreviated new drug application litigation; the risk that financial and operating results may differ from our projections; developments in the intellectual property landscape; challenges from and rights of competitors or potential competitors; developments in accounting guidance or practice; Ironwood’s or AbbVie’s accounting practices, including reporting and settlement practices as between Ironwood and AbbVie; the risk that we are unable to manage our expenses or cash use, or are unable to commercialize our products as expected; and the risks listed under the heading “Risk Factors” and elsewhere in our Annual Report on Form 10-K for the fiscal year ended December 31, 2022, and in our subsequent SEC filings. ____________________ 1 U.S. Census, 2017 National Population Projection Tables; Robin, Samantha G. et al, Prevalence of Pediatric Functional Gastrointestinal Disorders Utilizing the Rome IV Criteria, The Journal of Pediatrics, December 2017; Koppen, I. J. N. et al., Prevalence of Functional Defecation Disorders in Children: A Systemic Review and Meta-Analysis. J Pediatr. 2018. 2 Di Lorenzo C, Hyams JS, Saps M, et al. Chapter 16: Childhood Functional Gastrointestinal Disorders: Child/Adolescent. In: Drossman DA, Chang L, Chey WD, et al. Rome IV: Functional Gastrointestinal Disorders: Disorders of Gut-Brain Interaction. Raleigh, NC: Rome Foundation; 2016.