Real-world safety and effectiveness of tenofovir alafenamide for 144 weeks in Japanese patients with chronic hepatitis B.

Tenofovir alafenamide (TAF), a prodrug of tenofovir, delivers high levels of active drug to hepatocytes and is given in a lower dose than tenofovir disoproxil fumarate (TDF). TAF reduces viral replication in patients with chronic hepatitis B (CHB) similar to TDF and has shown a lower risk of the renal and bone toxicities associated with TDF use. This post-marketing surveillance study examined the safety and effectiveness of TAF in treatment-naïve and -experienced CHB patients who received TAF for 144 weeks at real-world clinical sites in Japan. Safety assessments included the incidence of adverse drug reactions (ADRs), renal and bone events, and changes in selected laboratory parameters. Effectiveness was based on the proportion of patients with HBV DNA levels below the lower limit of quantitation or <29 IU/mL. This analysis included 580 patients; 18.4% of whom were treatment-naïve. The cumulative incidence of ADRs was 0.21 per 100 person-months, and the incidence of serious ADRs was 0.01 (95% CI, 0.00-0.04) per 100 person-months. There were no ADRs of declines in estimated glomerular filtration rates, renal failure or proximal tubulopathy. The most common ADR was hypophosphataemia in seven (1.2%) patients. Two (0.4%) patients each had decreased blood phosphorus, bone mineral density decreased, dizziness and alopecia. Overall, the proportion of virologically suppressed patients increased from 68.8% at baseline to 97.5% at Week 144. These results confirm the real-world safety and effectiveness of TAF in Japanese patients with CHB and are consistent with the findings of other evaluations of the safety and efficacy of TAF in CHB.

The safety and effectiveness of remdesivir in a postmarketing surveillance study in Japan.

BACKGROUND: To evaluate the occurrence of adverse drug reactions (ADRs) and to assess mortality and health status in participants receiving remdesivir in real-world settings in Japan. METHODS: This postmarketing surveillance study used an all-case surveillance method for enrollment. Participants with SARS-CoV-2 infection administered remdesivir from July 2020 to November 2021 in Japan were eligible for inclusion. The observation period was from remdesivir treatment initiation to 4 weeks after the end of treatment or treatment discontinuation. Clinical status and outcomes were analyzed by Kaplan-Meier plots and compared across subgroups at baseline, Day 14, Day 28, and the final observation point. RESULTS: The analysis included 2128 participants (mean age, 67 years; 71.4 % male; 84.1 % with current comorbidities). ADRs and serious adverse drug reactions (SADRs) were reported among 10.4 % and 1.2 % participants, respectively. Overall, 191/2127 participants died (mortality rate [95 % confidence interval], 11.10 [9.66-12.75] per 100 person-months), 1511/2127 showed clinical improvement (117.8 [112.0-123.9] per 100 person-months), 1392/2127 recovered (103.9 [98.6-110.0] per 100 person-months), and 216/324 were extubated (107.0 [93.6-122.3] per 100 person-months). CONCLUSIONS: The incidence of ADRs and SADRs was low, and no new safety concerns were identified. Observed mortality and clinical improvement results were consistent with prior studies, confirming remdesivir's benefits in real-world settings in Japan.

Real-world Safety and Effectiveness of 24-week Sofosbuvir and Ribavirin Treatment in Patients Infected with Rare Chronic Hepatitis C Virus Genotypes 3, 4, 5, or 6 in Japan.

