Prospective randomized comparison of antiarrhythmic therapy versus first-line radiofrequency ablation in patients with atrial flutter

BACKGROUND

Despite the high success rate of radiofrequency (RF) ablation, pharmacologic therapy is still considered the standard initial therapeutic approach for atrial flutter.

OBJECTIVE

We prospectively compared the outcome at follow-up of patients with atrial flutter randomly assigned to drug therapy or RF ablation.

METHODS

Patients with at least two episodes of symptomatic atrial flutter in the last four months were randomized to regimens of either antiarrhythmic drug therapy or first-line RF ablation. After institution of therapy, end points included recurrence of atrial flutter, rehospitalization and quality of life.

RESULTS

A total of 61 patients entered the study, 30 of whom were randomized to drug therapy and 31 to RF ablation. After a mean follow-up of 21 ± 11 months, 11 of 30 (36%) patients receiving drugs were in sinus rhythm, versus 25 of 31 (80%) patients who underwent RF ablation (p < 0.01). Of the patients receiving drugs, 63% required one or more rehospitalizations, whereas post-RF ablation, only 22% of patients were rehospitalized (p < 0.01). Following RF ablation, 29% of patients developed atrial fibrillation which was seen in 53% of patients receiving medications (p < 0.05). Sense of well being (pre-RF 2.0 ± 0.3 vs. post-RF 3.8 ± 0.5, p < 0.01) and function in daily life (pre-RF 2.3 ± 0.4 vs. post-RF 3.6 ± 0.6, p < 0.01) improved after ablation, but did not change significantly in patients treated with drugs.

CONCLUSION

In a selected group of patients with atrial flutter, RF ablation could be considered a first-line therapy due to the better success rate and impact on quality of life, the lower occurrence of atrial fibrillation and the lower need for rehospitalization at follow-up.     

Prospective randomized comparison of therapy and no therapy for asymptomatic bacteriuria in institutionalized elderly women

Fifty elderly (mean age, 83.4 +/- 8.8 years) institutionalized women with asymptomatic bacteriuria were randomly assigned either to receive therapy for treatment of all episodes of bacteriuria identified on monthly culture or to receive no therapy unless symptoms developed. Subjects were followed for one year. The therapy group had a mean monthly prevalence of bacteriuria 31 +/- 15 percent lower than those in the no-therapy group, but periods free of bacteriuria lasting six months or longer were documented for only five (24 percent) subjects. For residents receiving no therapy, 71 percent showed persistent infection with the same organism(s). Antimicrobial therapy was associated with an increased incidence of reinfection (1.67 versus 0.87 per patient-year) and adverse antimicrobial drug effects (0.51 versus 0.046 per patient-year) as well as isolation of increasingly resistant organisms in recurrent infection when compared with no therapy. No differences in genitourinary morbidity or mortality were observed between the groups. Thus, despite a lowered prevalence of bacteriuria, no short-term benefits were identified and some harmful effects were observed with treatment of asymptomatic bacteriuria. These data support current recommendations of no therapy for asymptomatic bacteriuria in this population.     

Prospective comparison of prophylactic anti-biotic use between intravenous moxifloxacin and ceftriaxone for high-risk patients with post-ERCP cholangitis

