In the process of exploring standardized and efficient ethical review models for multi-center drug clinical trials, the ethical review alliance emerged as the times require. Compared with mature ethics committees, higher requirements have been put forward for the "young" ethics committees. By analyzing problems existing in review work of "young" ethics committees in the ethics review alliance, this paper discussed the measures to improve the review quality of "young" ethics committees and promote the standardized and efficient operation of the alliance, and put forward countermeasures and suggestions for improving the homogenization of ethics review and accelerating the clinical research process of innovative drugs.

Objective:To explore the clinical effect of a modified surgical procedure for replantation of severed digit-tips in Tamai zones I-II.Methods:From November 2019 to October 2022, the Department of Hand and Foot Microsurgery of the First Affiliated Hospital of Bengbu Medical College employed a modified procedure (to abandon the anatomically labelling of blood vessels and nerves after naked-eye debridement and fracture fixation, then perform the microscopic dissections and anastomoses of blood vessels and nerves, and the anastomosis of dorsal veins though an auxiliary small incision by the lateral nail fold of the severed digit-tip) to replant severed digit-tips in Tamai zones I-II of 26 patients (29 digits). The patients were 20 males (23 digits) and 6 females (6 digits), aged 3-66 years old, with mean age at 28 years old. Nineteen digit-tips were severed in Tamai zone I and 10 in Tamai zone II. The severed digit-tips were 7 of thumbs, 9 of index fingers, 5 of middle fingers, 5 of ring fingers and 3 of little fingers. Causes of injury were 12 of cut, 8 of crush and 6 of avulsion. Postoperative management included infection prevention, antispasmodic for 3 days and keeping in bed for 5 days. The time of surgery was recorded on all patients. Postoperative follow-ups were conducted at outpatient clinics for 6 to 12 months to observe the survival of digit-tips and the appearance, recovery of sensation and motor functions, strength of digits and patient satisfaction.Results:(1)The surgical time was about 1.0 hour for replantation of a severed digit-tip in Tamai zone I, while it took about 1.5 hours for those in Tamai zone II. (2)Survival rate and appearance: all 29 replanted digit-tips survived, except 2 in Tamai zone I which encountered venous occlusion and survived after small incision for bloodletting. Twenty-two digit-tips gained pulp fat pads with full digit pulps. Four avulsed digit-tips had mild atrophy of pulp. The 15 digit-tips severed in Tamai zone I were about 2 mm shorter than the healthy sides, but without deformity. One digit-tip had poor nail appearance due to preoperative fungal infection of nail bed. (3)Sensory recovery: with the British Medical Research Council (BMRC), 23 digit-tips recovered to S 3+, and 2 digit-tips of avulsion and 1 digit-tip of crush recovered to S 3. TPD of the replanted digit-tips were: 4-7 mm in those of cut injury; 6-8 mm in those of crush and 9-11 mm in those of avulsion. (4)Motion and digit strength: results of functional assessment according to the total active mobility standard promoted by China's Society for Surgery of the Hand were: 21 cases of excellent and 5 of good, without pain in digit pulp when pinching and griping. The mobility of the digits with replanted digit-tips of both Tamai zones I and II were close to that of the healthy sides. The motions of the digits with replanted digit-tips in Tamai zone I were close to the healthy sides and the 5 of those in Tamai zone II had 0° in extension and 2°-3° in flexion, due to the severed plane at distal interphalangeal joint. (5)Patient satisfaction: 25 patients were satisfied, however 1 patient was dissatisfied to the poor function of the distal interphalangeal joint due to the severed thumb-tip in Tamai zone II. Conclusion:Modified replantation procedure for severed digit-tip in Tamai zones I-II has significant achievement in cutting down the surgical time through a modified procedure of debridement and fracture fixation (tendon suture) by naked-eyes operation first, followed by dissections and anastomoses of the blood vessels and nerves under the surgical microscope. The auxiliary small incision by the lateral nail fold of digit-tip in Tamai zone I facilitates an exposure of a constant, healthy lateral nail fold vein. It enables the anastomosis with a high-quality vein, hence improves the success rate of replantation. The appearance and function of the replanted digit-tip are found better in the severed digit-tips of cut injury than those with injuries of avulsion and crush.

