ObjectiveTo systematically evaluate the outcomes of drug-eluting balloon (DEB) in treating coronary artery in-stent restenosis (ISR) by using meta-analysis and trial sequential analysis (TSA). MethodsWe searched PubMed, EMbase, The Cochrane Library（Issue 4, 2016）, CNKI, CBM, VIP and WanFang Data to collect randomized controlled trials (RCTs) regarding the treatment of ISR by DEB from inception to April 2016. After two reviewers independently screened citations, extracted data and assessed the bias risk of included studies, we carried out meta-analysis and TSA analysis by using RevMan 5.3 version and TSA v0.9 respectively. ResultsA total of 10 RCTs involving 1909 patients were included. Seven-hundred and forty-seven patients were included with regard to the comparison between DEB and POBA, 1162 patients were recruited to compare DEB and drug-eluting stents (DES). The results of meta-analysis revealed that DEB was associated with decreased mortality (OR=0.36, 95%CI 0.14 to 0.93, P=0.04), compared with that of plain old balloon angioplasty (POBA). And TSA showed that cumulative Z-curve strode the conventional threshold value but not the TSA threshold value which suggested a false positive result of meta-analysis. In comparison with that of POBA, DEB had a lower incidence of target lesion revascularization (TLR) (OR=0.16, 95%CI 0.07 to 0.38, P＜0.01). And the result of TSA displayed that the cumulative Z-curve strode both the conventional and TSA threshold value which validated the result of meta-analysis. Besides, the results of meta-analysis showed that there were no significant differences in mortality (OR=0.84, 95%CI 0.41 to 1.72, P=0.63) and TLR (OR=1.55, 95%CI 0.76 to 3.16, P=0.22) between DEB and DES. However, the result of TSA revealed that the cumulative Z-curve did not strode both the conventional and TSA threshold value, and the included sample size less was than required information size which suggested that the reliability of the meta-analysis needed more studies to confirm. While the subgroup analysis of EES revealed that DEB had a higher incidence of TLR than that of DEB (OR=3.37, 95%CI 1.59 to 7.15, P＜0.01). And the result of TSA displayed that the cumulative Z-curve strode both the conventional and TSA threshold value which validated the result of meta-analysis. ConclusionCurrent evidence shows, EES is superior to DEB in decreasing the incidence of TLR in patients with ISR, while DEB is superior to POBA. However, the comparison of DEB and other strategies on reducing of mortality in patients with ISR still needed more studies to prove.
ObjectiveTo systematically review the association between angiotension-converting enzyme (ACE) gene insertion/deletion (I/D) polymorphism and osteoarthritis (OA) by using meta-analysis and trial sequential analysis (TSA). MethodsThe PubMed, EMbase, CNKI, CBM, VIP, and WanFang Data were searched up to October 12th, 2016 for case-control or cohort studies on the correlation between ACE I/D polymorphism and OA risk. Two reviewers independently screened literature, extracted data and assessed the risk of bias of included studies. Then, meta-analysis and TSA analysis were performed using Stata 13.1 software and TSA v0.9 soft ware. ResultsA total of six case-control studies involving 1 165 OA patients and 1 029 controls were included. The results of meta-analysis showed that the ACE I/D was associated with OA risk (DD+DI vs. II: OR=1.72, 95%CI 1.02 to 2.90, P=0.04; DI vs. II: OR=1.65, 95%CI 1.06 to 2.56, P=0.03). Subgroup analysis of ethnicity showed that, in Caucasians, the ACE I/D was associated with OA risk (DD vs. DI+II: OR=2.10, 95%CI 1.54 to 2.85, P<0.01; DD+DI vs. II: OR=3.11, 95%CI 2.20 to 4.39, P<0.01; DD vs. II: OR=4.01, 95%CI 2.68 to 6.00, P<0.01; DI vs. II: OR=2.65, 95%CI 1.06 to 2.56, P<0.01; D vs. I: OR=2.11, 95%CI 1.72 to 2.58, P=0.73). And TSA showed that all of the cumulative Z-curve strode the conventional and TSA threshold value which suggested the result of the association between ACE I/D polymorphism and OA in Caucasians was very reliable. However, the association did not exist in Asians (DD vs. DI+II: OR=0.80, 95%CI 0.60 to 1.07, P=0.13; DD+DI vs. II: OR=1.08, 95%CI 0.87 to 1.35, P=0.49; DD vs. II: OR=0.86, 95%CI 0.62 to 1.20, P=0.38; DI vs. II: OR=1.18, 95%CI 0.93 to 1.50, P=0.19; D vs. I: OR=0.93, 95%CI 0.83 to 1.14, P=0.73). And the results of TSA displayed that all of the cumulative Z-curve did not strode both TSA threshold value and required information size line excepting for DD vs. DI+II genetic model which suggested that the sample-size in Asians was insufficient. ConclusionsThe ACE D allele maybe a risk factor for OA in Caucasians. However, the association between ACE I/D polymorphism and OA risk in Asians still need more studies to prove.
