ObjectiveTo evaluate the efficacy and safety of Xueshuantong combined with conventional western medicine for angina pectoris in coronary heart disease (CHD) patients. MethodsWe searched the Cochrane Library (2013.12), Medline (2013.10), EMbase (unlimited-2013.10), China Nation Knowledge Infrastructure (unlimited-2013.10) and the Wanfang Database (unlimitied-2013.10), Weipu Database (unlimited-2013.10), and CBM (unlimited-2013.10) on computers for parallel group randomized controlled trials (RCTs) comparing Xueshuantong and placebo for patients with angina pectoris. Three researchers selected the trials based on the inclusion and exclusion criteria and then extracted the data, assessed the quality of each trial independently. After cross checking, the Cochrane Collaboration's RevMan 5.1 software was used to perform Meta-analysis. ResultsThirteen RCTs and a total of 1 298 participants were involved. Meta-analysis showed that Xueshuantong combined with the conventional western medicine had better curative effect on angina pectoris for CHD than conventional therapy; stable angina pectoris [RR=1.24, 95%CI (1.12, 1.37), P<0.000 1]; unstable angina pectoris [RR=1.22, 95%CI (1.15, 1.29), P<0.000 01]. There was also significant difference in total curative effect between the two groups [RR=1.22, 95%CI (1.16, 1.29), P<0.000 01]. Xueshuantong also had better curative effect on improving performance of electrocardiogtram (ECG): stable angina pectoris [RR=1.30, 95%CI (1.11, 1.51), P=0.000 8]; unstable angina pectoris [RR=1.18, 95%CI (1.10, 1.28), P<0.000 1]. There was also significant difference in total curative effect on improving performance of ECG between the two groups [RR=1.21, 95%CI (1.13, 1.29), P<0.000 01]. But there was no significant difference in adverse effects rate between the two groups [RR=4.50, 95%CI (0.99, 20.53), P=0.05]. ConclusionCompared with conventional therapy, Xueshuantong combined with conventional western medicine has better curative effect with improved performance of ECG. The adverse effect rate between the two groups is not significantly different. But because of the small scale, inferior quality, and bias risk of these trials, large-scale, rational designed, multicenter RCTs are needed to confirm our conclusions.
Objective To assess the efficacy and safety of Shenmai injection for children with viral myocarditis. Methods All randomized and quasi-randomized controlled trials (RCTs and quasi-RCTs) of Shenmai injection for children with viral myocarditis were searched from CBM (1981 to November 2009), CNKI (1980 to November 2009) and VIP (1989 to November 2009), The Cochrane Library (Issue 1,2010), PubMed (1966 to 2009), EMbase (1966 to 2009). Cochrane systematic reviews Handbook 5.0.1 was taken as a reference to quality evaluation of the included studies, and the Cochrane Collaboration’s RevMan 5.0 software was used for data analyses. Results A total of 15 RCTs were included. The quality of the included trials was low. The result of meta-analyses showed that: (1) The effective rate (RR 1.16, 95%CI 1.07 to 1.25) and the ECG improvement rate (RR 1.55, 95%CI 1.25 to 1.93) in Shenmai injection group were better than those in the control group. CK and CK-MB in Shenmai injection were lower than those in the control group, but the AST level was similar in the two groups. (2) The effective rate (RR 1.12, 95%CI 1.01 to 1.25) and the ECG improvement rate (RR 1.35, 95%CI 1.07 to 1.70) in Shenmai injection group were better than those in the western medicine plus routine therapy (RT) group. CK, AST and LDH in Shenmai injection group were lower than those in the western medicine plus RT group, but CK-MB was similar in the two groups. (3) The effective rate (RR 1.26, 95%CI 1.12 to 1.42) in Shenmai injection plus RT and western medicine group was better than that in RT and western medicine group. CK and LDH-1 in Shenmai injection plus RT and western medicine group were lower than those in RT and western medicine group. Adverse reactions of Shenmai injection in 4 studies included mild rash, rubicundity and chest distress. No severe adverse reactions were reported. Conclusion The evidence currently available shows that Shenmai injection may have some effect on children with viral myocarditis, including improving the effective rate, reducing myocardial enzymes and improving the ECG improvement rate. However, because of the low methodological quality of the included trials, this conclusion needs to be interpreted cautionsly, and more well-designed, high-quality RCTs need to be performed.
