莫沙必利联合兰索拉唑治疗非糜烂性胃食管反流患者80例疗效观察

目的：探讨莫沙必利联合兰索拉唑治疗非糜烂性胃食管反流的临床疗效。方法：以随机数字表法将2012年10月－2014年10月我院收诊的140例非糜烂性胃食管反流患者分为观察组（80例）与对照组（60例）,观察组患者以莫沙必利联合兰索拉唑治疗,对照组患者以雷尼替丁联合多潘立酮治疗,比较两组的临床疗效及治疗前后食管动力。结果：观察组患者治疗总有效率显著高于对照组（92．5％ vs78．3％）（P ＜0．05）;治疗后两组患者的 LES 静息压力、食管体部远端波幅以及有效收缩率均较治疗前增加,且观察组较对照组显著增加（P ＜0．05）。结论：莫沙必利联合兰索拉唑治疗非糜烂性胃食管反流可显著抑制胃酸分泌、增加食管动力,临床疗效切实。     

兰索拉唑单用与兰索拉唑+氟哌噻吨美利曲辛联用治疗伴有负面情绪的糜烂性胃炎的对比研究

[目的]比较兰索拉唑单用与兰索拉唑+氟哌噻吨美利曲辛联用治疗伴有负面情绪的糜烂性胃炎的疗效。[方法]将120例伴有负面情绪的糜烂性胃炎患者纳入研究,随机分为观察组和对照组。对照组60例患者口服兰索拉唑肠溶片(湖北科益药业股份有限公司产品),15mg/次,2次/d。观察组60例患者在对照组的基础上加服氟哌噻吨美利曲片,1片/次、2次/d,2组均4周为一疗程。观察2组患者治疗前后的临床症状和黏膜糜烂情况、胃黏膜中前列腺素E2(PGE2)、丙二醛(MDA)含量、焦虑和抑郁情绪的情况。[结果]①治疗后,观察组患者的临床症状评分、黏膜糜烂评分均低于对照组,差异有统计学意义(P0.05)。②治疗后,观察组患者的HAMD评分、HAMA评分低于治疗前,差异有统计学意义(P0.05),对照组患者负面情绪评分与治疗前的差异无统计学意义(P0.05);③观察组患者的PGE2含量高于对照组、MDA含量低于对照组,差异有统计学意义(P0.05)。[结论]兰索拉唑+氟哌噻吨美利曲辛联用有助于改善临床症状和黏膜糜烂、缓解负面情绪,其整体疗效优于兰索拉唑单药治疗。     

本院住院患者注射用兰索拉唑用药合理性分析

目的分析本院住院患者注射用兰索拉唑临床应用的合理性。方法制定质子泵抑制剂用药评价标准,抽取本院2013年5月住院患者使用注射用兰索拉唑的病例225份,对病例中注射用兰索拉唑的适应证、用法用量、联合用药等进行回顾性统计分析。结果 225份病例中存在不合理用药病例97例,合格率为56.89%。主要存在无适宜证用药和用药疗程过长等。结论本院住院患者注射用兰索拉唑在临床应用过程中存在一些不合理现象,医院应尽早制定注射用兰索拉唑的使用标准或规范,加强对医务人员合理用药知识的培训,以提高药物使用的合理性。     

Effect of lansoprazole on intragastric pH

Lansoprazole is a newly developed proton pump inhibitor. The purpose of this study was to determine whether morning or evening dosage gave better control of 24-hr intragastric pH. In this study, we examined the antisecretory effect of lansoprazole by repeated intragastric pH monitoring on four occasions in eight normal subjects and compared median 24-hr pH values and pH threshold time of pH4 between morning and evening dosing, following the administration of lansoprazole 30 mg once daily in either the morning or evening for seven days. Intragastric pH was monitored before and after seven days of treatment. Both morning and evening dosing caused a rise in the intragastric pH. Median pH for 24 hr was 4.3 and 1.6 with and without lansoprazole morning dosing and 4.6 and 2.1 for evening dosing, respectively. The pH threshold curve shifted to the right with lansoprazole treatment in either case. However, no differences were found between morning and evening dosing in terms of median 24-hr pH values of pH threshold time of pH4. These results indicate that lansoprazole can be given once daily in either the morning or evening because of its potent and long-lasting antisecretory activity.     

