Clinical study of panipenem/betamipron for burn infections in the domain of plastic and reconstructive surgery]

The effectiveness and the safety of panipenem/betamipron, new antibiotics of the carbapenems for burn infections, were studied and the following results were obtained: 1. The preparation, 0.5 g/0.5 g, was administered by intravenous drip infusion twice a day to 11 cases of patients with burn infections. In 10 cases for which clinical effects were evaluable, results were rated as "excellent" in 2 cases, "good" in 2 cases and "fair" in 6 cases, with an efficacy rate of 40%. 2. Penetration to the affected tissue was studied in 2 cases. The tissue level of panipenem was 0.20 micrograms/g immediately after the end of drip infusion and 6.86 micrograms/g 60 minutes thereafter. 3. As for the safety, a slight increase in GOT, GPT and Al-P was noted in 1 case; a slight increase in GPT, NAG and beta 2MG was found in 1 case; and a slight increase in GOT, GPT, Al-P and LAP was noted in 1 case, as abnormal variations in laboratory test results.     

Use of cefminox in infections in the field of obstetrics and gynecology

A total of 15 cases of obstetrical and gynecological infections was treated with cefminox (CMNX, MT-141), a new cephamycin antibiotic, with following results. The subjects consisted of 3 cases of salpingitis, 2 cases of parametritis, 5 cases of endometritis, and 1 case each of puerperal fever, inflammation of the pelvic dead space, Bartholin's pyocele, vulvar abscess and suppurative mastitis. In 2 cases of endometritis, pelveoperitonitis and adnexitis were complicated, respectively. As a rule, CMNX was administered intravenously at a dosage of 1 g each twice a day by drip infusion route. The clinical results were rated as excellent in 8 cases, good in 6 cases and poor in 1 case, with an efficacy rate of 93.3%. No subjective or objective side effects were seen nor any abnormal laboratory test results were found.     

Clinical studies on imipenem/cilastatin sodium in perinatal use

The clinical efficacy and the safety of imipenem/cilastatin sodium (IPM/CS) in perinatal infections were studied. The results are summarized below. 1. Clinical efficacy was evaluated in 12 patients with intrauterine infections (endometritis), 3 patients with amniotic fluid infections, 2 patients with puerperal fever and 3 patients with other infections. The drug was administered by intravenous drip infusion at a 0.5g to 1.0g dose as IPM and the total doses during an entire course of treatment were 1.5g to 15g. 2. Clinical efficacies were excellent in 4 (20%) and good in 16 patients (80%) and the efficacy rate was 100%. Ten patients had not improved upon treatments with other previous antibiotics. 3. Infective bacteria were eradicated in 4, decreased in 1, and replaced in 6 patients. 4. No side effects or abnormal clinical laboratory test values were observed in any patient.     

Clinical evaluation of flomoxef in pediatrics and a study on the penetration into cerebrospinal fluid

The transfer to cerebrospinal fluid of a new oxacephem antibiotic flomoxef (FMOX, 6315-S) and its clinical efficacy against bacterial infections were investigated. 1. In 3 cases of purulent meningitis, cerebrospinal fluid concentrations of FMOX after one shot intravenous injection of 100 mg/kg during the acute stage of infections were 5.12-6.32 micrograms/ml and ratios of FMOX in cerebrospinal fluid in serum were about 5%. During the recovery stage, cerebrospinal fluid concentrations were about 3.8 micrograms/ml and cerebrospinal fluid/serum ratios were about 3.5%. 2. In 1 case of purulent meningitis, the treatment with FMOX was clinically effective but this case was classified as "unevaluable" because other drug was used concomitantly. FMOX was rated effective in other 2 cases of purulent meningitis. Of 9 cases of pneumonia, FMOX was rated very effective in 8 cases and it was rated only effective in the other. Of 4 cases of bronchitis, the drug was rated very effective in 3 cases and only effective in the other. FMOX was rated very effective against 2 cases of tonsillitis, also. 3. As side effects, thrombocytosis was observed in 3 of 20 cases examined. All cases, however, were deemed unrelated to the FMOX treatment and the side effect was only transient as are often found in courses of recovery from infections.     

