Colitis, Microscopic

A new study examines how multiple factors contribute to the miscommunication and understanding of the digestive disease, microscopic colitis. It's a hidden cause of diarrhea and the development of the disease is poorly understood. Multiple factors work against the diagnosis of microscopic colitis, an inflammatory digestive disease, because the symptom distress compared to patients with other causes of chronic diarrhea remains unknown. Now, a new study published in journal Gastro Hep Advances, shows patients may be unsure of a diagnosis based on their colonoscopy results, patients may not be prescribed the proper medications, and many patients may remain symptomatic one year after colonoscopy. The study, led by corresponding author Walker Redd, MD, a clinical outcomes and epidemiology fellow in the Division of Gastroenterology and Hepatology at the UNC School of Medicine, involved a cohort of patients from April 1, 2015 to December 22, 2020 enrolled at UNC Hospitals in Chapel Hill, NC. Patients participating in a follow-up survey included 74 with biopsy-confirmed microscopic colitis and 162 patients experiencing other causes of chronic diarrhea (diarrhea controls) after colonoscopy at a one-year follow-up. "We thought it was important to better understand the burden of symptoms among those patients with microscopic colitis within the context of all patients undergoing colonoscopy to evaluate diarrhea," Redd said. Survey results in regard to a microscopic colitis diagnosis showed 10% were unaware of the diagnosis. Among the controls, 7% reported a diagnosis of microscopic colitis despite no clinical documentation. Researchers also found that 15% of controls either thought they had microscopic colitis or were unsure of their diagnosis. While most of the cases received either a letter or phone call with the pathology results, the authors emphasized the importance of considering whether patients with a new diagnosis of microscopic colitis may benefit from a follow-up visit in the gastroenterology clinic for education and treatment. These results highlight how clear communication is needed to address next steps after a diagnosis of the chronic disease. "We were surprised that certain patients were unaware of their diagnosis and that some of the patients who remained symptomatic were not being treated with prescription medications because we would hope that patients understand their colonoscopy results and receive treatment for any ongoing symptoms," said Redd. "Identifying and addressing gaps in the communication of diagnostic results is an important area for future research." What is typically experienced with microscopic colitis and other causes of chronic diarrhea are similar symptoms such as: watery diarrhea, pain in the abdomen, urgent need to have a bowel movement, fecal incontinence and weight loss. The first line therapy recommended for microscopic colitis is budesonide. However, findings show 46% of cases received that kind of treatment. Also, just 26% of diarrhea controls with significant enough symptoms to warrant diagnostic colonoscopy were offered prescription treatment -- showing how these patients were likely undertreated. In addition, many cases continued to experience ongoing loose stools, urgency, and fecal incontinence at one year, providing further evidence that patients should be offered follow-up appointments to assess how they are responding to treatment. The final finding examines the magnitude of symptoms at one year follow-up. In the study, 15% of microscopic colitis cases reported nocturnal stools, 28% abdominal pain, 40% fecal urgency, 32% weight loss, and 21% fecal incontinence. The Microscopic Colitis Disease Activity Index (MCDAI), a tool used to assess disease severity and quality of life, showed significant improvement in microscopic colitis cases compared to controls at a one-year follow up, only 37% of controls had a an improved MCDAI score. Based on these results, cases showed improvement in symptoms whether or not they were treated with budesonide. As far as controls, symptomatic follow up was either similar or more severe than cases. "Hopefully, these findings will help increase awareness of the importance of communicating diagnostic colonoscopy findings as well as assessing and treating persistent symptoms following an initial diagnostic evaluation," said Redd. There is substantial symptom overlap between microscopic colitis and other causes of chronic diarrhea, Redd said, so much so that it makes it harder for providers to reliably distinguish the disease from other common conditions, like irritable bowel syndrome. Researchers concluded that colonoscopy should be considered for certain patients with diarrhea who do not respond to initial treatment or who are at higher risk for microscopic colitis. Furthermore, follow-up appointments, education, and communication can be used to empower patients as far as understanding the implications of a new microscopic colitis diagnosis and how to manage the disease. This study was funded in part by the National Institutes of Health.

