Reflections on the conduct of cell therapy clinical trials in medical institutes / 中华医学科研管理杂志

Objective:This paper introduces the concepts of " patient-centered cell therapy research management model", to provide reference for domestic medical institutions which conduct cell therapy clinical trials.Methods:We reviewed and summarized the experiences of conducting cell therapy at Peking University Shenzhen Hospital, including challenges and response plans regarding to the technology assessment, ethical evaluation risks and regulatory compliance. According to which, this paper aims to explore the reflections and practical experience of establishing a patient-centered, multi-stakeholder shared decision-making research management system.Results:The " patient-centered cell therapy research management model" ensures the reliability of research results through multi-stakeholder engagement in decision-making and management, adequate technical evaluation, effective ethical review and harmonized scientific research management, which not only meets the urgent health needs of the patient, but also promotes the standardized development of emerging technologies.Conclusions:The " patient-centered cell therapy research management model" is tailored for the cell therapy research, it is important to promote its further assessment and applications.

Research progress of associated risk factors in intervertebral disc degeneration / 中华骨科杂志

Low back pain is an important cause of disability worldwide. It has a high incidence rate and brings a huge burden to families and society. Intervertebral disc degeneration (IDD) is one of the leading factors causing low back pain and the pathological basis of degenerative disc diseases, such as intervertebral disc herniation and spinal stenosis. However, the etiology of IDD is complex, and the risk factors and specific mechanisms behind remain unclear. Some controversial views have also been observed. Surgery is often considered for patients with severe intervertebral disc diseases, but there is no effective treatment for IDD at the early and middle stages. It will be of great significance to in-depth explore the molecular biological mechanisms and related risk factors, which can bring benefits to the prevention, accurate diagnosis, early treatment, and rehabilitation of degenerative disc diseases. Refer to the literatures published in the past ten years, this paper describes the latest research progress on risk factors related to IDD in terms of aging, genetics, mechanical loading, low-grade infection, biological rhythms, smoking, metabolic disease, estrogen, and nutrition. The results show that IDD is affected by multiple risk factors. These factors can interact with each other, and lead to death, phenotypic transformation, and metabolic disorder of disc cells, leading to a reduction of extracellular matrix and an unbalanced microenvironment and eventually loss of structural integrity of intervertebral disc tissue and IDD. A good body clock, a controlled weight, an appropriate blood glucose level, adequate nutrition, no smoking, a good hormone level, moderate exercise, avoiding injury, and strict aseptic techniques in the clinic will bring benefits to the progress of IDD.

Current status of surgical diagnosis and treatment of pulmonary malignant ground glass nodules / 中华胸心血管外科杂志

In recent years, with the development of imaging technology, more and more ground-glass Nodule (GGN) in the lungs have been discovered. After GGN is detected, it should be further judged whether it is benign or malignant by combining with existing inspection methods. Common diagnostic and examination methods include PET/CT, fiberoptic bronchoscopy, CT-guided puncture biopsy and High Resolution CT (HRCT), each of them with its own advantages and disadvantages. For GGN with high malignant risk, minimally invasive surgical intervention is needed to prevent the progress of the disease. The hot issues of surgical treatment include the selection of minimally invasive surgical methods, the precise positioning of GGN in the lung, the accuracy and limitations of intraoperative freezing examination, lymph node dissection of GGN, and postoperative follow-up of malignant GGN diagnosed as cancer. Under the premise that surgical diagnosis and treatment play an increasingly important role in the management of GGN, this paper will review the existing GGN related studies and make a summary of the surgical diagnosis and treatment of malignant GGN.

Clinical analysis of 34 cases with sepsis and systemic capillary leak syndrome / 中华外科杂志

