ObjectiveTo explore the application of enhanced funnel plots (EFP) and trial sequential analysis (TSA) in robustness assessment of meta-analysis results.MethodsData were extracted from published meta-analysis. The EFP was used to evaluate the robustness of the significance and heterogeneity of the current meta-analysis. The TSA was used to judge the sufficiency of the cumulative sample size of the current meta-analysis and to assess the robustness of conclusions based on current evidence.ResultsThe EFP showed that the meta-analysis results of low-density lipoprotein (LDL) was robust, and the meta-analysis results of triglyceride (TG), total cholesterol (TC) and high-density lipoprotein (HDL) were not stable. The TSA showed that the cumulative sample size of LDL had reached the required information size (RIS), and the current conclusion was stable. The cumulative Z value of TG, TC and HDL neither reached the RIS nor passed through the TSA monitoring boundary or futility boundary, indicating that current conclusions were not robust.ConclusionsThe combination of EFP and TSA can make a comprehensive judgment on the robustness of current meta-analysis results, and provide methodological support in the robustness assessment of results for future systematic reviews and meta-analyses.
摘要:目的:探讨有机磷农药中毒患者阿托品使用方法,提高抢救成功率。方法: 对2005年6月至2009年6月我院收治的有机磷农药中毒病人281例进行分组,所有患者均使用阿托品疗法,A组为2007年以后132例序贯阿托品疗法患者,B组2007年以前为常规使用静推继之肌注阿托品疗法149例患者,根据有机磷农药对胆碱酯酶复能剂的疗效分为高效组和低效组,并结合病情严重程度共分为重度有机磷农药中毒胆碱酯酶复能剂高效组、重度有机磷农药中毒胆碱酯酶复能剂低效组,轻度有机磷农药中毒胆碱酯酶复能剂高效组、轻度有机磷农药中毒胆碱酯酶复能剂低效组4组,分别从达到阿托品化时间、维持阿托品化效果、反跳和中间综合征发生率、开始撤药平均时间、总住院费用、总住院平均时间、护士劳动强度进行总结和分析。结果: 维持阿托品化疗效Ａ组与B组间有显著差异,P值lt;0.01,开始撤药平均时间、总住院平均时间、总住院费用、护士劳动强度Ａ组与B组间均有差异,P值lt;0.05,发生反跳和中间综合征发生率、达到阿托品化时间在高效组间比较无差异,低效组间比较无差异,高效组与低效组比较有显著差异,P值lt;0.01,主要与中毒药物种类和病情严重程度有关,其次与阿托品治疗方法有关。 结论: 序贯阿托品疗法治疗有机磷农药中毒优于常规使用静推继之肌注阿托品疗法。Abstract: Objective: To discussion of atropine in organophosphorus pesticide poisoning patients with the use of two different methods to improve the success rate. Methods: For June 2005 to June 2009 inour hospital a total of organophosphorus pesticide poisoning 281 cases were divided into A group and B group, All patients were using atropine therapy, 132 cases of sequential therapy in patients with atropine is divided into A group, 149 cases of routine use of intravenous injection and intramuscular injection of atropine group patients were divided into B group, From the following aspects were analyzed and summarized, They are the maintenance of the effect of atropinization, the average time for the beginning of withdrawal, the total hospitalization costs, the total average time for hospitalization and nurses labor intensity. According to the organic phosphorus pesticide on the efficacy of cholinesterase agents are divided into efficient and inefficient groups groups, From the types of poisons, toxic ways, poisoning performance and Complications for stratified, They were divided into 4 groups, severe organophosphorus pesticide poisoning and cholinesterase reactivator can be highly effective group, severe organophosphorus pesticide poisoning and cholinesterase reactivator Lowefficacy group, mild organophosphorus pesticide poisoning and cholinesterase reactivator can be highly effective group, mild organophosphorus pesticide poisoning and cholinesterase reactivator Lowefficacy group, Correlation analysis Antijumping and the incidence of intermediate syndrome and atropinization time.Results:Maintain the efficacy of atropine of A group and B were significantly different between groups, Plt;0.01, the average time began to withdraw drugs, the total average time for hospitalization, total hospital charges, nursing labor intensity of A group and B are differences between the two groups, P＜0.05. Rebound occurs and the incidence of intermediate syndrome, to atropinization time high between the two groups showed no difference between the two groups showed no differences between inefficient and efficient group and inefficient group were significantly different, Plt;0.01, mainly related to poisoning by drug type and severity of illness, followed with atropine therapy. Conclusion:Atropine sequential therapy is superior to organophosphorus pesticide poisoning by conventional atropine treatmen.
