New risk stratification tool may predict requirement of blood transfusion among women undergoing laparoscopic myomectomy

Uterine fibroids are common benign tumors affecting women, and laparoscopic myomectomy is the standard surgical treatment for those who wish to retain their uterus. However, excessive bleeding during myomectomy is a significant concern, and risk factors for blood transfusion in this procedure have not been well studied. Laparoscopic myomectomy is associated with the risk of excessive bleeding, which may necessitate blood transfusion.

Understanding the factors contributing to this risk can aid in better patient management and outcomes. A recent retrospective cohort study aimed to identify these risk factors and develop a risk stratification tool for the need for blood transfusion during laparoscopic myomectomy. This study was published in the American Journal Of Obstetrics and Gynaecology by Kacey M. and colleagues.

The study analyzed data from the American College of Surgeons National Surgical Quality Improvement Program (NSQIP) database from 2012-2020. It included women who underwent laparoscopic myomectomy and compared those who required blood transfusion with those who did not. Multivariable analysis was conducted to identify independent risk factors, and a risk stratification tool was developed based on these factors.

The key findings of the study were:

  • 11,498 women underwent laparoscopic myomectomy during the study period.

  • 331 (2.9%) of these women required blood transfusion.

  • Preoperative factors associated with transfusion risk included Black or African American and Asian races, Hispanic ethnicity, bleeding disorders, ASA III/IV, and preoperative hematocrit value ≤35.0%.

  • Intraoperative factors included specimen weight >250 grams or ≥5 intramural myomas and operation time ≥197 minutes.

  • A risk stratification tool was developed based on these factors, allowing calculation of the mean probability of transfusion.

The study identified preoperative and intraoperative risk factors for blood transfusion in women undergoing laparoscopic myomectomy. A risk stratification tool was developed to assess the likelihood of transfusion based on these factors. Further validation studies are warranted to confirm the utility of this tool in clinical practice.

Reference:

Hamilton, K. M., Liao, C., Levin, G., Barnajian, M., Nasseri, Y., Bresee, C., Truong, M. D., Wright, K. N., Siedhoff, M. T., & Meyer, R. Characteristics associated with blood transfusion among women undergoing laparoscopic myomectomy: a NSQIP Study. American Journal of Obstetrics and Gynecology,2024. https://doi.org/10.1016/j.ajog.2024.02.010

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Can breast cancer be detected through spit test?

Scientists have developed a saliva test that screens for breast cancer, which is showing promising results in experimental testing, according to a study published Tuesday.

The new hand-held device detects breast cancer biomarkers from a tiny sample of spit, say researchers from the University of Florida and National Yang Ming Chiao Tung University in Taiwan, who published their findings in the Journal of Vacuum Science & Technology B.

“Imagine medical staff conducting breast cancer screening in communities or hospitals,” said Hsiao-Hsuan Wan, a UF doctoral student in the Department of Chemical Engineering and the study’s lead author. “Our device is an excellent choice because it is portable-about the size of your hand-and reusable. The testing time is under five seconds per sample, which makes it highly efficient.”

The new tool works by placing a saliva sample on a test strip, which is treated with specific antibodies that respond to cancer biomarkers. Electrical impulses are sent to contact points on the biosensor device. Signals are measured and translated into digital information about how much biomarker is present. The results are quick and easy to interpret, Wan said.

During testing, the device distinguished between healthy breast tissue, early breast cancer, and advanced breast cancer in a small group of 21 women. Their biosensor design uses common components like glucose testing strips and the open-source hardware-software platform Arduino.

Reference:

Hsiao-Hsuan Wan, Haochen Zhu, Jian-Sian Li, Fan Ren, Cheng-Tse Tsai; Yu-Te Liao; Dan Neal, Josephine F. Esquivel-Upshaw, Stephen J. Pearton, High sensitivity saliva-based biosensor in detection of breast cancer biomarkers: HER2 and CA15-3, Journal of Vacuum Science & Technology B, https://doi.org/10.1116/6.0003370.

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Daily upadactinibib may substantially improve enthesitis among psoriatic arthritis patients

Daily upadactinibib may substantially improve enthesitis among psoriatic arthritis patients suggests a new study published in the Rheumatology.

