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)
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 compare the social support condition of Three Gorges migrants, that is, latter resettled migrants (in Chongqing) versus outside moving migrants (in Shandong). Methods Migrants were selected in both Chongqing Municipality and Shandong Province by a cluster random sampling method, and the survey was performed by completing the questionnaire of general status and the social support rating scale (SSRS). Results A total of 319 among 330 questionnaires distributed to Chongqing migrants were effective, accounting for 98.3%, and 320 among 340 questionnaires distributed to Shangdong migrants were effective, accounting for 94.1%. The results of the survey on social support showed that, a) The total score of social support of Chongqing migrants was significantly lower than that of Shandong migrants (Plt;0.01); b) The total score of Chongqing migrants in different genders was significantly lower than that of Shandong migrants in the same gender, respectively (Plt;0.05); c) All the scores of Chongqing migrants were significantly lower than those of Shandong migrants at the same age level except the objective score of the migrants at the age below 50 (Plt;0.05); and d) All the scores of Chongqing migrants were significantly lower than those of Shandong migrants at the same education levels except the objective score of the migrants at the education level above junior high school (Plt;0.05). Conclusion Compared to the latter resettled migrants in Chongqing, outside moving migrants in Shandong obtain more social support and fully take advantage of that.
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.
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.
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.
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.
ObjectiveTo investigate the effect of curcumin on the expression regulation of endogenousβ-glucoronidase (β-GD) induced by lipopolysaccharide (LPS).Methods① Human normal intrahepatic biliary epithelial cell line (HiBEpiC) cells in the logarithmic growth phase were divided into blank control group (0 h group) and 7 different stimulation time groups. The cell density was adjusted to 1×104/mL, and the cells were stimulated with 100 mg/mL LPS for 1, 3, 6, 18, and 24 hours respectively, including another two groups where the cells were cultured with LPS-free medium for 18 and 24 hours after LPS stimulation for 24 h. ② HiBEpiC cells in the logarithmic growth phase were divided into blank control group, LPS+low, medium, and high concentration curcumin group. The cell density was adjusted to 1×104/mL. In the blank control group, cells were not stimulated with any reagent; in the LPS group, cells were stimulated with 100 mg/mL LPS, in the other three groups, the cells were stimulated with 100 mg/mL LPS and simultaneously 20, 40, and 80 μmol/L curcumin, respectively, for 24 hours. The expressions of c-myc and endogenous β-GD were detected by Western blot method.Results① The expressions of endogenous β-GD and c-myc in HiBEpiC cells gradually increased with the prolongation of treatment time by LPS, and the expression levels of β-GD and c-myc at each time point group were significantly different from those in the 0 h group (P<0.05). ② There were significant difference between any two groups of the blank control group, LPS group, LPS+low concentration of curcumin group, LPS+medium concentration of curcumin group, and LPS+high concentration of curcumin group (P<0.05).ConclusionCurcumin is able to inhibit the increased expression of endogenous β-GD induced by LPS, possibly via inhibiting expression of c-myc.