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1.
ObjectiveExcessive bleeding is an important complication of radical cystectomy. We aimed to assess whether preoperative administration of fibrinogen decreases perioperative bleeding and improves the outcome of radical cystectomy.DesignDouble-blinded randomized trial with two parallel arms.SettingThe study was conducted in the department of surgery at a teaching hospital affiliated with a University of Medical Sciences.PatientsIn total, 70 men undergoing radical cystectomy were randomized to fibrinogen (n = 35) and placebo-control groups. Mean (SD) age was 64.7 (7.4) years.InterventionsThe intervention group received 2 g fibrinogen concentrate diluted in 100 ml distilled water, and the control group received 100 ml normal saline; both intravenously 15 ̶ 30 min before the start of the surgery.Outcome measuresThe primary outcome was the amount of perioperative blood loss. The secondary outcomes were hemodynamic features and vital signs.Main resultsFibrinogen significantly decreased the volume of blood loss (p < 0.001) and the total number of transfused packed-cell units per group (38 vs. 115 units); and compensated the decrease of HCO3 (p = 0.030), the mean arterial pressure (p < 0.001), hemoglobin O2 saturation (p = 0.001), heart rate (p < 0.001), and temperature (p < 0.001) throughout the surgery compared with the placebo. Patients in the fibrinogen group had shorter Intensive Care Unit (p = 0.001) and hospital (p < 0.001) stay. We did not find any adverse reaction in our patients receiving fibrinogen concentrate.ConclusionFibrinogen concentrate reduces perioperative bleeding and the need for blood transfusion in radical cystectomy. It improves the outcomes of the surgery and decreases patients' length of stay in the healthcare system following radical cystectomy.RegistrationIranian Registry of Clinical Trials (IRCT) http://www.irct.ir/, reference number: IRCT20191013045091N1.Ethics codeShahid Beheshti University of Medical Sciences, reference number: IR.SBMU.RETECH.REC.1398.033.  相似文献   

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OBJECT: To determine if a 6-month regimen of prophylactic ursodeoxycholic acid is effective in the prevention of gallstones. SUMMARY BACKGROUND DATA: Rapid weight loss after surgery for the treatment of morbid obesity is associated with a high incidence of gallstone formation. METHODS: Patients with vertical banded gastroplasty (VBG) and adjustable gastric banding (AGB) were enrolled in this study. A single-center, randomized, double-blind, prospective trial evaluated 500 mg of ursodeoxycholic acid versus placebo, beginning within 3 days after surgery and continuing for 6 months or until gallstone development, for patients with morbid obesity. Transabdominal sonography or abdominal CT scan was obtained preoperatively at 3, 6, 12, and 24 months after surgery or until gallstone formation. RESULTS: From March 1997 to April 2000, 262 patients were submitted to surgery. Seventy-seven patients refused to participate in the study; 43 patients with previous gallstone operation or verified gallstones preoperatively were excluded. Of 152 patients, 76 were randomized to placebo and 76 to 500 mg of ursodeoxycholic acid daily. Preoperative age, sex, weight, BMI, and postoperative weight loss were not significantly different between groups. Gallstone formation was significantly less (P = 0.0018, Fisher exact test) frequent with ursodeoxycholic acid than with placebo at 12 months, 3% versus 22%, and 8% versus 30% (P = 0.0022) at 24 months, cholecystectomy in 4.7% versus 12%, respectively (P < 0,02, Fisher exact test). CONCLUSION: A daily dose of 500 mg of ursodeoxycholic acid for 6 months is effective prophylaxis for gallstone formation following gastric restrictive procedures.  相似文献   