A study was done to characterize the effect of upadacitinib 15 mg once daily (UPA15) on enthesitis in patients with psoriatic arthritis from the SELECT-PsA Phase 3 trials. Patients with an inadequate response/intolerance to ≥ 1 non-biologic DMARD (SELECT-PsA 1) or ≥ 1 biologic DMARD (SELECT-PsA 2) received UPA15, adalimumab 40 mg every other week or placebo (weeks 0-24) switched to UPA15 (week 24 onward). The Leeds Enthesitis Index (LEI) and Spondyloarthritis Research Consortium of Canada (SPARCC) index were used to assess improvement in enthesitis, enthesitis resolution, maintenance of enthesitis resolution, and protection from enthesitis development through week 56. Results: Data from 639 patients receiving UPA15 and 635 patients receiving placebo (including 317 patients who switched from placebo to UPA15) were analysed. UPA15 led to higher rates of enthesitis resolution vs placebo at week 24 (LEI: 59.8% vs 38.0%; SPARCC index: 50.6% vs 31.5%, respectively) and greater improvements in the LEI (-1.7 vs -1.0) and SPARCC index (-3.4 vs -1.9); improvements were maintained through week 56. Improvements were observed after 12 weeks of UPA15 treatment. Over 90% of patients without enthesitis (LEI = 0) at baseline receiving UPA15 were enthesitis-free at week 56, and UPA15 prevented recurrence of enthesitis at week 56 in > 80% of patients with enthesitis at baseline who achieved resolution (LEI = 0) at week 24. UPA15 is associated with a comprehensive improvement in enthesitis, with improvements observed after 12 weeks of treatment. Additionally, treatment with UPA15 was associated with maintaining an enthesitis-free state after resolution and protection against new-onset enthesitis.

Reference:

Cantini F, Marchesoni A, Novelli L, Gualberti G, Marando F, McDearmon Blondell E, Gao T, McGonagle D, Salvarani C. Effects of upadacitinib on enthesitis in patients with psoriatic arthritis: a post hoc analysis of SELECT-PsA 1 and 2. Rheumatology (Oxford). 2024 Feb 8:keae057. doi: 10.1093/rheumatology/keae057. Epub ahead of print. PMID: 38331400.

Keywords: Daily upadactinibib may substantially improve enthesitis among psoriatic arthritis patients, Cantini F, Marchesoni A, Novelli L, Gualberti G, Marando F, McDearmon Blondell E, Gao T, McGonagle D, Salvarani C, Rheumatology, Janus kinase inhibitor; Psoriatic arthritis; entheses; enthesitis; pain; upadacitinib.

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High-sensitivity CRP level predicts bronchiectasis exacerbation risk: Study

China: Baseline serum high-sensitivity C-reactive protein (hs-CRP) level at a stable state can predict the risk of bronchiectasis exacerbation, which indicates low-grade inflammation in bronchiectasis, a recent study in BMC Pulmonary Medicine has shown. High-sensitivity CRP is a simple blood test which is readily available in many healthcare facilities.

“Over a one-year follow-up period in the study comprising non-cystic fibrosis (CF) bronchiectasis patients, increased hs-CRP was significantly associated with a twofold increased risk of developing any bronchiectasis exacerbation (adjusted odds ratio [aOR] = 2.254),” the researchers wrote. Furthermore, the researchers observed a borderline significant association with an almost twofold increased risk of hospitalized bronchiectasis exacerbation (aOR=1.985).

The primary pathogenesis of non-cystic fibrosis bronchiectasis involves airway inflammation, abnormal mucus clearance and bacterial colonization, leading to progressive airway destruction and distortion.

Previous studies have shown the elevation of systemic inflammatory markers to correlate with increased disease extent, reduced lung function and higher risk of future severe exacerbations in bronchiectasis patients.

A significant correlation of circulating hs-CRP levels with HRCT (high-resolution computed tomography) scores and resting oxygen saturation in patients with stable-state non-CF bronchiectasis was suggested, there is a lack of data on the relationship between hs-CRP and the prognosis of bronchiectasis, and there is a little data on the role of hs-CRP in predicting bronchiectasis exacerbation.

