The use of placebo controls in acupuncture trials has been an international concern for many years. We discussed some common problems in placebo controls and introduced four kinds of control methods (sham acupuncture, non-points acupuncture, minimal acupuncture and non-specific sites acupuncture). For sham acupuncture, non-points acupuncture and non-specific sites acupuncture, patients who have received acupuncture are liable to doubt the intervention they are taking. Minimal acupuncture has better reliability but is limited to use in many diseases for its physiological effect. Needling on some special parts of the body, for example, head and back side of the body, can make balance among factors as reliability, physiological effect and feasibility. This paper recommends a control method needling special parts according to the tradiontional acupuncture theory, which provides references for acupuncture clinical trials.
By dividing the evolution of the U.S. clinical trial registration system into three phases—emergence, inception, and maturity—this study systematically traces its half-century development and reveals the underlying tensions and institutional logic. The U.S. clinical trial registration system is not merely a technical instrument, but a comprehensive institutional platform reconciling the conflicts among scientific rationality, commercial interests, and the public’s right to know. The emergence phase (1971—1985) originated from the establishment and public disclosure of the International Cancer Database to meet cancer research needs and safeguard patients’ survival rights. The inception phase (1986—2004) unfolded against the backdrop of the FDA’s drug approval crisis, with the construction of major disease registration systems breaking the regulatory deadlock and achieving an "incremental revolution". The maturity phase (2004—2016) centered on controlling publication bias and advancing institutionalization and legalization. The 2004 paroxetine incident galvanized global consensus on trial registration, and the 2007 U.S. Congressional mandate marked the pivotal turning point toward a fully mature system. Today, China still faces low registration rates and insufficient legal constraints. Drawing on the U.S. experience, China should prioritize institutional publicness, legal enforceability, and the containment of publication bias to strategically upgrade its clinical trial registration system.
ObjectiveTo detect the level of serum melanoma-inbibiting activity (MIA) in patients with uveal melanomas, and investigate the value of MIA in diagnosing and inspecting uveal melanomas.MethodsEnzyme-linked immunosorbent assay (ELISA) was used to detect the concentrations of MIA in peripheral serum of 27 patients with uveal melanoma, 6 with melanocyte tumor, 7 with other ocular tumors and 16 healthy individuals, respectively.ResultsThe concentration of MIA in patients with uveal melanoma was significantly higher than that in the healthy ones (16 individuals) and the patients with adenoma of non pigmented ciliary epithelium (4 patients), retinoblastoma (2 patients), and retinal angioma 91 patient). The concnetration of MIA in patients with uveal melanoma without scleral infiltration or remote metastasis was obviously lower than that in the patients with scleral infiltration or remote metastasis, but didn′t differ much from which in the patients with melanocyte tumor. In the patients with uveal melanoma without infiltration or remote metastasis, there was no significant difference of MIA level between patients with spindle cell and mixed and epithelioid cell.ConclusionThe level of serum MIA may be an effective index in diagnosing uveal melanoma, which can monitor the metastasis of uveal melanoma.(Chin J Ocul Fundus Dis, 2005,21:153-155)
ObjectiveTo summarize the current progress of vascularized bone grafting in the treatment of osteonecrosis of the femoral head (ONFH), and to provide reference for treatment of ONFH.MethodsThe literature at home and abroad on the treatment of ONFH with vascularized bone grafting was reviewed, and the mechanism, operating methods and effectiveness, indications, and complications were summarized.ResultsVascularized bone grafting is a commonly used clinical hip-preserving operation. By replacing necrotic bone tissue with vascularized bone, it can rebuild the blood circulation system, promote the healing of the necrotic area, and provide biomechanical support for the necrotic area of the femoral head, prevent the joint surface collapse. The main operations include the vascularized iliac bone flap grafting, the vascularized greater trochanter bone flap grafting, and the vascularized fibular grafting. The clinical application has achieved certain effectiveness, and the different procedures are suitable for different types of patients. The procedures need to be selected based on the patient’s overall condition, the cause of ONFH, the necrosis stage, and the degree of the evaluation.ConclusionVascularized bone grafting has a definite effectiveness in the treatment of ONFH in the young and middle-aged. It can significantly improve hip joint function, control the further development of the disease to a great extent, effectively delay or even avoid hip arthroplasty. It is a reliable hip-preserving operation worthy of promotion.
