PDCA循环理论在降低多烯磷脂酰胆碱液渗漏率中的应用

目的探讨PDCA循环在降低多烯磷脂酰胆碱液渗漏率中的应用效果。方法开展品质圈活动,将PDCA循环理论运用于多烯磷脂酰胆碱液静脉输液的护理管理,比较PDCA循环运用前后多烯磷脂酰胆碱液渗漏的发生情况。结果活动前多烯磷脂酰胆碱液的渗漏率为3.41%,活动后多烯磷脂酰胆碱液的渗漏率为0.56%,差异具有统计学意义(P0.01)。结论 PDCA循环理论运用于多烯磷脂酰胆碱的输液管理,可有效降低渗漏率,提高患者及家属满意度。     

1-棕榈酰溶血磷脂酰胆碱在诊断缺血性心脏病中的价值研究

目的筛选缺血性心脏病(IHD)患者血清内发生重要浓度变化的代谢物并探讨其临床价值。方法检测52例IHD患者和45名正常对照者10项与诊断心肌缺血或梗死有关的血液常规生化指标[包括丙氨酸氨基转移酶(ALT)、天门冬氨酸氨基转移酶(AST)、γ-谷氨酰基转移酶(GGT)、碱性磷酸酶(ALP)、乳酸脱氢酶(LDH)、α-羟丁酸脱氢酶(α-HBDH)、肌酸激酶MB同工酶(CK-MB)、肌酸激酶(CK)、C-反应蛋白(CRP)和心肌肌钙蛋白T(cTnT)]。血清中主要代谢物的代谢组学分析利用高效液相色谱-质谱(HPLC-MS)技术进行。相应数据经统计分析后,筛选并鉴定出有重要变化的代谢物。结果应用HPLC-MS发现4个平均质荷比(m/z)分别为496.33、478.34、184.13和991.71的离子碎片。经鉴定,4个离子碎片均来自于1-棕榈酰溶血磷脂酰胆碱(C16:0)。IHD组血清1-棕榈酰溶血磷脂酰胆碱(C16:0)浓度为(76.35±18.28)μmol/L,明显高于正常对照组[(64.24±15.56)μmol/L,P<0.001]。IHD组其他传统心肌指标与对照组比较,除AST升高外(P<0.05),其余9项均无明显差异(P>0.05)。受试者工作特性(ROC)曲线显示,诊断IHD时1-棕榈酰溶血磷脂酰胆碱(C16:0)的ROC曲线下面积(0.90±0.03)显著高于其他常规生化指标(P<0.05)。结论 1-棕榈酰溶血磷脂酰胆碱(C16:0)对IHD具有重要的临床价值。     

美他多辛联合多烯磷脂酰胆碱治疗酒精性肝病临床疗效观察

目的探讨美他多辛联合多烯磷脂酰胆碱治疗酒精性肝病的临床疗效。方法 60例酒精性肝病(ALD)患者随机分为治疗组和对照组,每组30例。对照组在一般治疗基础上给予多烯磷脂酰胆碱;治疗组在对照组基础上给予美他多辛;疗程均为4周。检测2组治疗前后血清谷丙转氨酶(ALT),谷草转氨酶(AST),胆红素(TBil),谷酰转肽酶(GGT)水平,比较2组治疗后症状、体征改善情况和临床有效率。结果 2组治疗后血清ALT、AST、TBil、GGT水平均明显降低。治疗组治疗后血清ALT、AST、TBil、GGT水平明显低于对照组。2组治疗后症状、体征改善情况无显著差异。治疗组临床有效率明显高于对照组。结论美他多辛和多烯磷脂酰胆碱联用治疗酒精性肝病,疗效优于单用多烯磷脂酰胆碱。     

