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Breast (Edinburgh, Scotland) Jun 2024This study aimed to demonstrate the superiority of cryocompression over cryotherapy alone in the prevention of chemotherapy-induced peripheral neuropathy (CIPN) grade 2...
Cropsi study: Efficacy and safety of cryotherapy and cryocompression in the prevention of chemotherapy-induced peripheral neuropathy in patients with breast and gynecological cancer-A prospective, randomized trial.
OBJECTIVE
This study aimed to demonstrate the superiority of cryocompression over cryotherapy alone in the prevention of chemotherapy-induced peripheral neuropathy (CIPN) grade 2 or above.
METHODS
This prospective randomized study was conducted between May 2020 and January 2023 in Innsbruck. Eligible patients had a diagnosis of gynecological cancer and received a minimum of 3 cycles of taxane-based CT (neoadjuvant, adjuvant or palliative therapy). Patients were randomized 1:1 to receive either cryotherapy or cryocompression on their upper extremities during chemotherapy (CT). We performed temperature measurements, two QoL questionnaires and neurological tests during CT and at follow-up 3 and 6-9 months after the completion of CT. CIPN was assessed using the CTCAE score.
RESULTS
Of 200 patients recruited, both groups showed a lower prevalence of CIPN in this study compared to recent literature. In the group receiving cryotherapy, the prevalence of grade 1 CIPN was 30.1 %, and that of grade 2 CIPN or above was 13.7 %; in the group treated with cryocompression, the prevalence of grade 1 CIPN was 32.8 %, and that of grade 2 or above CIPN was 17.2 %. We found a significant reduction in temperature in the cryotherapy and cryocompression groups. Regarding the two QOL questionnaires as well as the neurological tests no significant differences were found between the two groups.
CONCLUSION
Our study suggests that cryotherapy as well as cryocompression is a safe and effective way to cool patients' extremities to lower the prevalence of CIPN. Cryocompression was not more effective than cryotherapy alone in the prevention of CIPN.
PubMed: 38941655
DOI: 10.1016/j.breast.2024.103763 -
ACS Synthetic Biology Jun 2024Cas12f nucleases are one of the most compact genome editors, exhibiting promising potential for therapeutic applications. However, the availability of active Cas12f...
Cas12f nucleases are one of the most compact genome editors, exhibiting promising potential for therapeutic applications. However, the availability of active Cas12f genome editors remains relatively limited in the field. Here, we report the characterization and engineering of a novel miniature Cas12f endonuclease from (EsCas12f1, 433 amino acids). We elucidate the specific Protospacer Adjacent Motifs preference and the detailed biochemical properties for DNA targeting and cleavage. By employing rational design strategies, we systematically optimize the guide RNA of EsCas12f1, converting the initially ineffective CRISPR-EsCas12f1 system into an efficient bacterial genome editor. Furthermore, we demonstrate the capacity of EsCas12f1 for nucleic-acid diagnostics. In summary, our results enrich the miniature CRISPR-Cas toolbox and pave the way for the application of EsCas12f1 for both genome editing and diagnostics.
PubMed: 38941613
DOI: 10.1021/acssynbio.4c00154 -
JMIR MHealth and UHealth Jun 2024Hypertension is one of the most important cardiovascular disease risk factors and affects >100 million American adults. Hypertension-related health inequities are... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
Hypertension is one of the most important cardiovascular disease risk factors and affects >100 million American adults. Hypertension-related health inequities are abundant in Black communities as Black individuals are more likely to use the emergency department (ED) for chronic disease-related ambulatory care, which is strongly linked to lower blood pressure (BP) control, diminished awareness of hypertension, and adverse cardiovascular events. To reduce hypertension-related health disparities, we developed MI-BP, a culturally tailored multibehavior mobile health intervention that targeted behaviors of BP self-monitoring, physical activity, sodium intake, and medication adherence in Black individuals with uncontrolled hypertension recruited from ED and community-based settings.
OBJECTIVE
We sought to determine the effect of MI-BP on BP as well as secondary outcomes of physical activity, sodium intake, medication adherence, and BP control compared to enhanced usual care control at 1-year follow-up.