Inflammatory bowel disease (IBD) is an independent risk factor for serious infection, even at very low levels of gastrointestinal inflammation. IBD is an umbrella term for chronic inflammatory bowel diseases, with a population prevalence of around 0.5%. The main types of IBD are ulcerative colitis and Crohn's disease. Unlike irritable bowel syndrome (IBS), IBD results in visible damage to the intestinal mucous membrane. IBD is characterized by intermittent symptoms. Periods of high disease activity are sometimes followed by longer periods of low or no activity. However, the extent to which IBD patients with low disease activity are also at increased risk of serious infections, including sepsis, has been unclear. The current study, published in the journal Clinical Gastroenterology and Hepatology, included data on 55,626 individuals diagnosed with IBD. 'Serious infections' referred to infections requiring hospitalization. The difference between healed and unhealed The results show that during periods of low disease activity but active gastrointestinal inflammation, known as microscopic inflammation, there was an increased risk of being affected by serious infections compared to periods of microscopically healed intestinal mucosa. In the case of microscopic inflammation, the number of serious infections was 4.62 per 100 people per year. The corresponding figure for microscopically healed mucosa was 2.53. This corresponded to a 59% relative risk increase for residual microscopic gastrointestinal inflammation, on adjusting the results for various confounders. Interestingly, the results held true even after adjusting for the prescribed IBD medications, and were otherwise similar regardless of age group, sex, and level of education. The