Objective To assess the effectiveness and safety of irbesartan for hypertensive patients with hyperuricaemia. Methods The databases such as The Cochrane Library (Issue 2, 2010), MEDLINE (by the end of April 2010), SCI (by the end of April 2010), CBM (by the end of April 2010) and CNKI (by the end of April 2010) were searched to collected randomized controlled trails (RCTs) on irbesartan for hypertensive combined with hyperuricaemia. Studies were screened according to the inclusion and exclusion criteria; data were extracted; the methodological quality was evaluated; and meta-analyses were conducted by using RevMan 5.0.0 software. Results Nine studies involving 977 patients were included. The results of meta-analyses showed that compared with the control group, irbesartan was superior in decreasing serum uric acid (SUA) (MD=57.12, 95%CI 16.08 to 98.15, P=0.006); it was similar in controlling blood pressure (Systolic pressure: MD= –0.24, 95%CI –2.19 to 1.71, P=0.81; Diastolic pressure: MD=0.46, 95%CI –1.58 to 2.50, P=0.66), and lower in the incidence rate of adverse reaction (RR=0.07, 95%CI 0.02 to 0.24, P=0.000 1). Conclusion The study suggests that irbesartan is effective and safe to control blood pressure and decrease serum uric acid for hypertensive patients with hyperuricaemia. But because all nine included studies are graded C in quality, the conclusion still needs to be further verified by long-term, large scale and high quality studies.
ObjectiveTo investigate the efficacy and safety of using tamoxifen sequential with the third generation aromatase inhibitors versus the third generation aromatase inhibitors or tamoxifen alone for postmenopausal hormone receptor-positive breast cancer patients.MethodsThe Cochrane Library (Issue 10, 2016), PubMed, EMbase, CNKI, and WanFang Data were searched to collect randomized controlled trials on using tamoxifen sequential with the third generation aromatase inhibitors versus the third generation aromatase inhibitors or tamoxifen alone for postmenopausal hormone receptor-positive breast cancer patients from inception to October, 2016. 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 9 studies involving 22 005 patients were included. The results of meta-analysis showed that the sequential therapy group was superior to the tamoxifen monotherapy group on overall survival (HR=0.71, 95%CI 0.52 to 0.98, P=0.04) and recurrence-free survival (HR=0.60, 95%CI 0.46 to 0.79, P=0.000 3). However, no significant difference was found in overall survival and disease free survival between the sequential therapy group and the aromatase inhibitors monotherapy group. As to adverse events, compared with the tamoxifen monotherapy group, the sequential therapy group could reduce the incidence of endometrial hyperplasia (OR=0.22, 95%CI 0.11 to 0.45, P<0.000 01), death (OR=0.74, 95%CI 0.66 to 0.84, P<0.000 01) and metastasis (OR=0.79, 95%CI 0.68 to 0.91, P=0.001); however, the incidence of bone fracture was higher in sequential therapy group compared with intamoxifen monotherapy group (OR=1.31, 95%CI 1.13 to 1.51, P=0.000 3).ConclusionThe sequential therapy using tamoxifen and the third generation of aromatase inhibitors is better than tamoxifen monotherapy for postmenopausal hormone receptor-positive breast cancer patients. However, there is no significant difference in survival benefit between the sequential therapy and aromatase inhibitors monotherapy.
ObjectiveTo systematically evaluate the potential effectiveness of JinHuang powder in the treatment of diabetic foot ulcers (DFUs). MethodsDatabases including PubMed, The Cochrane Library, Web of Science, CBM, WanFang data, VIP and CNKI were electronically searched from their inception to December 2013, to identify randomized controlled trials (RCTs) about JinHuang powder for DFUs. Two reviewers screened literature according to the inclusion and exclusion criteria, extracted data and assessed the methodological quality of included studies, and then meta-analysis was performed by using RevMan 5.1 software. ResultsA total of 3 RCTs involving 198 patients were included. The results of meta-analysis showed that:the JinHuang powder group were superior to the control group in total effective rate (RR=1.25, 95%CI 1.10 to 1.41, P=0.00) and the wound healing time (SMD=-3.32, 95%CI -5.69 to -0.96, P=0.00). ConclusionCurrent evidence suggests that the JinHuang powder is an effective therapeutic method for DFUs. Because of the limitations of quantity and quality of the eligible studies, large sample size studies are needed to validate the conclusion.
Drug administration is an extremely important aspect in the design and conduct of randomized controlled trials, which can influence the reliability and quality of the trials’ results. This topic covers issues such as blinding, preparation, packaging, labeling, shipping, dispensing and returning of test articles. Good drug administration procedures should ensure the smooth implementation of large-scale multi-center randomized controlled trials and increase their reliability and usefulness.