Objective@#To study the clinical characteristics of sepsis with systemic capillary leak syndrome(SCLS) and to evaluate the therapeutic effect and clinical significance of fluid therapy adjusted timely in these patients.@*Methods@#The clinical data of 34 patients with sepsis and SCLS in the Department of Hepatobiliary Surgery ICU of General Hospital of People′s Liberation Army General Hospital from July 2014 to January 2016 were retrospectively analyzed.There were 21 males and 13 females, aged from 21 to 74 years, with an average age of 56.3 years.Primary disease as follows: 18 cases with severe acute pancreatitis, 7 postoperative cases of subtotal hepatectomy, 5 postoperative cases of pancreatoduodenectomy, 4 postoperative cases of cholelithiasis.These patients were divided into survival group and death group according to their 28-day survival status.The clinical data including C-reactive protein(CRP), platelets (PLT), brain natriuretic peptide (BNP), the level of arterial blood lactic acid(LAC), oxygenation index(PaO2/FiO2, OI), net fluid balance(NFB) and norepinephrine dosage(NE) were collected and compared between two groups at three different intervals(day 1-3, day 4-6, day 7-9). The measurement data and numeration data were statistically analyzed with t test and χ2 test respectively to explore the inherent characteristics of the disease evolution and its clinical significance.@*Results@#The survival group (n=23)and the death group(n=11)had no significant difference in the characteristics of basic clinical characters.The condition of the survival group and the death group were both in progress in 1-3 days period manifested as increased CRP(t=-0.473, P=0.640) and BNP levels(t=0.140, P=0.895), decreased PLT counts(t=-0.505, P=0.620) in the inflammatory response, decreased LAC(t=-1.008, P=0.320) and OI level (t=-2.379, P=0.020)in tissue perfusion index, and positive fluid balance(NFB: t=0.910, P=0.370), required NE(t=-0.853, P=0.400) to maintain effective perfusion pressure with systemic edema in both groups.There was no significant difference of all these clinical parameters between the two groups.The patients′ condition of the survival group reached a plateau phase, whereas all relative indicators of the death group implied significant aggravation and deterioration of systemic infection(CRP: t=-3.438, P=0.000; PLT: t=1.649, P=0.110; BNP: t=-10.612, P=0.000), tissue perfusion (LAC: t=-11.305, P=0.000; OI: t=2.743, P=0.010)and tissue edema NFB(t=-4.257, P=0.000) and NE(t=-7.956, P=0.000) in 4-6 days period.In the last 7-9 days period the patients′ condition of the survival group took a turn for improvement, yet the condition of the death group continued to deteriorate, refractory septic shock developed and multiple organ dysfunction syndrome followed afterwards inevitably(CRP: t=-10.036, P=0.000; PLT: t=6.061, P=0.000; BNP: t=-10.119, P=0.000; LAC: t=-24.466, P=0.000; OI: t=13.443, P=0.010; NFB: t=-8.345, P=0.000; NE: t=-7.121, P=0.000).@*Conclusions@#The condition of patient with sepsis and SCLS would be improved markedly at the critical turning point around 7-9 days period since the effective systemic treatment began.If the infection does not be significantly constrolled and SCLS still remains in a sustained extravasation period in 7-9 days, the prognosis of these patients may be worse and the mortality may be higher than that of the patients mentioned before.

Internal fixation plus bone grafting for treatment of thoracolumbar fractures via paraspinal intermuscular approach / 中华创伤杂志

Objective To test the safety and effectiveness of transpedicular fixation combined with transpedicular bone grafting via less invasive paraspinal intermusclar approach in treatment of thoracolumbar fractures.Methods The study involved 23 cases of thoracolumbar fractures treated with paraspinal multifidus intramusclular mini-incision,transpedicular bone grafting,and short-segment pedicle screw fixation from June 2009 to June 2012.There were 16 males and 7 females at age of 19-55 years (average 38.8years).Time from injury to surgery varied from 6 hours to 7 days (average 3.2 days).Fracture level was T11 in three cases,T12 in seven,L1 in nine,and L2 in four.According to Denis fracture classification,there were altogether 10 compression fractures and 13 burst fractures.McCormack load sharing classification scored average 5.3.Before operation,anterior vertebral body height ratio was average 58.6％(range,45 ％-73％) and kyphosis angle was average 23.7° (range,15°-34°).Results Operation lasted for average 95.5 minutes (range,75-130 minutes) with intraoperative bleeding of average 160.3 ml (range,115-220 ml).Unilateral incision that was averaged 3.5 cm (range 3.2-4.0 cm) in length obtained primary healing.Average follow-up time was 12.6 months (range,7.5-18 months).Average height of the anterior border was corrected to 97.3％ and average kyphosis angle was corrected to 4.6°.There was neither instrumentation failure nor symptom of persistent postoperative back pain.Conclusions Transpedicular fixation with transpedicular bone grafting via paraspinal muscle approach provides effective recovery of vertebral morphology and correction of kyphotic deformity.Furthermore,the technique gains advantages of easy operation,small trauma,less blood loss and rapid recovery.