多烯磷脂酰胆碱治疗胃癌术后超早期良性肝细胞性黄疸临床分析

目的观察多烯磷脂酰胆碱对胃癌术后超早期良性肝细胞性黄疸的治疗效果。方法选取在我科住院治疗的胃癌术后超早期良性肝细胞性黄疸27例,随机分为治疗组(14例)和对照组(13例),治疗组予多烯磷脂酰胆碱465 mg加5%葡萄糖注射液250 ml,每日1次静脉滴注;对照组予还原型谷胱甘肽1.2 g加5%葡萄糖注射液250 ml,每日1次静脉滴注。疗程均为1周,治疗结束后对两组疗效、胆红素水平及不良反应进行比较。结果治疗组及对照组治疗后总有效率分别为92.9%(13/14)、46.2%(6/13),组间比较差异有统计学意义(P0.05);胆红素分别为(9.22±1.22)μmol/L、(10.83±1.35)μmol/L,组间比较差异亦有统计学意义(P0.05)。两组均未出现明显不良反应。结论多烯磷脂酰胆碱治疗胃癌术后超早期良性肝细胞性黄疸效果良好,且无明显不良反应。     

多烯磷脂酰胆碱联合二甲双胍治疗非酒精性脂肪肝疗效观察

目的 观察多烯磷脂酰胆碱联合二甲双胍治疗非酒精性脂肪肝的疗效.方法 80例非酒精性脂肪肝患者随机分为治疗组及对照组各40例,治疗组给予多烯磷脂酰胆碱联合二甲双胍治疗,对照组单用多烯磷脂酰胆碱治疗,观察12周,比较用药前后患者丙氨酸转氨酶(ALT),天冬氨酸转氨酶(AST)、γ-谷氨酰转肽酶(γ-GT)、总胆固醇(TC)、甘油三酯(TG)的变化及治疗后临床疗效.结果 治疗前后比较,两组均可使ALT、AST、γ-GT显著下降(P＜0.05),治疗组效果更明显(P＜0.05),治疗组可使TC、TG显著下降(P＜0.05),对照组TC、TG无明显下降(P＞0.05);治疗组、对照组总有效率分别为80％、55％,两组比较差异有统计学意义(P＜0.05).结论 多烯磷脂酰胆碱联合二甲双胍治疗非酒精性脂肪肝疗效显著.     

多烯磷脂酰胆碱注射液的体外配伍稳定性研究

目的研究多烯磷脂酰胆碱注射液与注射用还原型谷胱甘肽、注射用丁二磺酸腺苷蛋氨酸冻千粉、果糖二磷酸钠注射液、维生素c注射液等配伍的稳定性,探索配伍禁忌的根源和性质。方法采用高效液相色谱法测定多烯磷脂酰胆碱注射液与还原型谷胱甘肽等注射剂不同比例配伍前后溶液的含量,并观察配伍溶液的外观、pH值、微粒以及含量的变化。色谱柱：20RBAXEclipseXDB-C18（4．6mm×150mm,5“m）;流动相：甲醇一磷酸（40：60）;柱温：30℃;检测波长：205nm;流速：1．0ml／min;进样量：20¨l;检测器：DAD。结果多烯磷脂酰胆碱注射液用氯化钠注射液稀释产生白色浑浊;多烯磷脂酰胆碱注射液与还原型谷胱甘肽等注射剂配伍后,24h内溶液的含量、pH值、微粒等均产生明显的变化。结论上述各药与多烯磷脂酰胆碱注射液注射液配伍后,溶液的稳定性较差,多烯磷脂酰胆碱注射液不能与还原性谷胱甘肽等注射剂配伍。     

胆宁片联合多烯磷脂酰胆碱治疗非酒精性脂肪肝疗效观察

目的:观察胆宁片联合多烯磷脂酰胆碱治疗非酒精性脂肪肝的临床疗效。方法:选取2016年4月～2017年4月我院收治的非酒精性脂肪肝患者132例,按随机数字表法分为对照组和实验组各66例。对照组采用多烯磷脂酰胆碱治疗,实验组采用胆宁片联合多烯磷脂酰胆碱治疗,比较两组临床疗效。结果:实验组治疗总有效率明显高于对照组(P0.05);治疗后,实验组HDL-c水平高于对照组,LDL-c、TC、TG及γ-GT、AST、ALT水平均低于对照组(P0.05)。结论:胆宁片联合多烯磷脂酰胆碱治疗非酒精性脂肪肝效果显著,能够有效改善患者肝功能及血脂水平。     

