Clinical and pharmacokinetics studies of ceftriaxone upon 2g once daily administration in respiratory tract infections

Clinical studies on ceftriaxone (CTRX) were conducted with 2 g once daily administration to respiratory tract infections. In addition, CTRX concentrations in serum, sputum and urine were determined. The results obtained are summarized as follows: 1. Clinical responses to CTRX in a total of 29 cases with respiratory tract infections were excellent in 7 cases, good in 13, fair in 8 and poor in 1 with a response rate of 69.0%. 2. CTRX concentrations in serum, sputum and urine (total and free body) were determined in 3 cases after intravenous drip infusion of 2g CTRX. Peak levels in sputum were 2.6 to 7.8 micrograms/ml, and CTRX maintained high sputum levels for 12 to 24 hours after administration.     

Clinical and bacteriological studies of ceftriaxone (CTRX) once daily administration in pediatric patients with respiratory tract infections]

Clinical studies of ceftriaxone (CTRX) were performed at a dose of 40 mg/kg once daily to evaluate its pharmacokinetics, and clinical and bacteriological efficacies in pediatric patients with respiratory tract infections. The following results were obtained. 1. Of 45 patients, clinical responses to CTRX were excellent in 34 (75.6%), good in 9 (20.0%) and poor in 2 (4.4%), indicating the overall efficacy rate of 95.6%. 2. Haemophilus influenzae (23 strains), Streptococcus pneumoniae (20 strains) and Moraxella catarrhalis (17 strains) were isolated from the patients as the main causative organisms. MIC90 of CTRX against these detected bacteria was < or = 0.06 microgram/ml with H. influenzae [beta-lactamase (-)/ABPC (S)], 0.25 microgram/ml with H. influenzae (BLNAR), 0.05 microgram/ml with PSSP, 1.0 microgram/ml with PISP/PRSP and 2.0 micrograms/ml with M. catarrhalis, respectively. 3. The eradication rate of causative organisms was 90.0% (27/30). 4. Serum levels of CTRX after administration of a 1-hour intravenous drip infusion of 40 mg/kg were investigated in 12 patients. Mean serum level at 24 hours after the administration was 9.4 +/- 2.8 micrograms/ml, which covered the level of MIC90 throughout the 24 hours. 5. No adverse reactions related to CTRX were observed. As the approved dosage of CTRX in pediatric patients is twice daily, while it is once daily in adults, there have been few reports on the efficacy of once-daily CTRX in pediatrics. According to the results of the study, it is suggested that once-daily CTRX for the pediatric patients with respiratory tract infections is useful. Further studies might be required to establish outpatient parenteral antibiotic therapy (OPAT) in pediatric infections.     

Clinical efficacy of ceftriaxone when administered once daily for respiratory tract infections in patients with advanced ages]

Ceftriaxone (CTRX), a new third generation cephalosporin, was investigated upon once daily administration for its clinical efficacy and safety on respiratory tract infections in patients with advanced ages. The results are summarized as follows: 1. Clinical responses to CTRX of 48 cases of advanced age patients with respiratory tract infections were good with an efficacy rate of 89.6%. 2. Adverse reactions to CTRX were mainly exanthema in 7 cases (14.6%). 3. Serum levels of CTRX were determined in 4 cases after intravenous drip infusion of 2 g CTRX. Serum levels were analyzed by one-compartment model. There was no evidence of accumulation of CTRX in the patients with advanced ages.     

Serum levels and sputum levels of cefmenoxime in respiratory tract infections

In 11 patients with respiratory tract infections, the concentrations of cefmenoxime (CMX) in serum and sputum after 1 hour intravenous administration of 2 g of CMX were investigated. The peak serum level of CMX was 102.2 +/- 11.4 micrograms/ml after 1 hour drip infusion, then declined and was 3.51 +/- 0.55 micrograms/ml after 5 hours. Sputum level of CMX was lower than serum level but it was able to cover enough for MIC of Haemophilus influenzae, Klebsiella pneumoniae, Escherichia coli, Streptococcus pneumoniae and the peak sputum level of CMX was 0.77 +/- 0.17 micrograms/g after from 2 hours to 4 hours. Among the 11 patients with respiratory tract infections, 2 patients showed excellent, 6 patients good, 3 patients poor results (isolated organisms of sputum were normal flora) and no side effects observed.     

