A Randomized Controlled Trial to Assess the Effects of Oral Alkali Therapy in Patients with Diabetic Kidney Disease

Background: To analyze the effects of oral alkali therapy on renal function, nutritional status and bone density in patients of diabetic kidney disease. Material & Methods: A randomized controlled trial was conducted on 60 patients of age>18 years with diabetic kidney disease who were not on dialysis and had plasma bicarbonate levels between 16 and 20 mmol/l. Patients were randomly divided into two groups: Test group (n=30) which received oral alkali therapy as sodium bicarbonate and control group (n=30) who did not receive oral alkali therapy. The patients were followed for 12 months to compare the improvement. Results: In comparison to controls, test group showed a significant improvement in the Hb (0.7 vs. 0.25, P =0.003), significantly less decrease in eGFR (-2.25 vs. -2.9, P=0.049), non-significant less increase in creatinine (-0.26 ± 0.4 vs. -0.43 ± 0.33, P=0.09), significant improvement in bicarbonate levels (7.5 vs. 1, p<0.0001), significant restoration of albumin (0.32 vs. 0.05, P<.0001), significant fall in iPTH levels (50 vs. 25, p=0.007) and ALP levels (32 vs. 12, p=0.015). Bone density (0.28 ± 0.17 vs. 0.01 ± 0.13, P<.0001) and clinical well-being VAS scores improved significantly among the cases (9.83 ± 5.65 vs. -1.67 ± 7.11, P<.0001). Conclusion: In conclusion, oral alkali therapy slows the rate of decline of renal function and the development of end stage renal disease in patients with advanced stages of CKD. This cheap and simple strategy, which is in line with current renal consensus documents, also improves the nutritional status of patients and bone density.

Rituximab, a Safer Option for Rheumatoid Arthritis: A Comparison of the Reported Adverse Events of Approved Monoclonal Antibodies

Monoclonal antibodies (mAbs), which are commonly used to treat rheumatoid arthritis (RA), have been linked to a variety of adverse events (AEs). The objective of the study was to compare the safety profiles of six FDA approved mAbs (sarilumab, tocilizumab, adalimumab, golimumab, infliximab, and rituximab) marketed for the treatment of RA. A systematic review of the literature was conducted using the databases PubMed, Cochrane Library, and Science Direct. The manuscript comprised a total of 23 clinical studies. The percentage of patients who had AEs was calculated and presented using box-whisker and forest plots. Infections and infestations were found to be the most common AEs in RA patients treated with mAbs. Raised alanine aminotransferase (ALT), aspartate aminotransferase (AST), upper respiratory tract infection (URTI), and nasopharyngitis were frequently reported. The most common AEs were reported with adalimumab. The highest percentage of patients reporting AEs was associated with golimumab (52%), while rituximab had the fewest AEs (4.9%). In conclusion, rituximab appears to be a safer treatment option for RA as it is found to be associated with a lower risk of AEs, particularly respiratory infections.

The Burden of Histoid Leprosy in Post Elimination Era

Histoid leprosy is a rare variant of lepromatous leprosy, may occur de novo or may occur in cases earlier treated with dapsone monotherapy. Demographic, clinico-histopathological and treatment details of biopsy proven cases of histoid leprosy, collected retrospectively from the leprosy clinic of tertiary care hospital of SMS Medical College, Jaipur. During the study period of 5 years (2011-2016), 28 (2.98 %), patients had histoid leprosy among total 937 patients of leprosy. Most were in 21 – 40 years of age group with M: F ratio 2.5: 1. Histoid lesions developed with primary diagnosis of lepromatous leprosy in (71.4%) and de novo in (28.6%). Predominant site of involvement was upper extremity (85.7%) and most common presentation was subcutaneous nodules, Nerve thickening seen in (85.7%), and ulnar nerve being most common. Neuritis and disabilities were present in 6 and 16 patients respectively. Type 2 reaction seen in17.9% (5/28) patients. Biopsy and slit skin smear of all cases were done. Most (25/28) cases responded well to standard one-year multibacillary drug therapy (MDT), it had to be extended in three cases up to 2 years. Histoid leprosy may occur de novo or may be due to inadequate therapy, resistant strains, earlier dapsone monotherapy. Although India as whole has achieved leprosy elimination in January 2006, however new cases continue to be reported. Occurrence of histoid leprosy specially with changed morphology of the lesions and poor histopathological correlation needs to be investigated as these cases may be important source of infection even in low endemic situations.

