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.
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.
ObjectiveTo evaluate the in vivo biological safety of porous zinc oxide (ZnO)/hydroxyapatite (HA) composite materials.MethodsThe porous ZnO/HA composite materials and porous HA materials were prepared by the spark plasma sintering technology. First, the materials were characterized, including scanning electron microscopy to observe the material structure, in vitro degradation experiments to detect the degradation rate of the materials, and inductively coupled plasma emission spectrometer to detect the concentration of Zn2+ dissolved out of the composite material degradation. Then the two kinds of material extracts were prepared for acute systemic toxicity test. Fifteen male Kunming mice were randomly divided into groups A, B, and C (n=5) and injected intraperitoneally with normal saline, HA extracts, and ZnO/HA extracts, respectively. The body mass of the mice was recorded before injection and at 24, 48, and 72 hours after injection. The liver and kidney tissues were taken at 72 hours for HE staining to evaluate the safety of the composite material. Finally, the biological safety of the material in vivo was evaluated by implantation experiment. The eighteen male New Zealand white rabbits were randomly divided into HA group and ZnO/HA group (n=9); a bilateral radius defect model (1 cm) was established, and the right forelimbs of the two groups were implanted with porous HA materials and porous ZnO/HA composite materials, respectively; the left untreated as a blank control. The general condition of the animals were observed after operation. The rabbit blood was collected at 1 day before operation and at 1 day, 1 week, 4 weeks, and 8 weeks after operation for routine blood test (inflammation-related indicators) and blood biochemistry (liver and kidney function-related indicators). X-ray films were taken at 4, 8, and 12 weeks after operation to observe the repair of bone defects.ResultsMaterial characterization showed that porous ZnO/HA composite materials had interconnected large and small pore structures with a pore size between 50 and 500 μm, which degraded faster than porous HA materials, and continuously and slowly dissolved Zn2+. The acute systemic toxicity test showed that the mice in each group had no abnormal performance after injection, and the body mass increased (P<0.05). HE staining showed that the cells shape and structure of liver and kidney tissue were normal. Animal implantation experiments showed that all rabbits survived until the experiment was completed; routine blood tests showed inflammation in each group (neutrophils, monocytes, and lymphocytes increased) at 1 day after operation, and all returned to normal at 8 weeks (P>0.05); compared with 1 day before operation, the content of inflammatory cells in the HA group increased at 1 day, 1 week, and 4 weeks after operation (P<0.05), and the ZnO/HA group increased at 1 day after operation (P<0.05); blood biochemistry showed that the liver and kidney function indexes were in the normal range; X-ray films showed that the ZnO/HA group had better osseointegration than the HA group at 4 weeks after operation.ConclusionThe porous ZnO/HA composite material has good in vivo biological safety and good bone repair ability, which is a potential bone repair material.
Objective To evaluate on immunogenicity and safety of measles-mumps-rubella-varicella vaccine. Methods The PubMed, BIOSIS Previews, CDSR, The Cochrane Library, CBM, CNKI and VIP were searched between Jan. 1990 and April 2010. Studies were included in the review if they were randomized controlled trials (RCTs) about measles (M) – mumps (M) – rubella (R) and varicella (V) vaccine. Trial screening, data exaction and quality assessment of the included trials were conducted by the method recommended by Cochrane Collaboration. Statistical analyses were conducted by using RevMan 4.2.10 software. Results Five RCTs were included. Among those there were 2 trials of B degree and 3 trials of C degree. Meta-analyses showed that to different inoculation methods, (MMRV or MMR+V) the rate of pain was not significantly different with RR 0.94 and 95%CI 0.83 to 1.05 (P=0.28). The rate of redness was not significantly different with RR 1.08 and 95%CI 0.90 to 1.29 (P=0.40). The rate of hardening was not significantly different with RR 1.16 and 95%CI 0.95 to 1.43 (P=0.14). The rate of fever was significantly different with RR 1.20 and 95%CI 1.12 to 1.29 (Plt;0.000 01). The rate of skin rash was not significantly different with RR 1.18 and 95%CI 1.00 to 1.41 (P=0.05). The serum measles antibody positive rate was not significantly different with RR 1.00 and 95%CI 0.99 to 1.01 (P=0.68). The serum mumps antibody positive rate was not significantly different with RR 0.99 and 95%CI 0.50 to 1.01 (P=0.11). The serum rubella antibody positive rate was not significantly different with RR 1.00 and 95%CI 0.99 to 1.01 (P=0.68). The se-rum varicella antibody positive rate was not significantly different with RR 1.00 and 95%CI 0.99 to 1.01 (P=0.58). Conclusion Compared with MMR+V vaccine, the MMRV vaccine has the same immune effect. In respect of immune safety, in addition to higher rate of fever after vaccination, other local or systemic reaction is good. For the role of reducing vaccination times and good performance on immune effect and safety, the MMRV vaccine can be regarded as candidate vaccine for children. The fever caused by the new component should be strengthened in the following study. Limited to the quality and account for the current original documents, citing evidence of this systematic review would be cautious. Future studies would expand the sample size, fulfill the test design, increase indicators to improve the quality of research and demonstration intensity.