Clinical studies on ciprofloxacin in chronic respiratory tract infection

Ciprofloxacin (CPFX), a new pyridone carboxylic acid, was administered orally to the patients with chronic respiratory tract infection and its clinical efficacy and safety were studied in a multicenter open trial. The results and summarized as follows. 1. The efficacy rate for the patients with acute exacerbation as 52.5% (21/40) in 2 week-treatment, and 75.0% (24/32) in 4 week-treatment. 2. The efficacy rate for the patients with chronic phase was 23.1% (6/26) in 2 week-treatment, and 26.9% (7/26) in 4 week-treatment, but acute exacerbation was not observed in any of the patients. 3. CPFX was administered to 6 patients over 60 days for the prophylaxis of acute exacerbation. Only 2 patients had acute exacerbation in 2 and 3 months after the start of the therapy, respectively. 4. Bacteriological eradication rate was high except P. aeruginosa, for which the eradication rate was about 20%. 5. Side effects were observed in 3 patients, and abnormal findings of laboratory tests were observed in 5 patients, though they were not severe. These results show that CPFX is a useful antimicrobial agent for the treatment of chronic respiratory tract infections.     

呼吸道感染的合理用药

<正>呼吸道感染是常见的疾病。在下呼吸道感染中, 肺炎对人类的威胁最大。2005年美国胸科学会和美国感染性疾病学会联合公布了有关肺炎的指南,对于肺炎的含义做了补充修订。该指南将肺炎发生情     

Serum and sputum levels of cefotetan used in respiratory tract infections

In 5 patients with respiratory tract infections, concentrations of cefotetan (CTT) in serum and sputum after 1 hour intravenous administration of 2 g of CTT to each patient were investigated, and following results were obtained. Serum levels of CTT The mean peak level of CTT was 232.0 +/- 16.2 micrograms/ml immediately after the 1 hour drip infusion, then declined gradually and was 48.0 +/- 8.8 micrograms/ml after 6 hours. Sputum levels of CTT Mean sputum levels of CTT were 2.15 +/- 0.19 micrograms/ml from 2 to 4 hours after the administration and 2.19 +/- 0.18 micrograms/ml from 4 to 6 hours. Clinical evaluation of CTT Clinical effects were excellent in 1 case, good in 3 cases and poor in 1 case. No side effects were observed.     

体外冲击波碎石后石街处理体会

我院用体外冲击波碎石术(ESWL)后,形成石街的30例病人,现将石街的发生和处理体会报道如下:1 资料与方法1.1 一般资料:我院1993年开展ESWL以来治疗泌尿系结石1900例,术前均经B超及静脉肾盂造影,显示患侧肾脏有分泌功能,伴有或不伴有肾积水。其中ESWL后形成石街的30例,男22例,女8例,年龄19-65岁,石街形成前,碎石次数1-7     

哌拉西林-他唑巴坦与头孢曲松治疗下呼吸道感染的成本-效果比较

目的比较哌拉西森-他唑巴坦与头孢曲松治疗下呼吸道感染的疗效和费用.方法 68例下呼吸道感染患者分成2组:A组(n=34)予哌拉西林-他唑巴坦4.5g静脉滴注q12h;B组(n=34)予头孢曲松2.0g静脉滴注qd.2组均以7～10d为一个疗程.结果 A组和B组临床有效率分别为88.2%和85.3%(P＞0.05),总医疗费用A组较B组高,分别为(7096±694)和(5460±520)元(P＜0.05).结论 2组疗效相似,费用有显著差异,A组医疗费用高,且不良反应发生率较B组高.     

Evaluation of once daily sotalol administration in man

1 Sotalol 400 mg orally was given to five healthy male volunteers as a single dose and then subsequently once daily for 8 days.

2 Following the single dose and again after the eighth daily dose, blood samples were obtained at 3, 7, 12, 24, 36 and 48 h for plasma sotalol estimation.

3 During the 8-day course of sotalol 400 mg once daily, the effect was assessed by exercise testing and blood samples drawn for plasma sotalol measurement at 0 and 3 h with each dose.

4 The elimination half-life after chronic administration (17.7 ± 2.6 h) was not significantly different from that obtained after the single dose (15.5 ± 1.2 h). No difference occurred either in the comparable plasma concentrations on both elimination curves. It would appear, therefore, that chronic administration of sotalol does not alter its kinetics.