BACKGROUND: The use of prophylactic antibiotics before endoscopic retrograde cholangiopancreatography(ERCP) is recommended by all major international gastroenterological societies, especially in the presence of an obstructed biliary system. This study compared the occurrence rate of post-procedural complications, including cholangitis and septicemia between prophylactic intravenous moxifloxacin and ceftriaxone in patients with bile duct obstruction scheduled for therapeutic ERCP.METHODS: From November 2013 to July 2015, 86 consecutive patients with biliary obstruction with one or more factors predicting benefits of antibiotic prophylaxis prior to ERCP were included in the current randomized open-label non-inferiority trial(Clinical Trial.gov identifier NCT02098486). Intravenous moxifloxacin(400 mg/day) or ceftriaxone(2 g/day)were given 90 minutes before ERCP, and were administered for more than 3 days if the patient developed symptoms and signs of cholangitis or septicemia. Recalcitrant cholangitis was defined as persistence of cholangitis for more than 5 days after ERCP or recurrence of cholangitis within 30 days after ERCP.RESULTS: Recalcitrant cholangitis occurred in 1(2.3%) and 2(4.8%) patients receiving intravenous moxifloxacin and ceftriaxone group, respectively(P=0.612). Septicemia was noted in1(2.3%) and 1(2.4%) patient in intravenous moxifloxacin and ceftriaxone group, respectively(P=1.0). The mean hospital stay was also not significantly different between the moxifloxacin and ceftriaxone groups(8.8±7.2 vs 9.1±9.4 days, P=0.867). Antibiotic resistance of the isolated pathogens by in vitro activity assay was noted in 1(2.3%) and 2(4.8%) patients in the moxifloxacin and ceftriaxone group, respectively(P=0.612). CONCLUSION: Intravenous moxifloxacin is not inferior to intravenous ceftriaxone for the prophylactic treatment of post-ERCP cholangitis and cholangitis-associated morbidity.     

In vitro comparison of mezlocillin and piperacillin plus tobramycin or gentamicin versus 100 gram-negative nosocomial bloodstream isolates

We compared the in vitro activity of mezlocillin and piperacillin, alone and in combination with tobramycin or gentamicin, against clinical isolates of gram-negative bacilli from hospitalized patients with 100 distinct episodes of nosocomial bacteremia. The minimum inhibitory concentrations (MICs) necessary to inhibit 50% and 90% of isolates showed that piperacillin was most active against Pseudomonas aeruginosa. The MIC needed to inhibit 90% of isolates also showed that mezlocillin was more active against Enterobacter cloacae. Activities of the two acylaminopenicillins were comparable against the rest of the isolates. Combining the acylaminopenicillins with either gentamicin or tobramycin decreased the MICs fourfold or more for both combinations. Synergy occurred more frequently with mezlocillin-gentamicin (12%), followed by piperacillin-tobramycin (9%), mezlocillin-tobramycin (6%), and piperacillin-gentamicin (5%). Antagonism for Enterobacteriaceae isolates was observed most frequently with the combination of piperacillin plus tobramycin (20%), followed by mezlocillin plus tobramycin (17.6%), piperacillin plus gentamicin (12.9%), and mezlocillin plus gentamicin (8.2%). There are very few differences in the activities of mezlocillin and piperacillin combined with either gentamicin or tobramycin versus nosocomial gram-negative bloodstream isolates.     

Acute interstitial nephritis associated with mezlocillin, nafcillin, and gentamicin treatment for Pseudomonas infection

Two patients developed acute interstitial nephritis (AIN) following treatment with mezlocillin sodium. Diagnosis was made by renal biopsy. Gallium 67 citrate scanning was abnormal in both. All patients were receiving multiple-drug therapy, but AIN has either not been described with the other drugs, or the temporal relationship between the AIN and termination of other drug therapy makes a causative relationship unlikely. All were infected with Pseudomonas aeruginosa. A role for the infecting organism or drug synergism in contributing to the renal disease cannot be excluded.     

Ceftriaxone versus Levofloxacin for antibiotic therapy in patients with acute cholangitis

INTRODUCTION: For the therapy of acute cholangitis complete biliary drainage and antibiotic therapy is needed. The aim of the current study was to compare intravenous therapy of acute cholangitis with Ceftriaxone or Levofloxacin in a prospective and randomized fashion. METHODS: Patients with biliary obstruction and clinical signs of infection received in addition to 1.5 g Metronidazole either 500 mg Levofloxacin/die or 2 g Ceftriaxone/die. Early on during ERCP, bile was aspirated via the cannulation catheter and cultured for bacteria under aerobic and anaerobic conditions. Minimal inhibitory concentrations of the respective antibiotics were determinate for each isolate. The clinical course was followed for at least 6 days with clinical and laboratory data. RESULTS: 60 patients with clinical signs of acute cholangitis were randomised. In 40 patients (66 %) biliary colonization with bacteria could be identified. In all bacterial species Levofloxacin showed significantly lower rates of in-vitro resistance as compared to Ceftriaxone. However, the percentage of patients with a clinical cure or significant improvement was the same in the two groups. CONCLUSIONS: The clinical effect of Levofloxacin and Ceftriaxone in patients with acute cholangitis showed no significant differences. Because of improved in-vitro efficiency, a calculated therapy with Levofloxacin might be advantageous.     