OBJECTIVE:At present,there are many reports on the related factors associated with the incidence of cervical spine instability in patients with rheumatoid arthritis,but there are problems such as small sample size and many confounding factors,and the research results of various studies on the same related factors are also different.This article analyzed the factors related to cervical spine instability in patients with rheumatoid arthritis by means of a systematic review. METHODS:Articles related to cervical spine instability in patients with rheumatoid arthritis were collected by searching both Chinese and English databases until March 2023.The outcome of cervical spine instability in patients with rheumatoid arthritis was used as the grouping criterion to abstract basic information,baseline patient characteristics,laboratory-related tests,medication use,and other relevant risk factors.Meta-analysis was done using Stata 14.0 software. RESULTS:(1)Sixteen relevant studies,all of moderate or above quality,were included,including seven studies with case-control studies and nine with cross-sectional studies.The overall incidence of cervical spine instability in patients with rheumatoid arthritis was 43.08%.(2)Meta-analysis showed:Related risk factors included female(OR=0.60,95%CI:0.44-0.82,P=0.002);age at disease onset(SMD=-0.52,95%CI:-0.86 to-0.18,P=0.003);duration of disease(SMD=0.58,95%CI:0.14-1.02,P=0.01);body mass index(OR=0.74,95%CI:0.63-0.88,P=0.001);rheumatoid factors positive univariate analysis subgroup(OR=1.33,95%CI:1.02 to 1.72,P=0.04),C-reactive protein(SMD=0.26,95%CI:0.16-0.35,P=0.00),erythrocyte sedimentation rate(SMD=0.15,95%CI:0.002-0.29,P=0.047),anti-cyclic-citrullinated peptide antibodies(OR=1.73,95%CI:1.19-2.51,P=0.004),28-joint Disease Activity Score(SMD=0.20,95%CI:0.04-0.37,P=0.02),destruction of peripheral joints(OR=2.48,95%CI:1.60-3.85,P=0.00),and corticosteroids(OR=1.91,95%CI:1.54-2.37,P=0.00)were strongly associated with the development of rheumatoid arthritis-cervical spine instability.Female and corticosteroid use were independently associated with the occurrence of rheumatoid arthritis-cervical spine instability. CONCLUSION:Based on clinical evidence from 16 observational studies,the overall incidence of rheumatoid arthritis-cervical spine instability was 43.08%.However,the incidence of cervical spine instability in rheumatoid arthritis patients varied greatly among different studies.Gender(female)and the use of corticosteroids were confirmed as independent correlation factors for the onset of cervical spine instability in patients with rheumatoid arthritis.The results of this study still provide some guidance for early clinical recognition,diagnosis,and prevention of rheumatoid arthritis-cervical spine instability.