study's first-named and corresponding author is Karl Mårild, an associate professor in pediatrics at the University of Gothenburg's Sahlgrenska Academy and a consultant at the Gastrointestinal and Liver Clinic at Queen Silvia's Children's Hospital in Gothenburg. Healing provides important protection "We have shown that even during periods of microscopic intestinal inflammation, IBD patients have an increased risk of serious infections, including sepsis, compared to periods when they have a microscopically healed mucosa," he explains. "This is also true for patients who appear to have low-active disease in clinical terms, but who have microscopic intestinal inflammation beneath the surface. "The results indicate that achieving a fully healed intestinal mucosa in IBD may reduce the risk of serious infections. This is important, as serious infections currently contribute toward increased morbidity and mortality in both children and adults with IBD." The results from the study are based on data from a national cohort (ESPRESSO) with information from Swedish health registers, and from the quality register for IBD (SWIBREG) on people in Sweden diagnosed with IBD between 1990 and 2016. This information was linked to data from microscopic intestinal examinations of patients with IBD.

来源：国家药监局   编辑：wangxinglai20042022年09月20日，国家药监局发布了散痛舒胶囊由处方药转换为非处方药公告，要求MAH在2023年6月15日前提交修订说明书、标签备案，提交备案之日起生产的药品，不得继续使用原药品说明书、标签。  公告主要内容根据《处方药与非处方药分类管理办法（试行）》（原国家药品监督管理局令第10号）的规定，经国家药品监督管理局组织论证和审核，散痛舒胶囊由处方药转换为非处方药。品种名单（附件1）及非处方药说明书范本（附件2）一并发布。请相关药品上市许可持有人在2023年6月15日前，依据《药品注册管理办法》等有关规定就修订说明书事项向省级药品监督管理部门备案，并将说明书修订的内容及时通知相关医疗机构、药品经营企业等单位。非处方药说明书范本规定内容之外的说明书其他内容按原批准证明文件执行。药品标签涉及相关内容的，应当一并修订。自备案之日起生产的药品，不得继续使用原药品说明书。