ABSTRACT
OBJECTIVE To provide the suggestions for improving t he enthusiasm of the public to report adverse drug reactions （ADRs），promoting pharmaceutical manufacturers to improve the smoothness of ADR reporting channels by the public and the enthusiasm of assuming the main responsibility for drug safety ，and to provide reference for the performance of drug safety supervision by regulatory departments in China. METHODS Taking 180 pharmaceutical manufacturers that had entered the top 1 000 in the world as the objects ，the questionnaire was prepared to investigate the smoothness of ADR reporting channels through 4 channels：contact number ，e-mail，official website and new media （including Wechat and microblog ） of enterprise . The questionnaire involved the establishment of public reporting channels ，the records and the feedback of enterprises. The existing problems were analyzed and suggestions were put forward. RESULTS & CONCLUSIONS More than 70％ of pharmaceutical manufacturers in China had established the channels for reporting ADR by the public ，which were mainly regular channels such as contact numbers and e-mail ，and each channel had the phenomenon that ADR information couldn ’t be reported. More than 60％ of the public channels established by manufactures lacked inquiry and supplement for the miss ing part of th e reported information ； only 24 pharmaceutical manufacturers provided feedback on ADR information ，and the feedback contents were monotonous. gywf2021-11It is suggested that pharmaceutical manufacturers should pay more attention to ADR monitoring among the public ，consider increasing multiple reporting channels while ensuring the smoothness of channels ，strengthen the training of employee ’s information collection ability to improve the quality of information ，timely feed back the ADR information reported by the public ， and increase the feedback content concerned by the public.
ABSTRACT
【Objective】 To provide reference for formulating preoperative blood preparation plan for malignant osteosarcoma scientifically and rationally under the persistent COVID-19 epidemic by studying the high-risk influencing factors related to intraoperative blood transfusion in patients with primary malignant osteosarcoma. 【Methods】 The general data, preoperative blood routine and coagulation parameter, clinicopathological record and surgical data of 120 patients with primary malignant osteosarcoma in Beijing Jishuitan Hospital from January 2020 to January 2021 were retrospectively analyzed by univariate analysis, multivariate regression analysis and Pearson correlation analysis to determine the high risk factors for intraoperative blood transfusion in patients with primary malignant osteosarcoma. 【Results】 The incidence of intraoperative and postoperative blood transfusion of malignant osteosarcoma patients were 48.33% (58/120) and 62.50% (75/120), with the average blood transfusion units at (1.36±1.14) U and (2.93±2.26) U, respectively. The univariate analysis showed that such factors as sex, preoperative Hct (%), preoperative Plt (×109/L), location of lesion, Huvos classification, incision length (cm), reconstruction length(cm) and intraoperative blood loss (mL) were significantly different (P<0.05). Multivariate logistic regression analysis showed that sex, location of lesion, Huvos classification, incision length (cm), reconstruction length(cm) and intraoperative blood loss (mL) were significantly different (P<0.05). 【Conclusion】 For primary malignant osteosarcoma with a high rate of intraoperative blood transfusion, early intervention should be carried out according to the high-risk factors of intraoperative blood transfusion, and preoperative blood preparation plan should be accurately formulated to effectively reduce the rate and units of blood transfusion in patients under the premise of surgery safety.
ABSTRACT
Objective@#Aimed to construct an immune-related risk signature and nomogram predicting endometrial cancer (EC) prognosis. @*Methods@#An immune-related risk signature in EC was constructed using the least absolute shrinkage and selection operator regression analysis based on The Cancer Genome Atlas (TCGA) and Gene Expression Omnibus (GEO) databases. A nomogram integrating the immune-related genes and the clinicopathological characteristics was established and validated using the Kaplan-Meier survival curve and receiver operating characteristic (ROC) curve to predict the overall survival (OS) of EC patients. The Estimation of STromal and Immune cells in MAlignant Tumor tissues using Expression data (ESTIMATE) R tool was used to explore the immune and stromal scores. @*Results@#CCL17, CTLA4, GPI, HDGF, HFE2, ICOS, IFNG, IL21R, KAL1, NR3C1, S100A2, and S100A9 were used in developing an immune-related risk signature evaluation model. The Kaplan-Meier curve indicated that patients in the low-risk group had better OS (p<0.001).The area under the ROC curve (AUC) values of this model were 0.737, 0.764, and 0.782 for the 3-, 5-, and 7-year OS, respectively. A nomogram integrating the immune-related risk model and clinical features could accurately predict the OS (AUC=0.772, 0.786, and 0.817 at 3-, 5-, and 7-year OS, respectively). The 4 immune cell scores were lower in the high-risk group. Forkhead box P3 (FOXP3) and basic leucine zipper ATF-like transcription factor (BATF) showed a potential significant role in the immune-related risk signature. @*Conclusion@#Twelve immune-related genes signature and nomogram for assessing the OS of patients with EC had a good practical value.
