Racecadotril Versus Loperamide in Acute Radiation Enteritis: A Randomized, Double-Masked, Phase 3, Noninferiority Trial.

PURPOSE: There is currently no gold standard for the management of acute radiation enteritis. We compared the efficacy and safety of Racecadotril, an anti-hypersecretory drug, versus Loperamide, an anti-motility agent, in acute radiation enteritis. METHODS AND MATERIALS: We conducted a randomized, double-masked, non-inferiority trial at a single research institute. Patients receiving curative radiation for pelvic malignancies, who developed grade 2 or 3 diarrhea (as per Common Terminology Criteria for Adverse Events, v 4.0) were included in the study. Patients in the intervention arm received Racecadotril and placebo. Patients in the control arm received Loperamide and placebo. The primary outcome was the resolution of diarrhea, 48 hours after the start of treatment. RESULTS: 162 patients were randomized between 2019 and 2022. On intention-to-treat analysis, 68/81 patients, 84%, (95% CI, 74.1%-91.2%) in the Racecadotril arm and 70/81, 86.4%, (95% CI, 77.0%-93.0%) in the Loperamide arm improved from grade 2 or 3 diarrhea to grade 1 or 0, (P= .66, χ2 test). The difference in proportion was 2.4% (95% CI: -8.5% to 13.4%). Since the upper boundary of the 95% CI crossed our non-inferiority margin of 10% (13.4%) we could not prove the non-inferiority of Racecadotril over Loperamide. Rebound constipation was more in the Loperamide arm compared to Racecadotril (17.3% vs 6.2%; P = .028) CONCLUSIONS: The non-inferiority of Racecadotril to Loperamide in acute radiation enteritis could not be demonstrated. However, Racecadotril can be the preferred drug of choice in acute radiation enteritis because Racecadotril does not affect bowel motility, achieved a high clinical success rate similar to that of Loperamide, and was associated with lesser side effects.

Postpartum Pulmonary-Renal Syndrome with Thrombotic Microangiopathy in Systemic Lupus Erythematosus.

Postpartum pulmonary syndrome as lupus flares in inactive or mild lupus is uncommon. The diagnosis and management of postpartum lupus flare in second pregnancy presenting with crescentic lupus nephritis (LN), secondary thrombotic microangiopathy (TMA), and severe lupus vasculitis in an undiagnosed systemic lupus erythematosus is extremely challenging. Here, in this case report, we present a young lady who presented with postpartum acute kidney injury (AKI) with systemic complaints about 4 weeks post-term uneventful delivery. Renal biopsy was suggestive of crescentic LN with severe lupus vasculitis. The stormy course was further complicated with diffuse alveolar hemorrhage, portal venous thrombosis, TMA, and anuric AKI requiring renal replacement therapy. She received multiple sessions of plasmapheresis, steroid, intravenous immunoglobulin, inj. cyclophosphamide, and started showing improvement after about 6 weeks of presentation.

A Joint Consensus of Rheumatologists and Dermatologists on Early Detection and Effective Management of Psoriatic Arthritis: India's Perspective.

Psoriatic arthritis (PsA) is a chronic inflammatory disease with clinical manifestations, including inflammatory arthritis and the presence of psoriasis (PsO). The present consensus statement evaluated the early diagnosis and treatment approaches in the management of psoriasis and psoriatic arthritis by rheumatologists and dermatologists. For PAN India representation, a panel of eight rheumatologists and five dermatologists from different institutes in India were constituted. These thirteen experts were divided into two groups (rheumatologists group and dermatologist group) who received a set of questionnaires each for diagnosis and treatment approaches in the management of psoriasis and psoriatic arthritis. Based on the responses received, a panel discussion took place, where the experts identified the early diagnostic criteria for PsA considering: Clinical signs and symptoms, and questionnaire-based PsA screening, which includes Psoriasis Epidemiology Screening Tool (PEST) for dermatologists and Classification Criteria for Psoriatic Arthritis (CASPAR) for rheumatologists. The experts also recommended shift from conventional disease-modifying anti-rheumatic drugs (DMARDs) to biologics like secukinumab, when there is extensive skin involvement and TNF inhibitors when there is extensive joint involvement. Overall, the objective of the consensus was to assist rheumatologists and dermatologists in the early diagnosis and management of patients of PsA and PsO in their clinical practice.

Predictive scoring system for risk of complications in pediatric dengue infection.

Background: Dengue infection has been a worrisome cause of mortality and morbidity in children. Though numerous scoring systems have been developed, they are in the adult population or are too complicated for use in children. Pediatric dengue infection has a wide spectrum from a mild illness to severe complications and an unpredictable course. Hence the need for a predictive scoring system where the possibility of complications can be identified which can contribute to reduction in mortality and morbidity of dengue by prompt referrals and anticipatory management. Methods: Prospective case cohort study of children with confirmed dengue fever. Results: 303 children were included and divided into two groups - the dengue fever group and the complicated dengue group based on the WHO clinical classification. The clinical and laboratory parameters were analysed individually, cut offs identified by ROC curves and compared for significance between the two groups. The parameters that emerged were hypotension, PCV ≥ 42%, platelet count ≤ 75000 cells/cumm, WBC ≥ 7000 cells/cumm, and ALT ≥ 70U/L.  Using the adjusted odd's Ratio, and coefficient, individual predictive scores were tabulated ranging from 0 to 3, with a total score of 0 to 7. A cut-off score of 2 was then identified based upon the sensitivity (84.13%) and specificity (72.50%) as the ideal score to predict complicated dengue. Internal validation of the score was done where the area under the curve for predicting complicated dengue was 0.86 (95% CI 0.8-0.92) with a P value of <0.001. Conclusion: Our dengue predictive scoring system has been developed using five indicators, with a score of two and above, out of seven, suggesting increased risk of developing complications. This has been validated internally and can be used to predict complicated dengue among children.