单用拉米夫定与联合α干扰素治疗慢性乙型肝炎的疗效观察

目的观察和对比单用拉米夫定与拉米夫定联合α干扰素治疗慢性乙型肝炎的安全性和疗效.方法拉米夫定组64例,单服拉米夫定,100mg或150mg,每日1次,其中54例(84.4%)用药超过12个月.联合组49例,拉米夫定用药2周后加用干扰素(甘乐能或罗荛愫),3MU～5MU肌肉或皮下注射,每周3次,24周后停干扰素,继续服拉米夫定,其中38例(77.6%)治疗超过12个月.两组在治疗6个月、12个月时分别进行疗效评价,并继续随访4～26个月.结果拉米夫定组和联合组6个月时ALT/AST复常率分别为90.6%/92.2%和89.8%/93.9%(P＞0.05);HBVDNA阴转率分别为96.9%和98.0%(P＞0.05);HBeAg的血清转换率为20.3%和28.6%(P＞0.05).12个月时两组ALT/AST的复常率分别为90.7%/90.7和89.5%/92.1%(P＞0.05);HBV DNA阴转率为88.9%和89.5%(P＞0.05);HBeAg的血清转换率则分别为31.5%(17/54)和55.3%(21/38),P＜0.05.HBeAg的血清转换率似乎与治疗前的转氨酶水平较高、HBeAg和HBV DNA水平较低有关.治疗9～24个月期间拉米夫定组9例(14.1%)、联合组6例(12.2%)发生HBV多聚酶YMDD变异.结论拉米夫定和干扰素联合治疗慢性乙型肝炎,安全性和耐受性良好,1年后HBeAg的血清转换率显著高于单用拉米夫定组.     

单用粒米夫定与联合α干扰素治疗慢性乙型肝炎的疗效观察

目的 观察和对比单用拉米夫定与拉米夫定联合α干扰素治疗慢性乙型肝炎的安全性和疗效。方法 拉米夫定组64例，单服拉米夫定，100mg或150mg，每日1次，其中54例（84．4％）用药超过12个月。联合组49例，拉米夫定用药2周后加用干扰素（甘乐能或罗尧愫），3MU－5MU肌肉或皮下注射，每周2次，24周后停干扰素，继续服拉米夫定，其中38例（77．6％）治疗超过12个月。两组在治疗6个月、12个月时分别进行疗效评价，并继续随访4－26个月。结果 拉米夫定组和联合组6个月时ATL／AST复常经分别为90．6％／92．2％和89．8％／93．9％（P＞0．05）；HBVDNA阴转率分别为96．9％和98．0％（P＞0．05）；HBeAg的血清转换率为20．3％和28．6％（P＞0．05）。12个月时两组ALT/AST 复常率分别为90．7％／90．7和89．5％／92．1％（P＞0．05）；HBVDNA阴转率为88．0％和89．5％（P＞0．05）；HBeAg的血清转换率则分别为31．5％（17／54）和55．3％（21／38），P＜0．05。HBeAg的血清转换率似乎与治疗前的转氨酶水平较高、HBeAg和HBVDNA水平较低有关。治疗9－24个月期间拉米夫定组9例（14．1％）、聚合组6例（12．2％）发生HBV多聚酶MDD变异。结论 拉米夫定和干扰素联合治疗慢性乙型肝炎，安全性和耐受性,1上后HBeAg的血清转换率显著高于单用拉米夫定组。     

Aztreonam or gentamicin combined with piperacillin as empiric antibiotic therapy during neutropenia of patients with hematologic diseases]

