Toxicity Assessment of a No-Pain Pharmacopuncture Extract Using a Standard Battery of In Vitro Chromosome Aberration Tests.

Objectives: Genotoxicity is evaluated through a chromosomal aberration test using cultured mammalian cells to determine the toxicity of no-pain pharmacopuncture (NPP), which has recently been used to treat musculoskeletal pain disorders in Korean medical clinical practice. Methods: An initial test was performed to determine the dosage range of the NPP, followed by the main test. In this study, NPP doses of 10.0, 5.0, and 2.5%, and negative and positive controls were tested. An in vitro chromosome aberration test was performed using Chinese hamster lung cells under short-term treatment with or without metabolic activation and under continuous treatment without metabolic activation. Results: Compared with the saline negative control group, NPP did not significantly increase the frequency of chromosomal abnormalities in Chinese hamster lung cells, regardless of the presence or absence of metabolic activation. Additionally, the number of cells with structural chromosomal abnormalities was significantly higher in the positive control group than that in the negative control group that received saline. Conclusion: Based on the above results, the chromosomal abnormality-producing effect of NPP was determined to be negative under these test conditions.

Anti-Inflammatory, Analgesic, Functional Improvement, and Chondroprotective Effects of Erigeron breviscapus (Vant.) Hand.-Mazz. Extract in Osteoarthritis: An In Vivo and In Vitro Study.

Osteoarthritis (OA) is a degenerative bone disease characterized by inflammation as a primary pathology and currently lacks therapeutic interventions to impede its progression. Erigeron breviscapus (Vant.) Hand.-Mazz. (EB) is an east Asian herbal medicine with a long history of use and a wide range of confirmed efficacy against cardiovascular and central nervous system diseases. The purpose of this study is to evaluate whether EB is worthy of further investigation as a treatment for OA based on anti-inflammatory activity. This study aims to assess the potential of EB as a treatment for OA, focusing on its anti-inflammatory properties. Analgesic effects, functional improvements, and inhibition of cartilage destruction induced by EB were evaluated in acetic acid-induced peripheral pain mice and monosodium iodoacetate-induced OA rat models. Additionally, the anti-inflammatory effect of EB was assessed in serum and cartilage tissue in vivo, as well as in lipopolysaccharide-induced RAW 264.7 cells. EB demonstrated a significant alleviation of pain, functional impairment, and cartilage degradation in OA along with a notable inhibition of pro-inflammatory cytokines, including interleukin-1ß, interleukin-6, matrix metalloproteinases 13, and nitric oxide synthase 2, both in vitro and in vivo, in a dose-dependent manner compared to the active control. Accordingly, EB merits further exploration as a potential disease-modifying drug for OA, capable of mitigating the multifaceted pathology of osteoarthritis through its anti-inflammatory properties. Nonetheless, additional validation through a broader experimental design is essential to substantiate the findings of this study.

Acupotomy combined with Korean medicine treatment in a patient with acute sacroiliac pain unresponsive to conventional therapy: A case report.

RATIONALE: Acute injury to the sacroiliac joint (SIJ) can result from high-energy external forces that cause a combination of axial loading and sudden rotational movements, resulting in severe pain that cannot be relieved by regular nonsteroidal anti-inflammatory drugs. The treatment includes injections of steroids and local anesthetics to reduce pain and promote healing. Here, we report the case of a patient with acute sacroiliac pain who did not respond to conventional injection therapy. PATIENT CONCERNS: A 58-year-old male patient who did not exercise regularly experienced pain in his left groin and difficulty walking while kicking on his right leg. He received two injections and manual therapy at a local orthopedic clinic; however, his symptoms did not improve despite taking painkillers. DIAGNOSES: Radiographic images showed no abnormalities. After confirming the cause of onset, pain pattern, physical examination, and tenderness, the patient was diagnosed with an acute SIJ sprain (static blood). INTERVENTIONS: At the first visit, a single acupotomy was performed on the seven treatment points identified during the physical examination, and immediate improvement in symptoms was confirmed. From then on, Korean medicine (KM) treatments, such as acupuncture, cupping, chuna, and bee venom pharmacopuncture, were performed. OUTCOMES: Immediately after acupotomy, groin pain improved by 80 %, gait immediately normalized, and the patient showed no symptoms at the 9th visit. LESSONS: For SIJ-type groin pain that does not respond to existing treatments, immediate relief is achieved after a single acupotomy at the exact treatment point. Therefore, in the future, the importance of identifying a precise treatment point for SIJ pain should be recognized, and the use of Korean medicine treatment techniques, including acupotomy, should be considered.

