ObjectiveTo investigate the socioeconomic benefits of enhanced recovery after surgery (ERAS) in perioperative period of selective laparoscopic cholecystectomy (LC) by prospective, randomized, controlled clinical study.MethodsA total of 90 patients were recruited in the Hetian Regional People’s Hospital from November 1, 2019 to December 25, 2019. PASS 11 software was used to calculate the sample size. They were grouped into an ERAS group and a tradition group by 1∶1 by random digital table. The patients in the ERAS and the tradition groups were treated with ERAS conception and traditional method respectively during the perioperative period. The postoperative hospitalization time, the first feeding time, the first getting out of bed time, and the first anal exhaust time after operation; the total hospitalization costs, intraoperative infusion, and postoperative total infusion; the intraoperative anesthesia intubation method, trocar layout, and operation time; the pain points of 6 h,12 h and 24 h after operation; the nausea and vomiting after operation; complications and re-hospitalization rate within 30 d after operation were compared between two groups.ResultsA total of 86 patients finally were included in the study, including 44 cases in the ERAS group and 42 cases in the tradition group. The basic data such as the gender, age, body mass index, etiology, blood routine, liver and kidney functions, etc. between the two groups were not statistically significant (P>0.05). Between the two groups, there were no significant differences in the intraoperative anesthesia intubation method, trocar layout, and operation time (P>0.05). Compared with the tradition group, the hospitalization time, the first feeding time, the first getting out of bed time, and the first anal exhaust time after operation were shorter (P<0.05); the total hospitalization costs, intraoperative infusion, and postoperative total infusion were less (P<0.05); the pain points of 6 h,12 h and 24 h after operation were lower (P<0.05); and the times of nausea and vomiting after operation were less (P<0.05) in the ERAS group. There were no complications such as the intraperitoneal bleeding, biliary leakage, and infection after operation, and no re-hospitalized patients within 30 d in both groups.ConclusionApplication of ERAS conception in selective LC perioperative period in Hetian Regional People’s Hospital of Xinjiang Uygur Autonomous Region cannot only shorten postoperative hospitalization time, reduce costs of hospitalization, help to overcome poverty, but also reduce occurrence of complications such as pain, nausea and vomiting, etc.
Objective To explore the feasibility and safety of non-gastrointestinal decompression after esophagectomy and the necessity of gastric tube or the time to remove gastric tube. Methods Thirty patients with esophageal cancer who underwent surgical treatment in the Department of Thoracic and Cardiovascular Surgery, Nanjing Drum Tower Hospital, were included in the trial from June to October 2017. The patients were randomly and equally assigned to a trial group (non-gastrointestinal decompression) or a control group (gastrointestinal decompression). There was no significant difference in age (P=1.000), sex (P=1.000), tumor location (P=0.732), pathological type (P=1.000), pathological stage (P=0.507), and operation time (P=0.674) between the two groups. The clinical effect between the two groups were compared. Results There was no statistical difference in incidences of anastomotic leakage (P=1.000), anastomotic bleeding (P=1.000), gastroesophageal reflux (P=1.000) between the two groups. And there was no statistical difference in time of the first flatus (P=0.629) and the first bowel movement (P=0.599) after operation between the two groups. Conclusion Without gastrointestinal decompression after Ivor Lewis esophagectomy does not increase the incidences of anastomotic leakage, anastomotic bleeding and gastroesophageal reflux, and has no significant effect on the recovery of gastrointestinal function. Without gastrointestinal decompression after Ivor Lewis esophagectomy is safe and feasible. Removing gastric tube on the second day after operation is reasonable and feasible.
