早期应用氨茶碱对窒息新生儿肾功能的影响

目的探讨早期应用氨茶碱对窒息新生儿肾功能的影响。方法 112例窒息新生儿,轻度窒息组76例,重度窒息组36例。每组患儿又随机分成试验组和对照组。在生后1h内试验组静脉滴注小剂量氨茶碱(5mg/kg),对照组静脉滴注等量注射用水,分别收集生后1、3、5d时尿液查尿N-乙酰-β-D-氨基葡萄糖苷酶(NAG)活性及β2微球蛋白,并每4h监测记录心率、呼吸、血压。结果在生后3、5d氨茶碱试验组尿NAG活性及β2微球蛋白明显低于对照组(P<0.05),有统计学意义。心率、呼吸、血压无明显差异(P>0.05)。结论早期应用氨茶碱能降低窒息新生儿尿NAG活性及β2微球蛋白,改善肾脏功能,对窒息新生儿肾脏有保护作用。     

尿α1-微球蛋白在新生儿窒息后肾损伤中的意义

目的探讨尿α1-微球蛋白在新生儿窒息后肾功能损伤的意义。方法窒息新生儿58例按出生时Apgar评分分为轻度窒息组32例、重度窒息组26例;同期选择30例健康足月新生儿作为健康对照组。所有患儿在生后3d内采用酶联免疫吸附法（ELISA）检测尿α1-微球蛋白（α1-MG）浓度,并与其血清尿素氮（BUN）、肌酐（Cr）水平进行对比。结果重度窒息组和轻度窒息组的BUN、Cr和尿α1-MG水平高于健康对照组,且重度窒息组BUN、Cr和尿α1-MG水平显著高于轻度窒息组,差异均有统计学意义（P〈0．01）。轻度窒息组和重度窒息组尿α1-MG异常检出率均显著高于同组血清BUN和Cr异常检出率,差异均有统计学意义（P〈0．05或P〈0．01）。结论尿α1-MG是评价新生儿窒息后肾功能损害的敏感指标。     

尿α1微球蛋白在窒息新生儿肾功能检测中的意义

为探讨新生儿窒息后肾功能损害的早期诊断方法,我们对本院近一年来的窒息足月新生儿在生后48～72h内进行尿α1微球蛋白、血肌酐（Cr）及血尿素氮（BUN）的检测,并与同期本院无窒息的足月新生儿做对照分析。现将结果报道如下：1资料与方法1.1分组资料窒息新生儿48例,其中男30例,女18例。日龄：〈1h20例（41.7%）;1h～,18例（37.5%）;12h～,8例（16.7%）;24～48h2例（4.2%）。生后1minApgar评分：4～7分（轻度     

百令胶囊治疗老年糖尿病肾病的临床观察

目的观察百令胶囊对老年糖尿病肾病（早期）的临床疗效。方法将60例老年糖尿病肾病（DN）患者按顺序1：1随机分为观察组和对照组,每组30例。观察组在一般治疗基础上给予百令胶囊1．0g,3次,d,治疗12周,对照组给予一般治疗,疗程12周。观察两组治疗前后24h尿微量白蛋白（mAlb）、血β2-微球蛋白（血β2-MG）、尿β2-微球蛋白（尿β2-MG）、N-乙酰-β-D-氨基葡萄糖苷酶（NAG）、空腹血糖（FBG）、血清总胆固醇（TC）和三酰甘油（TG）的变化情况。结果治疗12周后,观察组的mAlb,血、尿β2-微球蛋白和NAG酶较治疗前均有明显下降（P〈0．05）,两组间相比,mAlb、尿β2-微球蛋白和NAG酶的差异具有统计学意义（P〈0．05）;而两组患者的FBG、TC、TG治疗前后变化无明显差异,治疗后两组间的差异无统计学意义（P〉0．05）。结论百令胶囊能明显减少早期DN患者的尿微量白蛋白,降低其血、尿β2-微球蛋白和NAG酶,具有肾脏保护作用。     

