Objectives: We developed versions 2 and 3 of the Biological Prognostic Score (BPS) for advanced cancer patients and confirmed the prediction accuracy. Methods: We conducted a parametric survival analysis using blood test data, performance status (PS), clinical symptoms, age, sex, and cancer type as variables for advanced cancer patients who completed or suspended cancer treatment, in the development of BPS2 and BPS3. We then prospectively compared the accuracy between BPS2/BPS3 and the Palliative Prognostic Index (PPI). Results: We developed the BPS2 and BPS3 based on the data from 589 patients in a development cohort. While the former version was calculated based on the cholinesterase, blood urea nitrogen, and white blood cell counts, the latter was calculated based on the BPS2, ECOG PS and edema. For 206 patients in a validation cohort, the overall accuracy in prediction of survival for 3 and 6 weeks using the BPS2 and BPS3 were significantly higher than those for the PPI. Conclusion: The usefulness of BPS2 and BPS3 was suggested.

Objective: To develop and confirm the validity of a Biological Prognostic Score using only blood test results for prediction of prognosis in patients with advanced cancer. Methods: We conducted parametric survival time analysis using blood test results, age, sex, and primary diagnosis as independent variables, and event of death as a dependent variable, among patients in a palliative care unit (a development cohort). We then developed the Biological Prognostic Score (BPS). Thereafter, we confirmed the accuracy of the BPS and the Palliative Prognostic Index (PPI) prospectively among patients, who withdrew or withheld further curative or life-prolonging therapies, in other facilities (a validation cohort). Results: We developed the BPS, which consists of cholinesterase, blood urea nitrogen, and total iron-binding capacity, from 122 patients in a development cohort. We then examined 195 patients in a validation cohort and found that the area under the receiver operating characteristic curve for 1-9 week survival prediction was BPS=0.76-0.86 and PPI=0.69-0.73. Discussion: Our results suggest that the BPS was valid. It will be necessary to perform further examinations in multiple facilities and to explore more generalized parameters that could replace total iron-binding capacity in our BPS.

Pathogens handled in a Biosafety Level 3 (BSL-3) containment laboratory pose significant risks to laboratory staff and the environment. It is therefore necessary to develop competency and proficiency among laboratory workers, and promote behaviors and practices that enhance safety through biosafety training. Following installation of our BSL-3 laboratory at the Center for Microbiology Research-Kenya Medical Research Institute, in 2006, a biosafety training program was developed to provide training on BSL-3 safety practices and procedures. The training program was developed based on the World Health Organization specifications, with adjustments to fit our research activities and biosafety needs. The program is composed of three phases namely; initial assessment, a training phase that includes theory and practicum, and final assessment. This article reports the content of our training program.

A biocontainment facility is a core component in any research setting due to the services it renders towards comprehensive biosafety observance. The NUITM-KEMRI P3 facility was set up in 2007 and has been actively in use since 2010 by researchers from this and other institutions. A number of hazardous agents have been handled in the laboratory among them MDR-TB and yellow fever viruses. The laboratory has the general physical and operational features of a P3 laboratory in addition to a number of unique features, among them the water-air filtration system, the eco-mode operation feature and automation of the pressure system that make the facility more efficient. It is equipped with biosafety and emergency response equipments alongside common laboratory equipments, maintained regularly using daily, monthly and yearly routines. Security and safety is strictly observed within the facility, enhanced by restricted entry, strict documentation and use of safety symbols. Training is also engrained within the operation of the laboratory and is undertaken and evaluated annually. Though the laboratory is in the process of obtaining accreditation, it is fully certified courtesy of the manufactures’ and constructed within specified standards.

Pathogens handled in a Biosafety Level 3 (BSL-3) containment laboratory pose significant risks to laboratory staff and the environment. It is therefore necessary to develop competency and proficiency among laboratory workers and to promote appropriate behavior and practices that enhance safety through biosafety training. Following the installation of our BSL-3 laboratory at the Center for Microbiology Research-Kenya Medical Research Institute in 2006, a biosafety training program was developed to provide training on BSL-3 safety practices and procedures. The training program was developed based on World Health Organization specifications, with adjustments to fit our research activities and biosafety needs. The program is composed of three phases, namely initial assessment, a training phase including theory and a practicum, and a final assessment. This article reports the content of our training program.

