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 assess the methods, processes and evaluation criteria of burn models in rats. MethodsDatabases including MEDLINE, EMbase, CBM, CNKI, VIP and WanFang Data were electronically searched from inception to February 2016. The animal studies of burn models development in rats were included. Two reviewers independently screened literatures, extracted data, assessed the quality of included studies, and analyzed the outcomes. ResultsFifteen studies including 38 burn groups were identified. The results indicated:(1) depth of burn:50.00% burn models were partial thickness burn (II°), and 21.05% were full thickness burn (III°). (2) methods of induction:80.00% burn models were developed through high temperature liquid or solid tools. (3) burn sites:93.33% burns were on the back of rats. (4) induction temperature:66.67% induction temperature was between 80℃ and 100℃. (5) induction time:86.67% induction time was between 3 seconds and 100 seconds. (6) anesthesia:40.00% rats were anesthetized with intraperitoneal injection of pentobarbital sodium. (7) skin preparation:60.00% studies reported the skin was prepared by physical and chemical methods. (8) housing post surgery:13.33% studies reported the housing temperature post surgery. (9) intervention post surgery:13.33% studies reported antishock treatment. (10) assessment criteria:almost all studies evaluated the depth of burn through the macroscopic and microcosmic assessment. ConclusionBased on current animal studies, most burn models in rats are partial thickness and full thickness burn on the back of rats. Burn is inducted mainly by 80℃ to 100℃ hot liquid or solid tools within 30 seconds, according with skin preparation, anesthesia, antishock or analgesia management. The depth of burn is evaluated by the macroscopic and microcosmic assessment. However, there is no standard for the methods, processes, assessment and reporting of development of burn model in rats.
ObjectivesTo systematically review the efficacy and safety of bevacizumab combined with STUPP regimen for newly diagnosed glioblastoma.MethodsPubMed, EMbase, the Cochrane Library, CBM, CNKI, VIP and WanFang Data databases were searched to obtain randomized controlled trials (RCTs) of bevacizumab combined with STUPP regimen for newly diagnosed glioblastoma patients from inception to September 2017. Two reviewers independently screened literature, extracted data and assessed the risk of bias of included studies. Meta-analysis was then performed using RevMan 5.3 software.ResultsA total of 6 RCTs involving 2 835 patients were included. The results of meta-analysis showed that: the bevacizumab combined with STUPP regimen group was superior to the control group on PFS (HR=0.69, 95%CI 0.62 to 0.77, P<0.000 01). But the adverse events rate at the three and above three levels was significantly higher than the control group (P<0.05).ConclusionsCurrent evidence shows that bevacizumab combined with STUPP regimen for newly diagnosed glioblastoma can significantly prolong the PFS. The treatment group performs not as well as the control group on adverse event rate. Due to the limited quality and quantity of the included studies, more high-quality studies are required to verify above conclusions.
Objective To evaluate the efficacy and safety of vildagliptin vs. placebo for patients with type 2 diabetes.Methods The following databases as The Cochrane Library (Issue 2, 2010), PubMed (1978 to September, 2010), EMbase (1974 to September, 2010), CNKI (1978 to September, 2010), VIP (1989 to September, 2010) and CBM (1978 to September, 2010) were searched to collect the randomized controlled trials (RCTs) of vildagliptin vs. placebo in treating type 2 diabetes. Two reviewers screened the trials according to the inclusion and exclusion criteria, extracted the data, assessed the quality in accordance with the Cochrane Collaboration, and conducted meta-analyses with RevMan 5.0 software. Results A total of 13 studies were included. The results of meta-analyses showed that the vildagliptin given as monotherapy led to greater reduction in HbA1c compared with the placebo (MD= –0.76, 95%CI –0.94 to –0.58, Plt;0.000 01), but it was inferior to the placebo in losing weight (MD=0.68, 95%CI 0.29 to 1.07, P=0.000 6). When the vildagliptin was given as monotherapy, there was no statistical difference in the incidence of overall adverse events (AEs) (OR=1.00, 95%CI 0.83 to 1.21, P=0.98) and hypoglycaemia (OR=1.03, 95%CI 0.65 to 1.65, P=0.89). When the vildagliptin was combined with other oral antihyperglycemic drugs or insulin, it produced greater reduction in level of HbA1c (MD= –0.76, 95%CI –0.94 to –0.58, Plt;0.000 01), and there was no statistically significant difference between vildagliptin and placebo in weight loss (MD=0.40, 95%CI –0.25 to 1.05, P=0.23), AEs (OR=0.95, 95%CI 0.76 to 1.18, P=0.62) and hypoglycaemia (OR=1.11, 95%CI 0.49 to 2.53, P=0.80). Conclusion The vildagliptin treatment for type 2 diabetes is effective and safe. A long-term study in large scale with high quality is required to confirm its long-term outcomes.