窒息新生儿血电解质动态变化分析

目的分析窒息新生儿血清电解质动态变化及意义。方法窒息组新生儿343例按窒息程度分为轻度窒息组297例,重度窒息组46例;另设对照组41例。采用酶法测定血清K^＋、Na^＋、Cl^-、Ca^2＋浓度。结果窒息组新生儿血清K^＋、Cl^-、Ca^2＋水平显著低于对照组（均P〈0．01）;出生后24～48h血清K^＋、Na^＋、Cl^-、Ca^2＋水平显著低于24h内（均P〈0．01）;生后24—48h低钠血症、低氯血症、低钙血症的发生率显著高于24h（均P〈0．01）。轻、重度窒息组K^＋、Na^＋、Cl^-、Ca^2＋水平差异无统计学意义（均P〉0．05）。结论新生儿窒息后48h内血清K^＋、Na^＋、Cl^-、Ca^2＋水平逐渐降低,电解质紊乱发生率逐渐增高,应常规动态监测血电解质变化以指导及时治疗。     

82例糖尿病患者尿微量蛋白检测结果分析

目的探讨尿微量白蛋白（mALB）,β2微球蛋白（β2-MG）,α1微球蛋白（α1-MG）,尿转铁蛋白口RD与糖尿病肾病（DN）的关系。方法用速率散射比浊法,测尿微量白蛋白mALB,β2微球蛋白（β2-MG）,α1微球蛋白（α1-MG）,尿转铁蛋白（TRF）。尿蛋白定性用尿11联试纸。结果糖尿病蛋白阴性组与正常对照组比较,差异有统计学意义,P〈0．05。糖尿病阴性组与糖尿病阳性组mALB、α1-MG、TRF差异有统计学意义（P〈0．05）。但β2-MG的差异不明显,P〉0．05,差异无统计学意义。结论mALB,α1-MG,TRF对早期肾病有意义。     

黄芪颗粒联合厄贝沙坦治疗高血压早期肾损害的疗效观察

目的观察黄芪颗粒联合厄贝沙坦治疗高血压早期。肾损害的临床疗效。方法将70例高血压肾病患者随机分为对照组（35例）和观察组（35例）,对照组加用厄贝沙坦150mg,1次／日。治疗组除加用厄贝沙坦150mg,1次／日外,另加用黄芪颗粒4g,2次／日治疗。疗程3个月,治疗前及治疗后1月、3月复查以下各项指标：血压、血常规、电解质、肝功能、血清肌酐、血尿素氮、尿酸、24h尿蛋白定量、血、尿β2微球蛋白。结果和治疗前比较,治疗1月和3月后,对照组和观察组血、尿Bz微球蛋白、收缩压、舒张压、尿酸及24h尿蛋白定量均显著下降（P〈0．01）。和对照组比较,观察组治疗1月后,24h尿蛋白定量和血、尿β2微球蛋白水平均明显下降（P〈0．05）。治疗3月后,24h尿蛋白定量、肌酐、尿酸明显下降（P〈0．05）,血、尿β2微球蛋白水平均显著下降（P〈0．01）.结论黄芪颗粒联合厄贝沙坦治疗高血压早期肾损害可有效降低尿蛋白、改善肾功能。     

