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1.
OBJECTIVES: To evaluate the role of pentoxifylline as an adjuvant to operation and routine antibiotic treatment for perforated peritonitis. DESIGN: Randomised controlled clinical trial. SETTINGS: University hospital, India. SUBJECTS: 36 patients with clinically diagnosed and radiologically confirmed perforated peritonitis. 22 (61%) had typhoid enteric perforations, 11 (31%) had duodenal ulcer perforations while 3 (8%) had perforated gastric ulcers. INTERVENTION: Laparotomy with closure of perforation and lavage together with routine antibiotic treatment (ciprofloxacin and metronidazole), and random allocation to pentoxifylline 200 mg/day for 3 days in 500 ml of saline over 3-4 hours or saline alone (n = 18 in each group). MAIN OUTCOME MEASURES: Hospital stay, APACHE II scores, and the condition of the wound during the postoperative period. RESULTS: The baseline characteristics of the two groups were essentially similar. However, their preoperative APACHE II scores differed significantly (mean (SD) 12 (3) in the pentoxifylline group compared with 10 (2) in the saline group; p <0.01). The outcome was better in the pentoxifylline group in terms of significantly reduced hospital stay (median 8, range 6-17, compared with 11, 7-27, p=0.02) improved postoperative APACHE II scores (mean (SD) 8 (2) compared with 9 (2), p=0.02), and reduced incidence of wound infection (6/18 compared with 12/18, p=0.02). CONCLUSION: The addition of pentoxifylline to our standard management protocol for patients with perforated peritonitis helped to improve their outcome significantly compared with a placebo-treated group.  相似文献   

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Recombinant human Bone Morphogenetic Protein-2 (rhBMP-2) can replace autogenous bone grafting in single-level lumbar interbody fusion. Its use is associated with a higher initial price for the intervention; 2,970€ in Germany, 2,950€ in France and 2,266€ (£1,790) in UK. The aim of this study was to calculate the financial impact of rhBMP-2 treatment in Germany, UK and France from a societal perspective with a two-year time horizon. Based on clinical findings of a previously published study with a pooled data analysis, a health economic model was developed to estimate potential cost savings derived from reduced surgery time and secondary treatment costs, and faster return-to-work time associated with rhBMP-2 use compared with autogenous bone grafting. Country-specific costs are reported in 2008 Euros. From a societal perspective, overall savings from the use of rhBMP-2 in ALIF surgery compared with autograft are 8,483€, 9,191€ and 8,783€ per case for Germany, France and UK, respectively. In all the three countries savings offset the upfront price for rhBMP-2. The savings are mainly achieved by reduced productivity loss due to faster return-to-work time for patients treated with rhBMP-2. Use of rhBMP-2 in anterior lumbar fusion is a net cost-saving treatment from a societal perspective for Germany, France and UK. Improved clinical outcome for the patient combined with better health-economic outcome for the society support rhBMP-2 as a valuable alternative compared with autograft. V. Alt and A. Chhabra contributed equally to this work.  相似文献   

4.
Introduction Osteoporotic fractures in older people are a major and increasing public health problem. We examined the effect of vitamin D supplementation on fracture rate in people living in sheltered accommodation. Methods In a pragmatic double blind randomised controlled trial of 3 years duration, we examined 3,440 people (2,624 women and 816 men) living in residential or care home. We used four-monthly oral supplementation using 100,000 IU vitamin D2 (ergocalciferol). As a main outcome measure, we used the incidence of first fracture using an intention to treat analysis. This was a multicentre study in 314 care homes or sheltered accommodation complexes in South Wales, UK. Results The vitamin D and placebo groups had similar baseline characteristics. In intention-to-treat analysis, 205 first fractures occurred in the intervention group during a total of 2,846 person years of follow-up (7 fractures per 100 people per year of follow-up), with 218 first fractures in the control group over 2,860 person years of follow-up. The hazard ratio of 0.95 (95% confidence interval 0.79–1.15) for intervention compared to control was not statistically significant. Conclusion Supplementation with four-monthly 100,000 IU of oral vitamin D2 is not sufficient to affect fracture incidence among older people living in institutional care.  相似文献   

5.

