The efficacy of cefepime (Maxipime) in the treatment of abdominal sepsis in surgical patients]

The efficacy of cefepime in the treatment of 46 patients operated for general peritonitis of various genesis and severity (APACHE II not greater than 35) was studied. Cefepime was used in a dose of 2 g administered every 12 hours as slow intravenous infusions in 0.9 per cent sodium chloride solution in combination with metronidazole administered intravenously in a dose of 7.5 mg/kg body weight. The treatment course was 4 to 15 days. 45 patients were given diflucan for the prophylaxis of fungal superinfection, 3 patients were given aminoglycoside antibiotics (netilmicin or amikacin) and 2 patients were given vancomycin per os. The favourable clinical effect of the cefepime therapy was stated in 38 patients (82.6 per cent) including 4 out of 10 patients with initial APACHE II > 15. 101 isolates of aerobic gram-negative and gram-positive microbes from 38 patients treated with cefepime in combination with metronidazole were tested to estimate the bacteriological efficacy of the therapy and it was shown that only 5.9 per cent of them was resistant. The pathogen eradication was stated in 84.2 per cent of the patients.     

Multicentre study of comparative efficacy of meropenem and combined regimens for empirical antibacterial therapy of severe nosocomial infections: results of clinical and pharmacoeconomic analysis]

Adequacy and effectiveness of empirical antibacterial therapy of severe nosocomial infections with meropenem vs. combined regimens of antibacterial therapy were investigated and the ratio of the cost and effectiveness of the compared regimens was evaluated. A prospective, randomized, open, comparative study of two initiative regimens of empirical antibacterial therapy of severe nosocomial infections was performed: meropenem in a daily dose of 1.5-3 g and the standard regimen with the use of betalactams and fluoroquinolones in combination with aminoglycosides and/or metronidazole. Patients with recorded diagnosis of nosocomial pneumonia (including the ventilator-associated one) or abdominal infection with the signs of severe sepsis and severity of APACHE II > 14 were enrolled. The patients were stratified into 2 groups subject to the disease severity, i.e. APACHE II 15-20 and APACHE II 21-25. One hundred thirty five out of 166 patients with recorded nosocomial infection were included into the final estimate of the therapy adequacy and effectiveness (Protocol Analysis): 62 patients were treated with meropenem and in the treatment of 73 patients the standard antibacterial therapy was used. In the group of the patients treated with meropenem there were stated significantly higher clinical effectiveness (recovery in 80.6% of the patients vs. the control of 46.6%, p < 0.01) and pathogen eradication (89.6 and 48.1% respectively, p < 0.01). The difference in the clinical and bacteriological effectiveness of meropenem and the standard therapy was more evident in the subgroups of more severe patients (APACHE > 20). With the use of meropenem the probability of recovery from nosocomial infection was significantly higher (RR 1.73-1.94, p < 0.001) vs. the control. Meropenem provided significantly higher eradication of the pathogens: P. aeruginosa (88 and 40% respectively, p = 0.007), E. coli (100 and 46.7%, p = 0.003), Acinetobacter spp. (90.9 and 40%, p = 0.02). The antibacterial therapy with the use of meropenem was assessed as adequate in 51 out of 56 patients (91.1%), that was 3 times as frequent as with the use of the standard antibacterial therapy (33.9%). The cost-effectiveness coefficient with the use of meropenem was 2.2 times lower vs. the control. Therefore, the empirical therapy of severe nosocomial infections with meropenem proved to be more adequate and from the economic viewpoint more advantageous vs. the standard combined regimens of antibacterial therapy, that was evident from significantly higher clinical and bacteriological efficacy of the treatment and decrease of the terms of the patients hospitalization in intensive care units (on the average by 5 days).     