ABSTRACT
Objective:To explore the long-term clinical efficacy of subtalar arthrodesis for treating sinus tarsi syndrome (STS) with peroneal spasm.Methods:Clinical informationof 32 patients with sinus tarsi syndrome complicated with peroneal spasm who were treated by subtalar arthrodesis from January 2006 to December 2016 was retrospectively analysed. There were 19 males and 13 females, aged 29.3±10.9 y (range: 13-56 y), and course of disease is 2.1±1.7 y (range: 1-10 y). All patients suffered from tarsal sinus pain and intractable peroneal spasm. The aetiology was foot or ankle inversion sprainin 25 patients, lower limb nerve injury in four patients, and ambiguous causes in three patients.The patients were divided into three groups according to their initial symptoms. Group A: Patients with simple peroneal spasm underwent tarsal sinus debridement firstly and subtalar joint fusion after symptom recurrence. Group B: Patients with peroneal spasm combined with other symptomsunderwent sinus tarsal cleansing and other symptomatic operations, and received subtalar joint fusion after symptoms recurred. Group C: Patients with peroneal spastic flat foot were treated withsubtalar joint fusion directly.Preoperative and postoperative American Orthopaedic Foot & Ankle Society (AOFAS) ankle-hindfoot scores, visual analogue scale (VAS) scores for pain during daily activities, and 36-item short form health survey (SF-36) scoreswere investigated.Results:32 cases were successfully completed operation, following-up 87 (40, 133) months. Group A(14 cases): The patients were treated withsinus tarsi debridement first. But their symptoms recurred in an average of 7.7 months after surgery. Later they received subtalar joint fusion. Group B (15 cases): In addition to tarsal sinus debridement, 3 cases were undergone tarsal coalitions resection, 3 cases were got denervation of tarsal sinus, 6 cases were received subtalar joint stabilization, and 3 cases were released their peroneal tendons. Their symptoms recurred in an average of 6.4 months after surgery, and they eventually were undergone subtalar arthrodesis. Group C (3 cases): Their initial symptoms were severe, manifested as rigid flat feet caused by peroneal tendons spasm, so they directly underwent subtalar joint fusion. The average AOFAS ankle and hindfoot scores for all patients increased from 27.86±10.79 points before treatment to 86.34±7.17 points at the last follow-up after operation ( t=23.505, P<0.05). The VAS scores decreased from 8.00±1.57 points before treatment to 1.91±1.06 points at the last follow-up after operation ( t=18.407, P<0.05). The SF-36 scores increased from 35.84±12.12 points before treatment to 86.20±10.32 points at the last follow-up after operation ( t=24.203, P<0.05). Conclusion:Sinus tarsi syndrome with peroneal spasm due to its complicated etiology and pathogenesis can give priority to sinus tarsal debridement or other symptomatic surgeries. If the symptoms recur, subtalar arthrodesis can be an alternative choice to achieve the long-term effects.
ABSTRACT
Surgical resection is the best therapeutic option for patients with colorectal cancer liver metastasis. As patients with synchronous liver metastases from colorectal cancer, simultaneous resection of primary and metastatic lesions has been widely used. With the gradual maturation of laparoscopic technology, its minimally invasive, safe and effective characteristics make it better for simultaneous resection of colorectal cancer with liver metastasis. On the basis of grasping the principles of surgical treatment for colorectal cancer with liver metastasis, reasonable and full combination of the advantages of laparoscopy can enable patients get greater benefits with minimal trauma.
