Large-sample Clinical Trials Research Articles

Executive function deficits in patients with the first episode of late-life depression before and after SSRI treatment: A pilot fMRI study.

Executive function deficits (EFD) in late-life depression (LLD) has been reported to be associated with antidepressant treatment resistance, increased disability, and poor quality of life. However, the underlying neutral mechanisms of EFD in patients with the first episode of LLD remains unclear. A total of 27 patients with first-episode, drug-naive LLD and 27 non-depressed controls (NC) were recruited for the present research. Participants underwent the Trail Making Test, the 17-item Hamilton depression rating scale (HAMD-17) test, and task-state functional magnetic resonance imaging scans under the neutral Stroop task. LLD patients' executive functions, depressive symptoms, and brain activity were examined again after 6months of antidepressant treatment. Of the 27 LLD patients, 16 cases completed 6-month follow-ups. Patients in the LLD baseline group spent more time on the Trail Making Test A test than those in the NC group (p<0.05). In the presence of an incongruency between the word color and meaning, the accuracy rate of the neutral Stroop task in the LLD baseline group was lower, and the reaction time was greater than that in the NC group, with statistically significant difference (p<0.05). The HAMD-17 score in the LLD follow-up group was significantly lower than that in the LLD baseline group (p<0.05). More activated brain regions were present in the LLD baseline group than in the NC group when performing the neutral Stroop task. Compared with the LLD baseline group, abnormal activation of relevant brains in the cingulate-prefrontal-parietal network of LLD patients still existed in the LLD follow-up group. LLD patients engaged more brain areas than the NC group while performing the neutral Stroop task. Abnormal activation of the cingulate-prefrontal-parietal network could be a contributing factor to EFD in LLD. ChiCTR, ChiCTR2100042370 (Date of registration: 21/01/2021). We didn't enroll enough first-episode, LLD patients, the robustness of the findings need to be confirmed by large sample clinical trials.

Efficacy of taurine-enhanced enteral nutrition in improving the outcomes of critically ill patients: A systematic review and meta-analysis

Taurine is considered an immunomodulatory agent. From current reports on clinical studies, we conducted a systematic review and meta-analysis to investigate the effects of taurine-enhanced enteral nutrition (EN) on the outcomes of critically ill patients to resolve conflicting evidence in literature. Literature from PubMed, EMBASE, Web of Science, Cochrane Library, CNKI, SINOMED, and WanFang databases were retrieved, and randomized controlled trials (RCTs) were identified. The time range spanned from January 1, 2000, to January 31, 2024. The Cochrane Collaboration Tool was used to evaluate the risk of bias. We used the GRADE approach to rate the quality of evidence and the I2 test to assess the statistical heterogeneity of the results. Risk ratio (RR), mean difference (MD), and 95% confidence interval (95% CI) were used to analyze measurement data. Four trials involving 236 patients were finally included. The meta-analysis results indicated that taurine-enhanced EN did not reduce mortality (RR=0.70, p=0.45, 95% CI [0.28, 1.80], two trials, 176 participants, low quality). There was also no significant difference in length of stay in the intensive care unit (ICU) between the taurine-enhanced EN and control groups. Taurine-enhanced EN may reduce pro-inflammatory factor interleukin-6 (IL-6) levels in critically ill patients（the result about IL-6 cannot be pooled）. However, taurine-enhanced EN had no significant impact on high-sensitivity-C-reactive protein levels (MD=-0.41, p=0.40, 95% CI [-1.35, 0.54], two trials, 60 participants, low quality). Taurine-enhanced EN may reduce IL-6 levels and is not associated with improved clinical outcomes in critically ill patients, which may have potential immunoregulatory effects in critically ill patients. Given that published studies have small samples, the above conclusions need to be verified by more rigorously designed large-sample clinical trials.

Vonoprazan-amoxicillin dual therapy with different amoxicillin dosages for treatment-naive patients of Helicobacter pylori infection in China: a prospective, randomized controlled study.