5 Drug accumulation, measured as AUC_ss / AUC₁, showed a mean value of 0.95 ± 0.18, indicating that accumulation had not occurred.

6 Mean reduction of exercise heart rate ranged from a minimum of 20.5 ± 2.0% at time 0 on Day 8 to a maximum of 38.7 ± 1.1% at +3 h on Day 4. The minimum blockade in any individual during the 8 days was 14.5%.

7 There was a significant correlation between percentage reduction in exercise heart rate and plasma sotalol concentration.

8 Once daily administration of sotalol 400 mg orally would, therefore, appear to be an effective therapeutic regimen when sustained β-adrenoceptor blockade is required.

     

Clinical and bacteriological evaluation of ceftriaxone (CTRX) dosed once daily in children with community-acquired pneumonia]

Clinical and bacteriological evaluation was performed as follows on ceftriaxone (CTRX) at a dose of 50 mg/kg once daily to pediatric patients with community-acquired pneumonia. Of 48 subject patients, CTRX was markedly effective in 36 (75.0%), effective in 9 (18.7%), slightly effective in 2 (4.2%), and failure in 1 (2.1%), indicating the overall effective rate of 93.7%. In 47 (97.9%) patients with the exception of 1, it was observed during the period of administration that fever was resolved and clinical symptoms as well as radiographically abnormal shadows were found relieved or improved. Patients infected by an isolated strain accounted for 34 (70.8%), while those by multiple strains 14 (29.2%), indicating that either Streptococcus pneumoniae or Haemophilus influenzae, or both were detected in almost all patients (45 cases). Of the 48 patients, bacteriological effect was eliminated in 44 (91.7%), and replacement of the bacteria in the remaining 4 (8.3%). MIC90 of CTRX against detected bacteria was 0.2 microgram/ml with H. influenzae, < or = 0.025 microgram/ml with PSSP, 0.1 microgram/ml with PISP, and 0.39 microgram/ml with PRSP. Blood concentration of CTRX at 50 mg/kg upon completion of 1-hour drip intravenous infusion was 89.7 +/- 25.2 micrograms/ml, and 6.6 +/- 0.9 micrograms/ml at 24 hours after the completion, indicating that the concentrations had been well above the levels of MIC90 throughout the 24 hours. Abnormal symptoms, which were most likely adverse drug reactions, were not observed in any patients, and no abnormal changes were noted in patients, whose clinical lab values were taken before or after the administration. Situations may differ by region in Japan, however, infants under 3 are generally exempted from medical payment regardless of inpatients or outpatients. When hospitalized, psychological burden upon pediatric patients without guardians attended must be enormous. If they are over 3, there is a difference in medical costs between inpatients and outpatients, with greater economic burden on inpatients. Thus, it was considered worth attempting the outpatient treatment as one of new therapies for community-acquired pneumonia, though the outpatient treatment should not be encouraged without due consideration. Based on these results, CTRX dosed once daily to pediatric patients with community-acquired pneumonia is clinically and bacteriologically superior in usefulness. Further review may be necessary, however, it is considered that outpatient treatment can also serve as one of the options, if safety of once-a-day administration of CTRX can be established.     

阿米卡星全日剂量单次用药治疗下呼吸道感染的评价

对３５例耳、肾功能正常的下呼吸道细菌感染患者采用阿米卡星全日剂量单次给药评价其临床疗效及不良反应。结果表明,单次用药疗效与二次用药比较无明显差异。单次用药治疗前、后肾功能无明显变化,２例患者出现听力下降,但２周内恢复正常。二次用药治疗后３例病人尿β２－微球蛋白（β２－ＭＧ）、血α１－微球蛋白（α１－ＭＧ）出现异常变化;２例出现感音神经性耳聋患者１月内未恢复正常。提示：在获得满意疗效的同时,为有效降低不良反应,１５ｍｇ／ｋｇ全日剂量单次用药对患者更为有利。     

Clinical studies on TMS-19-Q.O tablet in respiratory tract infection

A new macrolide antibiotic preparation, TMS-19-Q.O tablet, was used to investigate the efficacy in the treatment of patients with respiratory tract infection, and the results obtained were as follows: Three hundred and seven cases were included in this report, and overall efficacy rate was 76.2%. Especially high clinical effect (86.0%) was observed in the treatment of patients with pneumonia including mycoplasmal pneumonia. Bacteriological effect was 87.5% in 51 cases identified as single infection of Gram-positive cocci and was 48.0% in 34 cases Gram-negative rods infection. Side effects were observed in 11 cases (3.50%): gastrointestinal disorder in 8, eruption in 2 and other in 1. Abnormality in laboratory tests was observed in 23 cases, hepatic disorder in 13, renal disorder in 3 and other laboratory tests in 7. It was considered from the results of clinical and bacteriological efficacy in different dose study that dose of TMS-19-Q should be 600 mg.     