Objective To explore the influence of different withdrawal time of trachea cannula on percutaneous dilational tracheostomy (PDT) in critically ill patients. Methods In this study, we retrospectively analyzed the clinical data of 185 critically ill patients experienced PDT, who had been admitted to the adult mixed ICU of Xiaolan Hospital of Southern Medical University from January 2015 to July 2017. The patients were divided into an early PDT group (EPDT group) and a delayed PDT group (DPDT group) according to the timing of withdrawing trachea cannula. Operation information such as operation time, blood loss and the incidence of complications were collected and compared between the two groups. Results Between the EPDT group and the DPDT group, there were no obvious differences in operation time (minutes: 6.5±2.6 vs. 7.3±3.5), amount of blood loss (ml: 5.2±2.8 vs. 6.0±3.4) or conversion to traditional operation (1.9% vs. 2.4%) (all P>0.05). Compared with the EPDT group, the DPDT group patients experienced more fluctuation of intraoperative vital signs, used more dose of sedative and analgesic drugs, and experienced higher occurrence of aspiration (18.3%vs. 5.6%), balloon burst (13.4% vs. 2.9%), guide-wire placing difficulty (11.0% vs. 1.9%) and tracheostomy cannula placing difficulty (14.6% vs. 2.9%) (all P<0.05). There were no statistical significances in postoperative complications such as postoperative-hemorrhage, pneumothorax, pneumoderm, the posterior tracheal injury or incision infection between the two groups (allP<0.05). More patients acquired postoperative pulmonary infection in the DPDT group than the EDPD group (12.2%vs. 5.8%, P>0.05), and there was no statistical significances in mechanical ventilation time between the two groups (days: 5.5±3.0vs. 6.0±2.5, P>0.05). Conclusions The operation and complications of PDT in critically ill patients are influenced by the timing of withdrawing trachea cannula. The standard procedure of withdrawing trachea cannula preoperatively may offer better clinical operability and lower technical risk.
Interpretation of the complete scientific connotation of functional foods accurately prior to approval and registration based on animal tests and small sample size human food tests is challenging. Further technical evaluation after market introduction should be carried out on safety, health function and other aspects of those widely used commercial scale production products. According to the analysis report on the consumption situation of post-marketing population submitted when applying for product registration extension since the implementation of the functional food registration and filing management measures more than 3 years ago, the post-marketing evaluation report of functional food still lacks systematic and perfect evidence support. Based on the successful experience of evidence-based medicine and post-marketing evaluation evidence, this paper analyzes the post-marketing evaluation content, evidence source construction, evidence classification and classification of functional food, and puts forward the preliminary idea of constructing post-marketing evaluation evidence body of functional food safety and health function technology from multiple view points, so as to provide insights into evidence system research in this field in the future.
This article introduces the measures that the scientific research base of West China Hospital has taken in its emergent response to the unexpected huge Wenchuan earthquake disaster, including safe evacuation, safety examination and removal of hidden dangers, damage reporting and a series of subsequent measures.
ObjectiveTo evaluate donor safety in living donor liver transplantation. MethodsThe clinical data of 356 donors underwent living liver donation in our center from January 2001 to September 2015 were retrospectively analyzed. These patients were divided into pre-2008 group(before January 2008) and post-2008 group(after January 2008). The donor safety was evaluated with regard to three aspects, i.e. complications, liver function, and quality of life. Results①There was no donor death in our center.②The overall complications rate was 23.3%(83/356). The proportion of ClavienⅠ, Ⅱ, Ⅲ, andⅣcomplications was 50.6%(42/83), 26.5%(22/83), 21.7%(18/83), and 1.2%(1/83), respectively. In all the donors, the incidence of ClavienⅠ, Ⅱ, Ⅲ, andⅣcomplications was 11.8%(42/356), 6.2%(22/356), 5.1%(18/356), and 0.3%(1/356), respectively. The overall complications rate in the post-2008 group was significantly lower than that in the pre-2008 group〔18.1%(41/227) versus 32.6%(42/129), P < 0.01〕. The most common complication was the biliary complication with an incidence of 8.4%(30/356).③The postoperative liver dysfunction was transient and generally retur-ned to normal level within a week.④The donor's quality of life was generally satisfied as assessed by the SF-36 tool, and 94.8%(239/252) of them would donate again if necessary. ConclusionEver improving surgical and anesthetic techniques, together with strict donor selection and specialized perioperative management, could guarantee a low donor morbidity and a satisfactory long-term prognosis.