Basic and clinical studies on cefminox in the field of obstetrics and gynecology

Fundamental and clinical studies on cefminox (CMNX, MT-141), a new cephamycin antibiotic, were performed and the following results were obtained. Concentration of CMNX was examined in serum, internal genital organs and retroperitoneal fluid after a single intravenous administration of 1.0 g dose. The venous serum level of CMNX was 62.8 +/- 7.02 microgram/ml (Mean +/- S.D.) at 30 minutes after the administration. The sufficient transfer of CMNX to internal genital organs and retroperitoneal fluid was demonstrated. In clinical trial, CMNX was given to 10 cases with obstetrical and gynecological infections. The efficacy was evaluated as excellent in 1 case, good in 8 cases and poor in 1 case. No side effects were observed in any of the cases treated with CMNX.     

Fundamental and clinical study on cefuzonam in the field of obstetrics and gynecology

Cefuzonam (L-105, CZON), a new beta-lactam antibiotic, was studied for its transfer into intrapelvic tissues and for clinical efficacy in the treatment of obstetrical and gynecological infection. 1. Following an intravenous 1 hour drip infusion of 1 g, the transferred CZON into uterine tissues reached and was maintained at effective concentrations which were defined as levels exceeding MICs against clinical isolates frequently obtained from patients in the field of obstetrics and gynecology. The peak concentration of CZON in the pelvic dead space exudate was estimated to be 20 micrograms/ml at 0.5-1 hour after infusion. 2. Subjects studied were 5 patients with the following infections: pyometra (3 cases), puerperal intrauterine infection (1 case), vaginal cuff infection (1 case). Clinical efficacies were good in 4 cases and poor in 1 case. No notable side effects or abnormal laboratory test results were noted.     

Clinical studies on cefoxitin in the treatment of respiratory tract infections

The clinical effects of cefoxitin (CFX) were studied in 31 cases of respiratory tract infections. The results were as follows: As for the clinical effects, CFX was excellent in 5 cases, good in 13, fair in 8 and poor in 5 out of 31 patients; the efficacy rate was 58.1%. The efficacy rate was 57.1% in bronchopneumonia, 61.1% in pneumonia and 50.0% in acute exacerbation of chronic respiratory tract infections. The efficacy rate was 70.6% in the group of 4 g/day or less and 42.9% in the group of 6 g/day or more. The efficacy rate was 50.0% in 6 cases that had not been responded to other antibiotics previously. As for side effects, skin eruption was observed in only 1 patient. No abnormality was observed in laboratory tests due to CFX. In conclusion, CFX is a useful drug in the treatment of respiratory tract infections.     

Pharmacokinetic and clinical studies of cefuzonam in obstetric and gynecologic infections

Cefuzonam (CZON, L-105), a new semisynthetic cephem antibiotic, was studied in the field of obstetrics and gynecology, pharmacokinetically and clinically. Following is a summary of the results. 1. Concentrations of CZON in serum and genital organs following intravenous drip infusion of 1 g of the drug over 60 minutes were measured. Samples were taken during 40 to 190 minutes after the end of the infusion. Ratios of concentrations of the drug transferred into genital organs to the concentration in the cubital venous serum were 0.5 to 1.5 in many cases. Levels of the drug in the genital organs examined well exceeded MICs for common causative organisms in obstetric and gynecologic infections. 2. Therapeutic effects of 1 g or 2 g of CZON by drip infusion twice daily were evaluated in 8 patients. Overall clinical efficacy was 62.5% (5/8). No side effects or abnormal laboratory findings due to the drug were noted. The results suggest that CZON is a useful antibiotic for obstetric and gynecologic infections.     