Comparison of adverse effects of trastuzumab with other drug combinations for the treatment of breast cancer: A review

OBJECTIVES: This study compares the adverse effects (AEs) associated with trastuzumab in the treatment of human epidermal growth factor receptor 2-positive breast cancer (HER-2 + BC) when used alone or in combination with chemotherapy or with tyrosine kinase inhibitors, so as to aid in rational treatment choices. MATERIALS AND METHODS: An electronic search was conducted on PubMed using the Mesh terms ‘BC’, ‘HER-2 positive’, ‘metastasis BC, ‘trastuzumab’, and ‘safety’. Data from 32 studies regarding AEs were extracted and categorised as trastuzumab + chemotherapy (T+C), trastuzumab biosimilar (Tb), trastuzumab + tyrosine kinase inhibitors+ chemotherapy (T+TKi+C), and trastuzumab + tyrosine kinase inhibitors (T+TKi). The data are presented as the mean percentage of AEs. The statistical comparison was represented by a box and whisker plot of the interquartile range value of AEs. RESULTS: AEs related to the gastrointestinal tract, skin, nervous, blood, and lymph were reported to be the most common in T+C, T+TKi+C, and T+TKi. Nausea, vomiting, diarrhoea, constipation, neuropathy peripheral, alopecia, rash, anaemia, leucopenia, raised aspartate transaminase and alanine transaminase were the most common complaints. AEs such as myalgia, nasopharyngitis, hypertension, and ejection fraction decrease was reported to be the most common in Tb. CONCLUSION: This study concluded that biosimilar of trastuzumab is safest for the treatment of HER-2-positive BC. Cardiovascular disorder is often reported in the biosimilar group, but this group has fewer AEs reported as compared with chemotherapy, and tyrosine kinase inhibitors groups related to other systems such as digestive, nervous, and respiratory. The choice of combination is depending on the type of BC and the condition of the patients. The patients must monitor for cardiotoxicity when the biosimilar of trastuzumab is used.

Systematic Review and Meta-Analysis Comparing the Safety of Natalizumab, Ocrelizumab, and Alemtuzumab in Treating Relapsing–Remitting, Primary Progressive, and Secondary Progressive Multiple Sclerosis

Three monoclonal antibodies—natalizumab (NTZ), ocrelizumab (OCR), and alemtuzumab (ALM)—are the mainstays for the treatment of both relapsing and progressive forms of multiple sclerosis (MS). Here, their safety in patients with MS is analyzed and compared for rational use, especially during the COVID-19 pandemic. All clinical studies published between 2016 and 2020 with the primary outcome of the occurrence of adverse events (AEs) with the use of NTZ, OCR, and ALM in the treatment of MS were systematically searched in the PubMed database. In this review, the percentage of patients reporting AEs was calculated and compared. The most common AEs associated with the use of NTZ, OCR, and ALM were infection and infestation. The percentage of patients reporting urinary tract infection, upper respiratory tract infection, and herpes was 16% using natalizumab, 7% using natalizumab and ocrelizumab, and 2% with ocrelizumab, respectively. The most common AEs, such as rashes, pyrexia, and influenza, were reported with ocrelizumab and alemtuzumab. Additionally, alemtuzumab was associated with immune thrombocytopenia (2%), respiratory infections (7%), and thyroid dysfunction (43%). All these data outcomes show that of the three monoclonal antibodies, natalizumab and ocrelizumab were associated with a reduced incidence of adverse events, making them a safer choice for MS.

