OBJECTIVE To analyze the occurrence characteristics and risk factors of adverse drug reactions （ADR） of gemcitabine for injection in national centralized volume-based procurement （hereinafter referred to as “centralized procurement”）， and provide reference for clinical safe drug use. METHODS A retrospective study was conducted to collect the relevant case reports of gemcitabine for injection reported to the National Adverse Drug Reaction Monitoring System by Inner Mongolia Autonomous Region from January 2022 to December 2023； basic information of patients， drug use status， patient outcomes， rational drug use and other information were collected， and the occurrence characteristics of ADRs with leukopenia， myelosuppression， neutropenia， thrombocytopenia and liver dysfunction were analyzed. Univariate analysis and multivariate Logistic regression were used to analyze the correlation of gender， age， combination of antitumor drugs， original malignant tumor and drug dose with ADR. RESULTS A total of 315 cases reports （315 patients） of gemcitabine-induced ADR were included in this study， with a male-to-female ratio of 1.42∶1 and age of （61.17±9.13） years. The primary malignant tumor was pancreatic cancer （73 cases， 23.17%）. Leukopenia， myelosuppression and nausea were the most common ADR， followed by neutropenia， thrombocytopenia， liver dysfunction and so on. The severity grade of ADR was mainly 1-2， and the outcome of most ADR was good. Multivariate Logistic regression analysis showed that combination of antitumor drugs was a risk factor for myelosuppression and neutropenia （RR＝2.154， 95%CI： 1.218- 3.807， P＝0.008； RR＝3.099， 95%CI： 1.240-7.744， P＝0.016）； gender （female） was a risk factor for leukopenia and liver dysfunction （RR＝0.508， 95%CI： 0.302-0.853， P＝0.010； RR＝0.301， 95%CI： 0.102-0.887， P＝0.029）. In terms of drug use rationality， there were 143 cases （45.40%） of drug 126.com use in accordance with the indications of the label， and 172 cases （54.60%） of off-label drug use. Among them， the primary malignant tumors were bladder cancer， bile duct cancer and ovarian cancer， which ranked the top three off-label drug use. CONCLUSIONS The ADR caused by gemcitabine in Inner Mongolia is mainly in the blood and digestive systems. The severity of ADRs is mainly classified as 1-2 levels， and most ADRs have good outcomes. Gender （female） and combination medication are risk factors for gemcitabine-induced ADR. Appropriate chemotherapy regimen should be selected according to the patient’s condition and physical condition， and ADR monitoring in blood and digestive systems should be strengthened during medication of gemcitabine.

Background: s/Aims: Non-invasive models stratifying clinically significant portal hypertension (CSPH) are limited. Herein, we developed a new non-invasive model for predicting CSPH in patients with compensated cirrhosis and investigated whether carvedilol can prevent hepatic decompensation in patients with high-risk CSPH stratified using the new model. Methods: Non-invasive risk factors of CSPH were identified via systematic review and meta-analysis of studies involving patients with hepatic venous pressure gradient (HVPG). A new non-invasive model was validated for various performance aspects in three cohorts, i.e., a multicenter HVPG cohort, a follow-up cohort, and a carvediloltreating cohort. Results: In the meta-analysis with six studies (n=819), liver stiffness measurement and platelet count were identified as independent risk factors for CSPH and were used to develop the new “CSPH risk” model. In the HVPG cohort (n=151), the new model accurately predicted CSPH with cutoff values of 0 and –0.68 for ruling in and out CSPH, respectively. In the follow-up cohort (n=1,102), the cumulative incidences of decompensation events significantly differed using the cutoff values of <–0.68 (low-risk), –0.68 to 0 (medium-risk), and >0 (high-risk). In the carvediloltreated cohort, patients with high-risk CSPH treated with carvedilol (n=81) had lower rates of decompensation events than non-selective beta-blockers untreated patients with high-risk CSPH (n=613 before propensity score matching [PSM], n=162 after PSM). Conclusions Treatment with carvedilol significantly reduces the risk of hepatic decompensation in patients with high-risk CSPH stratified by the new model.