Per rectal administration of antibiotics. Clinical use of ampicillin in respiratory tract infection in children

As one of our clinical studies on per rectal administration of antibiotics, children who suffered respiratory tract infection (RTI) were administered with ampicillin (ABPC) through this route. Our conclusions drawn from this study are as follows: 1. One hundred and eighty strains of aerobic bacteria which were isolated by us in 1984-1985 were tested for the sensitivity to ABPC using plate-disk method. MIC's of ABPC for all the strains of Streptococcus pyogenes were lower than 0.024 micrograms/ml. MIC's for all the strains of Streptococcus haemolyticus were 0.05-0.20 microgram/ml. MIC's for 88% of the strains tested of Haemophilus influenzae were 0.10-0.78 microgram/ml. 2. Bacterial flora in the respiratory tract of 97 cases of children, who suffered RTI, were cultured. Almost half of them were Gram-positive cocci, the rest belonged to Gram-negative groups. This indicates that broad-spectrum antibiotics should be chosen first even before the diagnosis of causative organisms is established. 3. Soon after a per rectal administration of ABPC to children, high blood concentrations of the drug were observed by paper-disk method. 4. Eleven cases, which included 2 cases of pneumonia, of 15 children who suffered RTI and were given this antibiotic were greatly improved within 3-10 days. No serious side effects were observed. 5. Our brief study reported here indicates that ABPC administration by rectal route is safe and useful for the clinical treatment of RTI of children.     

头孢匹罗头孢吡肟头孢曲松治疗下呼吸道感染的疗效比较

目的比较头孢匹罗、头孢吡肟、头孢曲松治疗下呼吸道轻中度感染的疗效和安全性。方法在139例患者中进行多中心、前瞻性、随机比较。头孢匹罗组（Ⅰ组）46例,头孢吡肟组（Ⅱ组）48例,头孢曲松组（Ⅲ组）45例。各组所用药物均为2g／a,静脉注射,疗程7d。结果3组临床疗效分别为82％、79％、60％;细菌阳性率48％（67／139）,细菌清除率分别为80％、78％、56％,3组比较Ⅰ、Ⅱ组间差异无显著性（P〉0．05）。Ⅰ、Ⅱ组与Ⅲ组间差异均有显著性（P〈0．05）。治疗过程中3组患者无1例出现皮疹及其他不良反应。结论头孢匹罗、头孢吡肟、头孢曲松各用2g／d治疗轻中度下呼吸道感染安全有效,且1周疗程足够。但在治疗这些疾病时,可先选用头孢曲松、当头孢曲松治疗无效时,再选用头孢匹罗或头孢吡肟。     

Clinical effect of ceftriaxone and cefditoren administration against oral and genital gonococcal infection

The clinical findings of genococcal infection (oral and genital) and the clinical effect of ceftiaxone (CTRX) and cefditoren (CDTR) administration were studied in Commercial Sex Workers (CSW). The gonococci were detected by DNA probe method (mouth), PCR method (genitals) and ELISA method (chlamydial antibody detection). 1) In the oral infection group (n = 20), chlamydial infection (65%), herpes infection (25%), and genital gonococcal infection (35%) were noted. Pharyngeal pain was observed in 9 out of 9 patients with tonsillitis and 4 out of 11 patients with pharyngitis. High fever and cervical lymphadenopathy were observed in 3 out of 9 patients with tonsillitis. 40% (8/20) of the partners had infections. Both CTRX administration (1 - 2 g/day x 3 days) (n = 11) and consecutive administration of CDTR (300 mg/day x 3 - 7 days) following CTRX administration (1 - 2 g/days x 1 - 3 days) (n = 9) were effective in all patients. 2) In the genital infection group (n = 35), chlamydial infection (65.7%), herpes infection (25.7%) and oral gonococcal infection (17.1%) were observed in 3 out of 6 patients with tonsillitis and 3 out of 6 patients with pharyngitis. The treatment was effective in all patients in the CTRX (1 - 2 g/day x 2 - 3 days) group (n = 14), CDTR (300 mg/day x 5 - 7 days) group (n = 5) and consecutive administration of CDTR (300 mg/day x 3 - 7 days) after CTRX (1 - 2 g/day x 1 - 3 days) and (n = 14). In pelvic peritonitis (n = 2), CTRX administration (2 - 4 g/day x 3 - 7 days) were effective.     