METHODS
We conducted a 1-year, 2-group randomized controlled trial of the MI-BP intervention compared to an enhanced usual care control group where participants aged 25 to 70 years received a BP cuff and hypertension-related educational materials. Participants were recruited from EDs and other community-based settings in Detroit, Michigan, where they were screened for initial eligibility and enrolled. Baseline data collection and randomization occurred approximately 2 and 4 weeks after enrollment to ensure that participants had uncontrolled hypertension and were willing to take part. Data collection visits occurred at 13, 26, 39, and 52 weeks. Outcomes of interest included BP (primary outcome) and physical activity, sodium intake, medication adherence, and BP control (secondary outcomes).
RESULTS
We obtained consent from and enrolled 869 participants in this study yet ultimately randomized 162 (18.6%) participants. At 1 year, compared to the baseline, both groups showed significant decreases in systolic BP (MI-BP group: 22.5 mm Hg decrease in average systolic BP and P<.001; control group: 24.1 mm Hg decrease and P<.001) adjusted for age and sex, with no significant differences between the groups (time-by-arm interaction: P=.99). Similar patterns where improvements were noted in both groups yet no differences were found between the groups were observed for diastolic BP, physical activity, sodium intake, medication adherence, and BP control. Large dropout rates were observed in both groups (approximately 60%).
CONCLUSIONS
Overall, participants randomized to both the enhanced usual care control and MI-BP conditions experienced significant improvements in BP and other outcomes; however, differences between groups were not detected, speaking to the general benefit of proactive outreach and engagement focused on cardiometabolic risk reduction in urban-dwelling, low-socioeconomic-status Black populations. High dropout rates were found and are likely to be expected when working with similar populations. Future work is needed to better understand engagement with mobile health interventions, particularly in this population.
TRIAL REGISTRATION
ClinicalTrials.gov NCT02955537; https://clinicaltrials.gov/study/NCT02955537.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)
RR2-10.2196/12601.
Topics: Humans; Male; Female; Hypertension; Middle Aged; Black or African American; Adult; Telemedicine; Aged; Blood Pressure; Medication Adherence; Black People
PubMed: 38941601
DOI: 10.2196/57863 -
Cancer Jun 2024Clinical trials conducted by the Intergroup Rhabdomyosarcoma (RMS) Study Group and the Children's Oncology Group have been pivotal to establishing current standards for...
Clinical trials conducted by the Intergroup Rhabdomyosarcoma (RMS) Study Group and the Children's Oncology Group have been pivotal to establishing current standards for diagnosis and therapy for RMS. Recent advancements in understanding the biology and clinical behavior of RMS have led to more nuanced approaches to diagnosis, risk stratification, and treatment. The complexities introduced by these advancements, coupled with the rarity of RMS, pose challenges to conducting large-scale phase 3 clinical trials to evaluate new treatment strategies for RMS. Given these challenges, systematic planning of future clinical trials in RMS is paramount to address pertinent questions regarding the therapeutic efficacy of drugs, biomarkers of response, treatment-related toxicity, and patient quality of life. Herein, the authors outline the proposed strategic approach of the Children's Oncology Group Soft Tissue Sarcoma Committee to the next generation of RMS clinical trials, focusing on five themes: improved novel agent identification and preclinical to clinical translation, more efficient trial development and implementation, expanded opportunities for knowledge generation during trials, therapeutic toxicity reduction and quality of life, and patient engagement.
PubMed: 38941509
DOI: 10.1002/cncr.35457 -
Medicine Jun 2024Multiple myeloma (MM) with extramedullary disease (EMD) is rare in clinical practice, and B cell maturation antigen (BCMA) CAR-T cell therapy is a novel therapy for... (Review)
Review
INTRODUCTION
Multiple myeloma (MM) with extramedullary disease (EMD) is rare in clinical practice, and B cell maturation antigen (BCMA) CAR-T cell therapy is a novel therapy for hematologic malignancies. Very few reports have been published on the effect of CAR-T-cell therapy in MM with EMD. Here, we report a case of MM with extramedullary lesions treated with BCMA CAR-T therapy.
CASE PRESENTATION
A 66-year-old female patient presented to our hospital with an enlarged left maxillary gingiva.
DIAGNOSIS
Diagnosis of indolent MM stage III (DS staging) and stage III (ISS and R ISS) with extramedullary lesions.
INTERVENTION
The patient underwent a clinical trial of humanized anti-BCMA CAR T cell therapy.
