营养不良的胃肠道肿瘤患者术后营养支持的随机对照研究

目的评价术后营养支持对营养不良的胃肠道肿瘤患者预后的影响。方法646例营养不良的胃肠道肿瘤患者随机分为肠外营养组(215例)和肠内营养组(215例)及对照组(216例),术后营养支持7d,采用等热卡[125.5kJ(30kcal)·kg-1·d-1]和等氮(0.25g·kg-1·d-1);对照组术后常规补液直至恢复正常饮食。观察比较术后死亡率、并发症发生率及住院时间。结果入选的3组患者资料具有可比性。术后总死亡率为1.5%,3组间差异无统计学意义。术后并发症发生率:肠外营养组33.5%(72例),肠内营养组28.4%(61例),对照组44.9%(97例);对照组与肠外营养组比较,P=0.001;与肠内营养组比较,P=0.000。肠内营养组感染性并发症发生率10.2%,明显低于肠外营养组的15.3%,P=0.002;而两组非感染性并发症发生率差异无统计学意义(21.9%vs.23.7%,P=0.06)。住院时间:肠外营养组(11.2±5.0)d,肠内营养组(9.8±3.4)d,对照组(14.5±7.1)d;肠内营养组住院时间短于肠外营养组,P=0.002;对照组与肠外营养组比较,P=0.003;与肠内营养组比较,P=0.001。结论术后营养支持可改善营养不良的胃肠道肿瘤患者的预后,术后早期肠内营养较肠外营养能降低术后感染性并发症发生率,并缩短住院时间。     

Digital versus analogue preoperative planning of total hip arthroplasties: a randomized clinical trial of 210 total hip arthroplasties

The objective of this randomized clinical trial was to compare the clinical and technical results of digital preoperative planning for primary total hip arthroplasties with analogue planning. Two hundred and ten total hip arthroplasties were randomized. All plans were constructed on standardized radiographs by the surgeon who performed the arthroplasty the next day. The main outcome was accuracy of the preoperative plan. Secondary outcomes were operation time and a radiographic assessment of the arthroplasty. Digital preoperative plans were more accurate in planning the cup (P < .05) and scored higher on the postoperative radiologic assessment of cemented cup (P = .03) and stem (P < .01) components. None of the other comparisons reached statistical significance. We conclude that digital plans slightly outperform analogue plans.     

Seton or glue for trans‐sphincteric anal fistulae: a prospective randomized crossover clinical trial

Objective Fibrin glue treatment of anal fistulae has been proposed to minimize the risk of faecal incontinence but its acceptance by coloproctologists is still poor because the published data is controversial. Therefore, we carried out a prospective randomized crossover trial comparing treatment with a commercial fibrin glue to classical seton treatment, with healing rate, hospital stay, healing time, faecal incontinence and postoperative pain as study outcomes. Method Sixty‐four homogeneous patients with trans‐sphincteric anal fistulae referred to seven colorectal units were randomized to undergo fibrin glue (39 patients) or seton (25 patients) treatment. Patients failing to heal after treatment with fibrin glue were re‐randomized to undergo a second injection with glue or seton treatment. Results Sixty‐two of the 64 patients completed the minimum 1‐year follow‐up period. Twenty‐one of 24 patients healed in the seton group compared with 15/38 in the fibrin glue group (P = 0.0007). The 23 failures after glue treatment were re‐randomized to have a second glue injection (eight patients) or a seton treatment (15 patients). Four of the eight (50%) patients treated with a second injection of glue, and nine out of the 15 (60%) patients in the seton group, healed. Patients treated with fibrin glue reported less postoperative pain and had a shorter hospital stay than patients treated with a seton; furthermore, faecal continence and anal manometry significantly worsened after seton treatment. Conclusion Seton treatment has a significantly higher probability of success compared with fibrin glue treatment but poses a higher risk of faecal incontinence. Fibrin glue could be considered as a first line of treatment for patients at risk of faecal incontinence or other comorbidities.     

A double-blind, prospective, randomized controlled trial comparing highly cross-linked and conventional polyethylene in primary total hip arthroplasty

Highly cross-linked polyethylene was developed to reduce articular bearing wear in total hip arthroplasty. In vitro studies have shown reduced wear in comparison with conventional polyethylene. A double-blind, prospective, randomized trial was performed comparing highly cross-linked and conventional polyethylene in 119 patients. The primary outcome variables were linear, 3-dimensional, and volumetric wear as determined by analysis of digitized radiographs using validated wear measurement software. Linear, 3-dimensional, and volumetric wear rates were significantly less in the highly cross-linked polyethylene group between 6 months and 4 years postoperatively (P < .05). The data presented here show that highly cross-linked polyethylene reduces short-term polyethylene wear. The intermediate and long-term clinical results of highly cross-linked polyethylene remain unknown pending further follow-up.     