Infant sleep interventions with sleep measurements using actigraphy: A systematic review.

AIM: This review investigated the outcomes and methodological quality of infant sleep intervention studies utilizing actigraphy. BACKGROUND: Parents need appropriate support for infant sleep from nurses. There are few methodological reports of actigraphy in infant sleep intervention studies that objectively measure infant sleep in a natural setting. DESIGN: This was a systematic review study. DATA SOURCES: Ovid MEDLINE, Embase, Cochrane, CINAHL and PsycINFO were searched from database establishment to 30 December 2021. REVIEW METHODS: This systematic review utilized the Cochrane Collaboration review guidelines. RESULTS: Eleven sleep intervention studies were reviewed. Three used extinction-based behavioural interventions, and eight included parental education programs. The infant sleep interventions positively affected the sleep outcomes of both infants and parents. Fairly consistent effects were found on infants' number of awakenings and sleep onset latency. However, parental psychosocial outcomes were inconsistent. All studies reported device placement, the algorithm for analysis, the use of a sleep diary and number of days/nights, but external movements affecting infants' sleep records were insufficiently reported. Only two studies had a low risk of bias. CONCLUSIONS: The infant sleep interventions had positive effects on both infants and their parents. Comprehensive methodological considerations are required for more standardized assessments using actigraphy for infant sleep evaluation.

Incidence of and Influencing Factors for Arm Lymphedema After Salvage Treatment for an Isolated Locoregional Recurrence of Breast Cancer.

PURPOSE: Data on subsequent arm lymphedema (SAL) after salvage treatment for locoregional recurrence (LRR) of breast cancer are limited. We conducted a study to evaluate the risk of SAL in patients with LRR. METHODS: We reviewed the data of patients with breast cancer who had LRR and were initially diagnosed between January 2003 and December 2017. Among the 214 patients who received curative salvage treatment, most had local (n = 125, 57.9%), followed by regional (n = 73, 34.1%), and locoregional (n = 16, 7.9%) recurrences. A competing risk analysis considering the factors of death and a second LRR were performed to exclude potential malignant lymphedema. We used the Fine-Gray subdistribution hazards model to estimate the hazard ratio (HR) for comparing the risk of SAL. RESULTS: With a median follow-up duration of 41.4 months (interquartile range, 25.6-65.1), 51 patients (23.8%) experienced SAL with a median interval of 9.9 months after treatment. The two-year cumulative incidence of SAL was 12.7%. Among the 18 patients with initial lymphedema, nine (50.0%) developed SAL. Multivariate analysis revealed that a history of lymphedema (HR, 4.61; p < 0.001) and taxane-based salvage chemotherapy (HR, 2.38; p = 0.009) were significantly associated with SAL development. CONCLUSION: Salvage treatment for LRR-induced SAL was performed in 24% of the patients. A history of initial lymphedema and salvage taxane-based chemotherapy increases the risk of developing SAL. Therefore, close surveillance for the incidence of SAL is required in patients opting for salvage treatment for LRR.

Association of clinical manifestations of secondary lymphedema and lymph node dissection sites in the lower extremities of patients with melanoma.

BACKGROUND: Lymphedema is a chronic, debilitating disease that often requires life-long management. Predicting clinical manifestations and prognosis is crucial in clinical practice because the treatment of lymphedema should be individualized for best clinical outcome. The aim of this study is to explore the location and severity of lymphedema secondary to inguinal and/or iliac lymph node dissection (LND) in patients with melanoma. METHODS: Patients with melanoma who received LND at a single tertiary medical center between 1 January 2010 and 31 September 2022 were retrospectively reviewed. Patient who received inguinal LND only were designate as the inguinal group while those who received both ilioinguinal LND were included in the ilioinguinal group. Volumetric measurement was used to objectify the severity and location of lymphedema. Clinical data was acquired for 12-15 months of follow-up. RESULTS: Among 81 patients, 43 (53%) had developed lymphedema in the lower extremities at an average of 33 days after the surgery. Initially, patients manifested with medial thigh lymphedema in the inguinal group while patients were presented with whole leg lymphedema in the ilioinguinal group. Lower leg volume of the ilioinguinal group was significantly higher than the inguinal group. After more than 12 months of lymphedema treatment, upper leg volume was higher in the ilioinguinal group than the inguinal group (12.7% vs 5.4%, p < 0.05). CONCLUSION: Lymphedema developed in early post-op period. The ilioinguinal group presented with a larger volume of lymphedema in the distal area of the legs. Even after sufficient treatment, predominant lymphedema remained in the proximal leg for the ilioinguinal group. Patients with both inguinal and iliac LND were associated with more severe lymphedema. Based on the dissection sites, the clinical manifestations and prognosis of leg lymphedema can vary widely. Thus, clinicians should consider the dissection site when approaching melanoma patients with lymphedema.