Clinical studies on flomoxef in respiratory tract infections

Flomoxef (FMOX, 6315-S) is a new oxacephem with a broad spectrum of antimicrobial activity. We used FMOX for treatment of 13 patients with respiratory tract infections including 4 cases of pneumonia, 5 of lung abscess and 4 of exacerbation of the chronic airway diseases. FMOX showed excellent in vitro antimicrobial activities against clinical isolates including 4 strains of Streptococcus pneumoniae, 2 strains of Haemophilus influenzae and each one strain of Escherichia coli and Klebsiella pneumoniae. Clinical responses were excellent in 3 cases, good in 7 and fair or poor in 3. No side effect was observed, but abnormal laboratory findings caused by FMOX administration were found in 2 cases; hypertransaminasemia and eosinophilia. However, neither of them was severe. From the above results, it is considered that FMOX will be useful for treatment of patients with respiratory tract infections.     

反复呼吸道感染患儿血清维生素A E水平的临床研究

目的 研究反复呼吸道感染(RRTI)患儿血清维生素A、E的水平。方法 选取2017年2～12月在安徽省妇幼保健院就诊的120例呼吸道感染患儿作为研究对象,其中反复呼吸道感染患儿60例作为RRTI组,非反复呼吸道感染患儿60例作为非RRTI组,选取同期体检的健康儿童42例作为对照组。比较3组对象血清维生素A、E水平及白细胞计数(WBC)、C反应蛋白(CRP)、血红蛋白(Hb)水平;分析血清维生素A、E水平与血清WBC、CRP、Hb水平的相关性。结果 3组对象维生素A、Hb水平进行比较,差异有统计学意义(P<0.05),RRTI组患儿血清维生素A、Hb水平均低于非RRTI组和对照组,差异有统计学意义(P<0.05)。维生素A检测水平分型比较,差异有统计学意义(P<0.05),RRTI组、非RRTI组和对照组血清维生素A缺乏率分别为85.00%、78.33%和40.48%。120例患儿血清维生素A水平与血清Hb水平呈正相关(r=0.186,P=0.018),与血清CRP水平呈负相关(r=-0.205,P=0.009)。结论 呼吸道感染儿童存在维生素A缺乏,以RRTI儿童维生素A缺乏最为明显。     

Clinical studies on flomoxef in respiratory infection

Clinical efficacy, bacteriological effect and safety of a new antibiotic flomoxef (FMOX, 6315-S) in respiratory infections were studied. Efficacy of FMOX in 6 patients with infectious diseases including 2 cases with pneumonia, 3 cases with acute exacerbation by respiratory infection, 1 case with obstructive pneumonia were clinically evaluated. Two strains of Haemophilus influenzae, 1 strain of Streptococcus pneumoniae and 1 strain of Staphylococcus aureus which were detected as causative organisms in 2 cases disappeared or decreased after treatment with FMOX. Assessing both clinical and bacteriological findings, effects of FMOX were good in 5 cases and fair in 1 case. No adverse effects were observed in clinical or laboratory findings. Consequently, FMOX is considered to be a very useful antibiotic in the treatment for respiratory infectious diseases.     

Clinical assessment of sulbenicillin in acute respiratory tract infection

The effectiveness of sulbenicillin was assessed in the treatment of 15 adults, 12 suffering from bronchopneumonia and three from lobar pneumonia. Six patients had concomitant complications. At a parenteral dose of 2 g twice or thrice daily for at least seven days, all patients became afebrile by the sixth day, and chest X-rays became normal in nine patients and improved in five. It is concluded that sulbenicillin, which was well tolerated, is clinically effective in the treatment of severe respiratory tract infections, also in patients with major impairment of their immune response systems.