Conducting quality monitoring to multi-center clinical research is an effective measure of quality control.This study explored the optimization of some key links of quality monitoring of TCM clinical research,i.e.optimization of CRA appointment,optimization of monitoring preparation,optimization of monitoring items,and optimization of monitoring feedback.For monitoring items,this study emphasized on research progress,protocol compliance,original data conservation,medication management,validity,CRF fill-in,informed consent singing and acquisition,EDC,traceability of lab examination,(severe) adverse event reporting in detail,thus providing the theoretical support for quality monitoring improvement of TCM clinical research.

Abstract: Beginning with 4-level quality control measures of clinical research in traditional Chinese medicine (TCM), we elaborated the implementation process and demands of quality control measures of each level, including quality control, monitoring, auditing, and inspection. On the basis of joint inspection experience of 41 projects of the "Prevention and Treatment of Difficult and Complicated Diseases of TCM" plan of the "11th Five-year National Key Technology R&D Program", we analyzed the ensuring effect of 4-level quality control system and joint inspection model, and then pointed out the existing problems in the executing process of quality control system at different levels and joint inspection model. Finally we investigated what should be revised in the quality control system and joint inspection model, thus providing the theoretical support for quality inspection improvement of TCM clinical research.

Objective To evaluate the expression and clinical significance of human papillomavirus(HPV)L1 caspid protein in cytologic specimens of the cervix.Methods The HPV L1 caspid protein in cytologic specimens of the cervix was detected by using immunochemistry in 309 women treated in Shenzhen Hospital of Peking University from Jan.2008 to May 2009.According to histological biopsy,of 309 liquid-based cytologic smears,there were 33 cases of normal cervixes or chronic cervititis,168 cases of grade I of cervical intraepithelial neoplasia(CIN I),84 cases of grade Ⅱ/Ⅲof CIN,and 24 cases of squamous cell carcinomas(SCC).Results The positive expression rate of HPV L1 caspid protein was 27.3%,66.7%,25.0%,and 0 in the normal cervixes or chronic cervititis,CIN I and CIN Ⅱ/Ⅲ,and SCC respectively.There was significant difference between CIN I or SCC and the normal cervixes or chronic cervititis,between CIN I with CIN Ⅱ/Ⅲ,and between CIN I or CIN Ⅱ/m with SCC(all P<0.0 1).The positive expression rate of HPV L1 caspid protein was reduced with the lesion progression from CIN I to CINⅡ/Ⅲ to SCC.309 cases were divided into two groups by 30 and 40 years of age,and there was no significant difference in the HPV L1 caspid protein expression between different age groups(P>0.05).The positive expression rate of HPV L1 caspid protein in the over-1000 RLU/PC viral load group was significantly higher than in the under-1000 RLU/PC viral load group(P<0.05).The sensitivity,specificity,positive predictive value,negative predictive value of HPV L1 caspid protein for detecting high-grade cervical lesions were 80.6%,60.2%,52.1% and 85.2%,respectively.Conclusion The positive rate of HPV L1 caspid protein is decreased with the lesion progression from CIN I to CIN Ⅱ/Ⅲto SCC.HPV L1 caspid protein among HPV-positive women can be a helpful molecular biomarker in risk assessment and prognostic prediction.