Effect Of Photodynamic Therapy In The Management Of Periodontal Disease - A Systematic Review

Background:Periodontitis is multifactorial disease which is initiated with plaque formation that will initiate an inflammatory response which can cause destruction of tissues & tooth supporting structure. If left untreated it will cause gingival recession and bone destruction which will lead to tooth mobility. Sometimes it is difficult to eliminate periodontal pathogens completely from deepest areas of periodontal pockets, to overcome these issues photodynamic therapy (PDT) was used as it is local non-invasive treatment modality without any side effects. Aim:The aim of present study was to investigate the effectiveness of Photodynamic Therapy (PDT) as an Adjunct To Scaling & Root Planing in the managementOf Periodontal Disease. Material And Methods:Literature was searched systemically and studies were identified based on the-PICO (Glossary of Evidence Based Terms 2007). Electronic database search of Pubmed, Google scholar, Medline and scopus was performed using (MESH) terms-Photodynamictherapy,periodontitis, microbiological assessment. Articles published between year 2009-2019 were reviewed. Patient treated with SRP alone on one side and other side with SRP+ PDT. Recording of Clinical parameters like PPD,CAL,BOP,PS,GR were done from baseline to 3,6 month. Microbiological and biochemical analysis were also evaluated to check level of RANKL/OPG, IL-1?, TNF-?, Aggregatibacter actenomycetocomitans, Porphyromonas gingivalis, Tanerella forsythia Conclusion::A large evidence suggest that PDT when used along with SRP resulted in significantimprovement in clinical parameters.Significant improvement in biochemical parameters such as IL-1? , Tnf-? , RANKL/OPG were also seen after periodontal therapy along with PDT when compared with SRP alone.

A study to know the various causes of pleural effusion and role of pleural fluid adenosine deaminase enzyme in tuberculous pleural effusion

Background: India has the maximum burden of both non MDR tuberculosis (TB) and Multidrug-Resistant (MDR) TB, as per data reported in Global TB Report 2018 and tuberculosis is remains one of the most common cause of pleural effusions.Methods: This was a cross-sectional study conducted in Department of Respiratory Diseases and a total of 110 patients with pleural effusion were included in the study, which were enrolled for treatment from July 2018 to June 2019.Results: One hundred and ten patients with pleural effusion were enrolled during the study period. There were 65 males (59%) and 45 (40.9%) females.  The overall mean age for males and females were 44.4±18.84 years (35-87 years) and 38.28±17.66 years (35-87 years) respectively. Tuberculous Pleural Effusion group (TPE) seen in 82 patients. Right sided pleural effusion (69.5 %) were more common than left sided (30.4 %). In TPE group the mean pleural fluid ADA level were 86.41±38.08 IU/L (range: 14-195 IU/L). The Malignant Pleural Effusion (MPE) group included 21 patients. In MPE group the mean pleural fluid ADA level were 34.10±32.88 IU/L (range: 8-144 IU/L). The difference in pleural fluid ADA levels between TPE and MPE group was statistically highly significant.Conclusions: Tuberculous pleural effusion was the most common cause of pleural effusion in present study and observed in 74.5% cases.

Identification of QTLs in oil palm (Elaeis guineensis Jacq.) using SSR markers through association mapping

