1.Current Status of Outcome Indicators in Randomized Controlled Trials of Traditional Chinese Medicine for Treating Chronic Atrophic Gastritis
Jie ZHANG ; Yaxi SHANG ; Qingrui YANG ; Yuyu LEI ; Huan CHEN ; Cailing LI ; Yu KANG ; Xiaoquan DU
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(17):193-202
ObjectiveThis paper aims to analyze the current status of outcome indicators in randomized controlled trials (RCT) of traditional Chinese medicine (TCM) for treating chronic atrophic gastritis (CAG), so as to provide references for constructing the core outcome set (COS) of TCM in the treatment of CAG. MethodChina National Knowledge Infrastructure (CNKI), Wanfang, VIP, SinoMed, PubMed, Embase, and Cochrane Library databases were searched for RCTs of TCM in the treatment of CAG in the last five years. The risk of bias of included studies was evaluated, and the selection status of outcome indicators was statistically analyzed. ResultA total of 150 RCTs were included, with a sample size of 44-398 cases. 164 outcome indicators were reported, with an application frequency of 1 229 times. The outcome indicators were classified into seven indicator domains according to functional attributes, followed by physical and chemical examination (69.41%), TCM syndrome (12.69%), symptoms and signs (11.15%), safety indicators (5.37%), quality of life (0.65%), long-term prognosis (0.65%), and economic evaluation (0.08%). According to the statistical analysis, there were problems in the selection of outcome indicators in RCTs of TCM for treating CAG, including various indicators, non-standard name reports, unclear primary and secondary indicators, random combination of subjective and objective indicators, neglected patient report outcome indicators, missing long-term prognosis and economic indicators, insufficient reporting of safety indicators, and inconsistent measurement tools and measurement time points. ConclusionIn the past five years, there have been many problems in the selection of outcome indicators in RCTs of TCM for treating CAG. It is necessary to actively promote the construction of the COS of TCM in the treatment of CAG and promote the high-quality development of clinical research of TCM.
2.Patient-reported outcomes of locally advanced gastric cancer undergoing robotic versus laparoscopic gastrectomy: a randomized controlled study
Qingrui WANG ; Shougen CAO ; Cheng MENG ; Xiaodong LIU ; Zequn LI ; Yulong TIAN ; Jianfei XU ; Yuqi SUN ; Gan LIU ; Xingqi ZHANG ; Zhuoyu JIA ; Hao ZHONG ; Hao YANG ; Zhaojian NIU ; Yanbing ZHOU
Chinese Journal of Surgery 2024;62(1):57-64
Objective:To compare the patient-reported outcomes and short-term clinical outcomes between robotic-assisted and laparoscopic-assisted radical gastrectomy for locally advanced gastric cancer.Methods:This single-center prospective randomized controlled trial was conducted in the Department of Gastrointestinal Surgery, Affiliated Hospital of Qingdao University from October 2020 to August 2022. Patients with locally advanced gastric cancer who were to undergo radical gastrectomy were selected and randomly divided into two groups according to 1∶1, and received robotic surgery and laparoscopic surgery, respectively. Patient-reported outcomes and short-term clinical outcomes (including postoperative complications, surgical quality and postoperative short-term recovery) were compared between the two groups by independent sample t test, Mann-Whitney U test, repeated ANOVA, generalized estimating equation, χ2 test and Fisher′s exact test. Results:A total of 237 patients were enrolled for modified intention-to-treat analysis (120 patients in the robotic group, 117 patients in the laparoscopic group). There were 180 males and 59 females, aged (63.0±10.2) years (range: 30 to 85 years). The incidence of postoperative complications was similar between the robotic group and laparoscopic group (16.7% (20/120) vs. 15.4% (18/117), χ2=0.072, P=0.788). The robotic group had higher patient-reported outcomes scores in general health status, emotional, and social domains compared to the laparoscopic group, differences in time effect, intervention effect, and interaction effect were statistically significant (general health status: χ2 value were 275.68, 3.91, 6.38, P value were <0.01, 0.048, 0.041; emotional: χ2 value were 77.79, 6.04, 6.15, P value were <0.01, 0.014, 0.046; social: χ2 value were 148.00, 7.57, 5.98, P value were <0.01, 0.006, 0.048). However, the financial burden of the robotic group was higher, the differences in time effect, intervention effect and interaction effect were statistically significant ( χ2 value were 156.24, 4.08, 36.56, P value were <0.01, 0.043,<0.01). Conclusion:Compared to the laparoscopic group, the robotic group could more effectively relieve postoperative negative emotions and improve recovery of social function in patients.