Use of pefloxacin in the treatment of patients with purulent wounds of soft tissues]

Pefloxacin was used in the treatment of 25 patients with wound infection in a dose of 400 mg orally twice a day for 10-12 days. As the monotherapy it was applied to 15 patients. 7 patients with clinical signs of non-clostridial anaerobic infection were treated with pefloxacin in combination with intravenous metronidazole. Pefloxacin was highly efficient in 96 per cent of the cases with extensive posttraumatic purulent wounds with and without bone affection, acute purulent wounds of the soft tissue, purulent wounds of the soft tissues in diabetic patients, trophic or decubitus ulcer. 266 clinical isolates of Staphylococcus aureus, Staphylococcus epidermidis, Escherichia coli, Proteus mirabilis, Enterobacter spp. and Acinetobacter spp, were tested and 75 to 100 per cent of them was shown to be susceptible to pefloxacin and ciprofloxacin. At the same time the isolates of Pseudomonas aeruginosa and Klebsiella spp. were more susceptible to ciprofloxacin. The pathogen eradication and eradication with superinfection in the cases treated with pefloxacin amounted to 92 per cent. The drug tolerance was good. No clinically significant adverse events were recorded.     

Evaluation of tolerance and efficacy of pefloxacin in the treatment and prevention of severe infections in children with mucoviscidosis and aplastic anemia]

Pefloxacin (Abaktal) efficacy and safety were investigated at 21 children (7-16 years old) randomized in 2 groups: children with mucoviscidosis and children with aplastic anemia. The drug was used at the dose 15-20 mg/kg per day bid for 14-28 days. Pefloxacin was used in combination with ceftazidime and amikacin. Combined therapy demonstrated good clinical efficacy. Bacteriological efficacy was not uniform: staphylococci were not isolated from sputum since the 7th day of treatment, but pseudomonads were cultured even on the 14th day of the treatment (the sensitivity to pefloxacin remained). The only but frequent side-effect was arthropathy. The background and some peculiarities of arthropathy development were analyzed. This phenomenon is called quinolone-induced synovitis. The risk group for quinolone-induced synovitis was estimated--children elder than 10 years with allergic anamnesis. Good clinical efficacy and tolerability of pefloxacin at the children with mucoviscidosis or aplastic anemia is a reason and base to cancel the limits to its use in pediatrics.     

降钙素原与APACHEⅡ评分对急性胰腺炎病情严重程度及预后的评估价值

目的:探讨血清降钙素原(PCT)与急性生理学与慢性健康状况评分(APACHE Ⅱ)对急性胰腺炎(AP)患者病情严重程度及预后的评估价值。方法:选取本院2012年5月-2015年5月收治的急性胰腺炎患者280例为研究对象。根据急性胰腺炎患者病情严重程度将其分为低危组(83例)、中危组(102例)和高危组(95例);按患者临床结局将其分为存活组(248例)及死亡组(32例),采用酶联免疫吸附法(ELISA)检测各组血清PCT水平同时记录APACHE Ⅱ评分情况,分别比较PCT水平的差异以及与APACHE Ⅱ评分的相关性,评价血清PCT及APACHEⅡ评分对急性胰腺炎患者病情严重程度及预后的评估价值。结果:低危组、中危组及高危组间血清PCT水平和APACHE Ⅱ评分的差异具有统计学意义(P0.05)。其中,高危组血清PCT水平和APACHE Ⅱ评分最高,中危组次之,低危组最低(P0.05);死亡组PCT水平及APACHE Ⅱ评分显著高于存活组(P0.05)。相关性分析显示血清PCT水平与APACHE Ⅱ评分呈正相关(r=0.64,P0.01)。以PCT2.13 ng/m L为评估急性胰腺炎患者预后不佳界限时,其敏感性和特异性分别79.2%和91.3%;以APACHE Ⅱ评分18.1分为评估急性胰腺炎患者预后不佳界限时,其敏感性和特异性分别为82.7%和90.1%;两者指标串联评估敏感性及特异性分别为86.1%和92.9%,ROC曲线下面积为0.921(95%CI 0.824~0.938)。结论:急性胰腺炎患者血清PCT水平和APACHE Ⅱ评分具有较好的相关性,血清PCT水平越高,APACHEⅡ评分越高,患者病情越严重及预后也越差,二者联合可作为预测急性胰腺炎患者病情严重程度及预后的敏感指标,具有较好的临床应用价值。     

Impact of furazolidone-based quadruple therapy for eradication of Helicobacter pylori after previous treatment failures