Efficacy and Key Materials of East Asian Herbal Medicine Combined with Conventional Medicine on Inflammatory Skin Lesion in Patients with Psoriasis Vulgaris: A Meta-Analysis, Integrated Data Mining, and Network Pharmacology.

Psoriasis is a chronic inflammatory disease that places a great burden on both individuals and society. The use of East Asian herbal medicine (EAHM) in combination with conventional medications is emerging as an effective strategy to control the complex immune-mediated inflammation of this disease from an integrative medicine (IM) perspective. The safety and efficacy of IM compared to conventional medicine (CM) were evaluated by collecting randomized controlled trial literature from ten multinational research databases. We then searched for important key materials based on integrated drug data mining. Network pharmacology analysis was performed to predict the mechanism of the anti-inflammatory effect. Data from 126 randomized clinical trials involving 11,139 patients were used. Compared with CM, IM using EAHM showed significant improvement in the Psoriasis Area Severity Index (PASI) 60 (RR: 1.4280; 95% CI: 1.3783-1.4794; p < 0.0001), PASI score (MD: -3.3544; 95% CI: -3.7608 to -2.9481; p < 0.0001), inflammatory skin lesion outcome, quality of life, serum inflammatory indicators, and safety index of psoriasis. Through integrated data mining of intervention data, we identified four herbs that were considered to be representative of the overall clinical effects of IM: Rehmannia glutinosa (Gaertn.) DC., Isatis tinctoria subsp. athoa (Boiss.) Papan., Paeonia × suffruticosa Andrews, and Scrophularia ningpoensis Hemsl. They were found to have mechanisms to inhibit pathological keratinocyte proliferation and immune-mediated inflammation, which are major pathologies of psoriasis, through multiple pharmacological actions on 19 gene targets and 8 pathways in network pharmacology analysis. However, the quality of the clinical trial design and pharmaceutical quality control data included in this study is still not optimal; therefore, more high-quality clinical and non-clinical studies are needed to firmly validate the information explored in this study. This study is informative in that it presents a focused hypothesis and methodology for the value and direction of such follow-up studies.

External Treatment of Pyritum for Musculoskeletal Trauma: a protocol for systematic review.

Objectives: Musculoskeletal trauma is a common type of injury that can result from damage to the muscular or skeletal system and has been recognized as a leading cause of death and disability worldwide. This study aims to analyze the efficacy of Pyritum external treatment for musculoskeletal trauma. Methods: Randomized controlled trials evaluating the external treatment effect of Pyritum on various types of musculoskeletal traumatic injuries will be considered and identified in the searches of eight databases from their inception to Feb 2023. There will be no restrictions with respect to the publication status, language, or country. The experimental intervention group will be treated with external application of Pyritum alone or in combination with other therapies, and the comparator intervention group will include all types of control interventions. The primary outcome will be measured as treatment efficacy rate, and secondary outcomes will include pain reduction, pain disappearance time, swelling, joint function, and recovery period. Assessment of the methodological quality of this study will be concluded using the risk of bias assessment recommended by the Cochrane Collaboration. If there are sufficient numbers of studies per group in terms of specific rating scales to compare the treatment effects of Pyrium alone and combined external treatment groups, we will consider subgroup analysis. Results: This systematic review will be conducted in compliance with the PRISMA-P statement. Conclusion: We will conduct an extensive search on the proposed topic within the available literature and provide systematic evidence for the efficacy and safety of external application of Pyritum for all types of musculoskeletal trauma. The evidence generated will help design interventions for the external use of Pyritum for this patient group.