Background  

Clinical practice guidelines recommend that the initial treatment of acute low back pain (LBP) should consist of advice to stay active and regular simple analgesics such as paracetamol 4 g daily. Despite this recommendation in all international LBP guidelines there are no placebo controlled trials assessing the efficacy of paracetamol for LBP at any dose or dose regimen. This study aims to determine whether 4 g of paracetamol daily (in divided doses) results in a more rapid recovery from acute LBP than placebo. A secondary aim is to determine if ingesting paracetamol in a time-contingent manner is more effective than paracetamol taken when required (PRN) for recovery from acute LBP.  相似文献   

6.
BACKGROUND: Chronic cough that persists despite medical treatment may respond to speech pathology intervention, but the efficacy of such treatment has not been investigated in prospective randomised trials. The aim of this study was to determine the efficacy of a speech pathology intervention programme for chronic cough. METHODS: A single blind, randomised, placebo controlled trial was conducted in 87 patients with chronic cough that persisted despite medical treatment. Patients were randomly allocated to receive either a specifically designed speech pathology intervention or a placebo intervention. Participants in both groups attended four intervention sessions with a qualified speech pathologist. RESULTS: Participants in the treatment group had a significant reduction in cough (8.9 to 4.6, p<0.001), breathing (7.9 to 4.7, p<0.001), voice (7.3 to 4.6, p<0.001) upper airway (8.9 to 5.9, p<0.001) symptom scores and limitation (2.3 to 1.6, p<0.001) ratings following intervention. There was also a significant reduction in breathing (6.8 to 5.6, p = 0.047), cough (7.6 to 6.3, p = 0.014), and limitation (2.3 to 2.0, p = 0.038) scores in the placebo group, but the degree of improvement was significantly less than in the treatment group (p<0.01). Clinical judgement of outcome indicated successful ratings in 88% of participants in the treatment group compared with 14% in the placebo group (p<0.001). CONCLUSION: Speech pathology is an effective management intervention for chronic cough which may be a viable alternative for patients who do not respond to medical treatment.  相似文献   

7.

Background context

Retrograde ejaculation (RE) is a complication of anterior lumbar interbody fusion (ALIF) techniques. Most commonly, this results from mechanical or inflammatory injury to the superior hypogastric plexus near the aortic bifurcation. Bone morphogenetic protein-2 (BMP-2) has been used in spinal fusions and has been associated with inflammatory and neuroinflammatory adverse reactions, which may contribute to RE development after anterior lumbar surgery.

Purpose

While controlling for anterior approach technique, we compared the incidence of RE with and without rhBMP-2 exposure, in large, matched cohorts of patients after ALIF.

Study design

Retrospective analysis of 10 years of prospectively gathered outcomes data on consecutive-patient cohorts having the same anterior exposure technique for ALIF with and without rhBMP-2 use.

Patient sample

All male patients without baseline sexual incapacity and having ALIF for lumbar spondylosis or spondylolisthesis of the lowest one or two lumbar levels with and without rhBMP-2, from 2002 through 2011.

Outcome measures

Diagnosis of RE as a new finding after ALIF compared against BMP-2 exposure, comorbid conditions, and other urological complications after ALIF surgery.

Methods

From the comprehensive surgical database at a high volume, university practice, male subjects having ALIF at one (L5/S1) or two levels (L4/5, L5/S1) from 2002 to 2011 were identified. Baseline comorbid factors, postoperative urinary catheter/retention events, and RE events were recorded and comparative incidence compared.

Results

There were four consecutive-patient cohorts identified: one before rhBMP-2 use was adopted (n=174), two cohorts in which BMP-2 use was routine (n=88 and n=151), and one final cohort after BMP-2 use was discontinued from routine use (n=59). The cohorts with and without BMP-2 exposure were closely comparable for age, approach, levels of surgery, comorbid factors affecting RE. Of 239 patients with ALIF and exposure to BMP-2, RE was diagnosed in 15 subjects (6.3%), compared with an RE diagnosis rate of two of 233 control patients without BMP-2 exposure (0.9%; p=.0012). Urinary retention after bladder catheter removal was also more frequently observed in patients exposed to BMP-2 (9.7%) compared with control patients (4.6%; p=.043). Of the baseline comorbid factors, medical or surgical treatment for prostatic hypertrophy disease was associated with an increased risk of RE in the BMP-2 patients (p=.034).

