ObjectivesUsing systematic literature review to analyze the effects of levetiracetam (LEV) on neonatal safety during early pregnancy.MethodsThe scope of the literature must be English literature, published from 1997 to 2018. Meta-analysis was performed by random effects models.ResultsSeven literatures were included. A total of 672 cases exposed to LEV in treatment group and 772 234 cases in control groups were selected for meta-analysis. There was no significant difference in neonatal malignancy between treatment group and control group［OR=1.05, 95% CI (0.54, 2.02), P=0.37］. Further, we evaluated the effect of LEV monotherapy and polytherapy on neonatal safety, a total of 464 monotherapy cases and 632 polytherapy cases respectively were selected for meta-analysis. The results showed that there was no significant difference between these two therapies in neonatal malignancy ［OR=0.54, 95% CI(0.31, 0.96), P=0.32］.ConclusionsAs the papers we included, levetiracetam in the treatment of epilepsy during pregnancy is relatively safe for newborn.
Objective To estimate the effect of desensitizing toothpaste containing arginine on dentine hypersensitivity. Methods Such databases as CNKI, PubMed, Web of Science and Cochrane Trials Register (Issue 4, 2008) were retrieved, and Google was used as a supplementary tool to search the information up to March 2010. Randomized controlled trials (RCTs) of treating dentine hypersensitivity with arginine-containing toothpaste were included, and the relevant information was extracted and the quality evaluation was undertaken. Meta-analyses were performed with RevMan 5.0 software. Results Five RCTs with 397 patients were included. The results of meta-analyses showed that at 8 weeks, arginine-containing toothpaste was significantly different from potassium-containing toothpaste in terms of tactile sensitivity test (SMD=1.32, 95%CI 0.68 to 1.96) and air blast test (SMD= –0.77, 95%CI –1.22 to 0.32) with a better therapeutic effect. Conclusion Current literature evidence shows that the arginine-containing toothpaste is effective for the dentine hypersensitivity. However, this study is based on a small number of RCTs and samples, so further studies with high-quality and large-sample RCTs are needed.
Objective To establish the overall diagnostic accuracy of the measurements of vascular endothelial growth factor (VEGF) for malignant ascites. Methods After a systematic review of current studies, sensitivity, specificity, and other measures of the value of ascites concentrations of VEGF in the diagnosis of malignant ascites were pooled by using random effects models. Qualified studies on evaluation of VEGF in diagnosis of malignant ascites in English and Chinese published from January 1990 to December 2009 were retrieved from The Cochrane Library, Cochrane Central Register of Controlled Trials, MEDLINE, EMbase, China National Knowledge Infrastructure (CNKI) databases, WanFang Data, and VIP Information. Two reviewers independently assessed the methodological quality of each study with the tool of QUADAS. Statistical analyses were performed by employing Meta-Disc 1.4 software. Meta-analyses of the reported sensitivity and specificity of each study and Summary Receiver Operating Characteristic (SROC) curve were performed. Results Seven studies met the inclusion criteria for the analysis. After testing the heterogeneity of the included studies, a random effect model was selected to calculate the pool weighted sensitivity and specificity with 95% confidence interval: the sensitivity was 0.81 (95%CI 0.75 to 0.85), the specificity was 0.90 (95%CI 0.86 to 0.94), the DOR was 50.45 (95%CI 28.37 to 89.73), and the AUC of SROC was 0.9507 (SE=0.013 0). The subgroups were analyzed to identify the sources of heterogeneity according to race and agent sources. There was homogeneity among the three studies with agents from Ramp;D company (χ2=0.05, P=0.9750; I2=0.0%), and the AUC of SROC were 0.9675 (SE=0.016 7). Conclusion VEGF has a highly accurate sensitivity and specificity with a b ROC curve, which makes it a new marker to differentiate malignant ascites from the benign.
Objective To compare the effects of high and low positive end-expiratory pressure( PEEP) levels on mortality and risk of barotrauma in patients with acute respiratory distress syndrome ( ARDS) . Methods Randomized controlled trials ( RCTs) were recruited from PubMed( 1966-2008. 9) ,EMBASE( 1980-2008. 9) , Cochrane Database ( Issue 2, 2008) , Chinese Cochrane Centre Database and CBMdisc ( 1978-2008. 9) . Related published and unpublished data and attached references were hand searched. All RCTs about ventilation with PEEP for patients with ARDS were included, then a systematic review were performed. Results Five eligible trials were enrolled in the systematic review. According to ventilation strategy, all trials were divided into subgroup A( low tidal volumes + high PEEP vs traditional tidal volumes + low PEEP) and subgroup B( low tidal volumes + high PEEP vs low tidal volumes + low PEEP) . In subgroup A, high PEEP was associated with a lower mortality[ RR 0. 59, 95%CI( 0. 43, 0. 82) ] and a lower prevalence of barotraumas [ RR 0. 24, 95% CI( 0. 09, 0. 70) ] in patients with ARDS. In subgroup B, the difference in mortality[ RR 0. 97, 95%CI( 0. 83, 1. 13) ] and barotraumas[ RR 1. 13, 95% CI( 0. 78, 1. 63) ]were not significant. Conclusions As compared with conventional ventilation, low tidal volumes and high PEEP ventilation strategy is associated with improved survival and a lower prevalence of barotraumas in patients with ARDS. It is necessary to further confirm the role of sole high PEEP in the ventilation strategy.
