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.
The National Health and Nutrition Examination Survey (NHANES) in the United States is a research program designed to assess the health and nutritional status of adults and children in the country. Due to its adoption of a complex sampling design, it is imperative to correctly apply the weights provided by NHANES to ensure the accuracy and external validity of research results. This article first introduces the relevant concepts of the NHANES database and its weights, followed by a practical demonstration of weight selection, calculation, and implementation in the R programming language. It further discusses the significance of using weights in NHANES data and systematically showcases how to perform weighted analysis based on R, providing a valuable reference for relevant researchers.
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)
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 effectiveness of partial translocation of flexor carpi radialis tendon in the treatment of traumatic dislocation of the first carpometacarpal joint. Methods The clinical data of 6 patients with traumatic dislocation of the first carpometacarpal joint who met the selection criteria between March 2020 and June 2024 were retrospectively analyzed. There were 3 males and 3 females with an average age of 33.5 years (range, 16-42 years). All the 6 cases were treated with plaster immobilization for 4-6 weeks, and the time from injury to operation was 6-12 weeks, with an average of 8.8 weeks. All patients underwent reconstruction of the metacarpophalangeal anterior oblique ligament and dorsal posterior oblique ligament of the first carpometacarpal joint with partial translocation of flexor carpi radialis tendon. The pain relief was evaluated by visual analogue scale (VAS) score before and after operation, and the pinch force, palmar abduction and radial abduction angles of the affected side and the healthy side were recorded before and after operation, and the ratio of the above indexes between the affected side and the healthy side was calculated to evaluate the effectiveness. ResultsAll the incisions healed by first intention after operation, and there was no complication related to operation such as neurovascular injury. All patients were followed up 6-19 months (mean, 12.7 months). The range of motion of the thumb on the affected side was the same as that on the healthy side, the first carpometacarpal joint was stable without recurrent dislocation and pain. At last follow-up, the VAS score, the pinch force of the affected side, the abduction angle of the palmar side of the affected thumb, the abduction angle of the radial side of the affected thumb, and the pinch force ratio, the palmar abduction angle ratio of the thumb, and the radial abduction angle ratio of the thumb of the affected side to the healthy side significantly improved when compared with those before operation (P<0.05). ConclusionPartial translocation of the flexor carpi radialis tendon to reconstruct the metacarpophalangeal and dorsal radial ligaments for the treatment of traumatic dislocation of the first carpometacarpal joint is a reliable surgical method.
Objective To explore the methods of intervention for street-based female sex workers (FSWs) by assessing the intervention process, and evaluate the effectiveness. Methods By cluster sampling procedure, many streetbased female sex workers in Yuzhong district were intervened systematically after informed consent. Before and after the intervention, questionnaire survey was conducted to understand their KAP towards AIDS and analyzed the results of the questionnaire and the effectiveness of intervention. Results The recognition rate abut AIDS knowledge was improved markedly, from the previous 28% to the later 70.5%; condom use in last act increased the previous 59% to the later 75%, consistent use in recent month changed from 4% to 26%; Peer education was trained. Conclusion systematical intervention among street-based female sex workers is critical for spread of AIDS.
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 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.
Objective To systematically evaluate the risk factors and population attributable risk of children leukemia in China, so as to provide references for policy-making. Methods The case-control studies about risk factors of children leukemia in China were searched in PubMed, CNKI, CBM, VIP and WanFang Data from inception to December 2011. According to the inclusion and exclusion criteria, two reviewers independently screened articles, extracted data, and evaluated the quality of the included studies. Then Meta-analysis was performed using STATA 11 and Excel 2003. The pooled odds ratio (OR) and 95% confidence interval (95%CI) of each risk factor were calculated, and the population attributable risk percent (PARP) based on the exposure rate of the risk factors was computed, and published bias was estimated according to the fail-safe number. Results A total of 15 case-control studies were included. The first 5 risk factors related to children leukemia were: dwelling environmental pollution (OR=2.782, 95%CI 2.268 to 3.413), house decoration (OR=2.525, 95%CI 1.736 to 3.673), maternal exposure to chemical hazards (OR=2.428, 95%CI 1.976 to 2.985), family history of tumor (OR=2.212, 95%CI 1.677 to 2.919), and child exposure to electromagnetic field around dwelling (OR=2.144, 95%CI 1.761 to 2.610). Factors with higher PARP were influenza history (37.56%), house decoration history (32.95%), X-ray exposure history (20.47%), and chemical hazards exposure history (17.37%). The fail-safe number showed the results were generally reliable. Conclusion In order to prevent and control children leukemia, positive and effective measures should be taken in the following aspects: strengthening child care, avoiding unnecessary X-ray exposure, and providing good living environment.