Efficacy of antibiotic prophylaxis in patients undergoing cystoscopy: a randomized clinical trial

Objective

To establish the efficacy of antibiotic prophylaxis prior to cystoscopy in outpatients in decreasing the incidence of post-procedure urinary tract infection.

Study design and setting

A randomized clinical trial in patients (men and women) older than 18 who underwent cystoscopy for any non-urgent indication. The intervention was Levofloxacin 500 mg single dose, and the control was placebo 500 mg single dose made with similar characteristics. The primary outcome was urinary tract infection (UTI) measured 3–10 days after the procedure. It was performed as per protocol analysis.

Results

Hundred and thirty-eight patients in each study arm completed the trial. The incidence of UTI in the intervention group was 0.7 % and in the placebo group was 3 % (p = 0.17), and no significant differences were found. The incidence of asymptomatic bacteriuria in the intervention group was 5.8 % and in the control group was 14.5 % (p = 0.01).

Conclusions

No significant differences were found in the use of prophylactic antibiotic compared to placebo to reduce the incidence of UTI in patients who undergo cystoscopy as an outpatient procedure with sterile urine demonstrated by urine culture.     

A randomized trial of hydroxyapatite-coated femoral stems in total hip arthroplasty: a 13-year follow-up

A prospective randomized trial comparing hydroxyapatite (HA)-coated and non-HA-coated femoral total hip arthroplasty components was conducted. Sixty-one consecutive patients undergoing primary hip arthroplasty were randomized to receive an identical femoral component with or without HA. Forty-eight hips were available for review at an average of 13 years and 5 months after surgery. The only femoral stem revised was secondary to femoral fracture after mitral valve area. All femoral stems were well fixed on x-ray with no evidence of loosening. There was no statistically significant difference in the revision rates or in the Harris hip score between the HA vs non-HA-coated groups. This study suggests there is no clinical advantage to the use of a hydroxyapatite coating on the femoral component of this design for primary total hip arthroplasty.     

COLOR: a randomized clinical trial comparing laparoscopic and open resection for colon cancer

BACKGROUND: Laparoscopic surgery has proven to be safe and effective. However, the value of laparoscopic resection for malignancy in terms of cancer outcome can only be assessed by large prospective randomized clinical trials with sufficient follow-up. METHODS: COLOR (COlon carcinoma Laparoscopic or Open Resection) is a European multicenter randomized trial that began in 1997. In 27 hospitals in Sweden, The Netherlands, Germany, France, Italy, Spain, and the United Kingdom, 1200 patients will be included. The primary endpoint of the study is cancer-free survival after 3 years. RESULTS: In <3.5 YEARS, >850 patients have been randomized for right hemicolectomy (47%), left hemicolectomy (11%), and sigmoidectomy (42%). Fifty seven patients were excluded after randomization. Forty six months after the start of the trial, the overall recurrence rate is 6.8%. The distribution of stage of disease is as follows: stage I, 25%; stage II, 41%; stage III, 32%; stage IV, 2%. CONCLUSION: Although laparoscopic surgery appears to be of value in the treatment of colorectal cancer, the final, results of randomized trials need to be considered to determine its definitive role. Given the current accrual rate, the COLOR study will be completed in 2002.     

Favorable clinical responses in subsets of patients from a randomized,multi-institutional melanoma vaccine trial

Background: A phase III, randomized, double-blind, multi-institutional trial was performed evaluating active specific immunotherapy using vaccinia melanoma oncolysate (VMO) in the surgical adjuvant setting in patients with stage II melanoma (UICC staging). The first interim analysis showed no significant difference in disease-free and overall survival. The data were further analyzed to identify subsets of patients with improved outcome when treated with VMO. Methods: Patients received either VMO or placebo of live vaccinia vaccine virus (V), once a week for 13 weeks and then once every 2 weeks for an additional 39 weeks or until recurrence. Having stratified patients according to sex, age, number of positive nodes, tumor thickness, and clinical stage, data were analyzed for disease-free survival and overall survival. Results: Male patients showed a 17% difference in overall survival at 4 years when treated with VMO (p=0.19). A subset of male patients <57 years of age with one to five positive nodes showed a 30% difference at 4 years with VMO (p=0.06). Patients with clinical stage I but pathological stage II disease (both male and female), who had undergone prophylactic node dissection, showed a 23% difference in survival at 3 years with VMO (p=0.11). Conclusions: This subset analysis shows encouraging survival benefit in certain subsets of patients and an increasing trend in overall survival. Further follow-up of this phase III trial from a second interim analysis will be forthcoming.Results of this study were presented at the 48th Annual Cancer Symposium of The Society of Surgical Oncology, Boston, Massachusetts, March 23–26, 1995.     