二甲双胍与多烯磷脂酰胆碱治疗非酒精性脂肪肝的对比研究

目的对比研究二甲双胍与多烯磷脂酰胆碱分别治疗非酒精性脂肪肝(nonalcoholic fatty liver disease,NAFLD)的临床效果。方法将75例NAFLD患者按简单随机方法分为研究组(38例)和对照组(37例)。对照组患者采用多烯磷脂酰胆碱治疗,研究组患者采用二甲双胍治疗,疗程均为6个月。观察患者治疗前后临床症状和血脂、肝功能的变化情况及临床疗效。结果研究组总有效率为81.6%(31/38),明显高于对照组的59.42%(22/37),P<0.05。研究组患者AST、ALT、TC、TG和LDL-C较治疗前均明显降低(P<0.01),HDL-C明显升高(P<0.05);对照组患者AST、ALT、TC、LDL-C较治疗前均明显降低(P<0.05),HDL-C明显升高(P<0.05),TG与治疗前比较差异无统计学意义(P>0.05)。治疗后研究组TG和LDL-C指标的改善好于对照组(均P<0.05)。结论二甲双胍和多烯磷脂酰胆碱治疗非酒精性脂肪肝均可获得明显疗效,对于TG和LDL-C指标的改善来说,二甲双胍的治疗效果较多烯磷脂酰胆碱更好。更多     

多烯磷脂酰胆碱与棓丙酯氯化钠存在配伍禁忌

我科2008-10收治1例冠心病患者,在医院治疗过程中出现一组配伍禁忌,现报告如下。 1配伍实例 多烯磷脂酰胆碱为黄色澄清液体,可提供高剂量多烯磷脂酰胆碱,这些多烯磷脂酰胆碱在化学结构上与内源性磷脂一致。它们主要进入肝细胞,并以完整的分子与肝细胞膜及细胞器膜相结合,另外,这些磷脂分子上可分泌入胆汁。     

多烯磷脂酰胆碱治疗酒精性脂肪肝的疗效观察

目的：探讨多烯磷脂酰胆碱治疗酒精性脂肪肝（AF）的疗效。方法：将60例AF患者随机分为治疗组和对照组各30例,治疗组用多烯磷脂酰胆碱、对照组应用甘利欣进行疗效对比。结果：治疗组30例中治愈18例,显效5例,有效5例,无效2例,总有效率为93.3% 对照组30例中治愈10例,显效4例,有效5例,无效11例,总有效率为63.3%。治疗组与对照组疗效比较差异有统计学意义（P〈0.01）。结论：在戒酒的基础上采用多烯磷脂酰胆碱治疗可以尽快改善患者症状和体征,改善肝功能,且具有良好的安全性。多烯磷脂酰胆碱是治疗酒精性脂肪肝的理想药物。     

Altered phospholipid composition and changed fatty acid pattern of the various phospholipid fractions of red cell membranes of cystic fibrosis children with pancreatic insufficiency

After two-dimensional thin-layer chromatography, it appears that the phospholipid composition of the erythrocyte membranes of cystic fibrosis children, compared with healthy ones, is changed by an increase of the phosphatidyl inositol content. The plasmalogen concentration of the membrane phospholipids is the same for both groups.The fatty acid pattern of the various red cell membrane phospholipid fractions was determined by gas chromatography (Tables II, III and IV), and significant changes were observed in the cystic fibrosis patients (Table V).Phosphatidyl choline and ethanolamine (non-plasmalogen forms) especially show strikingly abnormal fatty acid patterns similar to those in the various plasma lipid fractions.     

埃索美拉唑肠溶胶囊人体生物等效性试验

目的采用高效液相色谱法测定受试者口服埃索美拉唑肠溶胶囊与埃索美拉唑镁肠溶片后血药浓度,评价埃索美拉唑肠溶胶囊的生物等效性。方法 2009年9月-10月,36例健康男性受试者单次交叉口服埃索美拉唑肠溶胶囊(试验制剂)和埃索美拉唑镁肠溶片(参比制剂),测定给药后不同时间点血浆中埃索美拉唑经时血药浓度,采用DAS 2.0软件进行药物代谢动力学参数计算和生物等效性评价。结果受试者单次口服试验制剂与参比制剂后,达峰时间分别为(2.19±0.96)、(2.43±0.92)h,峰浓度分别为(1 748.86±615.81)、(1 442.92±476.41)μg/L,药时曲线下面积(AUC)0-t分别为(3 927.14±1 839.10)、(3 878.79±1 734.84)μg/L.h,AUC0-∞分别为(3 998.36±1 866.22)、(3 918.31±1 773.44)μg/L.h。试验制剂与参比制剂的生物等效性为94.0%,其90%CI为(82.3%,107.2%)。结论埃索美拉唑肠溶胶囊与埃索美拉唑镁肠溶片生物等效。     