Objective To analyze the death cause of residents in Zigong from 1985 to 2009, so as to provide the government with scientific information of health strategies, and disease prevention and control. Methods The death surveillance data in Zigong residents from 1985 to 2009 were collected, and the indexes such as all death mortality rate, infant mortality rate, maternal mortality rate, disease-specific mortality rate, age-specific mortality rate, and life expectancy were analyzed. Results The all death mortality rate had fluctuation of plus or minus 6‰, and the male mortality rate was higher than the female (χ2=8 059.769, P=0.000). The six main influencing factors of the death of Zigong residents were as follows: respiratory system diseases, circulatory system diseases, tumour, injury and poisoning regarded as external cause diseases, digestive system diseases, and infectious diseases and parasitic diseases. The mortality rates of different districts were statistically different (χ2=1 643.926, P=0.000), and Fushun County was the highest among them after standardization. The curve of mortality rate in different sex and age groups was changed alike letter “U”. The mortality rate was ascending with the age in the group of over 15 years old, the ascending trend was more evident especially after 50 years old. The infant mortality declined steadily and was well controlled. The maternal mortality declined obviously. The average life expectancy for the whole city was 74.72, which showed an ascending trend. Conclusion The chronic diseases are the main death cause of residents in Zigong. The prevention and controlling of acute infectious diseases and parasitic diseases should be persistently performed for declining both incidence rate and mortality rate. The Zigong city is gradually stepping into aging society, which requires the great development of senior work.
ObjectiveTo evaluate the predictive value of critical illness scores for hospital mortality of severe respiratory diseases in respiratory intensive care unit (ICU).MethodsThe clinical data of the patients who needed intensive care and primary diagnosed with respiratory diseases from June, 2001 to Octomber, 2012 were extracted from MIMIC-Ⅲ database. The Acute Physiology Score (APS) Ⅲ, Simplified Acute Physiology Score (SAPS) Ⅱ, Oxford Acute Severity of Illness Score (OASIS), Logistic Organ Dysfunction System (LODS), Systemic Inflammatory Response Syndrome (SIRS) and Sequential Organ Failure Assessment (SOFA) were calculated according to the requirements of each scoring system. ICU mortality was set up as primary outcome and receiver operating characteristic (ROC) analysis was performed to evaluate the predictive performances by comparing the areas under ROC curve (AUC). According to whether they received invasive mechanical ventilation during ICU, the patients were divided into two groups (group A: without invasive mechanical ventilation group; group B: with invasive mechanical ventilation group). The AUCs of six scoring systems were calculated for groups A and B, and the ROC curves were compared independently.ResultsA total of 2988 patients were recruited, male accounted for 49.4%, median age was 67 (55, 79), and ICU mortality was 13.2%. The AUCs of SAPSⅡ, LODS, APSⅢ, OASIS, SOFA and SIRS were 0.73 (0.70, 0.75), 0.71 (0.68, 0.73), 0.69 (0.67, 0.72), 0.69 (0.67, 0.72), 0.67 (0.64, 0.70) and 0.58 (0.56, 0.62). Subgroup analysis showed that in group A, the AUCs of OASIS, SAPSⅡ, LODS, APSⅢ, SOFA and SIRS were 0.81 (0.76, 0.85), 0.80 (0.75, 0.85), 0.77 (0.72, 0.83), 0.75 (0.70, 0.80), 0.73 (0.68, 0.78) and 0.63 (0.56, 0.69) in the prediction of ICU mortality; in group B, the AUCs of SAPSⅡ, APSⅢ, LODS, SOFA, OASIS and SIRS were 0.68 (0.64, 0.71), 0.67 (0.63, 0.70), 0.65 (0.62, 0.69), 0.62 (0.59, 0.66), 0.62 (0.58, 0.65) and 0.57 (0.54, 0.61) in the prediction of ICU mortality. The results of independent ROC curve showed that the AUC differences between groups A and B were statistically significant in terms of OASIS, SAPSⅡ, LODS, APSⅢ and SOFA, but there were no significant differences in SIRS.ConclusionsThe predictive values of six critical illness scores for ICU mortality in respiratory intensive care are low. Lack of ability to predict ICU mortality of patients with invasive mechanical ventilation should hold primary responsibility.
OBJECTIVE: To explore the feasibility of reconstructing tissue engineered vessel in vitro. METHODS: Bovine endothelial cells were isolated from calf thoracic aorta by enzyme digestion methods and subcultured and purified. The endothelial cells of the 3rd to 7th passages were seeded into the inner surface of tubular scaffold material by polyglycolic acid(PGA) coated with cross-linked collagen, and cultured in vitro for 10 days using dynamic rotation culture technique. Scanning electron microscopy was used to analyse the morphological characteristics, and prostacyclin released by endothelial cells was measured by radioimmunoassay of 6-keto-prostaglandin F1 alpha. RESULTS: The VIII factor staining of cultured endothelial cells was positive. The endothelial cells adhered well on the inner surface of tubular scaffold material with confluent monolayer covering(91.2 +/- 1.5)%. The endothelialized model released prostacyclin at a rate of (4.6 +/- 0.5) micrograms/cm2.min. There was significant difference to control group (P lt; 0.05). CONCLUSION: The PGA coating with collagen is an ideal scaffold for endothelial cells, the coverage rate is increased through dynamic rotation culture technique. It will lay a good foundation for architecture of a laminated structure of tissue engineered vessel.