Objectives Real-world evidence on the safety and effectiveness of direct-acting antivirals in patients infected with chronic hepatitis C virus (HCV) genotypes (GTs) 3, 4, 5, or 6 in Japan is limited. This prospective observational study assesses the real-world safety profile and treatment effectiveness among patients prescribed sofosbuvir with ribavirin (SOF+RBV) for HCV GT3-6 infection in Japan. Methods Adults receiving 24-week SOF+RBV treatment for HCV GT3-6 infection were prospectively enrolled and observed through 24 weeks post-treatment for treatment-emergent adverse events (AEs) considered related to SOF and/or RBV by treating physicians and for a sustained virologic response at 12 and 24 weeks post-treatment (SVR12, SVR24). Incidence rates of related AEs and serious AEs (SAEs) were calculated. Proportions of patients experiencing related AEs/SAEs and those achieving SVR12 and SVR24 were assessed overall and by baseline characteristics, including treatment experience and cirrhosis status. Results Among the 50 patients included in the safety analysis, 92% had GT3 infection. The incidence rates of related AEs and SAEs were low overall (1.52 and 0.25 per 100 person-weeks, respectively), with 6.0% and 14.0% patients experiencing AEs related to SOF or RBV, respectively. There were no marked differences in the occurrence of related AEs/SAEs by patient baseline characteristics. SVR12 and SVR24 were achieved in 83.7% (41/49) and 82.2% (37/45) of patients, respectively. Lower effectiveness was observed among treatment-experienced patients and patients with cirrhosis at baseline. Conclusion This study demonstrated that SOF+RBV treatment for HCV GT3-6 infection was safe, effective, and an important treatment option for this difficult-to-treat patient population in Japan.

Real-world safety and effectiveness of ledipasvir/sofosbuvir for the treatment of chronic hepatitis C virus genotype 1 in Japan.

As patients with chronic hepatitis C virus (HCV) tend to be older and/or have advanced liver disease in Japan, real-world data are needed to evaluate safe and effective treatment options. The study aim was to assess safety and effectiveness of ledipasvir/sofosbuvir (LDV/SOF) in a real-world cohort of Japanese patients with HCV genotype (GT) 1 infection overall and by patient subgroups: elderly, compensated cirrhotic, advanced fibrotic and those with hepatocellular carcinoma (HCC). A large prospective observational study was conducted, enrolling adult patients treated for HCV GT1 infection with LDV/SOF at clinical sites across Japan. Patients were observed for safety outcomes during and 4 weeks after treatment, and for sustained virologic response at 12-weeks post-treatment (SVR12). Incidence rates (IRs) of adverse drug reactions (ADRs) and serious ADRs (SADRs) and SVR12 rates were assessed overall and by subgroups. ADR and SADR IRs were low (2.26 and 0.17 per 100 person-months, respectively) and did not significantly differ in elderly patients or those with presence of compensated cirrhosis, worsening fibrosis or HCC. SVR12 rates were high overall (98.5%) and across subgroups investigated (≥94%), including patients who were elderly (98.2%), treatment-experienced (97.6%), advanced fibrotic (≥95.8%), had existing NS5A resistance-associated substitutions reported pre-treatment (95.0%), compensated cirrhosis (95.7%), HCC (94.0%) and other chronic liver diseases (96.1%). In this large, real-world observational study of Japanese patients with HCV GT1 infection, LDV/SOF treatment resulted in low incidence of adverse events, with high real-world effectiveness, even among patients with potentially higher risks of adverse safety outcomes and treatment failure.

The Paradox of Iridescent Signals.

Signals reliably convey information to a receiver. To be reliable, differences between individuals in signal properties must be consistent and easily perceived and evaluated by receivers. Iridescent objects are often striking and vivid, but their appearance can change dramatically with viewing geometry and illumination. The changeable nature of iridescent surfaces creates a paradox: how can they be reliable signals? We contend that iridescent color patches can be reliable signals only if accompanied by specific adaptations to enhance reliability, such as structures and behaviors that limit perceived hue shift or enhance and control directionality. We highlight the challenges of studying iridescence and key considerations for the evaluation of its adaptive significance.

The ecological significance of time sense in animals.

Time is a fundamental dimension of all biological events and it is often assumed that animals have the capacity to track the duration of experienced events (known as interval timing). Animals can potentially use temporal information as a cue during foraging, communication, predator avoidance, or navigation. Interval timing has been traditionally investigated in controlled laboratory conditions but its ecological relevance in natural environments remains unclear. While animals may time events in artificial and highly controlled conditions, they may not necessarily use temporal information in natural environments where they have access to other cues that may have more relevance than temporal information. Herein we critically evaluate the ecological contexts where interval timing has been suggested to provide adaptive value for animals. We further discuss attributes of interval timing that are rarely considered in controlled laboratory studies. Finally, we encourage consideration of ecological relevance when designing future interval-timing studies and propose future directions for such experiments.

Use of temporal and colour cueing in a symbolic delayed matching task by honey bees.