Conclusions

This study confirms previous reports of a higher rate of RE in ALIF procedures using rhBMP-2 and an open anterior approach to the spine. This effect may be associated with an increased risk of postoperative urinary retention after BMP-2 exposure. The magnitude of the RE effect may be increased with concomitant prostatic disease treatments.  相似文献   

8.
Complications in fracture repair that lead to a delay in union remain clinically problematic. We believe that unwanted pre-mature catabolism of the healing callus, for example, in stress shielded situations, diminishes the rate at which strength is restored in bone repair and possibly leads to delayed union. We hypothesized that a single systemic dose of a nitrogen-containing bisphosphonate (N-BP) would increase bone mineral content (BMC), volume, and mechanical strength of union in fracture repair. We also set out to investigate local delivery to assess whether systemic exposure could be eliminated, due to concerns of bisphosphonate dosing of non-target organs. After an open osteotomy fixed with a K wire, 40 12-week old Wistar male rats were divided into four groups of 10: saline control, bolus systemic subcutaneous injection of pamidronate (3 mg/kg), local low dose of pamidronate (0.1 mg), and a local high dose of pamidronate (1.0 mg). Rats were sacrificed 6 weeks post-operatively. Operated and non-operated femora underwent radiographic evaluation, quantitative computer tomography, and biomechanical testing in torsion. The growth plates and metaphyses of the tibia of the non-operated side were assessed for evidence of systemic exposure in the local groups. Significant increases in callus BMC and volume of the bolus systemic dose group were found compared to the saline control (p< or =0.05). Further, the strength of the systemic dose callus was increased by 60% from 0.35 Nm (+/-0.11) for the saline control callus to 0.56 Nm (+/-0.25) for the systemic group (p=0.05). Local treatment did not result in increased strength. The contralateral tibial growth plates of the local groups showed evidence of systemic exposure by the presence of retained primary spongiosa. This study confirms that a single perioperative systemic dose of pamidronate leads to significant increases in the BMC, volume, and strength of healing fractures in rats, making single dose N-BP therapy an appealing candidate for further examination in fracture repair.  相似文献   

9.
携载rhBMP-2微球的新型复合人工骨的释药及成骨活性研究   总被引:7,自引:0,他引:7  
目的 制备一种具有良好降解性和成骨活性,可注射的自凝固新型骨修复材料。方法制备携载rhBMP-2的聚乳酸与聚乙醇酸共聚物(PLGA)微球,并将其与rhBMP-2/磷酸钙骨水泥(CPC)复合。制备出rhBMP-2/PLGA微球/CPC复合人工骨。测定了复合材料释药速度,将复合材料及rhBMP-2-CPC分别植入兔双侧股骨髁骨缺损区域,通过X线、组织学观察比较不同时期材料的降解及成骨情况。结果 复合材料各时间点的体外释药量均大于单纯rhBMP-2/CPC组.与单纯rhBMP-2/CPC材料相比较,复合材料植入体内后不同时间点材料的降解和新骨生成均高于单纯rhBMP-2/CPC植入组。结论 rhBMP-2/PLGA微球的掺入可明显加快rhBMP-2的释放。提高材料的降解速度和成骨活性。  相似文献   

10.
We carried out a randomised, prospective, multicentre clinical trial of the treatment of Colles' fractures. A total of 339 patients was placed into two groups, those with minimally displaced fractures not requiring manipulation (151 patients) and those with displaced fractures which needed manipulation (188 patients). Treatment was by either a conventional Colles' plaster cast (a control group) or with a prefabricated functional brace (the Aberdeen Colles' fracture brace). Similar results were obtained in both groups with regard to the reduction and to pain scores but the brace provided better grip strength in the early stages of treatment. This was statistically significant after five weeks for both manipulated and non-manipulated fractures. At the tenth day the results were statistically significant only in manipulated fractures. There was no significant difference in the functional outcome between the two treatment groups. However, younger patients and those with less initial displacement had better functional results.  相似文献   