Objective To explore the application effect of a nursing management mode based on Swiss cheese model in safe medication for chemotherapy patients in daytime wards. Methods The study included chemotherapy patients in the Department of Day Care Ward of Tianjin Medical University Cancer Institute & Hospital between February and March 2023 (before improvement) and between June and July 2023 (after improvement). Before the improvement, a conventional nursing management mode was adopted, and after the improvement, a nursing management mode based on the Swiss cheese model was adopted. The medication safety ability of nurses, adverse drug events, and patients’ satisfaction of nursing before and after improvement were compared. Results Finally 150 patients were included before and after improvement, respectively. There was no statistically significant difference in age, gender, educational level, per capita monthly household income, tumor staging, and disease diagnosis between the two groups of patients (P>0.05). The total score of patients’ satisfaction of nursing after improvement was higher than before improvement (22.99±1.52 vs. 20.45±2.14, P<0.05), but there was no statistically significant difference in the dimensions of treatment environment and service attitude (P>0.05). There was no change in the nursing staff before and after the improvement, and a total of 34 nurses were included in the Department of Day Care Ward. The total score of the nurses’ medication safety ability was higher than before improvement [162.00 (160.75, 166.25) vs. 136.00 (135.00, 138.00), P<0.05], but there was no statistically significant difference in the dimensions of improving medication safety issues, multidisciplinary collaboration ability, and nursing professional responsibility (P>0.05). The incidences of adverse events during daytime chemotherapy after improvement were lower than before improvement (P<0.05). Conclusion The nursing management mode based on Swiss cheese model can improve the safety medication ability of nurses, reduce adverse events of chemotherapy medication in daytime wards, and improve patient satisfaction, which can be promoted in clinical practice.
Accurate detection of cephalometric landmarks is crucial for orthodontic diagnosis and treatment planning. Current landmark detection methods are mainly divided into heatmap-based and regression-based approaches. However, these methods often rely on parallel computation of multiple models to improve accuracy, significantly increasing the complexity of training and deployment. This paper presented a novel regression method that can simultaneously detect all cephalometric landmarks in high-resolution X-ray images. By leveraging the encoder module of Transformer, a dual-encoder model was designed to achieve coarse-to-fine localization of cephalometric landmarks. The entire model consisted of three main components: a feature extraction module, a reference encoder module, and a fine-tuning encoder module, responsible for feature extraction and fusion of X-ray images, coarse localization of cephalometric landmarks, and fine localization of landmarks, respectively. The model was fully end-to-end differentiable and could learn the intercorrelation relationships between cephalometric landmarks. Experimental results showed that the successful detection rate (SDR) of our algorithm was superior to other existing methods. It attained the highest 2 mm SDR of 89.51% on test set 1 of the ISBI2015 dataset and 90.68% on the test set of the ISBI2023 dataset. Meanwhile, it reduces memory consumption and enhances the model’s popularity and applicability, providing more reliable technical support for orthodontic diagnosis and treatment plan formulation.
ObjectiveTo determine the prognostic significance of change of systemic immune inflammation index (SII) before and after neoadjuvant chemotherapy (NCT) in advanced pancreatic cancer.MethodsThe patients with advanced pancreatic cancer who received the NCT before pancreatectomy and met the inclusion and exclusion criteria of this study from January 2013 to December 2016 in the Panjin Liao-Oil Gem Flower Hospital were retrospectively collected. The patients were designed into an increased SII group (SII before NCT was lower than after NCT) and decreased SII group (SII before NCT was higher than after NCT) according to the change of SII before and after NCT. The laboratory data before and after NCT were collected to calculate the SII and to analyze the relationship between the change of SII before and after NCT and the clinical outcomes. The clinicopathologic characteristics and postoperative 3-year survival rate of the two groups were compared. The Cox regression was used to evaluate the influencing factors of postoperative survival of advanced pancreatic cancer.ResultsAll of 103 patients were included, 42 of whom in the increased SII group and 61 in the decreased SII group. The proportions of the intraoperative tumor size >3 cm, CA19-9>37 U/mL after NCT, and postoperative complications in the increased SII group were significantly higher than those in the decreased SII group (P<0.05). All 103 patients were followed up from 9 to 81 months with median 13 months, the 3-year cumulative survival rate of patients in the increased SII group was significantly lower than that of patients in the decreased SII group (19.0% versus 42.6%, P=0.012). The results of the multivariate analysis showed that the CA19-9>37 U/mL after NCT [HR=2.084, 95%CI (1.140, 3.809), P=0.017], postoperative complications [HR=1.657, 95%CI (1.009, 2.722), P=0.046], the absent of postoperative adjuvant chemotherapy [HR=1.795, 95%CI (1.085, 2.970), P=0.023], and the elevated SII after NCT [HR=1.849, 95%CI (1.111, 3.075), P=0.018] were the independent risk factors affecting postoperative 3-year survival rate of patients with advanced pancreatic cancer.ConclusionsThe change value of SII before and after NCT is an independent risk factor for the prognosis of patient with advanced pancreatic cancer, the elevated SII after NCT is a poor prognosis index in patient with advanced pancreatic cancer. However, the evaluations of larger controlled trials are necessary at multiple institutions before introduction of SII as a prognostic indicator in clinical practice.