Background. One week of quadruple therapy including metronidazole is recommended for Helicobacter pylori treatment failures after first line therapy regardless of resistance status. This study investigated whether a quadruple regimen containing furazolidone could be effective as a third‐line (salvage) therapy. Methods. All patients with previous H. pylori treatment failure after a clarithromycin‐metronidazole ± amoxicillin combination plus acid suppression were given lansoprazole 30 mg twice a day (bid), tripotassiumdicitratobismuthate 240 mg bid, tetracycline 1 g bid, metronidazole 400 mg (PPI‐B‐T‐M) three times a day (tid) for 1 week. In the case of treatment failure with this second‐line therapy, the same regimen was applied for 1 week except for using furazolidone 200 mg bid (PPI‐B‐T‐F) instead of metronidazole (sequential study design). Results. Eighteen consecutive patients were treated with PPI‐B‐T‐M. Eleven of those 18 remained H. pylori positive (38.9% cured). Pretherapeutic metronidazole resistance was associated with a lower probability of eradication success (10% vs. 75%, p= .04). Ten of these 11 patients agreed to be retreated by PPI‐B‐T‐F. Final cure of H. pylori with PPI‐B‐T‐F was achieved in 9/10 patients (90%) nonresponsive to PPI‐B‐T‐M. Conclusions. In the presence of metronidazole resistance, PPI‐B‐T‐M as a recommended second‐line therapy by the Maastricht consensus conference achieved unacceptable low cure rates in our metronidazole pretreated population. In this population, metronidazole based second‐line quadruple therapy may be best suited in case of a metronidazole‐free first line‐regimen (e.g. PPI‐clarithromycin‐amoxicillin) or a low prevalence of metronidazole resistance. Furazolidone in the PPI‐B‐T‐F combination does not have a cross‐resistance potential to metronidazole and is a promising salvage option after a failed PPI‐B‐T‐M regimen.     

Single dose cefotaxime plus metronidazole versus three dose cefuroxime plus metronidazole as prophylaxis against wound infection in colorectal surgery: multicentre prospective randomised study.

OBJECTIVE--To establish whether a single preoperative dose of cefotaxime plus metronidazole was as effective as a standard three dose regimen of cefuroxime plus metronidazole in preventing wound infection after colorectal surgery. DESIGN--Prospective randomised allocation to one of two prophylactic antibiotic regimens in a parallel group trial. Group sequential analyses of each 250 patients were performed. SETTING--14 District general and teaching hospitals. PATIENTS--1018 Adults having colorectal operations were randomised, of whom 943 were evaluated. Demographic features, conditions requiring surgery, and operative procedures were similar in the two groups. Most patients had surgery for carcinoma of the colon or rectum. INTERVENTIONS--Group 1 received cefotaxime 1 g intravenously plus metronidazole 500 mg intravenously preoperatively. Group 2 received cefuroxime 1.5 g intravenously plus metronidazole 500 mg intravenously preoperatively, followed by cefuroxime 750 mg intravenously plus metronidazole 500 mg intravenously eight hours and 16 hours postoperatively. MAIN OUTCOME MEASURES--Development of surgical wound infection (as evidenced by the presence of pus), death, or discharge from hospital. RESULTS--Wound condition was scored on a five point scale on alternate days until discharge or for up to 20 days postoperatively. Wound infection rates were: group 1, 32/453 (7.1%; 95% confidence interval 4.7% to 9.4%); group 2, 33/454 (7.3%; 95% confidence interval 4.9% to 9.6%). Death rates (group 1: 26/470 (5.5%); group 2: 31/471 (6.6%], the incidence of postoperative complications, the median duration of hospital stay (12 days), and antibiotic tolerance were all similar in the two groups. Pooled data from groups 1 and 2 showed that wound infections were more frequent when minor faecal contamination had occurred at operation and when the duration of operation exceeded 90 minutes (greater than 90 min 11.2% of cases; less than 90 min 4.8%) and were associated with an extended hospital stay. CONCLUSIONS--A single preoperative dose of cefotaxime plus metronidazole is an efficacious as a three dose regimen of cefuroxime plus metronidazole in preventing wound infection after colorectal surgery and has practical advantages in eliminating the need for postoperative antibiotics.     

