ObjectiveTo summary the safety and efficiency of the minimally invasive direct cardiac surgery (MIDCS) approach in elderly patients with heart disease. MethodsWe retrospectively analyzed the clinical data of 60 patients underwent MIDCS in Beijng Anzhen Hospital between April 2010 and January 2013. There were 34 males and 26 females with mean age of 66.4±4.8 years and mean weight of 66.1±10.6 kg. ResultsMean cardiopulmonary bypass time and aortic cross-clamp time was 141.2±57.2 minutes and 99.8±37.6 minutes respectively. A total of 37 patients (90.2%) recovered to beat automatically after heart ceased operation. Median mechanical ventilation time was 17.1±9.1 hours. Mean intensive care unit stay was 22.1±12.2 hours. Mean post operative hospital stay was 7.0±2.5 days. Mean incision length was 5.3±0.9 cm. Mean pericardial draining volume was 466.6±412.1 ml in the first day after operation. No transfusion occurred in 27 (45.0%) patients. Early postoperative mortality was 3.3% (2/60). There were 2 patients of reexplorations for bleeding, 1 patient of the twice tracheal intubation, 1 patient of cardiac arrest after operation, 2 patients of poor healing of skin incision, and 1 patient of injury of right phrenic nerve. When leaving hospital, 47 patients were in heart functional class Ⅰ, 8 patients in class Ⅱ, and 3 patients in class Ⅲ. ConclusionMIDCS is associated with good operative effect in the near future with superior safety and broad application range in elderly patients with heart disease.
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 investigate the safety and feasibility of early mobilization in critically ill patients with femoral catheters, and to provide reference for guiding clinical rehabilitation training. MethodsThe literature on the safety and feasibility of early mobilization in critically ill patients with femoral catheters included in PubMed, EMbase, OVID, Springer-link, Wiley Online Library, and Web of Science up to June 2021 was searched, and relevant data were extracted for analysis. ResultsSeventy-two papers were initially screened, and 12 papers that met the criteria were finally included, covering 1 056 patients, and 489 patients had femoral catheters. Patients underwent 6 495 sessions of physical therapy, and a total of 62 patients had adverse events, including 14 (2.86%, 14/489) patients with catheter-related adverse events. ConclusionAlthough early mobilization in critically ill patients with femoral catheters may lead to adverse catheter-related events, the incidence is low. Therefore, the associated risks and benefits should be weighed in clinical practice, and femoral catheter is not recommended as a contraindication for early mobilization in critically ill patients.
Objective To study the efficacy and safety of combined anti-tuberculosis regimen containing bedaquiline in the treatment of multidrug-resistant tuberculosis (MDR-TB). Methods A total of 69 MDR-TB patients treated by joint regimen combined bedaquiline with other anti-tuberculosis drugs between March 2018 and August 2019 in Public Health Clinical Center of Chengdu were taken as the trial group, and 60 MDR-TB patients received treatment without bedaquiline between June 2016 and December 2017 in the same hospital were taken as the control group. The efficacy and safety of the two groups were compared. Results The 69 patients in the trial group included 44 males and 25 females, aged from 21 to 63 years, with an average of (34.6±11.0) years; 58 patients (84.1%) completed the 24-week treatment with bedaquiline, while 11 patients did not complete the treatment, including 3 deaths (4.3%), 1 loss of follow-up (1.4%), 1 withdrawal from the study (1.4%), and 6 discontinuation due to adverse events (8.7%). Among the 54 patients with positive results of tuberculosis on baseline sputum culture, 49 transformed to negative results within 24 weeks of treatment (the negative conversion rate was 90.7%), and the median negative conversion time was 13.0 weeks. The 60 patients in the control group included 45 males and 15 females, aged from 16 to 66 years, with an average of (35.5±13.2) years. Among the 53 patients with positive results of tuberculosis on baseline sputum culture, 30 transformed to negative results within 24 weeks of treatment (the negative conversion rate was 56.6%), and the median negative conversion time was 12.0 weeks. The negative conversion rate of sputum bacteria in the trial group was significantly higher than that in the control group (χ2=16.133, P<0.001). The most common adverse reactions in the trial group were liver function abnormalities (42 cases, 60.9%), prolonged QTc interval (37 cases, 53.6%), electrolyte disturbances (20 cases, 29.0%), and blood system damage (20 cases, 29.0%). In the 37 patients who experienced prolonged QTc interval, there were 8 patients with QTc intervals≥500 ms and 29 patients with QTc intervals ≥450 ms and <500 ms, with a median occurrence time of 16.0 weeks, among whom 25 patients experienced prolonged QTc interval in 4-48 weeks after the withdrawal of bedaquiline. Conclusion The negative conversion rate of tuberculosis sputum culture of patients with MDR-TB treated by bedaquiline combined with other anti- tuberculosis drugs is high, but electrocardiogram should be closely monitored during and after the treatment in order to guard against the potential cardiac toxic effects of bedaquiline.