高效液相色谱法测定胎盘灌流液中格列苯脲的浓度

目的建立测定胎盘灌流液中格列苯脲浓度的高效液相色谱(HPLC)检测方法。方法采用的色谱柱为Symmetry Shield RP C18(150 mm×4.6 mm,5μm),柱温40℃,流动相为NaH2PO4缓冲盐(25 mmol/L,pH值5.2)︰乙腈=1︰1;内标为格列齐特,流速1.0 mL/min,检测波长228 nm,采用液-液萃取预处理方法测定胎盘灌流液中格列苯脲的浓度。结果格列苯脲浓度线性范围为2.0～25.0μg/mL,线性方程为:y=0.226x+0.002,r=0.999 9(n=6),日内相对标准偏差(RSD)<3.1%,日间RSD<9.5%,方法学回收率为95.32%～103.35%。结论 HPLC检测方法灵敏、简便,可用于胎盘灌流液中格列苯脲浓度的检测。     

Choline in whole blood and plasma: sample preparation and stability

BACKGROUND: Choline is critical for a variety of biological functions and has been investigated as a biomarker for various pathological conditions including acute coronary syndrome. METHODS: A liquid chromatography-tandem mass spectrometry (LC-MS/MS) method was used to quantify choline in whole blood and plasma in freshly collected samples prepared with ultrafiltration or protein precipitation. We investigated the effects of preanalytical variables including types of anticoagulants and storage temperature and time. RESULTS: We observed no significant differences in whole-blood choline concentration in EDTA-anticoagulated vs heparin-anticoagulated samples: mean (SD) difference 0.9% (3.2%), P = 0.80. For plasma, choline concentrations with heparin in 5 of 12 volunteers were >10% higher than with EDTA, P = 0.01. One freeze-thaw cycle led to significant mean (SD) increases in choline concentrations in heparin whole blood, 19.3% (11.4%), P <0.01, and the effect was not significant for other sample types studied (P >0.33). For freshly collected samples stored at ambient temperature, choline concentrations in all types of samples increased with storage time. For EDTA whole blood, EDTA plasma, and heparin plasma, the choline concentration increased for the first 60 min and then stabilized. For heparin whole blood, the choline concentration continued to increase linearly with storage time for >4 h, at which time the choline concentrations were increased by approximately 50%. CONCLUSIONS: Sample collection, storage, and sample preparation procedures are critical for clinical measurements of choline in whole blood and plasma.     

Free choline in human plasma analysed by simple radio-enzymatic procedure: age distribution and effect of a meal

Ultrafiltration of plasma was shown to be a simple and rapid method to obtain a stable sample for direct measurement of free choline (Ch) in plasma by a radioenzymatic procedure. Free Ch was analysed in plasma from healthy volunteers fasted 12-15 h and 1 h after a meal. The free Ch concentration was found within narrow limits with a mean of 10.6 +/- 0.4 mumol/l in the fasted subjects and 11.5 +/- 0.3 mumol/l 1 h after a meal. The difference is significant (paired t test, P less than 0.01, n = 23). Dietary influence on the free Ch concentration in human plasma is suggested. In three newborn infants (1-3 min post partum) the Ch concentration in plasma from the umbilical vein was 24.5 +/- 1.9 mumol/l.     