依达拉奉联合尤瑞克林治疗急性脑梗塞的疗效观察

目的:观察依达拉奉联合尤瑞克林治疗急性脑梗塞的疗效及安全性。方法:将84例急性脑梗塞患者随机分为2组,对照组予依达拉奉30 mg加入生理盐水100 mL静脉滴注,每日两次。观察组在上述基础上另予尤瑞克林0.15 PNA加入生理盐水250mL中静脉滴注,每天一次。两组疗程均为2周。观察两组患者的神经功能缺损评分、疗效与不良反应。结果:两组患者神经功能缺损评分均较治疗前明显改善(P<0.01),观察组评分明显低于对照组(P<0.01)。观察组临床总有效率达97.6%,明显高于对照组的57.1%(P<0.01)。两组不良反应发生率无统计学差异。结论:达拉奉联合尤瑞克林治疗急性脑梗塞临床疗效好,安全性高。     

Efficacy of moxifloxacin in the treatment of secondary peritonitis]

Moxifloxacin efficacy was studied in a prospective open controlled incomparable surveillance of 22 patients at the age of 24 to 78 years (the average of 56.6 +/- 15.9 years old) with extended secondary peritonitis that developed before the hospitalization or not later than 48 hours after the hospitalization. Moxifloxacin (Avelox) was used in a dose of 400 mg every 24 hours at first intravenously as infusions and then orally in the same dose. The abdominal infection was severe (APACHE II of 6 to 12, the average of 8.0 +/- 2.2), in 6 (27.3%) patients signs of severe sepsis with polyorganic insufficiency were observed. The intravenous therapy was used for 3 to 7 days (the average of 3.91 +/- 0.92 days) and the oral therapy was used for 2 to 7 days (the average of 4.50 + 1.37 days). The total time of the treatment was 7 to 12 days (the average of 8.45 +/- 1.53 days). The recovery was recorded in 20 out of the 22 patients (90.9%), disappearance of the main signs of peritonitis being observed within 3-5 days of the treatment. Before the treatment 34 microbial strains were isolated. The most frequent pathogens were E.coli (35.4%) and Enterococcus faecalis (20.6%). In the etiological structure of the community-acquired peritonitis gramnegative enterobacteria prevailed (65%). All the isolates (except 1 strain of E. faecalis) were susceptible to moxifloxacin. The pathogen eradication was stated in 17 out of 18 patients (94.4%). Moderate adverse reactions were observed in 3 patients. Moxifloxacin evidently showed high clinical and bacteriological efficacies in the hospitalized patients with complicated intraabdominal infection including severe abdominal sepsis with the syndrome of polyorganic insufficiency. It can be used for monotherapy of patients with secondary extended peritonitis.     

BISAP、Ranson和APACHEⅡ评分系统对高脂血症性急性胰腺炎患者病情和预后的评估价值

目的:研究急性胰腺炎床旁指数(BISAP)、Ranson和急性生理与慢性健康状况Ⅱ(APACHEⅡ)评分系统对高脂血症性急性胰腺炎(HLAP)患者病情和预后的评估价值。方法:对2015年3月~2019年3月期间我院收治的160例HLAP患者的临床资料进行回顾性分析,其中轻度患者113例、中度患者26例、重度患者21例、并发症患者14例、死亡患者5例。采用Pearson相关检验三种评分与病情的相关性,分析三种评分与中/重度患者、并发症患者、死亡患者的关系,并通过受试者工作特征(ROC)曲线分析三种评分评估HLAP患者病情及预后的价值。结果:BISAP、Ranson、APACHEⅡ三种评分均随病情的加重呈上升趋势,有显著的正相关关系(P<0.05)。三种评分对HLAP患者病情严重程度具有较高的评估价值,曲线下面积(AUC)均在0.76以上,敏感度和特异度均高于0.7。BISAP评分≥3分、Ranson评分≥3分、APACHEⅡ评分≥8分的中/重度患者、并发症患者及死亡人数占比均分别高于BISAP评分<3分、Ranson评分<3分、APACHEⅡ评分<8分的患者(P<0.05)。三种评分对排除并发症和死亡的预测有较高价值,其特异度均在0.9以上。结论:BISAP、Ranson和APACHEⅡ评分系统应用于HLAP患者的病情和预后评估中均存在一定价值,值得临床推广应用。     