Oil palm (Elaeis guineensis Jacq.) is a perennial vegetable and a high oil-yielding crop (4–6 t/ha). There is a large scope for increasing the oil yield by selecting elite planting material for breeding programme in germplasm evaluation, characterization and utilization. In the present study, a diverse range of 150 oil palm genotypes were characterized using 12 quantitative variables with 54 genomic microsatellite markers. A wide variation was observed in the morphological traits among indigenous populations. Highly significant and positive correlations were observed between vegetative dry matter (VDM) and total dry matter (TDM) (0.862), and height and height increment (0.838). The first two principal component analyses explained 67.7% of total variation among morphological traits. The genotypes IC0610001-59 (Pune-2) and IC0610001-60 (Pune-2) were found highly promising based on less height increment, more TDM with high yield. For the mapping study, general linear model (GLM) approach, quantitative-trait loci (QTL) for annual height increment, number of bunches, bunch yield and bunch index were linked to simple-sequence repeat (SSR) loci mEgCIR3649 with phenotypic variance of 15.08, 10.43, 11.74, 15.39. TDM and VDM were linked to mEgCIR0192 (27.34 and 24.19%), mEgCIR3684 (16.84 and 18.30%), SPSC00163 (18.8 and 15.39%) and mEgCIR0555 (16.47 and 18.81%), with at a significant threshold (P) level of B0.001 and by mixed linear model (MLM) approach. TDM was linked to mEgCIR0555 with phenotypic variance of 20.72%, bunch yield and bunch index were linked to mEgCIR2813 at phenotypic variance of 17.11% and 12.88%, respectively, at a significant threshold (P) level of B0.01.

Clinical profile and outcome of patients admitted with swine-origin Influenza A H1N1 virus infection at a tertiary care hospital in Western India

Background: Most of the studies on swine flu H1N1 have been done during the pandemic phase. There was a sudden upsurge in virus activity in 2015 at many centers in India. The present study was designed to assess the current status and pattern of H1N1 infection. The primary objective of this study is to study the clinical profile of patients admitted with Swine-origin influenza A (H1N1) virus infection and Secondary objective is to study the clinical outcome in terms of morbidity and mortality.Methods: This was a retrospective observational study done at a tertiary care centre from March 2015 to April 2016. All admitted and confirmed cases of H1N1 swine flu infection were studied for demographic details, co-existing medical conditions and clinical presentation. Data regarding the course of disease, complications, treatments and outcomes were recorded from the clinical record.Results: Common presenting symptoms were cough and fever (95%). Common findings were fever (62.5%), tachycardia, tachypnea and crepitation on auscultation (58.5%). Associated comorbidities were Diabetes mellitus (19.5%), Chronic kidney disease (17%), immunosuppression (9.8%). Consolidation was seen in nearly half of the patients on radiological imaging. Complications noted in our patients were pneumonia (45%), respiratory failure (31%) and ARDS (14.6%). Seventeen percent of patients required non-invasive and invasive mechanical ventilation. Around 25 percent of cases, required ICU admission while two patients died during the hospital stay.Conclusions: The study emphasizes and restates the morbidities caused by H1N1 swine influenza infection as nearly half of the patients in this study experienced severe illness and complications.

National ethical guidelines for biomedical & health research involving human participants, 2017: A commentary

The Indian Council of Medical Research (ICMR) has been at the forefront in setting up the ethical guidance for the conduct of biomedical and health research in India. The latest version of National Guidelines for Biomedical and Health Research Involving Human Participants, 2017 was planned in order to provide a more detailed guidance to the existing topics in view of emerging ethical concerns and to add a number of newer areas in which guidance was lacking. The scope of the guidelines has been expanded to include socio-behavioural research related to health and research involving biological material and datasets. The guidelines have 12 sections which cover a wide range of topics and areas of research. The first six sections are more generic, applying to all types of biomedical and health research, while the next six sections are more subject specific. The guidelines have been revised in consultation with a large number of experts and stakeholders and went through an exhaustive process stretching over a period of two years in its drafting, review, consultation and finalisation. This commentary seeks to explain the process and key components of the Guidelines.

Lamotrigine-induced fulminant hepatic failure: an unusual presentation.

Lamotrigine (LTG) is indicated for the management of seizures either alone or in combination with other anticonvulsant agents. Adverse effects with it are usually mild. Less than 1% of subjects show deranged liver function tests during long therapy. Fulminant hepatic failure with LTG is an unusual presentation. We report a fatal case of hepatic failure with LTG monotherapy in a 22-year-old male patient suffering from a seizure disorder. Cases of LTG induced hepatotoxicity should be carefully monitored, particularly serious case of fulminant hepatic failure which should be adequately assessed and reported to determine their exact incidence.