Objective:To evaluate the clinical significance of the coincidence test with 3D mirror image of unaffected side in the treatment of contralateral calcaneal fracture.Methods:A retrospective analysis was performed of the 35 patients who had been treated for single calcaneal fracture by coincidence test with 3D mirror image of unaffected side from January 2016 to June 2018 at Department of Trauma Orthopedics, The Sixth Hospital of Ningbo. They were 29 males and 6 females with an average age of 44 years (from 18 to 71 years). By Sanders classification, 19 cases were type Ⅱ and 16 cases type Ⅲ. CT scan and reconstruction of both calcaneuses was performed. The image of unaffected calcaneus was mirrored by Mimics software to guide virtual treatment of contralateral calcaneal fracture. Preoperatively the virtual bilateral calcaneuses and the reduced calcaneus were 3D printed to guide the actual operation. The coincidence test with 3D mirror image of unaffected side was used to evaluate fracture reduction after operation. Postoperative parameters such as B?hler Angle, Gissane Angle, calcaneal width, and coincidence of the affected calcaneal bone were recorded at 12 months after surgery. The clinical outcomes were assessed by American Orthopaedic Foot and Ankle Society (AOFAS) ankle-hindfoot score and visual analogue scale (VAS) score.Results:In this cohort, operation time averaged 43.9 min (from 30 to 55 min), time from admission to operation 3.6 d (from 0 to 14 d), and hospital stay 6.3 d (from 3 to 11 d). The patients were followed up for an average of 18.8 months (from 13 to 24 months). All patients achieved bone union after an average of 17 weeks (from 12 to 26 weeks). Re-collapse of subtalar articular surface, talocalcaneal joint fusion, loss of calcaneal height or length, and calcaneal width increase were observed in none of the patients. The VAS scores averaged 2 (from 0 to 4), and the AOFAS scores 93.3 (from 76 to 98). The total coincidence was 95.2%±3.5%. Spearman test indicated a positive correlation between postoperative total coincidence and AOFAS score ( ρ=0.588, P<0.05). Conclusion:The coincidence test with 3D mirror image of unaffected side can be used to treat contralateral calcaneal fracture, with advantages of reduced surgical time, increased surgical accuracy and fine clinical outcomes.

Objective:To compare the biomechanical characteristics of screw only spatial weaving fixation and calcaneal plate fixation in calcaneal fractures.Methods:Sanders type III calcaneus fracture model was established by using calcaneus model specimens: the physiological model group were the normal calcaneal models; the steel plate group were conventional steel plate fixation fracture models; the metal screw group were fracture models with only metal screw weaving fixation; seven and nine absorbable screw spatial weaving groups (seven absorbable screw group, nine absorbable screw group) were used to weave and fix fracture models with seven and nine absorbable screws. Cyclic test and mechanical compression test were carried out, and load-displacement curves were recorded. The material properties of metal screw spatial weaving and calcaneal anatomical plate system were replicated, finite element fracture models were established, and the calcaneal internal fixation models of plate screw group and spatial weaving screw group were completed by reverse processing. The changes of biomechanical characteristics of calcaneal bone in human (70 kg) standing on one foot were simulated, and the distribution of structural strength was analyzed by Von Mises equivalent stress cloud diagram and displacement cloud diagram.Results:In the cyclic test of 20-200 N load, the physiological model group, the plate group, the metal screw group, the absorbable 7 screw group, the absorbable 9 screw group were 0.87±0.22, 0.82±0.08, 0.70±0.12, 1.04±0.13 and 0.83±1.76 mm, the difference in model gap was statistically significant ( F=3.16, P=0.037). Among them, the absorbable 7 screws group was larger than the metal screws group ( t=4.28, P=0.003), and the other pin-two comparisons were not statistically significant ( P>0.05). The deformation of the five groups was 0.37±0.06, 0.38±0.07, 0.38±0.06, 0.52±0.07 and 0.42±0.07 mm, and the difference was statistically significant ( F=4.39, P=0.010). The deformation of absorbable 7 screws group was greater than that of physiological model group, the plate group and metal screw group ( t=3.69, P=0.006; t=3.25, P=0.012; t=3.51, P=0.008). In static test, compression displacement was 7.14±0.79, 7.30±0.66, 6.95±0.28, 8.19±0.61 and 7.16±0.55 mm, the difference was statistically significant ( F=3.28, P=0.032). The displacement of the absorbable 7 screws group was greater than that of the metal screws group ( t=4.13, P=0.003). The stiffness changes were 570.60±122.62, 512.86±80.77, 497.40±66.50, 456.21±58.19 and 560.39±94.40 N/mm, respectively, with no statistical significance ( F=1.44, P=0.258). The results of finite element analysis showed that under 3 500 N axial pressure load, the maximum compression displacement and stiffness of the plate and screw set were 6.47 mm, 540.96 N/mm, and the Von Mises equivalent stress peaks were 450.31 and 353.15 MPa, respectively. The maximum compression displacement and stiffness of the braided screw group were 5.25 mm, 666.67 N/mm, and the peak Von Mises equivalent stress of the screw was 396.20 MPa. Conclusion:Compared with lateral plate fixation, spatial weaving fixation can provide sufficient biomechanical stability for calcaneal healing and is superior to plate fixation in terms of structural stability, which may help to improve the effectiveness of calcaneal fracture fixation.