A prospective,randomized study of quadruple therapy and high-dose dual therapy for treatment of Helicobacter pylori resistant to both metronidazole and clarithromycin

Background and Aim. Failure of primary anti‐H. pylori therapy results in a high rate of antimicrobial resistance. Here, we investigated the efficacy of high‐dose dual therapy and quadruple therapy as salvage treatments for eradication of H. pylori resistant to both metronidazole and clarithromycin. Patients and Methods. Patients with at least one treatment failure and infected with H. pylori resistant to both metronidazole and clarithromycin, were randomized to receive either omeprazole 4 × 40 mg and amoxicillin 4 × 750 mg; or omeprazole 2 × 20 mg, bismuthcitrate 4 × 107 mg, metronidazole 4 × 500 mg and tetracycline 4 × 500 mg. Both regimens were given for 14 days. In cases of persistent infection, a cross‐over therapy was performed. Results. Eighty‐four patients were randomized. Cure of H. pylori infection was achieved in 31 patients after dual therapy and in 35 patients after quadruple therapy (per protocol: 83.8% (95% CI, 67.9–93.8) and 92.1% (95% CI, 78.6–98.3), respectively (p = 0.71); intention to treat: 75.6% (95% CI: 59.7–87.6) and 81.4% (95% CI: 66.6–91.6), respectively (p = 0.60)). Cross‐over therapy was performed in six of nine patients, four of whom were cured of the infection. Conclusion. Both high‐dose dual therapy and quadruple therapy are effective in curing H. pylori infection resistant to both metronidazole and clarithromycin in patients who experienced previous treatment failures.     

Outcome prediction in sepsis combined use of genetic polymorphisms - A study in Japanese population

Genetic polymorphisms have recently been found to be related to clinical outcome in septic patients. The present study investigated to evaluate the influence of genetic polymorphisms in Japanese septic patients on clinical outcome and whether use of genetic polymorphisms as predictors would enable more accurate prediction of outcome. Effects of 16 genetic polymorphisms related to pro-inflammatory mediators and conventional demographic/clinical parameters (age, sex, past medical history, and APACHE II score) on ICU mortality as well as disease severity during ICU stay were examined in the septic patients (n=123) admitted to the ICU between October 2001 and November 2007 by multivariable logistic regression analysis. ICU mortality was significantly associated with TNF -308GA, IL1β -31CT/TT, and APACHE II score. Receiver-operating characteristics (ROC) analysis demonstrated that, compared with APACHE II score alone (ROC-AUC=0.68), use of APACHE II score and two genetic parameters (TNF -308 and IL1β -31) enabled more accurate prediction of ICU mortality (ROC-AUC=0.80). Significant association of two genetic polymorphisms, TNF -308 and IL1β -31, with ICU mortality was observed in septic patients. In addition, combined use of these genetic parameters with APACHE II score may enable more accurate prediction of outcome in septic patients.     

A trial of using augmentin (amoxicillin/clavulanate) in surgical practice]

The experience with the use of augmentin (amoxycillin/clavulane) in abdominal surgery for prophylaxis of postoperative purulent complications was analyzed. The drug was used in 44 patients after relatively pure operations, 37 of them having various risk factors. In 2 patients (4.5 per cent) of that group postoperative pyoinflammatory complications were recorded. For comparison the results of the prophylactic use of cefoperazone, cefamandole or ceftazidime in the group of 78 patients after relatively pure operations on the abdominal cavity organs were analyzed. Postoperative complications in the latter group amounted to 7.4 per cent (4 patients). The results of the treatment of patients in two groups after contaminated operations were also compared. The patients of one group (41 patients) were treated prophylactically with augmentin in a dose of 1200 mg intraoperatively followed by the drug use in a dose of 600 mg thrice daily for 1 to 2 days after the operation. Postoperative pyoinflammatory complications were recorded in 4 patients of that group (9.7 per cent). 78 patients of the other group were treated prophylactically with ceftazidime or cefoperazone in a dose of 2 g and metronidazole intraoperatively or cefoperazone in a dose of 2 g twice daily and metronidazole in a dose of 500 mg twice daily for 1 to 2 days after the operation. Postoperative infectious complications were recorded in 8 patients of that group (10 per cent). In the group of patients with acute cholecystitis treated with ciprofloxacin in a dose of 400 mg in combination, with metronidazole before the operation and for 1 to 2 days after the operation postoperative complications were recorded in 4 patients (17 per cent).     