Background: s/Aims: Non-invasive models stratifying clinically significant portal hypertension (CSPH) are limited. Herein, we developed a new non-invasive model for predicting CSPH in patients with compensated cirrhosis and investigated whether carvedilol can prevent hepatic decompensation in patients with high-risk CSPH stratified using the new model. Methods: Non-invasive risk factors of CSPH were identified via systematic review and meta-analysis of studies involving patients with hepatic venous pressure gradient (HVPG). A new non-invasive model was validated for various performance aspects in three cohorts, i.e., a multicenter HVPG cohort, a follow-up cohort, and a carvediloltreating cohort. Results: In the meta-analysis with six studies (n=819), liver stiffness measurement and platelet count were identified as independent risk factors for CSPH and were used to develop the new “CSPH risk” model. In the HVPG cohort (n=151), the new model accurately predicted CSPH with cutoff values of 0 and –0.68 for ruling in and out CSPH, respectively. In the follow-up cohort (n=1,102), the cumulative incidences of decompensation events significantly differed using the cutoff values of <–0.68 (low-risk), –0.68 to 0 (medium-risk), and >0 (high-risk). In the carvediloltreated cohort, patients with high-risk CSPH treated with carvedilol (n=81) had lower rates of decompensation events than non-selective beta-blockers untreated patients with high-risk CSPH (n=613 before propensity score matching [PSM], n=162 after PSM). Conclusions Treatment with carvedilol significantly reduces the risk of hepatic decompensation in patients with high-risk CSPH stratified by the new model.

Background: s/Aims: Non-invasive models stratifying clinically significant portal hypertension (CSPH) are limited. Herein, we developed a new non-invasive model for predicting CSPH in patients with compensated cirrhosis and investigated whether carvedilol can prevent hepatic decompensation in patients with high-risk CSPH stratified using the new model. Methods: Non-invasive risk factors of CSPH were identified via systematic review and meta-analysis of studies involving patients with hepatic venous pressure gradient (HVPG). A new non-invasive model was validated for various performance aspects in three cohorts, i.e., a multicenter HVPG cohort, a follow-up cohort, and a carvediloltreating cohort. Results: In the meta-analysis with six studies (n=819), liver stiffness measurement and platelet count were identified as independent risk factors for CSPH and were used to develop the new “CSPH risk” model. In the HVPG cohort (n=151), the new model accurately predicted CSPH with cutoff values of 0 and –0.68 for ruling in and out CSPH, respectively. In the follow-up cohort (n=1,102), the cumulative incidences of decompensation events significantly differed using the cutoff values of <–0.68 (low-risk), –0.68 to 0 (medium-risk), and >0 (high-risk). In the carvediloltreated cohort, patients with high-risk CSPH treated with carvedilol (n=81) had lower rates of decompensation events than non-selective beta-blockers untreated patients with high-risk CSPH (n=613 before propensity score matching [PSM], n=162 after PSM). Conclusions Treatment with carvedilol significantly reduces the risk of hepatic decompensation in patients with high-risk CSPH stratified by the new model.

Objective To construct a key technical indicator system for in-hospital treatment and nursing of patients with nuclear radiation injury, and provide a basis for the implementation of such treatment and nursing. Methods The draft of the key technical indicator system for in-hospital treatment and nursing of patients with nuclear radiation injury was determined by literature review, case study, and field investigation. The indicators of the system were determined through two rounds of Delphi consultation and using the precedence chart method. According to the criteria of indicator evaluation, the reliability of expert opinions, and the opinions of the research group, the indicators were refined and evaluated. Results Twenty experts were included for two rounds of consultation via mailed inquiries, with a 100% effective response rate in both rounds. The expert authority coefficients were both 0.945, and the Kendall’s W values were 0.347 and 0.448, respectively (P < 0.05). Following the expert consultations, 1 indicator was deleted, 12 indicators were added, and 6 indicators were modified. The key technical indicator system for in-hospital treatment and nursing of patients with nuclear radiation injury established in this study included 4 first-level indicators, 17 second-level indicators, and 73 third-level indicators. The means of importance assignment for all indicators were > 4.00, and the coefficients of variation were < 0.25. Conclusion The key technical indicator system for in-hospital treatment and nursing of patients with nuclear radiation injury established in this study is scientifically rigorous and practically grounded. The indicators demonstrate strong professional relevance and provide important guidance for in-hospital treatment and nursing of patients with nuclear radiation injury.

