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 identify and investigate the quality of randomized controlled trials (RCTs) of traditional Chinese medicine (TCM) in 11 non-key Chinese medical journals so as to learn about the current status and problems. Methods Eleven non-key medical journals of TCM from 1995 to 2000 were hand searched to identify the RCT and controlled clinical trials (CCTs). Each identified RCT or CCT was page by page verified by handsearchers based on the criteria developed by the Cochrane Handbook; the RCTs’ design, randomization method description, blind, baseline comparison, inclusion and exclusion criteria, diagnostic criteria,criteria for theraputic effectiveness, sample size, statistical method，described outcome, side effects, and follow up etc. were analyzed. Results In the related journals from 1995 to 2000, a total of 66 volumes and 390 issues were checked. As a result, 22 739 clinical studies were identified, of which 1 416 RCTs, only 24 (1.69%) were done with double blinding. There were 141 CCTs from 1995 to 2000, the total number of RCT increased from 95 to 1 416 and most of studies were on digestives diseases. Most of these studies had no detailed randomization method description, only 38 (2.68%) studies provided a methodology description. In addition, 1 220 (86.16% ) described outcome index, 1 203 (84.96%) used statistical method，934 (65.96%) had baseline comparison，828 (58.47%) described diagnostic criteria, 197 (13.91%) had inclusion and exclusion criteria，finally only 89 (6.29%) reported side effects. Conclusions Although the number of RCT has increased in the 11 non-key medical journals of TCM in the past six years, the quality of these RCTs needs to be improved.
ObjectiveTo investigate the feasibility and clinical effect of controlled hypotension in 3 cm single-port video-assisted thoracoscopic surgery (VATS) for the lymph node group 7 dissection in the left lung resection.
MethodsWe retrospectively analyzed the clinical data of 37 patients with lung cancer who underwent 3 cm single-port VATS from May 2015 to August 2015 in Tongji Hospital, and systolic blood pressure of 12 patients (7 males, 5 females, average age of 58.3 years, range 42-69 years) was controlled between 80-90 mm Hg by nitroglycerin or sodium nitroprusside while the pressure of 25 patients (14 males, 11 females, average age of 57.7 years, range 43-68 years) was not controlled when receiving lymph node group 7 dissection.
ResultsControlled hypotension in lymphadenectomy achieved satisfactory results. The lymphadenectomy time of 12 patients with controlled hypotension (18.5±4.3 min on average, range 15.6-25.3 min) was shorter than that of 25 patients without controlled hypotension (24.3±5.1 min on average, range 18.2-29.8 min); the difference was statistically significant (P<0.05).
ConclusionControlled hypotension is a simple and feasible method that increases the operating space, and reduces the difficulty of cleaning lymph nodes and the risk of bleeding.
Objective To discuss the safety，feasibility，and advantages of two-port laparoscopic cholecystectomy （LC）．Methods The clinical data of 114 patients underwent LC from June 2008 to October 2010 were retrospectively analyzed，of which 46 underwent two-port LC （two-port LC group，n=46） and 68 underwent three-port LC （three-port LC group，n=68）. The operation time，intraoperative blood loss，postoperative feeding time，postoperative pain，postoperative hospital stay，and hospitalization expenses were compared between two groups. Results All the operations were successful，no postoperative complications occurred in both groups．The operation time in the two-port LC group was longer than that in the three-port LC group （P＜0.05）. The intraoperative blood loss，postoperative feeding time，postoperative pain，and postoperative hospital stay had no significant differences in two groups （P＞0.05）. The hospitalization expenses in the two-port group was less than that in the three-port group（P＜0.05）. Conclusions Two-port LC is a safe and feasible operation in the simple gallstone patients. It is cautious in those patients with acute cholecystitis because of the restricted vision and operation．
Objective To evaluate the status of asthma control in asthmatic outpatients.Methods We performed an investigation by a questionnaire in a face-to-face setting from Feb 2006 to May 2006 in asthmatic outpatients of China-Japan Friendship Hospital.Results A total of 101 asthmatic patients were investigated with a mean age of 47±14.8 years and course of disease of 9.1±12.8 years.80.2% of the asthmatic patients had various social insurance.40.6% of the respondents had visited emergency department because of asthma exacerbation.The percentage of adults with lost workdays caused by asthma was 61.7% (29/47)，and which of children with lost schooldays was 75% (3/4).37.6% of asthmatic patients were completely controlled.Approximately three fourth of respondents (75.2%) was either well or completely controlled.72.3% of respondents had undergone a lung-function test during the past year.The one third of respondents (36.6%) owned oneself peak flowmeter.Only 12.9% reported kept regular use of peak flowmeter.87.1% of patients use inhaled corticosteroids (ICS) regularly.Conclusion With the implementation of patient education program and asthma guideline，the asthma control level has been further improved.
ObjectiveTo assess the prognostic significance of the Controlling Nutritional Status (CONUT) score in patients with non-small cell lung cancer (NSCLC) and its association with clinicopathological characteristics. MethodsThe relevant studies investigating the association between CONUT score and prognosis of NSCLC patients were systematically searched in the PubMed, Web of Science, EMbase, Cochrane Library, CNKI, Wanfang Database and other databases from their inception to July 2023. Two independent researchers screened the references according to predefined inclusion and exclusion criteria, extracted data and conducted quality assessment. The quality of included references was evaluated using New Castle-Ottawa Scale (NOS). The meta-analysis was performed using Stata 17.0 software, and a combined hazard ratio (HR) or odds ratio (OR) and 95% confidence interval (CI) were calculated to assess the association of CONUT score with prognosis and clinicopathological characteristics in NSCLC patients. ResultsA total of 17 cohort studies, comprising 5182 NSCLC patients with stage Ⅰ-Ⅳ, were included in this analysis. All studies had a NOS≥6 points. The meta-analysis showed that there was a significant correlation between CONUT score and overall survival (OS) as well as disease-free survival (DFS) among NSCLC patients: the higher the score, the shorter the OS [HR=1.87, 95%CI (1.58, 2.21), P<0.001] and DFS [HR=1.91, 95%CI (1.63, 2.24), P<0.001]. These differences were statistically significant. Furthermore, CONUT score was significantly associated with age, smoking status, tumor stage, and N stage (P<0.05). ConclusionA higher CONUT score is associated with a poorer OS and DFS in patients with NSCLC, and CONUT score can be used as a potential predictor of NSCLC prognosis.
With the continuous promotion of China’s medical and health system reform, the problem of unreasonable medical examination has gradually become prominent after the elimination of “raising healthcare by medicine” and “raising healthcare by medical device”, which has become the core of aggravating the economic burden of patients’ diseases. Based on the current situation of medical examination control mechanism in China, this study explores the medical examination control mechanism including institutional restraint mechanism, supervision and management mechanism, quality control mechanism from external regulation and internal control, so as to regulate the medical examination behavior, realize the normalization of supervision and management, promote the continuous improvement of medical examination quality, in order to enhance the rationality of medical examination. It is expected to provide a theoretical basis for health departments to explore and perfect the control mechanism of the medical examination.
ObjectiveTo review the risks and control of disease transmission in clinical transplantation of human allogenic bone.
MethodsThe related literature on diseases transmission, risks and control, and tissue banking technology in human allogenic bone application was extensively reviewed and analyzed.
ResultsThe tissue is not sterilized in transmission cases relative to human allogenic bone transplantation reported abroad. While no transmission case was reported domestically because of final sterilization and strict performance during preparation.
ConclusionStrict standard operation, virus inactivation, and final sterilization could effectively control the risks of diseases transmission in human allogenic bone transplantation.
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 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.