The vonoprazan (VPZ)-amoxicillin (AMO) dual therapy (VA) demonstrates a satisfactory eradication rate for Helicobacter pylori (H. pylori ). However, the optimal dosage of AMO in this regimen remains uncertain. The objective of this study is to investigate the efficacy of different doses of AMO in the VA regimen for first-line treatment of H. pylori infection. A total of 192 treatment-naive H. pylori -infected patients were randomly assigned to one of three groups: low-dose VA (LD-VA: VPZ 20 mg b.i.d + AMO 750 mg t.i.d), moderate-dose VA (MD-VA:VPZ 20 mg b.i.d + AMO 1000 mg t.i.d), and high-dose VA (HD-VA: VPZ 20 mg b.i.d + AMO 1250 mg t.i.d). All groups received 14 days of treatment. The study evaluated and compared the eradication rates, adverse events (AEs), and patient compliance among the three groups. Eradication rates for LD-VA, MD-VA, and HD-VA were 76.6% (49/64), 79.7% (51/64), and 84.4% (54/64), respectively, as determined by intention-to-treat analysis; 90.6% (48/53), 94.3% (50/53), and 98.1% (53/54) according to per-protocol analysis; 89.1% (49/55), 94.4% (51/54), and 96.4% (54/56) with modified intention-to-treat analysis (all P > 0.05). Although not statistically significant, numerically higher eradication rates were observed with the higher dose AMO VA regimen. There were no statistically significant differences in the incidence of AEs and compliance among the three VA regimens. Fourteen-day VA regimens with AMO doses exceeding 2 g/day demonstrated satisfactory eradication rates. HD-VA therapy is potentially the most effective regimen. Large-sample clinical trials are required to further validate these findings.

Efficacy of Cerebellar Transcranial Magnetic Stimulation in Treating Essential Tremor: A Randomized, Sham-Controlled Trial.

Repetitive transcranial magnetic stimulation (rTMS) of the cerebellar hemisphere represents a new option in treating essential tremor (ET) patients. We aimed to determine the efficacy of cerebellar rTMS in treating ET using different protocols regarding the number of sessions, exposure duration, and follow-up duration. A randomized sham-controlled trial was conducted, in which 45 recruit patients were randomly allocated to 2 groups. The first (active group) comprised 23 patients who were exposed to 12 sessions of active rTMS with 900 pulses of 1-Hz rTMS at 90% of the resting motor threshold daily on each side of the cerebellar hemispheres over 4 weeks. The second group (sham group) comprised 22 patients who were exposed to 12 sessions of sham rTMS. Both groups were reassessed at baseline and after 1 day, 1 month, 2 months, and 3 months using the Fahn-Tolosa-Marin tremor-rating scale (FTM). Demographic characteristics did no differ between the two groups. There were significant reductions both in FTM subscores A and B and in the FTM total score in the active-rTMS group during the period of assessment and after 3 months (p=0.031 and 0.011, respectively). However, subscore C did not change significantly from baseline when assessed at 2 and 3 months (p=0.073 and 0.236, respectively). Furthermore, the global assessment score was significantly higher in the active-rTMS group (p>0.001). Low-frequency rTMS over the cerebellar cortex for 1 month showed relative safety and long-lasting efficacy in patients with ET. Further large-sample clinical trials are needed that include different sites of stimulation and longer follow-ups.

A Short Review Based on the Article Entitled “Evaluation of Literature Quality of Traditional Chinese Medicine Treatment on Ischemic Optic Neuropathy”

These research results indicate that the quality of relevant literature on Traditional Chinese Medicine (TCM) treatment of ION is generally subpar. Future research should focus on studies where the intervention is acupuncture treatment and standardized and rigorous multi-center large-sample clinical trials.

The Efficacy and Safety of Pazopanib Plus Chemotherapy in Treating Recurrent or Persistent Ovarian Cancer: A Systematic Review and Meta-Analysis.