Objective To systematically review the efficacy and safety of different SGLT2 inhibitors in the treatment of heart failure. Methods The Cochrane Library, Web of Science, PubMed and EMbase databases were searched for randomized controlled trials on the efficacy and safety of SGLT2 inhibitors in patients with heart failure from inception to July 2, 2021. Two researchers independently screened literature, extracted data and evaluated the risk of bias of the included studies. Network meta-analysis was then performed using Stata 16.0 software. Results A total of 16 randomized controlled trials, including 15 312 patients, involving 5 interventions, namely dapagliflozin, empagliflozin, canagliflozin, sotagliflozin and ertugliflozin were included. Results of network meta-analysis showed that there was no significant difference in the compound outcome of hospitalization for heart failure or cardiovascular death, hospitalization for heart failure, all-cause mortality, risk of cardiovascular mortality and serious adverse reactions among patients with heart failure among 5 different SGLT2 inhibitors (P>0.05). Compared with placebo, both selective and non-selective SGLT2 inhibitors improved the risk of hospitalization for heart failure, hospitalization for heart failure, or compound cardiovascular mortality (P<0.05), while only selective SGLT2 inhibitors improved the risk of cardiovascular mortality, all-cause mortality, and serious adverse events (P<0.05). However, there was no significant difference between them (P>0.05). The area under the cumulative ordering probability curve of selective and non-selective SGLT2 inhibitors ranked first and second, except for the combined outcome of heart failure or cardiovascular death. Conclusion The current evidence indicates that there is no significant difference in the efficacy and safety of the 5 different SGLT2 inhibitors in the treatment of heart failure, and there is no significant difference between selective SGLT2 inhibitors and non-selective SGLT2 inhibitors. Due to the limited quantity and quality of included studies, more high-quality studies are needed to verify the above conclusion.
ObjectivesTo systematically review the efficacy and safety of oral drugs for treating women with uncomplicated lower urinary tract infection.MethodsPubMed, The Cochrane Library, EMbase, CBM, WanFang Data, CNKI and VIP databases were electronically searched to collect randomized controlled trials (RCTs) of oral drugs for treating females with uncomplicated lower urinary tract infection from inception to November, 2018. Two reviewers independently screened literature, extracted data and assessed risk of bias of included studies, then, network meta-analysis was performed by using " gemtc” packages in R 3.5.1 software.ResultsA total of 38 RCTs were included. The results of network meta-analysis showed that: quinolones (RR=1.24, 95%CI 1.11 to 1.37), furantoin (RR=1.21, 95%CI 1.06 to 1.37), trimethoprim-sulfamethoxazole (TMP-SMZ) (RR=1.20, 95%CI 1.06 to 1.35), fosfomycin (RR=1.17, 95%CI 1.04 to 1.31) and penicillin (RR=1.18, 95%CI 1.05 to 1.33) were superior to non-steroidal anti-inflammatory drugs (NSAIDS) in clinical cure. Quinolones were better than fosfomycin (RR=1.07, 95%CI 1.03 to 1.12), penicillin (RR=1.18, 95%CI 1.13 to 1.23) and cephalosporin (RR=1.13, 95%CI 1.08 to 1.19); furantoin was better than penicillin (RR=1.15, 95%CI 1.08 to 1.21) and cephalosporin (RR=1.10, 95%CI 1.04 to 1.17); TMP-SMZ was better than penicillin (RR=1.15, 95%CI 1.09 to 1.21) and cephalosporin (RR=1.11, 95%CI 1.04 to 1.16); fosfomycin was better than penicillin (RR=1.10, 95%CI 1.04 to 1.16) in bacteriological cure. The adverse effect rates of quinolones were lower than furantoin (RR=0.83, 95%CI 0.70 to 0.98), TMP-SMZ (RR=0.88, 95%CI 0.78 to 0.99) and fosfomycin (RR=0.74, 95%CI 0.59 to 0.93), and which of fosfomycin was higher than penicillin (RR=1.33, 95%CI 1.01 to 1.74) and NSAIDS (RR=1.46, 95%CI 1.11 to 1.92). All differences were statistically significant.ConclusionsCurrent evidence shows that uncomplicated lower urinary tract infection should be recommended to therapy containing quinolones. Due to limited quality and quantity of included studies, more high-quality studies are required to verify the above conclusion.