ABSTRACT
Objective@#To investigate clinical value of ankle arthroscopy in diagnosis of type Danis-Weber B ankle fracture with the distal tibiofibular syndesmosis injury.@*Methods@#From August 2014 to January 2018, a total of 52 cases of type Danis-Weber B ankle fractures with an average age of 35.37±11.19 years, including 31 males and 21 females were treated. Each patient underwent preoperative assessment, according to the patient's clinical manifestations and imaging examination before operation. The Cotton test and the external rotation test were conducted in the C arm X-ray to evaluate whether there is the distal tibiofibular syndesmosis injury. All fractures were treated with open reduction and internal fixation. Repair was conducted with 3.5 mm wire anchor and nail for triangular ligament injury. The Cotton test and external rotation test were performed under ankle arthroscopy. The injury of the lower tibiofibular syndesmosis was observed and evaluated by cotton test and external rotation test in patients who were found to be associated with lower tibiofibular joint injury. After internal fixation of fracture and repair of tibiofibular syndesmosis injury with TightRope, the repair effects of tibiofibular syndesmosis injury was observed under direct vision of ankle arthroscopy. The VAS score, AOFAS score and Baird-Jackson score was used as an index to observe the pain and ankle function before and after operation for 12 months follow-up.@*Results@#Preoperative X-ray showed 19 cases of lower tibiofibular joint injury. Preoperative CT showed 28 cases of lower tibiofibular joint injury. Preoperative MRI showed 39 cases of lower tibiofibular joint injury. A total of 36 cases of joint injury of lower tibiofibular syndesmosis were confirmed under arthroscopy of ankle. After repair of tibiofibular syndesmosis injury with TightRope, complete reduction and stability of inferior tibiofibular syndesmosis were confirmed under ankle arthroscopy. At 12 months after operation, the VAS score decreased from 8.13±1.32 points preoperation to 0.75±0.73 points after operation. The AOFAS and Baird-Jackson scores increased from 26.59±3.35 points, 16.44±3.63 points preoperation to 94.36±3.03 points, 90.29±6.45 points after operation, respectively. There was significant difference before and after operation (P<0.05). The postoperative VAS score, AOFAS score and Baird-Jackson score of 16 patients without lower tibiofibular ligament injury were confirmed in the ankle arthroscopy group, namely 0.58±0.67 points, 95.27±4.67 points, 91.98±9.23 points.@*Conclusion@#Ankle arthroscopy can be used to observe the injury of tibiofibular syndesmosis under direct vision. The positive rate of diagnosis of inferior tibiofibular syndesmosis injury was 69.2% (36/52). It can provide reliable evidence for correct diagnosis and treatment of type Danis-Weber B ankle fracture with lower tibiofibular joint injury with significant meaning in selecting operative methods and in evaluating the effect of lower tibiofibular ligament repair.
ABSTRACT
Objective To investigate clinical value of ankle arthroscopy in diagnosis of type Danis-Weber B ankle fracture with the distal tibiofibular syndesmosis injury.Methods From August 2014 to January 2018,a total of 52 cases of type Danis-Weber B ankle fractures with an average age of 35.37± 11.19 years,including 31 males and 21 females were treated.Each patient underwent preoperative assessment,according to the patient's clinical manifestations and imaging examination before operation.The Cotton test and the external rotation test were conducted in the C arm X-ray to evaluate whether there is the distal tibiofibular syndesmosis injury.All fractures were treated with open reduction and internal fixation.Repair was conducted with 3.5 mm wire anchor and nail for triangular ligament injury.The Cotton test and external rotation test were performed under ankle arthroscopy.The injury of the lower tibiofibular syndesmosis was observed and evaluated by cotton test and external rotation test in patients who were found to be associated with lower tibiofibular joint injury.After internal fixation of fracture and repair of tibiofibular syndesmosis injury with TightRope,the repair effects of tibiofibular syndesmosis injury was observed under direct vision of ankle arthroscopy.The VAS score,AOFAS score and Baird-Jackson score was used