Two Bundle Anatomical Reconstruction of the Posterolateral Corner of the Knee Using Auto-Harmstring / 中国运动医学杂志

Objective To introduce the method of two bundle anatomical reconstruction of the posterolateral corner(PLC) of the knee using auto-harmstring,and to evaluate the short-term clinical outcomes.Methods Using auto-harmstring,23 knees of 21 cases with acute or chronic posterolateral complex injuries were anatomically reconstructed from March 2003 to November 2005.There were 20 male and 1 female patients(mean age:32.3 years,ranging from 17 to 47 years)in this study with follow-up of at least 12 months(average:26.7 months,ranging from 12 to 31 months.Tow cases had isolated PLC injuries,21 knees had multiligamentous injuries,and 5 cases associated with meniscus injuries.The technique used includes:(1)an autogenous semitendinosus placed through trastibial bone tunnel from posterior to anterior and then turned to transfibulur bone tunnel to reconstruct the popliteus and popliteofibular ligament;(2)an autogenous gracilis tendon placed through transfibulur bone tunnel to reconstruct the fibulocolateral ligament(FCL).The transplanted grafts were secured to the femoral insertion of the popliteus and FCL respectively with metal or bioabsorbable interference screw.All patients were followed-up prospectively with clinical examinations and Lysholm knee scores.Results There was no varus knee instability in full extension,and one-grade varus instability with firm endpoint was found in 2 cases at 30? flexion.There was no increased external rotation in all of the 23 knees at 30? flexions(in prone position).Mean Lysholm knee scores were 89.2(range from 88 to 100).Conclusions Two bundle anatomical reconstruction of the PLC of the knee using auto-harmstring yields a stable knee with excellent function,mini-trauma,and reliable fixation of grafts,this technique is an ideal method for the treatment of PLC injuries.

Arthroscopic Double-Bundle Posterior Cruciate Ligament Reconstruction Using Achilles Tendon Allograft / 中国运动医学杂志

Objective To describe an alternative procedure of arthroscopic double-bundle posterior cruciate ligament (PCL)reconstruction using deep-frozen fresh allogenic achilles tendon and evaluate the follow-up outcome in early stage. Methods The ruptured PCL was reconstructed under arthroscopy using deep frozen fresh allogenic achilles tendon preparing in Y-shaped allografts, one bundle was used for anterolateral bundle, the other for posteromedial bundle. Absorbable screw was used to fix the soft tendon graft and metal screw was used to fix the bone graft. Results From March 2003 to August 2004, the procedure of arthroscopic double-bundle PCL reconstruction using allogenic achilles tendon was applied in 10 cases. The average follow-up period was 13.2 months(6～24 months, among them 6 cases were more than 12 months ). 2 cases with anterior cruciate ligament (ACL) injury were also reconstructed with hamstring tendons (semitendinosus and gracilis). 3 cases with rupture of postolateral horn of knee joint were anatomically reconstructed with hamstring tendons. Clinical results were carefully compared using the Lysholm score system before and after the operation, the average score was 50.3 preoperatively, and 91.2 postoperatively. The objective examination showed that the tibia post-migrating sign, posterior drawer test and Lachman test were positive in all the 10 cases preoperatively; whereas the posterior drawer test and Lachman test were negative postoperatively; the tibia post-migrating sign were weak positive in 3 cases with longer clinical histories(more than 1 year); the flexion range of the knee were slightly restricted (5?～20?) in the 2 cases with simultaneous ACL injury. Conclusions Allogenic achilles tendon is an ideal material for arthroscopic double-bundle PCL reconstruction. Arthroscopic double-bundle reconstructed PCL is in accordance with the anatomy and physiology of natural PCL. The injury and complications caused by the autograft can be alleviated. The allograft can be prepared in advance and the soft end of the implant can pass through the bone tunnel easily, and thus the operaton time under arthroscopy can be saved and the trauma caused by arthroscopy is abated. Arthroscopic double-bundle PCL reconstruction is sample, safe and effective.