Objective To assess the safety of intravenous infusion with self-made perfluorocarbon emulsion (PFE) in rats.Methods 35 Wistar rats were randomly divided into a normal control group and six PFE groups (n=5 in each group).The control group was intravenous injected with normal saline and six PFE groups with PFE.Blood samples were obtained from the PFE groups 5 min after injection via vena orbitalis for perfluorocarbon (PFC) measurement.The control group were sacrificed at 2 hours after injection，and the six PFE groups were respectively killed at 2 h，4 h，6 h，24 h，48 h and 10 d after injection.The blood levels of PFC，PaO2，GPT，GOT，BUN and Cr were measured.Pathological changes of lung，liver and kidney were also observed.Results All rats were in good health state after PFE intravenous injection with no obvious pathological changes in liver and kidney.PFC was wide distributed throughout the pulmonary alveoli and capillaries.The levels of GPT and GOT were higher in the PFC groups at 2，4，6 and 24 h than which in the control group (all Plt;0.05)，but there were no significant difference between the PFE 10 d group and the control group.The levels of BUN and Cr had no remarkably differences in all groups.Blood PFC concentrations were (20±1.8)mg/mL，(1.8±0.7)mg/mL，(1.5±0.6)mg/mL，(1.2±0.4)mg/mL，(0.5±0.2)mg/mL，(0.2±0.03)mg/mL，0 mg/mL in the PFE groups respectively at 5 min，2 h，4 h，6 h，24 h，48 h，10 d after injection.PaO2 of the PFE 2 h group was significant higher than which in the control group [(119.2±8.6)mm Hg vs (99.6±4.7)mm Hg，Plt;0.05].Conclusion Intravenous injection with PFE (10 mL/kg) can enhance PaO2 with good safety and no obvious influence on pathology of lung，liver and kidney，so may be used for the treatment study of acute lung injury.
Objective To observe the treatment efficacy and safety of glucosamine hydrochloride tablets on uremia patients with knee osteoarthritis (OA). Methods A total of 118 uremia patients with knee OA were selected and randomly divided into the glucosamine hydrochloride tablets treatment group (treatment group) and the coated aldehyde oxystarch capsules group (control group) with 59 cases in each group. The course was 8 weeks. The Lequesne Index was assessed for curative effect evaluation, and the change of blood indexes was observed to evaluate drug safety. Results The total effective rate of Lequesne Index in the treatment group was 72.9%, while that in the control group was 13.6%; the difference was statistically significant (χ2=42.303, P<0.001). There was no significant change in the two groups before and after treatment in terms of the patients’ dialysis adequacy, routine blood, blood electrolytes, liver and kidney function (P>0.05). Conclusion Glucosamine hydrochloride tablets is curative and safe in the treatment of uremia patients with OA.
Objective To systematically review the efficacy and safety of laparoscopic hepatectomy (LH) and open hepatectomy (OH) for patients with hepatocellular carcinoma (HCC). Methods PubMed, EMbase, The Cochrane Library, CBM, WanFang Data, CNKI databases were electronically searched to collect the case-control studies about LH vs. OH for patients with HCC from inception to December, 2015. 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 28 studies involving 1 908 patients were included. The results of meta-analysis showed that: the LH group was superior to OH group on complications (OR=0.35, 95%CI 0.26 to 0.48, P<0.000 01), hospital stay (MD=–4.18, 95%CI (–5.08, –3.29),P<0.000 01), and five years overall survival rate (OR=1.65, 95%CI 1.23 to 2.19,P=0.000 7) and disease-free survival rate (OR=1.51, 95%CI 1.12 to 2.03, P=0.006). However, no significant differences were found in one year and three years overall survival rate, disease-free survival rate, and postoperative recurrence rate. Conclusion Current evidence shows that the LH is superior to OH for the treatment of HCC, and may be amenable to surgery because of its safety and longtime efficacy. Due to limited quality and quantity of the included studies, more high quality studies are needed to verify above conclusion.