ObjectiveTo investigate the efficacy and safety of multiple-dose intravenous tranexamic acid (TXA) for reducing blood loss in complex tibial plateau fractures with open reduction internal fixation by a prospective randomized controlled trial. MethodsA study was conducted on patients with Schatzker type Ⅳ-Ⅵ tibial plateau fractures admitted between August 2020 and December 2022. Among them, 88 patients met the selection criteria and were included in the study. They were randomly allocated into 3 groups, the control group (28 cases), single-dose TXA group (31 cases), and multiple-dose TXA group (29 cases), using a random number table method. There was no significant difference (P>0.05) in terms of age, gender, body mass index, the Schatzker type and side of fracture, laboratory examinations [hemoglobin (Hb), activated partial thromboplastin time (APTT), prothrombin time (PT), fibrinogen (Fib), international normalized ratio (INR), D-dimer, and interleukin 6 (IL-6)], and preoperative blood volume. The control group received intravenous infusion of 100 mL saline at 15 minutes before operation and 3, 6, and 24 hours after the first administration. The single-dose TXA group received intravenous infusion of 1 g TXA (dissolved in 100 mL saline) at 15 minutes before operation, followed by an equal amount of saline at each time point after the first administration. The multiple-dose TXA group received intravenous infusion of 1 g TXA (dissolved in 100 mL saline) at each time point. The relevant indicators were recorded and compared between groups to evaluate the effectiveness and safety of TXA, including hospital stays, operation time, occurrence of infection; the occurrence of lower extremity deep vein thrombosis, intermuscular vein thrombosis, and pulmonary embolism at 1 week after operation; the lowest postoperative Hb value and Hb reduction rate, the difference (change value) between pre- and post-operative APTT, PT, Fib, and INR; D-dimer and IL-6 at 24 and 72 hours after operation; total blood loss, intraoperative blood loss, hidden blood loss, drainage flow during 48 hours after operation, and postoperative blood transfusion. Results ① TXA efficacy evaluation: the lowest Hb value in the control group was significantly lower than that in the other two groups (P<0.05), and there was no significant difference between the single- and multiple-dose TXA groups (P>0.05). The Hb reduction rate, total blood loss, intraoperative blood loss, drainage flow during 48 hours after operation, and hidden blood loss showed a gradual decrease trend in the control group, single-dose TXA group, and multiple-dose TXA group. And differences were significant (P<0.05) in the Hb reduction rate and drainage flow during 48 hours after operation between groups, and the total blood loss and hidden blood loss between control group and other two groups. ② TXA safety evaluation: no lower extremity deep vein thrombosis or pulmonary embolism occurred in the three groups after operation, but 3, 4, and 2 cases of intermuscular vein thrombosis occurred in the control group, single-dose TXA group, and multiple-dose TXA group, respectively, and the differences in the incidences between groups were not significant (P>0.05). There was no significant difference in the operation time between groups (P>0.05). But the length of hospital stay was significantly longer in the control group than in the other groups (P<0.05); there was no significant difference between the single- and multiple-dose TXA groups (P>0.05). ③ Effect of TXA on blood coagulation and inflammatory response: the incisions of the 3 groups healed by first intention, and no infections occurred. The differences in the changes of APTT, PT, Fib, and INR between groups were not significant (P>0.05). The D-dimer and IL-6 in the three groups showed a trend of first increasing and then decreasing over time, and there was a significant difference between different time points in the three groups (P<0.05). At 24 and 72 hours after operation, there was no significant difference in D-dimer between groups (P>0.05), while there was a significant difference in IL-6 between groups (P<0.05). Conclusion Multiple intravenous applications of TXA can reduce perioperative blood loss and shorten hospital stays in patients undergoing open reduction and internal fixation of complex tibial plateau fractures, provide additional fibrinolysis control and ameliorate postoperative inflammatory response.
摘要:目的: 探讨益活清下法早期联用用丙氨酰谷氨酰胺二肽治疗重症急性胰腺炎(severe acute pancreatitis, SAP)的疗效。 方法 :依据纳入和排除标准,选取我院中西医结合科收治的SAP80例,按1︰1随机分成早期组(40例)和晚期组(40例),早期组入院时便应用丙氨酰谷氨酰胺二肽治疗;晚期组入院5 d后加用丙氨酰谷氨酰胺二肽治疗。 结果 :两组入院时Ranson评分、CT评分、APACHEⅡ评分无统计学差异(P ＞005),治疗15 d后早期组APACHEⅡ评分(497±239分)明显低于晚期组(863±357分)(P ＜001);两组并发ARDS、肾功能衰竭、休克、肝功能不全、心功能衰竭、脑病及肠麻痹的发生率无统计学差异(P ＞005);早期组ARDS、肾功能衰竭、休克、肝功能不全、脑病及肠麻痹持续时间及住院病程短于晚期组(P＜005 );早期组感染率、手术中转率及病死率低于晚期组(P＜005 )。 结论 :益活清下法早期应用丙氨酰谷氨酰胺二肽治疗SAP,可缩短并发症的持续时间及病程,降低病死率和手术中转率。Abstract: Objective: To compare the effects of integrated basal treatment of Chaiqin Chengqi Decoction with alanylglutamine Dipeptide giving in different times for sever acute pancreatitis. Methods : The randomized parallel control was adopted. 80 patients of SAP were randomized to earlytreated group (40 cases were treated by AlaGln as soon as who entered hospital) and latetreated group (40 cases were treated by AlaGln after 5 days from who had entered hospital). The mortality, incidences of complication, operation and mortality,the duration of complication and the course of diseases, hospitalization were compared. Results : The mortality shown that in earlytreated group was lower than the latertreated group, there was statistically significantly difference. Ranson score, CT score, Acute Physiology and Chronic Heath EvaluationⅡscore (APACHEⅡ score) and the incidences of complications were no statistical differencein the two groups(P ＞005)in the early stage of hospitalization. But the APACHEⅡ score (497±239)in earlytreated group was lower than those in latetreated group(863±357)after 15 days(P ＜001 The duration of acute respiratory distress syndrome(ARDS ),renal failure, shock, hepatic failure, encephalopathy and enteroplegia were shorter in earlytreated group than those in latetreated group(P＜005 . The incidence of infection, operation and mortality were lower in earlytreated group than those in latetreated group(P＜005 . The course of diseases of earlytreated group was shorter than that of latetreated group (P＜005 . Conclusion : SAP treated by (CQCQD) and AlaGln in early stage can shorten the duration of complications and the hospitalization period, and reduce the incidences of infection, operation rates and mortality rate.
