Effect of intra-operative chemotherapy with 5-fluorouracil and leucovorin on the survival of patients with colorectal cancer after radical surgery: a retrospective cohort study

Background:The effect of intra-operative chemotherapy(IOC)on the long-term survival of patients with colorectal cancer(CRC)remains unclear.In this study,we evaluated the independent effect of intra-operative infusion of 5-fluorouracil in combination with calcium folinate on the survival of CRC patients following radical resection.Methods:1820 patients were recruited,and 1263 received IOC and 557 did not.Clinical and demographic data were collected,including overall survival(OS),clinicopathological features,and treatment strategies.Risk factors for IOC-related deaths were identified using multivariate Cox proportional hazards models.A regression model was developed to analyze the independent effects of IOC.Results:Proportional hazard regression analysis showed that IOC(hazard ratio[HR]=0.53,95%confidence intervals[CI][0.43,0.65],P<0.001)was a protective factor for the survival of patients.The mean overall survival time in IOC group was 82.50(95%CI[80.52,84.49])months,and 71.21(95%CI[67.92,74.50])months in non-IOC group.The OS in IOC-treated patients were significantly higher than non-IOC-treated patients(P<0.001,log-rank test).Further analysis revealed that IOC decreased the risk of death in patients with CRC in a non-adjusted model(HR=0.53,95%CI[0.43,0.65],P<0.001),model 2(adjusted for age and gender,HR=0.52,95%CI[0.43,0.64],P<0.001),and model 3(adjusted for all factors,95%CI 0.71[0.55,0.90],P=0.006).The subgroup analysis showed that the HR for the effect of IOC on survival was lower in patients with stage II(HR=0.46,95%CI[0.31,0.67])or III disease(HR=0.59,95%CI[0.45,0.76]),regardless of pre-operative radiotherapy(HR=0.55,95%CI[0.45,0.68])or pre-operative chemotherapy(HR=0.54,95%CI[0.44,0.66]).Conclusions:IOC is an independent factor that influences the survival of CRC patients.It improved the OS of patients with stages II and III CRC after radical surgery.Trial registration:chictr.org.cn,ChiCTR 2100043775.

Effectiveness of acupoint application of Xiaozhong Zhitong Tie on diarrhea in patients:a retrospective cohort study in China

OBJECTIVE:To provide the evidence for the efficacy of acupoint application(AA)for patients with diarrhea in a real-world setting.METHODS:This study is a national multicenter retrospective cohort study.Our study consecutively collected outpatient medical records of patients with diarrhea from hundreds of primary hospitals nationwide registered in Chun Bo Wan Xiang cloud platform from 22nd August,2020 to 5th November,2020.The patients were divided into the treatment group and the control group according to patient's condition and willingness.The control group was treated with Western Medicine,oral Chinese Medicine decoction,or both.The treatment group was added with AA based on the control group.Multiple logistic regression was used to evaluate the independent efficacy of AA in diarrheal recovery on the 3rd,7th,14th and 28th day.As a next step,we also performed stratified analysis and likelihood ratio test(LRT).Sensitivity analyses included propensity score matching(PSM),four PSM-related analyses and E-value.RESULTS:The treatment group showed better efficacy than the control group on the 14th and 28th day[the 14th day:OR=1.58,95%CI(1.15,2.19),P=0.005;the 28th day:OR=2.03,95%CI(1.43,2.88),P<0.001].No difference was observed in efficacy of AA for the treatment of diarrhea among the subgroups(P>0.05).PSM-related analyses confirmed the efficacy of AA in diarrheal recovery.The findings are unlikely to be nullified by an unmeasured confounding variable according to the results of E-values.CONCLUSIONS:The efficacy in the treatment group was significantly more improved than that in the control group on the 14th and 28th day.