RESULTS
Symptoms improved; left gingival hyperplasia and swelling resolved; left buccal mass resolved; and neck and submandibular masses resolved. Pathological examination of the exfoliated masses showed necrotic tissue.
CONCLUSION
MM with extramedullary lesions often has limited treatment options, and traditional chemotherapy methods are ineffective; however, BCMA CAR-T cell therapy can significantly improve the symptoms of extramedullary lesions in MM.
Topics: Humans; Multiple Myeloma; Female; Aged; B-Cell Maturation Antigen; Immunotherapy, Adoptive
PubMed: 38941416
DOI: 10.1097/MD.0000000000038541 -
Medicine Jun 2024To investigate whether intravenous administration of tranexamic acid (TXA) prior to arthroscopic rotator cuff repair improves operative blood loss, postoperative... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
To investigate whether intravenous administration of tranexamic acid (TXA) prior to arthroscopic rotator cuff repair improves operative blood loss, postoperative fibrinolytic index, inflammatory response, and postoperative pain.
METHODS
This was a prospective, double-blind, randomized controlled study. From January 2023 to February 2024, 64 patients who required arthroscopic rotator cuff repair were included and divided into tranexamic acid group (T group) group and control group (C group) according to the random number table method. In T group, 1000 mg TXA was administered intravenously 10 minutes before surgery, and an equivalent dose of normal saline was administered intravenously 10 minutes before surgery in C group. Intraoperative bleeding, postoperative fibrinolytic indexes, inflammatory indexes, pain scores, and occurrence of adverse effects were compared between the 2 groups.
RESULTS
Intraoperative bleeding in T group was lower than that in C group (P < .05); D-D and FDP in T group were significantly lower than those in C group (P < .05); postoperative TNF-α and IL-6 in 2 groups was higher than that before operation and T group was lower than C group (P < .05); The pain scores of the 2 groups after operation were lower than those before operation (P < .05), and there was no difference between the 2 groups (P > .05).
CONCLUSION SUBSECTIONS
TXA is able to reduce blood loss and inflammatory reactions, modulate fibrinolytic function, and promote postoperative recovery in patients undergoing arthroscopic rotator cuff repair, with no elevated risk of complications.
Topics: Humans; Tranexamic Acid; Male; Female; Antifibrinolytic Agents; Double-Blind Method; Middle Aged; Arthroscopy; Prospective Studies; Rotator Cuff Injuries; Blood Loss, Surgical; Pain, Postoperative; Aged; Adult; Administration, Intravenous
PubMed: 38941391
DOI: 10.1097/MD.0000000000038515 -
Medicine Jun 2024Dyskinesia is one of the most common complications of stroke. Acupuncture therapy (AT) and mirror therapy (MT) are promising rehabilitation measures for the treatment of... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Dyskinesia is one of the most common complications of stroke. Acupuncture therapy (AT) and mirror therapy (MT) are promising rehabilitation measures for the treatment of post-stroke dyskinesia. Although some studies suggested that AT and MT are effective and safe for dyskinesia, the effects, and safety remain uncertain due to lacking strong evidence. The purpose of this study is to investigate the efficacy and safety of AT combined with MT in the treatment of post-stroke dyskinesia.
METHODS
We searched the following databases: PubMed, Web of Science, Cochrane Library, EMBASE, Medline, China Knowledge Network, WANFANG, and China Biomedical Literature Database, from inception to 1 January 2023 to identify eligible studies. Total effective rate, the Fugl-Meyer assessment scale (FMA) upper and lower limb scores, modified Barthel index scores, Berg balance scale, modified Ashworth scale, and adverse reactions were adopted as outcome indicators. The Grading of Recommendations Assessment Development and Evaluation system was used by 2 independent reviewers to assess the quality of evidence for the outcome indicators included in the study. The statistical analysis was conducted by RevMan V.5.4 software.
RESULTS
A total of 24 randomized controlled studies included 2133 patients with post-stroke dyskinesia were included. The total effective rate of AT combined with MT was more advantageous in the treatment of post-stroke dyskinesia (relative risk = 1.31, 95% confidence interval [CI] [1.22-1.42], Z = 6.96, P < .0001). AT combined with MT was more advantageous for FMA upper limb score (mean difference [MD] = 6.67, 95% CI [5.21-8.13], Z = 8.97, P < .00001) and FMA lower limb score (MD = 3.72, 95% CI [2.81-4.63], Z = 7.98, P < .00001). Meta-analysis showed that AT combined with MT for post-stroke dyskinesia had a more advantageous modified Barthel index score (MD = 9.51, 95% CI [7.44-11.58], Z = 9.01, P < .00001).