11.
Forty patients undergoing day-case anaesthesia for surgical extraction of third molar teeth received either lysine acetylsalicylate 1.8 g in 10 ml of saline intravenously or a placebo injection of 10 ml of saline intravenously just prior to induction of anaesthesia. Lysine acetylsalicylate was associated with a significantly more satisfactory postoperative recovery overall. However, there was no significant difference in mean pain scores between the two treatment groups at 1, 6, 12 or 24 hours following administration. Both treatment groups self administered additional oral analgesics to the same extent during the first 24 hours following surgery.  相似文献   

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[目的]探讨rhBMP-2、bFGF双基因共转染兔骨髓间充质干细胞(bone marrow stem cells,BMSCs)复合nHA/RHLC/PLA支架及其体内异位成骨研究.[方法]构建携带rhBMP-2及bFGF基因片段的双基因表达载体prhBMP-2-IRES-bFGF并转染兔BMSCs,免疫细胞化学检测目的基因表达,进而与nHA/RHLC/PLA支架复合构建骨组织工程复合体.rhBMP-2及bFGF单独转染组、未干预BMSCs组设为对照.实时定量RT-PCR检测成骨相关基因(Ⅰ型胶原、骨连蛋白、骨桥蛋白)表达,扫描电镜观察细胞/材料复合情况.体外培养7 d后埋于自体股部肌袋,4周后取材,放射学及组织学方法检测成骨情况.[结果]转染后BMSCs的rhBMP-2及bFGF蛋白表达均呈阳性.复合材料后,其成骨相关基因表达明显高于rhBMP-2及bFGF单独转染组、未干预BMSCs组(P<0.05,n=3),放射学及组织学检测也证实其异位成骨明显.[结论]采用rhBMP-2及bFGF双基因转染技术能够有效促进BMSCs成骨分化,与新型材料nHA/RHLC/PLA支架复合所构建的骨组织工程复合体,体现出良好的体内外成骨活力,进一步研究将探讨其针对大段骨缺损的修复效能.  相似文献   

14.
BACKGROUND: Current British Thoracic Society guidelines do not recommend routinely the combined use of a benzodiazepine and opiate during flexible bronchoscopy (FB). A randomised, placebo controlled, double blind study was undertaken to determine whether hydrocodone in combination with midazolan improves cough suppression during FB without increasing the risk of desaturation. METHODS: 120 patients were randomised to receive midazolam and 5 mg i.v. hydrocodone or midazolam and placebo with topical anaesthesia. Pulse oximetry was recorded continuously during FB. Bronchoscopists and nurses charted their perception of cough and the patients rated their discomfort during the procedure on a 10 cm visual analogue scale (VAS). RESULTS: There was no significant difference between the two groups with regard to the indication for FB, duration of procedure (21 (11) min v 22 (10) min, p = 0.570), doses of supplemental lignocaine (171 (60) mg v 173 (66) mg, p = 0.766) and midazolam (4.5 (2.3) mg v 4.9 (2.7) mg, p = 0.309), lowest oxygen saturation (94.8 (2.7) v 94.9 (2.7), p = 0.433), and desaturations < or =90%. Perception of cough by both the bronchoscopist and the nurse was significantly lower in the hydrocodone group (3 (0-10) and 3 (0-10)) than in the placebo group (6 (0-10) and 6 (0-10)), respectively (p = 0.001). According to the VAS scale, patients' tolerance was also significantly better with hydrocodone than with placebo (2 (0-8) v 3 (0-9), p = 0.043). CONCLUSION: The combination of midazolam and hydrocodone markedly reduces cough during FB without causing significant desaturation, especially when invasive diagnostic procedures are performed.  相似文献   

