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 evaluate the effectiveness of combining three-dimensional printing (3DP) models with three-dimensional visualization (3DV) technology in the teaching of thoracoscopic sublobar resection. Methods From March 2024 to June 2025, 150 interns were randomly assigned by envelope method to the 3DV, 3DP, and combined (3DV+3DP) groups. Three theoretical tests and score changes were used to assess short- and long-term teaching outcomes, and a questionnaire survey was conducted to analyze learning experience. Results After teaching, scores improved significantly in all groups (P<0.001), with the greatest increase in the combined group (47.18±5.81), which was higher than the 3DV and 3DP groups (P<0.001 and P=0.002, respectively). At 1 month, scores declined in all groups (P=0.028), but the combined group showed the smallest decrease (−6.94 ± 6.05). The combined group also showed the most pronounced advantage in spatial cognition (38.0%). Conclusion Innovative 3DP+3DV instructional model improves sublobar lung resection teaching and shows better long-term retention and spatial cognition.
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.
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.
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.
Objective To appraise the current situation of randomized controlled trials (RCTs) on information of common-used digestive-related medicines afforded by medicine-salesmen. Methods RCTs on digestive-related medicines were assessed according to clinical epidemiologic standard. Results 60 medicines containing 252 therapeutic articles were searched and 75 RCTs were identified and assessed. Conclusion The qualities and quantities of RCTs of information on digestive-related medicines were of large difference, the RCTs afforded by the joint pharmaceutical enterprises are much better than those of foreign ones and domestic ones.
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.
Objective To assess the effects and safety of vasodilators for sudden sensorineurial hearing loss (SSHL). Search strategy Electronic databases: MEDLINE from 1966, EMBASE from 1974, the Cochrane Controlled Trials Register, Chinese Bio-medicine Database from 1989. Hand search: Five kinds of Chinese otolaryngology journals were searched. Literature references were checked intensively. Selection criteria Randomized controlled trials comparing vasodilators with placebo or other drugs in patients with SSHL. Data collection and analysis At least two reviewers independently assessed trials quality and extracted data. Main results Thirteen trials with 1 155 patients were eligible and included in the systematic review. Ten of the trials were from developed countries and them were from P. R. China. None of the four trials showed that the effects of vasodilators were better than placebo for SSHL. None of the seven trials showed that the effects of one kind of vasodilators were better than that of the other vasodilators. Two trials showed that other drugs, such as batroxobin and hypaque,were probably better than some vasodilators (dextran, papaverine, 654-2, danshen). Eight trials reported the side effects of vasodilators, such as pruritus, allergy, etc. Reviewers’ conclusions Base on the systematic review of current eligible randomized controlled trials, there is no evidence to prove that vasodilator therapy is better than placebo or other therapies for SSHL, or the effects of one kind of vasodilator are better than that of the other vasodilators. We can’t draw a reliable conclusion about the effects of vasodilators for SSHL at the moment. And we must pay attention to their potential adverse reactions.
Objective To systematically evaluate the effectiveness and safety of Puerarin on diabetic peripheral neuropathy. Methods A systematic review and evaluation of all available relevant randomized or quasi-randomized controlled trials of Puerarin for diabetic peripheral neuropathy from Cochrane Controlled Trials Register (150 issue of 2003), Medline (1966-2003. 2), EMbase (1984-2001. 12. 4), and the Chinese Biological Medicine Database (1978-2003. 2) were performed. The selection of studies, data extraction, and assessment of methodological quality were performed independently by two reviewers. The following outcomes were assessed: effectiveness of clinical symptoms, sensory nerve and motor nerve conduction velocities, and severe adverse events of Puerarin. Results Ten randomized controlled clinical trials including 726 patients met the inclusion criteria. At the end of the treatment, compared to general treatment or vitamin B, Puerarin showed significant positive effects on the total effect rate of therapy and increased peripheral nerve conduction velocity. No severe adverse events were observed during the treatment period. However, most included trials show some degree of study design or analysis defect. Conclusions Our analysis suggests that Puerarin appears to be an effective and safe treatment for diabetic peripheral neuropathy. However, due to the low quality trials included in this review, more rigorously designed, randomized, double-blind, placebo-controlled trials of Puerarin for diabetic peripheral neuropathy are needed to further assess its usefulness in diabetes peripheral neuropathy patients.
Objective To review systematically whether there is enough existing evidence that methylcobalamin is effective and safe in the treatment of the patients with diabetic peripheral neuropathy.Methods A Cochrane systematic review of all relevant randomized or quasi-randomized controlled trials of methycobalamin for diabetic peripheral neuropathy was performed. Clinical trials were searched from Cochrane Controlled Trials Register (Issue 4, 2003), MEDLINE (January 1966 to January 2004), EMBASE (January 1980 to January 2004), the Chinese Biological Medicine Database (1978 to January 2004), the Chinese Science and Technology Journal Full-text Database (1989 to January 2004) and references of all included trials. The selection of studies, data extraction and assessment of methodological quality were performed independently by two reviewers. The following outcomes were assessed: effectiveness of clinical signs and symptoms, sensory nerve and motor nerve conduction velocities and serious adverse events of methylcobalamin. Results Thirty randomized clinical trials including 1 949 patients met the inclusion criteria. The quality of the most included trials was of low level. The "funnel plot" of the comparison of thirteen studies of methylcobalamin with other B Vitamins studies showed symmetry, which indicated less possible publication bias and the result was partly reliable, but it could not indicate the whole publication biases. The results of meta-analysis indicated that methylcobalamin showed significantly positive effects on the improvement of the signs and symptoms of peripheral neuropathy, and the effects were better than the other vitamin B agents. The increase of some nerves conduction velocities by methylcobalamin was better than by the other vitamin B. No serious adverse events were observed during the treatment period.Conclusions Methylcobalamin appears to be a safe and effective treatment on diabetic peripheral neuropathy. However, the evidence is not b because of the low quality of most trials. Rigorously designed, randomized, double-blinded, placebo-controlled trials of methylcobalamin for diabetic peripheral neuropathy are needed to further assess the effect.