Effectiveness of a personalized digital exercise and nutrition-based rehab program for patients with gastric cancer after surgery: Study protocol for a randomized controlled trial.

Background: Patients with gastric cancer often encounter impaired quality of life and reduced tolerability to adjuvant treatments after surgery. Weight preservation is crucial for the overall prognosis of these patients, and exercise and supplemental nutrition play the main role. This study is the first randomized clinical trial to apply personalized, treatment stage-adjusted digital intervention with wearable devices in gastric cancer rehabilitation intervention for 12 months, commencing immediately after surgery. Methods: This is a prospective, multicenter, two-armed, randomized controlled trial and aims to recruit 324 patients from two hospitals. Patients will be randomly allocated to two groups for 1 year of rehabilitation, starting immediately after the operation: a personalized digital therapeutic (intervention) group and a conventional education-based rehabilitation (control) group. The primary objective is to clarify the effect of mobile applications and wearable smart bands in reducing weight loss in patients with gastric cancer. The secondary outcomes are quality of life measured by the EORTC-QLQ-C30 and STO22; nutritional status by mini nutrition assessment; physical fitness level measured by grip strength test, 30-s chair stand test and 2-min walk test; physical activity measured by IPAQ-SF; pain intensity; skeletal muscle mass; and fat mass. These measurements will be performed on enrollment and at 1, 3, 6, and 12 months thereafter. Conclusions: Digital therapeutic programs include exercise and nutritional interventions modified by age, body mass index, surgery type and postoperative days. Thus, expert intervention is pivotal for precise and safe calibration of this program. Trial registration: Clinicaltrials.gov identifier: NCT04907591 (registration date: June 11, 2020; https://clinicaltrials.gov/ct2/show/NCT04907591).

Risk factors associated with death due to severe fever with thrombocytopenia syndrome in hospitalized Korean patients (2018-2022).

BACKGROUND: Severe fever with thrombocytopenia syndrome (SFTS) has no vaccine or treatment and an extremely high fatality rate. We aimed to analyze and evaluate the risk factors for death associated with SFTS. METHODS: Among reports from 2018 to 2022, we compared and analyzed 1,034 inpatients aged 18 years or older with laboratory-confirmed SFTS who underwent complete epidemiological investigations. RESULTS: Most of the inpatients with SFTS were aged 50 years or older (average age, 67.6 years). The median time from symptom onset to death was 9 days, and the average case fatality rate was 18.5%. Risk factors for death included age of 70 years or older (odds ratio [OR], 4.82); agriculture-related occupation (OR, 2.01); underlying disease (OR, 7.20); delayed diagnosis (OR, 1.28 per day); decreased level of consciousness (OR, 5.53); fever/chills (OR, 20.52); prolonged activated partial thromboplastin time (OR, 4.19); and elevated levels of aspartate aminotransferase (OR, 2.91), blood urea nitrogen (OR, 2.62), and creatine (OR, 3.21). CONCLUSION: The risk factors for death in patients with SFTS were old age; agriculture-related occupation; underlying disease; delayed clinical suspicion; fever/chills; decreased level of consciousness; and elevated activated partial thromboplastin time, aspartate aminotransferase, blood urea nitrogen, and creatine levels.

A Systematic Review and Meta-Analysis of the Effects of Rehabilitation Using Digital Healthcare on Musculoskeletal Pain and Quality of Life.