Objective:To investigate the clinical effects of free superficial circumflex iliac artery (SCIA) superficial branch perforator flap combined with full-thickness skin graft far from the flap donor site in repairing the large wounds in extremities.Methods:The study was a retrospective observational study. From January 2020 to June 2022, 19 patients with large wounds in extremities who met the inclusion criteria were admitted to the First Affiliated Hospital of Bengbu Medical College, including 15 males and 4 females, aged 28-75 years. The debridement, fracture reduction and fixation, tendon, vessel, and nerve repair, and vacuum sealing drainage were performed in the first stage surgery. After debridement in the second stage surgery, the total wound area was 13.0 cm×8.0 cm-34.0 cm×15.0 cm. The tendon and bone exposed wound with area of 9.0 cm×6.0 cm-14.0 cm×7.0 cm was repaired with free SCIA superficial branch perforator flap with area of 10.0 cm×6.5 cm-15.0 cm×8.0 cm. The remaining granulation tissue wound with area of 5.0 cm×3.5 cm-13.0 cm×8.0 cm was repaired with full-thickness skin graft far from the flap donor site with area of 5.0 cm×3.5 cm-13.0 cm×8.0 cm. All the wounds in donor site were sutured. The operation time and amount of bleeding of patients during the surgery were recorded, the survival of flap and skin graft were observed after surgery. During follow-up, the flap and skin graft, scar in the donor site and its effect on donor site function were observed. At the last follow-up, the satisfaction of patients with the efficacy was evaluated by the efficacy satisfaction rating score.Results:The operation time of patients was 2.0-3.5 h. The amount of bleeding of patients during the surgery was 100-320 mL. One patient had ecchymosis and venous crisis in the edge of flap on the second day after surgery, and the flap survived after exploration. The flaps of the other patients survived smoothly. The skin grafts of patients all survived smoothly. Two patients had bloated flaps due to obesity in the later stage, and the expected results were achieved after flap thinning surgery 6 months after operation. During the follow-up of 6 to 24 months, the flaps had good elasticity and soft texture, and the skin grafts had no wear or ulceration; linear scars were left in all the donor sites but their functions were not affected. The patients were all satisfied with the efficacy.Conclusions:Free SCIA superficial perforator flap combined with full-thickness skin graft far from the donor site was used to repair the large wounds in extremities, which was safe, reliable, and less traumatic and short in operation time, and resulted in good postoperative appearance and function in the donor sites and recipient sites.

Objective To explore the predictive value of serum fibrinogen(Fbg)and pentaxin-3(PTX3)levels for perioperative major adverse cardiovascular events(MACE)in elderly patients undergoing hip re-placement surgery.Methods A total of 201 patients who underwent hip replacement surgery in the Qilu Hos-pital of Shandong University,Dezhou Hospital(the hospital)from January 2022 to December 2022 were re-garded as the study group,and based on the presence or absence of MACE during the perioperative period,pa-tients were separated into the non MACE group(183 cases)and the MACE group(18 cases).Another 150 healthy examinees from the hospital were selected as the control group.Fully automated biochemical analyzer and enzyme linked immunosorbent assay(ELISA)were applied to detect serum Fbg and PTX3 levels in re-search objects.Multivariate Logistic regression was applied to analyze the influencing factors of perioperative MACE in elderly patients undergoing hip replacement surgery.Receiver operating characteristic(ROC)curve was applied to evaluate the predictive value of serum indicators for perioperative MACE in elderly patients un-dergoing hip replacement surgery.Results Compared with the control group,the serum Fbg and PTX3 levels in the study group were obviously increased,and the differences were statistically significant(P＜0.05).There were 18 cases who had MACE in elderly patients undergoing hip replacement surgery,with an incidence rate of 8.95％.Compared with the non MACE group,the serum Fbg and PTX3 levels in the MACE group were obviously increased,and the differences were statistically significant(P＜0.05).Elevated serum Fbg,PTX3,cardiac troponin I(cTnI),brain natriuretic peptide(BNP)levels,and decreased left ventricular ejection fraction were independent risk factors for perioperative MACE in elderly patients undergoing hip arthroplasty(P＜0.05).The area under the curve(AUC)of single and combined detection of serum Fbg and PTX3 levels for predicting the occurrence of perioperative MACE in elderly patients undergoing hip arthroplasty was 0.824,0.809,and 0.917,respectively.The combined prediction value of the two was higher than that of indi-vidual prediction(Z combination-Fbg=2.333,P=0.019;Z combination-PTX3=3.110,P=0.001).Conclusion The periop-erative serum Fbg and PTX3 levels in elderly patients undergoing hip replacement surgery are elevated,and the combination of the two has good predictive value for the occurrence of perioperative MACE.