Fourty-two febrile episodes of 32 patients with hematologic disease during neutropenia were treated with two randomly assigned antibiotic combinations of either piperacillin plus gentamicin or piperacillin plus aztreonam. Eleven of the 22 febrile episodes treated with piperacillin plus gentamicin and 12 of the 20 febrile episodes treated with piperacillin plus aztreonam responded. Addition of cefamandole to non-responders improved the outcome in 2 of the 16 febrile episodes. Mean nadir leucocyte count, age, sex, and underlying disease were not significantly different in both groups. Side effects were tolerable in both groups, although 1 patient treated with piperacillin plus gentamicin showed severe renal impairment. Piperacillin plus aztreonam is as effective as piperacillin plus gentamicin as an empiric antibiotic combination in the treatment of febrile episodes with hematologic disease during neutropenia.     

High-dose ursodeoxycholic acid as a therapy for patients with primary sclerosing cholangitis

OBJECTIVES: To assess the tolerability and efficacy of high-dose (25-30 mg/kg per day) ursodeoxycholic acid (UDCA) in patients with primary sclerosing cholangitis (PSC). METHODS: Thirty patients with PSC were enrolled in this pilot study and treated for 1 yr. Changes in the Mayo risk score at 1 yr of treatment and projected survival at 4 yr were compared with that observed in patients randomized to placebo (n = 52) or UDCA (n = 53) at a dose of 13-15 mg/kg per day. RESULTS: A marked improvement in serum alkaline phosphatase activity (1265+/-172 vs 693+/-110 U/L, p < 0.001), AST (161+/-037 vs 77+/-13 U/L, p = 0.001), albumin (4.0+/-0.1 vs 4.2+/-0.1 g/dl, p = 0.03), and total bilirubin (1.6+/-0.3 vs 1.3+/-0.2 mg/dl, p = 0.1) occurred at 1 yr of therapy with high-dose UDCA. Changes in the Mayo risk score after 1 yr of treatment were significantly different among the three groups (p < 0.001), and these changes would be translated into a significantly different expected survival at 4 yr (p = 0.05). This expected survival at 4 yr was significantly different between placebo and the dose of 25-30 mg/kg per day (p = 0.04), but not between placebo and the dose of 13-15 mg/kg per day (p = 0.4). High-dose UDCA was well tolerated. CONCLUSIONS: UDCA at a dose of 25-30 mg/kg per day may be of benefit for patients with PSC, and this regimen deserves further evaluation in a long-term, randomized, placebo-controlled trial.     

Combined aspirin-oral anticoagulant therapy compared with oral anticoagulant therapy alone among patients at risk for cardiovascular disease: a meta-analysis of randomized trials

BACKGROUND: For patients receiving oral anticoagulant (OAC) therapy, deciding whether to add aspirin to their treatment is a common clinical scenario with no clear guidelines to aid practice. We performed a systematic review and meta-analysis of randomized controlled trials comparing these 2 treatment strategies (combined aspirin-OAC therapy vs OAC therapy alone) to assess the therapeutic benefits and risks. DATA SOURCES: Randomized controlled trials published up to June 2005 in MEDLINE, EMBASE, and Cochrane Library databases. STUDY SELECTION: Randomized controlled trials with at least 3 months of follow-up that compared aspirin-OAC therapy with OAC therapy alone, in which OAC was administered to achieve the same target international normalized ratio or was given at the same fixed dose in both treatment arms. DATA EXTRACTION: Two reviewers independently extracted data on study characteristics and outcomes. Pooled odds ratios (ORs) and associated 95% confidence intervals (CIs) were calculated for study outcomes in patients receiving aspirin-OAC therapy and OAC therapy alone. DATA SYNTHESIS: Ten studies were included, totaling 4180 patients. The risk for arterial thromboembolism was lower in patients receiving combined aspirin-OAC therapy compared with OAC therapy alone (OR, 0.66; 95% CI, 0.52-0.84). However, these benefits were limited to patients with a mechanical heart valve (OR, 0.27; 95% CI, 0.15-0.49). There was no difference in the risk for arterial thromboembolism with these treatments in patients with atrial fibrillation (OR, 0.99; 95% CI, 0.47-2.07) or coronary artery disease (OR, 0.69; 95% CI, 0.35-1.36). There was no difference in all-cause mortality with either treatment (OR, 0.98; 95% CI, 0.77-1.25). The risk for major bleeding was higher in patients receiving aspirin-OAC therapy compared with OAC therapy alone (OR, 1.43; 95% CI, 1.00-2.02). CONCLUSION: Our findings question the current practice of using combined aspirin-OAC therapy except in patients with a mechanical heart valve, given the questionable benefits in reducing thromboembolic events and the increased risk of major bleeding.     

