Evidence produced by clinical trial is the main basis for health care decision-making at all levels. In recent years, some problems been revealed in the national data audit of new drug clinical trials have sounded the alarm for the quality of clinical research in China. In addition to strengthening the implementation of clinical trial process management and supervision, we call attention to the coherence and consistency of trial design and implementation, including the promotion of clinical trial design in the agenda of improving the quality of the trials and putting forward reasonable suggestions. We hope that our work could make research ideas clear from the source of a clinical trial, with a view to avoid violating protocol behavior and provide standardized recommendations for improving the quality of clinical trials in China.
Objective To evaluate the effects of mass immunization campaign on the epidemiological characteristics of measles. Methods Comparison was made between the incidences of measles before and after the mass immunization campaign in 2007 in Shunqing prefecture of Nanchong city. Results The total number of the reported measles cases reached 460 during 2004 to 2007 in Shunqing prefecture of Nanchong city, and the respective annual rates of incidence were 4.04, 23.53, 11.84, and 33.57, respectively per 100 000 heads. Cases reported from April to July accounted to 73.91% of the total (340/460). Children under 15 were reported to have the highest incidence rate and accounted to 83.70% of the total (385/460), of which incidences of children under 1 accounted to 0%, 10.81%, 13.51% and 25.82%, respectively. Only 20.00% of the subjects (92/460) in this study had a definite history of measles vaccination. After the mass immunization campaign in September, 2007, only 10 cases were reported in 2008 and the incidence rate was 1.58 per 100 000 heads, a 95.29% decrease in incidence rate in comparison with that of the last year. Conclusion The mass immunization campaign has achieved substantial results.
ObjectiveTo summarize the recent progress of the controlled releasing delivery of biological factors for cartilage repair. MethodsThe recently published 1iterature at home and abroad on the controlled releasing delivery of biological factors for cartilage repair was reviewed and summarized. ResultsVarious biological factors have been applied for repairing cartilage. For better cartilage repair effects, controlled releasing delivery of biological factors can be applied by means of combining biological factors with degradable biomaterials, or by micro- and nano-particles. Meanwhile, multiple biologic delivery and temporally controlled delivery are also inevitable choices. ConclusionAlthough lots of unsolved problems exist, the controlled releasing delivery of biological factors has been a research focus for cartilage repair because of the controllability and delicacy.
ObjectiveTo evaluate the therapic efficacy for severe acute pancreatitis (SAP) during different periods. MethodsAccording to internalized standard, 234 patients with SAP admitted to this hospital from January 1986 to October 2009 were included, which were divided into two stages based on the time of admitting to this hospital. The first stage named prior operation group was from January 1986 to August 1998 (n=117), the second stage named individual treatment group was from September 1998 to October 2009 (n=117). There was comparability in demography and clinic between two groups. The prior operation group primarily underwent laparotomy and medication, and the individual treatment group underwent multiple combined therapies. These indexes were compared between two groups: hospital stay, cure rate, and mortality; the incidences of pancreatic pseudocyst, pancreatic and peripancreatic abscess, pancreatic encephalopathy, cardiac insufficiency, acute renal failure (ARF), acute respiratory distress syndrome (ARDS), and shock. The efficacies for early treatment, ascites, biliary pancreatitis, and pancreatic and peripancreatic complications were compared two groups by stratified analysis. ResultsCompared with the prior operation group, the hospital stay was shorter (Plt;0.05), cure rate was higher (Plt;0.001), and mortality was lower in the individual treatment group (Plt;0.001). During the treatments, the incidences of pancreatic pseudocyst, pancreatic and peripancreatic abscess, pancreatic encephalopathy, cardiac insufficiency, ARF, ARDS, and shock in the individual treatment group were lower than those in the prior operation group (Plt;0.05). According to the stratified analysis, the efficacies for early treatment, ascites, biliary pancreatitis, and pancreatic and peripancreatic complications in the individual treatment group were better than those in the prior operation group (Plt;0.001). ConclusionIn recent years, the change of therapeutic mode significantly improves the treatment efficacy for SAP.
