This article briefly introduces the management of clinical trials of investigational new drugs, hospital-made preparations, post-marketing drugs and other types of clinical trials. The WHO International Clinical Trial Register Platform (WHO ICTRP), Chinese Clinical Trial Register (ChiCTR) and Chinese Clinical Trial Registration and Publishing Collaboration (ChiCTRPC) are also described. People conducting trials are advised to apply the basic philosophy of evidence-based medicine in their implementation, which is considered to be one of the guarantees of the validity of clinical trials.
Objective To investigate the rehabilitation status of patients with cerebral apoplexy at different ages six months after discharge from hospital. Methods Using the Barthel Index, the Modified Rivermead Mobility Index, the Zung Self-rating Depression Scale, and a self-designed rehabilitation exercise questionnaire, we conducted a cross-sectional investigation on the daily living ability, mobility, depression, and self-rehabilitation exercise of 207 stroke patients six months after discharge, who were discharged from the Rehabilitation Department of West China Hospital of Sichuan University between April 2017 and July 2019. The rehabilitation status of young and middle-aged (≥20 and <60 years old) stroke patients and elderly (≥60 years old) stroke patients were compared. Results There were 91 elderly patients and 116 young and middle-aged patients. Six months after discharge, the incidences of dysfunction in daily living ability (97.8% vs. 90.5%; χ2=4.598, P=0.032) and depression (51.2% vs. 36.2%; χ2=4.043, P=0.044) were higher in the elderly patients than those in the young and middle-aged patients, and the mobility score (26.38±9.77 vs. 29.47±10.60; t=2.154, P=0.032) and the proportion of patients taking self-rehabilitation exercise (93.4% vs. 100.0%; χ2=5.708, P=0.017) were lower in the elderly patients than those in the young and middle-aged patients. Conclusions In the process of continued rehabilitation nursing, different rehabilitation nursing measures should be implemented according to different ages, focusing on elderly stroke patients, and strengthening the supervision and promotion of rehabilitation training of daily living ability and mobility, psychological nursing and self-rehabilitation exercise compliance of elderly patients.
摘要:目的：评价围手术期预防性应用抗菌药物现状及合理性。方法：采用回顾性调查的方法，随机抽查2009年度Ⅰ类切口手术围手术期病案500份，设计外科围手术期预防性应用抗生素调查表，对预防用药的适应证、用药种类、联合用药、给药时机及持续时间进行统计分析。结果：未使用抗生素5例，预防性使用抗生素495例，其中不合理80例（16.00％）。预防性使用抗生素总品规数为540，其中头孢菌素类453例（83.89%），青霉素类（包括加酶抑制剂）26例（4.81%），喹诺酮类44例（8.15%）。选用头孢唑啉钠178例（32.96%）居第一位，头孢替唑钠第二，151例（2796%）。结论：Ⅰ类切口手术患者围手术期预防性使用抗菌药物较为合理，但仍存在用药指征把握不严，抗菌药物的选择、抗菌药物使用时间较长等问题，有待进一步规范化管理。Abstract: Objective: To understand the current application of perioperative preventive antibiotics, and their rationality. Methods: Five hundred perioperative records of patients with incision Ⅰ were randomly chosen and surveyed in 2009. A questionnaire for prophylactic use of antimicrobial was designed. The indication of antimicrobial use, the species, combination, timing and drug duration were analyzed. Results: Our of 500, 495 used antimicrobial and 80 were unreasonable; 540 kinds of antimicrobial were used, included cephalosporin 453 cases (83.89%), penicillin class (including plus enzyme inhibitors) in 26 cases (4.81%), quinolone 44 cases (8.15%). Cefazolin sodium (178 patients, 32.96%) ranked first, second was cefazolin sodium (151, 27.96%). Conclusion: Perioperative use of antimicrobial prophylaxis in patients with incision Ⅰ is reasonable, but standardization management should be strengthened in the indication, species, and duration.