Chinese herbal medicine reduces mortality in patients with severe and critical coronavirus disease 2019: a retrospective cohort study

This study aimed to evaluate the efficacy of Chinese herbal medicine(CHM)in patients with severe/critical coronavirus disease 2019(COVID-19).In this retrospective study,data were collected from 662 patients with severe/critical COVID-19 who were admitted to a designated hospital to treat patients with severe COVID-19 in Wuhan before March 20,2020.All patients were divided into an exposed group(CHM users)and a control group(non-users).After propensity score matching in a 1:1 ratio,156 CHM users were matched by propensity score to 156 non-users.No significant differences in seven baseline clinical variables were found between the two groups of patients.All-cause mortality was reported in 13 CHM users who died and 36 non-users who died.After multivariate adjustment,the mortality risk of CHM users was reduced by 82.2%(odds ratio 0.178,95%CI 0.076–0.418;P<0.001)compared with the non-users.Secondly,age(odds ratio 1.053,95%CI 1.023–1.084;P<0.001)and the proportion of severe/critical patients(odds ratio 0.063,95%CI 0.028–0.143;P<0.001)were the risk factors of mortality.These results show that the use of CHM may reduce the mortality of patients with severe/critical COVID-19.

Clinical Course and Outcome Patterns of Acute-on-chronic Liver Failure:A Multicenter Retrospective Cohort Study

Background and Aims:Acute-on-chronic liver failure(ACLF)is acute decompensation of liver function in the setting of chronic liver disease,and characterized by high short-term mortality.In this study,we sought to investigate the clinical course of patients at specific time points,and to propose dynamic prognostic criteria.Methods:We assessed the clinical course of 453 patients with ACLF during a 12-week follow-up period in this retrospective multicenter study.The clinical course of patients was defined as disease recovery,improvement,worsening or steady patterns based on the variation tendency in prothrombin activity(PTA)and total bilirubin(TB)at different time points.Results:Resolution of PTA was observed in 231 patients(51%)at 12 weeks after the diagnosis of ACLF.Among the remaining patients,66(14.6%)showed improvement and 156(34.4%)showed a steady or worsening course.In patients with resolved PTA,the clinical course of TB exhibited resolved pattern in 95.2%,improved in 3.9%,and steady or worse in 0.8%.Correspondingly,in patients with improved PTA,these values for TB were 28.8%,27.3%,and 43.9%,respectively.In patients with steady or worsening PTA,these values for TB were 5.7%,32.3%,and 65.6%,respectively.Dynamic prognostic criteria were developed by combining the clinical course of PTA/TB and the clinical outcomes at 4 and 12 weeks after diagnosis in ACLF patients.Conclusions:We propose the following dynamic prognostic criteria:rapid progression,slow progression,rapid recovery,slow recovery,and slow persistence,which lay the foundation for precise prediction of prognosis and the improvement of ACLF therapy.

LipoCol Forte capsules reduce the risk of liver cancer:A propensity score-matched,nationwide,population-based cohort study

BACKGROUND Liver cancer is among the top five most common cancers globally. Lipid-lowering drugs such as statins can lower the risk of liver cancer, but may also cause liver damage. LipoCol Forte capsules(LFC), a red yeast rice product, have demonstrated significant antihypercholesterolemic effects and a good safety profile in clinical studies.AIM To evaluate whether LFC lowers the risk of liver cancer in adults in this propensity score-matched, nationwide, population-based cohort study.METHODS We used data from Taiwan’s National Health Insurance Research Database, which includes electronic medical records for up to 99.99% of Taiwan’s population. LFC users and LFC non-users were matched 1:1 by propensity scores between January 2010 and December 2017. All had followup data for at least 1 year. Statistical analyses compared demographic distributions including sex, age, comorbidities, and prescribed medications. Cox regression analyses estimated adjusted hazard ratios(aHRs) after adjusting for potential confounders.RESULTS We enrolled 33231 LFC users and 33231 non-LFC users(controls). No significant differences between the study cohorts were identified regarding comorbidities and medications [standardized mean difference(SMD) < 0.05]. At follow-up, the overall incidence of liver cancer was significantly lower in the LFC cohort compared with controls [aHR 0.91;95% confidence interval(CI): 0.86-0.95;P < 0.001]. The risk of liver cancer was significantly reduced in both females(aHR 0.87;95%CI: 0.8-0.94;P < 0.001) and males(aHR 0.93;95%CI: 0.87-0.98;P < 0.01) in the LFC cohort compared with their counterparts in the non-LFC cohort. The antitumor protective effects applied to patients with comorbidities(including hypertension, ischemic stroke, diabetes mellitus, hyperlipidemia, hepatitis B infection and hepatitis C infection). Those using LFC for more than 84 drug days had a 0.64-fold lower risk of liver cancer compared with controls(P < 0.001). Compared with controls, the risk of developing liver cancer in the LFC cohort progressively decreased over time;the lowest incidence of liver cancer occurred in LFC users followed-up for more than 6 years(27.44 vs 31.49 per 1,000 person-years;aHR 0.75;95%CI: 0.68-0.82;P < 0.001).CONCLUSION This retrospective cohort study indicates that LFC has a significantly protective effect on lowering the risk of liver cancer, in a dose-dependent and time-dependent manner.