ObjectivesTo systematically review the efficacy and safety of controlled hypotension for total hip or knee replacement.MethodsPubMed, EMbase, The Cochrane Library, CNKI, WanFang Data and CBM databases were electronically searched to collect randomized controlled trials (RCTs) on controlled hypotension for total hip or knee replacement from inception to September 2019. Two reviewers independently screened literature, extracted data and assessed the risk of bias of included studies, then, meta-analysis was performed by RevMan 5.3 software.ResultsA total of 15 RCTs involving 854 patients were included. The results of meta-analysis showed that compared with no controlled hypotension during surgery, controlled hypotension could reduce intraoperative blood loss (MD=?267.35, 95%CI ?314.54 to ?220.16, P<0.000 01), allogeneic blood transfusion (MD=?292.84, 95%CI ?384.95 to ?200.73, P<0.000 01), and 24 h postoperative mini-mental state examination (MMSE) score (MD=?1.08, 95%CI ?1.82 to ?0.34, P=0.004). However, there were no significant differences in 96 h postoperative MMSE score (MD=?0.11, 95%CI ?0.50 to 0.28, P= 0.57) and intraoperative urine volume (MD=57.93, 95%CI ?152.57 to 268.44, P=0.59).ConclusionsThe current evidence shows that controlled hypotension during total hip or knee replacement can reduce intraoperative blood loss and allogeneic blood transfusion. Furthermore, there is no obvious effect on the maintenance of blood perfusion in important organs, despite certain effects on the postoperative cognitive function, which can be recovered in short term. Due to limited quality and quantity of the included studies, more high quality studies are required to verify above conclusions.
ObjectiveTo systematically review the efficacy of dexmedetomidine for controlled hypotension in orthognathic surgery. MethodsThe PubMed, Embase, Cochrane Library, CNKI, VIP and WanFang Data databases were electronically searched to collect randomized controlled trials (RCTs) on dexmedetomidine for controlled hypotension in orthognathic surgery from inception to May, 2024. 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 8 RCTs involving 371 patients were included. The results of meta-analysis showed that the operation time of dexmedetomidine group was not significantly different from that of hypotensive drug group, but was shorter than that of saline group (MD=?23.20, 95%CI ?44.05 to ?2.35, P=0.03). There were no statistically significant differences in the mean arterial pressure and the intraoperative blood loss between dexmedetomidine group and the control group. Compared with those in the control group, the heart rate (MD=?18.78, 95%CI ?30.80 to ?6.77, P=0.002) and the incidence of postoperative adverse events (OR=0.25, 95%CI 0.08 to 0.76, P=0.01) in dexmedetomidine group were less than those in the control group significantly. ConclusionCurrent evidence shows that dexmedetomidine can be used effectively for controlled hypotension in orthognathic surgery. Due to the limited quality and quantity of the included studies, more high-quality studies are needed to verify above conclusion.
ObjectiveTo evaluate the feasibility and clinical effect of controlled hypotension in video-assisted thoracoscopic surgery (VATS) for subcarinal lymph node dissection in patients with lung cancer.MethodsWe analyzed the clinical data of 53 non-small cell lung cancer (NSCLC) patients undergoing VATS with controlled systolic blood pressure while dissecting the subcarinal lymph node from September to October 2016 in our department (a treatment group, including 31 males and 22 females with an average age of 53.20±8.80 years ranging 43-68 years). We selected 112 NSCLC patients undergoing VATS without controlled systolic blood pressure while dissecting the subcarinal lymph node from January to August 2016 in our department (a contol group, including 67 males and 45 females with an average age of 54.32±7.81 years ranging 39-73 years). The clinical data of both groups were compared.ResultsThe operation time and blood loss of the treatment group were less than those of the control group (177.6±39.4 min vs. 194.3±47.8 min, 317.9±33.6 ml vs. 331.2±38.7 ml, P<0.05). The duration of subcarinal lymph node dissection and total duration of lymph node dissection of the treatment group were also less than those of the control group (10.5±4.3 min vs. 13.6±5.2 min, 37.7±7.5 min vs. 48.7±6.4 min, P<0.001). The thoracic drainage at postoperative days 1, 2, 3 and total drainage volume, duration of tube placement and hospital stay of the treatment group were less than those of the control group (P<0.05). Whereas the postoperative complications of the two groups did not differ significantly (P>0.05).ConclusionControlled hypotension reduces the difficulty of dissecting subcarinal lymph nodes and the risk of bleeding, and produces less drainage volume, which is safe and effective.