3.Predictive model for interventional efficacy in lower extremity arteriosclerosis obliterans
Zhenwei YANG ; Qingrui WU ; Wenjie MA ; Ye TIAN
International Journal of Surgery 2024;51(7):446-454
Objective:To develop a predictive model for the intervention efficacy of lower extremity atherosclerotic occlusive disease (LEASO) and evaluate its performance to predict the outcomes of intervention therapy for patients with lower extremity atherosclerotic occlusive disease.Methods:This study retrospectively analyzed data from 238 patients with lower extremity atherosclerotic occlusive disease (LEASO), including 188 males and 50 females, aged between 35 and 88 years with a mean age of 68 years. These patients were randomly divided in a 7∶3 ratio into a training set ( n=166) and a testing set ( n=72) based on adverse outcomes, both training and test sets were divided into MALEs and non-MALEs groups. The training set had 67 MALEs and 99 non-MALEs, while the test set had 26 MALEs and 46 non-MALEs. Important variables related to outcome events were selected using LASSO regression in the training set and incorporated into a multifactorial logistic regression model to construct a predictive model. The model was visualized using forest plots and its performance was evaluated using data from both the training and testing sets. Results:Through LASSO regression, SIIRI(Systemic immune inflammatory response index, SIIRI), Rutherford >4, IP(Infrapopliteal, IP)>1, and P(Pedal, P)≥1 were selected as predictive indicators for the model. The area under the curve, sensitivity, and specificity of the model in the training set and testing set were 0.813, 80.6%, 72.7%, and 0.764, 65.4%, 80.4%. The calibration curve was consistent with expectations. The decision curves of the model had the highest accuracy, net benefit rate for clinical application of the model when the threshold probabilities of the training set and test set were in the range of 0~0.79 and 0~0.66.Conclusions:The predictive model built using preoperative Rutherford classification, IP classification, P classification, and SIIRI can identify high-risk individuals for early detection of MALEs and provide targeted intensified treatment. This model has practical significance in improving the prognosis of such patients and can be applied in clinical practice.
4.Patient-reported outcomes of locally advanced gastric cancer undergoing robotic versus laparoscopic gastrectomy: a randomized controlled study
Qingrui WANG ; Shougen CAO ; Cheng MENG ; Xiaodong LIU ; Zequn LI ; Yulong TIAN ; Jianfei XU ; Yuqi SUN ; Gan LIU ; Xingqi ZHANG ; Zhuoyu JIA ; Hao ZHONG ; Hao YANG ; Zhaojian NIU ; Yanbing ZHOU
Chinese Journal of Surgery 2024;62(1):57-64
Objective:To compare the patient-reported outcomes and short-term clinical outcomes between robotic-assisted and laparoscopic-assisted radical gastrectomy for locally advanced gastric cancer.Methods:This single-center prospective randomized controlled trial was conducted in the Department of Gastrointestinal Surgery, Affiliated Hospital of Qingdao University from October 2020 to August 2022. Patients with locally advanced gastric cancer who were to undergo radical gastrectomy were selected and randomly divided into two groups according to 1∶1, and received robotic surgery and laparoscopic surgery, respectively. Patient-reported outcomes and short-term clinical outcomes (including postoperative complications, surgical quality and postoperative short-term recovery) were compared between the two groups by independent sample t test, Mann-Whitney U test, repeated ANOVA, generalized estimating equation, χ2 test and Fisher′s exact test. Results:A total of 237 patients were enrolled for modified intention-to-treat analysis (120 patients in the robotic group, 117 patients in the laparoscopic group). There were 180 males and 59 females, aged (63.0±10.2) years (range: 30 to 85 years). The incidence of postoperative complications was similar between the robotic group and laparoscopic group (16.7% (20/120) vs. 15.4% (18/117), χ2=0.072, P=0.788). The robotic group had higher patient-reported outcomes scores in general health status, emotional, and social domains compared to the laparoscopic group, differences in time effect, intervention effect, and interaction effect were statistically significant (general health status: χ2 value were 275.68, 3.91, 6.38, P value were <0.01, 0.048, 0.041; emotional: χ2 value were 77.79, 6.04, 6.15, P value were <0.01, 0.014, 0.046; social: χ2 value were 148.00, 7.57, 5.98, P value were <0.01, 0.006, 0.048). However, the financial burden of the robotic group was higher, the differences in time effect, intervention effect and interaction effect were statistically significant ( χ2 value were 156.24, 4.08, 36.56, P value were <0.01, 0.043,<0.01). Conclusion:Compared to the laparoscopic group, the robotic group could more effectively relieve postoperative negative emotions and improve recovery of social function in patients.