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OBJECTIVE: This study was undertaken to evaluate the effect of triiodothyronine replacement on the early postoperative course of neonates undergoing aortic arch reconstruction. METHODS: We performed a randomized, double-blind, placebo-controlled trial of triiodothyronine supplementation in neonates undergoing either a Norwood procedure or two-ventricle repair of interrupted aortic arch and ventricular septal defect. Patients were assigned to receive a continuous infusion of triiodothyronine (0.05 micro/kg/h) or placebo for 72 hours after cardiopulmonary bypass. Primary end points were a composite clinical outcome score and cardiac index at 48 postoperative hours. RESULTS: We enrolled 42 patients (triiodothyronine n = 22, placebo n = 20). Baseline characteristics were similar in the treatment groups. Study drug was discontinued prematurely because of hypertension (n = 1) and ectopic atrial tachycardia (n = 1), both cases in the triiodothyronine group. Free and total triiodothyronine levels were higher in the triiodothyronine group than in the placebo group at 24, 48, and 72 postoperative hours (P < .001). The median clinical outcome scores were 2.0 (range 0-4) with triiodothyronine and 2.0 (range 0-7) with placebo (P = .046). Compared with those in the placebo group, neonates assigned to triiodothyronine had shorter median time to negative fluid balance (2.0 vs 2.5 days, P = .027). Cardiac index values were 2.11 +/- 0.64 L/min x m2 with triiodothyronine and 2.05 +/- 0.72 L/min x m2 with placebo (P = .81). Heart rate and diastolic blood pressure were not influenced by triiodothyronine supplementation, but systolic blood pressure was higher in the triiodothyronine group (P < .001). No serious adverse events were attributed to triiodothyronine administration. CONCLUSION: Triiodothyronine supplementation was safe and resulted in more rapid achievement of negative fluid balance after aortic arch reconstruction. Cardiac index at 48 hours was not significantly improved.  相似文献   

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目的探讨脐环充填式无张力疝修补术在治疗成人脐疝中的优越性。方法总结2002年1月至2009年12月间41例成人脐疝患者的治疗经验。其中Mayo法23例,无张力疝修补术18例。结果全组手术过程顺利。脐环充填式无张力疝修补术的平均手术时间(58±11 min)稍长于Mayo组(50±12 min),但术后疼痛感较轻及术后住院时间缩短(P0.05);两组均无切口感染病例。术后随访发现Mayo手术组有2例复发,无张力疝修补术组无复发。结论脐环充填式无张力疝修补术是治疗成人脐疝较好的术式,具有安全、术后恢复快、复发率低等优点。  相似文献   

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《Liver transplantation》2000,6(3):376-379
Background:Among persons who receive solid organ 0842 transplants, liver transplant recipients have the highest incidence of invasive fungal infection; however, no antifungal prophylaxis has been proven to be effective.Objective:To evaluate the efficacy and safety of prophylactic0842 fluconazole in liver transplant recipients.Design:Randomized, double-blind, placebo-controlled trial. 0842Setting:University-affiliated transplantation center.0842Patients:212 liver transplant recipients who received fluconazole0842 (400 mg/d) or placebo until 10 weeks after transplantation.Measurements:Fungal colonization, proven superficial 0842 or invasive fungal infection, drug-related side effects, and death.Results:Fungal colonization increased in 0842 patients who received placebo (from 60% to 90%) but decreased in patients who received fluconazole (from 70% to 28%). Proven fungal infection occurred in 45 of 104 placebo recipients (43%) but in only 10 of 108 fluconazole recipients (9%) (P < 0.001). Fluconazole prevented both superficial infection (29 of 104 placebo recipients became infected [28%] compared with 4 of 108 fluconazole recipients [4%]; P < 0.001) and invasive infection (24 of 104 placebo recipients became infected [23%] compared with 6 of 108 fluconazole recipients [6%]; P < 0.001). Fluconazole prevented infection by most Candida species, except C. glabrata. However, infection and colonization by organisms intrinsically resistant to fluconazole did not seem to increase. Fluconazole was not associated with any hepatotoxicity. Patients receiving fluconazole had higher serum cyclosporine levels and more adverse neurologic events (headaches, tremors, or seizures in 13 fluconazole recipients compared with 3 placebo recipients; P = 0.01). Although the overall mortality rate was similar in both groups (12 of 108 [11%] in the fluconazole group compared with 15 of 104 [14%] in the placebo group; P > 0.2), fewer deaths related to invasive fungal infection were seen in the fluconazole group (2 of 108 patients [2%]) than in the placebo group (13 of 104 patients [13%]) (P = 0.003).Conclusions:Prophylactic 0842 fluconazole after liver transplantation decreases fungal colonization, prevents superficial and invasive fungal infections, and has no appreciable hepatotoxicity. Although fluconazole prophylaxis is associated with fewer deaths from fungal infection, it does not improve overall survival. Patients receiving prophylactic fluconazole require close monitoring of serum cyclosporine levels to avoid neurologic toxicity.  相似文献   