Testicular embryonal cell carcinoma presenting as haemoptysis and skin nodules.

Embryonal cell carcinoma affects young males in the prime of their life with majority of tumours already having metastasised at the time of diagnosis. Subcutaneous metastasis from embryonal carcinoma is rare and is associated with widespread disease and poor prognosis. We report a case of 22-year-old male who presented with haemoptysis and skin nodules. Fine needle aspiration cytology of skin nodules and the lung lesion led to the diognosis of testicular embryonal cell carcinoma.

Role of temporalis muscle over activity in chronic tension type headache: effect of yoga based management.

The role of central versus peripheral mechanisms has always been questioned while explaining the etiopathogenesis of chronic tension type headache (CTTH). The following study was done to study the role of muscle spasm in CTTH. 15 patients of CTTH and 7 age matched controls were included in the study and their m. temporalis EMG was recorded for one minute each during rest, mental activity and maximal voluntary contraction and subjective pain scoring was done by visual analogue scale. The results revealed significant overactivity of m.temporalis in CTTH patients at rest when compared with control subjects (P = 0.01 and 0.03 left and right side respectively). After respective interventions namely non steroidal anti inflammatory drugs, botulinum toxin injections and yogic life style course, the EMG records revealed decrease in the mean EMG amplitude of m. temporalis during rest and mental activity more significantly after yoga based interventions (P = 0.03) and subjective pain scores decreased from 7.00 +/- 2.10 to 2.00 +/- 1.26 (P = 0.02) supporting the beneficial effect of such non invasive techniques.

Estimation of BCL-2 protein in carcinoma of the breast and its clinical correlation in locally advanced breast cancer.

The change in expression of apoptotic markers (Bcl-2 and Bax proteins) brought about by various chemotherapeutic regimens is being used for its predictive value for assessing response to neoadjuvant chemotherapy (NACT) in locally advanced breast carcinoma (LABC). AIMS: (1) Estimation of Bcl 2 expression in LABC, (2) Any change in Bcl 2 expression following chemotherapy in LABC, (3) Any relation of Bcl 2 estimation to changes in size of tumor, nodal status, age, and menopausal status. SETTINGS AND DESIGN: This was a prospective study of 120 cases of LABC. MATERIALS AND METHODS: All cases were subjected to biopsy and the tissue was evaluated immunohistochemically for apoptotic marker Bcl-2 family protein. Three cycles of NACT were given at three-weekly intervals. Modified radical mastectomy was performed and the specimens were re-evaluated for any change in the Bcl-2 family protein. The clinical response and immunohistochemical response were correlated and compared. STATISTICAL ANALYSIS: Coefficient of correlation was calculated by Pearson correlation coefficient (P-value). RESULTS: Clinical response, as measured by reduction in the tumor size, was observed in 81 (67.5%) patients while immunohistochemical response was observed in 67 (55.8%) patients. Correlation between immunohistochemical and clinical response was found to be statistically significant (P = 0.02). Nodal response was seen in 72 (60%) patients. There were no patients in the N o group; 22 (53.7%) of the N 1 patients were down-staged to N o , while 19 (46.3%) remained N 1 . In patients with N 2 disease, 11 (13.9%) were down-staged to N o status, 39 (49.4%) were down-staged to N 1 status, and 29 (36.7%) did not show any response. Immunohistochemical response was observed in 67 (55.8%) patients. Correlation between immunohistochemical and nodal responses was also found to be statistically significant (P = 0.03). CONCLUSIONS: This significant positive correlation between clinical and immunohistochemical responses highlights the importance of apoptotic marker Bcl-2 family protein in predicting the response of LABC to NACT.

Diabetic ketosis as a presenting feature of acromegaly.

Secondary diabetes mellitus is known to occur in acromegaly due to insulin resistance caused by growth hormone excess. However diabetes in acromegaly usually does not lead to ketosis. We describe here a case of acromegaly who presented in diabetes ketosis, which is unusual.