Objective
To systematically review the efficacy and safety of interferon based antiviral therapy for children with hepatitis B.
Methods
PubMed, EMbase, The Cochrane Library, WanFang Data and CNKI databases were searched to collect randomized controlled trials (RCTs) of interferon based antiviral therapy for children with hepatitis B from inception to December 2016. 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 12 studies involving 723 patients were included. The results of meta-analysis showed that: follow-up <12 months, the virological response rate (RR=2.82, 95%CI 1.98 to 4.02, P<0.000 01), serum HBeAg clearance rate (RR=3.02, 95%CI 1.95 to 4.67,P<0.000 01) and ALT normalization rate (RR=1.42, 95%CI 1.19 to 1.70,P=0.000 1) were significantly higher in the interferon group than the control group. Follow-up >12 months, the virological response rate (RR=1.75, 95%CI 1.18 to 2.60, P=0.006) and serum HBeAg clearance rate (RR=2.17, 95%CI 1.28 to 3.65, P=0.004) were also significantly higher in the interferon group. Severe adverse effects were not reported in included studies.
Conclusion
Current evidence shows that higher virological response is found in HBV infected children with interferon treatment. Due to limited quality and quantity of the included studies, more high quality studies are needed to verify above conclusion.
Objective
To evaluate the safety and efficacy of total hip arthroplasty (THA) in patients with end stage renal disease (ESRD).
Methods
Between December 2009 and May 2016, 30 THAs were performed in 28 patients with dialysis-dependent renal failure (18 patients) or renal transplantation (10 patients). A retrospective case control study was carried out to compare these 28 ESRD patients (ESRD group) with a matched cohort of 28 nonrenal patients (control group). There was no significant difference in gender, age, hip side, American Society of Anesthesiology (ASA) classification, comorbidities, and preoperative Harris score and hemoglobin (Hb) level between 2 groups (P>0.05). The complications during hospitalization, Hb level changes, perioperative transfusion rate, hospital stay, and hospitalization costs in 2 groups were evaluated; and the creatinine changes of dialysis patients in ESRD group were evaluated. During the follow-up period, 90 days readmissions, periprosthetic infection, prosthesis loosening, hip Harris score, and deaths were recorded.
Results
There was no loss of follow-up. The mean postoperative follow-up of ESRD group was 3.4 years (range, 1.0-7.4 years) and control group was 3.5 years (range, 1.0-7.4 years). Differences in hospital stay and the drop of Hb was not significant between 2 groups (P>0.05). The hospitalization costs and perioperative transfusion rate were significantly higher in ESRD group than in control group (P<0.05). There was no significant difference in creatinine value of dialysis patients in ESRD group between pre- and post-operation (t=1.804, P=0.089). At last follow-up, the Harris score was significantly higher than preoperative score in both groups (P<0.05); however, there was no significant difference in Harris score between groups (t=1.278, P=0.207). In ESRD group, 5 patients presented complications, 1 patient was readmitted to hospital, and 2 patients died during the follow-up. In control group, 1 patient presented complications, and there was no 90 days readmission and no death. During the follow-up period, there was no loosening or revision in 2 groups and the prosthesis was in good position.
Conclusion
THA can improve joint function and life quality of ESRD patients, but the risks of operation, perioperative complications, transfusion rate, and cost are high. Correct perioperative evaluation and management can help ESRD patients safely go through the perioperative period.
Objective To study efficiency and security of the recombinant adenoviralmediated gene transfer to the donor heart during the heart transplantation. Methods A total of 140 healthy male Wistar rats,aged 10 weeks, weighing 200250 g, were equally divided into the donor group and the recipient group, and then 70 rats in the recipient group were randomly andequally divided into 2 subgroups: the gene transfer group and the control group. The rat model of heterotopic heart transplantation(Abdomen)was developed, the donor hearts were removed and their coronary arteries were perfused with 800 μlof the recombinant adenoviral vectors encoding the β-galactosidase gene（Ad-LacZ）. The grafts were stored in the 4℃ cold saline solution for 30 minutes, and then the syngeneic transplant was performed. In the control group, saline of tales doses was perfused. The donor hearts were harvested at 3, 5, 7, 14, and 28days (n=7)after transplantation, and the β-galactosidase activity was assessed by the X-gal staining. At 28 days the major organs of the recipients were tested by the histopathological analysis and the polymerase chain reaction of the adenoviral E1A sequences. Results The successful gene transfer of the βgalactosidase gene was demonstrated in the adenovirus-perfused hearts, with no staining in the control group. The gene expression reached a peak level at 3, 5 and 7 days, and the averaged numbers of the total βgalactosidase positive staining cells per slice were 66.4±23.1, 91.3±32.4 and 68.7±22.7, respectively, with no significant difference between the groups (Pgt;0.05). At 14 days the gene expression gradually declined (32.1±13.9), and the significant difference was found when compared with that at 3, 5 and 7 days (Plt;0.05). At 28 days the cells positive for β-galactosidase were sparse (3.9±3.4), and the gene transfer was significantly less efficient compared with that at 3, 5, 7 and 14 days (Plt;0.05). The major organs of the recipients were not affected seriously at 28 days. No virus spread to other organs in this experimental protocol. Conclusion The ex vivo adenoviralmediated gene transfer intracoronarily to the donor heart during the heart transplantation is feasible and safe.