ObjectivesThe primary objectives of this rapid health technology assessment (RHTA) were to assess the safety and effectiveness of Da Vinci surgical system compared with traditional e surgeries, so as to provide the currently-available best evidence for health decision makers and clinical workers. MethodsA comprehensive search of electronic databases (EMbase, PubMed, The Cochrane Library, Web of Science, CNKI, VIP, CBM and WanFang Data) and relevant professional HTA websites were conducted from inceptionto October 9, 2012. Two reviews independently screen literature according to the inclusion and exclusion criteria, extracted data, and assess the quality of included studies. The data based on secondary studies were reported, and a final recommendation and its level was made based on assessment outcome. ResultsA total of 21 studies were included, encompassing 7 HTAs and 14 systematic reviews/metaanalyses. The included studies involved radical prostatectomy, hysterectomy, nephrectomy, coronary artery bypass graft, and gastric fundoplication. Though the included HTAs and systematic reviews/meta-analyses focus on different diseases, the outcomes showed significant differences existed between Da Vinci surgical system and other routine surgery in clinical effectiveness and safety of different diseases. Compared with routine surgery, Da Vinci surgical system shortened hospital stay; decreased operation conversion rates, blood loss and blood transfusion rates during surgery; but it increased operative time. Besides, compared with traditional laparoscopic surgery, Da Vinci surgical system shortened operation time and hospital stay, and decreased operation conversion rates, blood loss and blood transfusion rates during surgery. ConclusionCurrent evidence shows that the clinical effectiveness and safety outcomes of Da Vinci surgical system differ in diseases. Currently, most included HTAs and systematic reviews/meta-analyses are based on observational studies, relevant prospective randomized controlled trials lack, and the evidence is graded as low quality, health decision makers are suggested to apply this evidence with caution on the basis of comprehensive consideration.
ObjectivesUsing systematic literature review to analyze the effects of levetiracetam (LEV) on neonatal safety during early pregnancy.MethodsThe scope of the literature must be English literature, published from 1997 to 2018. Meta-analysis was performed by random effects models.ResultsSeven literatures were included. A total of 672 cases exposed to LEV in treatment group and 772 234 cases in control groups were selected for meta-analysis. There was no significant difference in neonatal malignancy between treatment group and control group［OR=1.05, 95% CI (0.54, 2.02), P=0.37］. Further, we evaluated the effect of LEV monotherapy and polytherapy on neonatal safety, a total of 464 monotherapy cases and 632 polytherapy cases respectively were selected for meta-analysis. The results showed that there was no significant difference between these two therapies in neonatal malignancy ［OR=0.54, 95% CI(0.31, 0.96), P=0.32］.ConclusionsAs the papers we included, levetiracetam in the treatment of epilepsy during pregnancy is relatively safe for newborn.
Objective To evaluate the biological safety of continuous carbonfiber reinforced polyolefin as hard tissue repair material. Methods Biocompatibility of the material was evaluated through hemolysis test, pyrogen test,skin irritation test, cytotoxicity test, ames test,in vitro chromosome aberration test, and bone marrow cells Micronuclei test. Results No obvious hemolysis, pyrogenic characteristics, sensitivity, cytotoxxicity, and mutagenicity were observed. Conclusion The continuous carbonfiber reinforced polyolefin composite material is of good biological safety. It meets all the demand made by biological safety as hardtissue repair material.