Patients with recurrent or persistent ovarian cancer often have poor prognoses, and their optimal treatment regimen remains unclear. Inhibition of angiogenesis is a valuable strategy for treating ovarian cancer, and the drug pazopanib is a potent, multitarget tyrosine kinase inhibitor. However, treatment with pazopanib in combination with chemotherapy remains controversial. We performed a systematic review and meta-analysis to clarify the efficacy and side effects of pazopanib combined with chemotherapy in the treatment of advanced ovarian cancer. The PubMed, Embase, and Cochrane databases were systematically searched for relevant randomized controlled trials published up to September 2, 2022. The primary outcomes of eligible studies included overall response rate (ORR), disease control rate, 1-year progression-free survival (PFS) rate, 2-year PFS rate, 1-year overall survival (OS) rate, 2-year OS rate, and adverse events. Outcomes from a total of 518 recurrent or persistent ovarian cancer patients from 5 studies were analyzed in this systematic review. Pooled results showed that pazopanib plus chemotherapy, when compared with chemotherapy alone, significantly improved the ORR (pooled risk ratio=1.400; 95% CI, 1.062-1.846; P = 0.017) but not the disease control rate, 1-year PFS, 2-year PFS, 1-year OS, or 2-year OS. Moreover, pazopanib increased the risk of neutropenia, hypertension, fatigue, and liver dysfunction. Pazopanib plus chemotherapy improved patient ORR but did not improve survival; it also increased the occurrence of several adverse events. Further large-sample clinical trials are needed to verify these results to guide pazopanib use in patients with ovarian cancer.

Research on Electroacupuncture Parameters for Cancer Pain Based on Data Mining.

Cancer pain, a common complication of this disease, has been widely treated by electroacupuncture in recent years. However, there are numerous treatment parameters that are not conducive to clinical translation applications. This study aims to summarize the stimulation parameters commonly used in electroacupuncture treating cancer pain by data mining and visualization techniques to provide a basis for the future acupuncture technology transformation and selection of optimal stimulation parameters. Nine databases, including Pubmed, Cochrane Library, Embase, Web of Science, OVID, China National Knowledge Infrastructure Database, China Biology Medicine disk, China Science and Technology Journal Database, and Wanfang Database, were searched for clinical studies on electroacupuncture treatment cancer pain published between January 2012 and September 2022. A database was established using Microsoft Excel 2020 and analyzed with SPSS Modeler 18.1 software and SPSS statistics 26.0 software. Twenty-four articles were included according to the established criteria. The most used electroacupuncture stimulation parameters were a dilatational wave, the current frequency of 2/100 Hz, stimulation duration of 30 minutes per treatment, and frequency of treatment once a day. Fifty-eight acupoints were mentioned, and the total frequency of acupoints involved was 156 times. The most used ones include Zusanli (ST36), Sanyinjiao (SP06), Hegu (LI04), Neiguan (PC06), Quchi (LI11), Taichong (LR03), Ashi point, Jiaji point, and those most generally used acupoints that are closely arranged on the Stomach Channel of Foot Yangming and the Spleen Channel of Foot Taiyin. The association analysis of acupoints revealed that the most supported acupoint pair was Sanyinjiao (SP06) and Zusanli (ST36). Cluster analysis demonstrated 3 groups, 1 for obligatory acupoints, 1 for Ashi point, and the third for Jiaji point. A dilatational wave, the current frequency of 2/100 Hz, 30-minute stimulation, and acupoints of the Stomach Channel of Foot Yangming and the Spleen Channel of Foot Taiyin selection are frequently used in electroacupuncture for treating cancer pain. Due to the limitations of this study, further research and more standardized, multi-center, large-sample clinical trials can be carried out to guide optimizing acupuncture treatment schemes and promote the formation of TCM-characteristic technologies for cancer pain.

The Association of Sperm DNA Fragment and Assisted Reproductive Outcomes: A Meta-Analysis.