Objective:To investigate the feasibility and clinical efficacy of posterior vertebral column resection (PVCR) combined with polymethylmethacrylate-augmented pedicle screw instrumentation and shortening of spinal column for stage Ⅲ Kümmell's disease with very severe collapse of fractured vertebra.Methods:From January 2017 to September 2021, 9 patients with stage Ⅲ Kümmell's disease with very severe collapse of fractured vertebra underwent PVCR combined with polymethylmethacrylate-augmented pedicle screw instrumentation and shortening of spinal column. Their medical records were retrospectively analyzed. There were 1 male and 8 females, aged (66.9±5.8) years. The injured vertebra was located at T 11 in 2 patients, at T 12 in 4, at L 1 in 2 and at L 2 in 1. X-ray, CT and MRI were performed before operation. The posterior intervertebral heights of adjacent vertebral bodies of the fractured vertebra in the median sagittal position were measured on CT or MRI to evaluate the shortening of the spinal column before PVCR. Recorded were intraoperative bleeding volume, operation time, complications, bone graft fusion, and American Spinal Injury Association (ASIA) grading at preoperation and the last follow-up. The visual analogue scale (VAS) pain scores, Oswestry disability index (ODI) scores, and kyphotic cobb angles at preoperation, 1 week and 3 months postoperation, and the last follow-up were compared to evaluate the clinical efficacy of PVCR. Results:All patients underwent surgery successfully, with tight closure of adjacent vertebrae after resection of the injured vertebra and bone grafting. Operation time was (240.6±23.2) min and intraoperative bleeding (505.6±95.0) mL. The 9 patients were followed up for (17.3±5.6) months. No worsening symptoms of nerve injury, cerebrospinal fluid leakage, or other serious complications were found after operation, nor such complications as loosening or breakage of internal fixation or adjacent vertebral fractures. Bone fusion was achieved at the bone graft sites in all patients by the last follow-up. The VAS and ODI scores and cobb angles at 1 week and 3 months postoperation and at the last follow-up were significantly decreased compared with preoperation ( P<0.05). There were no significant differences in VAS scores or cobb angles among postoperative 1 week and 3 months and the last follow-up ( P>0.05), but pairwise comparisons between different time points after operation showed significant differences in ODI, with postoperative 1 week > postoperative 3 months > the last follow-up ( P<0.05). The ASIA grading at the last follow-up was improved from preoperative grade C to grade D in 2 cases, from preoperative grade C to grade E in 1 case and from preoperative grade D to grade E in 5 cases. Conclusion:PVCR combined with polymethylmethacrylate-augmented pedicle screw instrumentation and shortening of spinal column is a feasible and effective surgical treatment for stage Ⅲ Kümmell's disease with very severe collapse of fractured vertebra, leading to good clinical efficacy.

Objective:To explore the utilization of cancer-related data from basic medical insurance databases in China, and promote the application of medical insurance data in cancer prevention and treatment.Methods:Database PubMed, Web of Science, Wanfang, and CNKI were used to select related research papers using data from basic medical insurance system in China published by December 2021. Descriptive analysis was conducted in terms of the number of publications, types of cancer, primary research contents and author affiliations.Results:A total of 65 papers were included in the study. The number of publications increased rapidly after 2016. The most studied cancer type was lung cancer, and healthcare costs were the most common research contents. Fujian, Beijing, and Anhui have made a better use of cancer-related medical insurance databases compared to other provincial regions. The accessibility of the New Rural Cooperative Medical Scheme data was limited due to the high regional barriers, while the accessibility of the urban basic medical insurance data was relatively high. The researchers from Peking University and Fudan University had higher utilization of basic medical insurance data compared with those from other institutions.Conclusions:The utilization of cancer-related data from basic medical insurance databases in China is limited because of poor accessibility, insufficient data sharing, and regional restrictions. Thus, it is urgent to improve data accessibility and promote the integration and utilization of regional medical insurance data.