as an index to observe the pain and ankle function before and after operation for 12 months follow-up.Results Preoperative X-ray showed 19 cases of lower tibiofibular joint injury.Preoperative CT showed 28 cases of lower tibiofibular joint injury.Preoperative MRI showed 39 cases of lower tibiofibular joint injury.A total of 36 cases of joint injury of lower tibiofibular syndesmosis were confirmed under arthroscopy of ankle.After repair of tibiofibular syndesmosis injury with TightRope,complete reduction and stability of inferior tibiofibular syndesmosis were confirmed under ankle arthroscopy.At 12 months after operation,the VAS score decreased from 8.13 ± 1.32 points preoperation to 0.75±0.73 points after operation.The AOFAS and Baird-Jackson scores increased from 26.59±3.35 points,16.44±3.63 points preoperation to 94.36±3.03 points,90.29±6.45 points after operation,respectively.There was significant difference before and after operation (P＜0.05).The postoperative VAS score,AOFAS score and Baird-Jackson score of 16 patients without lower tibiofibular ligament injury were confirmed in the ankle arthroscopy group,namely 0.58±0.67 points,95.27±4.67 points,91.98±9.23 points.Conclusion Ankle arthroscopy can be used to observe the injury of tibiofibular syndesmosis under direct vision.The positive rate of diagnosis of inferior tibiofibular syndesmosis injury was 69.2％ (36/52).It can provide reliable evidence for correct diagnosis and treatment of type Danis-Weber B ankle fracture with lower tibiofibular joint injury with significant meaning in selecting operative methods and in evaluating the effect of lower tibiofibular ligament repair.
ABSTRACT
Objective To evaluate the clinical value of ankle arthroscopy in diagnosis and treatment of Danis-Weber type B ankle fracture associated with injury to the distal tibiofibular syndesmosis.Methods A retrospective study was conducted of the 35 patients who had been treated at Department of Orthopaedics,Ruijin Hospital North for Danis-Weber type B ankle fracture from February 2014 to December 2016.They were 23 males and 12 females,with an average age of 43.1 years (from 18 to 65 years).Each of them underwent 4 examinations to detect whether injury to the distal tibiofibular syndesmosis was complicated or not:preoperative CT and MRI,C-ann roentgenography and ankle arthroscopy before and after internal fixation of the ankle.The diagnostic rates of the complicated injury by the 4 examinations were compared.The patients complicated with injury to the distal tibiofibular syndesmosis received surgical repair of the injury using TightRope in addition to internal fixation of the ankle,and injury to the deltoid ligament was repaired simultaneously using 3.5 mm anchor nails in case the injury was concomitant.The repair and stability of the distal tibiofibular syndesmosis were observed using ankle arthroscopy again.Results The Cotton and external rotation tests under C-arm roentgenography before surgery and after internal fixation of the ankle demonstrated that 13 cases were complicated with injury to the distal tibiofibular syndesmosis.Of the other 22 patients who had not been diagnosed with the injury by C-arm roentgenography,6,13 and 11 were diagnosed with the injury respectively by CT,MRI and ankle arthroscopy.The diagnostic rates of Danis-Weber type B ankle fracture associated with injury to the distal tibiofibular syndesmosis were 37.1％ (13/35),54.3％ (19/35),74.3％ (26/35) and 68.6％ (24/35) respectively by C-arm roentgenography,CT,MRI and ankle arthroscopy.In the sensitivity to the injury,MRI ＞ ankle arthroscopy ＞ CT ＞ C-arm roentgenography,with significant differences between them (P ＜ 0.05).The ankle arthroscopy confirmed the repair efficacy in the 24 patients complicated with injury to the distal tibiofibular syndesmosis and negative results of Cotton and external rotation tests in them.Additionally,ankle arthroscopy revealed 16 cases of injury to the deltoid ligament at the medial ankle.Conclusions Ankle arthroscopy can provide evidence for correct diagnosis and treatment of Type B ankle fracture complicated with injury to the distal tibiofibular syndesmosis,because it allows direct observation of the medial deltoid ligament of the ankle and the distal tibiofibular syndesmosis.It can be also used to assess the stability of the tibiofibular syndesmosis after repair of the injury.
