Bone grafting is a primary method for treating bone defects. Among various graft materials, xenogeneic bone substitutes are widely used in clinical practice due to their abundant sources, convenient processing and storage, and avoidance of secondary surgeries. With the advancement of domestic production and the limitations of imported products, an increasing number of bone filling or grafting substitute materials isentering clinical trials. Relevant experts have drafted this consensus to enhance the management of medical device clinical trials, protect the rights of participants, and ensure the scientific and effective execution of trials. It summarizes clinical experience in aspects, such as design principles, participant inclusion/exclusion criteria, observation periods, efficacy evaluation metrics, safety assessment indicators, and quality control, to provide guidance for professionals in the field.
Humans ; Bone Substitutes/therapeutic use* ; Randomized Controlled Trials as Topic/methods* ; Consensus ; Bone Transplantation ; Research Design

To explore the value of portable oto-endoscopy system in clinical teaching of otolaryngology residents.

To explore the value of portable oto-endoscopy system in clinical teaching of otolaryngology residents.

The existing doctor-patient communication pattern often falls prey to insufficient informed consent and even medical disputes. In the patient centered perspective, Zhejiang Provincial People′s Hospital explored a new communication mode centering on patients. Based on diagnosis-related groups catalogues and high-frequency surgeries catalogues of the departments, multimedia technology was called into play to produce dubbed PPTs and videos that were easy to understand, standardized and homogeneous, which were embedded into medical records system. Following observation of the PPT or video, patients could directly sign an informed consent on the computer. This practice not only deepens patient′s understanding and achieves homogeneous level of the communication, but also elevates doctor′s work efficiency, contributing to building a harmonious doctor-patient relationship.

The construction of safe hospital is the foundation of high-quality development of the hospital, and innovation provides power for the construction of safe hospital from the perspective of high-quality development. Taking Zhejiang Provincial People′s Hospital as an example, the authors introduced the innovation construction path of safe hospital in detail, and put forward the construction strategy of safe hospital with " two hearts" (patient-centered, employee-centered)and " four wings" (multimedia doctor-patient communication, Wulin aunt medical studio, integrated operation safety inspection, third-party medical liability insurance). Through the combination of basic safety management and innovative practice, the hospital vigorously promoted the culture of " two hearts" , and established an efficient collaborative information management system, so as to form replicable and promotable practical experience and promote the development of safe hospital.

In recent years， the incidence rate of andrological diseases has shown a significant growth trend. Considering the unavailability of a perfect theoretical system for andrology in traditional Chinese medicine （TCM） and the complex pathogenesis despite of the limited types of andrological diseases， it is necessary to improve the clinical efficacy of andrological diseases so as to satisfy the needs of patients. Therefore， the China Association of Chinese Medicine （CACM） organized the andrologists of TCM and western medicine and the outstanding young clinicians to discuss the andrological diseases responding specifically to TCM or integrated TCM and western medicine， such as chronic prostatitis， male infertility， benign prostatic hyperplasia， erectile dysfunction， and premature ejaculation， determine their diagnostic criteria in western medicine， and standardize the specifications for TCM diagnosis and treatment based on syndrome differentiation， thus formulating recognized and integrated diagnosis and treatment protocols. Apart from proposing suggestions on the treatment of such andrological diseases with TCM and western medicine， the experts have also figured out the andrological diseases responding specifically to TCM， the optimal intervention time of TCM and western medicine， and the suitable measures including surgery. The resulting consensus helps to better guide the formulation of accurate， personalized， and optimized treatment plans in clinical practice and improve the diagnosis and treatment effects of andrological diseases by giving full play to the advantages of TCM， which will in turn contribute to further innovation and development of TCM.

Objective To evaluate the surgical treatment of complex acetabular fractures through the lateral-rectus approach with pelvic reconstructive plate and antegrade posterior-column lag screws.Methods Between January 2014 and April 2018,29 patients were surgically treated for complex acetabular fractures at Department of Orthopaedic and Trauma,Taihe Hospital.They were 22 males and 7 females,aged from 19 to 72 years(mean,41.7 years).According to the Letournel-Judet classification,there were 4 transverse fractures,7 T-shape fractures,15 both column fractures and 3 anterior plus posterior hemitransverse fractures.In all the patients,the lateral-rectus approach was adopted;their anterior column fractures were fixated with pelvic reconstructive plate and screws and their posterior column fractures with antegrade lag screws.The operation time,intraoperative bleeding,fracture reduction,fracture union time,function of the affected hip and complications were recorded.Results The operation time ranged from 50 to 140 min,averaging 85 min;the volume of intraoperative bleeding ranged from 150 to 1,100 mL,averaging 315 mL.By the Matta criteria,the reduction was rated as excellent in 21 cases,as good in 7 and as poor in one,giving an excellent to good rate of 96.6％.The average follow-up was 16.2 months (from 6 to 30 months) for the 29 patients.Their fractures got united after an average of 11 weeks (from 7 to 13 weeks).According to the Merle d'Aubigné & Postel scoring system at the last follow-up,the function of the affected hip was excellent in 20 cases,good in 7 and fair in 2,yielding an excellent to good rate of 93.1％.There was one case of vasospasm of external iliac artery.No such complications were observed by follow-up as infection,deep venous thrombosis,heterotopic ossification,osteoarthritis or avascular necrosis of the femoral head.Conclusions The lateral-rectus approach with pelvic reconstructive plate and antegrade posterior-column lag screws is a suitable surgical treatment for complex acetabular fractures,leading to satisfactory clinical results.The lateral-rectus approach provides adequate exposure of the quadrilateral surface and facilitates insertion of the posterior column antegrade lag screws.

