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1.
Purpose
Intravesical injection of onabotulinumtoxinA is an effective treatment for overactive bladder (OAB). Nonetheless, the treatment outcome is unclear in OAB patients with central nervous system (CNS) lesions. This study evaluated the efficacy and safety of intravesical onabotulinumtoxinA treatment in elderly patients with chronic cerebrovascular accidents (CVAs), Parkinson’s disease (PD) and dementia.Materials and Methods
Patients with CVA, PD, dementia, and OAB refractory to antimuscarinic therapy were consecutively enrolled in the study group. Age-matched OAB patients without CNS lesions were selected to serve as a control group. OnabotulinumtoxinA (100 U) was injected into the bladder suburothelium at 20 sites. The clinical effects, adverse events, and urodynamic parameters were assessed at baseline and 3 months post-treatment. The Kaplan-Meier method was used to compare long-term success rates between groups.Results
A total of 40 patients with OAB due to CVA (23), PD (9), dementia (8) and 160 control patients were included in this retrospetive analysis. Improvement of urgency severity scale, increased bladder capacity and increased post-void residual volume were comparable between the groups at 3 months. Patients with CNS lesions did not experience increased risks of acute urinary retention and urinary tract infection; nonetheless, patients with CVA experienced a higher rate of straining to void. Long-term success rates did not differ between the patients with and without CNS lesions.Conclusion
Intravesical injection of 100 U of onabotulinumtoxinA effectively decreased urgency symptoms in elderly OAB patients with CNS lesions. The adverse events were acceptable, and long-term effects were comparable to OAB patients in general. Nonetheless, the possibility of longstanding urinary retention and chronic catheterization need careful evaluation for this very vulnerable population before choosing intravesical onabotulinumtoxinA treatment. 相似文献2.
Objectives
Recent studies have shown that chronic inflammation is involved in overactive bladder (OAB) syndrome. OAB could be a subtype of neurogenic inflammation. This pilot study investigated serum adipokine levels in patients with OAB refractory to antimuscarinic therapy.Methods
Thirty consecutive patients with OAB-dry (n = 16) or OAB-wet (n = 14) refractory to previous antimuscarinic treatment were prospectively enrolled in this study, a group of 26 normal subjects without lower urinary tract symptoms served as controls. Concentrations of serum C-reactive protein (CRP), nerve growth factor (NGF), and adipokines including interleukins ([IL], IL-1β, IL-6, IL-8), tumor necrosis factor (TNF)-α, monocyte chemotactic protein (MCP)-1, insulin, and leptin were quantified using a bead-based human serum adipokine panel B kit. Data were analyzed using the LX 200 platform. Patients were further classified as having dry or wet OAB and having medical diseases or not. The serum CRP, NGF, and adipokine levels were compared between OAB patients and the controls, and between OAB subgroups.Results
The serum concentrations of CRP, NGF, IL-1β, IL-6, IL-8, and TNF-α in OAB-dry and OAB-wet patients were significantly higher than among the controls. There was no significant difference in adipokine levels between OAB-dry and OAB-wet, or between OAB patients with and without medical diseases. Serum CRP and NGF levels were significantly higher only in OAB-wet or OAB patients with medical diseases than among controls. The MCP-1 levels, on the other hand, were significantly higher in OAB-dry or OAB patients with disease, than the controls.Conclusions
Both OAB-dry and OAB-wet patients showed increased serum CRP, NGF, and adipokine levels compared with the controls, suggesting chronic inflammation of the bladder involving both peripheral and central mechanisms in all OAB patients refractory to antimuscarinic therapy. The increased serum adipokine levels were not relevant to medical diseases. 相似文献3.
