ObjectiveTo explore the value of the long time lower abdominal aorta balloon block technology in the pelvis or sacrum tumor surgery. MethodsFrom January 2005 to June 2013, the sacrum or pelvic tumor patients underwent the long time lower abdominal aorta balloon block technology in the Orthopedics Department of West China Hospital of Sichuan University were enrolled. According to the balloon blocking time, patients were divided into A (<90 mins), B (90 to 180 mins), and C (>180 mins) groups. The intraoperative blood loss, blood transfusion amount, average lengths of hospital stay, postoperative volume of drainage, and postoperative complications were compared among the three groups. ResultsA total of 78 patients were included, of which 21 were in group A, 38 were in group B and 19 were in group C. All patients received en bloc resection, and did not experience intraoperative balloon shift and abdominal aorta flow leakage. Comparing the three groups, there were significant differences in intraoperative blood loss (P=0.026) and average lengths of hospital stay (P=0.021). Further pairwise comparison showed the intraoperative blood loss and average lengths of hospital stay in group C were significantly higher than those in group A and group B. In addition, there were no statistical differences among the three groups in blood transfusion amount, postoperative volume of drainage and postoperative complications. ConclusionIn the pelvis and sacrum tumor surgery, extending the time of abdominal aorta balloon block can reduce bleeding, save blood, increase the safety of surgery without increasing in postoperative complications.
Objective To evaluate the efficacy and safety of whole lung lavage in the treatment of pulmonary alveolar proteinosis ( PAP) .Methods Twelve patients who were diagnosed as PAP from September 2008 to October 2011 in Hunan Occupational Disease Hospital were recruited in the study. The changes of dyspnea symptom, lung-function, arterial blood gas, and chest image were compared before and after whole lung lavage treatment. Meanwhile, the safety of lung lavage was evaluated. Results All patients were relieved from dyspnea. The lung function, hypoxia, hyperventilation, and chest image were all obviously improved. The vital signs in the process of lung lavage were stable without serious complications. Conclusion Whole lung lavage is an effective and safe treatment for PAP.
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.
Objective To investigate the clinical efficacy and safety of hyperthermic intraperitoneal perfusion chemotherapy (HIPC) in treatment of advanced colorectal cancer.Methods The Meta-analysis was applied to analyze 8 randomized controlled quantitative studies published at domestic and abroad. These patients treated by HIPC after radical operation with colorectal cancer were included for the treatment group, and those treated only by radical operation with colorectal cancer for the control group. Relative risk (RR) of outcome variable of 3-year and 5-year survival rate and safety between the two groups were compared. Results There were 8 selected literatures, including 1 501 cases, in which 765 cases for treatment group, and 736 cases for control group. RR of 5-year survival rate of the total patients was 2.39 (95% CI: 1.66-3.45). RR of 3-year survival rate of the total patients was 2.13 (95% CI: 1.45-3.13). The results demonstrated that HIPC could improve 5-year and 3-year survival rate, and sensitivity analysis confirmed the conclusions more reliable. The security was described in 5 literatures, the available information showed smaller potential security issue. Conclusions HIPC after radical operation of advanced colorectal cancer can increase 5-year and 3-year survival rate of patients, improve the prognosis of patients. Whether patients with increased incidence of postoperative complications related to the HIPC is no clear-cut conclusions for lack of related research.
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.
ObjectiveTo systematically review the safety of different types of COVID-19 vaccines in the population.MethodsWeb of Science, PubMed, EMbase, The Cochrane Library, CNKI, WanFang Data and CBM databases were electronically searched to collect randomized controlled trials (RCTs) which reported safety of COVID-19 vaccines in population. Two reviewers independently screened literature, extracted data and assessed the risk of bias of included studies. Meta-analysis was then performed by using RevMan 5.4 software.ResultsA total of 5 RCTs involving 2 431 subjects were included. The results of the meta-analysis showed that COVID-19 vaccines developed more fever symptoms than placebo (RR=2.21, 95%CI 1.38 to 3.54, P=0.000 9). However, there was no significant difference in the incidence of adverse reactions (RR=1.28, 95%CI 0.96 to 1.70, P=0.10), injection site adverse reactions (RR=1.47, 95%CI 0.65 to 3.36, P=0.36) and systemic adverse reactions (RR=0.96, 95%CI 0.78 to 1.17, P=0.66) between two groups.ConclusionsCurrent evidence shows that COVID-19 vaccines are sufficiently safe. Due to limited quality and quantity of the included studies, more high-quality studies are required to verify the above conclusions.
ObjectiveTo observe effect and safety of interstitial chemotherapy with 5-fluorouracil sustained release agent in radical operation of colorectal cancer. MethodsOne hundred and sixty patients with colorectal cancer from October 2011 to December 2013 were randomly divided into observation group and control group according to an incomplete random method, 78 cases of them were in the observation group and 82 cases of them were in the control group. All the patients were performed radical resection of colorectal cancer. The abdominal cavity and pelvic cavity were washed after surgery. 5-fluorouracil sustained release agent was implanted in the observation group patients for interstitial chemotherapy, the implant site was at the tumor resection area and the mesenteric artery. Routine chemotherapy was performed in these two groups after operation. The postoperative complications were observed. The postoperative local recurrence rate, liver metastasis rate, and 24-month survival rate were recorded. ResultsThe rates of abdominal complications and toxic effects had no significant differences between these two groups (P > 0.05). The rates of 12-month and 24-month local recurrence and the rate of liver metastasis in the observation group were significant lower than those in the control group[1.3% (1/78) versus 8.5% (7/82), x2=8.934, P=0.023; 5.2% (4/78) versus 23.2% (19/82), x2=14.834, P=0.004; 10.3% (8/78) versus 18.3% (15/82), x2=12.034, P=0.016]. The rate of 24-month survival in the observation group was significant higher than that in the control group[94.9% (74/78) versus 84.1% (69/82), x2=11.465, P=0.010]. ConclusionThe good safety of interstitial chemotherapy with 5-fluorouracil sustained release agent could effectively decrease local recurrence rate and liver metastasis rate of colorectal cancer after radical operation and improve survival time of patients.