应用肾功能和肾损伤标志分子及肾血流变联合检测评价阿魏酸哌嗪联合厄贝沙坦治疗糖尿病肾病的意义

目的：探讨阿魏酸哌嗪分散片联合厄贝沙坦片治疗糖尿病肾病对患者肾损伤标志性蛋白、肾血流变学的影响，并对临床疗效进行分析。方法136例患者随机分为对照组和联合组，每组68例。对照组采用饮食及生活方式干预、降糖药物控制血糖，厄贝沙坦片口服，初始剂量0父．15 g／d，增量至0．3 g／d。联合组在对照组基础上加用阿魏酸哌嗪分散片，口服，100～200 mg／次，3次／d。2组均服用药8周。观察2组患者治疗前后肾功能（血肌酐、尿素氮、尿微量白蛋白／肌酐、尿微量蛋白排泄率）、肾损伤标志性蛋白（尿总蛋白、尿β2微球蛋白、尿视黄醇结合蛋白）、肾血流变学（全血黏度、血浆黏度、全血还原黏度、血小板聚集率、纤维蛋白原、红细胞压积）水平，并对治疗8周后临床效果进行评价。结果联合组治疗后血肌酐、尿微量蛋白排泄率、尿素氮、尿微量白蛋白／肌酐水平显著低于治疗前和对照组，差异有统计学意义（ P ＜0．05），对照组治疗后除外尿素氮与治疗前比较，差异无统计学意义（ P ＞0．05），其余指标均低于治疗前，差异有统计学意义（ P ＜0．05）。联合组治疗后尿总蛋白、尿β2微球蛋白、尿视黄醇结合蛋白水平显著低于治疗前和对照组，差异有统计学意义（ P ＜0．05）。对照组治疗后尿总蛋白水平低于治疗前，差异有统计学意义（ P ＜0．05），尿β2微球蛋白、尿视黄醇结合蛋白水平低于治疗前，但差异无统计学意义（ P ＞0．05）。联合治疗组全血黏度、血浆黏度、全血还原黏度、血小板聚集率、纤维蛋白原、红细胞压积水平显著低于治疗前和对照组，差异有统计学意义（ P ＜0．05），对照组除外红细胞压积，其余指标均低于治疗前，差异有统计学意义（ P ＜0．05）。联合组治疗后有效率显著高于对照组，差异有统计学意义（ P ＜0．05）。结论阿魏酸哌嗪分散片联合厄贝沙坦片治疗糖尿病肾病可以明显减少尿蛋白排泄、降低血黏度，增加肾脏血液灌注，从而改善患者肾脏功能。     

新生儿窒息程度与肾功能损害的相关性分析

目的：探讨新生儿窒息程度与肾功能损害的相关性。方法选取该院2009年1月-2012年12月诊治的窒息新生儿110例,分为轻度窒息组与重度窒息组各55例,并选取同时期健康新生儿55例作为对照组,观察各组窒息后当日、第3、7天时血清尿素氮（BUN）、肌酐（Cr）、尿酸（UA）、β2-微球蛋白（β2-MG）水平变化。结果当日血清 BUN、Cr、UA 比较,3组比较差异均无统计学意义（P ﹥0.05）;第3天,重度窒息组均高于轻度窒息组及对照组,差异均有统计学意义（P ﹤0.05）;第7天,3组比较差异无统计学意义（P ﹥0.05）;血清β2-MG 值当日、第3、7天重度窒息组均高于轻度窒息组及对照组,差异均有统计学意义（P ﹤0.05）。结论新生儿窒息后极易发生肾损害现象,与窒息程度存在正相关性,血清 BUN、Cr、UA、β2-MG 测定能够对窒息后肾损害症状予以有效诊断尤其是血清β2-MG 可以作为新生儿窒息后肾功能受损早期检测指标。     

尿肾功四项检测在糖尿病肾病早期诊断中的临床应用

目的研究和探讨尿肾功四项检测在糖尿病肾病早期诊断中意义。方法以我院2012年8月至2013年8月收治的71例糖尿病肾病患者为研究对象,选取71例健康体检者为对照组,对两组尿微量白蛋白（mALB）、尿β2-微球蛋白（β2-MG）、尿N-乙酰-β-氨基葡萄糖苷酶（N-AG）、尿肌酐（UCr）、mALB／UCr水平进行比较分析。结果经研究比较发现糖尿病肾病组患者的尿微量白蛋白（mALB）、尿β2-微球蛋白（β2-MG）、尿N-乙酰-D-氨基葡萄糖苷酶（NAG）、尿肌酐（UCr）、mALB／UCr水平均明显高于健康对照组,差异具有统计学意义（P〈0．05）。结论尿肾功四项检测在进行早期糖尿病肾病诊断中具有较好的特异性和较高的敏感性,可以作为糖尿病肾病早期诊断的可靠依据。     