Objectives To systematically review the efficacy and safety of de-escalation therapy for severe pneumonia. Methods We searched PubMed, EMbase, The Cochrane Library, CBM, CNKI, VIP and WanFang Data databases and the Chinese Clinical Trial Registry (www.chictr.org.cn) to collect randomized controlled trials (RCTs) of de-escalation therapy for patients with severe pneumonia from inception to June, 2017. Two reviewers independently screened literature, extracted data and assessed the risk of bias of included studies. Meta-analysis was then performed using RevMan 5.3 software. Results A total of 13 RCTs involving 1 860 patients were included. The results of meta-analysis showed that: the de-escalation therapy group was superior to the control group on clinical cure rate (RR=1.28, 95%CI 1.20 to 1.35, P<0.000 01), the total hospitalization time (MD=–6.86, 95%CI –9.12 to –4.59,P<0.000 01), remission time of complications (MD=–6.26, 95%CI –8.43 to –4.10,P<0.000 01) and mortality (RR=0.48, 95%CI 0.28 to 0.82,P=0.001). Reported cases of adverse reactions were rare, in which the degree of reactions ranged from mild to moderate. The safety was fairly satisfactory. Conclusions Current evidence shows that de-escalation therapy for patients with severe pneumonia has improved efficacy compared with conventional treatments, and can significantly shorten the total hospitalization time and reduce mortality. Due to the limited quality and quantity of the included studies, more high quality studies are required to verify above conclusions.
Objective To systematically review the effectiveness and safety of erlotinib for the elderly with Non-small-cell lung cancer (NSCLC). Methods Databases including The Cochrane Library, PubMed, EMbase, CBM, VIP, CNKI and WanFang Data were electronically searched for relevant randomized controlled trails (RCTs). Two reviewers independently screened literature according to the inclusion and exclusion criteria, extracted data, and assessed the methodological quality. Then, meta-analysis was performed using RevMan 5.0 software. Results Totally 5 studies were included. The results of meta-analysis showed that, the objective response rate and stable disease rate was similar between the erlotinib group and the control group with no significant difference (RR=0.99, 95%CI 0.34 to 2.93, P=0.99; RR=1.17, 95%CI 0.95 to 1.43, P=0.14). The incidences of Grade Ⅲ-Ⅳ neutropenia and thrombocytopenia were lower in the erlotinib group than those in the control group (OR=0.12, 95%CI 0.03 to 0.52, P=0.005; OR=0.19, 95%CI 0.04 to 0.91, P=0.04); and the incidences of nausea and vomiting as wel as liver impairments were alike between the two groups (OR=0.93, 95%CI 0.12 to 7.08, P=0.95; OR=0.80, 95%CI 0.24 to 2.68, P=0.71); the incidences of diarrhea and skin rashes in the erlotinib group were higher (OR=5.96, 95%CI 1.28 to 27.88, P=0.02; OR=6.77, 95%CI 1.52 to 30.10, P=0.01). Conclusion Current evidence shows that, erlotinib is effective and safe in treating the elderly with NSCLC with better effects and no serious adverse reaction. However, due to the limited quantity and quality of the included studies, more high quality studies with large sample size and long-term follow-up are still needed to verify the above conclusion.