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Abstract Background and Purpose: Ureteral stents are indispensable tools in endourology, although they often are associated with bothersome lower urinary tract symptoms. This study was conducted to evaluate the effect of alfuzosin on urinary symptoms, quality of life, and pain in patients after Double-J ureteral stent placement in a randomized, placebo-controlled trial. Patients and Methods: This study was conducted from July 2008 to May 2009. A total of 130 patients underwent placement of a Double-J stent after retrograde semirigid ureteroscopy for ureteral stones. They were randomized in two groups. Group 1 (n=65) received alfuzosin 10?mg once daily and group 2 (n=65) received placebo for 1 week. Both groups also received standardized analgesia. The stent symptoms were measured and recorded 1 week after the procedure. Statistical analyses were performed using the chi-square test and Student t test with P<0.05 considered significant. Results: The demographic profile including patient and stone-related parameters were comparable. Group 1 had significantly less urinary symptoms (P<0.05). The quality-of-life assessment was better in the alfuzosin arm than in the placebo arm (P<0.001). The mean pain score was 1.15 in group 1 and 3.89 in the placebo group (P<0.001). None of the patients in either of the arms withdrew from treatment; there were minimal adverse effects in the treatment arm. The limitation of the current work includes relatively smaller sample size and use of single type of stent. Conclusions: Alfuzosin 10?mg once daily in patients with a Double-J stent significantly decreases the bothersome urinary symptoms, besides decreasing significantly the pain associated with the stent.  相似文献   

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Background and purpose

High-volume infiltration analgesia may be effective in postoperative pain management after hip arthroplasty but methodological problems prevent exact interpretation of previous studies.

Methods

In a randomized, double-blind placebo-controlled trial in 12 patients undergoing bilateral total hip arthroplasty (THA) in a fast-track setting, saline or high-volume (170 mL) ropivacaine (0.2%) with epinephrine (1:100,000) was administered to the wound intraoperatively along with supplementary postoperative injections via an intraarticular epidural catheter. Oral analgesia was instituted preoperatively with a multimodal regimen (gabapentin, celecoxib, and acetaminophen). Pain was assessed repeatedly for 48 hours postoperatively, at rest and with 45° hip flexion.

Results

Pain scores were low and similar between ropivacaine and saline administration. Median hospital stay was 4 (range 2–7) days.

Interpretation

Intraoperative high-volume infiltration with 0.2% ropivacaine with repeated intraarticular injections postoperatively may not give a clinically relevant analgesic effect in THA when combined with a multimodal oral analgesic regimen with gabapentin, celecoxib, and acetaminophen.Continuous epidural analgesia (Choi et al. 2003) or continuous or single-shot peripheral nerve blocks (Boezaart 2006, Ilfeld et al. 2008) may provide sufficient analgesia after total hip arthroplasty (THA), but both techniques are associated with potential motor blockade, thereby hindering early rehabilitation (Choi et al 2003, Boezaart 2006, Ilfeld et al. 2008).Local infiltration analgesia (LIA) (Röstlund and Kehlet 2007, Kerr and Kohan 2008, Otte et al. 2008) with intraoperative infiltration of local anesthetic in the surgical wound and subsequent supplementary postoperative intraarticular or wound injections has been reported to be effective in knee arthroplasty (Andersen et al. 2008). However, for THA only limited and inconclusive data are available from placebo-controlled and randomized trials (Bianconi et al. 2003, Andersen et al. 2007 a, b, Busch et al. 2010) and from non-randomized cohort studies (Kerr and Kohan 2008, Otte et al. 2008). We therefore decided to evaluate the analgesic efficacy of LIA in a placebo-controlled, randomized and double-blind trial in fast-track bilateral hip arthroplasty with administration of either ropivacaine or saline to the wound, thereby limiting the large inter-individual pain response to THA. This design has proven valid in assessing the analgesic value of LIA in TKA (Andersen et al. 2008). The primary endpoint was pain on flexion of the hip joint 8 hours postoperatively.  相似文献   

