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 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.
Objective To compare the long-term outcome between breast-conserving therapy with mastectomy therapy for early stage invasive breast cancer through a Meta analysis of the randomized controlled trials published worldwide. Methods Cochrane systematic evaluation was used to search through Cochrane libraries of clinical comparative trials, PubMed, Embase, Cancer Lit, and so on. The quality of literatures was independently evaluated and cross-checked by two evaluators, indicators for assessment including death number at the end of follow-up, locoregional and total recurrence. The results were analyzed with RevMan 4.2.2 software. Results Six articles were involved in the Meta analysis with total 3 933 patients. No statistical difference was found in the death at the end of follow-up between breast-conserving therapy group and mastectomy therapy group (OR=1.05, 95% CI=0.93—1.19， P=0.45). Locoregional and total recurrence rate of breast-conserving therapy group were statistical higher than those in mastectomy therapy group (OR=1.64, 95% CI: 1.10—2.44， P=0.01； OR=1.42, 95% CI: 1.22—1.64， Plt;0.01). Conclusions Breast-conserving therapy and mastectomy therapy have comparable effects on mortality in patient with early stage invasive breast cancer, even after long-term follow up. However, breast-conserving therapy is associated with significantly greater risk of locoregional recurrence.
Objective To evaluate the subjective outcomes of sleepiness behavior and mood status applying continuous positive airway pressure（CPAP） in adults of elderly and middle-aged with obstructive sleep apnea syndrome（OSAS）. Methods Nine randomized controlled trails comparing nocturnal CPAP with inactive control appliances in adults with OSAS with the use of computerized search in related medical databases（MEDLINE，EMBASE，CBMdisk，etc） were included.The quality of literature was reviewed，and all data were extracted by two reviewers independently.Meta analysis was conducted used RevMan 4.2 software.Results 9 RCT involving 665 patients of elderly and middle-aged met the inclusion criteria.Meta analysis indicated that the score of Epworth sleepiness scale（ESS） and general health questionnaire-28（GHQ-28） declined significantly after CPAP treatment on effectiveness with WMD（random） －2.94，95 %CI －4.68 to －1.20，or WMD（fixed） －2.26，95 %CI －3.79 to －0.72，Plt;0.01.Nevertheless，hospital anxiety and depression scale（HADS） was not significantly different between CPAP and control with WMD（random） －0.89，95%CI －1.98 to 0.20，Pgt;0.05.Conclusion Current clinical evidence suggested that CPAP was effective in improving day-time subjective outcomes of sleepiness behavior and general mental health status in OSAS patients of elderly and middle-aged，although evidence of improving emotion disorder of anxiety and depression was not confirmed.
ObjectiveTo systematically evaluate the efficacy of steroids combined with antiepileptic drugs compared with alone antiepileptic drugs in the treatment of children with epileptic electrical status during sleep to provide evidence-based medical basis for its treatment.MethodsElectronic searches were maded in PubMed, Embase database, Cochrane Library, CNKI, Wanfang and the Chinese biomedical literature database for the literature about steroids combined with antiepileptic drugs compared with alone antiepileptic drugs in the treatment, and retrieval time is from January 1990 to October 2020. Two evaluators independently screened literature, extracted data, evaluated literature quality and risk of bias and checked each other. Meta analysis was performed by stata16.0 software.ResultsA total of 679 children with ESES were included in 10 studies, including 9 randomized controlled trials and 1 retrospective cohort study. Meta analysis results showed that there were statistically significant differences in clinical improvement rate [RR=1.31, 95%CI (1.21, 1.42), P<0.01], electroencephalogram discharge improvement rate [RR=1.35, 95%CI (1.25, 1.46), P<0.01] and cognitive intelligence score [SMD=1.19, 95%CI (0.80, 1.57), P<0.01] between steroids combined with antiepileptic drugs group and alone antiepileptic drugs group after 6 months follow-up. The incidence of adverse reactions in steroids combined with antiepileptic drugs group was higher than that in alone antiepileptic drugs group, and the difference was statistically significant [RR=4.13, 95%CI (1.06, 16.13), P<0.01]. All adverse reactions improved or disappeared after drug withdrawal.ConclusionCompared with alone antiepileptic drugs, steroids combined with antiepileptic drugs group has advantages in controlling epileptic seizures, improving electroencephalogram abnormalities and improving cognitive ability, and it is relatively safe.
Objective To evaluate the effectiveness and safety of traditional Chinese medicine (TCM) plus transcatheter arterial chemoembolization (TACE) compared with TACE alone, in the treatment of unresectable hepatocellular carcinoma (HCC). Methods The Cochrane Library, MEDLINE, EMBASE, CANCERLIT, CBM, CNKI and VIP were searched electronically. Relevant journals and conference proceedings were also handsearched. The quality of included studies was assessed according to the criteria recommended by the Cochrane Handbook for Systematic Reviews of Interventions, and meta-analyses were performed for homogeneous studies using The Cochrane Collaboration’s RevMan 4.2.10 software. Subgroup analyses by frequency of TACE (lt;3 or ≥3 times) were also performed. Results Thirty seven trials, all published in China, involving 2 653 participants were included. The quality of 2 studies was graded B (medium) and that of the other 35 was graded C (low). Meta-analyses showed that TCM plus TACE, compared with TACE alone, could significantly improve survival, tumor response (complete and partial), quality of life and clinical symptoms, and was also associated with a lower incidence of adverse reactions. Subgroup analyses indicated that, patients with less than three TACE had more significant improvement in survival and clinical symptoms, while patients with three or more TACE had more significant improvement in tumor response and quality of life. The incidence of adverse reactions was similar between these two different frequencies of TACE. Conclusions The treatment regimen of TCM plus TACE is superior to TACE alone in patients with unresectable HCC. As the existing data have a high risk of bias, the current evidence is insufficient to define the efficacy of the combination treatment, and further large-scale, high-quality randomized controlled trials are needed.