Efficacy of 2-week, second-line Helicobacter pylori eradication therapy using rabeprazole, amoxicillin, and metronidazole for the Japanese population

Background: Following the failure of first‐line Helicobacter pylori eradication therapy using a proton pump inhibitor, amoxicillin, and clarithromycin, second‐line therapy is conducted for 1 week using metronidazole instead of clarithromycin in Japan. Recent studies indicate that metronidazole‐containing therapy has a higher eradication rate with prolonged treatment duration, even with metronidazole resistance. The aim of this study was to reveal the efficacy of 2‐week metronidazole‐containing second‐line therapy. Methods: Eighty‐two consecutive outpatients who had failed in the first‐line eradication therapy were enrolled and second‐line therapy was initiated with 10 mg rabeprazole, 750 mg amoxicillin, and 250 mg metronidazole twice daily. After they had been screened by hematological examination 1 week after initiation, the treatment was continued for 2 weeks after initiation in patients without hematological abnormality. Cure was essentially confirmed by the urea breath test. Results: After one patient was lost, hematological examination showed elevated serum aminotransferase in 14 of 81 patients. Although it was mild without clinical issues, they were ethically excluded from this study. In the remaining 67 patients and the lost patient, the eradication rate with 2‐week therapy was 65/68 (96%, 95% confidence interval: 88–98%) by intention to treat analysis and 65/65 (100%, 94–100%) by per protocol analysis. The main adverse event was soft stools (39%), and no serious adverse event was observed. Conclusion: This 2‐week metronidazole‐containing second‐line therapy provides high efficacy in Japan where metronidazole resistance is rare.     

The role of cefepime, a 4th-generation cephalosporin, in treating patients with surgical sepsis]

Cefepime (Maxipime) was used in the management of 22 patients at the age of 18 to 73 years with the surgical sepsis syndrome (SAPS > 15). In 16 patients surgical sepsis was due to pancreatitis, appendititis, abdominal wound or trauma or complications after planned surgical interventions on the organs of the abdominal cavity. In the other 6 patients surgical sepsis was due to inflammatory processes in soft tissues after minor trauma. In 10 patients (group 1) cefepime was used after the pathogen verification and antibioticogram examination. In 12 patients (group 2) the antibiotic was used in the empirical therapy as the first line drug after the patients acceptance from another unit when the pathogen nature was obscure. Cefepime was administered intravenously in a dose of 2.0 g twice daily for 7 to 10 days in combination with metronidazole in a dose of 0.5 g thrice daily. After 5-6 days of the treatment the patients of group 1 were switched to the cefepime intramuscular regimen. The lethality totaled 18 per cent (4 patients). Three of them were from group 2. The patients died of progressive polyorgan insufficiency. It is characteristic that in no cases cefepime induced septic shock due to the endotoxin escape. No septicopyemia was as well observed even in the patients with verified bacteremia due to Staphylococcus aureus.     

Comparative clinical and epidemiological evaluation of beta-lactam antibiotics in the treatment of intraabdominal infections]

