ObjectiveTo evaluate donor safety in living donor liver transplantation. MethodsThe clinical data of 356 donors underwent living liver donation in our center from January 2001 to September 2015 were retrospectively analyzed. These patients were divided into pre-2008 group(before January 2008) and post-2008 group(after January 2008). The donor safety was evaluated with regard to three aspects, i.e. complications, liver function, and quality of life. Results①There was no donor death in our center.②The overall complications rate was 23.3%(83/356). The proportion of ClavienⅠ, Ⅱ, Ⅲ, andⅣcomplications was 50.6%(42/83), 26.5%(22/83), 21.7%(18/83), and 1.2%(1/83), respectively. In all the donors, the incidence of ClavienⅠ, Ⅱ, Ⅲ, andⅣcomplications was 11.8%(42/356), 6.2%(22/356), 5.1%(18/356), and 0.3%(1/356), respectively. The overall complications rate in the post-2008 group was significantly lower than that in the pre-2008 group〔18.1%(41/227) versus 32.6%(42/129), P < 0.01〕. The most common complication was the biliary complication with an incidence of 8.4%(30/356).③The postoperative liver dysfunction was transient and generally retur-ned to normal level within a week.④The donor's quality of life was generally satisfied as assessed by the SF-36 tool, and 94.8%(239/252) of them would donate again if necessary. ConclusionEver improving surgical and anesthetic techniques, together with strict donor selection and specialized perioperative management, could guarantee a low donor morbidity and a satisfactory long-term prognosis.
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 complication rate of CT-guided percutaneous lung biopsy and determine the risk factors. Methods A retrospective investigation of patients with CT-guided percutaneous lung biopsy in Ruijin Hospital, Shanghai Jiao Tong University School of Medicine between2002 and 2009 was performed. The risk factors for complications were determined by multivariate analysis of variables related to patients’demographics, lung lesions, biopsy procedures, and individual radiological features. Results 281 biopsy procedures were enrolled. The total complication rate was 55. 9% with pneumothorax 32. 4% ( 91/281) , hemoptysis 34. 5% ( 97 /281) , and cutaneous emphysema2. 1% ( 6 /281) , and with no mortality.The pneumothorax rate was correlated with lesion location, lesion depth, and number of pleural passes. The bleeding risk was correlated with lesion size, lesion depth, and age. Prediction models for pneumothorax and bleeding were deduced by logistic regression. The pneumothorax model had a sensitivity of 80. 0% and a specificity of 62. 4% . And the bleeding model had a sensitivity of 67. 4% and a specificity of 88. 8% .Conclusions Lesion location, lesion depth, and number of pleural passes were independent risk factors for pneumothorax. Lesion size, lesion depth, and age were independent risk factors for bleeding. The prediction models for pneumothorax and bleeding will helpfully reduce the complication of CT-guided lung biopsy.
Objective To assess the efficacy and safety of levoamlodipine besylate for essential hypertension. Methods We searched MEDLINE (1999 to October 2007), EMBASE (1999 to October 2007), The Cochrane Library (Issue 3, 2007), CNKI (1999 to 2007), Wanfang (1999 to 2007), VIP (1999 to 2007) and CBM (1999 to October 2007). The quality of included studies was critically evaluated. Data analyses were performed with The Cochrane Collaboration’ s RevMan 4.2 software. Results A total of 345 articles were retrieved, but only 17 were finally included. Meta-analyses showed that the effective rate in patients receiving levoamlodipine besylate was significantly higher than that in patients receiving indapamide (RD 0.14, 95%CI 0.06 to 0.22, P=0.0004), while no significant differences were noted between the levoamlodipine besylate group and other control groups. The incidence of adverse effects was significantly lower in the levoamlodipine besylate group compared to the indapamide group (RD –0.12, 95%CI –0.21 to –0.03, P=0.01), the amlodipine group (RD –0.06, 95%CI –0.11 to –0.01, P=0.02) and the nitrendipine group (RD –0.27, 95%CI –0.46 to – 0.08, P=0.006). No significant differences were observed between the levoamlodipine besylate group and other control groups. Conclusion Levoamlodipine besylate tends to have better efficacy and safety profiles compared with other antihypertensive drugs. However, most trials included in the review were of poor quality and, so, multi-center large-scale randomized controlled trials of higher quality are needed to confirm this.