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BACKGROUND & AIMS: In patients with severe, necrotizing pancreatitis, it is common to administer early, broad-spectrum antibiotics, often a carbapenem, in the hope of reducing the incidence of pancreatic and peripancreatic infections, although the benefits of doing so have not been proved. METHODS: A multicenter, prospective, double-blind, placebo-controlled randomized study set in 32 centers within North America and Europe. Participants: One hundred patients with clinically severe, confirmed necrotizing pancreatitis: 50 received meropenem and 50 received placebo. Interventions: Meropenem (1 g intravenously every 8 hours) or placebo within 5 days of the onset of symptoms for 7 to 21 days. Main Outcome Measures: Primary endpoint: development of pancreatic or peripancreatic infection within 42 days following randomization. Other endpoints: time between onset of pancreatitis and the development of pancreatic or peripancreatic infection; all-cause mortality; requirement for surgical intervention; development of nonpancreatic infections within 42 days following randomization. RESULTS: Pancreatic or peripancreatic infections developed in 18% (9 of 50) of patients in the meropenem group compared with 12% (6 of 50) in the placebo group (P = 0.401). Overall mortality rate was 20% (10 of 50) in the meropenem group and 18% (9 of 50) in the placebo group (P = 0.799). Surgical intervention was required in 26% (13 of 50) and 20% (10 of 50) of the meropenem and placebo groups, respectively (P = 0.476). CONCLUSIONS: This study demonstrated no statistically significant difference between the treatment groups for pancreatic or peripancreatic infection, mortality, or requirement for surgical intervention, and did not support early prophylactic antimicrobial use in patients with severe acute necrotizing pancreatitis.  相似文献   

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目的对比腹腔镜疝修补术网片固定、网片免固定与开放式无张力疝修补术治疗腹股沟疝的有效性及安全性,以期为未来腹股沟疝治疗术式的选择提供依据。 方法回顾性分析2015年1月至2018年1月,宝应县人民医院收治的腹股沟疝93例患者的临床资料,根据手术方法分为3组:A组,腹腔镜疝修补术网片固定(34例);B组,腹腔镜疝修补术网片免固定组(31例);C组,开放式无张力疝修补术(28例)。术后随访1年,对比3组患者手术实施情况、术后并发症发生情况及复发率。 结果B组术中失血量、手术时间、术后下床活动时间、进食时间、疼痛持续时间、住院时间、术后2 d疼痛评分与A组比较,差异无统计学意义(P>0.05);A、B组术中失血量少于C组,术后下床活动时间、进食时间、疼痛持续时间、住院时间短于C组,术后2 d疼痛评分低于C组,差异有统计学意义(P<0.05);3组手术时间两两比较,差异无统计学意义(P>0.05);3组术后并发症发生率、复发率比较,差异均无统计学意义(P>0.05)。 结论腹腔镜与开放式无张力疝修补术治疗腹股沟疝疗效相当,且患者术后均无较多并发症,安全性均理想。但因腹腔镜手术无需作较大切口,患者受到创伤小,术后恢复快,其应用价值优于开放式手术。腹腔镜术中补片在不固定的情况下仍能获得与补片固定后相似的效果,故腹腔镜网片免固定疝修补术操作简单,并发症少,临床推广价值更高。  相似文献   

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Women undergoing general anesthesia for dilatation and curettage have a high risk for postoperative nausea and vomiting. We therefore evaluated the efficacy and safety of ramosetron, a new compound having serotonin receptor antagonist activity, for preventing nausea and vomiting in termination of pregnancy. Eighty women scheduled for dilatation and curettage received, in a randomized, double-blind manner, an intravenous placebo or ramosetron at three different doses (0.15 mg, 0.3 mg, 0.6 mg) at the end of surgery (n = 20 per group). Emetic episodes and safety were assessed. The percentage of patients who were emesis-free (no nausea, no retching, no vomiting) during 0-24 h after anesthesia was 55% with ramosetron 0.15 mg (P = 0.5), 85% with ramosetron 0.3 mg (P = 0.02), and 90% with ramosetron 0.6 mg (P = 0.007), compared with 50% in the placebo group. No clinically serious adverse events due to the study drugs were observed in any group. Our results suggest that ramosetron 0.3 mg is an effective antiemetic for prophylaxis against emetic symptoms after dilatation and curettage. Increasing the dose to 0.6 mg provides no further benefit.  相似文献   