Rehabilitation using digital healthcare (DHC) has the potential to enhance the effectiveness of treatment for musculoskeletal disorders (MSDs) and associated pain by improving patient outcomes, while being cost-effective, safe, and measurable. This systematic review and meta-analysis aimed to evaluate the effectiveness of musculoskeletal rehabilitation using DHC. We searched PubMed, Ovid-Embase, Cochrane Library, and PEDro Physiotherapy Evidence Database from inception to October 28, 2022 for controlled clinical trials comparing DHC to conventional rehabilitation. We used a random-effects model for the meta-analysis, pooling the effects of DHC on pain and quality of life (QoL) by calculating standardized mean differences (SMDs) with 95% confidence intervals (CIs) between DHC rehabilitation and conventional rehabilitation (control). Fifty-four studies with 6240 participants met the inclusion criteria. The sample size ranged from 26 to 461, and the average age of the participants ranged from 21.9 to 71.8 years. The majority of the included studies focused on knee or hip joint MSD (n = 23), and the most frequently utilized DHC interventions were mobile applications (n = 26) and virtual or augmented reality (n = 16). Our meta-analysis of pain (n = 45) revealed that pain reduction was greater in DHC rehabilitation than in conventional rehabilitation (SMD: -0.55, 95% CI: -0.74, -0.36), indicating that rehabilitation using DHC has the potential to ameliorate MSD pain. Furthermore, DHC significantly improved health-related QoL and disease-specific QoL (SMD: 0.66, 95% CI: 0.29, 1.03; SMD: -0.44, 95% CI: -0.87, -0.01) compared to conventional rehabilitation. Our findings suggest that DHC offers a practical and flexible rehabilitation alternative for both patients with MSD and healthcare professionals. Nevertheless, further researches are needed to elucidate the underlying mechanisms by which DHC affects patient-reported outcomes, which may vary depending on the type and design of the DHC intervention.

Integrative medicine using East Asian herbal medicine for inflammatory pain in patients with rheumatoid arthritis: A protocol for systematic review and meta-analysis integrated with multiple data mining for core candidate discovery.

BACKGROUND: Rheumatoid arthritis is a chronic inflammatory autoimmune disease characterized by a wide range of clinical symptoms affecting various bodily functions, including skeletal, vascular, metabolic, and cognitive functions. This review aimed to evaluate the efficacy and safety of integrative medicine (East Asian herbal medicine combined with conventional medicine) used for the treatment of inflammatory pain in rheumatoid arthritis and to identify key candidate drugs based on the data. METHODS: A comprehensive literature search will be conducted in 4 core databases (PubMed, Excerpta Medica database, Cochrane Library, and Cumulative Index to Nursing & Allied Health Literature) 4 Korean databases (Oriental Medicine Advanced Searching Integrated System, Korean Studies Information Service System, Research Information Service System, and Korea Citation Index), 2 Chinese databases (Chinese National Knowledge Infrastructure Database and Wanfang data), and 1 Japanese database (Citation Information by National Institute of Informatics) for randomized controlled trials from December 13, 2022. Statistical analysis will be performed using R version 4.1.2 and R Studio program. The American College of Rheumatology 20/50/70 score and rate of adverse events will be the primary outcomes. All outcomes will be analyzed using a random-effects model to produce more statistically conservative results. Sensitivity, meta-regression, and subgroup analyses will be used to identify the sources of any heterogeneity in the study. The revised tool for assessing the risk of bias in randomized trials, version 2.0, will be used to evaluate methodological quality. The overall quality of evidence will be assessed according to the Grading of Recommendations Assessment, Development, and Evaluation Pro Framework. ETHICS AND DISSEMINATION: There are no ethical issues, as no primary data will be collected directly from the participants. The results of this review will be reported in a peer-reviewed scientific journal. TRIAL REGISTRATION: PROSPERO registration number: CRD42023412385.

Postoperative rehabilitation using a digital healthcare system in patients with total knee arthroplasty: a randomized controlled trial.

INTRODUCTION: Digital healthcare systems based on augmented reality (AR) show promise for postoperative rehabilitation. We compared the effectiveness of AR-based rehabilitation and conventional rehabilitation after total knee arthroplasty (TKA). MATERIALS AND METHODS: We randomly allocated 56 participants to digital healthcare rehabilitation group (DR group) and conventional rehabilitation group (CR group). Participants in the CR group performed brochure-based home exercises for 12 weeks, whereas those in the DR group performed AR-based home exercises that showed each motion on a monitor and provided real-time feedback. The primary outcome was change in 4-m gait speed. The secondary outcomes were the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score, health-related quality of life [assessed by the EuroQoL 5-Dimension 5-Level (EQ5D5L) questionnaire], pain [measured using a numeric rating scale (NRS)], Berg Balance Scale (BBS), range of motion (ROM), and muscle strength. Outcomes were measured at baseline (T0) and 3 (T1), 12 (T2), and 24 (T3) weeks after randomization. RESULTS: There was no significant difference in baseline characteristics of participants between two groups, except age and body mass index. No group difference was observed in 4-m gait speed (0.37 ± 0.19 and 0.42 ± 0.28 for the DR and CR groups, respectively; p = 0.438). The generalized estimating equation model revealed no significant group by time interaction regarding for 4-m gait speed, WOMAC, EQ5D5L, NRS, BBS, ROM, and muscle strength score. All outcomes were significantly improved in both groups (p < 0.001). CONCLUSION: The use of a digital healthcare system based on AR improved the functional outcomes, pain, and quality of life of patients after TKA. AR-based rehabilitation may be useful treatment as an alternative to conventional rehabilitation. TRIAL REGISTRATION: ClinicalTrials.gov (identifier: NCT04513353). Registered on August 9, 2020. http://clinicaltrials.gov/ct2/show/NCT04513353 .

