It has been 36 years since the first version of essential medicine list (EML) was released by WHO in 1977,when 18 versions of WHO-EML and four versions of children essential medicine list have been released. In 1982, the first version of national essential medicine list (NEML) was released in China. Till 2012, there were eight versions of NEML in total. This paper introduces WHO-EML in aspects of origin, idea, definition, design, and innovation of selection methodology,principle, and workflow; compares the evolution, design, selection methodology between WHO-EML and Chinese NEML; and points out the challenges of evaluation and decision making of Chinese NEML.
Objective To analyze the methodological quality of clinical practice guideline mentioned “evidence-based” in China. Methods We selected clinical guidelines developed based on evidence issued by the Chinese Medical Association in 2010-2012, and meanwhile, we conducted additional search for guidelines on clinical major diseases. Then, we selected literature according to the inclusion and exclusion criteria and evaluated the included guidelines according to 8 items relevant to methodological rigor which were selected from the Appraisal of Guidelines for Research and Evaluation (AGREE II). If the guidelines comply with the item, we recorded 1 point, otherwise 0 point. Results a) Among twenty-two included guidelines, 13 were originated and 9 were updated once every 3 to 5 years. b) Diseases covered stroke, diabetes, chronic hepatitis B, hypertension, pediatric nutrition, etc. c) The number of guideline references were 10 to 218, of which, nine guidelines cited 24 Cochrane systematic reviews (CDSRs), accounted for 2.62% (24/916). Among them, the acute ischemic stroke guideline cited the most (7 CDSRs). d) The number of experts involved in guidelines development was 2 to 95 and guidelines pages were 4 to 150. e) The guidelines’ quality generally scored 4 to 7, most of which described the process of guidelines development. The grades of recommendation were consistent with the levels of evidence. But most of the included guidelines did not clearly described literature research methods, peer reviewer, and update procedures. Conclusion There is a growing trend that clinical guidelines are developed based on evidence in China. However, the quality of reporting and the methodological rigor of guidelines need further improvement. The citation rates of Cochrane systematic reviews in these guidelines were relatively low. We suggest that guideline recommendations should be consistent with the levels of evidence and adapt to local conditions, and relevant support policies for guideline implementation in practice. In future, attention should be paid to the aspects of guideline development methods, reporting standard, guideline accessibility, and standard training for relevant personnel.
Abstract: Objective To evaluate the biological characteristics of decellularized bovine jugular vein valved conduit treated with dyemediated photo oxidation. Methods From July 2009 to July 2010, this study was carried out in Xijing Hospital affiliated to the Fourth Military Medical University. Forty bovine jugular vein valved conduits were obtained from Qinchuan scalpers aged between 2 to 6 years with the weight ranged from 200 to 400 kg. Then, the 40 conduits were divided into four groups by random digital table with 10 in each group. The conduits were treated with glutaraldehyde in the glutaraldehyde group (GA group), were decellularized in the decellularized group (DC group), were decellularized and treated with dyemediated photo oxidation in the decellularized and dyemediated photo oxidation treated group (DP group) , and were not dealt with in the control group (CO group). Thickness, appearance, histology, water content, shrinkage temperature, breaking strength, and soluble protein level of the conduit wall and valve were detected and compared among the four groups. Results Thickness and water content of the conduit wall and valve in the DP group were similar to those in the CO group (Pgt;0.05), while thickness of both wall and valve in the DP group was less than those in the GA group (wall: 0.8±0.1 mm vs. 1.1±0.1 mm; valve: 02±0.1 mm vs. 0.3±0.1 mm, Plt;0.05), and water content of the conduit wall and valve in the DP group was more than those in the GA group (wall: 86.1%±2.2% vs. 70.4%±2.8%; valve: 87.1%±2.5% vs. 72.1%±3.1%, Plt;0.05). The breaking strength and shrinkage temperature of the DP group were similar to those of the GA group (Pgt;0.05), while the shrinkage temperature (wall: 84.7±1.4 ℃ vs. 70.4±0.3 ℃; valve: 85.7±1.5 ℃ vs. 70.7±0.6 ℃, Plt;0.05) and the breaking strength (wall: 10.4±1.1 N vs. 6.8±1.0 N; valve: 8.0±0.9 N vs. 3.2±0.6 N, Plt;0.05) of the DP group were higher than those in the CO group. Conclusion Decellularized bovine jugular vein valved conduits treated with dyemediated photo oxidation have nice biological characteristics.Key words: Dyemediated photo oxidation; Decellularized; Bovine jugular vein valved conduit; Biological characteristics