Objective To evaluate the effectiveness and safety of ramelteon for chronic insomnia in adults. Methods The following databases as CENTRAL, PubMed, EMbase, ISI, CNKI, CBMdisc, VIP and WanFang Data were searched from the date of their establishment to November 2010. The randomized controlled trials (RCTs) meeting the inclusion criteria were included. The data extraction and quality assessment were conducted according to the methods of Cochrane Reviewers’ Handbook recommend by The Cochrane Collaboration, and meta-analysis was performed with RevMan5.0 software. Results A total of 5 RCTs involving 1 772 patients were included. The results of meta-analyses showed that: a) Effectiveness: In the effectiveness, ramelteon was superior to placebo in latency to persistent sleep (MD=18.36, 95%CI 11.55 to 25.18, Plt;0.000 01), total sleep time (MD= –15.47, 95%CI –22.50 to –8.43, Plt;0.000 1), sleep efficiency (MD= –3.39, 95%CI –5.32 to –1.46, P=0.000 6), sleep quality (MD=0.14, 95%CI 0.03 to 0.25, P=0.01) after one week treatment and latency to persistent sleep (MD=13.02, 95%CI 6.01 to 20.03, P=0.000 3) except for wake after sleep onset (MD= –8.79, 95%CI –17.24 to –0.35, P=0.04) after one month treatment. b) Safety: significant differences were only found in the female prolactin (MD=5.50, 95%CI 2.02 to 8.98, P=0.002) and male free testosterone (MD=15.30, 95%CI 0.62 to 29.98, P=0.04) between the two groups, rather than in all the other hormones concentration, rebound insomnia, withdrawal syndrome, next-day residual effects and incidence rate of adverse reactions. Conclusion Ramelteon has marked effects on adults’ chronic insomnia after 1-week treatment, but its effect is not obvious after 1-month treatment. The adverse reactions are mostly the somnolence, rising of male free testosterone and female prolactin concentration.
Objective To evaluate tissue regeneration, body reaction, and biological safety of xenogeneous bladder acellular matrix (BAM) that can be used to repair rabbit bladder. Methods Porcine BAM was prepared through physical, chemical, and enzymatic methods, and the effects of acellularization and the structure were observed with HE staining and scanning electron microscope (SEM). Eighteen New Zealand white rabbits (weighing, 2.5-3.0 kg) undergoing partial cystectomy were randomly divided into 2 groups. After partial (about 30%) cystectomy, the porcine BAM was used to replace partial rabbit bladder in the experimental group (n=12), and the incision was directly sutured as control group (n=6). The survival condition of animals was observed after operation. At 15 days, 1, 2, 3, and 6 months after operation, the blood routine, renal function, and electrolyte were tested by collecting the blood samples. At 1, 2, 3, and 6 months after operation, maximum bladder capacity, bladder leak point pressure, and bladder compliance were measured through urodynamic studies. Then gross observation was performed for regeneration of bladder, and the specimens of the bladder were harvested for HE staining and immunohistochemical staining. The surrounding organs and local lymphoid tissues were harvested for gross observation and HE staining. Results Cell components were completely removed in the porcine BAM, showing three-dimensional porous structure under SEM. All the animals survived during the experiment. At 15 days after operation, white blood cell count increased, and then returned to normal level in 2 groups, showing no significant difference between 2 groups (P gt; 0.05). The tests of renal function and electrolyte suggested no significant difference between 2 groups (P gt; 0.05). The level of serum creatinine showed a tendency of increase, but it remained within normal range at 6 months after operation. The maximum bladder capacity and compliance in experimental group were significantly higher than those in control group at 3 and 6 months after operation (P lt; 0.05), but no significant difference in bladder leak point pressure at each time point between 2 groups (P gt; 0.05). The urothelial regeneration, smooth muscle regeneration, and blood vessel regeneration were seen by histological observation in 2 groups. In the 2 groups, chronic inflammatory cells infiltration could be observed at 1 month postoperatively, and then chronic inflammatory cells decreased significantly (P lt; 0.05), until complete disappearance. There was no significant difference in score of chronic inflammatory cell infiltration between 2 groups at 3 and 6 months after operation (P gt; 0.05). The α-smooth muscle actin expression was significantly increased with time passing in 2 groups (P lt; 0.05), and it was significantly higher in control group than in experimental group at each time point (P lt; 0.05). In addition, gross and HE staining observations showed no abnormalities in surrounding organs and local lymphoid tissues. Conclusion No immune rejection response occurs when porcine BAM is used for xenotransplantation. It is indicated that porcine BAM is relative safety for xenotransplantation.