ObjectiveTo determine the efficacy of omalizumab in patients (12~75 years of age) with severe allergic asthma, and guide its clinical application. MethodsDatabases, including Pubmed, Web of Science and Embase, were searched to collect randomized controlled trials (RCTs).Data were extracted, and the quality of included RCTs was assessed by two reviewers, followed by meta-analyses using Review Manage 5.1 software. ResultsMeta-analyses of ten included RCTs showed that, compared with placebo, omalizumab reduced the rate of exacerbation per patient during both stable-steroid phase [RR=0.56, 95% CI(0.42, 0.75), P < 0.000 1] and steroid-reduction phase for patients with severe asthma [RR=0.53, 95% CI(0.48, 0.60), P < 0.000 01], reduced the number of patients experienced at least one exacerbation [RR=0.71, 95% CI(0.61, 0.84), P < 0.000 01], and significantly reduced the dosage of beclomethasone dipropionate (≥50%) [RR=1.51, 95% CI(1.24, 1.84), P < 0.001].Omalizumab significantly improved asthma-related quality of life [RR=1.25, 95% CI(1.13, 1.38), P < 0.000 01], albeit no indications of omalizumab reducing the rate of emergency visits [RR=0.63, 95% CI(0.28, 1.44), P < 0.001]. ConclusionThe addition of omalizumab to standard asthma therapy reduces asthma exacerbations, decreases inhaled corticosteroid and rescue medication use, and improves the quality of life in severe asthma patients.
ObjectivesTo systematically review the risk of arterial ischemic and metabolic adverse events in chronic myeloid leukemia (CML) patients treated with tyrosine kinase inhibitors (TKIs).MethodsPubMed, EMbase, The Cochrane Library, CNKI, WanFang Data and VIP databases were searched to collect clinical trials, observational studies and case reports of adverse events in CML patients treated with TKIs from inception to February 2017. Two reviewers independently screened literature, extracted data and assessed the risk of bias of included studies, then, meta-analysis was performed by using Stata 12.0 software.ResultsA total of 22 studies involving 4 223 patients were included. The incidence rates of ischemic heart disease in any grade were 2 per 100 patient-years (95%CI 2 to 3) for nilotinib, and 0 per 100 patient-years (95%CI 0 to 3) for imatinib. The incidence of ischemic heart disease in grade 3 or 4 was 1 per 100 patient-years (95%CI 0 to 2) for nilotinib. The incidence of peripheral arterial occlusive disease in any grade was 2 per 100 patient-years (95%CI 0 to 14) for nilotinib, and 0 per 100 patient-years (95%CI 0 to 2) for imatinib. The incidence of hypertension in any grade was 1 per 100 patient-years (95%CI 0 to 3) for nilotinib, and 44 per 100 patient-years (95%CI 27 to 71) for ponatinib. The incidence of hypertension in grade 3 or 4 was 2 per 100 patient-years (95%CI 0 to 15) for nilotinib, and 22 per 100 patient-years (95%CI 8 to 58) for ponatinib. The incidence of hyperlipidemia in any grade was 17 per 100 patient-years (95%CI 5 to 59) for nilotinib. The incidence of hyperglycemia in any grade was 11 per 100 patient-years (95%CI 9 to 15) for nilotinib, 2 per 100 patient-years (95%CI 1 to 4) for imatinib, 1 per 100 patient-years (95%CI 0 to 5) for dasatinib, and 19 per 100 patient-years (95%CI 19 to 20) for bosutinib. The incidence of hyperglycemia in grade 3 or 4 was 4 per 100 patient-years (95%CI 3 to 5) for nilotinib, and 1 per 100 patient-years (95%CI 1 to 2) for bosutinib.ConclusionsPatients treated with nilotinib have a greater possibility of ischemic heart and peripheral arterial occlusive disease compared with patients treated with imatinib. Patients treated with ponatinib have a high incidence rate of hypertension, and patients treated with nilotinib have a high incidence rate of hyperlipidemia. Patients treated with bosutinib and nilotinib have higher risk of hyperglycemia compared with patients treated with imatinib or dasatinib.