Bioavailability of lansoprazole granules administered in juice or soft food compared with the intact capsule formulation

BACKGROUND: The ability to administer the contents of an encapsulated-dose formulation in liquids or soft foods without compromising drug bioavailability is highly desirable for patients who are unable to swallow or have difficulty swallowing. OBJECTIVE: The purpose of this study was to compare the bioavailability of lansoprazole granules administered in 2 types of juice and a soft food with that of the intact capsule administered with water. METHODS: Healthy adult volunteers were eligible for this single-center, Phase I, single-dose, randomized, open-label, 4-period crossover study. Subjects received the enteric-coated granular contents of a 30-mg lansoprazole capsule in 3 test regimens (in 180 mL of orange juice, 180 mL of tomato juice, or 1 tablespoon of strained pears, each followed by 180 mL of water) and 1 reference regimen (the 30-mg intact capsule with 180 mL of water). The regimens were rotated at > or = 6-day intervals so that each subject received all 4 regimens. Blood samples for pharmacokinetic analyses were obtained during the 12 hours after each regimen. RESULTS: Twenty healthy adult volunteers (10 men, 10 women; mean age, 36 years [range, 19-53 years]) completed this study. Bioavailability of the 3 test regimens was assessed using the two 1-sided tests procedure for mean maximum plasma concentration and area under the plasma concentration-time curve (AUC) from time 0 through the last measurable concentration and AUC from time 0 to infinity. These results were compared with that of the intact capsule. This comparison indicated that the 90% CIs for all 3 test regimens were within the acceptable bioequivalence range of 0.80 to 1.25. Lansoprazole was well tolerated, with most of the adverse events being mild. Headache was the most frequently reported adverse event. CONCLUSION: The results of this study indicate that the bioavailability of lansoprazole granules, when administered in orange juice, tomato juice, or a small amount of strained pears, was similar to that of the intact capsule in these healthy adult volunteers.     

奥美拉唑肠溶片人体生物等效性研究

目的探讨奥美拉唑肠溶片在人体生物等效性。方法20名健康男性志愿者随机分为 A、B两组,随机交叉、自身对照试验设计,每名受试者在两周期内分别单剂量口服山西同达药业有限公司研制的奥美拉唑肠溶片（受试制剂）或阿斯利康制药有限公司生产的奥美拉唑肠溶片（参比制剂）各40 mg。HPLC-UV法测定血浆中的奥美拉唑浓度,采用DAS Ver2.1软件计算药动学参数：达峰浓度（Cmax ）、达峰时间（tmax ）、药时曲线下面积（AUC）和半衰期（t1/2）。结果口服奥美拉唑肠溶片受试制剂和参比制剂后,其主要药动学参数如下：Cmax分别为（1.43±0.40）mg/L和（1.51±0.42）mg/L;tmax分别为（1.70±0.38）h和（1.53±0.47）h;AUC0→10分别为（3.80±2.02）mg/（h·L）和（4.06±2.10）mg/（h·L）;AUC0→∞分别为（3.90±2.14）mg/（h·L）和（4.18±2.22）mg/（h·L）;t1/2分别为（1.54±0.89）h和（1.53±0.61）h。与参比制剂相比,受试制剂的相对生物利用度为（94.7±16.5）%。结论奥美拉唑肠溶片受试制剂与参比制剂两者共有生物等效性。     

Bioavailability of oral vitamin E formulations in adult volunteers and children with chronic cholestasis or cystic fibrosis

Purpose:  To test bioequivalence of oral vitamin E formulations, water-soluble tocofersolan (test) and water-miscible (reference), in healthy adult volunteers, and their bioavailability in children with chronic cholestasis or cystic fibrosis.
Methods:  In a two-way open randomized single dose cross-over design, 1200 IU were administered in 12 healthy volunteers and 100 IU/kg in 12 children with chronic cholestasis or cystic fibrosis.
Results:  In healthy volunteers, formulations were not bioequivalent with a higher exposure to tocofersolan. In cholestatic children tocofersolan bioavailability was significantly higher than reference formulation (maximum plasma concentration: P  = 0·008 and AUC: P  = 0·0026). Bioavailability was not statistically different in cystic fibrosis.
Conclusions:  Oral tocofersolan was more bioavailable than the reference formulation in children with chronic cholestasis and similarly bioavailable in cystic fibrosis. Tocofersolan may represent an alternative to painful intramuscular vitamin E injections in chronic cholestasis, or to other oral formulations in cystic fibrosis.