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 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.
ObjectiveTo summarize the experience of 4 patients with a great saphenous venous graft patency after 15 years of postoperitive great saphenous venous sequential aortic coronary artery bypass grafting. MethodWe retrospectively analyzed the clinical data of 4 patients accepted great saphenous vein aortic coronary artery bypass graft under moderate hypothermia cardiopulmonary bypass from November 1989 to December 1992 year. There were 3 males and 1 female with a mean age of 48.3 years ranging from 40-58 years. We harvested great saphenous vein under groin 45-50 cm. The proximal and distal anastomoses were performed with parachute technique under two clamps technique. Coronary artery bypass graft was performed by two sequential grafts routinely. Aspirin was given through nasal tube 6 hours after operation. The risk factors of arteriosclerosis were controlled by patients themselves after discharge. ResultFour patients received coronary angiography in 15, 16, 18, and 21 years after surgery and the grafts and both proximal and distal anastomoses were patent. The patients lived about 20 years without angina. Conclusioncarefully dealing with the vein graft, taking sequential bypass grafting to guarantee parabolic curve and meticulous anastomosis are preconditional and necessary for long-term patency.
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.
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.
Due to the competition of new drug research and clinical requirement, speeding up drug development and marketing requires faster and more flexible clinical trial design that meets the ethical requirements. Different adaptive designs have emerged in clinical trials of different stages and purposes, for trial efficiency improvement. Adaptive design is more widely used in the field of oncology. Compared with traditional design, adaptive design is more complicated and requires higher level of methodology from researchers. Therefore, implementing adaptive design requires careful consideration and adequate preparation. This paper aims to summarize the design of adaptive methods used in different trial stages so as to provide reference for clinical research designers and implementers.
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.
Objective To explore the feasibility and effectiveness of perforator propeller flap sequential transfer technique in repair of soft tissue defect of distal lower extremity. Methods Between July 2015 and July 2021, 10 patients with soft tissue defect of distal lower extremity were treated with perforator propeller flap sequential transfer technique. There were 8 males and 2 females, with a median age of 47 years (range, 6-71 years). The etiologies included malignant tumor in 5 cases, trauma in 3 cases, postburn scar contracture in 1 case, and diabetic foot ulcer in 1 case. The defects were located at the pretibial area in 1 case, the distal lower extremity and Achilles tendon in 3 cases, the dorsum of foot and lateral malleolar area in 4 cases, the heel in 1 case, and the plantar foot in 1 case. The size of the defect ranged from 5 cm×3 cm to 8 cm×8 cm. Peroneal artery perforator propellor flaps (the 1st flap) in size of 14 cm×4 cm to 29 cm×8 cm were used to repair the defects of distal lower extremity. The donor site defects were repaired with the other perforator propeller flaps (the 2nd flap) in size of 7 cm×3 cm to 19 cm×7 cm. The donor site of the 2nd flap was directly closed. ResultsAll the operations were successfully completed and all of the 2nd flaps were elevated within 1 hour. Eight the 1st flaps survived completely; 2 had venous congestion. Among the 2 patients with venous congestion, 1 had necrosis of the distal end of the flap, and the secondary wound was repaired by skin grafting; 1 recovered spontaneously after 7 days. The 2nd flaps totally survived. No complication such as hematoma or infection occurred. Primary closure was achieved in all the recipient and donor sites. All patients were followed up 2-39 months, with a median of 15.5 months. The color, texture, and thickness of the flaps matched well with those of recipient sites. The normal contour of the leg was preserved. During follow-up, no recurrence of malignance or ulcer was observed. The scar contracture was completely released. All patients were satisfied with the reconstructive outcomes. Conclusion The application of the perforator propeller flap sequential transfer technique can improve the repair ability of the lower extremity perforator propeller flap while ensuring the first-stage closure of the donor site, thereby improving the effectiveness.
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.
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.