Objective To compare the clinical effects of one-stage anastomosis on patients with middle and lower rectum carcinoma and intestinal obstruction and the ones without intestinal obstruction, and to evaluate the safety and feasibility of patients with middle and lower rectum carcinoma and intestinal obstruction undergoing one-stage anastomosis. Methods The data of patients diagnosed definitely by pathology as middle and lower rectum carcinoma underwent one-stage anastomosis in West China Hospital of Sichuan University between January 2007 and December 2008 was retrospectively analyzed. The clinical effects were compared between intestinal obstruction group and non-intestinal obstruction group. Results During this period, 525 patients were included into intestinal obstruction group (n=87) and non-intestinal obstruction group (n=438). Among the patients included, there were 307 males and 218 females. Ages were from 25 to 85 years, and the average age was 60 years old. According to tumor histology, there were 487 cases of adenocarcinoma, 29 of mucinous adenocarcinoma and 9 of other types. According to the degree of tumor differentiation, there were 140 cases of low differentiation, 372 of middle differentiation and 13 of high differentiation. According to TNM stage, there were 4 cases of stage 0, 93 of stageⅠ, 189 of stage Ⅱ, 202 of stage Ⅲ and 37 of stage Ⅳ. Constituent ratio of gender, distributions of distances from tumor to anus, TNM stages and differentiation degrees of tumor were significantly different between intestinal obstruction group and non-intestinal obstruction group (Plt;0.05); and there was no statistical difference in the age, pathological types， significant internal medical complications and operative types between the two groups (Pgt;0.05). There was no statistical diffe rence in operative duration and intraoperative blood loss between the two groups (Pgt;0.05). There was no statistical difference in postoperative time of first defecation, first out-of-bed activity and first oral feeding, and postoperative hospital stay between the two groups (Pgt;0.05); while time of first aerofluxus was earlier in intestinal obstruction group than that in non-intestinal obstruction group (Plt;0.05). There was no statistical significance in the disease incidence of postoperative complications between the two groups (Pgt;0.05). Conclusions Comparing with patients with non-intestinal obstruction, there is no significant evidence shows that one-stage anastomosis will affect the rehabilitation and increase the risk of complications in patients with middle and lower rectum carcinoma and intestinal obstruction. It is considered that it would be safe and feasible for patients with middle and lower rectum carcinoma and intestinal obstruction to have one-stage anastomosis; however, it is necessary for us to have more researches to evaluate the long-term clinical effect.
ObjectiveTo systematically review the clinical utilization of robotic bronchoscopes in diagnosis of pulmonary nodules, including MonarchTM and IonTM platforms, and then evaluate the efficacy and safety of the procedure. MethodsPubMed, EMbase, Web of Science and Cochrane Central Register of Controlled Trials databases were searched by computer for literature about the biopsy of pulmonary nodules with robotic bronchoscope from January 2018 to February 14, 2022. The quality of research was evaluated with Newcastle-Ottawa Scale. RevMan 5.4 software was used to conduct the meta-analysis. ResultsFinally, 19 clinical studies with 1 542 patients and 1 697 targeted pulmonary nodules were included, of which 13 studies used the IonTM platform and 6 studies used the MonarchTM platform. The overall diagnostic rate of the two systems was 84.96% (95%CI 62.00%-95.00%), sensitivity for malignancy was 81.79% (95%CI 43.00%-96.00%), the mean maximum diameter of the nodules was 16.22 mm (95%CI 10.98-21.47), the mean procedure time was 61.86 min (95%CI 46.18-77.54) and the rate of complications occurred was 4.76% (95%CI 2.00%-15.00%). There was no statistical difference in the outcomes between the two systems. Conclusion Robotic bronchoscope provides a high efficacy and safety in biopsy of pulmonary nodules, and has a broad application prospect for pulmonary nodules diagnosis.
Objective To compare the clinical efficacy and safety of thrombolysis with anticoagulation therapy for patients with acute sub-massive pulmonary thromboembolism. Methods The clinical data of 84 patients with acute sub-massive pulmonary thromboembolism were analyzed retrospectively, mainly focusing on the in-hospital efficacy and safety of thrombolysis and/ or anticoagulation. The efficacy was evaluated based on 6 grades: cured, markedly improved, improved, not changed, deteriorated and died. Results Among the 84 patients,49 patients received thrombolysis and sequential anticoagulation therapy( thrombolysis group) , 35 patients received anticoagulation therapy alone( anticoagulation group) . As compared with the anticoagulation group, the thrombolysis group had higher effective rate( defined as patients who were cured, markedly improved or improved, 81. 6% versus 54. 3%, P = 0. 007) , lower critical event occurrence ( defined as clinical condition deteriorated or died, 2. 0% versus 14. 3% , P = 0. 032) . There was no significant difference in bleeding rates between the two groups ( thrombolysis group 20. 4% versus anticoagulation group 14. 3% , P gt; 0. 05) . No major bleeding or intracranial hemorrhage occurred in any of the patients. Conclusions Thrombolysis therapy may be more effective than anticoagulation therapy alone in patients with acute sub-massive pulmonary thromboembolism, and thus warrants further prospective randomized control study in large population.