Objective:To investigate the clinical effect of three different tissue flaps in repairing patients with orbital region tissue loss after enlarged resection of malignant tumors in the orbital region, as well as the indication.Methods:Retrospective analysis of data of patients with malignant tumors in the orbital region treated in the Department of Oral and Maxillofacial Trauma and Orthognathic Surgery, the First Affiliated Hospital of Xinjiang Medical University (Affiliated Stomatological Hospital) between January 2017 and December 2021. All patients underwent extensive resection of periorbital malignant tumors and enucleation of orbital contents, depending on defects in periorbital soft/hard tissues and orbital contents, temporalis myofascial flap combined with full thickness skin grafts (TMF-FTSG group), modified pectoralis major myocutaneous flap (PMMF group), and free anterolateral thigh flap (ALTF group) were used to repair the tissue defect. The wound healing and complications of the donor and recipient areas were followed up after operation, and degree of mouth opening in the TMF-FTSG group was compared at 3 months after operation and before operation. The University of Washington quality of life scale (UW-QOL) score was compared among the three groups before and 1 year after operation (a total of 12 items, each item was assigned from 0 to 100 points, the higher the score, the better the recovery). Statistical software SPSS 26.0 was used to analyze the data. The measurement data were expressed as Mean±SD, and the paired t-test was used to compare the preoperative and postoperative data within the group, the difference was statistically significant at a P value less than 0.05. Results:A total of 22 patients were enrolled. There were 8 patients in TMF-FTSG group, 4 males and 4 females, aged (68.3±9.7) years. There were 6 patients in PMMF group, 5 males and 1 female, aged (65.8±7.8) years. There were 3 males and 5 females in ALTF group, aged (63.8±5.4) years. There were 12 cases of squamous cell carcinoma, 8 cases of basal cell carcinoma and 2 cases of adenoid cystic carcinoma. The size of soft tissue defect after tumor resection in TMF-FTSG group, PMMF group and ALTF group was 4 cm×4 cm-7 cm×8 cm, 4 cm×5 cm-9 cm×9 cm and 5 cm×6 cm-14 cm×9 cm, respectively. And the size of flaps ranged from 5 cm×4 cm to 8 cm×9 cm, from 5 cm×7 cm to 10 cm×10 cm, and from 10 cm×6 cm to 20 cm×9 cm, respectively. All donor sites and 20 recipient sites recovered in stage Ⅰ, 2 recipient sites recovered in stage Ⅱ. The patients were monitored for a mean of (27.2 ±13.0) months. During the period of follow-up, one patient, reconstructed with PMMF, died 13 months after surgery due to local tumor recurrence, while the others did not experience metastasis or recurrence. In TMF-FTSG group, the mouth opening was (3.60±0.36) cm 3 months after operation and (3.84±0.15) cm before operation, with no significant difference ( P>0.05). The UW-QOL scores of appearance, mood and anxiety in the three groups 1 year after operation were higher than those before operation ( P<0.05), and the one year after operation’s scores of activity and shoulder were lower than those before operation ( P<0.05). The UW-QOL scores of pain and recreation in TMF-FTSG group one year after operation were higher than those before operation ( P<0.05), the other two groups were also higher than those before operation, but the difference was not statistically significant ( P>0.05). There was no significant difference in the UW-QOL scores of swallowing, chewing, speech, taste, and saliva in the three groups at one year after operation and before operation ( P>0.05). Conclusion:In the repair of tissue defects after operation of malignant tumors in the orbital region, three distinct types of tissue flaps can be utilized to repair tissue defects. TMF-FTSG has certain advantages for patients with minor bone defects, whereas ALTF and PMMF are more appropriate for patients with extensive tissue loss. PMMF is an effective method of repair for patients with a history of radiotherapy and poor vascular health in the recipient area.