Objective To analyze the effect of sperm DNA fragmentation index (DFI) on the outcomes of in vitro fertilization (IVF) and intracytoplasmic sperm injection (ICSI). Methods Literature search was conducted on English databases PubMed, Cochrane, and Embase to obtain eligible studies. Results A total of 11 cohort studies were included and analyzed using the random effects model. The results illustrated that the IVF fertilization rate (RR = 0.94, 95% CI: 0.77-1.14, P = 0.61), pregnancy rate (RR = 0.83, 95% CI: 0.57-1.21, P = 0.32), and live birth rate (RR = 0.53, 95% CI: 0.16-1.80, P = 0.31) in the high DFI group were statistically insignificant with those in the low FI group. The correlations between DFI and ICSI fertilization rate (RR = 0.79, 95% CI: 0.52-1.18, P = 0.25), pregnancy rate (RR = 0.89, 95% CI: 0.74-1.06, P = 0.18), and live birth rate (RR = 0.89, 95% CI: 0.70-1.14, P = 0.36) were also not statistically significant. Conclusion This study has observed no significant correlation between sperm DFI and assisted reproductive outcomes. Multicenter large-sample clinical trials are required to conclusively determine the impact of DNA damage on the clinical outcomes of assisted reproduction.

Research on electroacupuncture parameters for knee osteoarthritis based on data mining

BackgroundKnee osteoarthritis, a common degenerative joint disease, has been widely treated by electroacupuncture in recent years. However, there are too many parameters of the treatment currently, resulting in various applications in clinical practice. This study aims to summarize the optimal stimulation parameters of electroacupuncture for knee osteoarthritis in clinical studies by applying data mining techniques.MethodsFour databases including Pubmed, Cochrane Library, Embase, and Web of Science were searched for clinical studies on electroacupuncture treating knee osteoarthritis from 2012 to 2021. A database was established by Microsoft Excel 2020 and analyzed by R Version 4.1.1.ResultsForty-six articles were included according to the established criteria. The most used electroacupuncture stimulation parameters were 0.30 mm × 40 mm needle, continuous wave, low frequency of current (mainly 2 Hz), stimulation duration for 30 min per treatment, and frequency of treatment for once a day. Eighteen acupoints were mentioned and the most used ones include Dubi (ST35), Liangqiu (ST34), Neixiyan (EX-LE4), Xuehai (SP10), Yanglingquan (GB34), and Yinlingquan (SP9), and those most generally used acupoints are closely arranged on the Stomach Channel of Foot Yangming. Cluster analysis showed two groups, one for obligatory acupoints and one for adjunctive ones. The association analysis showed the most supported acupoint pair was Liangqiu (ST34) and Xuehai (SP10).ConclusionsContinuous wave, low frequency of current (2 Hz), 30-min stimulation, and local acupoint selection are frequently used for electroacupuncture treating knee osteoarthritis. Due to the limitations of this study, further research and more standardized, multi-centered, and large-sample clinical trials should be conducted to provide more convincing evidence.

The role of vaginal microecology in the cervical cancer.

To explore the role of vaginal microecology in cervical cancer, so as to increase the understanding of cervical cancer and lay a foundation for future large-sample clinical trials. We reviewed and summarized the literature comprehensively, and discussed the relationship between vaginal microecology and HPV infection, CIN progression and cervical cancer, as well as the potential molecular mechanism and the prospects of probiotics and prebiotics in future cancer treatments. With the popularization of high-throughput sequencing technology and the development of bioinformatics analysis technology, many evidences show that the increase in the diversity of the bacterial community in the vaginal microecological environment and the decrease in the number of Lactobacilli are associated with the continuous infection of HPV and the further development of CIN, cervical cancer-related. Vaginal microecological imbalance has an important impact on the occurrence and development of cervical cancer. However, the pathogenesis is not completely clear, and more high-level basic research and longitudinal clinical studies are needed to verify.