ObjectiveTo compare the effectiveness of sequential method pure single-port lumpectomy-breast conserving surgery (SMPSL-BCS) in treating early-stage breast cancer patients with tumors in different quadrants. Methods A retrospective analysis was conducted on 200 early-stage breast cancer female patients admitted between January 2023 and December 2023. According to the quadrant where the tumor was located, the patients were allocated into the upper outer quadrant group (UO group), lower outer quadrant group (LO group), upper inner quadrant group (UI group), and lower inner quadrant group (LI group), with 50 cases in each group. There was no significant difference (P>0.05) in the baseline data, including age, body mass index, smoking history, marital status, comorbidities, affected breast side, maximum tumor diameter on ultrasound, maximum pathological tumor diameter, clinical tumor stage, molecular subtype, and disease duration. The operation time, intraoperative blood loss, postoperative drainage volume, and extubation time were recorded and compared between groups. Additionally, the occurrence of early-stage complications (1-3 months after operation; including subcutaneous fluid accumulation, incision infection, superficial skin burns) and late-stage complications (>3 months after operation; including pectoralis major muscle adhesion, changes in breast appearance and shape, sensory discomfort) were assessed. At 6 months after operation, the cosmetic outcome of breast-conserving surgery was rated for all groups. Results The UO group had the shortest operation time, followed by the UI group, LO group, and LI group, showing significant differences between groups (P<0.05). The UO group had the least intraoperative blood loss, followed by the LO group, UI group, and LI group; except for the difference between UO group and LO group, which was not significant (P>0.05), the differences between the other groups were significant (P<0.05). The UO group had the least postoperative drainage volume, followed by the LO group, UI group, and LI group; except for the difference between LO group and UI group, which was not significant (P>0.05), the differences between the other groups were significant (P<0.05). The extubation time of the LI group was significantly longer than that of the other groups (P<0.05). All patients were followed up 4-12 months, with an average of 8 months. And 193 patients were followed up more than 6 months, including 48 patients in UO group, 47 in LO group, 49 in UI group, and 49 in LI group. In the early-stage period, the LI group had a higher incidence of subcutaneous fluid accumulation after tube removal compared to the UO group and LO group (P<0.05), while there was no significant difference in the incidences of other early complications between groups (P>0.05). In the late-stage period, the LI group had significantly higher incidences of pectoralis major muscle adhesion and changes in breast appearance and shape than UO group and LO group (P<0.05), and a significantly higher incidence of sensory discomfort than UO group (P<0.05). There was no significant difference in the incidences of other late-stage complications between groups (P>0.05). At 6 months after operation, the cosmetic outcomes of breast-conserving surgery were significantly better in UO group, LO group, and UI group than in LI group (P<0.05); there was no significant difference between the other groups (P>0.05). Conclusion In the treatment of early-stage breast cancer using SMPSL-BCS, patients with tumors located in the upper outer quadrant show the best effectiveness. The effectivenesses are similar for patients with tumors in the lower outer and upper inner quadrants. However, patients with tumors in the lower inner quadrant do not experience significant advantages. Therefore, it is recommended that SMPSL-BCS should not be the first-choice surgical method for patients with tumors in the lower inner quadrant.
The robustness of results of statistical analysis would be altered on the condition of repeated update of traditional meta-analysis and cumulative meta-analysis. In addition, the cumulative meta-analysis lacks estimation of the sample size. While trail sequential analysis (TSA), which introduces group sequential analysis in meta-analysis, can adjust the random error and ultimately estimate the required sample size of the systematic review or meta-analysis. TSA is performed in TSA software. In the present study, we aimed to introduce how to use the TSA software for performing meta-analysis.
Objective To explore the effect of sequential nutritional intervention mode on improving early postoperative nutritional status in patients with gastric cancer. Methods A total of 30 patients who underwent radical gastrectomy for gastric cancer in the Department of Gastrointestinal Surgery, Ningbo No.2 Hospital between June and August 2022 were selected as the tiral group by convenience sampling, and another 30 patients who underwent radical gastrectomy for gastric cancer between September 2021 and January 2022 were retrospectively selected as the control group. The trial group received the sequential nutritional intervention model constructed by quality control circle activities in the Department of Gastrointestinal Surgery, and the control group received routine nutritional support. The nutritional status and quality of life of the two groups were evaluated one month after discharge. Results Before intervention, there was no statistically significant difference in the Patient-Generated Subjective Global Assessment (PG-SGA) score, serum albumin, serum prealbumin, body weight, or Quality of Life Questionnaire Core 30 (QLQ C30) score between the two groups (P>0.05). After intervention, both groups showed improvements in PG-SGA score, serum albumin, and serum prealbumin compared to before intervention (P<0.05); there was no significant change in body weight in the trial group (P>0.05), while the control group experienced a decrease in body weight (P<0.05); the trial group showed an improvement in QLQ C30 score (P<0.05), whereas the control group did not show significant change in QLQ C30 score (P>0.05). Compared to the control group after intervention, the trial group showed better PG-SGA score (7.97±1.65 vs. 8.83±1.26), serum albumin level [(40.61±1.30) vs. (39.93±0.78) g/L], serum prealbumin level [(0.266±0.030) vs. (0.229±0.051) g/L], body weight [(63.12±7.39) vs. (58.17±9.18) kg], and QLQ C30 score (62.63±9.01 vs. 57.23±7.13), with all differences being statistically significant (P<0.05). Conclusion Sequential nutritional intervention model is helpful to improve the early nutritional status and quality of life of patients after radical gastrectomy, and has clinical promotion value.