CONCLUSION
AT combined with MT is effective in improving motor function and daily living ability of patients, especially in improving muscle spasms. However, these results should be regarded with caution given the low quality of evidence for the evaluation results.
Topics: Humans; Acupuncture Therapy; Stroke; Dyskinesias; Stroke Rehabilitation; Randomized Controlled Trials as Topic; Combined Modality Therapy; Treatment Outcome
PubMed: 38941386
DOI: 10.1097/MD.0000000000038733 -
Medicine Jun 2024Our aim is to evaluate serum Raftlin levels as a biomarker for diagnosing and monitoring disease activity in patients with axial spondyloarthritis (axSpA) and Psoriatic... (Observational Study)
Observational Study
Our aim is to evaluate serum Raftlin levels as a biomarker for diagnosing and monitoring disease activity in patients with axial spondyloarthritis (axSpA) and Psoriatic arthritis (PsA). This trial included 40 axSpA patients, 40 PsA patients, and 40 healthy participants as the control group. Disease activity was assessed with Ankylosing Spondylitis Disease Activity Score for axSpA patients and The Disease Activity Index for Psoriatic Arthritis for PsA patients. The Spondyloarthritis Research Consortium of Canada index, health assessment questionnaire-disability index, and numeric rating scale were used to evaluate the enthesitis severity, disability, and pain status of all patients. Serum Raftlin levels were determined using the ELISA method. The 3 groups had no statistical differences regarding gender, age, weight, height, BMI, educational status, and exercise habits. The axSpA group had higher Raftlin levels than the PsA and control groups, and Raftlin levels were statistically significant in predicting the likelihood of axSpA. We found no statistically significant differences between the PsA and control groups. We found no statistically significant difference in Raftlin levels in HLA-B27 positive versus HLA-B27 negative patients in both axSpA and PsA groups. Our results also did not detect any correlation of Raftlin levels with Ankylosing Spondylitis Disease Activity Score, C-reactive protein, erythrocyte sedimentation rate, health assessment questionnaire-disability index, numeric rating scale, and Spondyloarthritis Research Consortium of Canada index in axSpA patients. Receiver operating characteristic analysis determined that Raftlin level ≥ 6.31 ng/mL discriminates axSpA from normal individuals with 92.5% sensitivity, 59% specificity, and an area under the curve of 0.738. Our results demonstrate that although serum Raftlin levels are elevated in axSpA patients, Raftlin cannot be used as an alone diagnostic marker for axSpA. Furthermore, it was not found to be related to the monitoring of disease activity, the level of pain, disability, or severity of enthesitis. This study is prospectively registered at www.clinicaltrials.gov (ID: NCT05771389).
Topics: Humans; Male; Female; Biomarkers; Arthritis, Psoriatic; Adult; Axial Spondyloarthritis; Severity of Illness Index; Middle Aged; Membrane Proteins; Case-Control Studies
PubMed: 38941376
DOI: 10.1097/MD.0000000000038770 -
Medicine Jun 2024Blood stasis (BS) refers to a pattern of symptoms resulting from circulatory dysfunction or stagnation in the human body. Due to its historical origin and diverse... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
Blood stasis (BS) refers to a pattern of symptoms resulting from circulatory dysfunction or stagnation in the human body. Due to its historical origin and diverse interpretations, communication between patients and doctors of traditional Korean medicine (DKMs) presents challenges. Efforts to improve patients understanding in traditional Korean medicine (TKM) have led to the development of disease-specific standard clinical practice guidelines. However, there is a limited focus on creating clinical practice guidelines or informative leaflet specifically addressing BS, which is a frequently encountered pattern of symptoms in TKM.