扫描二维码查看原文说明书范本非处方药说明书范本  散痛舒胶囊说明书  请仔细阅读说明书并按说明使用或在药师指导下购买和使用  [药品名称]  通用名称：散痛舒胶囊  汉语拼音：  [成份]  [性状]  [功能主治]祛风除湿，活血止痛。用于风湿瘀阻，关节肌肉痹痛及跌打损伤，瘀血肿痛。  [规格]每粒装0.3克（相当于原药材1.0克）  [用法用量]口服。一次3～5粒，一日3次，饭后服。  [不良反应]监测数据显示，本品有恶心、腹痛、呕吐、腹部不适、皮疹、瘙痒、头晕等不良反应报告。  [禁忌]  1.孕妇、经期及哺乳期妇女禁用。  2.对本品及所含成份过敏者禁用。  [注意事项]  1.忌食生冷、油腻食物。  2.年老体弱者应在医师指导下使用。  3.高血压、心脏病、肝病、糖尿病、肾病等患者应在医师指导下使用。  4.风湿性关节炎、类风湿性关节炎、痛风等所致肢体关节疼痛，以及严重关节变形、功能障碍者，应去医院就诊。  5.服药3天症状无缓解，应去医院就诊。  6.过敏体质者慎用。  7.本品性状发生改变时禁止使用。  8.请将本品放在儿童不能接触的地方。  9.如正在使用其他药品，使用本品前请咨询医师或药师。  [药物相互作用］如与其他药物同时使用可能会发生药物相互作用，详情请咨询医师或药师。  [贮藏]  [包装]  [有效期]  [执行标准]  [批准文号]  [说明书修订日期]  [药品上市许可持有人]  名称：  注册地址：  邮政编码：  电话号码：  传真号码：  网址：  [生产企业]  企业名称：  生产地址：  如有问题可与药品上市许可持有人联系往期信息公告主要内容根据《处方药与非处方药分类管理办法（试行）》（原国家药品监督管理局令第10号）的规定，经国家药品监督管理局组织论证和审核，奥美拉唑肠溶片由处方药转换为非处方药。品种名单及其非处方药说明书范本一并发布。  请相关药品上市许可持有人在2023年5月24日前，依据《药品注册管理办法》等有关规定，向省级药品监督管理部门提交修订说明书备案，并将说明书修订内容及时通知相关医疗机构、药品经营企业等单位。  非处方药说明书范本规定内容之外的说明书其他内容按原批准证明文件执行。药品标签涉及相关内容的，应当一并修订。药品上市许可持有人提交备案之日起生产的药品，不得继续使用原药品说明书。  特此公告。  扫描二维码查看原文说明书范本非处方药说明书范本  奥美拉唑肠溶片说明书  请仔细阅读说明书并按说明使用或在药师指导下购买和使用  【药品名称】  通用名称：奥美拉唑肠溶片  英文名称：  汉语拼音：  【成份】  【性状】  【作用类别】本品为抗酸类非处方药药品。  【适应症】用于胃酸过多引起的烧心和反酸症状的短期缓解。  【规格】10毫克  【用法用量】  口服。成人，一次1片，一日1次（每24小时），必要时可加服1片，用温开水送服。本品必须整片吞服，不可咀嚼或压碎，更不可将本品压碎于食物中服用。  【不良反应】  最常见不良反应（发生于1%-10%的患者）为头痛、腹部疼痛、便秘、腹泻、胃肠胀气和恶心/呕吐。在有些长期治疗病例中可发生胃粘膜细胞增生和萎缩性胃炎。  全球临床试验中3096例患者（其中2631例来自双盲或开放的国际多中心研究）暴露于奥美拉唑，发生率≥2%的不良反应包括头痛（6.9%）、腹痛（5.2%）、恶心（4.0%）、腹泻（3.7%）、呕吐（3.2%）和胃肠胀气（2.7%）。发生率≥1%的不良反应包括反酸（1.9%）、上呼吸道感染（1.9%）、便秘（1.5%）、头晕（1.5%）、皮疹（1.5%）、乏力（1.3%）、背痛（1.1%）和咳嗽（1.1%）。  在本品获准上市后使用过程中，已经发现如下不良反应。由于这些不良反应由数量不明的人群自发报告，因此难以估算其实际发生率或确定其与药物暴露之间的因果关系。按人体器官系统分类列出如下：  全身性疾病：超敏反应包括速发过敏反应、过敏性休克、血管性水肿、支气管痉挛、间质性肾炎、荨麻疹，发热，疼痛，疲乏，不适；  心血管系统：胸痛、心绞痛、心动过速、心动过缓、心悸、血压升高、外周水肿；  内分泌系统：男性乳房发育；  胃肠道系统：胰腺炎（某些可致命）、厌食、肠易激、粪便变色、食管念珠菌病、舌黏膜萎缩、口炎、口干、腹胀、显微镜下结肠炎。