ObjectiveTo evaluate the safety and efficacy of preoperation administration of enteral nutrition enriched ω-3 fatty acids for gastric cancer patients. MethodsA single center randomized controlled clinical trial was performed in 60 cases of gastric cancer in West China Hospital during January 2014 to June 2014, and cases were equally randomized divided into treatment group and control group. Cases of treatment group were given enteral nutrition enriched ω-3 fatty acids which was manufactured by Fresenius Kabi Deutschland GmbH for 5 consecutive days before operation, and cases of control group were given an isocaloric and isonitrogenous homogenized diet for 5 consecutive days before operation. The laboratory indexes of nutritional status and imflammatory factors were observed and compared between 2 groups on admission, preoperative day 1, postoperative day 3, and postoperative day 5. Liver and kidney function indexes which as the safety indexes were detected on admission and preoperative day 1. Vomiting, diarrhea, and infectious complications were recorded in addition. ResultsOn 3 days after operation, levels of interleukin-6 (IL-6) and α-acid glycoprotein (AAG) of treatment group were both lower than those of control group (P<0.05); on 5 days after operation, levels of C-reactive protein (CRP) of treatment group was lower than that of control group too (P<0.05); but at other time points, there were no significant differences in any index between the 2 groups (P>0.05). During the period of enteral nutrition, only 1 case suffered from bloating and 1 case suffered from diarrhea, both in treatment group, and the incidence of adverse reactions didn't differed between treatment group[6.7% (2/30)]and control group[0 (0/30)], P>0.05. Moreover, there were no significant differences between treatment group and control group in incidences of wound infection[3.3% (1/30) vs. 10.0% (3/30)], abdominal infection[0 (0/30) vs. 3.3% (1/30)], urinary infection[0 (0/30) vs. 3.3% (1/30)], and pulmonary infection[0 (0/30) vs. 6.7% (2/30)], but the total incidence of complication was lower in treatment group than that of control group[3.3% (1/30) vs. 23.3% (7/30)], P=0.026. ConclusionEnteral nutrition enriched ω-3 fatty acids can reduce the rate of infection-related complication for patients with gastric cancer, and has a sense of safety.
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 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 explore the efficacy and safety of the ketogenic diet (KD) in the treatment of genetic developmental and epileptic encephalopathy (DEE). Methods Clinical data from 42 children with genetically confirmed refractory epileptic encephalopathy treated in the Department of Neurology, Jinan Children’s Hospital, between January 2021 and October 2023 were retrospectively analyzed. A classic KD protocol was implemented, and outcomes including seizure frequency, electroencephalogram (EEG) improvement, and adverse reactions were observed at 3, 6, and 12 months post-treatment. Results Among the 42 children, the seizure-free rates at 3, 6, and 12 months of KD treatment were 16.7%, 16.7%, and 14.3%, respectively, while the effective seizure control rates were 69.0%, 52.4%, and 35.7%. At 3 months, comparison of baseline characteristics between the effective and ineffective groups showed no statistically significant differences in gender (P=0.095), age at onset (P=0.648), age at KD initiation(P=0.768), disease duration before KD (P=0.519), presence of abnormal brain MRI findings (P=0.226), epilepsy syndrome classification(P=0.344), or ion channel gene involvement (P=0.066). EEG improvement rates at 6 and 12 months were 54.2% (24 cases) and 42.8% (14 cases), respectively. Retention rates for KD at 3, 6, and 12 months were 100.0%, 71.4%, and 42.8%. Adverse reactions occurred in 7 patients (16.7%), primarily gastrointestinal symptoms (vomiting, constipation, diarrhea; 6 cases) and elevated uric acid (1 case), with no severe adverse events reported. Conclusion KD is an effective treatment for genetic DEE with favorable short-term safety, though long-term adherence requires attention.
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 assess the clinical efficacy and safety of paclitaxel in the first-line and second-line treatment of patients with small cell lung cancer (SCLC). Methods We searched The Cochrane Library, MEDLINE, EMBASE, CBM, CNKI, VIP and etc to collect all clinical controlled trials involving the addition of paclitaxel to chemotherapy in SCLC patients. Two reviewers evaluated the quality of included trials independently. The Cochrane Collaboration’s software RevMan 4.2.2 was used for meta-analyses. Results Nine trials involving 1675 SCLC patients were included. Five trials were randomized controlled trials, and all trails didn’t mention the blinding methods. Meta analyses indicated that the PET arm (paclitaxel+cisplatin+etoposide) had a similar response rate compared with the EP arm (etoposide+cisplatin) (OR1.35, 95%CI 0.98 to 1.85). The incidences of severe thrombocytopenia (OR 1.68, 95%CI 1.12 to 2.52) and lethal toxicity (OR 4.00, 95%CI 1.77 to 9.04) were higher in the PET arm than those in the EP arm, but the incidence of severe leukocytopenia was lower in the PET arm (OR 0.50, 95%CI 0.37 to 0.68). A total of 54 treatment-related deaths were reported. Conclusion In the first-line treatment of SCLC, the combination of paclitaxel, carboplatin and etoposide improved the progression-free survival, but the combination of paclitaxel and EP did not improve the survival and was more toxic than EP alone. Paclitaxel as the second-line treatment showed some therapeutic effect. Due to the poor quality and small sample size of included trials, more well-designed multi-center randomized controlled trials should be performed.