Lack of synergism of ampicillin and gentamicin in experimental listeriosis

Summary Strain SLCC 4013 ofListeria monocytogenes is susceptiblein vitro to ampicillin (MIC 0.5 mg/l) as well as to gentamicin (MIC 0.5 mg/l). Whereas treatment of mice infected with this virulent strain with 0.5 mg ampicillin twice a day resulted in a marked decrease in bacterial counts per spleen, the administration of 2 mg gentamicin twice a day hardly reduced bacterial multiplication. The combination of both drugs was not much more effective than ampicillin alone. Thus, a synergistic effect of both these antibiotics on intracellularly growing bacteria could not be demonstrated.

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Kein Synergismus zwischen Ampicillin und Gentamicin bei der experimentellen Listeriose

Zusammenfassung Der Stamm SLCC 4013 vonListeria monocytogenes warin vitro empfindlich gegenüber Ampicillin (MHK 0,5 mg/l) und Gentamicin (MHK 0,5 mg/l). Mäuse wurden zweimal pro Tag mit je 2 mg Ampicillin oder mit 2 mg Gentamicin behandelt, nachdem sie mit diesem virulenten Listerien-Stamm infiziert worden waren. Während die Behandlung mit Ampicillin die Keimzahlen pro Milz deutlich senkte, war Gentamicin nur wenig wirksam. Die Kombination der beiden Antibiotika hatte keinen synergistischen Effekt auf diese intrazellulär vermehrungsfähigen Bakterien.

     

急诊内镜治疗高龄急性化脓性胆管炎45例的疗效分析

目的探讨急诊内镜对高龄急性化脓性胆管炎患者的临床治疗效果。方法选取2011年3月至2014年3月笔者参与操作的90例高龄急性化脓性胆管炎患者为研究对象,将其按照治疗方式的不同分为观察组和对照组,对照组患者行急诊外科手术治疗,观察组患者行急诊内镜手术治疗,对比分析两组患者的临床治疗效果。结果观察组患者治疗总有效率95.56%、总不良反应率8.89%均优于对照组之71.11%、26.67%(P0.05),差异具有统计学意义。结论对急性化脓性胆管炎行内镜早期手术治疗能够促进病情恢复,降低了患者并发症率和死亡率。     

Prospective,randomized trial comparing four biofeedback techniques for patients with constipation

PURPOSE: The aim of this study was to compare four methods of biofeedback for patients with constipation. METHODS: Thirty-six patients were prospectively, randomly assigned to one of four protocols: 1) outpatient intra-anal electromyographic biofeedback training; 2) electromyographic biofeedback training plus intrarectal balloon training; 3) electromyographic biofeedback training plus home training; or 4) electromyographic biofeedback training, balloon training, and home training. All 36 patients received weekly one-hour outpatient biofeedback training. Success was measured by increased unassisted bowel movements and reduction in cathartic use. In all instances patients maintained a daily log in which documentation was maintained regarding each bowel evacuation and the need for any cathartics. RESULTS; There was a statistically significant increase in unassisted bowel movements for Groups 1, 2, and 4 (P<0.05) and a reduction in the use of cathartics in Groups 1, 2, and 3 (P<0.05). CONCLUSION: There was a significant improvement in outcome after all four treatment protocols for constipation; however, no significant difference was found among the treatments. Therefore, electromyographic biofeedback training alone is as effective as with the addition of balloon training, home training, or both.Supported in part by a grant from the Eleanor Naylor Dana Trust Fund.Poster presentation at the meeting of The American Society of Colon and Rectal Surgeons, San Antonio, Texas, May 2 to 7, 1998.     

