Objective To evaluate the efficacy and safety of different doses of metoprolol in the treatment of primary hypertension.Methods We searched for randomized controlled trials of different doses of metoprolol in the treatment of primary hypertension. We screened relevant studies according to predefined inclusion and exclusion criteria, evaluated the quality of the included studies, and performed meta-analyses by using The Cochrane Collaboration’s Revman 4.2.8 software. Results Five randomized controlled trials of different doses of metoprolol in the treatment of primary hypertension were included. Two were of high quality and the other three were of low quality. No study reported mortality or the incidence of cardiovascular events, but four studies reported the means and standard deviations of systolic and diastolic blood pressures and heart rate. Based on the two self-control studies, meta-analyses of the levels of systolic and diastolic blood pressures before and after treatment of different doses of metoprolol showed that the combined OR for systolic blood pressure levels was -4.62 [95%CI (-7.77, -1.47), P=0.004]; and for the diastolic blood pressure levels, the combined OR was -5.71 [95%CI (-6.75, -4.68), Plt;0.000 01]. Four studies reported adverse reactions, and meta-analysis of the incidence of non-specific adverse reactions showed that the combined OR was 2.61 [95%CI (1.33, 5.13), P=0.005]. Conclusion A dose-effect relationship may exist between the dose of metoprolol and antihypertensive effect in the treatment of hypertension. When the antihypertensive effect of low-dose metoprolol was inadequate, an increase in the dose may lower blood pressure further. Although high-dose metoprolol has higher incidence of adverse reactions, it can be tolerated by most patients. Therefore, in the treatment of hypertension with metoprolol, an individualized dosing regimen can be applied according to the patient’s tolerance, and blood pressure may be controlled ideally by a gradual increase of the metoprolol dose to its maximum tolerated dose.
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.
Objective To evaluate the efficacy and safety of latanoprost versus travoprost for primary open-angle glaucoma (OAG) and ocular hypertension (OH). Methods All the randomized controlled trials (RCTs) about treating primary open-angle glaucoma and ocular hypertension with latanoprost and travoprost were collected by searching MEDLINE, EMbase, OVID and CNKI. The assessment of methodological quality and data extraction of the included studies were performed independently by two reviewers, and the meta-analysis was conducted with RevMan 5.0 software. Results A total of 13 RCTs involving 1 433 patients were included. The results of meta-analyses showed that, a) At the second week, travoprost showed greater intraocular pressure (IOP) lowering efficacy compared with latanoprost (WMD= –1.47, 95%CI –2.62 to –0.33). At the first month (WMD= –0.50, 95%CI –1.52 to 0.52) and the sixth month (WMD= –0.12, 95%CI –0.85 to 0.61), the difference of IOP reduction between latanoprost and travoprost group was not significant; and b) The latanoprost-treated group showed fewer reported conjunctival congestion than the travoprost-treated group (OR=0.47, 95%CI 0.35 to 0.63). The difference in adverse events of eye pain (OR=0.55, 95%CI 0.27 to 1.12) and iris or skin depigmentation (OR=1.25, 95%CI 0.53 to 2.92) between latanoprost and travoprost group was not significant. Conclusion Latanoprost and travoprost are comparable in lowering IOP for OAG and OH patients. Latanoprost shows greater ocular tolerability with lower incidence of side effects as conjunctival congestion. This conclusion is not powerful enough in proof due to the medium methodology quality of the included studies, so a large number of high-quality RCTs with large sample are needed for objectively, entirely and precisely evaluating the efficacy.
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.
This paper introduces the current situation of patient safety movement in 20 years from its origin, and expounds the strategies of patient safety from six view points of medical reform, medical insurance, system, culture, education and training, and patient participation in patient safety, so as to promote the healthy development of patient safety work in China.
ObjectiveTo systematically review the safety of low molecular weight heparin (LMWH) in pregnancy. MethodsPubMed, EMbase, The Cochrane Library, WanFang Data, VIP, and CNKI databases were electronically searched to collect randomized controlled trials (RCTs) and cohort studies on the safety of LMWH in pregnancy from inception to March 30th, 2020. 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 77 RCTs and 13 cohort studies were included. The results of meta-analysis showed that LMWH increased the incidence of postpartum hemorrhage (RR=1.50, 95%CI 1.00 to 2.25, P=0.05). However, there was no significant difference. The incidence of hematological adverse events was different from the results of RCTs and cohort studies. The results of RCT subgroup analysis showed that LMWH increased ecchymosis at the injection site (RR=1.60, 95%CI 1.24 to 2.08, P=0.000 4). However, the incidence of overall skin system adverse events did not increase significantly. LMWH reduced the incidence of cardiovascular adverse events (RR=0.18, 95%CI 0.07 to 0.46, P=0.000 3). LMWH failed to increase the occurrence of fetal congenital malformations, digestive system, central nervous system, skeletal system, and systemic adverse events. ConclusionsCurrent evidence suggests that LMWH is relatively safe to use during pregnancy. However, whether it increases postpartum hemorrhage and hematological adverse events is unclear. Due to limited quality and quantity of the included studies, more high-quality studies are required to verify the above conclusions.