Objective To evaluate the effect of preoperative digital planning in acetabular reconstruction of total hip arthroplasty (THA) for development dysplasia of the hip (DDH). Methods A prospective study was performed on 42 patients with DDH undergoing primary THA between January 2009 and December 2011. The patients were divided into 2 groups according to whether preoperative digital planning was made or not; before operation, conventional imaging method was used in 23 cases (group A), and TraumaCad software was used for preoperative digital planning in 19 cases (group B). There was no significant difference in gender, age, body mass index, DDH classification, and preoperative Harris score between 2 groups (P gt; 0.05). The operation time, amount of bleeding, and postoperative complication were observed. After 7 days of operation, X-ray films were done to measure the vertical location, horizontal location, radiographic anteversion angle, radiographic inclination angle, and prosthesis size by TraumaCad software. The qualified rate of cup placement was compared between 2 groups. Coincidence rate of cup size between preoperative predicted by the digital planning and actually implanted in group B also was calculated. Results The operation time and the amount of bleeding were (119.25 ± 47.16) minutes and (410.00 ± 200.39) mL in group A and were (155.31 ± 84.03) minutes and (387.50 ± 251.99) mL in group B respectively, showing no significant difference between 2 groups (P gt; 0.05). Incision infection and prosthetic anterior dislocation occurred in 1 case of group A respectively, prosthetic posterior dislocation in 1 case of group B. The patients were followed up 1 year and 1 month to 4 years and 1 month (mean, 2 years and 8 months ) in group A, and 1 year and 3 months to 4 years (mean, 2 years and 7 months) in group B. At last follow-up, the Harris scores were 91.09 ± 5.35 in group A and 91.72 ± 3.48 in group B, which were significantly increased when compared with preoperative scores (P lt; 0.05), but no significant difference was found between 2 groups (t=0.41, P=0.69). The qualified rate of cup placement of group B (78.95%, 15/19) was significantly higher than that of group A (43.48%, 10/23) (χ2=5.43, P=0.02); the coincidence rate of the cup size between preoperative predicted by the digital planning and actually implanted was 68.42% (13/19). ConclusionPreoperative digital planning can further optimize the acetabular reconstruction in THA for DDH.
Objective To explore the expressions of bone morphogenetic protein 2 (BMP-2) and runt-related transcription facotr 2 (Runx2) and microarchitecture of trabecular bone periacetabula in adult patients with developmental dysplasia of the hip (DDH). Methods Between March and September 2008, the trabecular bone periacetabulum was collected from 8 patients with DDH who were scheduled for total hip arthroplasty (aged 37-55 years, 3 males and 5 females, trial group) and from 8 patients with avascular necrosis of the femoral head (Ficat stage II) who were scheduled for hip resurfacing arthroplasty (aged 36-55 years, 3 males and 5 females, control group). The expressions of BMP-2 and Runx2 in the trabecular bone were determined by real-time quantitative PCR, and the microarchitecture was observed by micro-CT and the following parameters were determined: bone volume/total volume (BV/TV), connectivity density (Conn.Dens), trabecular number (Tb. N), trabecular thickness (Tb.Th), trabecular separation (Tb.Sp), and structure model index (SMI). Results The expressions of BMP-2 and Runx2 were significantly lower in trial group than in control group (P lt; 0.05). The micro-CT showed sparse trabecular bone in trial group and dense trabecular bone in control group. BV/TV and Tb.N in trial group were significantly lower than those in control group, and SMI and Tb.Sp in trial group were significantly higher than those in control group (P lt; 0.05); there was no significant difference in Conn.Dens and Tb.Th between 2 groups (P gt; 0.05). Conclusion The trabecular bone is in a low metabolism condition and its microarchitecture is tendency to be osteoporosis trabecualr bone in adult patients with DDH. It may be related with the acetabular component loosening after total hip arthroplasty.