ObjectiveTo systematically review the efficacy and safety of laryngeal mask versus endotracheal tubes for laparoscopic surgery.MethodsPubMed, EMbase, The Cochrane Library, CNKI, WanFang Data and CBM databases were electronically searched to collect the randomized controlled trials (RCTs) about the efficacy and safety of laryngeal mask versus endotracheal tubes for laparoscopic surgery from inception to April, 2017. Two reviewers independently screened literature, extracted data and assessed the risk of bias of included studies. Then meta-analysis was performed by using RevMan 5.3 software.ResultsA total of 16 RCTs involving 1 593 patients were included. The results of meta-analysis showed that: there was no significant difference in the success rate of the first insertion (RR=0.99, 95%CI 0.96 to 1.02, P=0.55). The airway pressure of patients whose position were head higher than foot was significantly lower in the laryngeal mask group than in the tracheal intubation group (MD=–1.20, 95%CI –1.81 to –0.59, P=0.000 1), but there was no significant difference between two groups in reverse position patients (MD=0.48, 95%CI –0.90 to 1.87, P=0.49). The incidence of sore throat (RR=0.58, 95%CI 0.46 to 0.74, P<0.000 01), the incidence of blood stain (RR=0.48, 95%CI 0.30 to 0.77, P=0.002), the incidence of laryngeal spasm/bronchial spasm (OR=0.30, 95%CI 0.11 to 0.80, P=0.02) and the incidence of cough/hiccup (RR=0.10, 95%CI 0.07 to 0.15, P<0.000 01) in the laryngeal mask group were significantly lower than those in the tracheal intubation group.ConclusionThe current evidence shows that compared with tracheal intubation, laryngeal mask can effectively reduce airway pressure of patients whose position are head higher than foot. The risks of various complications are significant higher in tracheal intubation in laparoscopic surgery. Laryngeal mask can maintain patients' normal respiratory functions while reduce damage and do not increase the occurrence of reflux aspiration. Due to limited quantity and quality of the included studies, more high quality studies are needed to verify above conclusion.
ObjectiveTo evaluate the clinical efficacy and safety tolerance of perampanel in the treatment of Chinese adult epilepsy patients. Methods Clinical data of adult epileptic patients treated with perampanel in Department of Neurology, China-Japan Union Hospital of Jilin University from January 2020 to December 2022 were analyzed retrospectively by self-control method, including demographic and clinical characteristics of patients, changes of epileptic seizures before and after perampanel treatment and adverse events during the treatment of perampanel. To evaluate the clinical efficacy and safety of perampanel in Chinese adult epileptic patients. Results A total of 69 adult epileptic patients with complete follow-up data were included. The dosage range of perampanel was 2 ~ 8 mg. The total effective rate was 68.1%, and the seizure-free rate was 17.4%. The most common adverse reactions were mood change and dizziness, the incidence of adverse reactions was 52.2%, and the incidence of serious adverse reactions was 0.0%. In terms of analysis of influencing factors of efficacy, the results showed that single drug therapy or combination therapy, type of combined antiepileptic drug and treatment time of perampanel did not affect the efficacy (P>0.05), while dosage was an important factor affecting the efficacy of perampanel (P<0.05), and there was no significant difference in efficacy between the focal epilepsy group and the general epilepsy group (P>0.05). In terms of the analysis of factors related to the occurrence of adverse reactions, the results showed that the occurrence of adverse reactions was related to the dosage of perampanel (P<0.05), and was independent of whether it was monotherapy, the addition time of perampanel and the type of combined antiepileptic agents (P>0.05). Conclusion Perampanel has good efficacy and safety tolerance in the treatment of epilepsy in Chinese adults. Both monotherapy and additive therapy can effectively control seizures, and has a good effect on different seizure types. The most common adverse events during treatment were mood changes and dizziness, which could be alleviated and tolerated by most patients with prolonged treatment.