The assumption of fixed-effects model is based on that the true effect of the each trial is same. However, the assumption of random-effects model is based on that the true effect of included trials is normal distributed. The total variance is equal to the sum of within-trial variance and between-trial variance under the random-effects model. There are many estimators of the between-trial variance. The aim of this paper is to give a brief introduction of the estimators of between-trial variance in trial sequential analysis for random-effects model.
ObjectiveTo investigate the effectiveness of debridement-vacuum sealing drainage (VSD)-modified external fixation antibiotic-impregnated cement semi-open technique in treatment of chronic ulcer wounds. MethodsClinical data of 43 patients with chronic ulcer wounds who met the selection criteria and admitted between January 2019 and June 2023 were retrospectively analyzed. Among them, 23 cases were treated with debridement-VSD-modified external fixation antibiotic-impregnated cement semi-open technique (improved group), and 20 cases were treated with debridement-VSD-traditional antibiotic-impregnated cement technique (control group). There was no significant difference in gender, age, constituent ratio of patients with type 2 diabetes mellitus, constituent ratio of patients with smoking history, body mass index, wound site, and other baseline data between the two groups (P>0.05). The healing quality and healing time, the positive rate of bacterial culture after bone cement coating, the loosening rate of bone cement, the number of operations, the number of hospitalizations, the length of hospitalization, and the cost of hospitalization were recorded and compared between the two groups. Results Compared with the control group, the positive rate of bacterial culture after bone cement coating and the loosening rate of bone cement in the improved group was significantly lower, as well as the number of operations, the number of hospitalizations, the length of hospitalization, and hospitalization cost significantly reduced (P<0.05). Wound repair was completed in both groups without amputation. The wound healing quality of the improved group was better than that of the control group and the wound healing time was shorter, the differences were significant (P<0.05). All patients were followed up 1-5 years (mean 3.4 years), and no ulcers recurred during follow-up. ConclusionDebridement-VSD-modified external fixation antibiotic-impregnated cement semi-open technique in the treatment of chronic ulcer wounds can effectively reduce the loosening rate of bone cement, facilitate the induced membrane formation and wound healing, and significantly reduce the number of operations and shorten the length of hospital stay.
ObjectiveTo systematically evaluate the efficacy of high-flow nasal cannula oxygen therapy (HFNC) in Post-extubation acute exacerbation of chronic obstructive pulmonary disease (AECOPD) patients. MethodsThe Domestic and foreign databases were searched for all published available randomized controlled trials (RCTs) about HFNC therapy in post-extubation AECOPD patients. The experimental group was treated with HFNC, while the control group was treated with non-invasive positive pressure ventilation (NIPPV). The main outcome measurements included reintubation rate. The secondary outcomes measurements included oxygenation index after extubation, length of intensive care unit (ICU) stay, mortality, comfort score and adverse reaction rate. Meta-analysis was performed by Revman 5.3 software. ResultA total of 20 articles were enrolled. There were 1516 patients enrolled, with 754 patients in HFNC group, and 762 patients in control group. The results of Meta-analysis showed that there were no significant difference in reintubation rate [RR=1.41, 95%CI 0.97 - 2.07, P=0.08] and mortality [RR=0.91, 95%CI 0.58 - 1.44, P=0.69]. Compared with NIPPV, HFNC have advantages in 24 h oxygenation index after extubation [MD=4.66, 95%CI 0.26 - 9.05, P=0.04], length of ICU stay [High risk group: SMD –0.52, 95%CI –0.74 - –0.30; Medium and low risk group: MD –1.12, 95%CI –1.56- –0.67; P<0.00001], comfort score [MD=1.90, 95%CI 1.61 - 2.19, P<0.00001] and adverse reaction rate [RR=0.22, 95%CI 0.16 - 0.31, P<0.00001]. ConclusionsCompared with NIPPV, HFNC could improve oxygenation index after extubation, shorten the length of ICU stay, effectively improve Patient comfort, reduce the occurrence of adverse reactions and it did not increase the risk of reintubation and mortality. It is suggested that HFNC can be cautiously tried for sequential treatment of AECOPD patients after extubation, especially those who cannot tolerate NIPPV.