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BACKGROUND: Mild traumatic brain injury (MTBI) affects 750,000 persons in the United States annually. Five to fifteen percent have persistent dysfunction and disability. No effective, standard pharmacological treatment exists specifically for this problem. We designed a pilot research project to study the clinical effectiveness of homeopathic medicine in the treatment of persistent MTBI. METHOD: A randomized, double-blind, placebo-controlled trial of 60 patients, with a four-month follow-up (N = 50), was conducted at Spaulding Rehabilitation Hospital (SRH). Patients with persistent MTBI (mean 2.93 years since injury, SD 3.1) were randomly assigned to receive a homeopathic medicine or placebo. The primary outcome measure was the subject-rated SRH-MBTI Functional Assessment, composed of three subtests: a Difficulty with Situations Scale (DSS), a Symptom Rating Scale (SRS), and a Participation in Daily Activities Scale (PDAS). The SRH Cognitive-Linguistic Test Battery was used as the secondary measure. RESULTS: Analysis of covariance demonstrated that the homeopathic treatment was the only significant or near-significant predictor of improvement on DSS subtests (P =.009; 95% CI -.895 to -.15), SRS (P =.058; 95% CI -.548 to.01) and the Ten Most Common Symptoms of MTBI (P =.027; 95% CI -.766 to -.048). These results indicate a significant improvement from the homeopathic treatment versus the control and translate into clinically significant outcomes. CONCLUSIONS: This study suggests that homeopathy may have a role in treating persistent MTBI. Our findings require large-scale, independent replication.  相似文献   

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The authors report the results of a randomized, prospective study to assess the effectiveness of perioperative antibiotic prophylaxis in preventing postoperative infections following clean neurosurgical operations. The study group comprised 846 patients treated between October, 1979, and June, 1984. Antibiotics, including cefazolin and gentamicin, were administered only in the immediate preoperative and intraoperative periods. Sixteen patients, none of whom developed infections, were excluded from final statistical analysis because they had inadvertently been entered into the study while failing to meet entry criteria. Fifteen wound infections (3.64%) developed in the group of 412 patients who did not receive antibiotics, whereas only four infections (0.96%) were identified among the 418 patients who received antibiotics. The difference is statistically significant (p = 0.008) and represents a 74% reduction in infection rate with antibiotics. An analysis of subgroups of surgical procedures revealed a dramatic decrease in craniotomy infections from 6.77% to 0% (p = 0.003). Of the four infections that occurred among the antibiotic-treated patients, three were in cases where foreign bodies had been implanted. No complications of antibiotic usage were identified. The rates of infection in areas of the body other than the surgical wound were no different in the antibiotic-treated and nontreated groups. All wound infections in both antibiotic-treated and nontreated patients involved similar types of Gram-positive organisms, suggesting that antibiotic prophylaxis did not produce infections with resistant or unusual organisms. This study, combined with other recently published analyses, suggests that routine perioperative antibiotic prophylaxis can significantly reduce the incidence of postoperative neurosurgical infections.  相似文献   

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Background

The aim of the study was to investigate whether a multimodal analgesia (MMA) protocol reduces postoperative pain and opioids consumption in patients undergoing arthroscopic rotator cuff repair.

Methods

Fifty-four patients scheduled for arthroscopic rotator cuff repair were randomly assigned to either the MMA group or the control group. The primary outcome was visual analog scale (VAS) for pain. Secondary outcome measures included the time required for the VAS pain to reduce to that of a blood draw, (PCA) consumption, rescue morphine consumption, night awakening, and opioid-related side effects.