Background
Adverse events are poor patient outcomes caused by medical care. Their identification requires the peer-review of poor outcomes, which may be unreliable. Combining physician ratings might improve the accuracy of adverse event classification.Objective
To evaluate the variation in peer-reviewer ratings of adverse outcomes; determine the impact of this variation on estimates of reviewer accuracy; and determine the number of reviewers who judge an adverse event occurred that is required to ensure that the true probability of an adverse event exceeded 50%, 75% or 95%.Methods
Thirty physicians rated 319 case reports giving details of poor patient outcomes following hospital discharge. They rated whether medical management caused the outcome using a six-point ordinal scale. We conducted latent class analyses to estimate the prevalence of adverse events as well as the sensitivity and specificity of each reviewer. We used this model and Bayesian calculations to determine the probability that an adverse event truly occurred to each patient as function of their number of positive ratings.Results
The overall median score on the 6-point ordinal scale was 3 (IQR 2,4) but the individual rater median score ranged from a minimum of 1 (in four reviewers) to a maximum median score of 5. The overall percentage of cases rated as an adverse event was 39.7% (3798/9570). The median kappa for all pair-wise combinations of the 30 reviewers was 0.26 (IQR 0.16, 0.42; Min = −0.07, Max = 0.62). Reviewer sensitivity and specificity for adverse event classification ranged from 0.06 to 0.93 and 0.50 to 0.98, respectively. The estimated prevalence of adverse events using a latent class model with a common sensitivity and specificity for all reviewers (0.64 and 0.83 respectively) was 47.6%. For patients to have a 95% chance of truly having an adverse event, at least 3 of 3 reviewers are required to deem the outcome an adverse event.Conclusion
Adverse event classification is unreliable. To be certain that a case truly represents an adverse event, there needs to be agreement among multiple reviewers. 相似文献4.
Background
Hypoxia-inducible factor-1α (HIF-1α) and heme oxygenase-1(HO-1) are involved in the tissue hypoxic response.Hypothesis
HIF-1α and HO-1 levels may predict cardiac ischemia and adverse cardiac events during non-cardiac surgery.Methods
HIF-1α and HO-1 levels were determined in elderly patients undergoing non-cardiac surgery preoperatively and at 30 minutes, 48 and 72 hours postoperatively. Results were analyzed with respect to the occurrence of adverse cardiac events.Results
A total of 380 patients with a mean age of 65.3 years were included, and 54 (14.2%) who had adverse cardiac events during or after the surgery. HIF-1α and HO-1 levels in the adverse cardiac event group were significantly higher than in the group without adverse cardiac events at each time point (all, P<0.05). In multivariates regression analysis, the odds of an adverse cardiac event was increased by every 1-year increase in age (odd ratio [OR] 1.39, P<0.001), abnormal ECG at baseline (OR 2.27, P = 0.048), myocardial infarction history (OR 3.18, P = 0.015), and positive baseline cTnI level were associated with an increased likelihood of an adverse cardiac event (OR 8.78, P = 0.019), and for every 1 unit increase of HO-1, the odds of an adverse cardiac event increased by 1.30 (P = 0.002).Conclusion
Determination of preoperative HO-1 levels may aid in identifying patients at risk of developing ischemic cardiac events. 相似文献5.
Toshihiro Nagai Masato Sato Miyuki Kobayashi Munetaka Yokoyama Yoshiki Tani Joji Mochida 《Arthritis research & therapy》2014,16(5)
Introduction
Angiogenesis is an important factor in the development of osteoarthritis (OA). We investigated the efficacy of bevacizumab, an antibody against vascular endothelial growth factor and an inhibitor of angiogenesis, in the treatment of OA using a rabbit model of anterior cruciate ligament transection.Methods
First, we evaluated the response of gene expression and histology of the normal joint to bevacizumab treatment. Next, in a rabbit model of OA induced by anterior cruciate ligament transection, we used macroscopic and histological evaluations and real-time polymerase chain reaction (PCR) to examine the responses to intravenous (systemic) administration of bevacizumab (OAB IV group). We also investigated the efficacy of intra-articular (local) administration of bevacizumab in OA-induced rabbits (OAB IA group).Results
Histologically, bevacizumab had no negative effect in normal joints. Bevacizumab did not increase the expression of genes for catabolic factors in the synovium, subchondral bone, or articular cartilage, but it increased the expression of collagen type 2 in the articular cartilage. Macroscopically and histologically, the OAB IV group exhibited a reduction in articular cartilage degeneration and less osteophyte formation and synovitis compared with the control group (no bevacizumab; OA group). Real-time PCR showed significantly lower expression of catabolic factors in the synovium in the OAB IV group compared with the OA group. In articular cartilage, expression levels of aggrecan, collagen type 2, and chondromodulin-1 were higher in the OAB IV group than in the OA group. Histological evaluation and assessment of pain behaviour showed a superior effect in the OAB IA group compared with the OAB IV group 12 weeks after administration of bevacizumab, even though the total dosage given to the OAB IA group was half that received by the OAB IV group.Conclusions
Considering the dosage and potential adverse effects of bevacizumab, the local administration of bevacizumab is a more advantageous approach than systemic administration. Our results suggest that intra-articular bevacizumab may offer a new therapeutic approach for patients with post-traumatic OA.Electronic supplementary material
The online version of this article (doi:10.1186/s13075-014-0427-y) contains supplementary material, which is available to authorized users. 相似文献6.