ObjectiveTo evaluate the safety and myocardial protective results of single high-dose Atorvastatin loading before off-pump coronary artery bypass grafting (OPCAB). MethodsA total of 140 patients undergoing selective OPCAB in Jiangsu Province Hospital between February 2010 and August 2011 were recruited in this study. All the patients were randomly divided into a control group and an Atorvastatin loading group (single oral atorvastatin 80 mg)with 70 patients in each group. Biomarkers of cardiac injury including Troponin T (TnT), creatine kinase-MB (CK-MB)and myoglobin (Mb)were measured on admission, 6, 12, 24, 48, 72, 96 and 120 hours after OPCAB. Liver function (alanine aminotransferase (ALT), aspartate aminotransferase (AST)and total bilirubin (TBIL)), serum lipids (total cholesterol (TC), trigl-yceride (TG)and low-density lipoprotein cholesterol (LDL-C))and high-sensitivity C-reactive protein (hsCRP)were measured 2 days before OPCAB, 1, 4 and 7 days after OPCAB as well as before discharge. ResultsAll the patients successfully received OPCAB and were discharged. There was no statistical difference in preoperative clinical characteristics or above indexes between the 2 groups (P > 0.05). There was no statistical difference in ALT or AST between the 2 groups. Incidences of ALT (4.29% vs. 5.71%, P=1.000)and AST (4.29% vs. 0%, P=0.245)greater than 3 times above the upper normal limit were not statistically different between the 2 groups. Peak levels of postoperative TnT (0.23±0.27 ng/ml vs. 0.16±0.24 ng/ml, P=0.011), CK-MB (29.57±30.04 U/L vs. 17.73±14.07 U/L, P=0.001)and hsCRP (31.85±22.89 mg/L vs. 20.81±10.96 mg/L, P=0.001)of the control group were significantly higher than those of Atorvastatin loading group. Incidences of TnT greater than the upper normal limit (47.1% vs. 65.7%, P=0.041)and TnT greater than 5 times above the upper normal limit (8.6% vs. 22.9%, P=0.037)of Atorvastatin loading group were significantly lower than those of the control group. Incidence of CK-MB greater than the upper normal limit of Atorvastatin loading group was significantly lower than that of the control group (20.0% vs. 54.3%, P=0.000). ConclusionSingle high-dose Atorvastatin loading before OPCAB is safe and can alleviate postoperative myocardial injury.
ObjectivesTo systematically review the efficacy of His-bundle pacing (HBP) and right ventricular pacing (RVP).MethodsPubMed, The Cochrane Library, Web of Science, EMbase, CNKI, VIP and WanFang Data databases were electronically searched to collect randomized controlled trials (RCTs) and cohort studies on efficacy of HBP and RVP from inception to December, 2018. Two reviewers independently screened literature, extracted data and assessed risk of bias of included studies, then, meta-analysis was performed using RevMan 5.3 software.ResultsA total of 8 studies involving 1 130 patients were included. The results of meta-analysis showed that: HBP group was superior to RVP group in QRS duration (MD=–43.88, 95%CI –52.53 to –35.22, P<0.000 01), LVEF (MD=4.53, 95%CI 2.67 to 6.38, P<0.000 01), and NYHA (MD=–0.85, 95%CI –1.14 to –0.56, P<0.000 01). However, the operation time (MD=15.21, 95%CI 11.44 to 18.98, P<0.000 01) and fluoroscopy duration (MD=2.98, 95%CI 2.10 to 3.85, P<0.000 01) of HBP group were longer than that of RVP group.ConclusionsCurrent evidence shows that, compared with RVP, HBP is superior in maintaining of QRS duration, LVEF and NYHA; however, the operation time is longer. Due to limited quality and quantity of the included studies, more high quality studies are required to verify above conclusion.
Objective To evaluate the efficacy and safety of FTY720 (fligolimod) in different dosages in the treatment of Relapsing-Remitting Multiple Sclerosis (RRMS), so as to provide references for clinical practice. Methods Such databases as MEDLINE, EMbase, The Cochrane Liabrary, CBM and CNKI were searched for collecting randomized controlled trials (RCTs) of FTY720 in the treatment of RRMS, which were published from January 1, 2001 to December 31, 2010. The studies were retrieved and the data were extracted according to the predefined inclusion and exclusion criteria, the quality of included studies was evaluated with improved Jadad scale, and the Meta-analyses were performed with RevMan5.1 software. Results Three high quality RCTs were included. The Meta-analyses showed that: a) compared with the control group, orally taking FTY720 could obviously decreased the annualized relapse rate (OR=-6.67, 95%CI -10.75 to -2.60, P=0.001), the confirmed disability progression rate (OR=0.64, 95%CI 0.47 to 0.87, P=0.004), and the incidence rate of intensified lesion on T2-weighted magnetic resonance imaging scans (OR=0.28, 95%CI 0.21 to 0.37, Plt;0.00001); b) There was no significant difference (P=0.55) between the small dosage (0.5mg/d) group and the big dosage (1.25mg/d) group of FTY720; and c) The incidence of adverse events was significantly different among the 3 dosage groups (5mg/d, 1.25mg/d and 0.5mg/d), and the minimum dosage group (0.5mg/d) was safer than the other groups. Conclusion FTY720 is safe to treat RRMS, and it can obviously decrease the annualized relapse rate, confirmed disability progression rate and incidence rate of intense lesion on T2-weighted magnetic resonance imaging scans. There is no dosage-effect relationship found in treating RRMS with FTY720 in different dosages, but the 0.5mg/d FTY720 as the minimum dosage is the safest.