OBJECTIVE: To observe the clinical efficacy of electroacupuncture combined with ear tip bloodletting for insomnia with phlegm-fire disturbing heart. METHODS: A total of 60 cases with insomnia of phlegm-fire disturbing heart were selected, and the treatment of electroacupuncture combined with ear tip bloodletting was delivered. Acupuncture was applied at Yintang (GV24⁺), Shenting (GV24), Sishencong (EX-HN1) and bilateral Shenmen (HT7), Quchi (LI11), Zhaohai (KI6), Shenmai (BL62), Fenglong (ST40), Neiting (ST4), Yintang (GV24⁺) and Shenting (GV24) were connected to electroacupuncture, continuous wave, 2 Hz in frequency. In addition, bloodletting was applied at ear tip. The treatment was given for 4 weeks. Before treatment, and after 1,4 weeks into treatment, the scores of Pittsburgh sleep quality index (PSQI), Athens insomnia scale (AIS), insomnia severity index (ISI) and TCM syndrome were compared, and the clinical efficacy was evaluated in the patients. RESULTS: After 1,4 weeks into treatment, the scores of PSQI, AIS, ISI and TCM syndrome were decreased compared with those before treatment in the patients (P<0.05). Of 60 cases, 30 cases were cured, 19 cases markedly effective, 9 cases effective and 2 cases failed, and the total effective rate was 96.7% (58/60). CONCLUSION Electroacupuncture combined with ear tip bloodletting can improve the sleep quality and clinical symptoms in patients with insomnia of phlegm-fire disturbing heart.
Humans ; Male ; Female ; Electroacupuncture ; Middle Aged ; Sleep Initiation and Maintenance Disorders/physiopathology* ; Adult ; Bloodletting ; Acupuncture Points ; Aged ; Combined Modality Therapy ; Treatment Outcome ; Young Adult

BACKGROUND: Severe stroke has high rates of mortality and morbidity. This study aimed to investigate the clinical course, causes of worsening, and outcomes of severe ischemic stroke. METHODS: This prospective, multicenter cohort study enrolled adult patients admitted ≤30 days after ischemic stroke from nine hospitals in China between September 2017 and December 2019. Severe stroke was defined as a score of ≥15 on the National Institutes of Health Stroke Scale (NIHSS). Clinical worsening was defined as an increase of 4 in the NIHSS score from baseline. Unfavorable functional outcome was defined as a modified Rankin scale score ≥3 at 3 months and 1 year after stroke onset, respectively. We performed Logistic regression to explore baseline features and reperfusion therapies associated with clinical worsening and functional outcomes. RESULTS: Among 4201 patients enrolled, 854 patients (20.33%) had severe stroke on admission. Of 3347 patients without severe stroke on admission, 142 (4.24%) patients developed severe stroke in hospital. Of 854 patients with severe stroke on admission, 33.95% (290/854) experienced clinical worsening (median time from stroke onset: 43 h, Q1-Q3: 20-88 h), with brain edema (54.83% [159/290]) as the leading cause; 24.59% (210/854) of these patients died by 30 days, and 81.47% (677/831) and 78.44% (633/807) had unfavorable functional outcomes at 3 months and 1 year respectively. Reperfusion reduced the risk of worsening (adjusted odds ratio [OR]: 0.24, 95% confidence interval [CI]: 0.12-0.49, P  <0.01), 30-day death (adjusted OR: 0.22, 95% CI: 0.11-0.41, P  <0.01), and unfavorable functional outcomes at 3 months (adjusted OR: 0.24, 95% CI: 0.08-0.68, P <0.01) and 1 year (adjusted OR: 0.17, 95% CI: 0.06-0.50, P  <0.01). CONCLUSIONS: Approximately one-fifth of patients with ischemic stroke had severe neurological deficits on admission. Clinical worsening mainly occurred in the first 3 to 4 days after stroke onset, with brain edema as the leading cause of worsening. Reperfusion reduced the risk of clinical worsening and improved functional outcomes. REGISTRATION ClinicalTrials.gov , NCT03222024.
Humans ; Male ; Female ; Prospective Studies ; Ischemic Stroke/mortality* ; Aged ; Middle Aged ; Aged, 80 and over ; Stroke ; Brain Ischemia