Harold R Collard Eric Yow Luca Richeldi Kevin J Anstrom Craig Glazer 《Respiratory research》2013,14(1):73
Background
Acute exacerbation of idiopathic pulmonary fibrosis has become an important outcome measure in clinical trials. This study aimed to explore the concept of suspected acute exacerbation as an outcome measure.Methods
Three investigators retrospectively reviewed subjects enrolled in the Sildenafil Trial of Exercise Performance in IPF who experienced a respiratory serious adverse event during the course of the study. Events were classified as definite acute exacerbation, suspected acute exacerbation, or other, according to established criteria.Results
Thirty-five events were identified. Four were classified as definite acute exacerbation, fourteen as suspected acute exacerbation, and seventeen as other. Definite and suspected acute exacerbations were clinically indistinguishable. Both were most common in the winter and spring months and were associated with a high risk of disease progression and short-term mortality.Conclusions
In this study one half of respiratory serious adverse events were attributed to definite or suspected acute exacerbations. Suspected acute exacerbations are clinically indistinguishable from definite acute exacerbations and represent clinically meaningful events. Clinical trialists should consider capturing both definite and suspected acute exacerbations as outcome measures. 相似文献7.
Objective
Adverse event reports (AERs) submitted to the US Food and Drug Administration (FDA) were reviewed to assess the muscular and renal adverse events induced by the administration of 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors (statins) and to attempt to determine the rank-order of the association.Methods
After a revision of arbitrary drug names and the deletion of duplicated submissions, AERs involving pravastatin, simvastatin, atorvastatin, or rosuvastatin were analyzed. Authorized pharmacovigilance tools were used for quantitative detection of signals, i.e., drug-associated adverse events, including the proportional reporting ratio, the reporting odds ratio, the information component given by a Bayesian confidence propagation neural network, and the empirical Bayes geometric mean. Myalgia, rhabdomyolysis and an increase in creatine phosphokinase level were focused on as the muscular adverse events, and acute renal failure, non-acute renal failure, and an increase in blood creatinine level as the renal adverse events.Results
Based on 1,644,220 AERs from 2004 to 2009, signals were detected for 4 statins with respect to myalgia, rhabdomyolysis, and an increase in creatine phosphokinase level, but these signals were stronger for rosuvastatin than pravastatin and atorvastatin. Signals were also detected for acute renal failure, though in the case of atorvastatin, the association was marginal, and furthermore, a signal was not detected for non-acute renal failure or for an increase in blood creatinine level.Conclusions
Data mining of the FDA''s adverse event reporting system, AERS, is useful for examining statin-associated muscular and renal adverse events. The data strongly suggest the necessity of well-organized clinical studies with respect to statin-associated adverse events. 相似文献8.
9.
Lies Boelen Suzy Teutsch David P. Wilson Kate Dolan Greg J. Dore Andrew R. Lloyd Fabio Luciani 《PloS one》2014,9(7)
Background
Shared injecting apparatus during drug use is the premier risk factor for hepatitis C virus (HCV) transmission.Aims
To estimate the per-event probability of HCV infection during a sharing event, and the transmission probability of HCV from contaminated injecting apparatus.Methods
Estimates were obtained using a maximum likelihood method with estimated IDU and sharing events obtained from behavioural data.Settings
Cohort study in multiple correction centres in New South Wales, AustraliaParticipants
Subjects (N = 500) with a lifetime history of injecting drug use (IDU) who were followed up between 2005 and 2012. During follow-up, interviews for risk behaviours were taken and blood sampling (HCV-antibody and RNA testing) was performed.Measurements
Self-reported frequencies of injecting drugs and sharing events, as well as other risk behaviours and details on the nature of injecting events.Findings
The best estimate of the per-event probability of infection was 0.57% (CI: 0.32–1.05%). A sensitivity analysis on the likely effect of under-reporting of sharing of the injecting apparatus indicated that the per event infection probability may be as low as 0.17% (95% CI: 0.11%–0.25%). The transmission probability was similarly shown to range up to 6%, dependent on the presumed prevalence of the virus in injecting equipment.Conclusions
The transmission probability of HCV during a sharing event is small. Hence, strategies to reduce the frequency and sharing of injecting equipment are required, as well as interventions focused on decreasing the per event risk. 相似文献10.