Self-Hypnosis for Phantom Limb Pain: A Multiple-Case Study

Phantom limb pain occurs in more than half of the people who have undergone an amputation. Hypnosis can alleviate pain effectively in experimental, procedural, and chronic pain. Thus, in this multiple-case study, we determined whether hypnosis might be a successful complementary approach to help patients with phantom limb pain in alleviating their pain quality (i.e., sensitive and affective), intensity, fatigue, and emotional distress (i.e., anxiety and depression). Seven patients experiencing phantom limb pain were trained to perform self-hypnosis in five sessions over two and a half months. The patients were encouraged to practice at home daily throughout the study. Measures of the intensity of pain and fatigue, the severity of insomnia, anxiety, depression, and the quality of pain (i.e., sensitive and affective) were performed before and after self-hypnosis training. Six years after the completion of the study, the patients were contacted over the telephone to follow up on their practice of self-hypnosis. All patients reported a reduction in the intensity of pain, severity of insomnia, anxiety, and quality of pain. They also reported a positive change in their behaviors and the sensation of pain after performing hypnosis. At the six-year follow-up, three patients were still practicing hypnosis and reported better control over pain and being more relaxed. The main reason for most patients to stop practicing self-hypnosis was that they failed to find the time. Self-hypnosis can effectively ameliorate pain, fatigue, and emotional distress in patients suffering from phantom limb pain. Large-sample clinical trials with a mixed design are needed to confirm these results.

Lower Blood Lipid Level Is Associated with the Occurrence of Parkinson's Disease: A Meta-Analysis and Systematic Review.

Background The changes of blood lipid levels in patients with Parkinson's disease (PD) and its clinical relevance remain unclear. We aimed to evaluate the potential association of blood lipid and the occurrence of PD, to provide evidence to the clinical treatment and nursing care of PD. Methods We searched PubMed, Medline, Web of Science, Cochrane Library, Wanfang Database, Weipu Database, and China National Knowledge Infrastructure for studies related to the blood lipid levels and PD until November 30, 2021. Two researchers independently screened the literature and extricated the data including the levels of total cholesterol (TC), triglycerides (TG), high-density lipoprotein cholesterol (HDL-C), and low-density lipoprotein cholesterol (LDL-C). Newcastle-Ottawa Scale (NOS) was used to evaluate the quality of included studies. RevMan5.3 and Stata 12.0 software were used for statistical processing and analysis. Results A total of 15 cohort studies with 9740 participants involving 2032 PD patients and 7708 controls were included. Meta-analysis indicated that TC (SMD = −0.29, 95% CI −0.55∼−0.03, P=0.04), TG (SMD = −16.83, 95% CI −20.71∼−12.95, P < 0.001), HDL-C (SMD = −0.14, 95% CI −0.26∼−0.02, P < 0.001) and LDL-C (SMD = −0.26, 95% CI −0.50∼−0.01, P=0.04) level in the PD patients was significantly lower than that of health controls. Sensitivity analysis indicated that the results were stable. No significant publication bias was found between the synthesized outcomes. Conclusions Lower blood TC, TG, HDL-C, and LDL-C level are associated with the occurrence of PD. Limited by sample size and study population, further high-quality, large-sample clinical trials in different areas are needed to further determine the relationship between blood lipids and PD in the future.

Visualizing Research Trends and Identifying Hotspots of Traditional Chinese Medicine (TCM) Nursing Technology for Insomnia: A 18-Years Bibliometric Analysis of Web of Science Core Collection

