Efficacy and tolerability of milnacipran and escitalopram: a comparative study among patients of depression

Background: The present prospective, open labelled study was designed to evaluate the efficacy and tolerability of escitalopram, selective serotonin reuptake inhibitors (SSRI) in comparison with milnacipran, dual serotonin and noradrenaline reuptake inhibitors (SNRI) in the treatment of major depressive disorder.Methods: Outpatients (N=120) with an ongoing/newly diagnosed ICD-10 major depressive episode and having a minimum score of 8 on the 21-item Hamilton Depression Rating Scale (HDRS) were assigned to escitalopram, 10–20 mg/day (54 patients) and milnacipran 50-100mg (66 patients), for an 8 week treatment period with follow up at 2nd, 4th and 8th week. The parameters for efficacy were improvement (decrease in HDRS scores at 8 weeks from baseline values), response (decrease of ≥50% in the HDRS scores) and remission (HDRS score of ≤7). Tolerability was assessed by comparing the frequency of adverse effects and drop out rate due to the same at the end of 2nd, 4th and 8th week in both the groups.Results: Improvement, Response rate and Remission rates at the end of eight weeks were 71.11%, 83.33% and58.33% for escitalopram and 59.35%, 34.14% and75.6% for milnacipran respectively. Adverse experiences were reported by 14% of patients in escitalopram group and 79.2% patients in milnacipran group at 8 weeks. Additionally, there were significantly lesser dropouts due to adverse events in escitalopram (3.70%) than in milnacipran group (30%).Conclusions: Escitalopram, the Senantiomer of citalopram, is a safe and effective antidepressant with potentially superior tolerability and comparable efficacy to the dual reuptake inhibitor, Milnacipran

Antibiotic susceptibility pattern of bacteria isolated from patients of respiratory tract infection in a tertiary care hospital of Central India

Background: Respiratory tract infections are one of the commonest types of infections affecting the Indian population and are a significant cause of morbidity and mortality. To deal with multidrug resistance one should be armed with region specific data about the susceptibility patterns of antimicrobials. This study was planned to identify the common pathogens responsible for the respiratory tract infection and their antibiotic susceptibility patterns.Methods: Smears were prepared from the specimens and gram stains of all clinical samples were done. The organisms were grown on various media and identified according to the standard procedures. The susceptibility patterns of the bacterial pathogens were determined following the panel of antimicrobial agents. Descriptive statistics were used for data analysis.Results: Out of 513 samples 471 samples were further processed. Klebsiella (30.42%) was found to be commonest pathogen followed by Pseudomonas (28.36%). Ampicillin and piperacillin /tazobactam combination were found to be highly efficient against Pseudomonas (83% and 58.8% respectively), E. coli (68% and 50.7% respectively), and Klebsiella (43% and 30.3% respectively). Conclusions: In our study, we found penicillins as the most efficacious antimicrobials to treat respiratory pathogens. The study reveals that the antibiotic susceptibility pattern varies across regions. The prescription of a right antibiotic, for a right patient will help to minimize the menace of emergence of antimicrobial resistance

Knowledge, attitude and practices of pharmacovigilance among the postgraduate and undergraduate medical students in a tertiary care hospital in Central India

Background: Adverse Drug Reactions (ADRs) are one of the underestimated causes of morbidity and mortality. Monitoring of these ADRs is at the core of any pharmacovigilance program. ADR monitoring suffers from lack of reporting from health care personnels. Unless we know the current knowledge, attitude and practices of the budding doctors it’s difficult to design corrective measures to improve reporting. The present study was designed to assess the knowledge, attitude and practices of pharmacovigilance and ADR reporting among undergraduate and postgraduate medical students.Methods: This was a questionnaire-based, observational study. The questionnaire had six questions each pertaining to knowledge, attitude and practices of pharmacovigilance and ADR reporting. Factors discouraging ADR reporting were also studied. Descriptive statistics were carried out and one-way ANOVA was applied to find the statistical difference between the groups.Results: A total of 288 subjects were approached for the study of which 229 agreed to participate. It was observed that the knowledge of the participants regarding ADR reporting and pharmacovigilance was satisfactory. 68% of respondents felt that educational programmes have a positive effect on ADR reporting. 15% of respondents admitted of having reported an ADR. The mean scores of knowledge, attitude and practices of ADR reporting were considerably higher in postgraduates as compared to undergraduates (p-value <0.05).Conclusions: The study concluded that participants of study were aware of the importance of ADR reporting but it did not reflect in their practices. There is a need to create awareness and to educate these future physicians about Pharmacovigilance

Biofabrication of customized bone grafts by combination of additive manufacturing and bioreactor knowhow

This study reports on an original concept of additive manufacturing for the fabrication of tissue engineered constructs (TEC), offering the possibility of concomitantly manufacturing a customized scaffold and a bioreactor chamber to any size and shape. As a proof of concept towards the development of anatomically relevant TECs, this concept was utilized for the design and fabrication of a highly porous sheep tibia scaffold around which a bioreactor chamber of similar shape was simultaneously built. The morphology of the bioreactor/scaffold device was investigated by micro-computed tomography and scanning electron microscopy confirming the porous architecture of the sheep tibiae as opposed to the non-porous nature of the bioreactor chamber. Additionally, this study demonstrates that both the shape, as well as the inner architecture of the device can significantly impact the perfusion of fluid within the scaffold architecture. Indeed, fluid flow modelling revealed that this was of significant importance for controlling the nutrition flow pattern within the scaffold and the bioreactor chamber, avoiding the formation of stagnant flow regions detrimental for in vitro tissue development. The bioreactor/scaffold device was dynamically seeded with human primary osteoblasts and cultured under bi-directional perfusion for two and six weeks. Primary human osteoblasts were observed homogenously distributed throughout the scaffold, and were viable for the six week culture period. This work demonstrates a novel application for additive manufacturing in the development of scaffolds and bioreactors. Given the intrinsic flexibility of the additive manufacturing technology platform developed, more complex culture systems can be fabricated which would contribute to the advances in customized and patient-specific tissue engineering strategies for a wide range of applications.This work was supported by the NHMRC, the Australian Research Council and Hans Fischer Senior Fellowship, IAS-TUM. Pedro Costa acknowledges the Portuguese Foundation for Science and Technology for his PhD grant (SFRH/BD/62452/2009)

