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 investigate the short-term effectiveness of MAKO robot assisted complex total hip arthroplasty (THA). Methods The clinical data of 15 patients (17 hips) underwent MAKO robot assisted complex THA between May 2020 and June 2021 were analyzed retrospectively. There were 5 males and 10 females with the age ranged from 19 to 70 years (median, 49 years), included 9 cases (9 hips) of developmental dysplasia of the hip (Crowe type Ⅱ in 5 hips, type Ⅲ in 1 hip, and type Ⅳ in 3 hips), 1 case (2 hips) of rheumatoid arthritis, 2 cases (3 hips) of ankylosing spondylitis, 3 cases (3 hips) of secondary arthritis with a history of acetabular fracture and internal fixation. The acetabular cup abduction angle and anteversion angle were measured at 3 months after operation, and compared with those measured by MAKO robot system before and immediately after operation. The femoral offset and leg length discrepancy (LLD) were measured at 3 months after operation, which were compared with those before operation. Harris hip score (HHS) and visual analogue scale (VAS) score were used to evaluate hip function before operation and at 3 months after operation. Results All 15 patients (17 hips) completed the operation successfully. The operation time was 75-175 minutes, with an average of 116.3 minutes; the intraoperative blood loss was 100-800 mL, with an average of 381.3 mL. Two patients were not included in the statistics because of intraoperative and postoperative complications, the remaining 13 patients (15 hips) had no serious complication such as vascular and nerve injuries, and 3 patients had intermuscular vein thrombosis. The 13 patients (15 hips) were followed up 3-15 months, with an average of 8 months. At last follow-up, the position of prosthesis did not change and there was no signs of loosening. There was no significant difference in acetabular abduction angle at immediate and 3 months after operation when compared with preoperative one (P>0.05), and the acetabular anteversion angle was significantly lower than that before operation (P<0.05). There was no significant difference in acetabular abduction angle and anteversion angle between at immediate and 3 months after operation (P>0.05). The LLD, offset, HHS score, and VAS score were significantly improved at 3 months after operation when compared with preoperative ones (P<0.05). Conclusion MAKO robot assisted complex THA can achieve good short-term effectiveness, improve the hip range of motion, reduce the length difference between bilateral lower limbs, and improve the quality of patients’ life.
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 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 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 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 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.
Objective To analyze the causes of injury-related deaths of permanent residents in Zigong city, so as to provide scientific references for the prevention and control of injury deaths and for putting forward to relevant health policies as well. Methods Based on the death surveillance data of Zigong from 2001 to 2009, following indicators were analyzed, such as cause specific mortality, age specific mortality and potential years of life lost (PYLL). Results An accumulative total of 10 957 people died of injury from 2001 to 2009, and the crude mortality was 38.13/100 thousands, while the standardized mortality was 36.07/100 thousands. The highest mortality was at the age of more than 65 years of age. The first six injury death causes were as follows: drowning, transport accidents except motor vehicle, suicide, motor vehicle accidents, accidental falling and accidental poisoning. The PYLL of injury death was 334 325.50 person year, APYLL was 34.67 year, and the PYLL rate was 11.63‰ which was higher in male than that of female. Conclusion The epidemiological analysis of injury-related deaths shows an ascending trend, which is the main reason resulting in the loss of residents’ life. Injury has become one of the most serious problems of public health, and it should be prevented and controlled by formulating effective measures and strategies aiming at the injury death spectrum and the target population of Zigong city.
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.