Prospective surveillance for cholangiocarcinoma in unselected individuals with primary sclerosing cholangitis

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A comparison study of cognitive-behavioral therapy alone versus combination with tapered hypnotic agents in patients with chronic insomnia

<正>Objective To investigate the efficacy of cognitivebehavioral therapy for insomnia (CBT-i) or combination with tapered hypnotic agents. Methods Seventy-five patients were randomized into either CBT-i group (n=37)or combination group (n=38). The duration of treatment lasted for 8 weeks. The efficacy was evaluated by     

A randomized monocentric trial in febrile neutropenic patients: ceftriaxone and gentamicin vs cefepime and gentamicin

A prospective, randomized, controlled monocentric trial was performed to evaluate the efficacy and safety of once daily ceftriaxone 2 g plus gentamicin 5 mg/kg in comparison to cefepime 2 g t.i.d. plus gentamicin 5 mg/kg q.d. in the treatment of neutropenic fever. In case of fever (oral temperature > or =38.5 degrees C on one occasion or > or =38.0 degrees C twice within 24 h) and a granulocytopenia (neutrophil count below 500 or below 1000/microl when expected to fall below 500 within 72 h), patients with hematological malignancies or solid tumors were assigned to ceftriaxone or cefepime, each with gentamicin. The primary endpoint was defined as defervescence on day 4-6 followed by at least 7 afebrile days. Secondary endpoints were overall response, defined as defervescence on day 28 and toxicity. Two hundred eleven episodes were included. Fever of unknown origin (FUO) accounted for 124 episodes (58.8%), microbiologically defined infection (MDI) for 39 (18.5%), clinically defined infection (CDI) for 25 (11.8%), and both clinically and microbiologically defined infection (CMDI) for 19 episodes (9%). On an intent-to-treat basis 207 episodes were evaluable for the primary endpoint. Ceftriaxone plus gentamicin and cefepime plus gentamicin were successful in 49.5% and 51%, respectively. Overall response was achieved on study day 28 in 92.5% and 91%, respectively. Diarrhea was more frequent with ceftriaxone/gentamicin (6.5% vs 17%), while nausea/vomiting was less (12.1% vs 5%). Once-daily ceftriaxone plus gentamicin was not inferior to cefepime t.i.d. plus gentamicin q.d. in the empirical treatment of neutropenic fever.     

80岁以上患者急性梗阻性化脓性胆管炎合理治疗方式的选择

目的: 探讨内窥镜逆行胰胆管造影术(ERCP)治疗80岁以上患者急性梗阻性化脓性胆管炎的疗效、安全性及合理治疗方式的选择.方法: 收集2001-01/2007-12我院80岁以上由结石引起的急性梗阻性化脓性胆管炎患者439例,根据不同处理方式分为内镜治疗组(n=279)、手术治疗组(n=94)和保守治疗组(n=66),分析三组治疗方法的疗效、并发症发生率、死亡率、住院时间和住院费用等.结果: 保守治疗组和手术治疗组病死率分别为16.7%和8.5%,内镜治疗组死亡2例,14例失访.内镜治疗组并发症发生率明显低于手术治疗组(3.9%vs34.0%,P<0.01),死亡率、住院时间和住院费(万元)明显低于手术治疗组和保守治疗组(0.72%vs8.5%,16.7%;7.3±2.8 dvs11.4±3.7 d,15.3±4.9 d;1.23±0.54vs1.55±0.79,1.56±0.84,均P<0.05);手术治疗组的死亡率、住院时间也较保守治疗组低(均P<0.05).结论: 内镜治疗80岁以上患者急性梗阻性化脓性胆管炎安全有效,是其首选的治疗方式.