An efficient method of ultra-high performance liquid chromatography coupled with linear ion trap-Orbitrap (UHPLC-LTQ-Orbitrap) mass spectrometer was established to elucidate the metabolites of tanshinone Ⅰ and tanshinone ⅡA in rats. Urine and plasma samples were collected after oral gavage. After processing biological sample by solid phase extraction, Waters ACQUITY HPLC BEH C₁₈ column (2.1 mm×100 mm, 1.7 μm) was used with 0.1% formic acid (A) - acetonitrile (B) solution as the mobile phase for gradient elution. The plasma, urine and the blank samples were then analyzed by ESI-LTQ-Orbitrap equipped with an ESI ion source under positive ion mode. On the basis of the accurate mass measurements, multiple mass spectra and comparison of data with published literature, a total of 26 metabolites were tentatively identified and characterized in the rat samples. Among them, 7 metabolites were derived from tanshinone Ⅰ through metabolic pathways of glucuronide conjugation, hydroxylation, reduction reaction, demethylation reaction, methylation, sulfate conjugation and their composite reactions. Nineteen metabolites were derived from tanshinone ⅡA through metabolic pathways of hydroxylation, reduction reaction, methylation, sulfate conjugation, glucuronidation, glucosylation and their complicated reactions. The results showed that the metabolism of tanshinone Ⅰ and tanshinone ⅡA in rats could be comprehensively clarified by using UHPLC-LTQ-Orbitrap mass spectrometer, providing material basis for the further research in terms of pharmacodynamics, toxicology, and secondary development of Chinese medicine.
Animals ; Chromatography, High Pressure Liquid ; Diterpenes, Abietane ; blood ; metabolism ; urine ; Rats

Objective To investigate the incidence of radioactivity uptake in thymus combined with serum thyroglobulin (Tg) increase in differentiated thyroid cancer (DTC) patients after high-dose 131I treatments,in order to discuss the mechanism of thymus iodine uptaking and Tg increasing.Methods Retrospective analysis of the laboratory examinations and 131Iwhole body scan (131I-WBS) images in 316 DTC patients were performed.The radioactivity uptake in thymus and the Tg level were observed.Results Among 316 patients (total 735 case-times),4 patients of 5 cases-times 131I-WBS showed radioactivity uptake in thymus,accounting for 0.68％ (5/735).All the radioactivity uptake in thymus were found by posttreatment 131I whole body scan (Rx-WBS) and after the second radioactive iodine treatment.For 1 of 4 patients,Rx-WBS still showed thymic uptake 131I after the third radioactive iodine treatment.The serum Tg increased in 3 patients (4 caestimes Rx-WBS) of radioactivity uptake in thymus with the Tg level before Rx-WBS was 13.80 μg/L,＞300.00 μg/L,16.40 μg/L,20.60μg/L,respectively.Conclusion In order to avoid the inappropriate administration of radioiodine therapy,thymic uptake should be identified carefully in DTC patients whose radioactivity uptake is only found at the upper mediastinal and combined with serum Tg increase.

Objective To observe the concentration of the anti-HBs of children boosted with hepatitis A and B combined vaccine for 3 dosages, and to provide the basis for the implementation of hepatitis B booster immunization. Methods In September 2009 in Yuhuan by employing the cluster sampling method, 123 children, ranging from 6 to 9 years old, who had completed the basic immunization by 0-1-6 procedure without hepatitis B vaccine boosted and without anti-HBs were selected. In the year of 2011 (after 1 year of inoculation) and 2015 (5 years after inoculation), the venous blood samples were collected to determine the concentration of anti-HBs. Results Boosted with hepatitis A and B combined vaccine for 3 times, the anti-HBs of 102 subjects was tested in the next year, of which the anti-HBs of 82 subjects was detected again in the later 5 years. The results suggested that the positive rates of antibody enhanced were 92.16% after 1 year and 78.05% after 5 years, respectively. The average concentration of anti-HBs of these 82 subjects was 2.95 mIU/mL before inoculation, 141.76 mIU/mL one year later and 72.13 mIU/mL 5 years later and there was statistically significant difference among them (P <0.05) . The difference was not statistically significant between subjects with different years of birth (P>0.05) . Moreover, the interaction was existed between the year of blood detection and year of birth (P <0.05) . Conclusion To children aged 6-9 years old whose anti-HBs were negative after the primary immunization of hepatitis B, booster immunization with 3 dosages of hepatitis A and B combined vaccine shows good immune effect against hepatitis B virus.