ObjectiveTo understand the treatment status and economic burden of convulsive epilepsy patients in Hailin City, Heilongjiang Province, who had received an epilepsy management program that was terminated for 6 years, and to estimate the long-term effect of the epilepsy management program.MethodsFollow up the 234 patients in the program of epilepsy prevention and management in rural areas at the end of December 2011 by standardized questionnaire and interview.ResultsAmong the 234 patients who received antiepileptic drugs (AEDs) and follow-up management at the end of epilepsy prevention and management program in rural areas, 172 patients received Phenobarbitone (PB) and 62 patients received Sodium valproate (VPA). 86 patients completed the survey. Among them, 46 (53.49%) were still taking original drugs, 31 (36.05%) changed to other AEDs, 9(10.47%) gave up the treatment due to the closure of the program. The treatment costs of patients in adherence group were also lower than that of other patients, and the average cost was only 43.61% of that of the replace group. There were statistical significant differences in annual household income, drug costs, offset seizure frequency and current seizure frequency between the two groups.ConclusionThe epilepsy management program had remarkable long-term effects and short-term effects, it had advantages in treatment effect and reducing drug costs. It could be recommended throughout rural China.
ObjectiveTo investigate the incidence, severity and longitudinal trajectories of symptoms at various time points in the perioperative period of lung cancer patients, and to provide scientific basis for clinical staff to implement predictive nursing and dynamic management of symptom clusters. MethodsA prospective longitudinal investigation was conducted. The patients with lung cancer who underwent thoracoscopic lung surgery in four wards of the Department of Thoracic Surgery in our hospital were investigated by face-to-face and telephone follow-up before surgery, 1-2 days after surgery, on the day of discharge and 2 weeks after discharge. The investigation tool was the revised Chinese version of MD Anderson Symptom Inventory lung cancer specific module. Results A total of 192 patients with lung cancer were included in this study, including 59 males and 133 females, with an average age of (55.68±11.01) years. There were two symptom clusters (respiratory-gastrointestinal and emotional/psychological-disturbed sleep symptom clusters) before surgery, three symptom clusters (respiratory, gastrointestinal, and emotional/psychological-disturbed sleep symptom clusters) 1-2 days after surgery, three symptom clusters (pain-fatigue-emotional/psychological, respiratory, and gastrointestinal symptom clusters) on the day of discharge, and two symptom clusters (pain-fatigue-respiratory and respiratory symptom clusters) 2 weeks after discharge. The composition of symptoms was different in each time point during perioperative period. ConclusionThere are four symptom clusters in patients with lung cancer during perioperative period, which are pain-fatigue-disturbed sleep symptoms, gastrointestinal symptoms, respiratory symptoms and emotional/psychological symptoms. The symptom clusters of lung cancer patients at different time points are relatively stable, but the symptoms within the symptom clusters show dynamic changes. Medical staff should attach great importance to and continuously monitor the dynamic changes of perioperative symptom groups of lung cancer patients, do relevant education and nursing in advance, and timely adjust the management plan according to the symptom group evaluation results.
ObjectiveTo investigate the clinical value of DNA ploidy analysis system in the diagnosis of benignancy or malignancy with bronchial brushing or bronchoalveolar lavage fluid. MethodsWe studied 96 bronchial brush tablets or bronchoalveolar lavage fluid specimens confirmed pathologically between June 2012 and June 2013, in which there were 49 cases of benignancy and 47 malignancies. Bronchial brush pieces were acquired by clinicians when they performed bronchoscopy for the patients. Each bronchoalveolar lavage fluid specimen was made into two slides, of which one was stained by HE method for cytology analysis, and the other was stained with Feulgen method for DNA ploidy analysis through automatic imaging cytometer. ResultsThe specificity, sensitivity and accuracy of the routine cytological investigation were respectively 85.7%, 78.7% and 77.1%, while the three indexes for DNA ploidy analysis were 100.0%, 91.5% and 95.8%, respectively. ConclusionDNA ploidy analysis can improve the bronchial brushing or bronchoalveolar lavage fluid positive rate, and compared with cytological investigation, it is more specific and more sensitive with a high clinical value.