To fill this knowledge gap, James Chung-man HO, The University of Hong Kong, Queen Mary Hospital, Pokfulam, Hong Kong Special Administrative Region, China, and colleagues aimed to assess the association between hs-CRP level and the risks of bronchiectasis exacerbation.

For this purpose, they conducted a prospective study on Chinese patients with non-CF bronchiectasis from 1st October to 31st December 2021. Baseline serum hs-CRP was obtained at a stable state. The follow-up time lasted for one year. Co-primary endpoints included the development of any bronchiectasis exacerbation and hospitalized bronchiectasis exacerbation. A total of 123 patients were included.

The study showed that higher hs-CRP was associated with an increased risk of developing bronchiectasis exacerbation, adjusted odds ratio (aOR) of 2.254, and borderline significantly increased hospitalized bronchiectasis exacerbation with aOR of 1.985.

“Baseline serum hs-CRP level at stable state can predict bronchiectasis exacerbation in the subsequent year. This supports the role of chronic low-grade inflammation in bronchiectasis, as indicated by hs-CRP level, in association with bronchiectasis exacerbation risk,” the research team concluded.

Reference:

Kwok, W.C., Teo, K.C., Lau, K.K. et al. High-sensitivity C-reactive protein level in stable-state bronchiectasis predicts exacerbation risk. BMC Pulm Med 24, 80 (2024). https://doi.org/10.1186/s12890-024-02888-z

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Indian Pharma Market registers 8 percent surge to Rs 17,937 Crore in January 2024: IQVIA

New Delhi: In an impressive kickoff to 2024, the Indian pharmaceutical market surged by 8%, reaching a substantial Rs 17,937 crore in January, as per IQVIA’s market research data.

The Total Secondary Sales (TSA) for the industry recorded a growth of 10.1% in the Moving Annual Total (MAT) Jan’24, amounting to Rs. 214,476 Cr. Notably, within the same month, TSA touched Rs. 17,937 Cr, reflecting a growth of 7.9%. The Secondary Sales Audit (SSA) category stood at Rs. 181,238 Cr, indicating a 9.9% growth in MAT Jan’24 and a Rs. 15,171 Cr valuation for January 2024 alone, showcasing an 8.0% growth.

The report delves into transformative shifts in market shares among major pharmaceutical players, with Intas, Abbott, and Cipla exhibiting notable growth. The market saw the entry of new players like Loreal India, Mother Sparsh Baby, and Wonset Healthcare, adding dynamism, along with 14 brand transfers and 1986 Stock Keeping Units (SKUs) experiencing Price to Retailer (PTR) adjustments.

In-depth trend analysis of the Indian Pharmaceutical Market (IPM) across therapeutic categories reveals dynamic patterns. Cardiac, Anti-Diabetic, and Gastrointestinal categories showed remarkable growth, with specific drugs such as Enoxaparin and Meropenem showcasing 20% and 22% growth rates. The Dermatology market stood out with Emollients & protectives leading at 156 Cr, growing by 10%, and Sunscreens displaying the highest growth at 23%.

Within the Respiratory sector, Formoteral+Budesonide led with an 18% growth rate. The Neuro therapy segment featured Levetiracetam as the top contributor with 94 Cr in sales and an 8% growth rate. Tadalafil emerged as the leader in Urology therapy with a notable growth rate of 26%, while the Ophthalmology therapy, led by Methyl Cellulose, witnessed the highest sales of 40 Cr, despite a 2% degrowth.

Moving on, market share dynamics revealed shifts for major pharmaceutical companies like Mankind, Alkem, Macleods, and Dr. Reddy’s Laboratories (DRL). Among the top 10, Intas, Abbott, and Cipla demonstrated the highest growth, with Aristo emerging as the fastest-growing company at the MAT level. Notable improvements were seen for Zydus, Glenmark, USV, and Emcure, while some witnessed a decline.

The “Star Brands of the Month” section highlighted Foracort’s dominance with an impressive 20% growth. Sun Pharma maintained its top position among companies, while FDC and Ajanta showed improvement in their ranks.