Randomized clinical trial of multimodal optimization of surgical care in patients undergoing major colonic resection

BACKGROUND: The aim of this trial was to compare multimodal optimization with conventional perioperative management in a consecutive series of patients undergoing a wide range of colorectal procedures. METHODS: Thirty-nine patients undergoing major elective colonic resection were recruited prospectively. Patients were randomized to receive a ten-point multimodal optimization package or conventional perioperative care. All patients were administered epidural analgesia and opiates were avoided. Outcome measures recorded related to length of hospital stay, physical and mental function, and gut function. RESULTS: Optimization was associated with a significantly shorter median (interquartile range) hospital stay compared with conventional care (5 (4-9) versus 7.5 (6-10) days; P = 0.027). Duration of catheterization (P = 0.022) and duration of intravenous infusion (P = 0.007) were also less. Optimization was associated with a quicker recovery of gut function (P = 0.042). Grip strength was maintained in the postoperative period in the optimized group (P = 0.241) but not in the control group (P = 0.049). There were no differences in morbidity or mortality between the groups. CONCLUSION: Optimization is safe and results in a significant reduction in postoperative stay along with other improved endpoints. This cannot be directly attributed to improvement in any single outcome measure or to the use of epidural analgesia. Improvements are more likely to be multifactorial and may relate to an earlier return of gut function.     

Five-year follow-up of total disc replacement compared to fusion: a randomized controlled trial

Purpose

To evaluate long-term clinical results of lumbar total disc replacement (TDR) compared with posterior lumbar fusion.

Methods

This prospective randomized controlled trial comprised 152 patients; 80 were randomized to TDR and 72 to fusion. All patients had chronic low back pain (CLBP) and had not responded to nonsurgical treatment. Primary outcome measure was global assessment of back pain (GA), secondary outcome measures were back and leg pain, Oswestry Disability Index (ODI), EQ5D, and SF-36. All measures were collected from SweSpine (Swedish national register for spinal surgery) at 1, 2, and 5 years. Follow-up rate at 5 years was 99.3 %.

Results

Both groups showed clinical improvement at 5-year follow-up. For GA, 38 % (30/80) in the TDR group were totally pain free vs. 15 % (11/71) in the fusion group (p < 0.003). Back pain and improvement of back pain were better in the TDR group: VAS back pain at 5 years 23 ± 29 vs. 31 ± 27, p = 0.009, and VAS improvement of back pain at 5 years 40 ± 32 vs. 28 ± 32, p = 0.022. ODI and improvement in ODI were also better in the TDR group: ODI at 5 years 17 ± 19 vs. 23 + 17, p = 0.02 and ODI improvement at 5 years 25 ± 18 vs. 18 ± 19 (p = 0.02). There was no difference in complications and reoperations between the two groups.

Conclusions

Global assessment of low back pain differed between the two surgical groups at all follow-up occasions. Significant differences between groups concerning back pain, pain improvement, and ODI were present at 1 year and disappeared at 2 years, but reappeared at the 5-year follow-up.     

A randomized, controlled trial of aprotinin in neonates undergoing open-heart surgery

Background:  Neonates undergoing open-heart surgery are especially at risk for massive bleeding and pronounced inflammation. The efficacy of aprotinin, a serine protease inhibitor, at ameliorating these adverse effects of cardiopulmonary bypass has not been clearly demonstrated in neonates.
Methods:  Term neonates were enrolled and randomly assigned in a blinded fashion to receive saline (group P, placebo) or high-dose aprotinin (group A). Intraoperative management was standardized: surgeon, anesthesia, cardiopulmonary bypass and hemostasis therapy. Patients were admitted postoperatively to a pediatric cardiac intensive care unit. Primary outcome measure of efficacy was duration of the postoperative mechanical ventilation. Secondary outcome measures were total volume and units of blood products transfused intraoperatively and for 24 h after surgery, duration of chest tube in situ , and intensive care and hospital stays after surgery.
Results:  Twenty-six neonates were enrolled; 13 received aprotinin and 13 received placebo. The study was halted prematurely because of US Food and Drug Administation's concerns about aprotinin's safety. Baseline patient, surgery and cardiopulmonary bypass characteristics were similar between groups. No outcome variables differed between groups ( P  > 0.05). Duration of postoperative ventilation was 115 ± 139 h (group A); 126 ± 82 h (group P); P  = 0.29, and total blood product exposure was 8.2 ± 2.6 U (group A); 8.8 ± 1.4 U (group P); P  = 0.1. Postoperative blood creatinine values did not differ between groups. In-hospital mortality rate was 4%.
Conclusions:  Aprotinin was not shown to be efficacious in neonates undergoing open-heart surgery. It is unclear whether adult aprotinin safety data are relevant to neonates undergoing open-heart surgery.     