ABSTRACT
Objective To review the clinical data and visual outcomes after treatment of patients with dysthyroid op-tic neuropathy ( DON) .Methods We retrospectively examined the clinic data of the 38 patients (67 eyes) suffer-ing from DON and analysed the effect of glucocorticoids , radiation and orbital decompression .Results The study included 14 men and 24 women.32 patients ( 84.2%) received multiple treatment modalities .LogMAR vision acuity changed from (0.60 ±0.59) before treatment to (0.18 ±0.09) after treatment(P<0.01) .There were 59 eyes (88.1%) in the treatment effective group , 8 eyes (11.9%) in the ineffective group .38 eyes underwent ini-tial treatment with intravenous steroid pulse therapy and 35 eyes ( 92.1%) were effective .29 eyes were treated with other modalities and 24 eyes(82.8%) were effective(P<0.01).There were 3 eyes (5.1%) suffering from fixed eyeball movement in the effective group , while 4 eyes ( 50%) in the ineffective group ( P <0.05 ) .The thickness of the supraocular muscle group in the effective group was (7.63 ±1.19 ) mm, (8.81 ±0.83 ) mm in the ineffective group (P<0.05).Mean defect of the visual field was (2.41 ±2.82) in the effective group and (11.98 ± 7.07 ) in the ineffective group ( P<0.05 ) .Conclusions Treatment with multiple modalities effectively improved visual outcomes in cases of DON .Intravenous pulse steroid therapy was recommended as the initial modality .
ABSTRACT
Objective To investigate the clinical curative result of the new method of postermedial deepen of the fibular groove in the treatment of chronic peroneal tendon subluxation.Methods From March 2006 to October 2012,21 patients (15 male,6 female) with chronic peroneal tendon subluxation via a novel method of postermedial deepen of the fibular groove.In this group:Ⅰ grade 5 cases;Ⅱ grade 9 cases;Ⅲ grade 5 cases;Ⅳ grade 2 cases.All patients were followed up for at least 24 months.The American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot scale score and visual analogue score (VAS) were used to evaluate the clinical outcomes.Operation time,time to heal and complications were also recorded.Results The average operation time was 50 minutes (30-70 minutes).The blood loss was 30-60 ml,average 40 ml.All incisions healed after operation,no case of incision infection,skin necrosis and sural nerve,vascular injuryed.Mean AOFAS score was significantly increased from (55.2±7.1) preoperative to (93.6±5.6) postoperative.15 patients with excellent,good for 1 cases.The excellent and good rate was 100％ (16/16).VAS score by an average of (5.3±2.1) points down to (1.2±1.1) points postperative.All the patients can wear normal shoes postoperative,waking with normal gait.No patients had peroneal tendon tenosynovitis,tendon adhesion,fracture of lateral malleolus and other serious complications,no dislocation recurrent,strength of the peroneal muscle returns to normal.Conclusion The novel method of postermedial deepen of the fibular groove in the treatment of chronic peroneal tendon subluxation was safe and effective for ankle instability with a relatively short time.
ABSTRACT
Objective To explore the effects of melatonin (MT) on the expression of interleukin (IL)-10,interleukin-6 and interleukin-8 as well as the inflammatory reaction and nerve repair after acute spinal cord injury (SCI).Methods One hundred and eight Sprague-Dawley rats were randomly divided into a spinal cord injury group (group A),an MT treatment group (group B) and a sham operation group (group C),each with 36 rats.SCI models were established in the rats of groups A and B using a version of Allen's weight drop method (50gcf at the T12 level).Group C had removal of the lamina only.Ten minutes later,group A was injected with 5％ ethanol in saline (the MT solvent) and group B with 100 mg/kg of melatonin preparation.At 6,12,18 and 24 hours,IL-6,IL-8 and IL-10 levels in serum were detected in 6 rats of each group.At 18 hours post-surgery,spinal cord specimens were taken from 6 rats of each group for hematoxylin eosin staining,morphological examination and immunohistochemical SP detection of IL-10 expression.Results The specimens of group A showed inflammatory reaction and ulceration at 48 h; groups B and C had no ulcers.Group B showed the highest levels of IL-10 in serum and IL-10 mRNA in the spinal cord,while group C showed the lowest level.The differences were statistically significant.Group A had the highest levels of IL-6 and IL-8 and group C had the lowest.The difference between group B and groups A and C was significant.The morpho-logical observation showed that after melatonin treatment the IL-10 levels in the spinal cord's central canal and around the gray matter improved.Conclusions Melatonin can improve nerve lipid peroxidation and inflammatory reaction in the treatment of spinal cord injury by increasing IL-10 expression and inhibiting IL-6 and IL-8 expression.