奥美拉唑治疗期间，极罕见观察到患者出现胃底腺息肉，这些息肉为良性，在停止治疗后可逆转；  患有卓-艾综合征的患者在接受奥美拉唑长期治疗时报告发生胃十二指肠类癌，该发现被认为与基础疾病有关；  肝胆系统：肝衰竭（某些可致命）、肝坏死（某些可致命）、肝性脑病、肝细胞疾病、胆汁淤积、混合型肝炎、黄疸、肝功能指标升高（谷丙转氨酶、谷草转氨酶、谷氨酰转肽酶、碱性磷酸酶和胆红素）；  感染：艰难梭菌相关性腹泻；  代谢疾病及营养不良：低血糖、低镁血症（低镁血症也可能与低钾血症有关；严重低镁血症可能导致低钙血症）、低钙血症、低钾血症、低钠血症、体重增加；  肌肉骨骼系统：肌无力、肌痛、肌痉挛、关节疼痛、腿部疼痛、骨折；  神经系统/精神性疾病：抑郁、激动、攻击性、幻觉、意识模糊、失眠、紧张不安、淡漠、嗜睡、焦虑、梦异常、震颤、感觉异常、眩晕、味觉障碍；  呼吸系统：鼻衄、咽痛；  皮肤和皮下组织：亚急性皮肤型红斑狼疮、中毒性表皮坏死松解症（某些可致命）、史蒂文斯-约翰逊综合征、多形性红斑、光敏性、荨麻疹、皮疹、皮炎、瘙痒、瘀点、紫癜、脱发、皮肤干燥、多汗、药物反应伴嗜酸性粒细胞增多和全身性症状（DRESS）、急性全身发疹性脓包性皮病（AGEP）；  耳部和迷路系统：耳鸣；  眼部疾病：视神经萎缩、前部缺血性视神经病变、视神经炎、干眼综合征、眼刺激、视物模糊、复视；  泌尿生殖系统：间质性肾炎、血尿、蛋白尿、血肌酐升高、镜下脓尿、尿路感染、糖尿、尿频、睾丸疼痛；  血液和淋巴系统：粒细胞缺乏症（某些可致命）、溶血性贫血、全血细胞减少症、中性粒细胞减少症、贫血、血小板减少症、白细胞减少症、白细胞增多症。  【禁忌】  1.已知对奥美拉唑、其他苯并咪唑类或本品中任何其他成份过敏者禁用。超敏反应可能包括速发过敏反应、过敏性休克、血管性水肿、支气管痉挛、间质性肾炎和荨麻疹。  2.与其它质子泵抑制剂（PPI）一样，奥美拉唑不应与奈非那韦、阿扎那韦合用。  3.对本品过敏者、严重肾功能不全者及婴幼儿禁用。  【注意事项】  1.使用不得超过7天，如症状未缓解，请咨询医师或药师。  2.两个月以内不得再次服用，如症状反复，应立即就医。  3.本品在以下情况下请勿使用：吞咽困难或疼痛；呕血；便血或黑便。这些可能是严重情况的征兆，请咨询医师。  4.肝功能不全或血象不正常的患者请在医师指导下使用。  5.假如出现烧心持续或加重症状，请停用本品并去医院就诊。  6.国内目前尚无儿童使用本品的经验。  7.孕期、哺乳期妇女慎用。  8.如服用过量或出现严重不良反应，应立即就医。  9.对本品过敏者禁用，过敏体质者慎用。  10.本品性状发生改变时禁止使用。  11.请将本品放在儿童不能接触的地方。  12.如正在使用其他药品，使用本品前请咨询医师或药师。  13.胃恶性肿瘤  当怀疑或者确诊胃溃疡，出现报警症状（如无意识的明显消瘦、反复呕吐、吞咽困难、呕血或者黑便）时，应先排除恶性肿瘤，因为治疗可能会掩盖症状进而导致延误诊断。  完成PPI治疗后出现缓解欠佳或早期症状复发的成人患者，考虑额外随访和诊断检测。对于老年患者，需考虑内窥镜检查。  经本品治疗症状得到缓解的成人患者，仍然不能排除存在胃恶性肿瘤的可能性。  14.萎缩性胃炎  长期接受奥美拉唑治疗的患者，胃体病理活检时偶见萎缩性胃炎。  15.急性间质性肾炎  在服用PPI（包括奥美拉唑）的患者中观察到急性间质性肾炎。急性间质性肾炎可能发生在PPI治疗期间任何时候，通常由特发性超敏反应造成。如发生急性间质性肾炎，应停用本品。  16.氰钴胺（维生素B12）缺乏  长期（例如超过3年）每日接受抑酸药物治疗可能导致胃酸过低或胃酸缺乏继而引起维生素B12吸收不良。有罕见的抑酸治疗引起氰钴胺缺乏的文献报告。如果观察到氰钴胺缺乏相应的临床症状，则应考虑该诊断。  17.艰难梭菌相关性腹泻  已发表的观察研究表明，PPI治疗（如本品）可能会增加艰难梭菌相关性腹泻（CDAD）的风险，尤其是在住院患者中。如果腹泻未见改善，则应考虑该诊断。  18.与氯吡格雷的相互作用  应避免奥美拉唑与氯吡格雷联合使用。氯吡格雷是一种前体药物，其活性代谢产物抑制血小板聚集。