A case of cholesterol embolization syndrome mimicking rapidly progressive renal failure causing end-stage kidney disease.

Cholesterol embolization syndrome is an uncommon complication of coronary angioplasty. Its clinical manifestations are nonspecific and may be ascribed to other causes mimicking vasculitis syndrome. In an appropriate clinical setting, the diagnosis can be confirmed by tissue biopsy. In this case report, we present a middle-aged male who presented with cutaneous and renal manifestations within two weeks of primary angioplasty. The patient had progressive clinical deterioration in the form of dry gangrene of toes and end-stage renal disease requiring surgical amputation and maintenance hemodialysis respectively within two months of symptoms onset.

Expression of MUC1 mucin in potentially malignant disorders, oral squamous cell carcinoma and normal oral mucosa: An immunohistochemical study.

BACKGROUND: Mucins alteration in glycosylation is associated with the development and progression of malignant diseases. Therefore, mucins are used as valuable markers to distinguish normal and disease conditions. Many studies on MUC1 expression have been conducted on variety of neoplastic lesions other than head and neck region. None of the study has made an attempt to show its significance in potentially malignant disorders (PMDs) and oral squamous cell carcinoma (OSCC). Hence, ours is one of the pioneer studies done to assess and evaluate the same. AIMS: This study aims to compare and correlate the expression of MUC1 mucin protein in normal oral mucosa (NOM), PMD's and OSCC by immunohistochemical method. MATERIALS AND METHODS: Institutional study, archived tissue sections of OSCC (n = 20), PMD's (n = 20) and NOM (n = 20) were immunostained for MUC1 mucin and percentage of positive cells evaluated. Results obtained were statistically analyzed using Kruskal-Wallis test, Mann-Whitney test and Student's t-test. RESULTS: The mean MUC1 mucin positive cells in the study groups were as follows, 40% in OSCC, 28% in PMD's and 0.75% in NOM. Higher mean immunohistochemical score was observed in OSCC group followed by PMD's group and NOM group. The difference in immunohistochemical score among the groups was found to be statistically significant (P < 0.001). CONCLUSION: The result of the current study suggests that determination of MUC1 mucin expression may be a parameter in the diagnosis of malignant behavior of PMD's to OSCC. MUC1 mucin expression may be a useful diagnostic marker for prediction of the invasive/metastatic potential of OSCC.

Osteochondroma (OC) of the Condyle of Left Mandible: A Rare Case.

Osteochondroma (OC) is one of the most common benign condylar tumours having both chondroma and osteoma. However, this tumour is most frequently found on the metaphyses of long bones and is unusual on the skull. When it affects the mandibular condyle, the cause could be due to trauma to the tempero mandibular joint (TMJ). Here, in this report we present a rare case of osteochondroma of left condyle region in a 36-year-old man. The patient had noticed pain in the left TMJ for six months. The lesion is surgically removed and histologically evaluated which composed of chondrocytes dispersed in hyaline matrix along with a rim of calcified bone at one end.

Investigation of nano lipid vesicles of methotrexate for anti-rheumatoid activity.

BACKGROUND: The purpose of this study was to formulate and evaluate nano lipid vesicles of methotrexate (MTX) for its anti-rheumatoid activity. METHODS: In this study the principle of both active as well as passive targeting using MTX-loaded stealth liposomes as per the magic gun approach was followed. Stealth liposomes of MTX were prepared by thin-film hydration method using a PEGylated phospholipid-like DSPE-MPEG 2000. Similarly, conventional liposomes were prepared using phospholipids like DPPC and DSPC. Conventional liposomes were coated with a hydrophilic biocompatible polymer like chitosan. They were investigated for their physical properties and in vitro release profile. Further, in vivo screening of the formulations for their anti-rheumatoid efficacy was carried out in rats. Rheumatoid arthritis was induced in male Wistar-Lewis rats using complete Freund's adjuvant (1 mg/mL Mycobacterium tuberculosis, heat killed in mineral oil). RESULTS: It was found that chitosan coating of the conventional liposomes increased the physical stability of the liposomal suspension as well as its entrapment efficiency. The size of the unsonicated lipid vesicles was found to be in the range of 8-10 µm, and the sonicated lipid vesicles in the range of 210-260 nm, with good polydispersity index. Further, chitosan-coated conventional liposomes and the PEGylated liposomes released the drug for a prolonged period of time, compared to the uncoated conventional liposomes. It was found that there was a significant reduction in edema volume in the rat group administered with the test stealth liposomal formulations and chitosan-coated conventional liposomes (PEGylated and chitosan-coated conventional) compared to that of the control and standard (administered with free MTX) group of rats. PEGylated liposomes showed almost equal efficacy as that of the chitosan-coated conventional liposomes. CONCLUSION: Lipid nano vesicles of MTX can be administered by intravenous route, whereby the drug selectively reaches the target site with reduced toxicity to other organs.

Growth and development of catla (Catla catla) fed with different levels of diet containing Spirogyra sp.

The effect of Spirogyra sp. incorporated into diet formulations on the growth and body composition of Indian major carp, catla (Catla catla) was investigated in a 45 days feeding trial. Spirogyra dry powder was mixed with different feed ingredients in different amounts (0%, 10%, 25%, 37% and 40% of the total feed). Carps fed with Spirogyra demonstrated higher feed conversion ratio. The study also revealed a direct relationship between the amount of Spirogyra in the diet, and muscle protein and fat contents in the fish. In general, this study demonstrated the benefits of incorporating Spirogyra into carp feeds.