Isolated left lung aplasia with bronchial asthma.

Congenital lung anomalies are categorised as pulmonary agenesis, aplasia and hypoplasia with distinct clinical implications. An 8-year-old boy was referred for an opaque left hemithorax for which he had received antituberculous therapy. A detailed evaluation including flowing contrast computed tomography of the thorax and fiberoptic bronchoscopy led to a diagnosis of left lung aplasia. He also had wheezing dyspnea, which was confirmed as bronchial asthma. Congenital lung defects with associated asthma was reported only twice till date. A high index of suspicion is required to recognise such a patient.

Cytogenetic causes for recurrent spontaneous abortions - An experience of 742 couples (1484 cases).

BACKGROUND: First trimester pregnancy loss is a very common complication and a matter of concern for couples planning pregnancy. Balanced chromosomal rearrangements in either parent is an important cause of recurrent pregnancy loss particularly in the first trimester. AIMS: In this study an evaluation of the contribution of chromosomal anomalies in causing repeated spontaneous abortions was made. METHODS AND MATERIALS: A review of the cytogenetic data in 742 couples (1484 individuals) with recurrent spontaneous abortions who were examined for chromosomal aberrations in the period 1990-2003 is presented. Women who had at least two abortions, or spontaneous abortions preceded or followed by fetal deaths or birth of a malformed child, and patients who had recurrent spontaneous abortions (> 3) with normal live issue/s were studied. RESULTS: Chromosomal rearrangements were found in 31 individuals (2%). These abnormalities included 22 (2.9%) structural aberrations, 9 (1.2%) numerical anomalies. In addition to these abnormalities, 21 (3.2%) chromosomal variants were also found. CONCLUSION: Chromosomal analysis is an important etiological investigation in couples with repeated spontaneous abortions as it helps in genetic counseling and deciding about further reproductive options.

Effectiveness of ethylene glycol bis (2-aminoethyl ether) tetraacetic acid (EGTA) against cerium toxicity.

Therapeutic efficacy of EGTA (ethylene glycol bis (2-aminoethyl ether) tetraacetic acid) against cerium intoxicated mice was studied. Administration of cerium showed significant decrease in haemoglobin percentage, RBC counts and blood glucose level with an increase in the activity of serum transaminases and WBC counts. Decrease in the activity of alkaline phosphatase and glycogen content was noted in liver and kidney after cerium exposure. Light and electron microscopical investigations showed that these changes were recouped considerably with the administration of EGTA suggesting its therapeutic efficacy against cerium toxicity.

Comparative effectiveness of CaNa3DTPA and tiron along with alpha-tocopherol against beryllium-induced biochemical alterations in rats.

The therapeutic efficacy of chelating agents CaNa3DTPA (calcium trisodium diethylene triamine penta acetic acid) and Tiron (sodium-4,5-dihydroxy-1,3-benzene disulphonate) with and without antioxidant, alpha-Tocopherol was evaluated in the treatment of beryllium-induced toxicity in female albino rats. The animals were exposed to beryllium (as beryllium nitrate) at a dose of 1 mg/kg (ip) once a day for 28 consecutive days followed by chelation therapy by CaNa3DTPA (0.1 mM/kg, ip) and Tiron (471 mg/kg, ip) with and without alpha-Tocopherol (25 mg/kg, orally) for 5 consecutive days after toxicant administration. Tissue biochemistry revealed severe alterations in liver and kidney. A significant fall in total protein and glycogen contents, alkaline phosphatase, adenosine tri-phosphatase and succinic dehydrogenase level was noticed. On the contrary, an elevation in acid phosphatase was recorded. The significant rise in hepatic lipid peroxidation and decreased level of hepatic reduced glutathione showed toxicity due to beryllium. CaNa3DTPA with alpha-Tocopherol showed moderate therapeutic efficacy while Tiron in combination with alpha-Tocopherol exerted statistically more beneficial effects to reverse biochemical alterations in different variables altered due to beryllium intoxication.