The comprehensive analysis further unveiled an 8% growth for Indian companies and 7% for MNCs, with the acute segment witnessing a 6% growth and the chronic segment showing an 11% growth in January 2024.

Significant changes in Price to Retailer (PTR) across the pharmaceutical industry, particularly affecting the top 50 brands, were observed. A total of 1986 Stock Keeping Units (SKUs) underwent PTR adjustments, indicating a dynamic pricing landscape. Notable brands within the top 50 that experienced PTR changes include Foracort, Augmentin, Thyronorm, Liv-52, Udiliv, Azithral, Budecort, Rantac, Pantop, Volini, Gemer, Pantop-D, and Gluconorm-G.

Moreover, the dataset for January 2024 revealed noteworthy developments with 622 new packs introduced during the month, including prominent names like Loreal India, Mother Sparsh Baby, and Wonset Healthcare. These introductions contribute to the evolving product portfolio within the pharmaceutical sector, bringing diverse offerings to consumers. The dataset also highlighted 14 brand transfers, indicating shifts in brand ownership or changes in marketing strategies among pharmaceutical companies.

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Doctors rejoining duties without approval after higher studies: JnK Health and Medical Education dept issues advisory

Srinagar: The Jammu and Kashmir Health Department has recently directed the Directorate of Health Services, J & K to submit adjustment/posting proposals of in-service doctors, who come back after studies, for required approval.

Issuing an advisory in this regard, the Health Department has barred the Directorate from issuing any posting orders without prior consultation/consent of the Administrative Department.

This comes after the Department noted that after completing their studies or tenure postings, doctors approach the Directorate for re-joining their posts, without getting prior approval from the Administrative Department. This way, the Administrative Department remains unaware of such doctors who join back the Department.

Based on the Government Order dated 17.10.2019, the order dated 08.07.2021 and HME circular dated 29.12.2020, the In-service doctors in Jammu and Kashmir are granted permission to pursue higher study or tenure postings.

Also Read:I ncentive marks to in-service candidates in PG Medical admissions laudable, benevolent: Madras HC refuses to interfere with policy

For this, the Health and Medical Education Department conveys the necessary No Objection Certificate in favour of the in-service doctors. Only after getting the NOC from the Department, do the doctors who get selected for the courses proceed to pursue higher studies/tenure postings in various health Institutions within or outside the Union Territory of Jammu and Kashmir.

However, the Department highlighted that “After completion of the studies/tenure postings, the doctors approach the concerned Directorates of Health Services, Jammu/Kashmir for re-joining which utilize their services at their own level without seeking prior approval of the Administrative Department. By virtue of this, the Administrative Department is kept unaware about the whereabouts of these doctors who join back the Department.”

Therefore, in its recent advisory dated 15.02.2024, the Deputy Secretary to the Government, Javed Iqbal clarified that no postings will be given to such doctors without prior approval from the Administrative Department.

Issuing direction to the DHS to comply with this order, the Advisory mentioned, “Accordingly, it is impressed upon both the Directorates of Health Services, Jammu/Kashmir to ensure that the adjustment/posting proposals of utilizing the services of in-service doctors, who report back to the parent Directorates, are submitted to the Administrative Department for necessary approval.”

“Henceforth, no such adjustment/posting order shall be issued by the Directorates at their own level without prior consultation/consent of the Administrative Department,” it further added.

To view the advisory, click on the link below:

https://medicaldialogues.in/pdf_upload/j-k-advisory-232587.pdf

Also Read: NEET PG candidates who join seats upto round 2 of AIQ or State quota counselling cannot participate in further rounds under any quota: HC

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KarXT shows remarkable safety and efficacy in schizophrenia patients: Lancet

The medication KarXT represents a significant departure from the conventional antipsychotic drugs by targeting muscarinic receptors instead of blocking the D2 dopamine receptors. This novel treatment for schizophrenia has shown remarkable efficacy and tolerability in a recent clinical trial. The outcomes of this study were published in The Lancet journal.