Magnetic resonance imaging features of preserved vs divided and repaired piriformis during total hip arthroplasty: a randomized controlled trial

The aim of this study was to compare the muscle grade and bulk of the divided and repaired piriformis tendon by the standard posterior approach with the preserved tendon by a piriformis-sparing (PS) approach, in total hip arthroplasty. Twenty-two patients were randomized to either approach. Patients received preoperative and 3 months and 2 years postoperative magnetic resonance imaging scans. Patients and evaluators were blinded to allocation. There was significantly less deterioration in piriformis muscle grade (P = .029) and bulk (P = .015) in the PS group at 3 months. At 2 years, only the difference in grade remained significant (P = .001). There was no difference in Oxford hip scores. In conclusion, a PS approach avoids the marked wasting and deterioration in muscle grade that occurs postoperatively in the standard posterior approach.     

Mannitol and dopamine in patients undergoing cardiopulmonary bypass: a randomized clinical trial

In this prospective, randomized, placebo-controlled, double-blinded study, we determined the effects of two commonly used adjuncts, mannitol and dopamine, on beta(2)-microglobulin (beta(2)M) excretion rates in patients undergoing coronary artery bypass graft surgery with cardiopulmonary bypass (CPB). beta(2)M excretion rate has been described as a sensitive marker of proximal renal tubular function. One-hundred patients with a preoperative serum creatinine level 相似文献   

Epidural infusion of bupivacaine and fentanyl reduces perioperative myocardial ischaemia in elderly patients with hip fracture--a randomized controlled trial

BACKGROUND: Perioperative myocardial ischaemia is an important risk factor for cardiac morbidity and mortality after noncardiac surgery. The impact of analgesic management on the incidence and severity of cardiac ischemia was studied in 77 elderly patients undergoing surgical treatment of traumatic hip fracture. METHODS: After hospital admission and written consent, patients were randomised to conventional analgesic regimen (intramuscular oxycodone, OPI group) or continuous epidural infusion of bupivacaine/fentanyl (EPI group). The analgesic regimens were started preoperatively. Patients were operated under spinal anaesthesia and the treatments were continued three days postoperatively. ECG was continuously recorded. ST segment depression of > or = 0.1 mV or elevation of > or = 0.2 mV lasting > or = 1 min were considered as ischaemic episodes. Nocturnal arterial oxygen saturation (SaO2) was recorded perioperatively, and subjective pain was assessed every morning using a visual analogue scale (VAS). RESULTS: Fifty-nine (OPI 30, EPI 29) patients were evaluable for efficacy. Thirteen patients (43%) in the OPI and 12 patients (41%) in the EPI group had ischaemic episodes (NS). However, significantly more patients in the OPI group had ischaemic episodes during the surgery (8 vs. 0 in the EPI group, P=0.005). The median (quartal deviation) total ischaemic burden (i.e. integral of ST-change vs. time) in patients with ischaemic episodes was ten times larger in the OPI group (340 [342] mm x min) compared with the EPI group (30 [36] mm x min) (P=0.002). There were no significant differences between the groups in average heart rates or in heart rates at the start of ischaemic episodes or in maximal heart rates during the attacks. Average nocturnal SaO2 was similar in the two groups and there were no differences in the number of hypoxaemic (SaO2<90%) episodes. Preoperatively there were no differences in subjective pain, but postoperative and average perioperative VAS scores for pain were almost 40% lower in the EPI group (P=0.006). Perioperative myocardial infarctions were not detected. CONCLUSIONS: Continuous epidural bupivacaine/fentanyl analgesic regimen, started preoperatively, reduces the amount of myocardial ischaemia in elderly patients with hip fracture.     