METHODS
This study aimed to bridge the gap between patients and DKMs by developing an informative leaflet focusing on BS for metabolic diseases. We assessed its appropriateness through expert advisory meetings and the Delphi process, and evaluated its clinical effectiveness. We conducted a prospective, randomized, crossover trial to compare the clinical effectiveness of using BS leaflets in TKM treatment. The hypothesis investigated whether the leaflet group would show higher scores in satisfaction of DKMs' explanations, understanding of DKMs' explanations, improving the reliability of TKM, satisfaction with treatment time, improvement in explanations compared to previous TKM experiences, and necessity of managing BS treatment, compared to the no-leaflet group.
RESULTS
In a study involving 40 patients (mean age: 62.3 ± 7.8 years), symptoms persisted for an average of 16.75 ± 9.3 hours daily, with a severity rating of 2.53. The leaflet group exhibited significantly higher satisfaction scores than the no-leaflet group in all aspects (all P < .0001). After confirming the absence of sequence and period effects using a linear-mixed effect model, we were able to ascertain the presence of a treatment effect, as evidenced by statistically significant higher scores across all survey items in the leaflet group compared to the no-leaflet group (all P < .0001).
CONCLUSION
Expert consensus on symptoms aligning with the BS pattern resulted in the development of an informative leaflet. Its utilization notably improved patient satisfaction, comprehension, and trust in TKM treatment, unaffected by temporal influences, thus demonstrating its clinical effectiveness. In summary, the BS leaflet significantly enhanced patient understanding and optimized treatment procedures.
Topics: Humans; Female; Cross-Over Studies; Prospective Studies; Male; Middle Aged; Medicine, Korean Traditional; Aged; Patient Satisfaction; Pamphlets; Treatment Outcome
PubMed: 38941368
DOI: 10.1097/MD.0000000000038702 -
Medicine Jun 2024Combining hydromorphone with ropivacaine in ultrasound-guided erector spinae plane blocks enhances postoperative analgesia and reduces interleukin-6 expression in breast... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
Combining hydromorphone with ropivacaine in ultrasound-guided erector spinae plane blocks enhances postoperative analgesia and reduces interleukin-6 expression in breast surgery patients.
METHODS
In this study, breast cancer patients undergoing modified radical mastectomy were randomized into 3 groups for anesthesia (30 patients in each group): standard general (group C), Erector Spinae Plane Block (ESPB) with ropivacaine (group R), and ESPB with ropivacaine plus hydromorphone (group HR). Diagnosis: Breast cancer patients. Postsurgery, pain levels, IL-6, anesthetic doses, additional analgesia needs, and recovery milestones were compared to evaluate the efficacy of the ESPB enhancements.
RESULTS
The 3 groups were not significantly different in baseline characteristics, operation time, number of cases with postoperative nausea, and serum IL-6 concentrations at T1 (the time of being returned to the ward after surgery). At T2 (at 6:00 in the next morning after surgery), the serum IL-6 concentration in group HR was significantly lower than that in groups R and C (P < .05); the intraoperative doses of remifentanil, sufentanil, and propofol were significantly lower in groups HR and R than those in group C (P < .05); Groups HR and R had significantly lower visual analog scale scores at T3 (4 hours postoperatively), T4 (12 hours postoperatively), and T5 (24 hours postoperatively) than those in group C (P < .05); the proportions of patients receiving postoperative remedial analgesia were significantly lower in groups HR and R than in group C (P < .05); groups HR and R had significantly lower proportions of patients with postoperative nausea than group C (P < .05); the time to the first anal exhaust and the time to the first ambulation after surgery were significantly shorter in groups HR and R than those in group C (P < .05).
CONCLUSION
Hydromorphone combined with ropivacaine for ESPB achieved a greater postoperative analgesic effect for patients receiving MRM under general anesthesia. The combined analgesia caused fewer adverse reactions and inhibited the expression level of the inflammatory factor IL-6 more effectively, thereby facilitating postoperative recovery. ESPB using hydromorphone with ropivacaine improved pain control post-MRM, reduced adverse effects, and more effectively suppressed IL-6, enhancing recovery.
Topics: Humans; Ropivacaine; Female; Hydromorphone; Middle Aged; Nerve Block; Pain, Postoperative; Prospective Studies; Anesthetics, Local; Breast Neoplasms; Mastectomy, Modified Radical; Analgesics, Opioid; Adult; Interleukin-6; Paraspinal Muscles; Ultrasonography, Interventional; Drug Therapy, Combination; Pain Measurement
PubMed: 38941366
DOI: 10.1097/MD.0000000000038758