Objective To explore the short-term efficacy and safety of intra-arterial thrombolysis (IAT) in the treatment of retinal artery occlusion (RAO) with the assistance of the rescue green channel in the eye stroke center. Methods A prospective, interventional, single-center study. Thirty-eight eyes from 38 RAO patients who received IAT treatment in Guangdong Provincial People’s Hospital were enrolled. All the patients were rescued via the green channel in our eye stroke center. Data from comprehensive ocular examinations including best-corrected visual acuity (BCVA) and optical coherence tomography angiography (OCTA) were collected. BCVA was measured with Snellen chart and converted to the logarithmic minimum angle of resolution (logMAR) unit for statistical analysis. RTVue XR OCTA was used to measure vascular densities (VD) of the superficial capillary plexus (SCP), deep capillary plexus (DCP) and radial peripapillary capillary (RPC), and central retinal thickness (CRT). All RAO eyes attempted IAT treatment and 34 eyes were successful. Four eyes failed to complete IAT because of the occlusion of internal or common carotid arteries on the same side with the RAO eyes. Ocular examinations in post-operative 1-3 days were performed with the same devices and methods as those before surgery. Parameters measured before and after surgery include BCVA, VD of SCP, DCP, RPC, and CRT. Data of the green channel collected include the time intervals from onset of RAO to first presentation in local hospitals, and from onset of RAO to our eye stroke center. Comparisons of VD and CRT between the RAO eyes and contralateral healthy eyes were performed with independent samples Mann-Whitney U test; comparisons of VD and CRT in RAO eyes before and after IAT surgery were performed with paired samples Wilcoxon Rank Sum test. Results Among the 34 RAO patients who had successful IAT surgery, 18 (52.9%, 18/34) were males and 16 (47.1%, 16/34) were females; the mean age was (51.0±12.9) years old. There were 30 and 4 eyes diagnosed as central RAO and branch RAO respectively. The logMAR BCVA before and after IAT surgery was 2.52±0.61 and 2.18±0.85 respectively, and the difference was statistically significant (Z=－3.453, P=0.002). Before surgery, VD of SCP, DCP and RPC were significantly decreased and CRT was significantly increased in the affected eye compared with the contralateral healthy eyes, with the statistical significance (P＜0.001). Compared with those before surgery, the VD of SCP and DCP were significantly improved after surgery (Z=－2.523, －2.427; P=0.010, 0.014), while there was no difference in VD of RPC and CRT (Z=－1.448, －1.454; P=0.150, 0.159). The time interval between onset of RAO and first visit to the hospital was (6.56±6.73) hours; the time interval between onset of RAO and the arrival at our hospital was (24.11±19.90) hours. No cerebral stroke was observed in the early post-operative period and no cerebrocardiovascular events were observed later. he time interval between onset of RAO and the arrival at our hospital was (24.11±19.90) hours. No cerebral stroke was observed in the early post-operative period and no cerebrocardiovascular events were observed later. Conclusions The short-term efficacy and safety of IAT in the treatment of RAO were satisfactory. The rescue time window might be prolonged.
ObjectiveTo evaluate the safety, efficacy, and cost-effectiveness of different uses of oxidized regenerated cellulose (ORC) in video-assisted thoracoscopic surgery (VATS) for lung cancer resection to provide a reference for the selection, clinical use, and rational utilization of absorbable hemostatic materials. MethodsA retrospective analysis of relevant data from inpatients who underwent VATS for lung cancer resection at a tertiary hospital from July 2019 to January 2020 and from July 2020 to December 2020 was conducted. Patients were divided into two groups based on the use of ORC: 1) combined use group (ORC and collagen sponge) and 2) sole-use group (ORC). Safety, efficacy, and economic outcome indicators were compared between the two groups. ResultsThe main analysis included a total of 904 patients, with 466 in the combined use group and 438 in the sole-use group. Compared to the combined use group, the sole-use group had a significantly longer hospital stay, used fewer hemostatic drugs, had a lower average cost of hemostatic materials, and a lower median total hospitalization cost (P<0.05). No statistically significant difference was found between the two groups in terms of intraoperative blood loss volume, massive blood loss rate, perioperative transfusion rate, reoperation rate, postoperative 48-hour drainage volume, bloody drainage fluid rate, or postoperative laboratory test indicators. ConclusionThere was no significant difference in the safety or efficacy of VATS for lung cancer resection between the sole use of ORC and the combined use of ORC, but the sole use of ORC was associated with a lower cost of hemostatic materials and a lower total hospitalization cost. The sole use of hemostatic gauze in VATS for lung cancer resection may be a more cost-effective choice.
