Use of Hypotension Prediction Index may reduce Intraoperative Hypotension Outcomes, suggests study

In surgery, it is common for patients to experience intraoperative hypotension, with up to 87% of patients experiencing at least one instance of low mean arterial pressure (less than 65 mmHg). This hypotension can result in serious complications including delirium, acute kidney injury, myocardial ischaemia, and stroke. Thus, it is crucial to prevent and promptly address intraoperative hypotension to enhance perioperative outcomes for surgical patients. Recent systematic review and meta-analysis aimed to evaluate the effect of using the hypotension prediction index (HPI) on various measures of intraoperative hypotension, including time-weighted average (TWA), area under the hypotension threshold (AUHT), incidence, and duration. The review included 8 randomized controlled trials (RCTs) with a total of 613 patients. The key findings are: 1. TWA of hypotension during surgery was significantly lower in the HPI group compared to the control group (mean difference (MD) = -0.19 mmHg, 95% CI: -0.31, -0.08, p=0.001). 2. AUHT was also significantly lower in the HPI group compared to control (MD = -65.03 mmHg x min, 95% CI: -105.47, -24.59, p=0.002). 3. The incidence of hypotension was significantly lower in the HPI group compared to control (risk ratio = 0.83, 95% CI: 0.7, 0.99, p=0.04). 4. The total duration of hypotension was significantly shorter in the HPI group versus control (MD = -12.07 min, 95% CI: -17.49, -6.66, p<0.001). 5. Hypotension duration as a percentage of total surgery time was also significantly lower in the HPI group (MD = -6.30%, 95% CI: -10.23, -2.38, p=0.002).

Conclusion

The authors conclude that the available evidence supports the role of HPI in minimizing various measures of intraoperative hypotension. However, the certainty of evidence was low to moderate for the studied outcomes. The authors note limitations including high heterogeneity between studies, potential publication bias, small sample sizes, and conflicts of interest in most studies. Overall, this meta-analysis provides support for the use of HPI to reduce intraoperative hypotension, but further well-designed RCTs are needed to confirm these findings.

Key Points

1. The time-weighted average (TWA) of hypotension during surgery was significantly lower in the group using the hypotension prediction index (HPI) compared to the control group.

2. The area under the hypotension threshold (AUHT) was also significantly lower in the HPI group compared to the control group.

3. The incidence of hypotension was significantly lower in the HPI group compared to the control group.

4. The total duration of hypotension was significantly shorter in the HPI group compared to the control group.

5. The duration of hypotension as a percentage of total surgery time was significantly lower in the HPI group.

6. The authors conclude that the available evidence supports the use of HPI in minimizing various measures of intraoperative hypotension, but the certainty of evidence was low to moderate and further well-designed studies are needed to confirm these findings.

Reference –

Sriganesh K, Francis T, Mishra RK, Prasad NN, Chakrabarti D. Hypotension prediction index for minimising intraoperative hypotension: A systematic review and meta‑analysis of randomised controlled trials. Indian J Anaesth 2024;68:942‑50.

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Habit of Daily Flossing may help Lower Cardiovascular Risk and Mortality: Study

Daily Flossing may lower cardiovascular risk and mortality suggests a new study published in The Journal of the American Dental Association.

Increasing evidence suggests that daily oral hygiene self-care measures may alleviate cardiovascular disease (CVD) risk. The authors aimed to determine the influence of self-reported dental flossing behavior on the prevalence of CVD events, CVD-linked mortality, and a CVD risk marker of inflammation (ie, C-reactive protein [CRP]). Data from 18,801 adult participants of the 2009-2016 National Health and Nutrition Examination Surveys were analyzed about flossing behaviour, prevalence of CVD events, mortality cause data, and CRP levels. Information on mortality was obtained from the US mortality registry, updated to 2019. Participants who answered the flossing question were divided into 4 groups according to their frequency of flossing: not flossing (0 d/wk); occasional flossing (1-3 d/wk); frequent flossing (4-6 d/wk); and daily flossing (7 d/wk). Multiple logistic regression and Cox proportional hazard regression were used for analysis.