Pharmacokinetic and clinical studies on cefuzonam in obstetrics and gynecology

Cefuzonam (CZON), a new cephem antibiotic agent, was studied in terms of its pharmacokinetics and clinical efficacy in the field of obstetrics and gynecology, and the results were summarized as follows. 1. The absorption and the tissue penetration of CZON into intrapelvic genital organs were good. The peak serum level in uterine artery after an intravenous drip infusion of 1.0 g was 49.0 micrograms/ml, and the highest peak level of 23.0 micrograms/g in tissues was obtained. After drip infusion of 2.0 g, the peak serum level in uterine artery was 137 micrograms/ml and the highest peak tissue concentration was 54.6 micrograms/g. Tissue concentrations of the drug changed in a similar pattern to serum levels and a dose-dependent response was recognized. 2. The penetration of CZON into intrapelvic dead space exudate was good. The level reached a peak of 8.17 micrograms/ml 4 hours after and intravenous drip infusion of 1.0 g and diminished slowly. 3. The clinical efficacy of CZON at a daily dose of 2 g was evaluated in 21 cases of obstetrics and gynecologic infections. The efficacy rate was 85.7% (18/21 cases). Bacteriologically, the eradication rate obtained was 93.3%. No side effects or abnormal laboratory values were observed.     

Clinical and laboratory evaluations of ceftazidime in perinatal use. A study of ceftazidime in the perinatal co-research group

Efficacy and safety of ceftazidime (CAZ) in women during the perinatal period and their neonates were evaluated by a perinatal co-research group, and the results obtained were summarized as follows. Following an intravenous bolus injection or a drip infusion of CAZ from 1 g to 2 g, CAZ was transferred to maternal serum, umbilical cord serum and amniotic fluid rapidly and effectively. In 31 cases of perinatal infections, clinical efficacy was excellent in 10 cases, good in 18 and poor in 3, with an efficacy rate of 90.3%. In 85 cases given CAZ for prophylaxis of infections accompanying premature rupture of the membrane or following cesarean section, prophylactic effects were noted in 81 cases (efficacy rate: 95.3%). Neither adverse effects, nor abnormal laboratory findings were observed in any case. Also, no abnormalities in total serum bilirubin were observed in any neonates. From the above results, CAZ is considered to be a safe and useful drug for infections in women in perinatal period, usually in a unit dose of 1 g twice daily, or if necessary, 2 g twice daily.     

氨曲南治疗肺部感染和胸膜炎9例

本文报告氨曲南治疗需氧G~-杆菌感染9例(肺部8例、胸腔1例),剂量为1.0g,q8h静滴疗程5-10d,平均7±SD2d,临床有效为3/9例,未见任何副作用。     

Pharmacokinetics and clinical studies of cefmetazole in the otorhinolaryngological field

Cefmetazole (CMZ), a new cephamycin preparation, has been investigated to give following results. 1) Pharmacokinetics: Serum and tonsil concentration of CMZ were determined by micropore method in humans. The mean concentrations in 5 cases about 30 minutes after administration of 0.5--1.0 g intravenously were 55.4 micrograms/ml in serum, 21.7 micrograms/g in tonsil. 2) Clinical studies: Seventy-one patients with ear, nose and throat infections were treated with CMZ receiving 1 to 6 g per day intravenously (one shot and drip infusion). Thirty-eight of 70 patients were cured excellent, 19 were good, 8 were fair and 6 were failure and effective rate was 80.3%. Adverse reaction was observed in 4 cases. Three cases showed exanthema and 1 case showed fever elevation.     