ObjectiveTo investigate the clinical value of quick sequential organ failure assessment (qSOFA) score in predicting the outcome of patients with septic shock. MethodsWe collected the clinical data of 170 patients with septic shock treated in the Emergency Intensive Care Unit between January 2013 and January 2014. According to the 28-day outcomes of the patients, they were recorded as survival group and non-survival group. We calculated the qSOFA score, acute physiology and chronic health evaluation (APACHE)Ⅱ score on patients' admission. Using receiver operating characteristic (ROC) curve, we analyzed the qSOFA score, the effect of APACHE Ⅱ score in predicting the 28-day prognosis for patients with septic shock. The correlation between qSOFA score and APACHEⅡ score was also assessed. ResultsThe qSOFA and APACHEⅡ scores in non-survivors were higher than those in the survivors. According to ROC curve analysis, the area under the curve for qSOFA score and APACHE Ⅱ score was 0.666 and 0.791, respectively. For qSOFA score with 2 cut-off points to evaluate the prognosis of septic shock, the sensitivity was 62.7%, specificity was 61.1%, positive predictive value was 56.0%, negative predictive value was 67.4%, positive likelihood ratio was 1.61, and negative likelihood ratio was 0.61. For the APACHEⅡ score with 24 cut-off points to evaluate the prognosis of septic shock, the sensitivity was 70.7%, specificity was 80%, positive predictive value was 73.6%, negative predictive value was 67.3%, positive likelihood ratio was 3.54, and negative likelihood ratio was 0.37. The correlation coefficient of qSOFA score and APACHE Ⅱ score was 0.499. ConclusionThe qSOFA score is useful to evaluate the prognosis of the patients with septic shock early in Emergency Department.
Trial sequential analysis (TSA) could be performed in both TSA software and Stata software. The implementation process of TSA in Stata needs the command of "metacumbounds" of Stata combines with the packages of "foreign" and "ldbounds" of R software. This paper briefly introduces how to implement TSA using Stata software.
In recent years, investment in new drug development in China has surged; however, challenges such as difficulties in efficacy validation, high failure rates, and lengthy, costly clinical trials have been faced. The traditional model is insufficient for addressing these issues, necessitating innovation. Adaptive design (AD), particularly sequential multiple assignment randomized trials (SMART), has emerged as a flexible and efficient new pathway for drug development. This study focused on the two-stage design of SMART, analyzed its principles, and contrasted it with randomized controlled trials, group sequential designs, and crossover designs. The advantages of SMART are highlighted in terms of its precision in evaluating treatment strategies, minimizing sample waste, and enhancing the exploration of complex treatment pathways. Through case analyses, we demonstrated that SMART significantly improved clinical trial efficiency and the quality of treatment decisions, representing an innovative solution to the challenges of new drug development. This study aims to provide strategic references for clinical researchers and promote the adoption of adaptive designs in China, facilitating the efficient advancement of new drug development.
ObjectivesTo systematically review the association between the SIX6 gene rs10483727 mutation and primary open angle glaucoma (POAG).MethodsPubMed, Web of Science, The Cochrane Library, CNKI, WanFang Data and VIP databases were searched to collect case-control studies on the SIX6 gene rs10483727 polymorphism and primary open angle glaucoma from inception to December 28th, 2018. Two reviewers independently screened literature, extracted data and assessed the risk of bias of included studies. Meta-analysis was performed by Stata 12.0 software.ResultsSeventeen case-control studies in 16 papers were included, involving 9 886 patients and 19 663 controls. The results of meta-analysis showed that rs10483727 polymorphism in SIX6 gene was associated with the risk of POAG in the Asians and Caucasians. However, no association was found in the Africans.ConclusionsThe current evidence shows that rs10483727 polymorphism in SIX6 gene is associated with the risk of POAG in the Asians and Caucasians.
Objective To detect the false-negative results of cumulative meta-analyses of Cochrane Urology Group with the trial sequential analysis (TSA). Methods The Urology Group of The Cochrane Library (Issue 6, 2016) was searched to collect meta-analyses with negative results. Two researchers independently screened literature and extracted data of included meta-analyses. Then, TSA was performed using TSA software version 0.9 beta. Results A total of 11 papers involving 12 meta-analyses were included. The results of TSA showed that, four (33%) out of 12 meta-analyses were potentially false-negative results for failing to surpass the trial sequential monitoring boundary and to reach the required information size. Conclusion Some of the negative results of systematic reviews from Cochrane Urology Group was false-negative. TSA can help researchers to identify the false-negative results of meta-analyses.