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 systematically evaluate the effectiveness and safety of minimally invasive video-assisted thyroidectomy (MIVAT) and conventional open thyroidectomy (COT) in treatment of thyroid carcinoma without lymph node metastasis. Methods Databases including PubMed, EMbase, The Cochrane Library (Issue 3, 2015), WanFang, CBM, VIP and CNKI were searched to collect the randomized controlled trails (RCTs) and non-RCTs about MIVAT and COT in treatment of thyroid carcinoma without lymph node metastasis. The retrieval time was from inception to October 2015. The studies were screened according to the inclusion and exclusion criterias, and the data was extracted and the quality of studies was evaluated by 2 reviewers independently. Then the Meta-analysis was conducted by using RevMan 5.2 software. Results A total of 13 non-RCTs involving 3 083 cases were included. The results of Meta-analysis showed that: compared with COT group, operative time of MIVAT group was longer (MD=31.36, 95% CI: 27.68-35.03, P<0.05), hospital stay (MD=-0.16, 95% CI: -0.28--0.04, P=0.01) and length of scar (MD=-1.51, 95% CI: -1.63--1.39, P<0.05) of MIVAT group were shorter, but there was no significant difference in the incidences of transient hypocalcemia (OR=1.29, 95% CI: 0.93-1.78, P=0.13), transient laryngeal nerve palsy (OR=1.42, 95% CI: 0.93-2.17, P=0.11), hemotoma (OR=1.21, 95% CI: 0.64-2.29, P=0.56), recurrence (OR=0.61, 95% CI: 0.28-1.33, P=0.22), number of retrieved central lymph nodes (MD=-0.10, 95% CI: -0.98-0.78, P=0.82), and the size of tumors (MD=-0.02, 95% CI: -0.06-0.02, P=0.39) between the 2 groups. Conclusion MIVAT is safe and feasible in treatment of thyroid carcinoma without lymph node metastasis when its indications are strictly controlled.
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.
ObjectiveTo evaluate the effectiveness and safety of the additional catheter-directed thrombolysis (CDT) and conventional treatment (CT) for treatment primary deep vein thrombosis. MethodsDatabases such as CNKI, WanFang Data, Pubmed, EMBASE.com, Medline, CBM, CSJD, CJFD, and the Cochrane Library were electronically searched from the date of their establishment to 30 June, 2013, and the relevant literatures and conference proceedings were also manually searched to include randomized controlled trials (RCTs) on comparison of additional CDT versus CT for primary deep vein thrombosis. Two reviewers independently screened studies according to the inclusion and exclusion criteria, extracted data, and accessed the methodological quality of the included studies. Then the meta-analysis was performed by using RevMan 5.1 software. Publication bias was assessed by STATA software. A meta-regression model was used to describe between study variability. ResultsTwo RCTs including 3 literatures contain 224 patients reporting data on safety and efficacy of CDT versus CT were included. There were no publication bias (Begg'S test, Z=1.02. P > 0.05;Egger'S test, t=0.98, P > 0.05). The results of meta-analysis showed that:in 6 months after surgery iliofemoral vein patency rate of CDT group was higher than that of CT group (OR=3.62, 95% CI:1.51-8.64, P=0.004), in 6 months after surgery CDT group with a lower rate than CT group of the iliofemoral vein occlusion and (or)venous reflux rate (OR=0.24, 95% CI:0.11-0.53, P=0.000), and the incidence rate of PTS in 24 months after surgery in CTD group was less than that of CT group (OR=0.55, 95% CI:0.31-0.96, P=0.040). There were no statistically significant of the major complications after surgery between CDT group and CT group (OR=1.34, 95% CI:0.12-15.69, P=0.810). But the incidence rates of minor complications and total complications after surgery in CT group were lower than those of CDT group (OR=13.67, 95% CI:4.08-45.83, P < 0.00 01 and OR=11.67, 95% CI:4.40-30.99, P < 0.000 01). ConclusionsCDT is a effective and positive way to treat early deep venous thrombosis especially in terms of the patency of vascular and prevent the occlusion and PTS. Due to the limitation of the included studies, large sample size, multicenter, and high quality studies are needed to verify the above conclusion, such as the ATTRACT Study. The intracavitary therapy could be applied to clinic combining individual conditions of patients.