Background Acute pancreatitis is one of the most severe acute abdominal conditions. Recently with the understanding of pathophysiology and pathogenesis of acute pancreatitis, cytokines, especially platelet-activating factor (PAF), have been shown to play an important role. Lexipafant is a potent inhibitor of PAF. It has shown exiting results in the animal experiments, so randomized controlled studies are needed to assess the impact of lexipafant for acute pancreatitis. Objectives To determine whether lexipafant can alter the course, prevent or treat organ failure and reduce mortality in acute pancreatitis. Search strategy Electronic databases were searched and reference lists from included studies were also handsearched. Published abstracts from conference proceedings and ten kinds of Chinese medical journals were handsearched for additional citations. Personal contaction with colleagues and experts in the field of pancreatitis was performed to identify potentially relevant trials. Selection criteria Randomized, controlled trials, In which participants went in hospital within 72 hours of belliache episode, comparing lexipafant to placebo or other interventions on organ failure rate or mortality of acute pancreatitis. Data collection and analysis Data related to the clinical outcomes were extracted by two reviewers independently, if there was any divarication, they would have a discussion. Main Results Three studies meet the inclusion criteria up to 2001. Compared with control group, lexipafant had the tendency of reducing the early deaths (odds ratio [OR] 0.56, 95% confidence interval [CI] 0.23 to1.38, P=0.2), accelerating the recovery of organ failure (OR 0.40, 95%CI 0.12 to 1.32, P=0.13) and reducing the occurrence of new organ failure OR 0.34, but these results had no statistical significance. A large-scale multicentre randomized controlled trial including 1 500 patients has been completed in America, but the result has not been published. Reviewers’ Conclusions Current evidence couldn’t draw the final conclusion. So the large-scale of randomized controlled trials is required.
Objective To evaluate the current situation of randomized controlled trials/ clinical controlled trials (RCT/CCT) on chronic gastritis and whether it could offer reliable evidence for clinical practice in China. Method RCT/CCT on chronic gastritis from eight Chinese clinical journals were searched manually and assessed according to international standard. Results 823 issues containing 213 therapeutic articles were searched and 81 RCT/CCT were identified and assessed. Conclusions The quantity and quality of RCT/CCT on Chronic gastritis in China could not meet the need of clinical practice. RCT/CCT of western medical therapy are much better than those of traditional Chinese therapy and integrated traditional Chinese and western medical therapy ones.
Objective To assess the efficacy and safety of fibfinogen-depleting agents (snake venom extracts) in the treatment of acute ischemic stroke. Method A systematic review of all the relevant randomized controlled trails (RCTs) was performed. RCTs were identified from the Cochrane Stroke Group’s Specialized Trials Register, additional electronic and handsearching, and personal contract with pharmaceutical companies. We included all completed and unconfounded truly or quasi-randomized trials in patients with ischemic stroke comparing fibrinogen depleting agents for analysis. Results Ten completed and one ongoing RCTs have been identified so far. Up to 1998, only three trials using ancrod (182 patients) met the inclusion criteria. Ancrod was associated with a significant reduction in early deaths (5.6% vs. 16%; odds ratio [OR], 0.33; 95% confidence interval [CI], 0.13 to 0.85; 2P=0.02) suggesting that treatment of 100 patients would avoid about 10 early deaths. The frequency of asymptomatic intracranial hemorrhage shown by computed tomography was similar between ancrod-treated and control groups (7.6% vs. 9.6%; OR 0.78; 95%CI 0.26 to 2.33; 2P=0.65). No major intracranial or extracranial hemorrhages or recurrent ischemic strokes occurred in the ancord-allocated patients. There were nonsignificant trends in favor of ancrod in death from any cause (OR 0.57; 95%CI 0.27 to 1.23; 2P=0.15) and death or disability (OR 0.52; 95%CI 0.26 to 1.03; 2P=0.06) at the end of trial follow-up. Up to 2000, other two trials published results. This review will be updated with new trial results soon, which will provide more data. Conclusions There were too few patients and outcome events to draw reliable conclusions from the present data. Although ancrod-like agents appeared promising, their routine use cannot be recommended at the moment. Future trials should test simpler fixed-dose regimens to allow better generalizability.