新生儿窒息后早期血糖动态监测研究

目的　了解新生儿窒息后血糖的动态变化以及其母分娩前 2h内应用影响糖代谢的药物对窒息新生儿血糖的影响。方法　将符合新生儿窒息诊断的新生儿 ,用微量血糖仪取足跟血一滴测定生后 1h内、3h、2 4h和 72h的血糖值。调整葡萄糖的输入速度和输入量 ,与对照组新生儿进行比较。结果　新生儿窒息后能增加新生儿生后高血糖及低血糖的发生率 ,以高血糖为主 ,并且与其母分娩前 2h内静脉注射影响糖代谢的药物有显著性的关系 (P <0 .0 1) ,通过调整葡萄糖的输入速度及量 ,血糖异常的发生率 ( 1、3、2 4、72h分别为 3 3 .3 3 %、17.19%、15 .79%和 1.89% )逐渐降低。结论　新生儿窒息和其母应用影响糖代谢的药物均可以引起新生儿糖代谢紊乱 ,通过控制葡萄糖的输入量及速度可以纠正糖代谢紊乱。     

窒息新生儿血CRP水平与WBC计数动态变化的比较分析

目的探讨在新生儿围产期窒息后动态监测血C-反应蛋白(CRP)水平和白细胞(WBC)计数的临床价值。方法选择2012年7月～2012年12月入住我院新生儿室的围产期重度窒息、血培养阴性的足月剖宫产新生儿作为窒息组(n=24),同期入住新生儿室的足月剖宫产顺产新生儿作为对照组(n=12)。分别监测各组新生儿出生后第1天、第2天及第3天的血CRP水平和WBC计数。结果各组血CRP水平在出生后第2天较第1、3天均明显升高(P<0.05);窒息组血WBC计数在出生后第1、2天较第3天均明显升高(P<0.05),而对照组血WBC计数在出生后第2天较第1、3天均明显升高(P<0.05)。窒息组各时间点血CRP水平较对照组均明显升高(P<0.05),以出生后第2天最明显;出生后第1天窒息组血WBC计数较对照组均明显升高(P<0.05)。结论新生儿重度窒息后血CRP水平和WBC计数均明显升高且呈规律性动态变化,两者均与生后第3天降至正常。在临床上联合监测血CRP水平和WBC计数有助于把早期新生儿重度窒息与细菌感染鉴别,对避免误诊为细菌感染而过度使用抗生素具有重要意义。     