Honey bees (Apis mellifera) are known for their capacity to learn arbitrary relationships between colours, odours and even numbers. However, it is not known whether bees can use temporal signals as cueing stimuli in a similar way during symbolic delayed matching-to-sample tasks. Honey bees potentially process temporal signals during foraging activities, but the extent to which they can use such information is unclear. Here, we investigated whether free-flying honey bees could use either illumination colour or illumination duration as potential context-setting cues to enable their subsequent decisions for a symbolic delayed matching-to-sample task. We found that bees could use the changing colour context of the illumination to complete the subsequent spatial vision task at a level significantly different from chance expectation, but could not use the duration of either a 1 or 3 s light as a cueing stimulus. These findings suggest that bees cannot use temporal information as a cueing stimulus as efficiently as other signals such as colour, and are consistent with previous field observations suggesting a limited interval timing capacity in honey bees.

Spontaneous quantity discrimination of artificial flowers by foraging honeybees.

Many animals need to process numerical and quantity information in order to survive. Spontaneous quantity discrimination allows differentiation between two or more quantities without reinforcement or prior training on any numerical task. It is useful for assessing food resources, aggressive interactions, predator avoidance and prey choice. Honeybees have previously demonstrated landmark counting, quantity matching, use of numerical rules, quantity discrimination and arithmetic, but have not been tested for spontaneous quantity discrimination. In bees, spontaneous quantity discrimination could be useful when assessing the quantity of flowers available in a patch and thus maximizing foraging efficiency. In the current study, we assessed the spontaneous quantity discrimination behaviour of honeybees. Bees were trained to associate a single yellow artificial flower with sucrose. Bees were then tested for their ability to discriminate between 13 different quantity comparisons of artificial flowers (numeric ratio range: 0.08-0.8). Bees significantly preferred the higher quantity only in comparisons where '1' was the lower quantity and where there was a sufficient magnitudinal distance between quantities (e.g. 1 versus 12, 1 versus 4, and 1 versus 3 but not 1 versus 2). Our results suggest a possible evolutionary benefit to choosing a foraging patch with a higher quantity of flowers when resources are scarce.

Two years of Truvada for pre-exposure prophylaxis utilization in the US.

INTRODUCTION: Truvada® (TVD) was approved in July 2012 by the US FDA for pre-exposure prophylaxis (PrEP) in combination with safer sex practices to reduce the risk of sexually acquired HIV-1 in high-risk adults. This study explores the characteristics of US PrEP users and their prescribers over the past two years. MATERIALS AND METHODS: A previously described algorithm was used to identify TVD for PrEP by excluding use for HIV treatment, post-exposure prophylaxis, and off-label treatment of chronic hepatitis B. National electronic patient level data from ~55% of all US retail pharmacies that dispensed TVD between January 1, 2012 and March 31, 2014 was collected. De-identified patient-level data including prescription refill data, medical claims and patient demographics were analyzed via logistic regression to estimate the odds of change by year. RESULTS: A total of 3253 unique individuals who started TVD for PrEP between January 1, 2012 and March 31, 2014 were included in this analysis. Women comprised 42.0% of PrEP users. Although mean age was 38.1+11.9 years, with males being significantly older (39.3+11.6) than females (36.4+12.3), 11.5% of individuals were under 25 years old. The proportion of males under 25 was 7.4% (95% CI 6.3-8.7); significantly lower than that of women, 17.2% (95% CI 15.3-19.3). New starts have increased from 293 in 2012 to 472 Q1 2014. During the 12-month period ending March 31, 2013 and March 31, 2014 the number of new starts among females dropped from 44.5% to 22.9%. CONCLUSIONS: The population of TVD for PrEP users in the US nationally appears to be shifting demographically. It continues to be initiated mostly by primary care providers. Over a two-year period new starts of Truvada for PrEP have increased considerably among males. While the overall proportion of female users decreased between Q1 2012 and Q1 2014, females that started on PrEP are younger than males. More community-level data on PrEP usage will be helpful in informing local efforts to integrate PrEP in HIV prevention messaging and services.

Central stentoplasty: technique for unipedicular single midline vertebral body stent implantation.