A randomized controlled trial of postoperative rehabilitation using digital healthcare system after rotator cuff repair.

A digital healthcare system based on augmented reality (AR) has promising uses for postoperative rehabilitation. We compare effectiveness of AR-based and conventional rehabilitation in patients after rotator cuff repair (RCR). This study randomly allocates 115 participants who underwent RCR to digital healthcare rehabilitation group (DR group) and conventional rehabilitation group (CR group). The DR group performs AR-based home exercises using UINCARE Home+, whereas the CR group performs brochure-based home exercises. The primary outcome is a change in the Simple Shoulder Test (SST) score between baseline and 12 weeks postoperatively. The secondary outcomes are the Disabilities of the Arm, Shoulder and Hand (DASH) score; Shoulder Pain And Disability Index (SPADI) score; EuroQoL 5-Dimension 5-Level (EQ5D5L) questionnaire score; pain; range of motion (ROM); muscle strength; and handgrip strength. The outcomes are measured at baseline, and at 6, 12, and 24 weeks postoperatively. The change in SST score between baseline and 12 weeks postoperatively is significantly greater in the DR group than in the CR group (p = 0.025). The SPADI, DASH, and EQ5D5L scores demonstrate group×time interactions (p = 0.001, = 0.04, and = 0.016, respectively). However, no significant differences over time are observed between the groups in terms of pain, ROM, muscle strength, and handgrip strength. The outcomes show significant improvement in both groups (all p < 0.001). No adverse events are reported during the interventions. AR-based rehabilitation shows better improvement in terms of shoulder function after RCR compared to conventional rehabilitation. Therefore, as an alternative to the conventional rehabilitation, the digital healthcare system is effective for postoperative rehabilitation.

A Case of Vancomycin-Induced Drug Reaction with Eosinophilia, Systemic Symptoms and Multiorgan Involvement Proven Using Lymphocyte Transformation Test.

Drug-induced hypersensitivity syndrome (DiHS), also referred to as drug reaction with eosinophilia and systemic symptoms (DRESS), is a rare but potentially life-threatening condition induced by drug hypersensitivity that leads to significant morbidity and mortality and often occurs in patients undergoing combination antibiotic therapy. Due to a recent increase in the incidence of methicillin-resistant Staphylococcus aureus infections, the occurrence of vancomycin-induced DiHS/DRESS has increased rapidly. However, because of insufficient pharmacogenetic data on vancomycin-induced drug eruptions in Asians coupled with the risk of re-eliciting the symptoms by provocation tests, confirmation of the culprit drug in vancomycin-induced DiHS/DRESS is often challenging. Here, we report a case of vancomycin-induced DiHS/DRESS, where the causal relationship was confirmed using a lymphocyte transformation test (LTT). A 51-year-old woman was treated with combination antibiotics, including vancomycin, for infective pericarditis. The patient subsequently developed fever, facial edema, generalized rash followed by multiple internal organ involvement, including the kidney, lung, liver, and heart. Thus, based on the International Registry of Severe Cutaneous Adverse Reaction (RegiSCAR) criteria, the case was diagnosed as 'definite' DiHS/DRESS, although the culprit drug was obscured by combination antibiotic therapy. The LTT confirmed that vancomycin, but not other glycopeptide antibiotics, specifically induced T-cell proliferation in this case. Collectively, our case suggests that clinicians can utilize LTT to identify the causative medication of DiHS/DRESS when the clinical information is limited to defining the culprit drug.

Rapidly progressing generalized bullous fixed drug eruption after the first dose of COVID-19 messenger RNA vaccination.

