Traditional Chinese medicine (TCM) has some unique advantages in the prevention and treatment of cancer. Due to different ideas and mechanism of between TCM and biomedicine in the prevention and treatment of cancer, the clinial effect evaluation approches of biomedicine could not be used as a beneficial method to scientifically evaluate the effects of TCM. From three angles, this article analyzes the key issues regardsing the evaluation methods of TCM as an adjuvant therapy of cancer. It draws lessons from the idea of quality-adjusted survival (QAS), proposes Two-in-One (TIO) method to evaluate the effects of TCM as adjuvant therapy of cancer, which reflects the combined value of the individual patient dynamic information and provides methodological support for the effect evaluation of TCM.
Objective To compare the efficacy of plating versus intramedullary nailing in the treatment of adult humeral shaft fracture. Methods We identified eligible studies in PubMed (1950 to September 2007), MEDLINE (1950 to September 2007), OVID CINAHL (1950 to September 2007), OVID EBM (3rd Quarter 2007), CBMdisk (1978 to June 2007) and CNKI (1981 to June 2007). We also handsearched several Chinese orthopedic journals. Data were extracted and evaluated by two reviewers independently. Randomized controlled trials (RCTs) comparing plating versus intramedullary nailing for humeral shaft fracture in adults were included and the quality of these trials was critically assessed. Data analyses were conducted with Stata 10.0. Results Six RCTs involving 425 patients were included, among which the statistical heterogeneity was not significant (Pgt;0.1). Cumulative meta-analyses showed that intramedullary nailing might increase the re-operation rate in studies conducted before the year of 2000 (OR=0.39, 95%CI 0.17 to 0.90, P=0.03), but the difference was not significant in studies conducted after 2000 (OR=0.54, 95%CI 0.27 to 1.08, P=0.08). Intramedullary nailing might increase the incidence of shoulder impingement compared with plating (OR=0.13, 95%CI 0.03 to 0.65, P=0.01). The rates of non-union, deep infection, iatrogenic radial nerve injury and internal fixation failure were similar between plating and intramedullary nailing. Meta-analyses were not conducted for union time, operation time and bleeding (transfusion) volume, because the relevant data were not available from the included trials. Conclusion Intramedullary nailing may increase the incidence of shoulder impingement. The rates of re-operation, non-union, deep infection, iatrogenic radial nerve injury and internal fixation failure are similar between plating and intramedullary nailing. Further well-designed and large-scale randomized controlled trials are required to determine the effects of plating and intramedullary nailing on these outcomes.
Poor compliance in clinical studies is a risk factor leading to bias of results of clinical research. However, while the subject compliance has received extensive attention, researcher compliance has not been paid enough attention. The problem of researcher compliance runs through the whole process of clinical research. How to control and evaluate the researcher compliance is the key problem in clinical research. Based on the current situation of poor compliance of clinical researchers, this paper summaried the information of five different dimensions that affects the researcher compliance in clinical research, clarified the relevant factors that may affect the researcher compliance in the process of clinical research, and analyzed the influence of the factors related to the researcher compliance on the quality control of clinical research, hence establishing a foundation for further research on control strategies and evaluation techniques of researcher compliance.
Objective To evaluate the cl inical outcomes of primary anterior focus debridement, bone autograft, and internal fixation via transperitoneal approach in treating tuberculosis of the lumbosacral junction. Methods From February 2002 to April 2007, 16 patients with tuberculosis of the lumbosacral junction underwent anterior radical debridement, autologous il iac bone graft (two pieces of il iac bone, 5 cm × 3 cm in size), and internal fixation via transperitoneal approach, including 4 males and 12 females aged 27-63 years old (average 38 years old). The course of the disease ranged from 6 to 18 months (average 10 months). All patients experienced various degrees of pain in the lumbosacral area and toxic symptoms of thetuberculosis. Nine cases were compl icated with radicular pain in the lower extremities, and 3 cases had saddle area anaesthesia. Two cases were initially diagnosed as lumbar intervertebral disc protrusion and treated accordingly. The segments involved by the tuberculosis were L5-S1 level in all cases. The average erythrocyte sedimentation rate (ESR) was 61 mm/hour. Imaging examination confirmed the diagnosis of spinal tuberculosis. All cases received four antitubercular drugs and nutrition support for nerve before operation. Operation was performed when hepatorenal function was normal, and the toxic symptom of the tuberculosis was under control or ESR was decreased. Results Operation was performed safely in all cases without injuries of abdominal viscera, major blood vessel, cauda equina nerve and ureter. All wounds healed by first intention. No recurrence of tuberculosis and formation of sinuses occurred. All cases were followed up for 12-37 months (average 21 months). No such compl ications as tuberculous peritonitis and intestinal obstruction occurred. No postoperative erectile dysfunction and retrograde ejaculation occurred in the 4 male patients. ESR was recovered to normal 3-6 months after operation, and regular X-ray and CT exams showed no displacement of grafted bone. All patients achieved bony fusion 12 months after operation without the occurrence breakage and loosening of titanium plate and screw. The radical pain in the lower extremities and the saddlearea anaesthesia disappeared. Four patients had pain in the il iac donor site, 2 patients had mild pain in the lumbosacral area, and the pain was el iminated after symptomatic treatment. The therapeutic effect was graded as excellent in 14 cases and good in 2 cases according to the therapeutic effect evaluation criteria of Chen and co-workers. Conclusion The surgical treatment of tuberculosis of the lumbosacral junction with primary anterior focus debridement, bone autograft, and internal fixation via transperitoneal approach can achieve satisfying bony fusion and reconstruct spinal stabil ity.
Agedness; Intertrochanteric fracture; Replacement of artificial femoral head
【Abstract】 Objective To summarize the technique and effect of the therapy for severe fracture and dislocation ofankle joint by operation. Methods From March 2003 to February 2006, 76 cases were treated with primary open restorationand internal fixation for dislocated ankle joint fracture, with 47 males and 29 females, with the average age of 36.4 years (ranging from 18 years to 65 years). According to AO criterion, these fresh fractures were classified into 13 cases for type C3-1, 45 cases for type C3-2 and 18 cases for type C3-3. Based on the Gustilo-Anderson standard, 23 open fractures were classified into 17 cases for type II and 6 cases for type Ⅲ A. The operation was delayed from 1 hours to 24 hours after the injury. Results All incisions healed at the first stage except 4 cases which delayed union because of simple infection by revision with ointment. A total of 72 cases were followed up, with the average time of 18.5 months (from 12 months to 35 months). The time of bone union was from 12 weeks to 24 weeks. The screws of fixation for lower tibia-fibula joint were found to be ruptured in 2 cases when further consultation was performed in the 16th and 20th week after the operation, respectively, and were broken within 1 year after the operation. These screws were taken out 12 weeks postoperative in 28 cases, while the whole internal fixations of the rest caseswere taken out 1 year after the operation. The postoperative function of malleolus extended from 21.7º to 26.8º and flection from 38.5º to 44.7º. Assessed by the American Orthopaedic Foot and Ankle Society Cl inical Rating Scales, 23 cases were excellent, 36 good, 13 fair, and the choiceness rate reached 81.94%. Conclusion These procedures, together with reduction by twist after hospital, open and internal fixation in time, and parenchyma managed with internal fixation, are important to attain satisfactory effect for the treatment of severe fracture and dislocation of ankle joint.