Additive tissue manufacturing for breast reconstruction: Combining CAD/CAM with adipose tissue engineering

The primary aim of this multidisciplinary project was to develop a new generation of breast implants. Disrupting the currently prevailing paradigm of silicone implants which permanently introduce a foreign body into mastectomy patients, highly porous implants developed as part of this PhD project are biodegradable by the body and augment the growth of natural tissue. Our technology platform leverages computer-assisted-design which allows us to manufacture fully patient-specific implants based on a personalised medicine approach. Multiple animal studies conducted in this project have shown that the polymeric implant slowly degrades within the body harmlessly while the body's own tissue forms concurrently

Efficacy and tolerability of milnacipran and escitalopram: a comparative study among patients of depression

Background: The present prospective, open labelled study was designed to evaluate the efficacy and tolerability of escitalopram, selective serotonin reuptake inhibitors (SSRI) in comparison with milnacipran, dual serotonin and noradrenaline reuptake inhibitors (SNRI) in the treatment of major depressive disorder.Methods: Outpatients (N=120) with an ongoing/newly diagnosed ICD-10 major depressive episode and having a minimum score of 8 on the 21-item Hamilton Depression Rating Scale (HDRS) were assigned to escitalopram, 10–20 mg/day (54 patients) and milnacipran 50-100mg (66 patients), for an 8 week treatment period with follow up at 2nd, 4th and 8th week. The parameters for efficacy were improvement (decrease in HDRS scores at 8 weeks from baseline values), response (decrease of ≥50% in the HDRS scores) and remission (HDRS score of ≤7). Tolerability was assessed by comparing the frequency of adverse effects and drop out rate due to the same at the end of 2nd, 4th and 8th week in both the groups.Results: Improvement, Response rate and Remission rates at the end of eight weeks were 71.11%, 83.33% and58.33% for escitalopram and 59.35%, 34.14% and75.6% for milnacipran respectively. Adverse experiences were reported by 14% of patients in escitalopram group and 79.2% patients in milnacipran group at 8 weeks. Additionally, there were significantly lesser dropouts due to adverse events in escitalopram (3.70%) than in milnacipran group (30%).Conclusions: Escitalopram, the Senantiomer of citalopram, is a safe and effective antidepressant with potentially superior tolerability and comparable efficacy to the dual reuptake inhibitor, Milnacipran

Sustained regeneration of high-volume adipose tissue for breast reconstruction using computer aided design and biomanufacturing

Adipose tissue engineering offers a promising alternative to the current breast reconstruction options. Here we investigated patient-specific breast scaffolds fabricated from poly(D.L)-lactide polymer with pore sizes >1mm for their potential in long-term sustained regeneration of high volume adipose tissue. An optimised scaffold geometry was modelled in silico via a laser scanning data set from a patient who underwent breast reconstruction surgery. After the design process scaffolds were fabricated using an additive manufacturing technology termed fused deposition modelling. Breast-shaped scaffolds were seeded with human umbilical cord perivascular cells and cultured under static conditions for 4 weeks and subsequently 2 weeks in a biaxial rotating bioreactor. These invitro engineered constructs were then seeded with human umbilical vein endothelial cells and implanted subcutaneously into athymic nude rats for 24 weeks. Angiogenesis and adipose tissue formation were observed throughout all constructs at all timepoints. The percentage of adipose tissue compared to overall tissue area increased from 37.17% to 62.30% between week 5 and week 15 (p<0.01), and increased to 81.2% at week 24 (p<0.01), while the seeded endothelial cells self-organised to form a functional capillary network. The presented approach of fabricating customised scaffolds using 3D scans represents a facile approach towards engineering clinically relevant volumes of adipose tissue for breast reconstruction

Transformation of Breast Reconstruction via Additive Biomanufacturing

Adipose tissue engineering offers a promising alternative to current breast reconstruction options. \ud However, the conventional approach of using a scaffold in combination with adipose-derived precursor \ud cells poses several problems in terms of scalability and hence clinical feasibility. Following the body-as-\ud a-bioreactor approach, this study proposes a unique concept of delayed fat injection into an additive \ud biomanufactured and custom-made scaffold

Additive manufacturing in biomedical sciences and the need for definitions and norms

The application of additive biomanufacturing represents one of the most rapidly advancing areas of biomedical science, in which engineers, scientists, and clinicians are contributing to the future of health care. The combined efforts of a large number of groups around the globe have developed a strong research thrust that has resulted in a large number of publications. Reviewing this body of literature, there is an increasing trend of research groups inventing their own definitions and terminology. This has made it difficult to find and compare the results. Therefore, to move the field constructively forward, it is a conditio sine qua non to clarify various terminologies and standards. Based on this background, this article advocates tightening the terminology and has the objective of penning out definitions that will ultimately allow the development of official industry standard terms, such as American Society for Testing and Materials and or International Organization for Standardization for technologies developed for Tissue Engineering and Regenerative Medicine