与奥美拉唑等药物联合用药时，后者抑制CYP2C19活性，可影响氯吡格雷代谢为活性代谢产物。80毫克奥美拉唑和氯吡格雷联合使用，可降低氯吡格雷的药理活性，即使两者相隔12小时给药。当使用奥美拉唑时，应考虑使用其他药物进行抗血小板治疗。  19.骨折  多项已发表的观察性研究表明，PPI治疗可能增加骨质疏松相关骨折（髋骨、腕骨或脊柱）的风险。接受高剂量（定义为每日多次给药）和长期（1年或更久）PPI治疗的患者，骨折风险增加。患者应根据医疗情况使用最低剂量和最短疗程的PPI治疗。对于有骨质疏松相关骨折风险的患者，应根据相关治疗指南处理。  20.低镁血症  在接受质子泵抑制剂（PPI）治疗至少3个月（绝大多数治疗1年后）的患者中，罕见无症状和有症状的低镁血症病例报告。严重不良事件包括手足抽搐、心律失常和癫痫发作。低镁血症可能导致低钙血症和/或低钾血症，并可能加重高危患者的潜在低钙血症。对于大多数患者，纠正低镁血症需补镁并停用PPI。  预期需延长PPI治疗或有合并用药如地高辛或可能导致低镁血症的药物（如利尿剂），需要考虑定期监测血镁浓度。  对有低钙血症风险的患者（如甲状旁腺功能减退症），考虑在开始使用本品前及治疗时定期监测血镁和血钙的浓度。必要时，补充镁和/或钙。如果低钙血症治疗无效，考虑停止使用PPI。  21.合用圣约翰草或利福平  诱导CYP2C19或CYP3A4的药物（如圣约翰草或利福平）可显著降低奥美拉唑的血药浓度。本品应避免与圣约翰草或利福平合并使用。  22.与神经内分泌肿瘤诊断性检查的相互作用  血清嗜铬粒蛋白A（CgA）水平会因药物导致的胃酸降低而继发升高。CgA水平升高会导致神经内分泌瘤的诊断性检查出现假阳性。医疗人员在评估血CgA水平前应暂停使用奥美拉唑至少14天，若初始检测CgA水平升高，应考虑复查该指标。由于不同实验室的正常参考值可能存在差异，如需进行一系列检查（如监测），应在同一实验室中进行。  23.合并使用甲氨蝶呤  文献资料提示，PPI和甲氨蝶呤（主要是高剂量）合并使用可能会增加甲氨蝶呤和/或其代谢产物的血清浓度，延长高血清浓度的持续时间，可能导致甲氨蝶呤中毒。部分患者在使用高剂量甲氨蝶呤时可考虑暂时停用PPI。  24.亚急性皮肤型红斑狼疮（SCLE）  仅有非常少数的几例亚急性皮肤型红斑狼疮与PPI有关联。如果皮损发生，特别是暴露在阳光下的部位，且伴随关节痛，患者应及时寻求医疗帮助，专业的医疗人员须考虑停止服用奥美拉唑。曾使用PPI且经过治疗后的亚急性皮肤型红斑狼疮，再次服用其他PPI，可能会增加亚急性皮肤型红斑狼疮的风险。  25.严重皮肤不良反应  有与PPI的使用有关的严重皮肤不良反应的报告，包括史蒂文斯-约翰逊综合征(SJS)，中毒性表皮坏死松解症 (TEN)，药物反应伴嗜酸性粒细胞增多和全身性症状（DRESS）和急性全身发疹性脓包性皮病（AGEP）。在出现严重皮肤不良反应的体征或症状或者其他超敏反应的体征时，应停用本品并考虑进一步评估。  26.使用PPI治疗可能会导致胃肠道感染风险轻微升高，如沙门氏菌和弯曲杆菌感染。  27.对于长期服用奥美拉唑的患者，特别是使用1年以上者，应定期进行监测。  28.长期反复出现消化不良和烧心症状的患者应定期就诊。  29.患者如果出现以下情况，应咨询医生：既往患有胃溃疡或胃肠道手术史，因消化不良或烧心连续治疗4周以上，患有黄疸或重度肝病，年龄在55岁以上且出现新的或最近有症状变化。  30.本品含有乳糖。患有半乳糖不耐症、Lapp乳糖酶缺乏症或葡萄糖-半乳糖吸收不良等罕见遗传疾病的患者不应服用本品。  31.本品为肠溶片，服用时注意不要嚼碎，以免药物在胃内过早释放而影响疗效。  32.对驾驶和机械操作能力的影响：本品基本不影响驾驶或机械操作能力。可能会出现药物不良反应如头晕和视觉障碍。如果受到影响，患者不应驾驶或操作机械。  【药物相互作用】  1.奥美拉唑对其他活性物质药代动力学的影响  （1）pH依赖性吸收的活性物质：  在奥美拉唑治疗期间，胃酸的降低可能会促进或抑制呈胃pH依赖性吸收的活性物质的吸收。  