Vertebral body stenting, or stentoplasty, is a novel percutaneous option in spinal cement augmentation. Conventional stentoplasty requires insertion of two paramedian stents per vertebral body through a bipedicular approach. We developed an unipedicular approach in which we implant a single stent into the midline of the vertebral body using cone-beam CT guidance and hereby describe the technical details and feasibility, in this technique that we termed "central stentoplasty."

Worldwide, mortality risk is high soon after initiation of hemodialysis.

Mortality rates for maintenance hemodialysis patients are much higher than the general population and are even greater soon after starting dialysis. Here we analyzed mortality patterns in 86,886 patients in 11 countries focusing on the early dialysis period using data from the Dialysis Outcomes and Practice Patterns Study, a prospective cohort study of in-center hemodialysis. The primary outcome was all-cause mortality, using time-dependent Cox regression, stratified by study phase adjusted for age, sex, race, and diabetes. The main predictor was time since dialysis start as divided into early (up to 120 days), intermediate (121-365 days), and late (over 365 days) periods. Mortality rates (deaths/100 patient-years) were 26.7 (95% confidence intervals 25.6-27.9), 16.9 (16.2-17.6), and 13.7 (13.5-14.0) in the early, intermediate, and late periods, respectively. In each country, mortality was higher in the early compared to the intermediate period, with a range of adjusted mortality ratios from 3.10 (2.22-4.32) in Japan to 1.15 (0.87-1.53) in the United Kingdom. Adjusted mortality rates were similar for intermediate and late periods. The ratio of elevated mortality rates in the early to the intermediate period increased with age. Within each period, mortality was higher in the United States than in most other countries. Thus, internationally, the early hemodialysis period is a high-risk time for all countries studied, with substantial differences in mortality between countries. Efforts to improve outcomes should focus on the transition period and the first few months of dialysis.

Changing patterns of anemia management in US hemodialysis patients.

BACKGROUND: Erythropoiesis-stimulating agents and adjuvant intravenous iron have been the primary treatment for anemia in chronic kidney disease. Recent clinical and policy-related events have challenged this traditional paradigm, particularly in regard to erythropoiesis-stimulating agents. Less is known about the impact of these events on intravenous iron use. METHODS: United States Renal Data System data (2002-2008) on Medicare hemodialysis patients were examined. For each patient, monthly intravenous iron dose, erythropoiesis-stimulating agent dose, and hemoglobin values were determined. Data were summarized by calendar quarter and plotted for the entire sample and by demographic, clinical, and facility-level subgroups. Marginal means for these variables also were computed to account for changes in patient characteristics over time. RESULTS: Quarterly iron use increased from 64% in 2002 to 76% in 2008. Mean quarterly iron dose increased from 500 mg in 2002 to 650 mg in 2008. Mean monthly erythropoiesis-stimulating agent dose (per quarter) increased from 2002 to 2006 and then declined. Mean hemoglobin values followed a pattern similar to erythropoiesis-stimulating agent dose. The same patterns in iron, erythropoiesis-stimulating agent dose, and hemoglobin were generally observed across demographic, clinical, facility, and geographic subgroups, with some important differences between subgroups, specifically race and dialysis vintage. CONCLUSIONS: Anemia management patterns have changed markedly between 2002 and 2008, with a steady increase in intravenous iron use even after declines in erythropoiesis-stimulating agent dose and hemoglobin. The clinical impacts of these changes need further evaluation.

Hospitalization risks related to vascular access type among incident US hemodialysis patients.