Objective:To investigate the clinical effect of three different tissue flaps in repairing patients with orbital region tissue loss after enlarged resection of malignant tumors in the orbital region, as well as the indication.Methods:Retrospective analysis of data of patients with malignant tumors in the orbital region treated in the Department of Oral and Maxillofacial Trauma and Orthognathic Surgery, the First Affiliated Hospital of Xinjiang Medical University (Affiliated Stomatological Hospital) between January 2017 and December 2021. All patients underwent extensive resection of periorbital malignant tumors and enucleation of orbital contents, depending on defects in periorbital soft/hard tissues and orbital contents, temporalis myofascial flap combined with full thickness skin grafts (TMF-FTSG group), modified pectoralis major myocutaneous flap (PMMF group), and free anterolateral thigh flap (ALTF group) were used to repair the tissue defect. The wound healing and complications of the donor and recipient areas were followed up after operation, and degree of mouth opening in the TMF-FTSG group was compared at 3 months after operation and before operation. The University of Washington quality of life scale (UW-QOL) score was compared among the three groups before and 1 year after operation (a total of 12 items, each item was assigned from 0 to 100 points, the higher the score, the better the recovery). Statistical software SPSS 26.0 was used to analyze the data. The measurement data were expressed as Mean±SD, and the paired t-test was used to compare the preoperative and postoperative data within the group, the difference was statistically significant at a P value less than 0.05. Results:A total of 22 patients were enrolled. There were 8 patients in TMF-FTSG group, 4 males and 4 females, aged (68.3±9.7) years. There were 6 patients in PMMF group, 5 males and 1 female, aged (65.8±7.8) years. There were 3 males and 5 females in ALTF group, aged (63.8±5.4) years. There were 12 cases of squamous cell carcinoma, 8 cases of basal cell carcinoma and 2 cases of adenoid cystic carcinoma. The size of soft tissue defect after tumor resection in TMF-FTSG group, PMMF group and ALTF group was 4 cm×4 cm-7 cm×8 cm, 4 cm×5 cm-9 cm×9 cm and 5 cm×6 cm-14 cm×9 cm, respectively. And the size of flaps ranged from 5 cm×4 cm to 8 cm×9 cm, from 5 cm×7 cm to 10 cm×10 cm, and from 10 cm×6 cm to 20 cm×9 cm, respectively. All donor sites and 20 recipient sites recovered in stage Ⅰ, 2 recipient sites recovered in stage Ⅱ. The patients were monitored for a mean of (27.2 ±13.0) months. During the period of follow-up, one patient, reconstructed with PMMF, died 13 months after surgery due to local tumor recurrence, while the others did not experience metastasis or recurrence. In TMF-FTSG group, the mouth opening was (3.60±0.36) cm 3 months after operation and (3.84±0.15) cm before operation, with no significant difference ( P>0.05). The UW-QOL scores of appearance, mood and anxiety in the three groups 1 year after operation were higher than those before operation ( P<0.05), and the one year after operation’s scores of activity and shoulder were lower than those before operation ( P<0.05). The UW-QOL scores of pain and recreation in TMF-FTSG group one year after operation were higher than those before operation ( P<0.05), the other two groups were also higher than those before operation, but the difference was not statistically significant ( P>0.05). There was no significant difference in the UW-QOL scores of swallowing, chewing, speech, taste, and saliva in the three groups at one year after operation and before operation ( P>0.05). Conclusion:In the repair of tissue defects after operation of malignant tumors in the orbital region, three distinct types of tissue flaps can be utilized to repair tissue defects. TMF-FTSG has certain advantages for patients with minor bone defects, whereas ALTF and PMMF are more appropriate for patients with extensive tissue loss. PMMF is an effective method of repair for patients with a history of radiotherapy and poor vascular health in the recipient area.

In the process of exploring standardized and efficient ethical review models for multi-center drug clinical trials, the ethical review alliance emerged as the times require. Compared with mature ethics committees, higher requirements have been put forward for the "young" ethics committees. By analyzing problems existing in review work of "young" ethics committees in the ethics review alliance, this paper discussed the measures to improve the review quality of "young" ethics committees and promote the standardized and efficient operation of the alliance, and put forward countermeasures and suggestions for improving the homogenization of ethics review and accelerating the clinical research process of innovative drugs.