Pharmacokinetic, bacteriological and clinical studies of cefuzonam in the field of obstetrics and gynecology. Study group of cefuzonam in the field of obstetrics and gynecological infections

A multi-center open study was conducted to investigate cefuzonam (CZON, L-105) regarding to its pharmacokinetic, bacteriological and clinical aspects in the field of obstetrics and gynecology with the participation of 31 medical institutions and the related facilities. The results are summarized as follows. 1. Peak MICs of CZON for Staphylococcus aureus, coagulase (-) staphylococci, Escherichia coli, Klebsiella pneumoniae, Bacteroides fragilis group, Peptostreptococcus spp. isolated from obstetrical and gynecological infections with relatively high frequencies were 0.39, 0.20, 0.024, 0.024-0.05, 12.5, 0.20 microgram/ml, respectively, with an inoculum size of 10(6) CFU/ml. 2. When 1 g of CZON was given through bolus injection, the maximum concentration (Cmax) of CZON in pelvic dead space exudate was 18.7 micrograms/ml at 60.9 minutes (Tmax) after the injection; Cmax's in all female genital tissues were observed at 0.6-27.9 minutes and ranged from 11.9-26.3 micrograms/g. The Cmax 8.3 micrograms/ml, in the pelvic dead space exudate was noted at 97.0 minutes after the end of the intravenous drip infusion of 1 g over 1 hour, and Cmax's in genital tissues were 14.3-30.0 micrograms/g at the end of infusion. With 1 hour drip infusion of 2 g, Cmax's in genital tissues were 35.0-53.9 micrograms/g at the end of infusion. 3. The clinical efficacy of CZON was evaluated in 206 evaluable patients with obstetric and gynecologic infections. Efficacy rates classified by types of infections were 97.1% (67/69) for intrauterine infections, 81.6% (31/38) for intrapelvic infections, 91.8% (45/49) for adnexitis, 95.2% (20/21) for infections of the external genital organs and 86.2% (25/29) for other infections. 4. Side effects were observed in 7 of the 262 patients: eruption in 6 cases, itching in 2, diarrhea in 1. Abnormal laboratory test values were noted in 9 of the 256 patients. Most of them were slight elevation of hepatic function values. CZON showed satisfactory clinical efficacy and potent antibacterial activity, hence it appears that CZON will be a very useful antibiotic for obstetric and gynecologic infections.     

美罗培南两步点滴法治疗重症监护病房严重感染的疗效分析

目的：评价美罗培南两步点滴法治疗重症监护病房（ICU）严重感染,与传统延长输注法比较,是否能获得更高的临床疗效和细菌学疗效。方法：随机选择56例ICU严重感染患者分为两组,每组28例,试验组予美罗培南针（0.5~2.0）g+0.9%氯化钠针100 mL,q8h或q6h,前半量在0.5 h内以输液泵泵入,后半量在2.5 h内以输液泵匀速泵入;对照组予美罗培南针（0.5~2.0）g+0.9%氯化钠针100 mL,q8h或q6h,微泵静脉输注3 h。比较两组治疗前后各观察指标的变化情况,评价治疗后临床疗效、细菌学疗效和不良反应发生情况。结果：治疗后的白细胞计数、中性粒细胞比率、C-反应蛋白、降钙素原等炎性指标改善情况,试验组均优于对照组。临床疗效比较试验组总有效率为50.0%、对照组为35.7%（P<0.05）,差异具有统计学意义;细菌清除率比较,试验组和对照组分别为64.0%和39.1%（P<0.05）,差异具有统计学意义;不良反应发生率比较,试验组和对照组分别为10.7%和14.3%,差异无统计学意义（P>0.05）。结论：美罗培南两步点滴法治疗ICU严重感染,能显著提高临床疗效和细菌学疗效。     