BACKGROUND: The excess morbidity and mortality related to catheter utilization at and immediately following dialysis initiation may simply be a proxy for poor prognosis. We examined hospitalization burden related to vascular access (VA) type among incident patients who received some predialysis care. METHODS: We identified a random sample of incident US Dialysis Outcomes and Practice Patterns Study hemodialysis patients (1996-2004) who reported predialysis nephrologist care. VA utilization was assessed at baseline and throughout the first 6 months on dialysis. Poisson regression was used to estimate the risk of all-cause and cause-specific hospitalizations during the first 6 months. RESULTS: Among 2635 incident patients, 60% were dialyzing with a catheter, 22% with a graft and 18% with a fistula at baseline. Compared to fistulae, baseline catheter use was associated with an increased risk of all-cause hospitalization [adjusted relative risk (RR) = 1.30, 95% confidence interval (CI): 1.09-1.54] and graft use was not (RR = 1.07, 95% CI: 0.89-1.28). Allowing for VA changes over time, the risk of catheter versus fistula use was more pronounced (RR = 1.72, 95% CI: 1.42-2.08) and increased slightly for graft use (RR = 1.15, 95% CI: 0.94-1.41). Baseline catheter use was most strongly related to infection-related (RR = 1.47, 95% CI: 0.92-2.36) and VA-related hospitalizations (RR = 1.49, 95% CI: 1.06-2.11). These effects were further strengthened when VA use was allowed to vary over time (RR = 2.31, 95% CI: 1.48-3.61 and RR = 3.10, 95% CI: 1.95-4.91, respectively). A similar pattern was noted for VA-related hospitalizations with graft use. Discussion. Among potentially healthier incident patients, hospitalization risk, particularly infection and VA-related, was highest for patients dialyzing with a catheter at initiation and throughout follow-up, providing further support to clinical practice recommendations to minimize catheter placement.

Corticosteroids in peri-radicular infiltration for radicular pain: a randomised double blind controlled trial. One year results and subgroup analysis.

The objective of this study is to evaluate the efficacy of corticosteroids in patients with radicular pain due to lumbar disc herniation or lumbar spinal stenosis through a prospective randomised, double blind controlled trial, and whether there was an effect on subsequent interventions such as additional root blocks or surgery. Peri-radicular infiltration of corticosteroids has previously been shown to offer no additional benefit in patients with sciatica compared to local anaesthetic alone. It is not known if the response to peri-radicular infiltration is less marked in certain subgroups of patients such as those with radicular pain due to lumbar spinal stenosis. Previous studies have suggested that peri-radicular infiltration of corticosteroids may obviate the need for subsequent interventions and we therefore further investigated this in the current study. We randomised 150 patients to receive a single injection with either bupivacaine alone or bupivacaine and methylprednisolone. Patients were assessed at 6 weeks and 3 months after the injection using standard outcome measures including Oswestry Disability Index (ODI), visual analogue score for leg pain and patient's subjective assessment of outcome. At 1-year follow-up, we looked at the outcome in terms of the need for subsequent interventions such as additional root blocks or surgery. At 3-month follow-up, there was no statistically significant difference in the standard outcome measures between the two injection groups. At a minimum 1-year post injection, there was no difference in the need for subsequent interventions in either group. Patients with lumbar spinal stenosis had a less marked reduction in the ODI at 3 months with a mean change of 3.3 points when compared with 15 points for patients with lumbar disc herniation. In conclusion, peri-radicular infiltration of corticosteroids for sciatica does not provide any additional benefit when compared to local anaesthetic injection alone. Corticosteroids do not obviate the need for subsequent interventions such as additional root blocks or surgery.

Recreational drug use and risk of Kaposi's sarcoma in HIV- and HHV-8-coinfected homosexual men.

Experimental data suggested that exposure to recreational drugs might adversely affect antitumor immunity, which led us to examine the hypothesis that use of marijuana, cocaine, poppers, and amphetamines might increase the risk of Kaposi's sarcoma (KS) in HIV- and HHV-8-coinfected homosexual men. We analyzed data prospectively collected from the Multicenter AIDS Cohort Study (MACS) between 1984 and 2002. Among the 1335 HIV- and HHV-8-coinfected white men, 401 KS cases were identified. Multivariable Cox regression models were used to estimate the effects of time-varying recreational drug use on KS risk adjusting for potential confounders. The effects of both recent use (6 months prior) of recreational drugs and lagged exposure (i.e., use from 3 and 5 years prior) were examined. We did not observe any clear association with KS for recent use of any of the four drugs. In the analyses using lagged exposures, KS risk was associated with use of poppers 3-5 years prior [hazard ratio (HR)(3 years prior) = 1.27, 95% CI (0.97-1.67), HR(5 years prior) = 1.46 (1.01-2.13)]. However, no clear dose-response relationship was observed. These findings do not support a biological association between use of these substances and KS development in HIV- and HHV-8-coinfected homosexual men.

Associations between variants of the 8q24 chromosome and nine smoking-related cancer sites.