Pharmacokinetic, bacteriological and clinical studies on aztreonam in neonates

Pharmacokinetic, bacteriological and clinical studies on aztreonam (AZT) were performed in neonates. The results obtained are summarized as follows. 1. Plasma levels and urinary excretion of AZT were determined in 18 neonates with ages between 1 and 30 days (gestation periods were 36 to 40 weeks and birth weights were 1,890 to 4,300 g) and in 2 infants with 54 and 60 days of age (gestation periods were 36 and 40 weeks, and birth weights were 2,300 and 3,300 g, respectively) upon one-shot intravenous injection of AZT 10 mg/kg (7 cases) or 20 mg/kg (11 cases) to the 18 neonates and 20 mg/kg to the 2 infants. Ampicillin (ABPC) 25 mg/kg was simultaneously injected to 5 cases of the neonates given AZT 20 mg/kg by one-shot intravenous injection and plasma concentrations of ABPC in these 5 cases were also studied. Plasma concentrations in neonates at 0.5 hour after intravenous injection of AZT 10 mg/kg were 11.5 to 27.6 micrograms/ml (average 20.3 +/- 5.5 micrograms/ml) and decreased with half-lives of 2.72 to 5.70 hours (average 3.81 +/- 1.28 hours), and the plasma levels at 8 hours after administration were 3.3 to 8.7 micrograms/ml (average 5.8 +/- 2.5 micrograms/ml). In the cases given AZT at 20 mg/kg, plasma levels at 0.5 hour were 12.4 to 48.8 micrograms/ml (average 35.9 +/- 11.6 micrograms/ml) and decreased with half-lives of 1.69 to 4.14 hours (average 2.94 +/- 0.76 hours) and AZT levels at 8 hours were 1.1 to 10.6 micrograms/ml (average 5.6 +/- 3.6 micrograms/ml). Urinary recovery rates in the first 8 hours after intravenous injection of the 10 mg/kg group were 15.5 to 61.9% (average 37.8 +/- 21.8%) and 16.3 to 62.2% (average 43.5 +/- 16.2%) for the 20 mg/kg group. Plasma concentrations in infants after administration of AZT 20 mg/kg were 33.0 to 35.6 micrograms/ml (average 34.3 +/- 1.8 micrograms/ml) at 0.5 hour and decreased with half-lives of 1.76 to 3.77 hours (average 2.77 +/- 1.42 hours) and AZT plasma levels at 8 hours were 1.4 to 5.8 micrograms/ml (average 3.6 +/- 3.1 micrograms/ml). Urinary recovery rates were 35.4 to 64.8% (average 50.1 +/- 20.8%). These results suggested that AZT shows a dose-dependent, high plasma concentration even in the neonatal period, as well as good urinary excretion from an early stage of the administration.(ABSTRACT TRUNCATED AT 400 WORDS)     

Pharmacokinetic, bacteriological and clinical studies of ceftizoxime in neonates

Pharmacokinetic, bacteriological and clinical studies of ceftizoxime (CZX) were performed in neonates. 1. Serum concentrations and urinary excretion of CZX were investigated in 12 neonates ranging ages from 1 to 27 days (gestational age, 35-41 weeks; birth weight, 2,150-4,030 g) and 2 infants ranging ages from 55 to 57 days (gestational age, 39-40 weeks; birth weight, 2,320-2,650 g). Each of the subjects was given a single intravenous dose of 20 mg/kg by one shot. Serum concentrations of CZX in the neonates were 24.9-53.7 micrograms/ml at 1/4 hour after intravenous injection, with an average of 40.6 +/- 7.6 micrograms/ml. Serum half-lives of CZX were 1.32-4.75 hours and averaged 2.60 +/- 1.06 hours. Serum concentrations ranged from 2.01 to 14.6 micrograms/ml at 6 hours after injection with an average of 7.70 +/- 3.89 micrograms/ml. In the 2 infants, serum concentrations were 42.0 and 46.2 micrograms/ml at 1/4 hour (average: 44.1 +/- 3.0 micrograms/ml), and 2.91 and 5.04 micrograms/ml at 6 hours after injection (average: 3.98 +/- 1.51 micrograms/ml). Half-lives were 1.54 hours in 1 infant and 1.93 hours in the other (average: 1.74 +/- 0.28 hours). Furthermore, 6-hour urinary recovery rates were 28.5-71.7% (average: 49.3 +/- 12.8%) in the neonates and 42.1-55.5% (average: 48.8 +/- 9.5%) in the infants. The above results suggest that the following 3 points are accepted; 1) peak serum concentrations (at 1/4 hour) in neonates were similar to those in infants and older children irrespective of age (days after birth). 2) Serum half-lives of CZX in neonates shortly after birth were 4 or 5 times longer than those in older children, but decreased rapidly with the advance of day-ages. The half-life in neonates of 2 weeks of age or so became shorter to about twice the normal value in infants. Furthermore, half-lives of the drug in those at an age of the first half of infancy were similar to those in older children. 3) The urinary excretion rates tended to be somewhat low with neonates soon after birth, but became very similar to those in infants and older children at a relatively early stage.(ABSTRACT TRUNCATED AT 400 WORDS)     