Results: Daily flossing was associated with lower prevalence of CVD events after adjusting for age, sex, sociodemographic factors, and lifestyle habits (model 2); the odds ratio was 0.71 (95% CI, 0.59 to 0.85) for CVD prevalence in the daily flossing group compared with the not flossing group. The odds ratio for CVD prevalence for each additional day of flossing was 0.95 (95% CI, 0.93 to 0.98; P for linear trend < .001) in model 2, and remained statistically significant after model 2 was further adjusted for metabolic syndrome. Daily flossing compared with not flossing was associated with lower risk of experiencing CVD mortality (hazard ratio, 0.64; 95% CI, 0.49 to 0.84) in model 2. The hazard ratio of CVD mortality for each additional day of flossing was 0.94 (95% CI, 0.90 to 0.98; P for linear trend = .002) in model 2. Participants in the not flossing group had significantly elevated CRP levels, even after multivariable adjustments. Poor flossing behavior is associated with higher prevalence of cardiovascular events, increased risk of experiencing CVD mortality, and elevated CRP levels. Improvement in flossing behavior can have an additional benefit in the prevention of CVD events. Cardiologists need to advise patients to improve their personal oral hygiene practices, in addition to the standard diet and exercise advice.

Reference:

Nebu Philip, Faleh Tamimi, Abdulla Al-Sheebani, Abdulrahman Almuzafar, Zumin Shi,

The effect of self-reported flossing behavior on cardiovascular disease events and mortality: Findings from the 2009-2016 National Health and Nutrition Examination Surveys,

The Journal of the American Dental Association, 2024. ISSN 0002-8177. https://doi.org/10.1016/j.adaj.2024.09.017.

Key Words

Flossing, cardiovascular, diseas, eperiodontal disease, oral hygiene, mortality, Nebu Philip, Faleh Tamimi, Abdulla Al-Sheebani, Abdulrahman Almuzafar, Zumin Shi,The Journal of the American Dental Association

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Excessive screen time linked to early puberty and accelerated bone growth, claims research

Exposure to blue light, like that from smartphones or tablets, may accelerate bone growth and bone age, leading to early puberty in rats. This research, presented at the 62nd Annual European Society for Paediatric Endocrinology Meeting in Liverpool, sheds light on how the use of blue light-emitting devices could impact growth and development and raises important questions about the long-term health effects in children, who are increasingly exposed to screens from a young age.
As children grow and develop, long bones such as the femur progressively elongate at each end. These growing ends – areas of smooth, elastic cartilage known as ‘growth plates’ – eventually solidify which stops growth in height. Girls generally stop growing and reach their maximum height between ages 14 and 16, while boys finish their growth between 16 and 18 years of age. However, in recent years, several studies have reported a rise in early puberty in both girls and boys, in which they might grow quickly at first but often stop growing earlier than usual. One factor may be the increased use of blue light-emitting devices.
In this study, researchers from Gazi University in Turkey examined 18 male and 18 female rats aged 21-days-old, equally divided into three groups of six and exposed to either a normal light cycle, six hours or 12 hours of blue light until the first signs of puberty. They measured their length and femurs and found that the rats exposed to blue light had a faster growth, particularly in their bones, and started puberty earlier compared to those in standard light conditions.
Previous research from the same group has also shown that rats exposed to blue light have a higher risk of early puberty. However, this association has never been studied in bone growth and pubertal development before. “This is the first study to show how blue light could potentially influence physical growth and development, prompting further research into the effects of modern screen exposure on children’s growth,” said lead researcher Dr Aylin Kılınç Uğurlu.
Although Dr Kılınç Uğurlu warned: “As this a rat study, we cannot be sure that these findings would be replicated in children but our data suggest that prolonged exposure to blue light accelerates both the physical growth and maturation of the growth plate, leading to early puberty.”
“While the increased growth may sound beneficial, our study also found that blue light exposure led to earlier structural changes in the growth plates of the rats’ bones, suggesting an impact on long-term bone age,” said Dr Kılınç Uğurlu. “This means their bones matured too soon which could potentially cause them to be shorter than average as adults.”
The researchers are now planning to investigate how blue light exposure before puberty affects height and skeletal development in adult rats. “We want to explore the long-term effects of pre-pubertal blue light exposure and find out whether certain exposure durations or intensities have reversible or permanent effects on the skeleton later in life,” said Dr Kılınç Uğurlu. “Ultimately, this research could lead to preventative measures for safe screen use during childhood development.”

