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.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.
4.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.
5.Study on Anti-Depression Active Ingredients of Bupleuri Radix Based on UPLC-Q-TOF/MS Integrated with CORT-Induced Poorly Differentiated PC12 Depression Cell Model
Jingbo YU ; Yue HAN ; Ziyang ZHOU ; Qingrui MU ; Jingmei CHEN ; Yuqin OUYANG ; Zhang FEI ; Yuhong WANG
World Science and Technology-Modernization of Traditional Chinese Medicine 2023;25(6):2012-2024
Objective To analyze the chemical constituents in the water extract of Bupleuri Radix and investigate the active ingredients of Bupleuri Radix for the treatment of depression.Methods The chemical constituents in the water extract of Bupleuri Radix were identified by Ultra-high-performance liquid chromatography coupled with quadrupole time-of-flight mass spectrometry(UPLC-Q-TOF/MS).CORT-induced poorly differentiated PC12 depression cell model was launched,and PC12 cells were pretreated with monomeric compounds from Bupleuri Radix for 24 h.The cell viability and LDH release rate were measured by CCK-8 assy kit and LDH assay kit,respectively.Results A total of 53 compounds were identified in the water extract of Bupleuri Radix,mainly including type Ⅰ,type Ⅱ and type Ⅲsaikosaponins.Among them,saikosaponin A,saikosaponin B2,saikosaponin C,saikosaponin E,saikosaponin F and 6″-acetyl saikosaponin A contributed the most to the metabolite profile of Bupleuri Radix,and could improve the viability of CORT-induced PC12 cells(P<0.05,P<0.01).Furthermore,saikosaponin A,saikosaponin B2,saikosaponin C,saikosaponin E and saikosaponin F could decrease the LDH release rate of CORT-induced PC12 cells(P<0.05,P<0.01).Conclusion The major anti-depression active ingredients in Bupleuri Radix may be Saikosaponin A,saikosaponin B2,saikosaponin C,saikosaponin E and saikosaponin F,which lays a foundation for the research of the quality control and pharmacodynamic material basis of Bupleuri Radix.
6.Inhibition of miR-146a-5p and miR-8114 in Insulin-Secreting Cells Contributes to the Protection of Melatonin against Stearic Acid-Induced Cellular Senescence by Targeting Mafa
Shenghan SU ; Qingrui ZHAO ; Lingfeng DAN ; Yuqing LIN ; Xuebei LI ; Yunjin ZHANG ; Chunxiao YANG ; Yimeng DONG ; Xiaohan LI ; Romano REGAZZI ; Changhao SUN ; Xia CHU ; Huimin LU
Endocrinology and Metabolism 2022;37(6):901-917
Background:
Chronic exposure to elevated levels of saturated fatty acids results in pancreatic β-cell senescence. However, targets and effective agents for preventing stearic acid-induced β-cell senescence are still lacking. Although melatonin administration can protect β-cells against lipotoxicity through anti-senescence processes, the precise underlying mechanisms still need to be explored. Therefore, we investigated the anti-senescence effect of melatonin on stearic acid-treated mouse β-cells and elucidated the possible role of microRNAs in this process.
Methods:
β-Cell senescence was identified by measuring the expression of senescence-related genes and senescence-associated β-galactosidase staining. Gain- and loss-of-function approaches were used to investigate the involvement of microRNAs in stearic acid-evoked β-cell senescence and dysfunction. Bioinformatics analyses and luciferase reporter activity assays were applied to predict the direct targets of microRNAs.
Results:
Long-term exposure to a high concentration of stearic acid-induced senescence and upregulated miR-146a-5p and miR- 8114 expression in both mouse islets and β-TC6 cell lines. Melatonin effectively suppressed this process and reduced the levels of these two miRNAs. A remarkable reversibility of stearic acid-induced β-cell senescence and dysfunction was observed after silencing miR-146a-5p and miR-8114. Moreover, V-maf musculoaponeurotic fibrosarcoma oncogene homolog A (Mafa) was verified as a direct target of miR-146a-5p and miR-8114. Melatonin also significantly ameliorated senescence and dysfunction in miR-146a-5pand miR-8114-transfected β-cells.
Conclusion
These data demonstrate that melatonin protects against stearic acid-induced β-cell senescence by inhibiting miR-146a- 5p and miR-8114 and upregulating Mafa expression. This not only provides novel targets for preventing stearic acid-induced β-cell dysfunction, but also points to melatonin as a promising drug to combat type 2 diabetes progression.
7.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.
8.Therapeutic effect of endoscopic submucosal dissection on the treatment of early gastric cancer
Qingrui ZHANG ; Yueming ZHANG ; Liyan XUE ; Shun HE ; Lizhou DOU ; Yong LIU ; Lei SHI ; Yantao TIAN ; Dongbing ZHAO ; Guiqi WANG
Chinese Journal of Oncology 2020;42(9):752-757
Objective:To analyze the long-term therapeutic effect of endoscopic submucosal dissection (ESD) on the treatment of early gastric cancer (EGC).Methods:We retrospectively reviewed EGC patients who underwent ESD at Cancer Hospital, Chinese Academy of Medical Sciences (CAMS), from January 2009 to December 2016. The incidence rates of local recurrence, synchronous cancer and heterogeneous cancer were analyzed. Kaplan-Meier method was used to analyze 5-years recurrence free survival (RFS) and 5-years disease special survival (DSS) of all patients.Results:A total of 255 EGC patients were enrolled in this study, included 175 differentiated early gastric cancer (D-EGC) patients and 80 undifferentiated early gastric cancer (UD-EGC) patients. Among them, 171 patients within the extended indication of ESD while 84 patients beyond the extended indication of ESD. Among the 225 patients, the incidence rates of local recurrence, synchronous cancer and heterogeneous cancer were 2.0%, 2.0% and 2.4%, respectively. The local recurrence rates of D-EGC group and UD-EGC group was 1.7% and 2.5%, respectively, without significant difference ( χ2=0.176, P=0.675). The incidence rates of synchronous and heterogenous cancer in the D-EGC group were 2.3% and 3.4%, higher than 1.2% and 0 of UD-EGC group, although there was no significant difference ( χ2=0.306, P=0.580 vs χ2=2.809, P=0.094). There were no significant differences in 5-years RFS (91.3% vs 95.9%, P=0.236) and 5-years DSS (100% vs 98.6%, P=0.156) between D-EGC group and UD-EGC group. Conclusions:The long-term outcome of ESD in the treatment of EGS is good. More attention should be paid to the occurrence of local recurrence and heterogeneous cancer in EGC patients undergo ESD. These patients still have a good long-tern outcome even undergoing ESD for more than once.