Pharmacokinetics and clinical studies on aztreonam in neonates

Pharmacokinetic and clinical studies on aztreonam (AZT) were performed in neonates. Serum concentrations and urinary excretion of AZT were determined in 12 neonates with ages between 0 and 7 days (birth weights were between 1,260 and 3,500 g) upon intravenous injection or 1 hour drip intravenous infusion of AZT at 20 mg/kg. Serum concentrations of AZT at 1 hour after i.v. administration were 54.0 +/- 12.5 micrograms/ml, and half-lives were 6.01 +/- 0.70 hours. Serum concentrations of AZT reached their peaks at the end of drip infusion with levels of 42.1 +/- 17.6 micrograms/ml in the d.i.v. group and half-lives were 6.40 +/- 1.88 hours. Urinary recovery rates in the first 12 hours after administration were 28.5 +/- 6.4% for the i.v. group and 32.3 +/- 13.9% for the d.i.v. group. AZT was administered to 12 neonatal patients (2 cases of sepsis, 2 cases of suspected sepsis, 3 cases of pneumonia, 2 cases of urinary tract infection and 3 cases for prophylaxis), and clinical effectiveness, bacteriological efficacy and adverse reactions were evaluated. Clinical efficacies in 9 cases except 3 cases with prophylactic use were excellent in 1 case, good in 5 cases, fair in 1 case, poor in 1 case and unknown in 1 case, thus the efficacy rate was 75%. Bacteriological effects in 3 strains with Gram-negative bacilli were eradicated in 2 strains and unchanged in 1 strain, hence the bacteriological eradication rate was 66.7%. Increased GOT and GPT were observed in 1 cases as abnormal laboratory test results, but the abnormality was not serious.(ABSTRACT TRUNCATED AT 250 WORDS)     

Laboratory and clinical studies of sulbactam/ampicillin in pediatric field

We have carried out laboratory and clinical studies on sulbactam/ampicillin (SBT/ABPC). The results are summarized as follows. SBT/ABPC was given by 30-minute drip infusion to 1 child at a single dose of 15 mg/kg and to 2 children at a single dose of 30 mg/kg. After the 30-minute drip infusion, peak serum levels of ABPC(SBT) obtained for the 2 dose levels were 18.0 micrograms/ml (12.4 micrograms/ml) for the former dose level and 81.0 micrograms/ml (53.7 micrograms/ml) and 300 micrograms/ml (200 micrograms/ml) for the latter at the end of injection, and half-lives were 0.84 hour (0.82 hour) for the former and 0.96 hour (1.44 hours) and 0.93 hour (1.19 hours) for the latter. In another trial, SBT/ABPC was given to 1 child at a single dose of 60 mg/kg. After the 30-minute drip infusion, peak serum level of ABPC (SBT) was 82.3 micrograms/ml (45.9 micrograms/ml), and half-life was 1.20 hours (1.36 hours). The urinary excretion rates of ABPC (SBT) were 51.3% (49.5%), 55.8 +/- 10.4% (65.3 +/- 9.1%), 74.0% (76.1%) up to 6 hours after the 30-minute drip infusion of 15 mg/kg, 30 mg/kg and 60 mg/kg, respectively. Treatment with SBT/ABPC was made in 21 cases of pediatric bacterial infections: 8 cases of tonsillitis, 4 cases of bronchitis, 3 cases of pneumonia and 1 case each of pharyngitis, peritonsillar abscess, lymphadenitis, impetigo, abscess and urinary tract infection. Results obtained were excellent in 14 cases, good in 7 cases. No significant side effect due to the drug was observed in any cases except 1 case of fever and rash.     