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Sacubitril/Valsartan Outperforms ACEI/ARB Therapy in Kidney Recovery for Thrombotic Microangiopathy: JAMA

China: A recent cohort study has suggested that sacubitril/valsartan may offer superior kidney function benefits for patients with thrombotic microangiopathy (TMA) associated with malignant hypertension (mHTN), compared to traditional angiotensin-converting enzyme inhibitors (ACEIs) and angiotensin receptor blockers (ARBs).

The research, published in JAMA Network Open, highlights the potential of sacubitril/valsartan as an advanced therapeutic option for managing this severe kidney condition.

Thrombotic microangiopathy, characterized by the formation of blood clots in small blood vessels, often leads to acute kidney injury and can be challenging to treat effectively. The standard approach for managing TMA associated with mHTN has traditionally involved using ACEIs and ARBs, both of which help control blood pressure and provide renal protection. Treatment strategies are still not well established.

Against the above background, Jianbo Li, Guangdong Provincial Key Laboratory of Nephrology, Guangzhou, China, and colleagues aimed to assess the kidney outcomes of sacubitril/valsartan, an angiotensin receptor-neprilysin inhibitor (ARNI), compared to angiotensin-converting enzyme inhibitors and angiotensin receptor blockers in patients with thrombotic microangiopathy associated with malignant hypertension.

For this purpose, the researchers conducted a single-center cohort study in China, enrolling consecutive patients diagnosed with mHTN-associated TMA through kidney biopsy between January 2008 and June 2023.

The study compared the effects of sacubitril/valsartan and ACEIs or ARBs on kidney outcomes, assessing both treatments during hospitalization and after discharge. The primary outcome of interest was kidney recovery, defined as either a 50% reduction in serum creatinine levels, normalization of serum creatinine levels to the reference range, or kidney survival without dialysis for more than one month. Secondary outcomes included a 15% increase in the estimated glomerular filtration rate (eGFR) from baseline and kidney survival free from dialysis.

To analyze the effectiveness of sacubitril/valsartan compared to ACEI/ARB therapy, the researchers employed propensity score matching (PSM) and Cox proportional hazards regression analysis. These methods were used to evaluate the association between the therapies and kidney recovery outcomes, aiming to determine which treatment offers better benefits for patients with mHTN-associated TMA.

The study led to the following findings:

  • Among the 217 patients (mean age, 35.9 years; 86.6% men) included in the study, 66 received sacubitril/valsartan, and 151 received ACEI/ARBs at baseline.
  • Sacubitril/valsartan treatment was associated with a shorter time to the primary outcome compared with ACEI/ARB treatment (31.7% versus 32.5%; adjusted hazard ratio [aHR], 1.85).
  • Sacubitril/valsartan treatment was independently associated with shorter time to a 15% increase in eGFR (32.6% versus 55.4%; aHR, 2.13) and kidney survival free from dialysis (47.8% versus 28.1%; aHR, 2.63) compared with ACEI/ARB treatment. These differences remained significant in the PSM comparison.

“The findings indicated that sacubitril/valsartan may offer superior benefits for kidney recovery in managing this serious condition,” the researchers concluded.