ObjectiveTo evaluate the efficacy and reversible effect of anti-VCAM-1 ultrasound-targeted microbubbles on extracorporeal circulation (ECC) related bone marrow neutrophil releasing. MethodsThirty-six male SD rats were randomly divided into 6 groups with 6 rats in each group, including an antibody group (group A), antibody with ultrasound group (group AU), targeted microbubble group (group T), targeted microbubble rupture group (group TU), post-ECC plasma simulation group (group MC) and control group (group C) after in situ perfusion model establishment. Rats in group C received buffer perfusion for 4 cycles, and rats in other groups received perfusion for 5 cycles. After buffer perfusion for the first cycle, post-ECC plasma was infused to each group from the second cycle to the fifth cycle in group MC, A, AU, T and TU. Rats in group A and AU received injection with anti-VCAM-1 antibodies, while rats in group T and TU were given anti-VCAM-1 targeted microbubbles after the second perfusion cycle. Same ultrasound radiation was given to group AU and TU in the third perfusion cycle. Neutrophil counts from perfusate were compared among the 6 groups. ResultsUnder simulated inflammatory condition after ECC, compared with group MC, significant reduction of neutrophil count released from bone marrow was found in group A and T, especially in group T (P < 0.05). After ultrasonic radiation, neutrophil mobilization recovered in group TU and its neutrophil count was significantly higher than that of group T (P < 0.05). There was no significant difference in neutrophil count between group A and AU in each perfusion cycle (P > 0.05). ConclusionsAnti-VCAM-1 targeted microbubbles can block the binding of VCAM-1 and its ligand, and form a barrier on the surface of bone marrow sinusoids endothelium to inhibit neutrophils migrating and releasing. The binding of VCAM-1 and its ligand on microbubbles is separated by cavitation of disrupting microbubbles with ultrasound, and neutrophils recover the ability to cross the sinusoidal endothelium of bone marrow in inflammatory conditions to achieve the controllability of neutrophil releasing.
In 2007, the findings from clinical trials on stroke treatment have been both encouraging and disappointing. In order to interpret the challenges and opportunity in evidence-based stroke practice, we reviewed several major clinical trials in stroke that were published last year. It revealed that we should strengthen the evidence base for acute stroke care by conducting more high-quality randomized controlled trials and by increasing the energy, resources and manpower available for these trials.
ObjectiveTo assess the efficacy and safety of low-(10 mg) and high-dose (20 mg) of recombinant tissue typeplasminogen activator (rt-PA) catheter-directed thrombolysis for lower limb ischemia by using meta-analysis. MethodsThe literatures of randomized clinical trials (RCT) concerning low-versus high-dose rt-PA catheter-directed thrombolysis for lower limb ischemia study were searched using the national and international electronic databases.The literatures were screened and quality evaluated according to the inclusion and exclusion criteria, and analyzed by using the Cochrane Center the RevMan 5.2 software. ResultsA total of 4 RCT studies, with a total of 360 patients (192 patients in low dose group and 168 patients in high-dose group) were included.No statistical difference were noted in low-versus high-dose group with regard to ankle-brachial index (RR=0.20, 95%CI=-0.43-0.02, P=0.07), 30 days amputation-free survival (RR=1.00, 95%CI=0.94-1.08, P=0.91), 6 months the probability of restenosis (RR=1.00, 95%CI=0.60-1.67, P=1.00), and the incidence of groin hematoma (< 5 cm, RR=1.24, 95%CI=0.56-2.77, P=0.59).But the incidence of bleeding and the incidence of stress ulcer in low-dose group were lower than those in high-dose group (RR=2.38, 95%CI=1.10-5.15, P=0.03;RR=2.49, 95%CI=1.21-5.13, P=0.01). ConclusionTwo doses of rt-PA treatment of limb ischemia similar efficacy, but the incidence of low-dose regimen of complications is significantly lower than the high dose regimen.