Comparison of the prophylactic antithrombotic effect of indobufen and warfarin in patients with nephrotic syndrome: a randomized controlled trial

PurposeThe risk of thromboembolic events is elevated in patients with nephrotic syndrome, and warfarin use has been associated with an increased risk of bleeding. Indobufen, a selective cyclooxygenase-1 inhibitor, is currently being evaluated for the prevention of thromboembolic events in nephrotic syndrome. This study aimed to compare the efficacy and safety of indobufen with that of warfarin in patients with nephrotic syndrome.Materials and methodsThis multicenter, randomized, three-arm, open-label, parallel controlled trial involved a total of 180 adult patients with nephrotic syndrome from four centers in China. Patients were randomly assigned to receive 100 mg indobufen (bid), 200 mg indobufen (bid), and 3 mg warfarin (qd) daily for 12 weeks. The primary endpoints included thromboembolic and bleeding events, while laboratory results and adverse events constituted secondary endpoints.ResultsNo thromboembolic events occurred in the high-/low-dose indobufen and warfarin groups. Moreover, the use of a low dose of indobufen significantly reduced the risk of minor bleeding events compared with warfarin use (2% versus 18%, p < .05). Finally, adverse events were more frequent in warfarin-treated patients.ConclusionsThis study found that indobufen therapy provided equivalent effects in preventing thromboembolic events compared with warfarin therapy, while low dose of indobufen was associated with a reduced risk of bleeding events, thus it should be recommended for the prevention of thromboembolic events in clinical practice in patients with nephrotic syndrome.Trial registration numberChiCTR-IPR-17013428.     

加速康复外科理念在肝胆管结石手术治疗中应用的前瞻性随机对照研究

目的探讨加速康复外科(enhanced recovery after surgery,ERAS)理念应用于肝胆管结石手术治疗的安全性与有效性。方法将2014年1月至2015年10月来我院肝胆科行开腹手术治疗的肝胆管结石患者80例随机分为两组:ERAS组40例,应用ERAS理念进行围手术期处理;对照组40例,按传统方法进行围手术期处理。比较两组患者术后疼痛评分、首次下床活动时间、恢复肛门排气时间、住院天数、住院费用及两组术后并发症发生情况等。结果共73例患者完成试验,其中ERAS组36例,对照组37例。ERAS组患者术后疼痛评分、首次下床活动时间、恢复肛门排气时间、住院天数、住院费用均明显优于对照组(P0.05);术后并发症两组无统计学差异(P0.05)。结论 ERAS理念应用于肝胆管结石手术患者安全、有效,可加速患者的康复。     

谷氨酰胺增强型肠内营养对危重病患者临床结局的影响:随机对照试验的系统评价

目的 系统评价谷氨酰胺(Gln)增强型肠内营养治疗对危重病患者预后及治疗费用的影响.方法 检索8个生物医学数据库(<中国生物医学文献数据库>、、<科学引文索引数据库>等)1976年以后的文献资料.鉴定随机对照试验(RCT),纳人研究的标准包括:(1)采用随机对照的临床研究,设立平行对照;(2)危重病患者,急性生理与慢性健康评估评分Ⅱ大于10分或烧伤面积大于30%TBSA者;(3)以肠内营养中是否添加Gln作为研究组与对照组的惟一差别;(4)临床结局指标包括患者死亡、院内感染、器官功能衰竭发生情况、住院日及费用.研究方法学质量按照Cochrane系统评价员手册及Jadad评分量表进行评定.用Rev Man 5.0软件进行Meta分析.结果 224篇相关文献中,共7项RCT符合全部纳入标准.死亡情况:共5项研究报告了545例患者中的死亡例数,研究间无异质性(P=0.46),合并相对危险度(RR)为0.94,95%置信区间(CI)为0.68～1.30,P=0.70.Gln组死亡风险与对照组比较,差异无统计学意义(P>0.05).院内感染:共3项研究报告了489例患者中的院内感染发生情况.研究间无异质性(P=0.08),采用固定效应模型,合并RR=0.72,95%CI为0.52～0.99,P=0.04.与对照组比较,Gln组院内感染率下降了28%.器官功能衰竭:共3项研究报告了460例患者中发生器官功能衰竭或MODS的情况,研究间无异质性(P=0.65),采用固定效应模型,合并RR=1.27,95%CI为0.70～2.30,P=0.43.Gln组与对照组比较,差异无统计学意义(P>0.05).住院时间:4项研究报告了患者入住重症监护病房(ICU)的时间,其中3项研究以中位数(四分位间距)形式表示结果,2组患者比较差异无统计学意义(P>0.05);另1项研究给出了2组患者入住ICU时间的x±s,差异亦无统计学意义(P>0.05).此外,有3项关于重症烧伤患者的研究给出了住院时间,研究间无异质性(P=0.08),采用固定效应模型,合并均数差值为-7.24,95%CI为-13.28～-1.19,P=0.02.与对照组比较,Gln组住院时间约缩短7.24 d.结论 Gln增强型肠内营养用于危重病患者,可以降低院内感染的发生率,有可能缩短重症烧伤患者住院时间,但病死率及经济学指标尚需进行更多大样本研究进一步验证.