注射用泮托拉唑钠与注射用头孢唑肟钠配伍稳定性考察

目的考察室温[（20±1）℃]下,注射用泮托拉唑钠与注射用头孢唑肟钠在0.9%氯化钠注射液中的配伍稳定性。方法将泮托拉唑钠与头孢唑肟钠配伍后,在0～6 h内观察配伍液的外观变化,测定pH值,采用反相高效液相色谱法-二极管阵列检测器同时测定泮托拉唑钠与头孢唑肟钠配伍后的含量变化。结果6 h内混合液外观无明显变化,pH值及含量变化明显。结论在室温[（20±1）℃]下6 h内,注射用泮托拉唑钠与注射用头孢唑肟钠在0.9%氯化钠注射液中配伍不稳定。     

泮托拉唑联合氟哌噻吨美利曲辛治疗非糜烂性胃食管反流病的疗效观察

目的观察泮托拉唑联合氟哌噻吨美利曲辛治疗非糜烂性胃食管反流病的疗效。方法将60例NERD患者单盲随机分为两组,对照组予泮托拉唑治疗;观察组予泮托拉唑联合氟哌噻吨美利曲辛治疗,每组30例,连续治疗4周,观察两组患者临床症状积分变化。结果两组反酸、烧心、胸痛、咽部不适症状治疗后与治疗前比较,差异有显著统计学意义(P<0.01);两组间治疗后症状积分无差异;观察组治疗后症状积分总计较对照组明显下降,差异有统计学意义(P<0.05);观察组总有效率明显高于对照组,差异有统计学意义(P<0.05)。结论泮托拉唑联合氟哌噻吨关利曲辛对NERD有较好疗效。     

生长抑素与垂体后叶素分别联合泮托拉唑治疗肝硬化静脉曲张破裂出血的随机对照试验

目的研究生长抑素与垂体后叶素分别联合泮托拉唑治疗肝硬化静脉曲张破裂出血的疗效和副作用。方法患者被随机分为治疗组和对照组,均给予静滴国产泮托拉唑40mg,一日二次。治疗组静脉注射国产生长抑素0.25mg,然后持续泵入0.25mg/h;对照组持续泵入垂体后叶素0.2-0.4u/min。结果治疗组和对照组48h止血有效率分别为90.32%、68.75%,二者相比有统计学差异（P〈0.05）。治疗组和对照组平均止血时间分别为（29±16.36）h、（38±17.58）h,治疗组所用止血时间少于对照组（P〈0.05）。治疗组不良反应少于对照组。结论生长抑素治疗肝硬化静脉曲张破裂出血较垂体后叶素更有效、更安全,不良反应更少;泮托拉唑有优良的抑酸作用,且价格相对低廉,临床工作中可进一步推广生长抑素联合泮托拉唑治疗肝硬化静脉曲张破裂出血。     

泮托拉唑钠片的薄膜包衣工艺改进

目的解决泮托拉唑钠片的薄膜包衣工艺问题。方法采用正交试验法对泮托拉唑钠片的薄膜包衣工艺进行优化改进。结果经片面外观检查,外观合格率达100％。结论经优化改进的工艺完全可行。     

Relative potency of proton-pump inhibitors—comparison of effects on intragastric pH

Aim  Comparative potency of proton-pump inhibitors (PPIs) is an important clinical issue. Most available trials have compared the different PPIs at one or a few selected specific dosages, making it difficult to derive quantitative equivalence dosages. Here we derived PPI dose equivalents based on a comprehensive assessment of dose-dependent effects on intragastric pH. Methods  All available clinical studies reporting the effects of PPIs on mean 24-h intragastric pH were sought from electronic databases including Medline. Studies included were restricted to those targeting the Caucasian population, and healthy volunteers or gastroesophageal reflux disease (GERD) patients. The dose-effect relationships for mean 24-h intragastric pH and for percentage of time with pH > 4 in 24 h were analyzed for each PPI using pharmacodynamic modeling with NONMEM and a model integrating all available data. Results  Fifty-seven studies fulfilled the inclusion criteria. Based on the mean 24-h gastric pH, the relative potencies of the five PPIs compared to omeprazole were 0.23, 0.90, 1.00, 1.60, and 1.82 for pantoprazole, lansoprazole, omeprazole, esomeprazole, and rabeprazole, respectively. Compared with healthy volunteers, patients with GERD needed a 1.9-fold higher dose and Helicobacter pylori-positive individuals needed only about 20% of the dose to achieve a given increase in mean 24-h intragastric pH. Conclusion  The present meta-analysis provides quantitative estimates on clinical potency of individual PPIs that may be helpful when switching between PPIs and for assessing the cost-effectiveness of specific PPIs. However, our estimates must be viewed with caution because only a limited dose range has been tested and not exactly the same study conditions were applied for the different substances.     