夫西地酸钠与万古霉素治疗ICU病房耐甲氧西林金黄色葡萄球菌的疗效与安全性研究

目的评价夫西地酸钠与万古霉素治疗ICU病房耐甲氧西林金黄色葡萄球菌(MRSA)的疗效与安全性。方法将2011年1月至2013年1月入住我院ICU病房的MRSA感染病例61例,随机分为2组,对照组34例,给予万古霉素1 g,静脉滴注,2次/d;实验组27例,给予夫西地酸钠0.5 g,静脉滴注,3次/d;两组药溶媒均为0.9%氯化钠注射液100 mL,每次给药时间均>60 min,疗程均为5²0 d,具体根据病情严重程度和患者临床反应而定。比较两组抗菌药物治疗前后的临床疗效、细菌清除率及安全性。结果实验组与对照组的临床有效性、细菌清除率和不良反应发生率分别为81.48%、70.37%、11.11%和85.29%、79.41%、17.65%,两组比较差异均无统计学意义(P均>0.05)。结论夫西地酸钠治疗MRSA感染临床疗效与细菌清除率与万古霉素相当,且不良反应发生率低,因此可用于替代万古霉素用于ICU病房MRSA感染的治疗。     

不同靶浓度瑞芬太尼对老年患者异丙酚靶控输注半数效应室浓度的影响

目的：探讨不同效应室靶浓度瑞芬太尼对异丙酚靶控输注半数效应室浓度（ECe50）的影响。方法：择期静脉复合全麻下行经尿道前列腺电切术患者60例,年龄65～85岁,按瑞芬太尼效应室靶控浓度的不同随机分成3组,瑞芬太尼0.5 ng/ml（R0.5）;瑞芬太尼1.0 ng/ml（R1.0）;瑞芬太尼1.5 ng/ml（R1.5）,每组20例。达到效应室靶浓度后,按照序贯试验原则靶控输注（TCI）异丙酚,进电切镜出现体动反应,则下一例采用高一级浓度,反之,采用低一级浓度,各相邻浓度之间均为等比级数,比率为1.2。计算异丙酚ECe50及其95%可信区间（CI）。结果：R0.5组异丙酚的ECe50为2.37μg/ml,其95%可信区间为（2.22,2.53）,R1.0组异丙酚的ECe50为1.84μg/ml,95%可信区间为（1.75,1.94）,R1.5组异丙酚的ECe50为1.66μg/ml,95%可信区间为（1.60,1.71）。结论：增加瑞芬太尼靶浓度可降低异丙酚靶控输注浓度,但随着浓度增加,麻醉风险加大。     

Study on a new cephamycin preparation cefminox in the field of pediatrics

Cefminox (CMNX, MT-141) was studied both fundamentally and clinically in the field of pediatrics with following results. The MIC of CMNX for Bordetella pertussis was 0.10 micrograms/ml in inoculum size 10(6) cells/ml. Following administration of 10 and 20 mg/kg of CMNX as drip infusion over 1 hour, the blood levels of the drug were 49.0 +/- 18.1 and 69.1 micrograms/ml at completion of infusion, 28.8 +/- 7.7 and 61.6 micrograms/ml at 1.5 hours, 23.6 +/- 9.3 and 44.1 +/- 3.8 micrograms/ml at 2 hours and 1.4 +/- 1.4 and 4.0 +/- 0.6 micrograms/ml at 7 hours, with T1/2 of 1.03 and 1.41 +/- 0.03 hours, respectively. Within the first 7 hours after administration, 61.4 +/- 8.2 and 55.9 +/- 0.8% of the drug dosed were excreted at active form in urine. In child with encephalitis, drug considered to be good as a cephem antibiotic was achieved in the cerebrospinal fluid (the ratio of the level in the cerebrospinal fluid to that in the serum was 7.3%). In addition, in the pus in empyema also high level was reached (its ratio against blood level was 53%). In the treatment of 31 cases of acute infections of pediatric field including upper and lower airway infections, empyema, whooping cough, acute urinary tract infections and phlegmon, CMNX was administered intravenously either as one shot injection as drip infusion. The clinical results obtained were rated as good or more in 93% of the cases and as fair or more in 100% of the cases. The main dosage of CMNX in these cases was about 60 to 70 mg/kg per day in 2 or 3 divided doses. S. aureus, S. pyogenes, S. pneumoniae, H. influenzae and ABPC resistant strain of E. coli demonstrated in various materials could be eradicated after intravenous injection of CMNX. CMNX was administrated for a period of 2 to 16 days to a total amount of 1.5 to 26.5 g. In none of these cases side effects developed nor any abnormality was revealed by hematological findings or results of renal or liver function.     