We performed a retrospective, comparative study to evaluate efficacy, safety and economic outcomes of empiric cefoperazone/sulbactam monotherapy compared with the meropenem, imipenem/cilastatine and combination of cefepime plus metroindazol in patients with intra-abdominal infection. A total of 468 patients diagnosed with intra-abdominal abscess, peritonitis, pancreatitis were included in the study (the severity of infection according to scale APACHE II was less than 15). Patients were randomized to be treated with either 500 mg meropemen i.v. every 8 hours or 500 mg imipenem/cilastatine i.v. every 8 hours or 2 g cefepime i.v. every 12 hours plus 500 mg metronidazol twice daily or cefoperazone/sulbactam 2 g daily administered every 12 hours. Overall positive clinical responses (cure or improvement) were achieved at the end of treatment for 87.5 patients in meropenem group, 86.6% in the imipenem/cilastatin group, 85.3% in the cefepime group and 86.8% in cefoperazone/sulbactam group. Total cost of the treatment per 100 patients with intra-abdominal infections for cefoperazone/sulbactam was 1957031 roubles, for combinations of cefepime with metronidazol--2497815 roubles. For carbapenem group cost achieved for meropenem--3085291 rub., for imipenem/cilastatin--2653388 roubles. Rate "cost-effectiveness" in total: 784.47$ for cefepime, and 834.39$ for imipenem/cilastatine, 970.21$ for meropenem and 615.4$ for cefoperazone/sulbactam. The most expensive treatment was considered to be with meropenem and imipenem/cilastatine, main share is determined by initial cost of preparations. Less expensive was treatment by cefoperazone/sulbactam with cefepime and by metronidazol.     

Seven-Day Triple Therapy with Lansoprazole, Clarithromycin, and Metronidazole for the Cure of Helicobacter pylori Infection: A Short Report

Background To refine our understanding of anti- Helicobacter pylori treatment regimens further, we evaluated the efficacy and safety of lansoprazole given in combination with clarithromycin and metronidazole for 7 days in an open-label, multicenter study.
Materials and Methods. H. pylori -positive patients self-administered lansoprazole, 30 mg; clarithromycin, 500 mg; and metronidazole, 500 mg bid for 7 days. Patients were assessed at pretreatment, at which time the presence of H. pylori was documented by rapid urease test or histology and culture, following study drug administration (week 1) for a brief evaluation only, and at least 4 weeks posttreatment (week 5), including endoscopy with collection of biopsy specimens for culture and histology testing.
Results. Of the 60 patients enrolled in the study, 59 had confirmed H. pylori infection, and 51 were included in an intent-to-treat analysis of efficacy. Primary metronidazole and clarithromycin resistance were observed in 84% and 8% of study patients, respectively. One month after the end of therapy, H. pylori infection was cured in 40 of 51 patients (78%); 95% confidence interval, 65%–89%). The triple-therapy regimen was well-tolerated, with only 2 patients (4%) requiring premature withdrawal from the study due to treatment-related adverse events. Taste perversion (15.0%) and diarrhea (11.7%) were the most frequently reported adverse events possibly or probably related to study medication during the treatment period.
Conclusion. Despite a high prevalence of metronidazole resistance, a 1-week, triple-drug combination of lansoprazole, clarithromycin, and metronidazole is effective treatment for and well-tolerated by patients with H. pylori infection.     

Subjective adverse reactions to metronidazole in patients with amebiasis

Subjective adverse reactions to metronidazole were analyzed in 111 patients with amebiasis. Metronidazole was administered to 36 patients at a daily dose of 2250 mg and 75 patients at daily doses lower than 2250 mg. The reactions reported included nausea without vomiting in 11 (9.9%) patients, nausea with vomiting in 2 (1.8%), dysgeusia in 2 (1.8%), diarrhea in 1 (0.9%), headache in 1 (0.9%), numbness in 1 (0.9%), dizziness in 1 (0.9%), urticaria in 1 (0.9%), exanthema in 1 (0.9%), and discomfort in 1 (0.9%). Nausea was reported by 28% (10/36) of the patients receiving metronidazole at a daily dose of 2250 mg and 4% (3/75) of the patients receiving lower daily doses. The duration of the metronidazole administration in days was not associated with the appearance of nausea. No life-threatening adverse reactions were identified, and good clinical therapeutic effects were observed in 96% (107/111) of the patients. While metronidazole appears to be a safe anti-protozoal agent for patients with amebiasis, our results indicate that a daily metronidazole dose of 2250 mg is excessive for amebiasis, as it often induces nausea.     

Long term survival after intensive care.