泮托拉唑治疗高血压脑出血并发应激性溃疡出血的临床疗效

目的比较泮托拉唑与雷尼替丁治疗高血压脑出血并发应激性溃疡出血的临床效果。方法166例高血压脑出血并发应激性溃疡出血患者随机分为两组：治疗组和对照组各83例,治疗组采用泮托拉唑治疗;对照组采用雷尼替丁治疗。结果治疗组与对照组总有效率分别是94．0％和69．9％。两组比较差异有显著统计学意义（P〈0．01）。结论泮托拉唑较雷尼替丁能更有效地治疗高血压脑出血并发应激性溃疡出血。     

泮托拉唑联合凝血酶治疗36例上消化道出血患者的临床研究

目的探讨上消化道出血的临床治疗方法。方法采用泮托拉唑联合凝血酶治疗36例上消化道出血患者。结果治疗组的显效率和总有效率高于对照组（P〉0.05）,治疗组输血量明显少于对照组（P〈0.05）。结论泮托拉唑联合凝血酶治疗上消化道出血,可减少病人出血量,从而进一步减少病人输血量。     

致康胶囊治疗胃十二指肠溃疡出血的效果观察

目的探讨致康胶囊对胃十二指肠溃疡出血的治疗效果。方法将80例胃十二指肠溃疡出血患者随机分为治疗组（46例）和对照组（34例）,对照组予以泮托拉唑20mg静脉滴注,2次／d;治疗组则在上述治疗基础上加用致康胶囊每次1．2g口服,每天3次。疗程均为1周。结果治疗组总有效率为95．7％（44／46）;对照组为79．4％（27／34）,两组比较差异有统计学意义（X2=5．164,P〈0．05）。结论致康胶囊治疗胃十二指肠溃疡出血的效果较好,并且不良反应少。     

泮托拉唑预防高血压脑出血后应激性溃疡出血的临床研究

目的探讨高血压脑出血患者早期应用泮托拉唑对预防应激性溃疡出血的效果。方法将244例高血压脑出血患者随机分为泮托拉唑治疗组与甲氰咪胍治疗组。在常规治疗基础上。泮托拉唑组加用泮托拉唑40mg静脉注射,2次／d：甲氰咪胍组加用甲氰咪胍400rag静脉注射,2次/d。患者出现溃疡出血时均应立即行止血、对症处理。分析对比两组应激性溃疡出血的发生率、死亡率及出血时间。结果泮托拉唑治疗组与甲氰咪胍治疗组相比,应激性溃疡发生率明显降低,死亡率明显下降,出血持续时间显著缩短。结论早期预防性应用泮托拉唑可以降低高血压性脑出血后应激性溃疡出血的发生率,降低死亡率,改善患者预后。     

Lack of pharmacodynamic and pharmacokinetic interaction between pantoprazole and phenprocoumon in man

Objective: Pantoprazole is a selective proton pump inhibitor characterized by a low potential to interact with the cytochrome P450 enzymes in man. Due to the clinical importance of an interaction with anticoagulants, this study was carried out to investigate the possible influence of pantoprazole on the pharmacodynamics and pharmacokinetics of phenprocoumon. Methods: Sixteen healthy male subjects were given individually adjusted doses of phenprocoumon to reduce prothrombin time ratio (Quick method) to about 30–40% of normal within the first 5–9 days and to maintain this level. The individual maintenance doses remained unaltered from day 9 on and were administered until day 15. Additionally, on study days 11–15, pantoprazole 40 mg was given per once daily. As a pharmacodynamic parameter, the prothrombin time ratio was determined on days 9 and 10 (reference value) and on days 14 and 15 (test value), and the ratio test/reference was evaluated according to equivalence criteria. Results: The equivalence ratio (test/reference) for prothrombin time ratio was 1.02 (90% confidence interval 0.95–1.09), thus fulfilling predetermined bioequivalence criteria (0.70–1.43). The pharmacokinetic characteristics AUC_0–24h and C_max of S(−)-and R(+)-phenprocoumon were also investigated using equivalence criteria. Equivalence ratios and confidence limits of AUC_0–24h and of C_max of S(−)-phenprocoumon (0.93, 0.87–1.00 for AUC_0–24h; 0.95, 0.88–1.03 for C_max) and of R(+)-phenprocoumon (0.89, 0.82–0.96; 0.9, 0.83–0.98) were within the accepted range of 0.8–1.25. Conclusion: Pantoprazole does not interact with the anticoagulant phenprocoumon on a pharmacodynamic or pharmacokinetic level. Concomitant treatment was well tolerated. Received: 26 January 1996/Accepted in revised form:22 May 1996