Ji-Yeon Han Kyu-Sung Lee Won Hee Park Choal Hee Park Jeong Gu Lee Jeong Zoo Lee Duk Yoon Kim Yong Gil Na Dong Deuk Kwon Myung-Soo Choo 《PloS one》2014,9(11)
Objectives
Patients with overactive bladder (OAB) often have trouble perceiving urgency because of difficulties in distinguishing between urgency and desire to void. Empirical antimuscarinic treatment of patients with frequency only may be reasonable if conservative management has failed. We compared the efficacy of solifenacin in patients with frequency with or without urgency.Materials and Methods
This multicenter, 12-week, open-label, comparative, non-inferiority clinical trial assessed whether the solifenacin efficacy for frequency without urgency is non-inferior to its efficacy for frequency with urgency. All patients had micturition frequency ≥8 voids/day with or without urgency. Primary efficacy variable: daily frequency change at 12 weeks relative to baseline. Secondary efficacy variables: change at 12 weeks relative to baseline in Patients'' Perception of Bladder Condition (PPBC), OAB Symptom Score (OABSS), and Benefit, Satisfaction, Willingness to continue (BSW) questionnaire.Results
Of the 286 enrolled patients, 240 (83.9%) completed the study (without urgency n = 115; with urgency n = 125). Full dataset analysis revealed that the groups without and with urgency exhibited significant reductions in daily micturition frequency of −2.49±0.35 (mean ± standard error) and −2.63±0.37, respectively. The lower limit of the 95% two-sided CI of the comparison of the two group means was −1.14, which is smaller than the −0.8 margin of clinical equivalence. The two groups did not differ in improvement in PPBC, OABSS, or BSW scores. Both tolerated the treatment well.Conclusions
It was not possible to verify that the solifenacin efficacy for frequency alone was non-inferior to its efficacy for OAB. Nevertheless, solifenacin tended to be effective for frequency regardless of urgency.Trial Registration
ClinicalTrials.gov NCT00979472相似文献11.
Wilson K Hawken S Kwong JC Deeks S Crowcroft NS Van Walraven C Potter BK Chakraborty P Keelan J Pluscauskas M Manuel D 《PloS one》2011,6(12):e27897
Background
Live vaccines have distinct safety profiles, potentially causing systemic reactions one to 2 weeks after administration. In the province of Ontario, Canada, live MMR vaccine is currently recommended at age 12 months and 18 months.Methods
Using the self-controlled case series design we examined 271,495 12 month vaccinations and 184,312 18 month vaccinations to examine the relative incidence of the composite endpoint of emergency room visits or hospital admissions in consecutive one day intervals following vaccination. These were compared to a control period 20 to 28 days later. In a post-hoc analysis we examined the reasons for emergency room visits and the average acuity score at presentation for children during the at-risk period following the 12 month vaccine.Results
Four to 12 days post 12 month vaccination, children had a 1.33 (1.29–1.38) increased relative incidence of the combined endpoint compared to the control period, or at least one event during the risk interval for every 168 children vaccinated. Ten to 12 days post 18 month vaccination, the relative incidence was 1.25 (95%, 1.17–1.33) which represented at least one excess event for every 730 children vaccinated. The primary reason for increased events was statistically significant elevations in emergency room visits following all vaccinations. There were non-significant increases in hospital admissions. There were an additional 20 febrile seizures for every 100,000 vaccinated at 12 months.Conclusions
There are significantly elevated risks of primarily emergency room visits approximately one to two weeks following 12 and 18 month vaccination. Future studies should examine whether these events could be predicted or prevented. 相似文献12.
Objective
The study examined the personal resources, Self-efficacy and Coping Strategies, in a sample of pre-adolescents who experienced an emotionally and socially critical event, such as the earthquake of the 6th of April 2009, related to age and gender.Methods
198 pre-adolescents, 84 girls and 114 boys (Age Mean 12 years), attending Secondary School in L''Aquila meso-seismic area. The emotional, behavioural and social capacities have been assessed with specific questionnaires administered collectively ten months after the earthquake.Results
Multidimensional analyses produced differentiated profiles according to gender and age: self-efficacy-perception and coping strategy profiles, based on quartiles calculations, revealed the difficulties of the subjects in estimating their ability to cope with the world of relations and emotions after the critical event.Conclusions
The intervention could be specific to the cognitive, emotional and relational state of children and adolescents and differentiated before (prevention), during (intervention) and after the event (intervention and prevention). 相似文献13.