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.
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 summarize the treatment outcomes of antegrade sequential anastomosis of great saphenous veins in off-pump coronary artery bypass grafting for coronary atherosclerotic heart disease. Methods A total of 116 patients with coronary atherosclerotic heart diseases underwent off-pump coronary artery bypass grafting from January 2013 to June 2015 in our hospital. There were 63 males and 53 females with a mean age of 42–80 (64.26±9.67) years. Left internal mammary artery was anastomosed to left anterior descending artery. The rest of the target vessels received antegrade sequential anastomosis of great saphenous veins with the order of proximal ascending aorta, diagonal branch, circumflex branch, obtuse marginal branch, left ventricular branch and posterior descending artery. Results All patients were performed off-pump coronary artery bypass grafting successfully without death or perioperative myocardial infarction. A total of 436 grafts were adopted with 3.75±0.53 in each patient. Three patients suffered low cardiac output syndrome, and were cured after administration of vasoactive drugs combined with the intra-aortic balloon pump. One patient suffered tardive pericardial tamponade and one acute renal failure, who were cured with disappearance of angina symptoms and increase of activities without discomfort. Conclusion Antegrade sequential anastomosis, as a safe and effective method, can reduce aortic stoma, save the length of grafts, shorten operative time and quickly restorate blood supply of myocardium in off-pump coronary artery bypass grafting.
ObjectiveTo evaluate the short- and mid-term outcomes of sequential anastomosis and simple anastomosis of saphenous vein in off-pump coronary artery bypass grafting.MethodsThe clinical data of 438 patients who underwent sequential anastomosis of saphenous vein and 165 patients who underwent simple anastomosis of saphenous vein from 2015 to 2018 in Daxing Teaching Hospital were retrospectively analyzed. After propensity score matching, 130 pairs of patients were included in the sequential anastomosis group [78 males and 52 females, aged 60 (52, 68) years] and simple anastomosis group [80 males and 50 females, aged 61 (52, 70) years]. The short- and mid-term clinical outcomes were compared.ResultsThe two propensity score-matched groups had similar baseline clinical data. No significant difference was found between sequential anastomosis and simple anastomosis groups in the in-hospital outcomes, including in-hospital death (1.5% vs. 1.5%, P=1.000), the incidence of complications (4.6% vs. 6.2%, P>0.05), and the mean flow of grafts (30.0±11.8 mL/min vs. 28.0±9.5 mL/min, P=0.597). The operation time of the sequential anastomosis group was shorter than that of the simple anastomosis group (142.5±21.2 min vs. 186.3±27.6 min, P<0.001). The drainage of the sequential anastomosis group was less than that of the simple anastomosis group (204.7±39.6 mL vs. 271.3±48.3 mL, P<0.001). The follow-up time was 12-60 (28.3±8.9) months, during which the mortality of the two groups was not statistically different (3.2% vs. 4.0%, P=0.796).ConclusionThe saphenous vein sequential anastomosis of saphenous vein is superior to the simple anastomosis. Sequential anastomosis technique can reduce aortic anastomosis, shorten operation time, and reduce bleeding drainage during off-pump coronary artery bypass grafting. The short- and mid- term clinical effects are satisfactory.
Cumulative meta-analysis could help researchers to justify the effectiveness of the intervention and whether the obtained evidence is sufficient. However, the process of the meta-analysis does not adjust the repeated testing of the null hypothesis and neither quantifies the statistical power. The sequential meta-analysis has solved the aforementioned problems and has been widely used in the clinical practice and decision-making. Currently several methods of sequential meta-analysis have been proposed and these methods differ from each other. Of which, the methodology of trial sequential (TSA) is well developed and corresponding performance is relatively easy; the methodology of double-triangular test of Whitehead is lagged than TSA and its performance is relatively difficult; the approach of semi-Bayes refers to the theory of Bayes and it's very difficult to generalize. Our paper aimed to give a brief introduction of the methodology of the sequential meta-analysis.