Reference:

Li J, Liu Q, Lian X, et al. Kidney Outcomes Following Angiotensin Receptor-Neprilysin Inhibitor vs Angiotensin-Converting Enzyme Inhibitor/Angiotensin Receptor Blocker Therapy for Thrombotic Microangiopathy. JAMA Netw Open. 2024;7(9):e2432862. doi:10.1001/jamanetworkopen.2024.32862

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Adding immunotherapy to neoadjuvant chemoradiation may improve outcomes in esophageal cancer: Study

Bottom Line: In patients with unresectable, locally advanced esophageal cancer, the triple combination of radiation, chemotherapy, and immunotherapy made tumors more amenable to surgery, which was associated with significantly improved outcomes.

Journal in Which the Study was Published: Clinical Cancer Research, a journal of the American Association for Cancer Research.

Background: “Curative resection unequivocally serves as the cornerstone for treating resectable esophageal squamous cell carcinoma (ESCC); however, because of lack of symptoms and early detection, fewer than half of patients have resectable disease at the time of diagnosis,” said Yin Li, MD, senior author of the study and director of section of esophageal and mediastinal oncology at the Chinese Academy of Medical Sciences and Peking Union Medical College.

Given the unfavorable long-term prognosis of patients who receive chemoradiation alone—only about 36% survive at least five years, according to Li—there is a desperate need for improved strategies.

Immune checkpoint inhibitors, both alone and in combination with chemotherapy, are standard –of care for those with advanced, recurrent, and metastatic ESCC. They’re also approved for adjuvant therapy after complete resection following neoadjuvant chemoradiation. But Li and his team wanted to investigate whether adding immune checkpoint inhibitors to chemoradiation can help downstage tumors and improve resectability.

How the Study was Conducted: To address this possibility, in a phase II clinical trial, patients between the ages of 18-75 were enrolled at their institution to receive three steps of treatment: radiation in conjunction with nab-paclitaxel (Abraxane) and cisplatin chemotherapy in step 1, the immune checkpoint inhibitor tislelizumab (Tevimbra) plus chemotherapy in step 2, and, if possible, surgery in step 3.

Results: Of the 30 patients enrolled, five discontinued treatment during chemoradiotherapy and one patient received surgery ahead of schedule without subsequent immunotherapy. Of the 24 patients who also received subsequent chemoimmunotherapy, four discontinued the treatment, and 19 received surgery. Overall, 20 patients underwent surgery and had complete resections.

Of these 20 patients, 19 had experienced major pathologic responses at the time of surgery, with 13 having complete pathologic responses. Most importantly, compared to the 10 patients who did not undergo surgery, the 20 who had surgery had significantly longer survival, both overall and without disease progression, with 82% and 72% reductions in risk of death and progression, respectively, at one year follow-up. More than half of those who underwent surgery were still free of disease at two years.

Author’s Comments: “The neoadjuvant treatment approach we tested has the potential to make initially unresectable tumors resectable, giving patients the opportunity to have a durable cancer-free state.”

“Our trial clearly demonstrated the effectiveness of combining chemoradiotherapy, chemoimmunotherapy, and surgery compared to nonsurgical management alone,” according to Li. “We were confident in potential benefits of adding immunotherapy to chemoradiotherapy, but the remarkable pathologic complete response and the strong survival outcomes far exceeded our expectations.”

The clinical study also utilized circulating tumor DNA (ctDNA)-based liquid biopsies throughout the course of care, including monitoring for relapse, which, Li said, “allowed us to gain valuable insights into the molecular landscape and minimal residual disease trajectory of these patients.”

Study Limitations: Limitations of the study include its small sample size, due in part to treatment discontinuations, and thus point to the need for phase III trials to validate these findings as well as explore the optimal sequencing of therapies.

