In September 2012, the Assessment for Ethics Review of Traditional Chinese Medicine (TCM) Re-search with Human Participants (named CAP, Chinese medicine assessment human research protection system) was officially commissioned to the World Federation of Chinese Medicine Societies to organize by the State Ad-ministration of TCM. Through the assessment of 20 medical institutions, a comprehensive analysis on ethical re-view platform was conducted. Combined with current regulatory system of ethics in the U.S., this article discussed independent assessment on important CAP features of local brands, the practice and benefit of construction pro-motion based on assessment and continuous improvement, as well as the importance of vigorously promote CAP assessment .

This article analyzes the concept,the formation process,the main content of the United States food defense plan,the duties of stakeholders and the key points of the implementation.This article also summarizes the characteristics,similarities and differences between China and the United States in terms of food defense system,discusses the difficulties and put forward some suggestions for the food defense plan in China.

OBJECTIVE： To compare the quality of ceftazidime for injection among the domestic and imported products METHODS： The ceftazidime was observed and determined with respect to the property， color and clarity of the solution， insoluble particle， content of pyridine， polymer of ceftazidime and marked content of ceftazidime RESULTS： There were some differences in above－ mentioned parameters among products of different factories， however， the parameters were within the range of standard CONCLUSION： The quality of domestic products is reliable and comparable to that of imported ones

BACKGROUND:Diabetes mel itus can give rise to bone metabolic disorders that may involve long-term hyperglycemia, hypoglycemic agents, diet control, estrogen, insulin-like growth factor, leptin, body mass, sex and age.
OBJECTIVE:To establish type 2 diabetic rat models, and to explore the influence of type 2 diabetes on bone metabolism.
METHODS:High-fat and high-glucose diets combining with 35 mg/kg streptozotocin were used to induce type 2 diabetic model in seven male Sprague-Dawley rats (diabetic group). Thirteen rats in control group were given intraperitoneal injection of the same amount of citric acid and sodium citrate buffer. At 4 weeks after modeling, the bone density of rats was serum detected by dual-energy X-ray, levels of fasting blood-glucose, cholesterol, triacylglycerol, serum calcium, phosphate, alkaline phosphatase, fasting insulin, osteocalcin and C-terminal telopeptide-I were measured, and morphology of bone was observed.
RESULTS AND CONCLUSION:Compared with control group, (1) the rat body mass and fasting blood-glucose kept on an overt rise in the diabetic group (P<0.05);(2) levels of cholesterol, triacylglycerol, fasting insulin and alkaline phosphatase, as wel as insulin resistance index were significantly increased, but insulin sensitivity index was significantly decreased in the diabetic group (P<0.05). (3) There were no significant differences in the levels of serum calcium, phosphate, alkaline phosphatase, osteocalcin and C-terminal telopeptide-I between two groups (P>0.05). (4) In the diabetic group, thinner and sparse bone trabeculae were split presenting more free broken ends;(5) the bone density in lumbar spine, double femoral, pelvic and thoracolumbar spine were al significantly decreased (P<0.05). (6) In conclusion, the type 2 diabetic rat model can be successful y induced by 5-week feeding high-fat and high-glucose diets combining with intraperitoneal injection of 35 mg/kg streptozotocin;these mode rats hold some characters, such as hyperglycemia, dyslipidemia, insulin resistance, diminished bone density, and accelerated bone resorption.

BACKGROUND:At present, the methods of treating unstable comminuted radial head fractures contain open reduction and internal fixation and metal prosthesis replacement. There were success cases treated by the two methods, but some shortcomings simultaneously existed.
OBJECTIVE:To compare the clinical therapeutic effects of replacement of the radial head with metal prosthesis with open reduction and internal fixation for the treatment of unstable comminuted radial head fractures.
METHODS:A prospective randomized control ed analysis was performed in 45 cases of unstable comminuted radial head fractures. These cases received open reduction and internal fixation and metal prosthesis replacement. This study compared the Broberg and Morrey elbow joint function score and the incidence of complications after fixation, and performed statistical analysis.
RESULTS AND CONCLUSION:The subjects were fol owed up for 1-5 years, averagely 2.8 years. According to Broberg and Morrey scores, the average score was 90.1 and the incidence of complications was 13.6%in the prosthesis replacement group. The average score was 76.8 and the incidence of complications was 47.9%in the open reduction. Significant differences were visible between the two groups (P<0.01). Compared with the open reduction group, prosthesis replacement for unstable comminuted radial head fractures obtained better joint function and lower incidence of complications.

BACKGROUND:Mason II type and III type radial head fractures with massive bone are mainly treated by open reduction and metal fixation, but metal implants have to be removed in the second operation, which increased patients’ travail and financial burden. Absorbable screw/rod also can be used to treat radial head fractures, and has its special advantages due to the low price and no second operation. OBJECTIVE:To compare the clinical therapeutic effects of absorbable rod and Herbert screw for the treatment of Mason II or III type radial head fractures. METHODS:A total of 80 patients with Mason II and III type radial head fractures were equal y assigned to experimental and control groups. They received open reduction and internal fixation. The experimental group was treated with absorbable rod and the control group received Herbert screw. RESULTS AND CONCLUSION:A total of 79 patients were fol owed up for averagely 34 months. No significant difference in average operative time, fracture healing time, Broberg and Morrey elbow scores and incidence of complications was detected between the experimental and control groups (P>0.05). However, treatment costs were lower in the experimental group than in the control group (P<0.05). Results indicated that the therapeutic effects between absorbable rod and Herbert screw for Mason II or III type radial head fractures were similar. However, absorbable rod for radial head fractures can avoid the second operation for removal of the implant. Therefore, we recommend absorbable rod in the choice of internal fixation materials.