Pharmacokinetic and clinical evaluations on ceftriaxone in neonates

1. Ten neonates 0 to 28 days old (gestation: 37-42 weeks; birth weight: 2,160-3,640 g) received 20 mg/kg CTRX (8 cases) or 10 mg/kg (2 cases) by intravenous bolus injection, while 9 infants 35 days to 9 months old (gestation: 37-43 weeks; birth weight: 2,800-3,560 g) received 20 mg/kg by intravenous bolus injection, and their blood drug concentrations and urinary drug excretions were examined. Average blood levels of CTRX in the 20 mg/kg dosage group were 114 +/- 14.6 micrograms/ml at 30 minutes, 109 +/- 12.8 micrograms/ml at 1 hour, 100 +/- 12.6 micrograms/ml at 2 hours, 87.9 +/- 15.8 micrograms/ml at 4 hours, 72.8 +/- 15.3 micrograms/ml at 6 hours, and 50.1 +/- 12.3 micrograms/ml at 12 hours in the neonates; and 113 +/- 20.0 micrograms/ml at 30 minutes, 101 +/- 14.7 micrograms/ml at 1 hour, 83.6 +/- 9.3 micrograms/ml at 2 hours, 70.3 +/- 10.7 micrograms/ml at 4 hours, 56.9 +/- 8.6 micrograms/ml at 6 hours, and 35.7 +/- 9.2 micrograms/ml at 12 hours in the infants. Average half-lives of CTRX in blood were 10.3 +/- 4.5 hours in the neonates, and 6.6 +/- 1.9 hours in the infants. Average blood concentrations of CTRX in the 10 mg/kg dosage neonate group were 63.8 +/- 6.0 micrograms/ml at 30 minutes, 57.8 +/- 2.5 micrograms/ml at 1 hour, 53.5 +/- 0.7 micrograms/ml at 2 hours, 41.8 +/- 7.4 micrograms/ml at 4 hours, 32.4 +/- 5.9 micrograms/ml at 6 hours, and 20.8 +/- 1.1 micrograms/ml at 12 hours, and the half-life was 7.2 +/- 0.4 hours. These results suggest that blood concentrations are apparently dose-related in the neonate period; that the peak levels of the neonate and infant groups were similar (the levels at 30 minutes) not showing a relationship to age, gestation period or to birth weight; and that the higher the age was the shorter the half-life became with the half-life in the one week old group was 1.5 times as long as that in the older infant group. The half-life in the younger infant group, however, was similar to that in the older infant group. Urinary excretion was examined in 4 neonates and 2 infants. Average urinary recovery rates in 12 hours after intravenous injection were 40.8 +/- 8.3% in the neonate group and 44.8 +/- 12.8% in the infant group, showing that CTRX is excreted well even in the neonate period.(ABSTRACT TRUNCATED AT 400 WORDS)     

Evaluation on ceftriaxone administered intravenously in neonates

Ceftriaxone (CTRX) was clinically evaluated and its pharmacokinetics studied in neonates. The results obtained are summarized below. 1. Blood levels of CTRX at 8 to 12 hours after intravenous injection with a single dose of 10 to 20 mg/kg ranged from 14.9 to 32.8 micrograms/ml, while T1/2 ranged from 8.2 to 24.8 hours. 2. Blood levels of CTRX at 11 hours after the completion of drip infusion which lasted one hour with a dose level 10 to 20 mg/kg, ranged from 10.6 to 25.0 micrograms/ml, while T1/2 was 5.4 to 22.8 hours. 3. Multiple intravenous administrations were given to premature infants, but blood levels did not show evidence of drug accumulation. 4. Urinary excretion in 6 hours after an intravenous injection or a drip infusion with 10 approximately 20 mg/kg of CTRX ranged from 13.8 to 58.5% of the dosage. 5. The subjects in this study were 9 neonates with suspected sepsis, pneumonia, Staphylococcus epidermidis or Staphylococcus aureus infections (sepsis, staphylococcal scalded skin syndrome, pneumonia), acute bronchitis or meconium aspiration syndrome. Efficacies CTRX were excellent or good in all these cases administered in a daily dose of 19.5 to 41.6 mg/kg for 4 to 11 days. 6. No general side effects or abnormalities were observed in blood count, or hepatic or renal function.     