This consensus will introduce the characteristics of fillers used in the surgical cavities of domestic nasal surgery patients based on relevant literature and expert opinions. It will also provide recommendations for the selection of cavity fillers for different nasal diseases, with chronic sinusitis as a representative example.
Humans ; Nasal Cavity/surgery* ; Nasal Surgical Procedures ; China ; Consensus ; Sinusitis/surgery* ; Dermal Fillers

Objective To systematically evaluate the incidence rate of low-level viremia(LLV)in chronic hepatitis B(CHB)patients and related influencing factors,and to provide evidence-based medicine evidence for effective intervention and prevention of LLV in clinical practice.Methods This study was conducted according to the PRISMA guideline,with a PROSPERO registration number of CRD42023455304.CNKI,Wanfang Data,VIP,SinoMed,PubMed,Embase,Web of Science,and the Cochrane library were searched for observational studies on LLV and related influencing factors in CHB patients published up to July 21,2023.Stata 16.0 software was used to perform the meta-analysis.Results A total of 12 articles were included,with a total sample size of 3408 cases,among whom there were 1181 patients with LLV.The meta-analysis showed that the incidence rate of LLV was 32.8%(95%confidence interval[CI]:27.6%—38.3%)in treatment-experienced CHB patients.High HBsAg quantification(odds ratio[OR]=2.107,95%CI:1.782—2.491,P<0.001),positive HBeAg(OR=3.258,95%CI:2.629—4.038,P<0.001),high HBV DNA level at baseline(OR=1.286,95%CI:1.157—1.430,P<0.001),and history of entecavir treatment(OR=3.089,95%CI:1.880—5.074,P<0.001)were risk factors for LLV;duration of antiviral therapy≥3 years(OR=0.175,95%CI:0.093—0.331,P<0.001)and high alanine aminotransferase level at baseline(OR=0.985,95%CI:0.978—0.992,P<0.001)were protective factors against LLV.The sensitivity analysis showed no significant change in effective value,suggesting that the results of the meta-analysis were relatively stable.The funnel plot of the studies included was basically symmetrical,and the results of the Egger's test and the Begg's test suggested that there was no obvious publication bias in the articles included.Conclusion Clinicians should guide decision making based on the influencing factors for LLV and related clinical evidence,so as to reduce long-term clinical risks and avoid adverse outcomes.

Objective To evaluate the application value of the three-point localization method in improving the quality and efficiency of four-chamber view acquisition in cardiac magnetic resonance(CMR)imaging.Methods A total of 215 patients who underwent four-chamber view in CMR imaging from January 2022 to October 2023 were retrospectively enrolled and divided into two groups.The control group(n=109)received traditional localization method while the study group(n=106)received three-point localization method.The image quality of mitral valve,tricuspid valve and cruciform structure in four-chamber view images were assessed by two radiologists using a Likert 4-piont scale.The time-consumption from scout imaging to the finish of four-chamber view imaging was recorded.Constituent data and numeral data were compared by Chi-square test and two-sample t test,respectively.Kappa test was used to analyze the inter-observer consistency.Results There were no significant inter-group differences in gender,age,disease profile,or the radiographers'experience.The mean quality scores of the mitral valve,tricuspid valve and cruciform structure in the control group and the study group were 3.44±0.64 and 3.63±0.49(P=0.023),3.43±0.67 and 3.53±0.60(P=0.202),3.71±0.49 and 3.83±0.35(P=0.047),respectively.The image quality score was higher in the study group than in the control group,with the differences in mitral valve and cruciform structure reaching statistical significance.The time-consumption for obtaining four-chamber view for the control group and the study group was 11.67±3.49 minutes and 7.212±1.83 minutes,respectively,with statistically significant differences(P＜0.001).Conclusion Compared with the traditional localization method,the three-point localization method provides better image quality in four-chamber view imaging with shortened imaging time.