Objective To investigate the effectiveness of absorbable pins for reconstructing pelvic stability in Salter innominate osteotomy for treating development dysplasia of the hip (DDH). Methods Between January 2003 and December 2008, 392 patients (440 hips) with DDH underwent a Salter procedure. There were 68 boys (82 hips) and 324 girls (358 hips) with a mean age of 3 years and 3 months (range, 1 year and 6 months-5 years). According to Tonnis classification criteria, 13 hips were rated as grade I, 304 hips as grade II, 82 hips as grade III, and 41 hips as grade IV. Based on the degree of displacement of the femoral head and acetabular index on the anteroposterior pelvic X-ray film, operation method was selected before operation. A total of 341 hips were managed with open reduction and Salter innominate osteotomy, and 99 hips with Salter innominate osteotomy and femoral shortening rotating osteotomy. All cases underwent autologous iliac crest grafting and fixation between osteotomy sites and bone graft with 2 absorbable pins. Results At 1 day after operation, anteroposterior pelvic X-ray examination showed concentric reduction in all hips, having no instability of the joint of the osteotomy sites or bone graft shifting. A total of 368 patients (413 hips) were followed up 1 to 7 years (mean, 3 years and 10 months). At 3 months after operation, no bone graft in stability or shift, and sliding or loosening of pins occurred. At last follow-up, concentric reduction rate was 100%; after hip loading, 358 patients had no claudication and limited hip activities, who had the stability of hips and negative Allis and Ortalani signs. No abnormal height growth was observed in all patients. According to Mckay’s hip function evaluation criteria, the results were excellent in 390 hips, good in 16 hips, and fair in 7 hips, with an excellent and good rate of 98.3%; according to Severin X-ray criteria, the results were excellent in 386 hips, good in 17 hips, and fair in 10 hips, with an excellent and good rate of 97.6%. Conclusion Absorbable pins can replace steel pins for fixation of the osteotomy sites and bone graft in Salter innoninate because of flexible and convenient operation without a need for reoperation of steel pins extraction.
Objective To investigate the effectiveness of Y-shaped osteotomy for treatment of developmental coxa vara in children. Methods Between January 2008 and October 2011, 10 cases (14 hips) of developmental coxa vara were treated. There were 4 boys (5 hips) and 6 girls (9 hips), aged 5-12 years (mean, 7.8 years). All the children had obvious lameness and limitations of hip abduction, adduction, and rotation. The anteroposterior pelvic X-ray films showed that the collodiaphysial angle ranged from 46 to 110° (mean, 87°); Hilgenreiner-epiphyseal angle (HE) ranged from 36 to 93° (mean, 57°); and the articulotrochanteric distance (ATD) ranged from — 25 to 6 mm (mean, — 3 mm). The subtrochanteric Y-shaped osteotomy was performed and angle steel plate was used for internal fixation. Results All incisions healed by first intention without surgery-related complication. All cases were followed up 14-40 months (mean, 18 months). The symptom of lameness disappeared or obviously alleviated; the range of motion of hip abduction, adduction, and rotation were increased. Postoperative X-ray films showed that the vertical epiphyseal plate of proximal femur was returned to the horizontal. After operation, the collodiaphysial angle was 130-153° (mean, 137°); HE angle was 23-35° (mean, 27°); and the ATD was 3-22 mm (mean, 14 mm). According to LIU Jiande’s assessment standards, the results were excellent in 5 hips, good in 8 hips, and fair in 1 hip, and the excellent and good rate was 92.8%. The other children had no recurrence of coxa vara except 1 case after 30 months. Conclusion The Y-shaped osteotomy is a simple and effective method to treat developmental coxa vara in children, which can fully correct the deformity, and patients can exercise early because of firm internal fixation.