Safety review in 10,008 users of lansoprazole in daily practice

Purpose —Soon after the introduction of the proton pump inhibitor, lansoprazole, a 4‐year observational follow‐up study was started to evaluate the safety of this drug in naturally‐occurring groups of patients in The Netherlands. Results of this study were compared with clinical trial data and the limited published data from observational studies. Methods — prospective, observational study in which patients with a new episode of lansoprazole use were followed during the medication period for a maximum of 2 years. All (adverse) events during use were documented by the prescriber, irrespective of possible association with lansoprazole therapy. Results — total of 805 general practitioners (GPs) and 266 specialists provided a total of 10,008 lansoprazole users with a broad range of diagnoses. Of all patients, 17.4% reported one or more adverse events. The profile and frequency of reported adverse events was consistent with results from clinical trials and other observational studies. The most frequently reported adverse events were diarrhoea, headache, nausea, skin disorders, dizziness and generalized abdominal pain/cramps. There was no new evidence of rare adverse events. Furthermore, no lansoprazole‐related unlabelled adverse events of clinical significance were recorded. Conclusions — Although the patterns of use of lansoprazole in daily practice deviated to some extent from the diagnoses in the information leaflet, lansoprazole was found to have a highly acceptable safety profile in this large naturally‐occurring group of users. Reporting rates were higher soon after introduction of lansoprazole before falling to a lower stable level. Copyright © 2000 John Wiley & Sons, Ltd.     

兰索拉唑有关物质的合成

 目的 为加强对兰索拉唑原料药和制剂产品的质量控制,合成存在于该药品中的3个有关物质。方法 以2-氯甲基-3-甲基-4-(2,2,2-三氟乙氧基)吡啶盐酸盐和2-巯基苯并咪唑为起始原料,用化学法合成2-{［3-甲基-4-(2,2,2-三氟乙氧基)-2-吡啶基］甲基硫代}-1H-苯并咪唑（1）,2-{［3-甲基-1-氧-4-(2,2,2-三氟乙氧基)-2-吡啶基］甲磺酰基}-1H-苯并咪唑（2）,2-{［3-甲基-4-(2,2,2-三氟乙氧基)-2-吡啶基］甲磺酰基}-1H-苯并咪唑（3）。结果 在甲醇钠的作用下起始原料经缩合得到（1）,收率97%。化合物1与两倍摩尔量的间氯过氧苯甲酸（m-CPBA）先在0 ℃下反应1 h,再在25 ℃下反应3 h氧化得到（2）,收率91％;化合物1与两倍摩尔量的m-CPBA在-15 ℃的作用下,氧化得到（3）,收率58％,本实验结果经质谱、核磁等确证。结论 本实验反应条件温和,原料易得,操作简单,收率高,同时由于溶剂和试剂单一,利于回收套用,降低成本,减少污染。     

高效液相色谱-高分辨轨道阱质谱联用法对兰索拉唑肠溶制剂的杂质谱研究

采用高效液相色谱-高分辨轨道阱质谱联用检测方法，建立二维在线除盐检测方法对兰索拉唑肠溶制剂法定检验条件下检出的杂质进行结构推定，建立兼容质谱检测器的色谱方法对法检方法无法分离的杂质进行测定和结构推定，检出杂质结构的鉴定方法根据有无杂质对照品而异来推定其结构，以此考察不同企业间产品杂质谱的差异性。二维在线除盐方法的一维色谱条件同《中华人民共和国药典》（2020版）有关物质项下，二维质谱条件采用Waters C₁₈ T3（2.1 mm × 100 mm，1.7 μm）色谱柱，0.1%甲酸水-乙腈流动相，梯度洗脱。兼容质谱的色谱条件采用Agilent Extend C₁₈（4.6 mm × 150 mm， 5 μm）色谱柱，流动相A相：25 mmol/L乙酸铵，B相：25 mmol/L乙酸铵-乙腈（1∶4）[用冰乙酸调节pH至6.5]，梯度洗脱。二维在线除盐方法检出杂质9个，其中5个为已知杂质A ~ E，4个为未知杂质。兼容质谱检测器方法检出杂质14个，其中9个为未知杂质（4个与二维在线除盐方法结果一致，5个为该条件下新检出）。对未知杂质的结构进行了推测和来源归属。本文建立的两个高效液相色谱-高分辨轨道阱质谱联用检测方法对兰索拉唑制剂的质量控制和工艺评价具有指导意义。     

王君1 王贺勇2(1.河南省洛阳市老城区人民医院内科,471000；2.四川省中西医结合医院肾内科,610000)*通讯作者联系方式：312148683@qq. com,13838456451

目的 观察健胃愈疡片联合三联疗法治疗胃溃疡的临床疗效。方法 将80例胃溃疡患者按随机配对法分为两组,对照组采用三联疗法(兰索拉唑+阿莫西林+甲硝唑)治疗,治疗组在三联疗法治疗的基础上加用健胃愈疡片治疗。两组治疗1个月后,比较临床疗效及用药安全性。结论 健胃愈疡片联合三联疗法治疗胃溃疡临床疗效明显优于单用西药治疗,有很好的临床应用前景。