15.
AIM: To report the 15-year follow-up of displaced intra-articular calcaneal fractures from a randomised controlled trial of conservative versus operative treatment published in 1993. PATIENTS AND METHODS: Of the initial study, 46 patients (82%) were still alive at a mean of 15 years post injury and 26 patients (57%) agreed to review. The patients had been randomly allocated to either conservative or operative treatment in the original study. Clinical [American orthopaedic foot and ankle society hindfoot scale (AOFAS), foot function index (FFI) and calcaneal fracture score] and radiological (B?hler's angle and calcaneum height) outcome measures were used. The grade of osteoarthritis was also assessed at long-term follow-up. RESULTS: At long-term follow-up, the clinical outcomes were not different between conservative versus operative treatment. AOFAS hindfoot scale: conservative=78.5 and operative=70, p=0.11; FFI: conservative=24.4 and operative=26.9, p=0.66; calcaneal fracture score: conservative=70.1 and operative=63.5, p=0.41. The radiological outcomes were also not different between both groups. B?hler's angle: conservative=10.4 degrees and operative 16.9 degrees , p=0.07; height of calcaneum: conservative=37.2mm and operative=38.2mm, p=0.57; grade of osteoarthritis of the sub-talar joint: p=0.54. There was no correlation between B?hler's angle and the outcome measures in either group. CONCLUSION: The results of this 15-year follow-up of displaced intra-articular calcaneal fracture randomised controlled trial were equivalent between conservative and operative treatment and demonstrate similar findings to those at one year follow-up.  相似文献   

16.

Background

Several randomised trials have been published on the effect of low-intensity pulsed ultrasound (LIPUS) on fracture healing in both distal radius and tibia fractures. Most studies showed a positive effect on time to clinical and radiological healing. We hypothesised that LIPUS has a beneficial effect on the healing of fresh clavicle fractures as well and studied its effect in non-operatively treated shaft fractures.

Methods

We conducted a randomised double blind, placebo-controlled multi-centre trial in 101 adult patients with a non-operatively treated fresh clavicle shaft fracture. Of these patients, 49 used a placebo transducer and 52 patients had an active transducer with ultrasound stimulation (Exogen 2000®). Data were analysed on intention to treat basis. Baseline parameters of both groups were not significantly different.

Results

There were no differences in time to subjective clinical fracture healing, resumption of daily activities, sports or professional work, Visual Analogue pain Scores (VAS) and use of pain medication.

Conclusion

Our findings did not confirm that LIPUS accelerates clinical healing time of fresh clavicle shaft fractures.

Level of evidence

Level 1 evidence that low-intensity pulsed ultrasound does not accelerate clinical fracture healing in non-operatively treated fresh midshaft clavicle fractures.  相似文献   

17.
The Royal Colleges, The Audit Commission, and politicians have encouraged day-case care for patients undergoing arthroscopic knee surgery. However, there remains both public and professional concern regarding the acceptability and safety of this form of management, although there are clear economic benefits. In a prospective randomised controlled trial, 50 patients underwent arthroscopic surgery as a day-case and 50 patients were admitted overnight. Outcome was assessed by postal questionnaire 4 weeks after discharge. A linear visual analogue scale was used to measure pain levels. The response rate was 93%. The diagnoses and types of arthroscopic surgery were similar in both groups. In total, 94% of day-cases and 91% of patients admitted overnight expressed overall satisfaction. Pain after discharge was similar in both groups. Day-case management was preferred by 90% of day-case patients and by 64% of those admitted overnight. Of patients in the day-case group, 12% had to be admitted overnight because of recovery problems, but 7% of patients randomised to overnight stay discharged themselves. One patient admitted overnight required readmission because of a wound haematoma. Patients who had received day-case management returned to work significantly faster than those who had been admitted. Modern anaesthetic techniques with special attention to anti-emesis and pain control have reduced postoperative morbidity to acceptable levels. Provided that patients are properly selected and well informed, day-case care is preferable for the majority of patients undergoing arthroscopic surgery of the knee.  相似文献   