ObjectiveTo explore the research hotspot and frontier direction of TCM nursing of insomnia and provide reference for the follow-up study of the optimal scheme of TCM nursing of insomnia.BackgroundInsomnia is a common sleep-wake disorder, affects 6–10% of adults and was associated with independent higher risks of cardiovascular disease and diabetes. TCM Nursing Techniques of insomnia has a long history and has shown a definite impact. However, it's still lack of analysis in the field of the most commonly used and effective techniques, as well as the co-morbidities associated with insomnia. Therefore, the database was searched and analyzed to find effective TCM Nursing Techniques for insomnia and related diseases related to insomnia.MethodRandomized controlled trials on the intervention of TCM Nursing Techniques in insomnia were retrieved from Web of Science Core Collection and imported into CiteSpace 5.6.R5 visualization software. The works of literature were co-cited by keywords authors and institutions for visual analysis, and the co-morbidities associated with insomnia of TCM Nursing Techniques in literature was extracted manually. The symptoms of co-morbidities associated with insomnia were imported into Cytoscape 3.9.0 software and clustered by CytoHubba.ResultAs of October 20, 2021, the literature published in the last 20 years from Web of Science Core Collection was screened, and the publication period of the included literature was from 2004 to 2021. From 2016 to now, the total number of articles has been increasing. A total of 146 articles were included, and the highest production year was 2020. There is little cooperation between states, institutions, and authors. China (including Hong Kong and Taiwan) and Hong Kong Polytech University are leading countries and institutions in this area. MYUNGHAENG HUR is the most cited author, and J ALTERN COMPLEM MED is the most cited journal. According to cluster analysis and keyword frequency, auricular therapy, aromatherapy, and acupressure are the three most commonly used techniques. While the top five co-morbidities are fatigue, anxiety, depression, pain and hemodialysis. The three frontier topics and the main research directions are sleep quality, comorbid insomnia and clinical trial design.ConclusionWe found that acupressure, aromatherapy, and auricular acupoint therapy are the most commonly used nursing methods of TCM to intervene in insomnia. However, these studies have limitations such as small sample size, lack of objectivity in evaluating sleep quality, and high heterogeneity of intervention measures, which are not conducive to forming TCM clinical nursing guidelines. Therefore, it is necessary to adopt objectified sleep quality evaluation methods, select suitable acupoints according to TCM theories, and design multi-center large-sample clinical trials based on the safety principle of randomized blind control. This study provides an in-depth perspective for insomnia research on TCM Nursing Techniques and includes information for follow-up research on TCM Nursing Techniques of insomnia.

Allogeneic Chimeric Antigen Receptor T Cells for Hematologic Malignancies.

Autologous chimeric antigen receptor (CAR) T cell therapy has been extensively studied over the past decades. Currently, autologous CAR T products are FDA-approved to treat B cell acute lymphoblastic leukemia (B-ALL), large B cell, mantle cell, and follicular lymphomas, and multiple myeloma. However, this therapy has drawbacks including higher cost, production lead time, logistical complexity, and higher risk of manufacturing failure. Alternatively, allogeneic CAR T cell therapy, currently under clinical trial, has inherent disadvantages, including cell rejection, graft versus host disease, and undetermined safety and efficacy profiles. Different strategies, including modifying HLA and T cell receptor expression using different effector cells, are under investigation to circumvent these issues. Early allogeneic CAR T therapy results for B-ALL and B-NHL have been promising. Large sample clinical trials are ongoing. Here, we discuss the pros and cons of allo-CAR T for hematologic malignancies and review the latest data on this scalable approach.

Acupuncture for amnestic mild cognitive impairment: A pilot multicenter, randomized, parallel controlled trial.

Introduction:Patients with amnesic mild cognitive impairment (aMCI) are more likely to develop Alzheimer disease than corresponding age normal population. Because Alzheimer disease is irreversible, early intervention for aMCI patients seems important and urgent. We have designed a pilot multicenter, randomized, parallel controlled trial to assess the efficacy and safety of acupuncture on aMCI, explore the feasibility of acupuncture in the treatment of aMCI, so as to provide a reference for large-sample clinical trials in the next stage.Method:We designed a pilot multicenter, randomized, parallel controlled trial. This trial aims to test the feasibility of carrying out a large-sample clinical trial. In this trial, 50 eligible patients with aMCI will be included and allocated to acupuncture group (n = 25) or sham acupuncture group (n = 25) at random. Subjects will accept treatment 2 times a week for 12 weeks continuously, with a total of 24 treatment sessions. We will select 6 acupoints (GV20, GV14, bilateral BL18, bilateral BL23). For the clinical outcomes, the primary outcome is Montreal cognitive assessment, which will be assessed from baseline to the end of this trial. And the secondary outcomes are Mini-mental State Examination, Delayed Story Recall, Clinical Dementia Rating scale, Global Deterioration Scale, Activity of Daily Life, Alzheimer Disease Assessment Scale-Cognitive Section, brain magnetic resonance imaging, brain functional magnetic resonance imaging, and event-related potential P300, which will be assessed before and after treatment. In addition, we will assess the safety outcomes from baseline to the end of this trial and feasibility outcome after treatment. We will evaluate neuropsychological assessment scale (Montreal cognitive assessment, Mini-mental State Examination, Alzheimer Disease Assessment Scale-Cognitive Section) at 3 months and 6 months after treatment.Discussion:This pilot trial aims to explore the feasibility of the trial, verify essential information of its efficacy and safety. This pilot study will provide a preliminary basis for carrying out a larger clinical trial of acupuncture on aMCI in near future.