The Consolidated Standards of Reporting Trials (CONSORT) statement aims to enhance the quality of reporting for randomized controlled trial (RCT) by providing a minimum item checklist. It was first published in 1996, and updated in 2001 and 2010, respectively. The latest version was released in April 2025, continuously reflecting new evidence, methodological advancements, and user feedback. CONSORT 2025 includes 30 essential checklist items and a template for a participant flow diagram. The main changes to the checklist include the addition of 7 items, revision of 3 items, and deletion of 1 item, as well as the integration of multiple key extensions. This article provides a comprehensive interpretation of the statement, aiming to help clinical trial staff, journal editors, and reviewers fully understand the essence of CONSORT 2025, correctly apply it in writing RCT reports and evaluating RCT quality, and provide guidance for conducting high-level RCT research in China.
Objective To assess the effectivess and safety of Shenkang capsule in the treatment of chronic glomerulonephritis （Qiyinliangxu Syndrome）. Methods A double blind, double dummy and randomized controlled method was adopted. A total of 96 patients were randomized to the treatment group （Shenkang capsule, 2 capsules, twice a day） and the control group （Shenyankang capsule, 2 capsules, twice a day）. The therapeutic course for both groups was 2 months. Results All the results were analyzed on the basis of retention-to-treat（ITT） and per-protocol-population （PP）. For effect of chronic glomerulonephritis in the treatment group, the clinical control rates were 12.86% （9/70） with ITT analysis and 14. 75% （9/61） with PP analysis; the good improvement rates were 12. 86% （9/70） with ITT analysis and 14. 75% （9/61） with PP analysis; the total effective rates were 48. 58% （34/70） and 55.73% （34/61）. In the control group, the clinical control rates were 4. 17% （1/24） with ITT analysis and 5.00% （1/20） with PP analysis respectively; the good improvement rates were 4. 17% （1/24） with ITT analysis and 5.00% （1/20） with PP analysis respectively; the total effective rates were 45. 83% （11/24） with ITT analysis and 55.00% （11/20） with PP analysis. There was no statistical difference between the two groups （P〉0.05）. For Qiyinliangxu syndrome improvement, in the treatment group, the clinical control rate and good improvement rate were 18. 57% （13/70） with ITT analysis and 21.31% （13/61） with PP analysis respectively; the total effective rates were 81.43% （57/70） with ITT analysis and 93. 44% （57/61） with PP analysis respectively; In the control group, the clinical control rate and good improvement rate were 20. 84% （ 5/24 ） with ITT analysis and 25.00% （5/20 ） with PP analysis respectively; the total effective rates were 75. 00% （18/24） with ITT analysis and 85. 00% （17/20） with PP analysis respectively. The results showed no statistical difference between the two groups （P 〉0. 05）. No adverse effects were found. Conclusions No statistical difference was detected between Shengkang capsule and Shenyan capsule groups. No obvious toxic adverse effects were found.
In order to improve the understanding of pragmatic randomized controlled trial (pRCT), to promote high-quality implementation of such trials, and to provide technical guidance for researchers to conduct such trials scientifically, the working group of China REal world data and studies ALliance (ChinaREAL) hereby develop a technical guidance. The guidance provides technical specifications of pRCT in terms of the concept and scope of application, planning and study design, conduct, data management and quality control, statistical analysis, and ethical issues. It emphasizes that the trial sites and settings, patient population, interventions, controls, outcomes, follow-ups and other factors should be considered when planning and designing. Meanwhile, the guidance recommends that estimation of sample sizes for different types of trial designs should be based on individual pRCTs, and it also provides suggestions for data management, quality control, principles of statistical analysis, analysis requirements for each type of trial designs, and ethical considerations.