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Vitamin E Shows Promise for Treating Antipsychotic-Induced Movement Disorders: A Case Report

Dubai: Antipsychotic medications are essential in managing psychiatric conditions like schizophrenia and bipolar disorder, but they often come with severe side effects. Among these, extrapyramidal symptoms (EPS) and tardive dyskinesia (TD) are particularly challenging, causing involuntary, repetitive movements that can significantly impair quality of life. A recent case report published in Cureus Journal sheds light on the potential effectiveness of vitamin E as an adjunctive treatment for these debilitating conditions.

This case highlights the potential effectiveness of vitamin E in treating TD and other EPS, especially when introduced early in the progression of the disorder.

The case concerns a 28-year-old man with a psychotic disorder who developed severe EPS and TD after receiving paliperidone injections. Symptoms included muscle rigidity, parkinsonian gait, and pronounced involuntary motor disturbances. Despite discontinuing paliperidone and trying multiple conventional treatments—including procyclidine, propranolol, clonazepam, and omega-3 supplements—his symptoms persisted.

A novel approach was adopted with the introduction of oral vitamin E at a dose of 400 IU daily. The patient showed a remarkable 80% reduction in symptoms within weeks. His Abnormal Involuntary Movement Scale (AIMS) score, a tool used to assess TD severity, dropped from 24 to 4. Encouraged by these results, clinicians gradually increased the vitamin E dosage to 1200 IU daily while tapering other medications. Ultimately, the patient experienced a complete resolution of symptoms, with his AIMS score reaching 0 and no recurrence of psychotic episodes.

This case by Syed Ali Bokhari, Psychiatry, Al Amal Psychiatric Hospital, Emirates Health Services, Dubai, ARE, and colleagues highlights vitamin E’s potential as an effective treatment for TD and EPS, particularly in patients unresponsive to standard therapies. The antioxidant properties of vitamin E are thought to combat oxidative stress, which plays a role in TD’s pathophysiology. Although research on vitamin E’s efficacy in treating TD has been mixed, this report contributes to growing evidence supporting its benefits, especially when initiated early.

The patient’s recovery underscores the importance of exploring alternative treatments for antipsychotic-induced side effects. It also emphasizes the need for larger clinical trials to determine optimal dosing and identify patients most likely to benefit from vitamin E therapy.

For individuals affected by antipsychotic-induced TD, vitamin E may represent a hopeful step toward improved management of this challenging condition, offering not only symptom relief but also a chance at a better quality of life.

“Although existing literature offers mixed evidence on the effectiveness of vitamin E, this case contributes to the expanding research indicating its potential benefits, particularly when administered early in the disease. Larger-scale studies are needed to determine optimal treatment protocols and identify the patient groups most likely to respond favorably to vitamin E therapy,” the researchers concluded.

Reference:

Elnoor M, Bokhari S, Singh M, et al. (August 30, 2024) Effectiveness of Vitamin E in Treatment of Antipsychotic-Induced Tardive Dyskinesia and Extrapyramidal Symptoms: A Case Report. Cureus 16(8): e68231. doi:10.7759/cureus.68231

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ESP block tied to significantly lower opioid consumption in patients undergoing lumbar spine surgery, finds study

The current body of research does not definitively demonstrate whether the erector spinae plane (ESP) block or the thoracolumbar interfascial plane (TLIP) block is better at providing pain relief and reducing opioid consumption in lumbar spine surgeries. Recent systematic review and meta-analysis aimed to compare the efficacy and safety of ultrasound-guided erector spinae plane (ESP) block versus thoracolumbar interfascial plane (TLIP) block in patients undergoing lumbar spine surgeries. The primary outcome assessed was 24-hour opioid consumption, and secondary outcomes included visual analogue scale (VAS) scores at 1 and 24 hours and various complications such as nausea and vomiting, sedation, respiratory depression, and pruritus.

Findings of the Review

The review included six randomized controlled trials (RCTs) comprising 492 patients. The findings revealed that the ESP block demonstrated significantly lower 24-hour opioid consumption and lower VAS pain scores at 1 and 24 hours compared to the TLIP block. Importantly, no significant difference was noted in adverse events such as nausea and vomiting, sedation, respiratory depression, and pruritus between the two groups.