Prognostic value of C-reactive protein to albumin ratio in metastatic colorectal cancer: A systematic review and meta-analysis.

Background:In recent years, several observational studies have investigated the association between C-reactive protein to albumin ratio (CAR) and prognosis of metastatic colorectal cancer (mCRC), and yielded controversial outcomes.Methods:Eligible studies assessing the relationship of CAR with survival and clinicopathological parameters in mCRC were searched from PubMed, Cochrane library, and Embase databases up to February 3, 2021. Overall survival (OS), progression-free survival, recurrence-free survival, and disease-free survival were synthetically calculated and compared.Results:A total of 6 studies including 771 patients were enrolled in this systematic review. Pooled results indicated that elevated CAR was significantly associated with poorer OS (hazard ratio: 2.393; 95% confidence interval: 1.949–2.938, P < .01) as well as decreased progression-free survival/disease-free survival/recurrence-free survival (hazard ratio: 1.731; 95% confidence interval: 1.261–2.375, P < .01). Additionally, high CAR was significantly consistent with increased modified Glasgow Prognostic Score and neutrophil–lymphocyte ratio.Conclusion:High CAR could be a negative prognostic marker for mCRC patients. More large-sample clinical trials are still needed to confirm the prognostic significance of CAR in mCRC.

Tranexamic Acid versus Epsilon-Aminocaproic Acid in Total Knee Arthroplasty: A Meta-Analysis.

Objective At present, the effect of tranexamic acid (TXA) and epsilon-aminocaproic acid (EACA) on total knee arthroplasty (TKA) remains controversial. Therefore, the aim of this meta-analysis is to compare the differences between the effects of TXA and EACA in TKA. Methods We used electronic databases, including PubMed, Embase, MEDLINE, Ovid, ScienceDirect, Cochran Library, Google Scholar, clinical trial, and Chinese related databases, for literature search to find any effect of TXA and EACA in TKA. The differences between groups were compared by odds ratio (OR), weighted mean difference (WMD), and 95% confidence interval (CI). A total of four studies, including 3 randomized controlled trials (RCT) and 1 cohort study, were involved in this meta-analysis, involving 1836 participants. Among these participants, 816 belonged to the TXA group and 1020 belonged to the EACA group. Results Meta-analysis indicated no difference in surgery time (WMD = 0.01, 95% CI −0.35 to 0.36), total amount of blood loss (WMD = 0.14, 95% CI −0.09 to 0.37), transfusion rate (OR = 0.74, 95% CI 0.20 to 2.78), transfusion units per patient (SMD = −0.15, 95% CI −0.54 to 0.25), complications (OR = 0.75, 95% CI 0.37 to 1.55), and length of stay (SMD = −0.01, 95% CI −0.11 to 0.08). Conclusions Our results suggest that the effect of TXA is not superior to EACA in TKA. However, this conclusion still needs to be further confirmed by multicenter and large-sample clinical trials.

Meta-Analysis Study on Treatment of Children's Attention Deficit Disorder with Hyperactivity.