Bleeding complications after percutaneous kidney biopsies–nationwide experience from Brunei Darussalam

BACKGROUND Kidney biopsy serves as a valuable method for both diagnosing and monitoring kidney conditions.Various studies have identified several risk factors associated with bleeding complications following the procedure,but these findings have shown inconsistency and variation.AIM To investigate the risk of bleeding complications following percutaneous kidney biopsy in Brunei Darussalam.We sought to explore the relevant clinical and pathological risk factors associated with these complications while also considering the findings within the broader international literature context.METHODS We conducted a retrospective study of all adult patients who underwent kidney biopsy in Brunei Darussalam from October 2013 to September 2020.The outcomes of interest were post-biopsy bleeding and the need for blood transfusions.Demographics,clinical,laboratory and procedural-related data were collected.Logistic regression analysis was used to identify predictors of outcomes.RESULTS A total of 255 kidney biopsies were included,with 11%being performed on transplanted kidneys.The majority of biopsies were done under ultrasound guidance(83.1%),with the rest under computer tomography guidance(16.9%).The most common indications for biopsy were chronic kidney disease of undefined cause(36.1%),nephrotic syndrome(24.3%)and acute kidney injury(11%).Rate of bleeding complication was 6.3%–2%frank hematuria and 4.3%perinephric hematoma.Blood transfusion was required in 2.8%of patients.No patient lost a kidney or died because of the biopsy.Multivariate logistic regression identified baseline hemoglobin[odds ratio(OR):4.11;95%confidence interval(95%CI):1.12-15.1;P=0.03 for hemoglobin≤11 g/dL vs.>11 g/dL)and the presence of microscopic hematuria(OR:5.24;95%CI:1.43-19.1;P=0.01)as independent risk factors for post-biopsy bleeding.Furthermore,low baseline platelet count was identified as the dominant risk factor for requiring postbiopsy transfusions.Specifically,each 10109/L decrease in baseline platelet count was associated with an 12%increase risk of needing transfusion(OR:0.88;95%CI:0.79-0.98;P=0.02).CONCLUSION Kidney biopsies were generally well-tolerated.The identified risk factors for bleeding and transfusion can help clinicians to better identify patients who may be at increased risk for these outcomes and to provide appropriate monitoring and management.

Effects of bilirubin on perioperative myocardial infarction and its long-term prognosis in patients undergoing percutaneous coronary intervention

BACKGROUND Although bilirubin is known to be an antioxidant,any relationship with coronary heart disease remains controversial.To the best of our knowledge,no previous study has investigated the association between bilirubin and perioperative myocardial infarction(PMI),including its long-term prognosis.AIM To investigate the impact of bilirubin levels on PMI in patients undergoing percutaneous coronary intervention(PCI),and long-term prognosis in post-PMI patients.METHODS Between January 2014 and September 2018,10236 patients undergoing elective PCI were enrolled in the present study.Total bilirubin(TB)and cardiac troponin I(cTnI)levels were measured prior to PCI and cTnI at further time-points,8,16 and 24 h after PCI.Participants were stratified by pre-PCI TB levels and divided into three groups:<10.2;10.2-14.4 and>14.4μmol/L.PMI was defined as producing a post-procedural cTnI level of>5×upper limit of normal(ULN)with normal baseline cTnI.Major adverse cardiovascular events(MACEs)included cardiac death,MI,stroke and revascularization during a maximum 5-year follow-up.RESULTS PMI was detected in 526(15.3%),431(12.7%)and 424(12.5%)of patients with pre-PCI TB levels of<10.2,10.2-14.4 and>14.4μmol/L(P=0.001),respectively.Multivariate logistical analysis indicated that patients with TB 10.2-14.4 and>14.4μmol/L had a lower incidence of PMI[TB 10.2-14.4μmol/L:Odds ratio(OR):0.854;95%confidence interval(CI):0.739-0.987;P=0.032;TB>14.4μmol/L:OR:0.846;95%CI:0.735-0.975;P=0.021]compared with patients with TB<10.2μmol/L.Construction of a Kaplan-Meier curve demonstrated a higher MACE-free survival time for patients with higher TB than for those with lower TB(log-rank P=0.022).After adjustment for cardiovascular risk factors and angiographic characteristics,multivariate Cox analysis showed that a TB level>14.4μmol/L was associated with a reduced risk of MACEs compared with a TB level<10.2μmol/L(hazard ratio 0.667;95%CI:0.485-0.918;P=0.013).CONCLUSION Bilirubin was a protective factor in PMI prediction.For post-PMI patients,elevated bilirubin levels were independently associated with a reduced risk of MACEs during long-term follow-up.