9.Long-term outcome after endoscopic resection for early colorectal carcinoma
Lizhou DOU ; Yueming ZHANG ; Shun HE ; Yong LIU ; Qingrui ZHANG ; Lei SHI ; Shuangmei ZOU ; Guiqi WANG
Chinese Journal of Oncology 2020;42(9):758-764
Objective:To analysis the clinical and follow-up data of the early colorectal carcinoma (ECC) after endoscopic resection, and explore the long-term outcome of patients who underwent the endoscopic resection.Methods:During June 2008 to June 2016, data of endoscopic resection for 550 cases of ECC were collected, including general information and follow-up data. The influence factors of disease-free survival rate of ECC after endoscopic resection were analyzed and the risk factors on long-term outcomes such as submucosa invasion depth, poorly differentiated adenocarcinoma, vascular invasion and positive vertical margin were investigated.Results:The mean follow-up time of 550 patients treated with endoscopy was (60.7±36.8) months. Among them, 433 cases were high-level intra-mucosal neoplasia, 117 cases were submucosa invasion carcinoma (the invasion depth <1 000 μm were 33 cases, ≥1 000 μm were 84 cases), 461 cases were curative resection, while 89 cases were non-curative resection. During the follow-up, 6 patients occurred recurrence or metastasis, including 2 patients with local recurrence (1 patient accompanied by lymph node metastasis) and 4 patients with lymph node metastasis (2 patients accompanied by distant metastasis). The overall 5-years disease-free survival rate was 98.8%, the 5-years disease-free survival rate was 100.0% for patients with curative resection and 93.3% for patients with non-curative resection. A total of 89 cases underwent non-curative resection were accompanied with invasion depth ≥1 000 μm, vascular invasion, poorly differentiated adenocarcinoma and positive vertical margin. Among them, 62 cases were accompanied with 1 risk factor, 23 cases with 2 risk factors and 4 cases with 3 risk factors. The risks of lymph nodes and distant metastasis raised with the increase of risk factors.Conclusions:The incidence of lymph node metastasis in ECC is extremely low. Endoscopic treatment can achieve a good long-term outcome. Close follow-up should be conducted after endoscopic treatment, and additional treatment should be selected reasonably for the early colorectal carcinoma after endoscopic non-curative resection to improve the therapeutic efficacy of endoscopic resection.
10.Clinical outcomes of endoscopic piecemeal mucosal resection for superficial esophageal carcinoma and precancerous lesions
Lei SHI ; Yong LIU ; Shun HE ; Yueming ZHANG ; Lizhou DOU ; Yan KE ; Xudong LIU ; Qingrui ZHANG ; Guiqi WANG
Chinese Journal of Oncology 2020;42(9):746-751
Objective:To explore the short and long-term outcomes of endoscopic piecemeal mucosal resection including endoscopic mucosal resection (EMR) and multiband mucosectomy (MBM) for superficial esophageal carcinoma and precancerous lesions, and analyze the risk factors for prognosis.Methods:From March 1 2001 to May 31 2017, 371 patients with 416 lesions who were diagnosed as superficial esophageal carcinoma or high-grade intraepithelial neoplasm and underwent EMR or MBM were retrospectively enrolled in this study. Long-term recurrence free survival (RFS) rate and the risk factors, including submucosal invasion, poorly differentiation, vascular invasion and positive vertical margin, for the long-term outcome were also analyzed.Results:The incidence of complication was 17.1% in the EMR group and 17.4% in the MBM group, without significant difference ( P=1.000). The median follow-up period was 70.6 months. The 5-years RFS was 93.9% and 10-years RFS was 87.8%, respectively. Local recurrence was found in 2 cases in each group and they were curatively treated by endoscopic submucosal dissection. Heterogeneous multiple primary esophageal cancer was diagnosed in 5 and 3 cases for the EMR and MBM group, of whom 5 cases were curatively treated with endoscopic resection. Other 3 cases were diagnosed with advanced esophageal cancer, of whom 2 patients died. Lymph node metastasis (LNM) was found in 5 cases in the EMR group and 4 cases in the MBM group, of whom 6 patients died. Distant metastasis was found in 5 cases in the EMR group and 3 cases in the MBM group, of whom 5 patients died. There were 83 patients combined with risk factors including submucosal invasion, poorly differentiation, vascular invasion and positive vertical margin, of whom 8 patients were diagnosed as LNM and 8 patients as distant metastasis. The 5-years RFS of patients with 1, 2, and 3 risk factors were 93.6%, 82.2%, and 25.0%, and the difference was statistically significant ( P<0.001). Conclusions:EMR and MBM are both safe and feasible procedures for superficial esophageal carcinoma and precancerous lesions. Additional treatments should be selected according to the variety of risk factors to acquire better long-term outcome and life quality.

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