Objective To evaluate the safety and efficacy of gefitinib in comparison with platinum-based doublets chemotherapy as a first-line precision treatment for advanced non-small cell lung cancer (NSCLC), and find the benefit population of gefitinib. Methods The Cochrane Library, PubMed, Embase, China National Knowledge Internet, VIP database and China Biology Medicine database were searched to collect the randomized contolled trials (RCTs) of gefitinib vs. platinum-based doublets chemotherapy for advanced NSCLC from inception to November, 2017. The data in the included RCTs were extracted, and the qualities were assessed in accordance with Cochrane Collaboration, and a Meta-analysis was conducted with RevMan 5.3 software. Results Four trials were included, including 968 subjects in the gefitinib group and 968 subjects in the chemotherapy group, and a majority of the subjects were diagnosed advanced adenocarcinoma, and all of the subjects were East Asians. The results of Meta-analysis showed that in all population or patients with epidermal growth factor receptor (EGFR) mutation-positive, gefitinib was better than chemotherapy in progression-free survival (PFS) [in all population: hazard ratio (HR)=0.76, 95% confidence interval (CI) (0.67, 0.85), P<0.000 01; in patients withEGFR mutation-positive: HR=0.42, 95%CI (0.35, 0.50), P<0.000 01] and objective response rate (ORR) [in all population: risk ratio (RR)=1.30, 95%CI (1.15, 1.47), P<0.000 1; in patients withEGFR mutation-positive: RR=1.92, 95%CI (1.46, 2.52), P<0.000 01], and there was no significant difference between the two groups in overall survival (OS) (P>0.05); but inEGFR mutation-negative, chemotherapy was better than gefitinib in PFS [HR=2.09, 95%CI (1.05, 4.13), P=0.03]. Subgroup analysis showed that in female patients, for patients with Performance Status (PS) score 0 or 1, and the ones who never smoked, gefitinib was better than chemotherapy in PFS (P<0.05); but there was no significant difference between the two groups in OS (P>0.05). The incidences of rash, itching, dry skin, paronychia, diarrhea, aminotransferase abnormality were higher in the gefitinib group (P<0.05), while the incidences of hair loss, vomiting, nausea, constipation, anorexia, leukopenia, thrombocytopenia, and neutropenia, anemia, fatigue, nerve toxicity reaction were higher in the chemotherapy group (P<0.05). Conclutions Based on the current evidence, in patients with adenocarcinoma of East Asians, the benefit population are those with the characteristics of EGFR mutation-positive, female, never smoking, and PS 0 or 1. In the aspect of safety, the common adverse drug events in subjects treated with gefitinib are the damage of skin mucous membrane, but the incidences of digestive system diseases and the blood system diseases are less in patients treated with gefitinib than those with chemotherapy.
Objective To assess the efficacy of telbivudine in the treatment of chronic hepatitis B (CHB). Methods Randomized controlled trials (RCTs) of telbivudine therapy vs. lamivudine therapy in both Chinese and English were retrieved from seven electronic databases with a cut-off date in February 2010, including PubMed, EMbase, VIP, CBM, CNKI, and The Cochrane library. The meta-analyses and evaluation on methodology quality were performed for the included studies. Results Two RCTs as Grade-A study were included. The meta-analyses showed that telbivudine was superior to lamivudine in aspects of therapeutic response (RR=1.28, 95%CI 1.10 to 1.48, P=0.001), ALT normalization (RR=1.12, 95%CI 1.01 to 1.23, P=0.02), and PCR-negative HBV DNA or below the lower limit (RR=1.44, 95%CI 1.36 to 1.53, Plt;0.000 01), primary treatment failure (OR=0.28, 95%CI 0.18, to 0.43, Plt;0.000 01), viral breakthrough (OR=0.38, 95%CI 0.32 to 0.47, Plt;0.000 01) and viral resistance (OR=0.44, 95%CI 0.36 to 0.55, Plt;0.000 01). Conclusion Based on the current clinical evidence, telbivudine demonstrates superiority in comparison with lamivudine on all direct measures of antiviral efficacy for CHB. Because of the short follow-up duration and the small sample size of the included studies, it is expected to further discuss the long-term efficacy.
Objective To systematically evaluate the effectiveness of intra-articular hyaluronic acid injection after arthroscopic debridement for knee osteoarthritis (KOA). Methods Databases including The Cochrane Library, SCI, MEDLINE, EMbase, CBM and WanFang Data were searched from inception to 2012, so as to collect randomized controlled trials (RCTs) on intra-articular hyaluronic acid injection after arthroscopic debridement (combined therapy) vs. monotherapy in treating KOA. Two reviewers independently screened literature according to inclusion and exclusion criteria, evaluated quality, and extracted data. Then the meta-analysis was conducted using RevMan5.0 software. Results A total of 7 RCTs involving 526 patients were included. The results of meta-analyses showed that: there was no significant difference in the excellent-good rate between the combined therapy group and the monotherapy groups including either the intra-articular hyaluronic acid injection group (RR=1.40, 95%CI 0.99 to 1.98, P=0.06) or the arthroscopic debridement group (RR=1.09, 95%CI 0.93 to 1.26, P=0.29). But the intra-articular hyaluronic acid injection group was inferior to the combined therapy group in improving Lysholm score, with a significant difference (MD=–14.81, 95%CI –17.55 to –12.08, Plt;0.000 01). Conclusion Arthroscopic debridement combined with intra-articular hyaluronic acid injection for KOA shows no significant difference in the excellent-good rate compared with the monotherapy, but it is superior to the monotherapy of hyaluronic acid injection in improving Lysholm score, so it is believed the combined therapy group is superior to the control groups in therapeutic effects. Due to the limited quantity and quality of the included studies, this conclusion needs to be proved by performing more high quality RCTs