Objective
To investigate the efficacy of LDL-C lowering treatment on NSTE-ACS, and to analyze the target LDL-C level for clinical treatment.
Methods
PubMed, EMbase, the Cochrane Central Register of Controlled Trials, Web of Science databases were searched up to January 2016 for randomized controlled trials assessing the effects of LDL-C lowering therapy on major adverse cardiac events (MACE) in patients with NSTE-ACS. Two reviewers independently screened litertures, extracted data and assessed the risk of bias of included studies, and then meta-analysis was performed by using Stata12.0 and RevMan 5.3 software.
Result
A total of 12 RCT including 4 702 individuals with NATE-ACS were included. The results of meta-analysis showed that, compared with the control group, the statin group could significantly reduced the risk of MACE (RR=0.68, 95% CI 0.549 to 0.834,P=0.000). With 18.68 months of follow-up, patients in target LDL-C level from over 70 mg/dL to less than 100 mg/dL group had lower risk of MACE than other LDL-C level group. When LDL-C lower 20% to 40% than baseline with 28.99 months follow-up, patients in target of LDL-C level from over 70 mg/dL to less than 100 mg/dL group had lowest risk of MACE (RR=20.143, 95% CI 6.946 to 58.414,P=0.000).
Conclusion
LDL-C lower treatment can lower the risk of MACE in patients with NSTE-ACS. Patients in target LDL-C level from over 70 mg/dL to less than 100 mg/dL group have relatively low risk of MACE, in which patients who lower 20% to 40% LDL-C than baseline will get more benefits from LDL-C lowering therapy.
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 effect of pars plana vitrectomy (PPV) combined total peeling of internal limiting membrane (ILM) versus fovea-sparing peeling of ILM for myopic foveoschisis. MethodsA evidence-based medicine study. Chinese and English as search terms for myopic foveoschisis, vitrectomy, and peeling of internal limiting membrane were used to search literature in China National Knowledge Infrastructure, Wanfang database, VIP database, PubMed of National Library of Medicine, Medline, Embase, and Cochrane Library. The high myopic macular schisis was selected as the research object, the intervention method was PPV combined with complete ILM peeling and combined with foveal preservation ILM peeling surgery clinical control study between Jan 1, 2010, and Jun 31, 2021. Incomplete or irrelevant literature and review literature were excluded. The method of Newcastle-Ottawa Scale system was used to evaluate the included literature. The literature was meta-analyzed by RevMan5.3 software. The mean difference (MD) and a confidence interval (CI) of 95% were used to describe the effect sizes of continuous data, fixed effects model was performed. The data including the best corrected visual acuity (BCVA), central fovea thickness (CFT), and postoperative macular hole (MH) were analyzed. ResultsIn those databases, 232 articles based search stratery were totally retrieved, and 10 articles (417 eyes) were finally included for meta-analysis with 245 eyes for PPV combined total peeling of ILM and 172 eyes for PPV combined fovea-sparing peeling of ILM. Meta-analysis results showed there was no significant difference in BCVA and CFT between the two groups (BCVA: MD=0.05, 95%CI 0.00-0.11; P＞0.05; CFT: MD=－4.79, 95%CI －18.69-9.11, P＞0.05). It was compared with the incidence of MH, the difference was statistically significant (odds ratio=5.70, 95%CI 2.22-14.61, P＜0.05). ConclusionBCVA and CFT could be improved by PPV combined total and fovea-sparing peeling of ILM for myopic foveoschisis; compared with complete ILM peeling, the incidence of MH was lower after foveal-sparing ILM peeling.
Objective To evaluate the diagnostic value of Em18 by enzyme-linked immunosorbent assay (ELISA) in the patients with alveolaris echinococcosis (AE). Methods We searched MEDLINE, EMBase, PubMed, The Cochrane Library, and other databases to collect the studies which evaluated the diagnostic value of Em18 in the patients with AE. QUADAS items were used to evaluate the quality of the included studies. The heterogeneity of the included studies and meta-analyses was analyzed by using RevMan 4.2.10. The Summary Recevier Operating Characteristic (SROC) curve was performed by meta-disc. Results Eight studies involving 409 patients with AE diagnosed by the gold standard, 1105 patients with other diseases, and 216 healthy people were included. Meta analyses showed that the pooled sensitivity and pooled specificity of purified Em18 in ELISA were 91.5% and 91.7%, and those of recombinant Em18 were 92.2% and 95.7%, respectively. The AUC of SROC of purified Em18 and recombinant Em18 were 0.966 6 and 0.978 9, respectively. Conclusion Purified Em18 and recombinant Em18 have high value in diagnosis of AE by ELISA.