Trial Sequential Analysis

The review also conducted a trial sequential analysis (TSA) which suggested that additional studies are necessary to strengthen the findings. The primary objective was to explore the efficacy of the blocks in terms of 24-hour opioid consumption, with secondary objectives including VAS scores and safety profiles. The study followed the recommendations of the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement for conducting and reporting the results.

Review Limitations

The ESP block was found to have a lower 24-hour opioid consumption and reduced VAS pain scores at 1 and 24 hours compared to the TLIP block. Despite the statistically significant findings, the review highlighted the need for caution due to limitations such as the small sample size and clinical heterogeneity across the included studies. The authors also stressed the importance of further research with larger sample sizes to strengthen the findings.

Conclusion

In conclusion, the meta-analysis found that the ESP block is superior to the TLIP block in terms of 24-hour opioid consumption and VAS pain scores at 1 and 24 hours in patients undergoing lumbar spine surgery. However, it emphasized the need for caution and further research to validate and strengthen these findings.

Overall Study Contribution

Overall, the study provided comprehensive insights into the relative efficacy and safety of the ESP block and TLIP block in lumbar spine surgeries, contributing valuable evidence to the field of anesthesia and pain management in orthopedic and spine surgeries.

Key Points

– Comparison of ultrasound-guided erector spinae plane (ESP) block versus thoracolumbar interfascial plane (TLIP) block in lumbar spine surgeries

– Primary outcome: 24-hour opioid consumption, secondary outcomes: VAS scores at 1 and 24 hours, and various complications – Findings from 6 randomized controlled trials (RCTs) with 492 patients

– ESP block resulted in significantly lower 24-hour opioid consumption and lower VAS pain scores at 1 and 24 hours compared to TLIP block

– No significant difference in adverse events between the two groups – Trial sequential analysis (TSA) suggested the need for additional studies to strengthen the findings, with emphasis on the small sample size and clinical heterogeneity as limitations

– Conclusion: ESP block is superior to TLIP block in terms of 24-hour opioid consumption and VAS pain scores at 1 and 24 hours, but caution and further research are emphasized to validate and strengthen the findings

– Overall study contribution: Offers valuable evidence for anesthesia and pain management in orthopedic and spine surgeries

Reference –

Majage S, Ravikumar RH, Prasanna M, Chandramouli M, Datta PK, Baidya DK. Comparison of efficacy of ultrasound‑guided erector spinae plane block versus thoracolumbar interfascial plane block in patients undergoing lumbar spine surgeries: A systematic review and trial sequential meta‑analysis. Indian J Anaesth 2024;68:752‑61

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Ulcerative colitis causally related to male infertility, claims research

Ulcerative colitis causally related to male infertility, claims research published in the PLOS ONE.