With the development of society and the economy, the prevalence of attention deficit hyperactivity disorder (ADHD) has been increasing. Due to its high comorbidity and high harm, it has received increasing attention. It causes damage to functions in multiple areas, and this damage may continue into adulthood. ADHD is a common developmental disorder characterized by persistent attention deficit and hyperactivity/impulsivity. ADHD often merges with other diseases, such as oppositional defiant disorder, conduct disorder, personality disorder, anxiety disorder, mood disorder, and substance dependence. The disease tends to cause children with learning difficulties, poor grades, strained relationships with family members and children of the same age, lack of self-esteem, and children with low occupation, low income, substance abuse, and antisocial personality characteristics when they grow up to adults. Many countries have formulated ADHD treatment guidelines for this purpose, but there is still a lack of consensus. This article uses literature research and the meta method: RevMan 5.3 software is used for data analysis. The analysis results show that traditional Chinese medicine has characteristics and advantages in the clinical total effective rate and hyperactivity index score in the treatment of ADHD. The overall clinical syndrome differentiation of the treatment can be summarized as liver and kidney yin deficiency and liver yang partial prosperity. The overall medication is based on the methods of nourishing yin and clearing heat, calming the liver and nourishing kidney, and nourishing yin and suppressing yang. The efficacy and safety evaluation of traditional Chinese medicine in the treatment of ADHD need to be further verified by large-sample clinical trials with strict design and standardized outcome index reporting.

Identification of the Molecular Subgroups in Idiopathic Pulmonary Fibrosis by Gene Expression Profiles.

Background Idiopathic Pulmonary Fibrosis (IPF) is one of the most common idiopathic interstitial pneumonia, which can occur all over the world. The median survival time of patients is about 3-5 years, and the mortality is relatively high. Objective To reveal the potential molecular characteristics of IPF and deepen the understanding of the molecular mechanism of IPF. In order to provide some guidance for the clinical treatment, new drug development, and prognosis judgment of IPF. Although the preliminary conclusion of this study has certain guiding significance for the treatment of IPF and so on, it needs more accurate analytical approaches and large sample clinical trials to verify. Methods 220 patients with IPF were divided into different subgroups according to the gene expression profiles, which were obtained from the Gene Expression Omnibus (GEO) database. In addition, these subgroups present different expression forms and clinical features. Therefore, weighted gene coexpression analysis (WGCNA) was used to seek the differences between subtypes. And six subgroup-specific WGCNA modules were identified. Results Combined with the characteristics of WGCNA and KEGG enrichment modules, the autophagic pathway was only upregulated in subgroup I and enriched significantly. The differentiation pathways of Th1 and Th2 cells were only upregulated and enriched in subgroup II. At the same time, combined with clinical information, IPF patients in subgroup II were older and more serious, which may be closely related to the differentiation of Th1 and Th2 cells. In contrast, the neuroactive ligand-receptor interaction pathway and Ca+ signaling pathway were significantly upregulated and enriched in subgroup III. Although there was no significant difference in prognosis between subgroup I and subgroup III, their intrinsic biological characteristics were very different. These results suggest that the subtypes may represent risk factors of age and intrinsic biological characteristics and may also partly reflect the severity of the disease. Conclusion In conclusion, current studies have improved our understanding of IPF-related molecular mechanisms. At the same time, because the results show that patients from different subgroups may have their own unique gene expression patterns, it reminds us that patients in each subgroup should receive more personalized treatment.

Clinical follow-up of children with immune-tolerant chronic hepatitis B receiving antiviral therapy

Objective To investigate the long-term clinical benefits of antiviral therapy in children with immune-tolerant chronic hepatitis B. Methods Long-term follow-up was performed for 46 children with immune-tolerant chronic hepatitis B who were enrolled in the treatment group of the previous randomized controlled trial, and clinical evaluation was performed at weeks 108, 120, 132, 144, 168, and 192 after the trial started. Results All 46 patients completed the follow-up. From week 96 (after the clinical trial started) to week 192 (when the follow-up ended), another 3 patients achieved serum HBV DNA clearance, another 7 patients achieved serum HBeAg clearance, another 6 patients achieved HBeAg seroconversion, and another 3 patients achieved HBsAg seroconversion, while there was no change in the number of patients who achieved serum HBsAg clearance, with a total number of 37 (80.4%), 22 (47.8%), 21 (45.7%), 10(21.7%), and 10(21.7%), respectively. Among these patients, 9(19.6%) did not achieve HBV DNA clearance and they all had virologic breakthrough after drug withdrawal. Conclusion Further large-sample clinical trials are needed to investigate antiviral therapy for children with immune-tolerant chronic hepatitis B.