Objective To explore the postoperative influence of intra-abdominal implantation of sustained-releasing 5fluorouracil on the hepato-renal function, immune function, nutritional state and complications in patients with gastric and colorectal cancer. Methods Sixty-five patients with gastric or colorectal cancer were included into this study from January to June 2009. The patients (35 cases of gastric cancer, 18 cases of colon cancer and 12 cases of rectal cancer) were randomly divided into experimental group (n=25) and control group (n=40). In experimental group, 400 mg sustained-releasing 5-fluorouracil was used. Blood samples were gained before operation, the second day and the seventh day after operation to examine the indexes of hepato-renal function, immune function and nutritional state. Complications， venting time and length of stay after operation were also recorded. Results There was no statistical significance for distribution of tumor stages and patients’ gender between experimental group and control group (Pgt;0.05). Preoperative indexes of hepato-renal function, immune function and nutritional state were also not reached statistical significance between two groups (Pgt;0.05). Compared with control group, the indexes of total protein and transferrin were decreased and urea nitrogen and IgM were increased in the second day after operation in experimental group (Plt;0.05). The number of lymphocyte was increased, while CD4, Alb, total protein and IgA were decreased in the seventh day after operation in experimental group, respectively. The time of passage of gas of experimental group was longer than that of control group (Plt;0.05).Conclusion Intra-abdominal implantation of sustained-releasing 5-fluorouracil is safe and feasible, which does not increase the complications and the time of length stay after operation. However, there is a little influence on immune function and gastrointestinal function after operation for intra-abdominal implantation of sustained-releasing 5-fluorouracil.
Objective To compare clinical outcomes and safety between minimally invasive mitral valve replacement via right minithoracotomy （mini-MVR） and traditional mitral valve replacement （MVR）. Methods Clinical data of 68 patients with valvular heart diseases who underwent mini-MVR from February 2009 to December 2011 in Wuhan Asia Heart Hospital were retrospectively analyzed. There were 36 males and 32 females in this mini-MVR group with their mean age of 34.2±11.2 years. Preoperatively， there were 21 patients with mitral stenosis （MS）， 17 patients with mitral insufficiency （MI）， 30 patients with MS and MI， and 19 patients with tricuspid insufficiency （TI）. Another 200 patients with valvular heart diseases who underwent traditional MVR during the same period were included as the control group. There were 86 males and 114 females in the control group with their mean age of 49.4±13.2 years. Preoperatively， there were 85 patients with MS， 66 patients with MI， 49 patients with MS and MI， and 76 patients with TI. Hospital mortality， aortic crossclamp time， length of intensive care unit （ICU） stay， postoperative chest tube drainage， reexploration for bleeding and postoperative morbidities were compared between the two groups. Results There was no in-hospital death in the mini-MVR group. There was no statistical difference in hospital mortality， cardiopulmonary bypass time， incidence of reexploration for bleeding， postoperative arrhythmias， dialysis-requiring acute renal failure and wound infection between the two group （P＞0.05）. Aortic crossclamp time of the mini-MVR group was significantly longer than that of the control group. But postoperative mechanical ventilation time （10.2±3.1 h vs. 15.2±7.1 h， P=0.008）， chest tube drainage（92.0±28.0 ml vs. 205.0±78.0 ml， P=0.000）， blood transfusion （0.8±1.6 U vs. 1.9±2.1 U， P=0.006）， length of ICU stay （14.0±8.0 h vs. 26.0±12.0 h， P=0.003） and length of hospital stay （14.8±4.6 d vs. 19.7±3.2 d， P=0.006）of the mini-MVR group were significantly shorter or less than those of the control group. Conclusion The safety of mini-MVR is comparable to that of traditional MVR without causing higher postoperative morbidities， while the postoperative recovery after mini-MVR is better than traditional MVR.
Objective To assess the efficacy and safety Losartan for essential hypertension associated withhyperuricemia. Methods Included randomized controlled trials of Losartan versus Valsartan. Electronic searchconducted in CENTRAL, the Cochrane Library (until 2008, Issue 4), PubMed, EMBASE, Chinese Biomedicine database,Chinese Scientific Journals Full-text Database, and China Journal Full-text Database (until 2008, Issue 10). Two reviewers extracted data independently. RevMan 5.0 software developed by the Cochrane Collaboration was used for Metaanalysis.Results Only 7 trials with 1 136 eligible patients were included in the systematic review. Meta-analysis showedno significant difference in reductions of systolic blood pressure, diastolic blood pressure, and adverse events betweenLosartan and Valsartan groups. However, a significant difference of serum uric acid reduction was observed betweenLosartan and Valsartan group. Losartan play a significant role of decreased serum uric acid levels. Conclusions Based on this systematic review, Losartan is effective and well tolerated in reducing BP and serum uric acid levels. Further large randomized, double blind, placebo controlled trials are needed in long-term safety and efficacy and different subgroups of Losartan.
Objective To systematically review the safety of rifapentine vs. rifampicin for pulmonary tuberculosis. Methods PubMed, EMbase, The Cochrane Library, CBM, VIP, WanFang Data and CNKI databases were electronically searched to collect randomized controlled trials (RCTs) of rifapentine vs. rifampicin for pulmonary tuberculosis up to September 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. Results A total of 26 RCTs involving 3 624 cases were included. The results of meta-analysis showed that the rifapentine group was superior to the rifampicin group on the incidence of abnormal liver function (RR=0.31, 95%CI 0.32 to 0.47, P<0.000 01), skin rash occurrence rate (RR=0.24, 95%CI 0.16 to 0.37,P<0.000 01), the incidence of leukopenia (RR=0.41, 95%CI 0.31 to 0.54,P<0.000 01), and the incidence of gastrointestinal reaction (RR=0.46, 95%CI 0.37 to 0.57,P<0.000 01) with statistical significance. Conclusions Current evidence shows that compared with rifampicin, rifapentine can effectively reduce the adverse reactions of patients. Due to limited quality and quantity of the included studies, more high quality studies are needed to verify the above conclusion.