Effect of treatment course of comprehensive intervention with Traditional Chinese Medicine on mortality of acquired immunodeficiency syndrome patients treated with combined antiretroviral therapy

OBJECTIVE:To investigate the effect of a treatment course of comprehensive intervention with Traditional Chinese Medicine(TCM) on the mortality of patients with acquired immunodeficiency syndrome(AIDS) treated with combined antiretroviral therapy(c ART).METHODS:AIDS patients who had taken c ART in a national TCM human immunodeficiency virus treatment trial program(NTCMTP) before 2009 were enrolled in this study and followed for 36 months from November 2009.Patients enrolled in the NTCMTP in 2004 were taken as the first group,those enrolled in 2006 as the second group,and those enrolled in 2009 as the third group.Cumulative survival rates were calculated by the life table method.Survival curves for subgroups were compared by the log-rank test.Hazard ratios were calculated with a Cox proportional hazards model.RESULTS:A total of 1443 AIDS patients were followed for 3 years(4198 person-years).During this period,91(6.3%) patients died and 13(0.9%) were lost to follow-up.The total mortality rate was 2.17/100 person-years.The mortality rate of patients enrolled in the NTCMTP in 2004 was 1.49/100 person-years,which was lower than that of patients enrolled in 2006(2.23/100 person-years) and 2009(3.48/100 person-years).After adjusting for other factors,a shorter time of treatment with TCM,male sex,older age,lower CD4 + T-cell counts,and long-term treatment with c ART were risk factors of mortality.CONCLUSION:Long-term treatment with TCM decreased the mortality risk of AIDS patients.Factors such as being male,older age,CD4+ T-cell counts,and time of treatment with TCM and c ART were correlated with mortality.

Relationship between the Level of Serum Golgi Protein 73 and the Risk of Short-term Death in Patients with ALD-ACLF

Background and Aims:As a hepatocellular carcinoma biomarker,serum Golgi protein 73(GP73)is reportedly related to inflammation.Acute-on-chronic liver failure(ACLF)is characterized by severe systemic inflammation.In this study,we aimed to explore the association between the GP73 level and short-term mortality in patients with alcohol-associated liver disease-related ACLF(ALD-ACLF).Methods:This retrospective cohort study involved 126 Chinese adults with ALD-ACLF.Baseline serum GP73 level was measured using enzymelinked immunosorbent assay.Patients were followed-up for 90 d and outcomes were assessed.Data were analyzed using multivariate Cox regression and piecewise linear regression analyses.The predictive value of GP73 and classic models for the short-term prognosis of participants were evaluated and compared using receiver operating characteristic curves.Results:The serum GP73 level was independently associated with an increased mortality risk in patients with ALD-ACLF.Compared with the lowest tertile,the highest serum GP73 level predisposed patients with ALD-ACLF to a higher mortality risk in the fully adjusted model[at 28 days:hazard ratio(HR):4.29(0.99–18.54),p=0.0511;at 90 days:HR:3.52(1.15–10.79),p=0.0276].Further analysis revealed a positive linear association.GP73 significantly improved the accuracy of the Child-Turcotte-Pugh score,model for end-stage liver disease score,and model for end-stage liver diseasesodium score in predicting short-time prognosis of patients with ALD-ACLF.Conclusions:The serum GP73 level is a significant predictor of the subsequent risk of death in patients with ALD-ACLF.GP73 improved the predictive value of classic prognostic scores.