Context
Violence towards others is a seldom-studied adverse drug event and an atypical one because the risk of injury extends to others.Objective
To identify the primary suspects in adverse drug event reports describing thoughts or acts of violence towards others, and assess the strength of the association.Methodology
From the Food and Drug Administration (FDA) Adverse Event Reporting System (AERS) data, we extracted all serious adverse event reports for drugs with 200 or more cases received from 2004 through September 2009. We identified any case report indicating homicide, homicidal ideation, physical assault, physical abuse or violence related symptoms.Main Outcome Measures
Disproportionality in reporting was defined as a) 5 or more violence case reports, b) at least twice the number of reports expected given the volume of overall reports for that drug, c) a χ2 statistic indicating the violence cases were unlikely to have occurred by chance (p<0.01).Results
We identified 1527 cases of violence disproportionally reported for 31 drugs. Primary suspect drugs included varenicline (an aid to smoking cessation), 11 antidepressants, 6 sedative/hypnotics and 3 drugs for attention deficit hyperactivity disorder. The evidence of an association was weaker and mixed for antipsychotic drugs and absent for all but 1 anticonvulsant/mood stabilizer. Two or fewer violence cases were reported for 435/484 (84.7%) of all evaluable drugs suggesting that an association with this adverse event is unlikely for these drugs.Conclusions
Acts of violence towards others are a genuine and serious adverse drug event associated with a relatively small group of drugs. Varenicline, which increases the availability of dopamine, and antidepressants with serotonergic effects were the most strongly and consistently implicated drugs. Prospective studies to evaluate systematically this side effect are needed to establish the incidence, confirm differences among drugs and identify additional common features. 相似文献14.
Yang Peng Xiaohua Ye Ying Li Tao Bu Xiaofeng Chen Jiaqi Bi Junli Zhou Zhenjiang Yao 《PloS one》2013,8(11)
Objective
To evaluate whether teicoplanin could be an alternative to vancomycin for treatment of MRSA infection in Chinese population using a meta-analysis in randomized controlled trials.Methods
The following databases were searched: Chinese Biomedical Literature database (CBM), Chinese Journal Full-text database (CNKI), Wanfang database, Medline database, Ovid database and Cochrane Library. Articles published from 2002 to 2013 that studied teicoplanin in comparison to vancomycin in the treatment of MRSA infected patients were collected. Overall effects, publishing bias analysis and sensitivity analysis on clinical cure rate, microbiologic eradication rate and adverse events rate were performed by using Review Manager 5.2 and Stata 11.0 softwares.Results
Twelve articles met entry criteria. There was no statistically significant difference between the two groups regarding the clinical cure rate (risk ratio [RR], teicoplanin vs vancomycin, 0.94; 95% CI, 0.74∼1.19; P = 0.60), microbiological cure rate (risk ratio [RR], teicoplanin vs vancomycin, 0.99; 95% CI, 0.91∼1.07; P = 0.74) and adverse event rate (risk ratio [RR], teicoplanin vs vancomycin, 0.86; 95% CI, 0.40∼1.84; P = 0.70).Conclusions
The meta-analysis results indicate that the two therapies are similar in both efficacy and safety, thus teicoplanin can act as an effective alternative to vancomycin for treating patients infected by MRSA. 相似文献15.
16.
Background
Observational studies have reported higher mortality among older adults treated with first-generation antipsychotics (FGAs) versus second-generation antipsychotics (SGAs). A few studies examined risk for medical events, including stroke, ventricular arrhythmia, venous thromboembolism, myocardial infarction, pneumonia, and hip fracture.Objectives
1) Review robust epidemiologic evidence comparing mortality and medical event risk between FGAs and SGAs in older adults; 2) Quantify how much these medical events explain the observed mortality difference between FGAs and SGAs.Data sources
Pubmed and Science Citation Index.Study eligibility criteria, participants, and interventions
Studies of antipsychotic users that: 1) evaluated mortality or medical events specified above; 2) restricted to populations with a mean age of 65 years or older 3) compared FGAs to SGAs, or both to a non-user group; (4) employed a “new user” design; (5) adjusted for confounders assessed prior to antipsychotic initiation; (6) and did not require survival after antipsychotic initiation. A separate search was performed for mortality estimates associated with the specified medical events.Study appraisal and synthesis methods
For each medical event, we used a non-parametric model to estimate lower and upper bounds for the proportion of the mortality difference—comparing FGAs to SGAs—mediated by their difference in risk for the medical event.Results
We provide a brief, updated summary of the included studies and the biological plausibility of these mechanisms. Of the 1122 unique citations retrieved, we reviewed 20 observational cohort studies that reported 28 associations. We identified hip fracture, stroke, myocardial infarction, and ventricular arrhythmias as potential intermediaries on the causal pathway from antipsychotic type to death. However, these events did not appear to explain the entire mortality difference.Conclusions
The current literature suggests that hip fracture, stroke, myocardial infarction, and ventricular arrhythmias partially explain the mortality difference between SGAs and FGAs. 相似文献17.