Abstract Defecation disorder is one of the most common complications after orthopedic surgery, which seriously affects patients' quality of life. Based on review of national and international publications pertaining to influencing factors and interventions of postoperative defecation disorders, this review analyzes the associations of orthopedic surgery-related factors with postoperative defecation disorders, and summarizes the common interventions for postoperative defecation disorders, including medication, physical therapy and daily life management, so as to provide insights into prevention and treatment of defecation disorders after orthopedic surgery.

Objective : To establish a Nomogram clinical predictive model of liver failure (PHLF) after hepatectomy for hepatocellular carcinoma (HCC) based on ICG⁃R15 . Methods : Clinical data of 219 patients with hepatocellular carcinoma who underwent radical hepatectomy in the second affiliated Hospital of Anhui Medical University from February 2017 to March 2022 were analyzed retrospectively . The influencing factors of PHLF were screened by Logistics regression and the Nomogram model for predicting the occurrence of PHLF was established . Compared with the traditional model , its predictive efficiency was tested . Results : In this study , ICG⁃R15 ( OR = 1 . 07 , P < 0. 05) , PLT ( OR = 0. 99 , P < 0. 05) , INR ( OR = 1 . 50 , P < 0. 05) , HBV⁃DNA > 1000IU ( OR = 2. 26 , P < 0. 05) , AFP > 400ng/L ( OR = 2. 60 , P < 0. 05) and open surgery ( OR = 0. 26 , P < 0. 05) were the influencing factors of PHLF . A Nomogram prediction model was established based on these factors , and through ROC and DCA analysis , it was found that the prediction efficiency and clinical value of this model were better than those of the traditional model . Conclusion The Nomogram clinical predictive model of hepatocellular carcinoma (HCC) PHLF is successfully established based on ICG⁃R15 .

Objective To investigate and analysis the actuality and demands of scientific researchers in state clinical research facility of TCM, in order to provide evidences for policy making. Methods All the trainees taken part in the meeting for the training of clinical research method were assigned to answer the self-designed questionnaire. Results Of all these people, 47.58 percent people had senior professional title, 84.14 percent people had doctorate or master degree, 57.24 percent people had participated in project research at provincial or ministerial level as key personnel, 35.17 percent people had participated in a key disease research as directors, 65.52 percent people had taken methodology training of clinical research,30.34% of who trained by evidence-based medicine. The majority of these people had clear understanding in methodology of clinical research, who believed that evidence-based medicine and system evaluation are the most difficult subjects to understand and practice, hoping to learn more about the knowledge on statistics. Conclusion Clinical researchers of state clinical research facility of TCM had sound basis for scientific research, but relatively lacking of key disease research and systematic knowledge of scientific methodology, which needed to be enhanced.

BACKGROUND:The therapeutic regimen of intraarticular calcaneal comminuted fractures commonly selects plate and screw fixation. However, for case of posterosuperior calcaneal fracture, the weakness of achil es tendon stretch and plate screw fixation results in difficulty or maintenance of reduction. OBJECTIVE:To investigate the therapeutic effects of open reduction and internal fixation with steel screw and Steinmann pins for comminuted calcaneal intra-articular and posterosuperior fractures. METHODS:From December 2009 to December 2013, forty patients with fractures of comminuted calcaneal posterosuperior fractures were randomly divided into two groups. In the control group, patients were treated by open reduction and internal fixation by plate screw only. In the experimental group, patients were treated by open reduction and internal fixation by combination of plate screw and Steinmann pin. The Gissane and Bohler angles of the calcaneus were measured from lateral radiograph before and 4 weeks after surgery, and the MARYLAND score was assessed at the last fol ow-up. Gissane and Bohler angle and MARYLAND score were compared in each group and among different groups. RESULTS AND CONCLUSION:Al patients were fol owed up for 9-23 months. BOHLER and GISSANE angles were significantly bigger at 4 weeks after surgery compared with pre-treatment in both groups (P<0.05). BOHLER and GISSANE angles were significantly bigger in the experimental group than in the control group at 4 weeks after surgery (P<0.05). During final fol ow-up, the average score by MARYLAND Foot Score was 78 in the experimental group and 67 in control group, with their excellent and good rate of 80%and 73%. The excellent and good rate was significantly higher in the experimental group than in the control group (P<0.05). These data indicated that open reduction and internal fixation with combination of plate screw and Steinmann pin has better efficacy in treatment of the comminuted calcaneal intra-articular and posterosuperior fractures compared with plate and screw fixation alone. Their fixation is firm. Functional exercise can be performed earlier. Postoperative recovery of function of the affected limbs is better than plate and screw fixation alone.