18.
BackgroundBreech presentation occurs in up to 3% of pregnancies at term and may be an indication for caesarean delivery. External cephalic version can be effective in repositioning the fetus in a cephalic presentation, but may be painful for the mother. Our aim was to assess the efficacy of remifentanil versus placebo for pain relief during external cephalic version.MethodsA randomized, double-blind, controlled trial that included women at 36–41 weeks of gestation with non-cephalic presentations was performed. Women were randomized to receive either a remifentanil infusion at 0.1 μg/kg/min and demand boluses of 0.1 μg/kg, or saline placebo. The primary outcome was the numerical rating pain score (0–10) after external cephalic version.ResultsSixty women were recruited, 29 in the control group and 31 in the remifentanil group. There were significant differences in pain scores at the end of the procedure (control 6.5 ± 2.4 vs. remifentanil 4.7 ± 2.5, P = 0.005) but not 10 min later (P = 0.054). The overall success rate for external cephalic version was 49% with no significant differences between groups (remifentanil group 54.8% vs. control group 41.3%, P = 0.358). In the remifentanil group, there was one case of nausea and vomiting, one of drowsiness and three cases of fetal bradycardia. In the control group, there were three cases of nausea and vomiting, one of dizziness and nine cases of fetal bradycardia.ConclusionIntravenous remifentanil with bolus doses on demand during external cephalic version achieved a reduction in pain and increased maternal satisfaction. There were no additional adverse effects, and no difference in the success rate of external cephalic version or the incidence of fetal bradycardia.  相似文献   

19.
OBJECTIVE: To examine the role of radiography in screening trauma patients with suspected injury to the cervical spine. SUBJECTS AND METHODS: Over a period of 2 years, 5172 people were admitted to our trauma service and 297 (5.4%) were found to have cervical fractures. The radiographic and CT films and reports of 245 of these 297 patients were reviewed. RESULTS: The 245 subjects had sustained 309 distinct individual injuries. Radiography detected injuries in 108 cases (44.1%) and CT detected injuries in 243 cases (99.2%). The two fractures missed by CT occurred at C2; one fracture was obscured by dental artefacts and the other was in the horizontal plane of the scan. Both fractures were detected on lateral radiographs of the region. CONCLUSION: CT is superior to radiography for identification of cervical spine fractures. The fractures most likely to be missed by CT occur at C2. We recommend that CT be used as the primary screening method for people with suspected cervical injury, together with a single lateral view of the cervical spine to include the C2 region.  相似文献   

20.
This study evaluated the ability of recombinant human bone morphogenetic protein-2 (rhBMP-2) delivered in an injectable calcium phosphate carrier (alpha-BSM) to accelerate healing in a rabbit ulna osteotomy model compared to untreated surgical controls. Healing was assessed by radiography, histology and biomechanics. Bilateral mid-ulnar osteotomies were created in 16 skeletally mature rabbits. One limb in each animal was injected with either 0.1 mg rhBMP-2/alpha-BSM (BMP) (N=8) or buffer/alpha-BSM (BSM) (N=8). Contralateral osteotomies served as untreated surgical controls (SXCT). Gamma scintigraphy showed 75%, 45% and 5% of the initial 125I-rhBMP-2 dose was retained at the osteotomy site at 3 h, 1 week and 3 weeks. The biological activity of rhBMP-2 (alkaline phosphatase activity from bioassay) extracted from alpha-BSM incubated in vitro up to 30 days at 37 degrees C was unchanged. Radiographs demonstrated complete bridging of the BMP limbs at 4 weeks whereas none of the BSM or SXCT limbs were bridged. Post-mortem peripheral quantitative computed tomography determined mineralized callus area was 62% greater in BMP limbs compared to SXCT limbs. Torsional stiffness and strength were 63% and 103% greater in BMP limbs compared to SXCT limbs. There was no difference in torsional properties between BSM and SXCT limbs. Failure occurred outside the osteotomy in four out of seven of the BMP limbs. All BSM and SXCT limbs failed through the osteotomy. Histology showed bony bridging of the osteotomy and no residual carrier in the BMP limbs. BSM and SXCT groups showed less mature calluses composed of primarily fibrocartilaginous tissue and immature bone in the osteotomy gap. These data indicate rhBMP-2 delivered in alpha-BSM accelerated healing in a rabbit ulna osteotomy model compared to BSM and SXCT groups.  相似文献   

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