5.Application of information sharing assisted decision-making intervention in patients with knee replacement
Jing PENG ; Qingrui YANG ; Yuan FU ; Yan LI ; Panfeng JIANG ; Xiaoxia FANG
Chinese Journal of Modern Nursing 2024;30(20):2757-2761
Objective:To explore the application effect of information sharing assisted decision-making intervention in knee replacement patients.Methods:A total of 94 inpatients undergoing knee replacement in Department of Orthopedics in Xinxiang Central Hospital from January to December 2022 were selected by the convenient sampling method, and they were divided into the control group and the observation group according to random number table method, with 47 cases in each group. The control group adopted routine clinical decision-making management, while the observation group implemented information sharing assisted decision-making intervention based on the control group. On the 5th day after surgery, Control Preference Scale (CPS), Chinese version of Preparation Decision Making Scale (PreDM) and Decision Participation Satisfaction Scale were used to evaluate the decision participation, decision readiness and decision satisfaction of patients in two groups.Results:In the control group, active, cooperative and passive decision-making participation accounted for 21.28% (10/47), 27.66% (13/47) and 51.06% (24/47), respectively. In the observation group, 42.55% (20/47), 44.68% (21/47) and 12.77% (6/47) of the participants were active, cooperative and passive, respectively. There was a statistically significant difference in the distribution of decision participation between the two groups ( P<0.01). The PreDM score and decision participation satisfaction score of the observation group were higher than those of the control group, and the differences were statistically significant ( P<0.01) . Conclusions:Information sharing assisted decision-making intervention can effectively improve the decision-making participation of knee replacement patients and improve their decision-making readiness and satisfaction.
6.Association between childhood growing environment and depressive symptoms in old persons aged 60 to 74 years
Yang MA ; Yueqin HUANG ; Haixia LIU ; Zekun SUN ; Hongxu ZHANG ; Qingrui ZHANG
Chinese Mental Health Journal 2024;38(11):943-948
Objective:To explore the association between childhood growing environment and depressive symptoms in young old persons aged 60 to 74 years.Methods:The data of the fourth wave of China Health and Re-tirement Longitudinal Study in 2018 and the life course survey in 2014 were used to secondary analysis.A total of 7 642 young old persons aged 60 to 74 years were included,and the 10-item of the Center for Epidemiological Stud-ies Depression(CES-D-10)scale was used to evaluate the depressive symptoms.The generalized linear mixed effects model was used to explore the relationship between childhood growing environment and depressive symp-toms in the young old persons.Results:The detection rate of depressive symptoms occurrence in the young old per-sons was 37.2%.The risk factors of depressive symptoms included female(OR=1.89),rural(OR=1.35),hav-ing hunger experience(OR=1.22),poor relationship with male dependents(OR=1.72),female caregiver's expe-riences of being bedridden due to illness(OR=1.38),community insecurity(OR=1.59),more harmonious neigh-borhood relationship(OR=1.20)and less harmonious neighborhood relationship(OR=1.81).The protective fac-tors of depressive symptoms occurrence included moderate(OR=0.79)and high(OR=0.50)per capita house-hold income,and educated father(OR=0.84)(P<0.05).Conclusion:Childhood growing environment is an influ-ential factor of depressive symptoms in the young old persons.The long-term health effects of childhood environ-ment should be paid attention to.
7.Research progress in the role of LRRC15 in the pathogenesis of non-tumor diseases
Miaomiao XIN ; Xin GUAN ; Qingrui YANG ; Min FU
Chinese Journal of Microbiology and Immunology 2024;44(8):734-740
Leucine-rich repeat containing protein 15 (LRRC15) gene encodes a type Ⅰ transmembrane protein with 15 leucine-rich repeats(LRRs), which is involved in the occurrence and development of various diseases. Previous studies on LRRC15 gene have mostly focused on its tumor-promoting effects, while the immunoregulatory roles of this gene in non-neoplastic diseases are in the exploratory stage, such as controlling viral infection, participating in changing the functions of osteoblasts and chondrocytes, and promoting the release of pro-inflammatory cytokines, osteogenic differentiation, as well as the proliferation, migration and angiogenesis of fibroblast-like synoviocytes. This paper summarizes the research status and possible roles of LRRC15 gene in non-tumor diseases, hoping to reveal the significant role of this gene in immune regulation.