Pharmacokinetic, bacteriological and clinical studies on imipenem/cilastatin sodium in neonates

Pharmacokinetic, bacteriological and clinical studies on imipenem/cilastatin sodium (IPM/CS) were performed in neonates. The results obtained are summarized as follows. 1. Plasma levels and urinary excretion of IPM and CS sodium were determined in 7 neonates with ages between 7 and 26 days (gestation periods were 37 to 41 weeks and birth weights were 2,410 to 3,890 g) upon 1 hour drip intravenous infusion of IPM/CS at 10 mg/10 mg/kg, or 20 mg/20 mg/kg. Mean plasma concentrations of IPM reached their peaks at the end of infusion with levels of 12.7 +/- 3.0 micrograms/ml for the group given 10 mg/10 mg/kg, and 19.1 +/- 4.1 micrograms/ml for 20 mg/20 mg/kg. The concentration of IPM in plasma showed a dose-response to the 10 mg/10 mg/kg and 20 mg/20 mg/kg dosages. Concentrations decreased with half-lives of 1.87 +/- 0.71 hours and 1.97 +/- 0.21 hours for the low and the high dosages, and plasma levels at 8 hours after administration were 0.3 +/- 0.1 microgram/ml and 0.8 +/- 0.3 microgram/ml, respectively. Mean urinary recovery rates in 8 hours after administration were 37.6 +/- 11.8% and 26.8 +/- 17.2% for the low and the high dosages. While, mean plasma concentrations and mean urinary recovery rates of CS were higher than those of IPM, mean plasma half-lives of CS were similar to IPM. 2. IPM/CS was administered to 11 neonatal patients (with ages between 1 and 26 days) of various bacterial infections, and clinical effectiveness, bacteriological efficacy and adverse reactions were evaluated. Clinical efficacies in cases including 7 with acute pneumonia and 1 each with suspected septicemia, intrauterine infection, acute urinary tract infection and periproctal abscess were judged excellent in 10 and good in 1 case, and the efficacy rate was 100%. Causative organisms isolated from these patients included 3 strains of Escherichia coli and 1 strain each of Streptococcus pyogenes, Streptococcus agalactiae Enterococcus faecalis and Haemophilus influenzae. All the organisms were eradicated by IPM/CS, thus the bacteriological eradication rate was 100%. No adverse reactions were observed, but decreased platelet in 1 patient and increased GOT in 2 patients were found as abnormal laboratory test values. These changes, however were transient, and returned to normal after discontinuation of IPM/CS. It was concluded that the clinical results of IPM/CS are indicative of excellent efficacy, safety and usefulness of the drug in the treatment of infections in neonates.     

Experimental and clinical evaluation of latamoxef in newborn and premature infants

Fundamental and clinical studies in infants including neonates on latamoxef (LMOX) were carried out, and following results were obtained. In fundamental studies, half-lives of LMOX were 5.79, 4.38 hours, at dose 10 mg/kg by intravenous injection and intravenous drip infusion in neonates, respectively. And urinary excretions were 6.8, 15.6% for 6 hours, respectively. In 28--50 day-old neonates, half-lives were 2.26--4.3 hours at dose 20 mg/kg, and urinary excretions were ranged from 14.3 to 37.0%. Clinical results were following. In 8 cases of bronchopneumonia and 2 cases of pertussis, the clinical efficacy rate was 100% at daily dose 38--100 mg/kg twice or third a day by intravenous injection or intravenous drip infusion for 6--9 days duration. All causative organisms (K. pneumoniae 1, S. aureus 1) were eliminated after LMOX 43 or 38 mg/kg/day dose administration. Side effect and laboratory abnormal value were not noticed in all cases. We finally have a conclusion that LMOX should be administered 40--70 mg/kg/day, and given twice or third a day by intravenous injection or intravenous drip infusion.