A study was done to explore the causal relationship between ulcerative colitis (UC) and male infertility using Mendelian randomization method with single nucleotide polymorphism (SNP) as the instrumental variables. Genetic loci closely associated with UC were extracted as instrumental variables and male infertility was the outcome variable in pooled data from the gene-wide association study (GWAS),which was derived from European ethnic groups. The UC data(ebi-a-GCST003045) contained a total sample size of 27432 individuals and 110944 SNPs, and the male infertility data(finn-b-N14_MALEINFERT) contained a total sample size of 73479 individuals and 16377329 SNPs. The SNPs highly correlated with UC were screened from ebi-a-GCST003045(P<5×10−8 as the screening condition, the linkage disequilibrium coefficient was 0.001,and the width of the linkage disequilibrium area was 10000 kb).SNPs related to male infertility from finn-b-N14_MALEINFERT (the minimum r2>0.8,replacing the missing SNPs with SNPs with high linkage, and deleting SNPs without substitution sites) were extracted. MR analysis was performed using MR-Egger regression, the weighted median and the inverse-variance weighted (IVW) respectively, and the causal relationship between UC and male infertility was evaluated by OR and 95% CI, and the Egger-intercept method was used to test for horizontal multiplicity, and the sensitivity analysis was performed using “leave-one-out method”. Finally, they used Bayesian Weighted Mendelian Randomization (BWMR) approach to test the results of MR study. Results: A total of 86 SNPs were included as IVs, with OR and 95% CI of 1.095(0.820~1.462)、1.059(0.899~1.248)、1.125(1.002~1.264) for MR-Egger, the weighted median and IVW results respectively, and P value of less than 0.05 for IVW, indicating that a causal relationship between UC and male infertility was causally related. The results of MR analysis combined with BWMR analysis also showed positive genetic causal relationship between UC and male infertility.MR-Egger regression showed an intercept of -2.21×10−3 with a standard error of 0.006 and P = 0.751, there was no horizontal pleiotropy for the IVs of exposure factors. Heterogeneity tests showed no heterogeneity and the results of the “leave-one-out” sensitivity analysis were stable. There is a causal association between UC and male infertility, which increases the risk of developing male infertility.

Reference:

Wang X, Li T, Chen Q. Causal relationship between ulcerative colitis and male infertility: A two-sample Mendelian randomization study. PLoS One. 2024;19(5):e0303827. doi:10.1371/journal.pone.0303827

Keywords:

Wang X, Li T, Chen, Ulcerative colitis, causally, related, male infertility, claims, research

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Early Tenofovir Treatment and Vaccination Effective in Preventing Hepatitis B Transmission During Pregnancy: JAMA

China: A recent randomized clinical trial published in JAMA investigated the effectiveness of Tenofovir (TDF) in preventing mother-to-child transmission (MTCT) of Hepatitis B virus (HBV) during pregnancy. It found that in pregnant women with high HBV viremia, starting TDF treatment at 16 weeks of gestation, along with infant HBV vaccination, was as effective as the standard approach, which involves starting TDF at 28 weeks combined with hepatitis B immune globulin (HBIG) and infant HBV vaccination.

“These findings support initiating TDF treatment at 16 weeks of gestation, along with administering the HBV vaccine to infants, as an effective strategy to prevent mother-to-child transmission of HBV, particularly in regions where HBIG is unavailable,” the researchers wrote.

The standard approach to preventing mother-to-child transmission of hepatitis B virus in highly viremic mothers includes maternal antiviral prophylaxis starting at week 28 of gestation, combined with an HBV vaccine series and HBIG for newborns. However, in resource-limited areas where HBIG is unavailable, Calvin Q. Pan, Guangzhou Medical University, Guangzhou, China, and colleagues sought to determine if initiating tenofovir disoproxil fumarate (TDF) at gestational week 16, along with HBV vaccinations for infants, is as effective as the standard care approach in preventing MTCT in mothers with high HBV viremia.

For this purpose, the researchers conducted an unblinded, 2-group randomized noninferiority trial at seven tertiary hospitals in China. Two hundred eighty pregnant individuals with HBV DNA levels exceeding 200,000 IU/mL were enrolled between June 2018 and February 2021. Participants were randomly assigned to receive either TDF starting at gestational week 16 with infant HBV vaccinations or TDF starting at week 28 with HBV vaccinations and HBIG for infants.

The primary outcome was the MTCT rate at 28 weeks, with noninferiority determined by a maximum absolute difference of 3%.

The study led to the following findings:

  • A total of 280 pregnant individuals enrolled in the trial, with 95% completing the study.
  • Among live-born infants, the MTCT rate was 0.76% (1/131) in the experimental group and 0% (0/142) in the standard care group using the last observation carried forward.
  • In the per-protocol analysis, the MTCT rate was 0% in both groups (0/124 in the experimental group and 0/141 in the standard care group).
  • Between-group differences met the criterion for noninferiority (0.76% and 0% with respective upper 90% CI limits of 1.74% and 1.43%).
  • Congenital defects and malformations rates were lower in the experimental group (2.3%) than the standard care group (6.3%), with a difference of 4%.