Objective To assess the effectiveness and safety of different dual antiplatelet therapies in patients undergoing percutaneous coronary intervention. Methods Such databases as The Cochrane Library, MEDLINE, EMbase, CBM, CNKI and WanFang Data were searched to collect the randomized controlled trials (RCTs) and observational studies on the effectiveness and safety of dual antiplatelet therapies both short-duration (≤6 months) and long-duration (gt;6 months) after percutaneous coronary intervention. The literature was screened according to the inclusive and exclusive criteria by two reviewers independently, the quality was evaluated, the data were extracted, and meta-analyses were performed by using RevMan 5.1 software. Results Eight trials were included, of which 3 were RCTs involving 7 475 patients, and 5 were observational studies involving 12 744 patients. Meta-analyses on RCTs showed that the incidence of death or myocardial infarction in the long-duration treatment group was lower than that of the short-duration treatment group (OR=0.74, 95%CI 0.56 to 0.98, Plt;0.000 1), while meta-analyses on observation studies showed the similar result (OR=0.7, 95%CI 0.45 to 1.08, P=0.11). With the variables of published year and follow-up time, the heterogeneity of cohort studies was discussed through meta-regression (Z=3.61, P=0.000) which indicated that both published year and follow-up time might be the source of heterogeneity due to their contribution. For RCTs, the incidence of severe bleeding events in the short-duration treatment group was lower than that in the long-duration treatment group (OR=1.29, 95%CI 0.99 to 1.69, P=0.06). For observational studies, the incidence of late stent thrombosis in the long-duration treatment group was lower than that in the short-duration treatment group (OR=0.40, 95%CI 0.15 to 1.07, P=0.07). Conclusion The long duration (gt;6months) of dual antiplatelet therapy in patients undergoing percutaneous coronary intervention can reduce the incidence of death or myocardial infarction and decrease the tendency of late stent thrombosis, but cannot obviously increase the incidence rate of severe bleeding events. The current evidence shows no marked superiority in longer duration (gt;12months) of dual antiplatelet therapy.
ObjectiveTo systematically review the clinical efficacy and safety of afatinib in the treatment of advanced non-small cell lung cancer (NSCLC).MethodsWe electronically searched databases including The Cochrane Library, PubMed, EMbase, CNKI, WanFang Data and VIP to collect randomized controlled trials (RCTs) about the afatinib for advanced non-small cell lung cancer from inception to October 2016. Two reviewers independently screened literature, extracted data and assessed the risk of bias of included studies. Then, meta-analysis was performed using RevMan 5.3 software. ResultsEight RCTs were included. The results of meta-analysis showed that afatinib could significantly prolonged progression-free survival (PFS) for lung adenocarcinoma patients (HR=0.43, 95%CI 0.32 to 0.57, P<0.000 01), but there was no significant difference between the two groups in terms of overall survival (OS) in patients with lung adenocarcinoma (HR=1.03, 95%CI 0.85 to 1.23, P=0.79). In addition, afatinib significantly increased the patient’s adverse reactions including diarrhea, skin rashes, nausea and vomiting.ConclusionAfatinib can improve PFS in patients with lung adenocarcinoma, but it does not prolong OS. Due to the limited quantity and quality of included studies, the above conclusions are still needed to be verified by more high quality studies.
Objective To systematically review the effect of different nutrient interventions on the physical function of elderly people with frailty through network meta-analysis. Methods The PubMed, Cochrane Library, EMbase and Web of Science were electronically searched to collect randomized controlled trials of different nutrient interventions on physical function of the elderly with frailty, from database inception to June 30, 2022. Two reviewers independently screened the literature, extracted data, and assessed the risk of bias of the included studies. Network meta-analysis was then performed using ADDIS 1.16.8, GeMTC 14.3, and Stata 15.0 software. Results A total of 13 studies involving 1 144 patients were included. There was no statistically significant difference in handgrip strength, time up to go test, gait speed, and short physical performance battery (SPPB) among different nutrient interventions. Significant differences were not found in vitamin D+ whey protein (VDWP) vs. placebo and Leu vs. placebo in handgrip strength, or VDWP vs. placebo in SPPB. The probability ranking diagram showed that the most effective of handgrip strength, time up to go test, gait speed, and SPPB were milk protein concentrate (MPC80), L-carnitime (L-Car), leucine (Leu), and MPC80, respectively. Conclusion The current evidence suggests that nutritional intervention did not significantly improve physical function in the frail elderly. MPC80, Leu, L-Car, and VDVEWP may play a role in improving the physical function of frail elderly people. Nutritional support programs that increase the above nutrients, combined with exercise training may become a better way to improve the physical function of frail elderly.