Objective To evaluate the efficacy and safety of trimetazidine (TMZ) for chronic congestive heart failure. Methods We searched The Cochrane Library (Issue 3, 2006), MEDLINE (1990-2006), EMBASE (1990-2004), and the Chinese Biomedicine Database (1990- 2006 ) for parallel group randomized controlled trials (RCTs) and cross-over design trials comparing TMZ and placebo or open controls for patients with heart failure.We used The Cochrane Collaboration’s RevMan 4.2 software for data analyses. Results Four RCTs and two cross-over design trials were included. Meta-analyses showed that: compared with the control group, TMZ may improve the NYHA cardiac functional grade (RR 0.85, 95%CI 0.76 to 0.95), increase the total exercise time (WMD 51.40 seconds, 95%CI 15.56 to 87.25), the maximal metabolic equivalents (WMD 0.82, 95%CI 0.28 to 1.37), and the ejection fraction (WMD 7.29%, 95%CI 6.28 to 8.31), but may decrease the left ventricular end-diastolic volume (WMD –12.19 ml, 95%CI –15.29 to –9.09), the left ventricular end-diastolic diameter (WMD –6.05 mm, 95%CI –7.10 to –4.99), the left ventricular end-systolic volume (WMD –16.94 ml, 95%CI –20.34 to –13.55), the left ventricular end-systolic diameter (WMD –5.42 mm, 95%CI –5.98 to –4.86), and the serum brain natriuretic peptide (WMD –239.59 pg/ml, 95%CI –276.53 to –202.65). TMZ may also improve the quality of life (WMD 12.36, 95%CI 5.16 to 19.55). Conclusions TMZ plus standard medical therapy has a beneficial effect on the indices of cardiac function, and may also improve the patient’s quality of life. However, because available RCTs for this systematic review are too small and poor quality, (mainly focusing on the heart failure induced by ischemic heart diseases and merely taking intermediate indices as outcome measures), further high-quality large-scale RCTs with death as the endpoint and which include subgroup analysis of non-ischemic heart failure, are required in order to provide more reliable evidence.
ObjectiveTo systematically review the efficacy and safety of autologous mononuclear cells transplantation in osteonecrosis of the femoral head.MethodsPubMed, EMbase and The Cochrane Library were electronically searched to collect randomized and non-randomized controlled trials on autologous mononuclear cells transplantation for osteonecrosis of the femoral head from inception to July 31th, 2020. Two reviewers independently screened literatures, extracted data and assessed risk of bias of included studies. Meta-analysis was then performed using RevMan 5.4 software.ResultsA total of 17 studies involving 645 hips in mononuclear cells group and 557 hips in cell-free group were included. The results of meta-analysis showed that compared with cell-free therapy, mononuclear cells therapy could improve hip function in term of Hairrs score (MD=8.11, 95%CI 4.36 to 11.87, P<0.000 1), Merle D`Aubigné Postel score (MD=2.23, 95%CI 0.97 to 3.49, P=0.000 5), WOMAC score (MD=?10.81, 95%CI ?15.80 to ?5.81, P<0.000 1), Lequesne index (MD=?2.97, 95%CI ?5.42 to ?0.52, P=0.02) and alleviate the pain (MD=?9.13, 95%CI ?12.40 to ?5.86, P<0.000 01), delay the progression of radiological staging (RR=0.55, 95%CI 0.34 to 0.89, P=0.01) and reduce the rate of total hip arthroplasty (RR=0.61, 95%CI 0.43 to 0.86, P=0.005). In terms of safety, mononuclear cell therapy did not increase the rate of complications (RR=0.77, 95%CI 0.33 to 1.83, P=0.56).ConclusionsThe current evidence shows that autologous mononuclear cells therapy is a safe and effective way for osteonecrosis of the femoral head. Due to limited quality and quantity of the included studies, more high quality studies are required to verify above conclusions.