“For pregnant women with HBV and high viremia levels, starting TDF at gestational week 16 alongside HBV vaccination for infants proved to be noninferior to the standard approach of initiating TDF at week 28 combined with HBV vaccination and HBIG for infants,” the researchers concluded.

Reference:

Pan CQ, Dai E, Mo Z, et al. Tenofovir and Hepatitis B Virus Transmission During Pregnancy: A Randomized Clinical Trial. JAMA. Published online November 14, 2024. doi:10.1001/jama.2024.22952

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Low serum creatinine level associated with higher presence of knee OA in both men and women: Study

Researchers identified that low serum creatinine levels were significantly associated with higher presence and increased severity of radiographic knee osteoarthritis (OA) in individuals aged 50 years or above. A recent study presumes that serum creatinine might be a potential biomarker for assessing the presence and severity of knee OA. The study was published in Yonsei Medical Journal by Lim CW and colleagues.

Knee OA is a very common condition, but it affects mainly older adults. It consists of degeneration of the articular cartilage and underlying bone of the joints. This often results in pain, stiffness, and limitation in mobility-all factors that highly affect quality of life. Whereas the exact pathophysiology of knee OA is complex and multifactorial, recent studies have discussed the possibility of serum creatinine levels serving as a biomarker for the disease. Serum creatinine, the waste product formed from the normal breakdown of muscle tissue, is usually used to assess kidney function. However, its relation to musculoskeletal diseases such as knee OA has not been greatly analyzed. This study assessed the association of serum creatinine level with the presence and severity of knee OA, considering possible confounding variables.

The investigators performed a cross-sectional study based on data from the Korea National Health and Nutrition Examination Survey from 2009 to 2011. For this study, there were 3,428 participants aged ≥50 years. The Kellgren-Lawrence grading system is one of the most widely used and accepted systems for assessing the presence and severity of radiographic OA; this was used to grade knee OA. Logistic regression and receiver operating characteristic analyses tested the association between serum creatinine levels and the presence of knee OA, whereas ordinal regression tested the effect of creatinine on the severity of OA.

For this study, the participants were diagnosed with knee OA using radiographic imaging, and then the severity of the disease was determined based on the Kellgren-Lawrence scale. The level of serum creatinine was determined and logistic regression analysis conducted in order to ascertain the odds ratio of presence of knee OA according to levels of creatinine. It also used ordinal regression analysis to examine how creatinine level might influence the severity of knee OA according to K-L grades. All of these analyses also included stratification by sex, to indicate any possible difference between men and women.

Results

  • The significant association of low serum creatinine with the radiographic presence of knee OA observed in this study was similarly present among men and women.

  • Knee OA was significantly associated with low serum creatinine levels, with ORs of 0.118 (95% CI 0.045-0.314, p<0.001) for men and 0.148 (95% CI 0.040-0.549, p=0.004) for women.

  • Low levels of serum creatinine were also significantly associated with increasing knee OA severity according to the K-L grading.

  • The K-L scale-measured severity of knee OA was inversely related to the levels of serum creatinine: β -1.923 (SE, 0.478; p<0.001) for men and -1.532 (SE, 0.575; p=0.008) for women.

This study demonstrated that lower levels of serum creatinine are associated with a higher prevalence and greater severity of radiographic knee osteoarthritis among men and women aged 50 years and older. Their findings indicate that serum creatinine can potentially act as an important biomarker for classifying risk and disease progression of knee OA and may offer some advantages in early detection and management of this common condition.

Reference

Lim, C. W., Ryu, D. J., & Suh, Y. J. (2024). Association between low serum creatinine levels and knee osteoarthritis in Koreans without renal insufficiency. Yonsei Medical Journal, 65(9), 519. https://doi.org/10.3349/ymj.2023.0456

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