Objective To summarize the methods and applications for quantitative measurement of iron in human.Methods The methods and applications for quantitative measurement of iron in human were analyzed retrospectively via reviewing the literatures domesticly and abroad， and summarized the advantages and disadvantages respectively. Results The methods for quantitative measurement of iron included laboratory tests， pathology examinations， CT， superconducting quantum interference device investigation （SQUID）， and MRI. Conclusions Laboratory test is the most simple and economic method for quantitative measurement of iron in human. Percutaneous liver biopsy is the gold standardmethod. Radiologic examinations， especially MRI， may be main methods of measuring liver iron content in future.
ObjectiveTo investigate the prevalence and risk factors of sever early childhood caries (SECC) among 3 to 5 years old children of Uyghur and Han in Kashi city, and to provide scientific basis for the establishment of oral hygiene policies for caries prevention and diagnostic among children. MethodsAccording to the basic methods of Third National Oral Health Investigation in 2005, a stratified multistage cluster randomly sampling design was applied. The deciduous caries of 893 Uyghur and Han children aged from three to five in ten kindergartens of Kashi city were clinically examined. Data were collected by questionnaire from their parents, and the result analyzed using SPSS 17.0 software. ResultsThe caries prevalence rate of primary tooth was 74.69% and the total prevalence of SECC was 39.19%. The risk factors for SECC include lower age (OR=1.537, 95% CI 1.132 to 2.086, P=0.006), the more frequencies of drinking coke (OR=1.448, 95% CI 1.008 to 2.080, P=0.045), eating fruits (OR=1.840, 95% CI 1.347 to 2.512, P=0.000), drinking milk (OR=1.794, 95% CI 1.311 to 2.456, P=0.000), and before bedtime eating or after brush eating (OR=1.833, 95% CI 1.199 to 2.802, P=0.005), as well as the higher age of starting brush (OR=2.053, 95% CI 1.448 to 2.910, P=0.000). The protective factors for SECC include the more frequency of brushing (OR=0.612, 95% CI 0.445 to 0.844, P=0.003), and higher household income (OR=0.526, 95% CI 0.423 to 0.654, P=0.000). ConclusionThere is a high prevalence of SECC in Kashi city. It is necessary to strengthen the prevention and education activities, and perform early preventive works for caries disease of children.
Objective To investigate the mastery of the management knowledge of patients with atrial fibrillation after coronary artery bypass grafting by cardiac surgeons in Beijing tertiary hospitals, and the practice status and obstacles of following the guidelines for postoperative atrial fibrillation. Methods A convenient sampling method was used to select cardiac surgeons from four tertiary hospitals in Beijing, and a self-designed questionnaire on the management of postoperative atrial fibrillation patients was used. Results A total of 227 valid questionnaires were collected. Only 47.9% of doctors and 12.8% of nurses passed in knowledge, and 31.3% of doctors and 28.5% of nurses passed in behavior. Among them, risk factor assessment, preventive medication, stroke and bleeding risk assessment were the weakest. "Lack of departmental requirements" was identified as a common barrier to healthcare workers' adherence to guidelines. Job title and participation in training were common influencing factors that affected the knowledge and behavior of healthcare workers, and knowledge level was an important factor affecting healthcare worker behavior. Conclusion In order to improve the effect of CABG surgery and improve the quality of postoperative patient management, hospitals should further strengthen the knowledge and skills training of medical staff on the management guidelines of postoperative atrial fibrillation with CABG, formulate relevant systems to ensure the clinical implementation of guidelines.
Objective To perform a cross-sectional study on mental situations of parents of student victims in Wenchuan earthquake and analysis the data to produce best evidences for the government on their decision-making. Methods By the use of questionnaires, interviewer, and observation, we performed field study on 225 student victims’ parents selected by simple random sampling to collect their demographic characteristics, economic and mental status. Results (1) Of the 123 student victims the only child of the family account for 91.87%, female account for 50.41%, the pupil and below, the middle school student, and the college account for 48.78%, 50.41%, 0.81% respectively. (2) Mental and behavior differences between fathers and mothers were significant. (3) The parents declining to accept the death of their children are not in a good social support. (4) The parents with good family economics and high education are more likely to accept the death of children. Conclusion (1) We should build a ‘Mutual Aid’ organization to help those parents construct a good social support net. (2) To take the advantage of rural hospitals to build the long-acting mechanism of the psychological intervention. (3) To perform the psychological intervention corresponding to right period and right aimed group.