Results

The MMA group showed significantly less postoperative pain at postoperative 5 h, and 9 a.m. and 5 p.m. at 4th postoperative day (P < 0.001, = 0.040, and 0.013, respectively). MMA also shortened the time for postoperative pain to reduce down to the blood draw pain level from 5 days in the control group to 2 days in the MMA group. MMA also significantly reduced PCA consumption for up to 24 h postoperatively (P = 0.038) and rescue morphine consumption during the first 6 h and between 48 and 60 h postoperatively (P = 0.036 and 0.044, respectively). No significant differences were observed between the MMA and control groups with respect to side effects.

Conclusion

The MMA protocol used in this study was found to reduce postoperative pain and opioid consumption during the acute postoperative period after arthroscopic rotator cuff repair without increasing side effects after arthroscopic rotator cuff repair.  相似文献   

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OBJECTIVE: To determine whether the use of prophylactic antibiotics is effective in the prevention of postoperative wound infection after Lichtenstein open mesh inguinal hernia repair. SUMMARY BACKGROUND DATA: A recent Cochrane meta-analysis (2003) concluded that "antibiotic prophylaxis for elective inguinal hernia repair cannot be firmly recommended or discarded." METHODS: Patients with a primary inguinal hernia scheduled for Lichtenstein repair were randomized to a preoperative single dose of 1.5 g intravenous cephalosporin or a placebo. Patients with recurrent hernias, immunosuppressive diseases, or allergies for the given antibiotic were excluded. Infection was defined using the Centers for Disease Control and Prevention criteria. RESULTS: We included 1040 patients in the study between November 1998 and May 2003. According to the intention-to-treat principle, 1008 patients were analyzed. There were 8 infections (1.6%) in the antibiotic prophylaxis group and 9 (1.8%) in the placebo group (P = 0.82). There was 1 deep infection in the antibiotic prophylaxis group and 2 in the placebo group (P = 0.57). Statistical analysis showed an absolute risk reduction of 0.19% (95% confidence interval, -1.78%-1.40%) and a number needed to treat of 520 for the total number of infections. For deep infection, the absolute risk reduction is 0.20% (95% confidence interval, -0.87%-0.48%) with a number needed to treat of 508. CONCLUSIONS: A low percentage (1.7%) of wound infection after Lichtenstein open mesh inguinal (primary) hernia repair was found, and there was no difference between the antibiotic prophylaxis or placebo group. The results show that, in Lichtenstein inguinal primary hernia repair, antibiotic prophylaxis is not indicated in low-risk patients.  相似文献   

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HYPOTHESIS: The addition of molgramostim (recombinant human granulocyte-macrophage colony-stimulating factor) to antibiotic therapy for nontraumatic and generalized abdominal sepsis is effective and has a significant impact on length of hospitalization, direct medical costs, and mortality. DESIGN: Randomized, double-blind, placebo-controlled clinical trial. SETTING: Tertiary referral center. PATIENTS: Fifty-eight patients with abdominal sepsis. INTERVENTIONS: Patients were allocated to receive, in addition to ceftriaxone sodium, amikacin sulfate, and metronidazole, molgramostim in a daily dosage of 3 microg/kg for 4 days (group 1) or placebo (group 2). Antibiotics were administered for at least 5 days and discontinued after clinical improvement had occurred and white blood cell count had been normal for 48 hours. MAIN OUTCOME MEASURES: Time to improvement, duration of antibiotic therapy, hospital stay, complications, mortality, and adverse reactions to drugs. RESULTS: Median time to improvement was 2 days in group 1 and 4 days in group 2 (P<.005). Median length of hospitalization was 9 and 13 days, respectively (P<.001), and median duration of antibiotic therapy was 9 and 13 days, respectively (P<.001). Numbers of infectious complications in the 2 groups were, respectively, 6 and 16 (P = .02); of residual abscesses, 3 and 5; and of deaths, 2 and 2. Costs per patient were 12,333 dollars and 16,081 dollars (US dollars), respectively. CONCLUSION: Addition of molgramostim to antibiotic therapy reduces the rate of infectious complications, the length of hospitalization, and costs in patients with nontraumatic abdominal sepsis.  相似文献   

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