Methods: This prospective, single-arm study included 11 patients (eight men; mean age, 62.7 years) with ≥3-months’ chronic pain history due to lumbar disease. Subcutaneous TCZ injections were administered twice, at a 2-week interval. We evaluated low back pain, leg pain, and leg numbness using numeric rating scales and the Oswestry Disability Index (ODI; baseline and 6 months postinjection); serum IL-6 and tumor necrosis factor-α levels (baseline and 1 month postinjection); and clinical adverse events. Results: Intractable symptoms reduced after TCZ administration. Low back pain improved for 6 months. Improvements in leg pain and numbness peaked at 4 and 1 month, respectively. Improvements in ODI were significant at 1 month and peaked at 4 months. Serum IL-6 was increased at 1 month. IL-6 responders (i.e., patients with IL-6 increases >10 pg/mL) showed particularly significant improvements in leg pain at 2 weeks, 1 month, and 2 months compared with nonresponders. We observed no apparent adverse events. Conclusions Systemic TCZ administration improved symptoms effectively for 6 months, with peak improvements at 1–4 months and no adverse events. Changing serum IL-6 levels correlated with leg pain improvements; further studies are warranted to elucidate the mechanistic connections between lumbar disorders and inflammatory cytokines.

Methods: A total of 14 patients with unilateral radicular symptoms and five healthy subjects were subjected to simultaneous apparent T2 mapping and neurography with nerve-sheath signal increased with inked rest-tissue rapid acquisition of relaxation enhancement signaling (SHINKEI-Quant) using a 3-Tesla magnetic resonance imaging. The Visual Analog Scale (VAS) score for neck pain and upper arm pain was used to evaluate clinical symptoms. T2 relaxation times of the cervical dorsal root ganglia of the brachial plexus were measured bilaterally from C4 to C8 in patients with radicular symptoms and from C5 to C8 in healthy controls. The T2 ratio was calculated as the affected side to unaffected side. Results: When comparing nerve roots bilaterally at each spinal level, no significant differences in T2 relaxation times were found between patients and healthy subjects. However, T2 relaxation times of nerve roots in the patients with unilateral radicular symptoms were significantly prolonged on the involved side compared with the uninvolved side (p<0.05). The VAS score for upper arm pain was not significantly correlated with the T2 relaxation times, but was positively correlated with the T2 ratio. Conclusions In patients with cervical radiculopathy, the SHINKEI-Quant technique can be used to quantitatively evaluate the compressed cervical nerve roots. The VAS score for upper arm pain was positively correlated with the T2 ratio. This suggests that the SHINKEI-Quant is a potential tool for the diagnosis of cervical nerve entrapment.

Purpose: In this multicenter retrospective observational study, we examined the early effects of romosozumab in patients with severe osteoporosis in terms of time-course changes in bone metabolism marker, improvement in bone density, and adverse effects. Materials and Methods: Patients with severe osteoporosis were included. We investigated the progress of TRACP 5b and P1NP before and 1–2 months after the administration of romosozumab. We also investigated the bone density of lumbar spine, femoral neck, and the entire femur, measured by the DXA method, before and 5–7 months after the administration of romosozumab. Results: A total of 70 patients (7 males and 63 females, age 75.0±3.6 years) participated in this study. Significant improvements in TRACP 5b and P1NP levels were observed before and 1–2 months after romosozumab administration. The average bone density of lumbar spine, femoral neck, and the entire femur were measured before and 5–7 months after romosozumab administration;and a significant increase only observed in the lumbar spine. Conclusion Consistent with the findings of previous clinical studies, romosozumab has both bone formation-enhancing and bone resorption effects (dual effect). In addition, romosozumab also demonstrated improvement in bone density from the early phase after the administration, though the result was only seen in the lumbar spine.

Purpose: In this multicenter retrospective observational study, we examined the early effects of romosozumab in patients with severe osteoporosis in terms of time-course changes in bone metabolism marker, improvement in bone density, and adverse effects. Materials and Methods: Patients with severe osteoporosis were included. We investigated the progress of TRACP 5b and P1NP before and 1–2 months after the administration of romosozumab. We also investigated the bone density of lumbar spine, femoral neck, and the entire femur, measured by the DXA method, before and 5–7 months after the administration of romosozumab. Results: A total of 70 patients (7 males and 63 females, age 75.0±3.6 years) participated in this study. Significant improvements in TRACP 5b and P1NP levels were observed before and 1–2 months after romosozumab administration. The average bone density of lumbar spine, femoral neck, and the entire femur were measured before and 5–7 months after romosozumab administration;and a significant increase only observed in the lumbar spine. Conclusion Consistent with the findings of previous clinical studies, romosozumab has both bone formation-enhancing and bone resorption effects (dual effect). In addition, romosozumab also demonstrated improvement in bone density from the early phase after the administration, though the result was only seen in the lumbar spine.