ABSTRACT
Objective To evaluate the influence of simple subtalar arthrodesis to the motion and degeneration of midfoot.Methods Data of 37 patients (27 males,10 females) with an average age of 42.6 years who had undergone subtalar joint fusion from January 1996 to August 2011 were retrospectively analyzed.The MOS item short form health survey (SF-36),American Orthopaedic Foot and Ankle Society (AOFAS) midfoot score were used.Midfoot sagittal and coronal motion were measured on ankle radiographs of maximum plantar flexion and dorsiflexion.On sagittal plane,the Meary angle was measured and the bilateral tarsometatarsal joints mobility was compared.On coronal plane,tibio-plantar angles (TPA) on 30 degrees varus slope and 30 degrees valgus slope were respectively measured on the anterio-posterior ankle X-ray films to observe the changes of midfoot activities.Besides,single photon emission computed tomography/computed tomography (SPECT/CT) of bilateral foot and ankle was taken to estimate the degeneration of midfoot joint.Results All the 37 patients were followed-up,with mean follow-up period of 9.2 years.The average SF-36 scores was increased from 34.26± 11.02 points preoperatively to 77.59± 12.57 points postoperatively.The average AOFAS midfoot scores were 86.14± 16.79 points preoperatively and 86.43± 16.70 points postoperatively without any statistical significant difference.On sagittal plane,medial tarsometatarsal joints mobility was limited by 20％.According to coronal plane of varus slope,the average TPA of healthy side and operated side were 61.32° and 64.91°,respectively,so the varus mobility of operated side was limited by 12.5％.While standing on the valgus slope,the average TPA of both sides were 76.54° and 82.28°,which indicated that valgus mobility of operated side was reduced by 42.6％.35.1％ patients of talonavicular joint,56.8％ patients of calcaneocuboid joint,and 27.0％ patients of metatarsal cuboid joint were found mild joint degeneration on SPECT/CT images without any clinical symptoms.Conclusion Subtalar arthrodesis can affect midfoot with less limit of sagittal mobility and more limit of coronal movement.And the lateral joints degeneration is more likely to happen for their compensatory activity.
ABSTRACT
Objective To evaluate the curative effect and related factors of the treatment for the osteochondral lesion of talus (OLT) by the osteochondral autografts harvested from medial femoral condyle of the ipsilateral knee.Methods The data of 15 OLT patients was retrospectively analyzed who received the operation during July 2009 to November 2012.There were 8 males,and 7 females,with an average age of 49.6±17.2 years (range,19-73 years).International Knee Documentation Committee (IKDC) and Lysholm score were used to evaluate the knee function preoperatively and postoperatively respectively.The ankle functions and pain were assessed according to American Orthopaedic Foot and Ankle Society (AOFAS) ankle and hind-foot score and visual analogue scale (VAS) preoperatively and postoperatively respectively.Correlations between age or follow-up duration and all the score increments were further analyzed by Spearman rank correlation test.Results Twelve patients complete the follow up,with an average duration of 21.8±10.4 months.The average IKDC,Lysholm,AOFAS,and VAS were 90.91±6.44,95.33±8.00,63.58±18.50,and 7.25±1.54 respectively before operation,and 85.63±11.89,90.75±11.83,90.33±4.98,2.17±1.19 respectively after operation.Correlation coefficients of age between AOFAS,Lysholm,and IKDC score increments were -0.74,-0.63,and-0.76,respectively.There were 4 cases which received excellent effect (33％),5 cases (42％) good and 3 (25％) fair.Conclusion The ankle joint function of patients with OLT recovered well by treated with osteochondral autografts harvested from medial femoral condyle of the ipsilateral knee operation.A correlation was found between patients' age and postoperative functional recovery of ankle and knee joint.