Recent genome-wide association studies identified key single nucleotide polymorphisms (SNPs) in the 8q24 region to be associated with prostate cancer. 8q24 SNPs have also been associated with colorectal cancer, suggesting that this region may not be specifically associated to just prostate cancer. To date, the association between these polymorphisms and tobacco smoking-related cancer sites remains unknown. Using epidemiologic data and biological samples previously collected in three case-control studies from U.S. and Chinese populations, we selected and genotyped one SNP from each of the three previously determined "regions" within the 8q24 loci, rs1447295 (region 1), rs16901979 (region 2), and rs6983267 (region 3), and examined their association with cancers of the lung, oropharynx, nasopharynx, larynx, esophagus, stomach, liver, bladder, and kidney. We observed noteworthy associations between rs6983267 and upper aerodigestive tract cancers [adjusted odds ratio (ORadj), 1.69; 95% confidence interval (95% CI), 1.28-2.24], particularly in oropharynx (ORadj, 1.80; 95% CI, 1.30-2.49) and larynx (ORadj, 2.04; 95% CI, 1.12-3.72). We also observed a suggestive association between rs6983267 and liver cancer (ORadj, 1.51; 95% CI, 0.99-2.31). When we stratified our analysis by smoking status, rs6983267 was positively associated with lung cancer among ever-smokers (ORadj, 1.45; 95% CI, 1.05-2.00) and inversely associated with bladder cancer among ever-smokers (ORadj, 0.35; 95% CI, 0.14-0.83). Associations were observed between rs16901979 and upper aerodigestive tract cancer among never-smokers and between rs1447295 and liver cancer among ever-smokers. Our results suggest variants of the 8q24 chromosome may play an important role in smoking-related cancer development. Functional and large epidemiologic studies should be conducted to further investigate the association of 8q24 SNPs with smoking-related cancers.

Randomised placebo-controlled trial on the effectiveness of nasal salmon calcitonin in the treatment of lumbar spinal stenosis.

This is a double blind randomised controlled trial to assess the effectiveness of nasal salmon calcitonin in the treatment of lumbar spinal stenosis. The trial compared the outcome of salmon calcitonin nasal spray to placebo nasal spray in patients with MRI confirmed lumbar spinal stenosis. Lumbar spinal stenosis is one of the commonest conditions encountered by spine surgeons. It more frequently affects elderly patients and lumbar decompression has been used to treat the condition with variable success. Non operative measures have been investigated, but their success ranges from 15% to 43% in patients followed up for 1-5 years (Simotas in Clin Orthop 1(384):153-161, 2001). Salmon calcitonin injections have been investigated in previous trials and may have a treatment effect. Nasal salmon calcitonin has become available and if effective would have advantages over injections. Forty patients with symptoms of neurogenic claudication and MRI proven lumbar spinal stenosis were randomly assigned either nasal salmon calcitonin or placebo nasal spray to use for 4 weeks. This was followed by a 'washout' period of 6 weeks, and subsequent treatment with 6 weeks of nasal salmon calcitonin. Standard spine outcome measures including Oswestry disability index (ODI), low back outcome score, visual analogue score and shuttle walking test were administered at baseline, 4, 10 and 16 weeks. Twenty patients received nasal salmon calcitonin and twenty patients received placebo nasal spray. At 4 weeks post treatment there was no statistically significant difference in the outcome measures between the two groups. The change in ODI was a mean 1.3 points for the calcitonin group and 0.6 points for the placebo group (P = 0.51), the mean change in visual analogue score for leg pain was 10 mm in the calcitonin group and 0 mm in the placebo group (P = 0.51). There was no significant difference in walking distance between the two groups, with a mean improvement in walking distance of 21 m in the calcitonin group and 8 m in the placebo group (P = 0.78). At the end of the trial the ODI had improved by a mean of 3.7 points in the calcitonin group and 3.8 points in the placebo group (P = 0.44). This randomised placebo controlled trial has not shown any treatment effect in patients with lumbar spinal stenosis treated with nasal salmon calcitonin.

The effect of duration of symptoms on standard outcome measures in the surgical treatment of spinal stenosis.