The EMERGENT-2 trial, a phase 3 study was conducted across 22 inpatient sites in the USA that assessed the effectiveness and safety of KarXT in individuals experiencing acute psychosis due to schizophrenia. The participants were randomly assigned to receive either KarXT or a placebo over a 5-week period.

The results from the trial revealed that KarXT led to a substantial reduction in both positive and negative symptoms of schizophrenia when compared to placebo. Also, the drug was well tolerated with the participants experiencing fewer adverse events than anticipated.

The mechanism of action of KarXT differs from that of traditional antipsychotics which offers a promising alternative for individuals with schizophrenia. The most common adverse events associated with KarXT included constipation, dyspepsia and headache that were generally manageable. The rates of extrapyramidal motor symptoms, weight gain and somnolence were comparable between the KarXT and placebo groups.

These findings have sparked optimism suggesting that KarXT could revolutionize the treatment landscape for schizophrenia. Further trials, including EMERGENT-3, EMERGENT-4 and EMERGENT-5 are underway to provide additional insights into the long-term efficacy and safety of KarXT. Overall, KarXT offers new possibilities to improve the quality of life of the individuals affected by schizophrenia.

Source:

Kaul, I., Sawchak, S., Correll, C. U., Kakar, R., Breier, A., Zhu, H., Miller, A. C., Paul, S. M., & Brannan, S. K. (2024). Efficacy and safety of the muscarinic receptor agonist KarXT (xanomeline–trospium) in schizophrenia (EMERGENT-2) in the USA: results from a randomised, double-blind, placebo-controlled, flexible-dose phase 3 trial. In The Lancet (Vol. 403, Issue 10422, pp. 160–170). Elsevier BV. https://doi.org/10.1016/s0140-6736(23)02190-6

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CDSCO releases regulatory guidelines for sampling of drugs, cosmetics and medical devices

New Delhi: In order to streamline and rationalize the sampling procedure of drugs, cosmetics and medical devices and maintaining a centralized monthly database of Not of Standard Quality (NSQ) /Spurious drugs to publish on Central Drugs Standard Control Organisation (CDSCO) website, the apex drug regulator has released regulatory guidelines for sampling of drugs, cosmetics and medical devices by Drugs Inspectors of Central and State Drug Authorities.

Earlier, the draft regulatory guidelines for sampling of drugs, cosmetics and medical devices by Drugs Inspectors of Central and State Drug Authorities was circulated to all zonal/sub zonal offices of CDSCO and State Licensing Authorities for their inputs and suggestions. After evaluating all the essential feedback on the draft guidelines, the drug regulator has now issued final guidelines.

The main objective of the guidelines is to check the quality & efficacy of drugs & cosmetic available in the market with their approved specifications and to monitor the quality of the API, Excipients and finished products of drugs, cosmetic and medical devices in all parts of the distribution chain throughout the authorized shelf-life. It also aims to ensure that existing control methods are satisfactory and to investigate the Not of Standard Quality (NSQ) Product, identify Unapproved Products/ Without License sales outlets, and identify Spurious drugs in the distribution chain. Moreover, it focuses on identifying sales outlets where repetitive NSQ/ Spurious drugs are reported, among other purposes

The document outlines the regulatory guidelines for the sampling of drugs, cosmetics, and medical devices by drugs inspectors of the Central and State Drug Authorities in India. It emphasizes the importance of good quality medicines for effective disease management and highlights the risks of substandard or spurious drugs to patients.
Further the guidelines focus on the sampling plan, selection of samples and sampling locations, number and quantity of samples, timelines, database/monitoring, NSQ/Spurious alerts, and testing laboratories. It also addresses the lack of defined methodology for sample selection in the past and provides detailed criteria for sample selection, including various identified risks and factors to consider.

Through its annexures, the guidelines specifies the quantity of drugs, cosmetics, vaccine, medical devices sample required for complete analysis.