奈非那韦、阿扎那韦：  与奥美拉唑联用时，奈非那韦和阿扎那韦的的血药浓度会降低。  禁止联合使用奥美拉唑与奈非那韦。联用奥美拉唑（40毫克，每日一次）使奈非那韦平均暴露量减少约40%，药理学活性代谢产物M8的平均暴露量下降约75%-90%。相互作用还可能包括对CYP2C19的抑制作用。  不推荐联合使用奥美拉唑和阿扎那韦。在健康志愿者中，联合使用奥美拉唑（40毫克，每天一次）和阿扎那韦300毫克/利托那韦100毫克，使阿扎那韦的暴露量减少75%。阿扎那韦剂量增加至400毫克不能补偿奥美拉唑对阿扎那韦暴露量的影响。在健康志愿者中，与使用阿扎那韦300毫克/利托那韦100毫克（每天一次）相比，联合使用奥美拉唑（20毫克，每天一次）和阿扎那韦400毫克/利托那韦100毫克，使阿扎那韦的暴露量减少大约30%。  地高辛：  健康受试者同时服用奥美拉唑（20毫克，每日一次）与地高辛，导致地高辛生物利用度升高10%。很少报道地高辛毒性。但是，老年患者给予高剂量奥美拉唑时应谨慎。如果必须联合使用，应该加强对地高辛的治疗药物监测。  氯吡格雷：  健康受试者中的研究结果显示，氯吡格雷（300毫克负荷剂量/75毫克日维持剂量）和奥美拉唑（每日80毫克口服）之间的药代动力学（PK）/药效学（PD）相互作用，导致氯吡格雷活性代谢产物的暴露量平均下降46%，并导致血小板聚集的最大抑制作用（ADP诱导）平均下降16%。  关于奥美拉唑和氯吡格雷PK/PD相互作用在重大心血管事件的临床意义，观察性研究和临床研究均有不一致的数据报告。应避免同时使用奥美拉唑和氯吡格雷。  其他药物：  与奥美拉唑联用，泊沙康唑、厄洛替尼、酮康唑和伊曲康唑的吸收显著降低，可能会影响其临床疗效。应避免本品联合使用泊沙康唑、厄洛替尼。  （2）经CYP2C19代谢的活性物质：  奥美拉唑是一种中等强度的CYP2C19抑制剂，CYP2C19为奥美拉唑的主要代谢酶。因此，合并使用同样经由CYP2C19代谢的活性物质会降低其代谢，进而使这些物质的全身暴露量升高。此类药物包括R-华法林和其它维生素K拮抗剂、西洛他唑、地西泮和苯妥英。  西洛他唑：  在一项交叉研究中，健康受试者接受40毫克剂量的奥美拉唑，使西洛他唑的Cmax和AUC分别增加了18%和26%，其中一种活性代谢物分别增加了29%和69%。  苯妥英：  在开始奥美拉唑治疗后的前两周内，建议监测苯妥英血药浓度，如果进行苯妥英剂量调整，则应在结束奥美拉唑治疗后监测并进一步调整剂量。  （3）未知机理  沙奎那韦：  奥美拉唑与沙奎那韦/利托那韦联用导致沙奎那韦的血药浓度升高大约70%，与HIV感染患者的良好耐受性相关。  他克莫司：  合用奥美拉唑可使他克莫司的血药浓度升高。应加强对他克莫司浓度以及肾功能（肌酐清除率）的监测，必要时调整他克莫司的剂量。  甲氨蝶呤：  据报道，与质子泵抑制剂合并用药时，部分患者甲氨蝶呤水平增加。给予高剂量的甲氨蝶呤时，可以考虑暂时停用奥美拉唑。  2.其他活性物质对奥美拉唑药代动力学的影响  （1）CYP2C19和/或CYP3A4抑制剂：  由于奥美拉唑通过CYP2C19和CYP3A4代谢，已知可抑制CYP2C19或CYP3A4的活性药物（如克拉霉素和伏立康唑）可能降低奥美拉唑的代谢速率，进而导致奥美拉唑血药浓度升高。合用伏立康唑可使奥美拉唑的暴露量至少翻倍。由于高剂量奥美拉唑具有良好耐受性，一般无需调整奥美拉唑剂量。但是，对于重度肝功能损害患者，如果需要长期治疗，应考虑调整剂量。  （2）CYP2C19和/或CYP3A4诱导剂：  已知可诱导CYP2C19和/或CYP3A4的活性药物（如利福平和圣约翰草）可使奥美拉唑代谢速率增加，进而导致奥美拉唑血药浓度降低。  3.如与其他药物同时使用可能会发生药物相互作用，详情请咨询医师或药师。  【药理作用】  本品为H+-K+-ATP酶质子泵抑制剂，通过小肠吸收后，经血液循环，在胃壁浓集，从而抑制胃酸。  [贮藏]  [包装]  [有效期]  [执行标准]  [批准文号]  [说明书修订日期]  [生产企业]  企业名称：  生产地址：  邮政编码：  电话号码：传真号码：  网址：  如有问题可与生产企业联系