The effect of the duration of symptoms on the outcome of lumbar decompression surgery is not known. The aim of our study was to determine the predictors of functional outcome of lumbar decompression surgery for degenerative spinal stenosis with particular emphasis on the duration of symptoms. In this prospective cohort study, we recruited 100 patients with a full data set available at 1-year and 85% at 2-year follow-ups: 49 females and 51 males with an average age of 62 (range 52-82). The pre- and post-operative outcome measures were Oswestry disability index (ODI), low back outcome score (LBOS), pain visual analogue score (VAS), modified somatic perception (MSP) and modified Zung depression (MZD) score. Dural tear occurred in 14%, and there was one post-operative extra-dural heamatoma. Overall, the ODI improved from a pre-operative of 56 (+/-13) to a 1-year ODI of 40 (+/-22) and at 2-year ODI of 40 (+/-21). The VAS improved from an average of 8 to 5.2 at 1 year and 4.9 at 2 years. There was a statistical significant association between symptom duration and the change in ODI (P=0.007 at 1-year follow-up, P=0.001 at 2-year follow-up), LBOS (P=0.001 at 1-year follow-up, P<0.001 at 2-year follow-up) and VAS (P=0.003 at 1-year follow-up, P=0.001 at 2-year follow-up). Subgroup analyses showed that patients with symptom duration of less than 33 months had a more favourable result. In addition, the patients who rated the operation as excellent had a statistically significantly shorter duration of symptoms. We have not found a predictive value for age at operation, MSP or MZD. The number of levels of decompression and the different types of decompression surgery did not influence the surgical results. Our study indicates that the symptom duration of more than 33 months has a less favourable functional outcome.

The efficacy of corticosteroids in periradicular infiltration for chronic radicular pain: a randomized, double-blind, controlled trial.

STUDY DESIGN: A randomized, double-blind controlled trial. OBJECTIVES: To determine the treatment effect of corticosteroids in periradicular infiltration for chronic radicular pain. We also examined prognostic factors in relation to the outcome of the procedure. SUMMARY OF BACKGROUND DATA: Various studies have examined the therapeutic value of periradicular infiltration using treatment agents consisting of local anesthetic and corticosteroids for radicular pain, secondary to lumbar disc herniation and spinal stenosis. There is currently no randomized trial to determine the efficacy of a single injection of corticosteroids for chronic radicular pain. METHODS: Eligible patients with radicular pain who had unilateral symptoms who failed conservative management were randomized for a single injection with bupivacaine and methylprednisolone or bupivacaine only. Outcome measures included the Oswestry Disability Index, visual analogue score for back pain and leg pain, claudication walking distance, and the patient's subjective level of satisfaction of the outcome. RESULTS: We recruited 43 patients in the bupivacaine and methylprednisolone group and 43 patients in the bupivacaine only group. The follow-up rate is 100%. Five patients had early termination of the trial for discectomy and further root block. There is no statistically significant difference in the outcome measures between the groups at 3 months (change of the Oswestry Disability Index [P = 0.68], change in visual analogue score [back pain, P = 0.68; leg pain, P = 0.94], change in walking distance [P = 0.7]). Duration of symptoms has a statistically significant negative association with the change in Oswestry Disability Index (P = 0.03). CONCLUSION: Clinical improvement occurred in both groups of patients. Corticosteroids did not provide additional benefit.

Complications and functional outcome following fixation of complex, intra-articular fractures of the distal radius with the AO Pi-Plate.

This study investigates the efficacy of the AO Pi-plate in the treatment of complex, intra-articular fractures of the distal radius. We retrospectively analysed the clinical and radiological results of 19 consecutive patients who underwent open reduction and internal fixation for dorsally displaced, intra-articular fractures of the distal radius using the AO Pi-plate. The final functional outcome was assessed using the Gartland & Werley scoring system. The average follow-up period was 34.3 months. Wrist movement was restored to a near normal range in all the patients. The functional outcome as measured by the Gartland & Werley scoring system showed excellent and good results in 15 (88%) of the patients. The implant was removed in 4 (23%) of the patients due to extensor tenosynovitis and restriction of flexion. This study demonstrates that although the functional outcome following fixation of complex distal radius fractures with the AO Pi-plate is good, there is a risk of developing extensor tenosynovitis and limitation of flexion. We recommend that the implant be used sparingly and if used then elective removal of the implant should be considered after fracture union.