To read the official notice, click on the following link:

https://medicaldialogues.in/pdf_upload/dcgi-circularregulatory-guidelines-for-sampling-232561.pdf

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Effects of strength training with or without beta-hydroxy-beta-methylbutyrate on medical ICU patients during hospitalization

Recently published research paper is a multicentre, four-arm randomised controlled trial that investigates the effects of resistance training (RT) and beta-hydroxy-beta-methylbutyrate (HMB) intervention on physical function, muscle strength, and quality of life in medical intensive care unit (ICU) patients. The study found that resistance training and the combination of resistance training and HMB intervention resulted in significant increases in physical function and muscle strength compared to the control group, as assessed by six-minute walking distance and short physical performance battery scores. However, no significant changes were observed in the HMB-only group. Muscle strength, indicated by MRC and grip strength tests, also significantly improved in the resistance training and combination groups. The study did not find significant differences in terms of 60-day mortality, prevalence of ICU-acquired weakness, muscle mass, quality of life, or other functional aspects among the treatment groups and usual care. The conclusions suggest that resistance training with or without HMB during the entire hospitalisation intervention improves physical function and muscle strength in medical ICU patients, but does not significantly impact muscle mass, quality of life, or 60-day mortality.

Study Methodology

The study was conducted in 10 ICUs at five academic and tertiary comprehensive hospitals in Fujian province, China, and included a total of 112 adult patients with internal medical diagnoses admitted to the ICU. Data analysis using a generalised linear mixed model showed significant improvements in physical function and muscle strength in the resistance training and combination treatment groups compared to the control group. The study also included detailed information on the intervention protocols, patient selection criteria, group assignments, and the statistical analysis conducted.

Conclusion and Further Research

Overall, the study provides evidence that resistance training, with or without HMB intervention, can effectively enhance physical function and muscle strength in medical ICU patients. However, the findings also highlight the need for further investigation to determine the potential synergistic effects of combining high-protein supplementation with HMB and to explore potential implementation strategies. The paper acknowledges some limitations related to the sample size and population heterogeneity, and emphasizes the need for future research with larger samples and stratified analyses to validate the study’s findings and explore potential implementation strategies.

Reference –

Wu, TT., Chen, QL., Lin, XX. et al. Effects of a multilevel intervention of resistance training with or without beta-hydroxy-beta-methylbutyrate in medical ICU patients during entire hospitalisation: a four-arm multicentre randomised controlled trial. Crit Care 27, 493 (2023). https://doi.org/10.1186/s13054-023-04698-x.

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Low iron levels closely associated with higher risk of coeliac disease: BMJ

A recent study explored the complex interplay between genetics and health and uncovered a potential environmental trigger for the rising prevalence of coeliac disease. The key findings of the study were published in the recent edition of BMJ Open Gastroenterology.

This study utilized Mendelian randomization which suggests a significant association between iron deficiency and the development of this autoimmune condition. The two-sample Mendelian randomization study were conducted to explore the relationship between single nucleotide polymorphisms (SNPs) associated with the iron status and the presence of coeliac disease. 

The findings revealed four SNPs that were strongly linked to systemic iron status. These genetic variants were not associated with known risk factors for coeliac disease that indicated a distinct pathway in disease development. This research used data from the UK Biobank that encompassed a vast group of over 336,000 individuals, including 1,855 diagnosed with coeliac disease and meticulously examined the genetic landscape.

The analysis demonstrated a clear inverse relationship between iron levels and coeliac disease risk. The individuals genetically predisposed to lower iron levels expressed an increased susceptibility to the autoimmune condition. This compelling association persisted even after rigorous sensitivity analyses which reaffirms the robustness of the findings.

The implications of this study offer a potential opportunity for coeliac disease prevention. Highlighting the role of iron deficiency as a major contributing factor could help us to stay informed targeted interventions and public health strategies in reducing the disease burden. The outcomes of this research underscore the importance of considering environmental factors in the disease susceptibility. Unearthing the genetic underpinnings of coeliac disease help us shape novel preventive measures and personalized interventions.

Source:

Hujoel, I. A., & Hujoel, M. L. A. (2024). Investigating the role of iron status in the development of coeliac disease: a Mendelian randomisation study. In BMJ Open Gastroenterology (Vol. 11, Issue 1, p. e001236). BMJ. https://doi.org/10.1136/bmjgast-2023-001236

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