Background
Medical devices increasingly depend on computing functions such as wireless communication and Internet connectivity for software-based control of therapies and network-based transmission of patients’ stored medical information. These computing capabilities introduce security and privacy risks, yet little is known about the prevalence of such risks within the clinical setting.Methods
We used three comprehensive, publicly available databases maintained by the Food and Drug Administration (FDA) to evaluate recalls and adverse events related to security and privacy risks of medical devices.Results
Review of weekly enforcement reports identified 1,845 recalls; 605 (32.8%) of these included computers, 35 (1.9%) stored patient data, and 31 (1.7%) were capable of wireless communication. Searches of databases specific to recalls and adverse events identified only one event with a specific connection to security or privacy. Software-related recalls were relatively common, and most (81.8%) mentioned the possibility of upgrades, though only half of these provided specific instructions for the update mechanism.Conclusions
Our review of recalls and adverse events from federal government databases reveals sharp inconsistencies with databases at individual providers with respect to security and privacy risks. Recalls related to software may increase security risks because of unprotected update and correction mechanisms. To detect signals of security and privacy problems that adversely affect public health, federal postmarket surveillance strategies should rethink how to effectively and efficiently collect data on security and privacy problems in devices that increasingly depend on computing systems susceptible to malware. 相似文献18.
Monti DA Mitchell E Bazzan AJ Littman S Zabrecky G Yeo CJ Pillai MV Newberg AB Deshmukh S Levine M 《PloS one》2012,7(1):e29794
Background
Preclinical data support further investigation of ascorbic acid in pancreatic cancer. There are currently insufficient safety data in human subjects, particularly when ascorbic acid is combined with chemotherapy.Methods and Findings
14 subjects with metastatic stage IV pancreatic cancer were recruited to receive an eight week cycle of intravenous ascorbic acid (three infusions per week), using a dose escalation design, along with standard treatment of gemcitabine and erlotinib. Of 14 recruited subjects enrolled, nine completed the study (three in each dosage tier). There were fifteen non-serious adverse events and eight serious adverse events, all likely related to progression of disease or treatment with gemcitabine or erlotinib. Applying RECIST 1.0 criteria, seven of the nine subjects had stable disease while the other two had progressive disease.Conclusions
These initial safety data do not reveal increased toxicity with the addition of ascorbic acid to gemcitabine and erlotinib in pancreatic cancer patients. This, combined with the observed response to treatment, suggests the need for a phase II study of longer duration.Trial Registration
Clinicaltrials.gov NCT00954525相似文献19.
Objective
Percutaneous kyphoplasty (PKP) is now widely performed to treat VCF, which is usually caused by osteoporosis. Previous researches have reported unsuspected malignancies found by biopsy. However, the safety and cost-effective profiles of routine biopsy during PKP are unclear. The purpose of this study was to evaluate the feasibility of routine biopsy during PKP in treatment of VCF.Methods
Ninety-three patients (September 2007–November 2010) undergoing PKP without biopsy were reviewed as the control group. One hundred and three consecutive patients (November 2010–September 2013) undergoing PKP with biopsy of every operated vertebral level were prospectively enrolled as the biopsy group. The rate of unsuspected lesions was reported, and the severe adverse events, surgical duration, cement leakage rate and pain control were compared between the two groups.Results
No statistically significant differences were found between the two groups, regarding the severe adverse events, surgical duration, cement leakage rate and pain control. Four unsuspected lesions were found in the biopsy group, three of which were malignancies with a 2.9% (3/103) unsuspected malignancy rate. The economic analysis showed that routine biopsy was cost-effective in finding new malignancies comparing with a routine cancer screening campaign.Conclusions
Routine biopsy during PKP was safe and cost-effective in finding unsuspected malignancies. We advocate routine biopsy in every operated vertebral level during PKP for VCF patients. 相似文献20.