Objective:To study a safe anatomical range of the lateral calcaneus for safe surgical approaches.Methods:In 15 cadaveric specimens of the calcaneus, the coordinate axes X, Y, Z were established on the apex of the fibula (the lowest point) as the origin on the lateral side of the calcaneus. In the main part of the lateral calcaneus in the third quadrant of coordinates, the spatial quantification was conducted of the 4 important anatomical structures on the lateral calcaneus (calcaneofibular ligament insertion, common peroneal tendon sheath, lateral calcaneal artery and nerve). The trend trajectory of each structure was summarized. Based on the summary of above measurements, the safety ranges were coincided to find a safe anatomical range for a surgical approach that might lead to the least probability of damaging the important lateral calcaneal structures.Results:The distances from the 4 important anatomical structures to the X, Y, and Z axes of the main part of the lateral calcaneus in the third quadrant are respectively: (21.40±3.38) mm, (18.47±3.91) mm, and (25.06±3.45) mm for the lateral calcaneal artery; (16.53±4.77) mm, (16.27±3.68) mm, and (23.13±4.00) mm for the lateral calcaneal nerve; (9.73±1.73) mm, (11.47±2.13) mm, and (10.87±1.59) mm for the common peroneal tendon sheath; (22.33±2.84) mm for the calcaneofibular ligament insertion. The above 4 important structures mainly converge at the origin O and the anterior 1/3 of the tangent to the outer edge of the calcaneus. In this range, a safe surgical approach can be designed that is located at >2.5 cm below the lowest point of the fibula and 2.1 cm behind the rear side of the arc range.Conclusion:A safe surgical approach can be designed in the safe convergence range of important anatomical structures of the lateral calcaneus to reduce iatrogenic injury to the important structures on the lateral side of the calcaneus.

OBJECTIVETo investigate the clinicopathologic characteristics, differential diagnosis and biological behavior of extracardiac rhabdomyoma.

METHODSNine cases of extracardiac rhabdomyoma diagnosed between January of 1997 and July of 2014 were reviewed. The clinical, pathologic and immunohistochemical profiles were evaluated.

RESULTSThere were 5 males and 4 females at diagnosis with age ranging from 2 years and three months to 59 years (mean, 37.6 years). Sites included the head and neck region (7 cases), chest (1 case ) and vagina wall (1 case). Clinically, most cases manifested as a subcutaneous nodule or as a submucosal polypoid lesion with a mean diameter of 3.2 cm. Histologically, 4 were adult-type rhabdomyoma characterized by tightly packed large round or polygonal rhabdomyoblasts with abundant eosinophilic to clear cytoplasm; 3 were myxoid variant of fetal rhabdomyoma composed of immature myofibrils, spindled and primitive mesenchymal cells embedded in a myxoid background, 1 was an intermediate form of fetal rhabdomyoma consisting of densely arranged differentiated myoblasts with little myxoid stroma; 1 was a genital rhabdomyoma composed of elongated or strap-like myoblasts scattered in loose fibrous connective tissue. By immunohistochemistry, they showed diffuse and strong positivity for desmin, MSA and myoglobin with variable expression of myogenin. A case of intermediate type also stained for α-smooth muscle actin. Follow up data (2 months ~ 17 years) showed local recurrence in one patient 6 months after surgery.

CONCLUSIONSRhabdomyoma is a distinctively rare benign mesenchymal tumor showing skeletal muscle differentiation, which may occassionally recur if incompletely excised. Familiarity with its clinical and morphological variants is essential to avoid misdiagnosing this benign lesion as embryonal rhabdomyosarcoma.

Adolescent ; Adult ; Cell Differentiation ; Child ; Child, Preschool ; Desmin ; analysis ; Diagnosis, Differential ; Female ; Head and Neck Neoplasms ; chemistry ; pathology ; Humans ; Immunohistochemistry ; Male ; Mesenchymoma ; pathology ; Middle Aged ; Myogenin ; analysis ; Neoplasm Recurrence, Local ; Rhabdomyoma ; chemistry ; pathology ; Rhabdomyosarcoma, Embryonal ; pathology ; Thoracic Neoplasms ; chemistry ; pathology ; Thoracic Wall ; pathology ; Vaginal Neoplasms ; chemistry ; pathology