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 evaluate the efficacy of Gefitinib for patients with non-small-cell lung cancer (NSCLC). Methods We searched several databases, including MEDLINE (1991 to June 2008), The Cochrane Library (Issue 4, 2008) and CBMDisc (1978 to Feb. 2008). Randomized controlled trials (RCTs) were included in the meta-analyses, which were done using The Cochrane Collaboration’s RevMan 4.2 software. We also included retrospective case reports published in Chinese journals. Results Eight RCTs and 36 uncontrolled case reports were analyzed. The results of the RCTs showed that 250 mg/d Gefitinib had similar efficacy to 500 mg/d, but the side effect was significantly less for the lower dose. When used as a combined first-line treatment or a third-line treatment, Gefitinib was not superior to placebo on response rate, survival rate and life span. When used as second-line treatment, it did not prolong median survival, though it gave a higher response rate than placebo. Gefitinib caused many more side effects than placebo. Gefitinib exhibited similar efficacy to docetaxel in objective response rate [OR 1.18, 95%CI (0.84, 1.67), P=0.35], but was better for symptom and quality-of-life improvement [OR 1.58, 95%CI (1.33, 1.89), Plt;0.00001]. The overall uncontrolled clinical studies showed the following results: complete response rate was 2.2%, partial response rate was 25.8%, disease stable rate was 40.0% and progressive disease rate was 32.0%. The average median survival time was 8.9 months; the average time to progressive disease was 5.2 months, and the 1-year survival rate was 44.2%. The average median survival from EAP studies (6.9 months) was shorter than that for all the studies as well as the registered clinical trials (10.0 months). The average periods to progressive disease for registered clinical trials (3.2 months) and EAP studies (4.4 months) were somewhat shorter than that found for all studies combined, though response rate and 1-year survival rate were similar. Since there was no controlled clinical study, it was hard to conclude from the results whether Gefitinib brought any clinical benefit to NSCLC patients in China. Conclusion Gifitinib is not suitable as a combined first-line treatment or a third-line treatment for NSCLC. The clinical favor from gefitinib in the second-line treatment remains uncertain. There is not enough evidence to show whether Chinese people are more sensitive to Gefitinib, and its use in the second-line treatment of NSCLC needs to be tested further.
ObjectiveTo evaluate the effectiveness of levetiracetam (LEV) added on to usual care, in treating children refractory partial seizure epilepsy.MethodsWe searched the Cochrane library, EMBASE and PubMed between January 1998-January 2017, We systematically searched CNKI database and Wanfang data, Chinese biology medline and the manual retrieval related magazines.RevMan 5.3 statistical software for Meta analysis.ResultsAccording to the enrollment criteria, fourtrials were included involving 498 participants according to the intent-to-treat, 268 for LEV, and 230 for placebo groups.We assessed the following outcomes: 50% or greater seizure reduction, seizure freedom, adverse effects, proportion of dropouts and quality of life. There was no evidence of statistical heterogeneity between trials.We assessed outcomes by using a meta-analysis to calculate odds ratio (OR) with 95% confidence intervals (95% CI). For the 50% or greater reduction in focal seizure frequency outcome, the OR was significantly in favour of LEV [OR=2.94, 95% CI(1.99, 4.34)].Participants were significantly more likely in LEV groups than placebo groups to get seizure free[OR=5.31, 95% CI(2.49, 11.32)]. There was no significance between LEV groups and placebo groupsin the rate of Treatment withdrawal[OR=0.76, 95% CI(1.32, 1.82)]. Somnolence[OR=2.57, 95% CI(1.36, 4.86)]and changes in behaviour [OR=2.54, 95% CI(1.56, 4.14)] were significantly associated with LEV. Other adverse effects were not significantly associated with LEV in children.ConclusionThe existing evidence suggests that LEV add in treatment of children refractory epilepsy have definite curative effect, LEV long-term treatment effect is stable, good security, retention rate is higher, can be used in clinical further promotion.
ObjectiveTo investigate the short-term efficacy of laparoscopic sleeve gastrectomy (LSG) for obesity with type 2 diabetes mellitus (T2MD) in China. MethodsClinical randomized controlled trial literatures about domestic LSG treatment of obesity with T2MD were obtained from Wanfang Data, China Knowledge Resource Integrated Database, PubMed and Web of Science English Data. The literatures were selected according to the inclusive and exclusive criteria, then evaluated. Methodological quality assessment and meta analysis were evaluated according to the data extracted from those literatures. The short-term efficacy (fasting blood glucose or glycosylated hemoglobin) was evaluated after operation. ResultsOne hundred and seven patients performed LSG were retrieved from 7 literatures. The levels of fasting blood glucose and glycosylated hemoglobin on the postoperative 6 months were all obviously decreased as compared with the levels before operation (fasting blood glucose:MD=2.99, 95% CI 2.39-3.60, P < 0.000 01; glycosylated hemoglobin:MD=2.24, 95% CI 1.43-3.04, P < 0.000 01), which on the postoperative 12 months were all obviously decreased as compared with the levels on the postoperative 6 months (fasting blood glucose:MD=0.56, 95% CI 0.16-0.95, P=0.006; glycosylated hemoglobin:MD=0.52, 95% CI 0.22-0.81, P=0.000 6). The postoperative fasting blood glucose and glycosylated hemoglobin levels in patients accepted LSG showed a downward trend. ConclusionsLSG on obesity with T2MD has an obvious short-term curative effect. But its long-term efficacy still needs to be supported by large samples randomized controlled clinical research data.