8.Syndrome Differentiation-based Treatment of Diarrhea-predominant Irritable Bowel Syndrome with Chinese Medicine via 5-HT Signaling Pathway: A Review
Qingrui YANG ; Zeyu HU ; Yuyu LEI ; Xinzhu LI ; Huan CHEN ; Wei CUI ; Haitao LIU ; Xiaoquan DU
Chinese Journal of Experimental Traditional Medical Formulae 2023;29(24):250-259
Diarrhea-predominant irritable bowel syndrome (IBS-D) is a chronic functional bowel disorder characterized by abdominal pain and diarrhea, with visceral hypersensitivity and abnormal gastrointestinal dynamics as the pathophysiological basis. The brain-gut interaction plays a role in pain-related functional gastrointestinal disorders, especially IBS-D. 5-Hydroxytryptamine (5-HT), as an important brain-gut peptide regulating gastrointestinal function, affects brain activity, gastrointestinal motility, pain perception, mucosal inflammation, and immune response through brain-gut interaction and is associated with the occurrence and development of IBS-D. In recent years, traditional Chinese medicine (TCM) has shown great potential to mitigate gastrointestinal symptoms and improve the quality of life with its holistic view and treatment based on syndrome differentiation. Studies have shown that TCM treats IBS-D by regulating the 5-HT signaling pathway. With a focus on syndrome differentiation in TCM, this paper systematically describes the efficacy and mechanism of TCM in treating different TCM syndromes of IBS-D via the 5-HT signaling pathway, aiming to provide a scientific basis for TCM treatment of this disease.
9.Safety of simultaneous vaccination of 13-valent pneumococcal polysaccharide conjugate vaccine with other vaccines in Shanghai from 2017 to 2021
Shoufei YANG ; Jiechen LIU ; Zhuoying HUANG ; Qingrui BAI ; Xiang GUO ; Jia REN
Shanghai Journal of Preventive Medicine 2022;34(8):751-755
ObjectiveTo compare the incidence of adverse events following immunization (AEFI) between vaccination with 13-valent pneumococcal polysaccharide conjugate vaccine (PCV13) alone and with other vaccines at the same time. MethodsWe obtained PCV13 vaccination adverse reaction reports for children vaccinated in Shanghai between 2017‒2021 from the National Immunization Program Information Management System and collected the information and the data of children vaccinated with PCV13 from The Shanghai vaccination information system. We compared the incidence of adverse reactions between stand-alone and simultaneous vaccination. ResultsA total of 11 175 PCV13 AEFI cases after stand-alone vaccination and 215 PCV13 AEFI cases after simultaneous vaccination were reported during 2017‒2021 in Shanghai, and the incidence rates were 1 252.34/105 and 1 455.75/105, respectively. ORV was the one mostly vaccinated with PCV13 at the same time, and the AEFI incidence was 1 706.67/105. The most reported symptom was fever after PCV13 vaccination, no matter by stand-alone and simultaneous vaccination with the respective incidence rates of 876.69/105 and 1 442.21/105. ConclusionIn general, PCV13 vaccinated with other vaccines at the same time slightly increases the incidence of AEFI.
10.Efficacy and Safety of Anti-Tumor Necrosis FactorAlpha Agents for Patients with Intestinal Behcet’s Disease: A Systematic Review and Meta-Analysis
Qingfeng ZHANG ; Chunyan MA ; Rongrong DONG ; Weizhen XIANG ; Meiqi LI ; Zhenzhen MA ; Qingrui YANG
Yonsei Medical Journal 2022;63(2):148-157
Purpose:
Intestinal Behcet’s disease (BD) is a systemic autoimmune disease for which treatment options are limited. As a prospective therapeutic strategy for intestinal BD, anti-tumor necrosis factor-alpha (anti-TNF-α) agents have received increasing attention. In this study, we conducted a systematic review and meta-analysis to evaluate the efficacy and safety of anti-TNF-α agents for patients with intestinal BD.
Materials and Methods:
We searched PubMed, Embase, and Cochrane Library databases up to July 1, 2021 and articles that met the eligibility criteria were further assessed. Pooled rates were synthesized by a randomized effects model using Stata software.
Results:
Eleven clinical trials covering 671 patients with intestinal BD were included. According to compositive data, the pooled rate for remission was 39% [95% confidence interval (CI) 26–52] in patients receiving anti-TNF-α agents. Intestinal symptoms were cured in 70% (95% CI 53–84) of the patients, and the rate for endoscopic healing was 65% (95% CI 52–78). Corticosteroid discontinuation was achieved in 43% (95% CI 28–58) of the patients, and the dose reduction of corticosteroid was 20.43 mg (95% CI 13.4–27.46). There were 239 adverse events and 80 serious adverse events during follow-up.
Conclusion
Our study indicated that anti-TNF-α agents may serve as an effective treatment with acceptable safety for patients with intestinal BD. However, more robust evidence from randomized controlled trials is urgently needed to assess the long-term efficacy and safety of anti-TNF-α agents for those patients.

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