OBJECTIVE--To examine the long term survival of critically ill patients admitted to an intensive therapy unit and to ascertain the effects of age, severity of illness, and diagnostic category at admission on survival. DESIGN--Retrospective observational study with prospectively gathered data on all patients admitted to the unit between June 1985 and July 1987 and followed up until 1 January 1989. SETTING--Regional intensive therapy unit. PATIENTS--513 critically ill adult patients, 16 of whom were excluded because measurements on severity of illness scoring were not available. MAIN OUTCOME MEASURES--Age, severity of illness (determined with the acute physiology and chronic health evaluation (APACHE) II score), and diagnostic category on admission; deaths in the unit; and long term survival after discharge. Details of the survivors were sent to the Registrar General for Scotland, who issued copies of death certificates for the patients who had died between discharge and 1 January 1989. RESULTS--Of 497 patients, 119 (24%) died in the intensive therapy unit and 120 (24%) after discharge, leaving 258 (52%) who were still alive at two years. The median (APACHE II) score was 13 and about half of the patients were aged 55 years or more. A wide range of critical illnesses, except neurosurgical emergencies, were treated. Survival analysis showed that only 41 (34%) of 122 patients with an APACHE II score of greater than or equal to 20 were alive at one year (95% confidence interval 25 to 42) compared with 124 (80%) of 155 patients with a score of less than 10 (73 to 87). Of the 144 patients aged 65 or more, only 68 (47%) survived to one year (39 to 55) but 90 (83%) of the 109 patients aged between 18 and 34 survived a similar period (76 to 71). Mortality was also related to diagnostic category; 71% of trauma victims survived to one year compared with only 41% of those admitted with gastrointestinal pathology. Univariate analysis of the results showed that age, severity of illness, and diagnosis were all predictors of long term survival. Multivariate analysis, however, showed that only age and severity of illness were independent prognostic factors. CONCLUSIONS--Long term survival of patients treated in an intensive therapy unit is related to severity of illness and to age. The outcome from critical illness in the elderly population is poor.     

Efficacy and Safety of Metronidazole Monotherapy versus Vancomycin Monotherapy or Combination Therapy in Patients with Clostridium difficile Infection: A Systematic Review and Meta-Analysis

Background

Clostridium difficile infection (CDI) has become a global epidemiological problem for both hospitalized patients and outpatients. The most commonly used drugs to treat CDI are metronidazole and vancomycin. The aim of this study was to compare the efficacy and safety of metronidazole monotherapy with vancomycin monotherapy and combination therapy in CDI patients.

Methods

A comprehensive search without publication status or other restrictions was conducted. Studies comparing metronidazole monotherapy with vancomycin monotherapy or combination therapy in patients with CDI were considered eligible. Meta-analysis was performed using the Mantel-Haenszel fixed-effects model, and odds ratios (ORs) with 95% confidence intervals (95% CIs) were calculated and reported.

Results

Of the 1910 records identified, seventeen studies from thirteen articles (n = 2501 patients) were included. No statistically significant difference in the rate of clinical cure was found between metronidazole and vancomycin for mild CDI (OR = 0.67, 95% CI (0.45, 1.00), p = 0.05) or between either monotherapy and combination therapy for CDI (OR = 1.07, 95% CI (0.58, 1.96), p = 0.83); however, the rate of clinical cure was lower for metronidazole than for vancomycin for severe CDI (OR = 0.46, 95% CI (0.26, 0.80), p = 0.006). No statistically significant difference in the rate of CDI recurrence was found between metronidazole and vancomycin for mild CDI (OR = 0.99, 95% CI (0.40, 2.45), p = 0.98) or severe CDI (OR = 0.98, 95% CI (0.63, 1.53), p = 0.94) or between either monotherapy and combination therapy for CDI (OR = 0.91, 95% CI (0.66, 1.26), p = 0.56). In addition, there was no significant difference in the rate of adverse events (AEs) between metronidazole and vancomycin (OR = 1.18, 95% CI (0.80, 1.74), p = 0.41). In contrast, the rate of AEs was significantly lower for either monotherapy than for combination therapy (OR = 0.30, 95% CI (0.17, 0.51), p<0.0001).

Conclusions

Metronidazole and vancomycin are equally effective for the treatment of mild CDI, but vancomycin is superior for the treatment of severe CDI. Combination therapy is not superior to monotherapy because it appears to be associated with an increase in the rate of AEs.