Clinical evaluation of amikacin by intravenous drip infusion for infections in the field of internal medicine

Amikacin (AMK) by intravenous drip infusion was given to patients with infections in the field of internal medicine and the results were followings: AMK was administered to 19 patients. Diagnosis included sepsis or suspected sepsis (11 cases), pneumonia (2 cases), chronic respiratory tract infections (3 cases) and urinary tract infections (3 cases). Underlying disease included hematologic disease (13 cases), lung fibrosis (1 case), chronic respiratory insufficiency (1 case), diabetes mellitus (1 case), hepatic coma and bronchial asthma (1 case) and prostatic hypertrophy (1 case). Nineteen episodes responded to single therapy (2 cases) or combined therapy with other antibiotics (17 cases). AMK by intravenous drip infusion (dissolved in not less than 100 ml of saline or glucose) was administered at the dose of 200 mg/day to 600 mg/day divided into 2 or 3 times, over 1 hour to 2 hours. The mean duration of therapy was 10 days and the mean total dose was 4.3 g. Clinical effects: Excellent in 7 cases, good in 7 cases, fair in 3 cases and poor in 2 cases, and efficacy rate was 74%. Bacteriological effects: Disappeared in 3 cases, partly disappeared and unchanged in 3 cases, superinfection in 1 case and newly appeared in 1 case. Four strains out of 7 cases of which were detected the causative bacteria were disappeared. GM resistant bacteria (S. marcescens in 2 strains and C. diversus in 1 strain) were disappeared by the administration of AMK, also some clinical symptoms and signs were improved. No side effects and no abnormalities in laboratory findings were noted in any cases attributed to AMK. In conclusion, high efficacy rate was obtained without any side effects, intravenous drip infusion of AMK seemed to be useful for infections in patients with bleeding tendency (e.g. leukemia) or malignant disease.     

Clinical evaluation of cefminox in children

In a total of 13 children with infections, ranging in age from 1 month to 6 years, cefminox (CMNX, MT-141), a new antibiotic of cephem group, was administered 14 times and its absorption, excretion, clinical results and safety were determined. Following intravenous drip infusion of CMNX, high blood level was achieved, with half-life of about 1 hour (0.77 to 1.13 hours). The urinary recovery rate was approximately 80% within the first 6 hours after completion of administration. Clinical results were rated as effective in 8 out of 12 assessable cases (66.7%). In any of the cases treated no side effects developed nor any abnormal changes in laboratory finding were observed. From these results, CMNX is considered to be a new antibiotic useful and safe for use in the field of pediatrics.     

Clinical studies on the effectiveness of SM-4300, a new non-modified gammaglobulin preparation suitable for intravenous use, in refractory infections

Eighteen cases of various infections, mostly having severe underlying diseases and showing no or insufficient responses to antibacterial chemotherapy, were treated with additional intravenous drip infusion of SM-4300 (2.5 or 5 g, once a day, for 1-3 days). Eight of the cases were excluded from the assessment of the effectiveness, as they died too early, or as their fever was supposed to have been "tumor fever" retrospectively. SM-4300 was found to be effective in 2 out of 5 septicemia cases, in 3 pneumonia cases, including 1 complicated with septicemia, out of 4, and also in 1 patient with liver abscess, as well as in another of meningitis caused by Campylobacter fetus; i.e. the efficacy rate was estimated as 60% in total. Any side effects attributable to SM-4300 were observed in none of the 18 cases. These results obtained seem to endorse the usefulness of the preparation.