Generalized bullous fixed drug eruption (GBFDE) is a rare type of life-threatening severe cutaneous adverse reaction that is considered a medical emergency because of its potential lethality. Currently, only a few cases of bullous adverse reactions have been reported after coronavirus disease 2019 (COVID-19) vaccination. We describe a patient with distinct clinical, histopathological, and immunological findings that are consistent with severe GBFDE, after Pfizer messenger RNA COVID-19 vaccination. An 83-year-old man presented with a fever and well-demarcated multiple erythematous patches that occurred only 4 h after receiving the first dose of COVID-19 Pfizer vaccination. Over the next few days, the patches became generalized and turned into blisters covering approximately 30% of the body surface. The patient was started on intravenous methylprednisolone and oral cyclosporine. There were no additional blistering lesions after 10 days of treatment, prompting a gradual dose reduction. Our case suggests that a stepwise vaccination adhering to the standard dosing schedule should be warranted with close monitoring for possible significant side effects.

Effectiveness of personalized treatment stage-adjusted digital therapeutics in colorectal cancer: a randomized controlled trial.

BACKGROUND: Colorectal cancer survivors often experience decline in physical performance and poor quality of life after surgery and during adjuvant therapies. In these patients, preserving skeletal muscle mass and high-quality nourishment are essential to reduce postoperative complications and improve quality of life and cancer-specific survival. Digital therapeutics have emerged as an encouraging tool for cancer survivors. However, to the best of our knowledge, randomized clinical trials applying personalized mobile application and smart bands as a supportive tool to several colorectal patients remain to be conducted, intervening immediately after the surgical treatment. METHODS: This study is a prospective, multi-center, single-blinded, two-armed, randomized controlled trial. The study aims to recruit 324 patients from three hospitals. Patients will be randomly allocated to two groups for one year of rehabilitation, starting immediately after the operation: a digital healthcare system rehabilitation (intervention) group and a conventional education-based rehabilitation (control) group. The primary objective of this protocol is to clarify the effect of digital healthcare system rehabilitation on skeletal muscle mass increment in patients with colorectal cancer. The secondary outcomes would be the improvement in quality of life measured by EORTC QLQ C30 and CR29, enhanced physical fitness level measured by grip strength test, 30-sec chair stand test and 2-min walk test, increased physical activity measured by IPAQ-SF, alleviated pain intensity, decreased severity of the LARS, weight, and fat mass. These measurements will be held on enrollment and at 1, 3, 6 and 12 months thereafter. DISCUSSION: This study will compare the effect of personalized treatment stage-adjusted digital health interventions on immediate postoperative rehabilitation with that of conventional education-based rehabilitation in patients with colorectal cancer. This will be the first randomized clinical trial performing immediate postoperative rehabilitation in a large number of patients with colorectal cancer with a tailored digital health intervention, modified according to the treatment phase and patient condition. The study will add foundations for the application of comprehensive digital healthcare programs focusing on individuality in postoperative rehabilitation of patients with cancer. TRIAL REGISTRATION: NCT05046756. Registered on 11 May 2021.

Single-Dose Intramuscular Toxicity Test Using No-Pain Pharmacopuncture in Sprague-Dawley Rats.

Objectives: This study aimed to evaluate the potential toxicity of a recently developed and clinically used No-Pain pharmacopuncture (NPP) solution. We also assessed the lethal dose of the NPP agent following a single intramuscular injection in Sprague-Dawley (SD) rats. Methods: Animals were divided into two groups the NPP test material group and the normal saline control group. A single intramuscular injection of the NPP agent (1.0 mL/animal) was administered to rats of the NPP test material group. The control group rats received the same volume of normal saline. Both female and male rats were included in each group. All rats were monitored for clinical signs and body weight changes for 14 days after administration of the test substance or saline. At the end of the observation period, a gross necropsy was conducted and localized tolerance at the injection site was analyzed. Results: No mortality was observed in the NPP test material and control groups. Moreover, no test substance-related effects were observed on clinical signs, body weight, necropsy findings, and localized tolerance at the injection site. Conclusion: The approximate lethal dose of the NPP agent is greater than 1.0 mL/animal under the conditions used in this study. Additional toxicity evaluations and clinical studies are needed to confirm the safety of NPP use in clinical practice.