Objective To investigate the effectiveness of subtrochanteric shortening with overlapping femoral resection in total hip arthroplasty for Crowe type IV developmental dysplasia of the hip (DDH). Methods Between January 2004 and December 2010, 37 patients (44 hips) with Crowe type IV DDH underwent subtrochanteric shortening with overlapping femoral resection in total hip arthroplasty with cementless prosthesis. There were 15 males (18 hips) and 22 females (26 hips) with an average age of 42 years (range, 24-46 years). Unilateral hip was involved in 30 cases and bilateral hips in 7 cases. Preoperative X-ray films showed complete dislocation of the femoral head and hypoplasia of the acetabulum and proximal femur. Before operation, the leg discrepancy was (5.5 ± 1.1) cm, and the Harris score was 32.1 ± 5.2. Results The mean operation time was 4.3 hours (range, 3-6 hours); the mean blood loss was 760 mL (range, 600-1 000 mL). All patients obtained primary healing of incision. The patients were followed up 1-8 years (mean, 6.7 years). Pain relief was achieved; 6 cases had mild claudication; 3 cases had femoral nerve palsy; and no stretch injury of sciatic nerve was observed. X-ray films showed that acetabular cups were in normal position. The healing time of fracture was 3-6 months (mean, 3.7 months). The leg discrepancy was (1.5 ± 1.0) cm at 1 day after operation, showing significant difference when compared with preoperative one (t=16.45, P=0.00). The Harris score was 94.3 ± 3.8 at 3 months after operation, showing significant difference when compared with preoperative score (t=59.15, P=0.00). No revision of acetabular and femoral prostheses was performed during follow-up. Conclusion Subtrochanteric shortening with overlapping femoral resection in total hip arthroplasty is a safe method of restoring the anatomic hip center in Crowe type IV DDH in adults. It can avoid reduction difficulty caused by soft tissue contracture and injuries of sciatic nerve and femoral nerve caused by limb lengthening.
Objective To compare the biomechanical effects between rotational acetabular osteotomy and Chiari osteotomy for developmental dysplasia of the hip (DDH) by biomechanical test. Methods Sixteen DDH models of 8 human cadaver specimens were prepared by resecting the upper edge and posterior edge of acetabulum. And the Wiberg central-edge angle (CE) of the DDH model was less than 20°. Then the rotational acetabular osteotomy was performed on the left hip and Chiari osteotomy on the right hip. When 600 N loading was loaded at 5 mm/minute by a material testing machine, the strain values of normal specimens, DDH specimens, and 2 models after osteotomies were measured. Results In normal specimens, the strain values of the left and right hips were 845.63 ± 533.91 and 955.94 ± 837.42 respectively, while the strain values were 1 439.03 ± 625.23 and 1 558.75 ± 1 009.46 respectively in DDH specimens, which was about 2 times that of normal hips. The morphology and X-ray examinations indicated that the DDH model was successfully established. The strain value was 574.94 ± 430.88 after rotational acetabular osteotomy, and was significantly lower than that of DDH specimens (t=4.176, P=0.004); the strain value was 1 614.81 ± 932.67 after Chiari osteotomy, showing no significant difference when compared with that of DDH specimens (t=0.208, P=0.841). The strain value relieved by rotational acetabular osteotomy was significantly higher than that by Chiari osteotomy (t= — 2.548, P=0.023). Conclusion Rotational acetabular osteotomy is better than Chiari osteotomy in relieving hip joint stress of DDH.
Objective To summarize the surgical technique and the effectiveness of Becker V-shaped lateral rotation osteotomy in total hip arthroplasty (THA) for Crowe type IV development dislocation of the hip (DDH). Methods Between January 2000 and December 2009, 18 patients (22 hips) with Crowe type IV DDH underwent THA. There were 3 males and 15 females with an average age of 54 years (range, 41-75 years). The unilateral hip was involved in 14 cases and bilateral hips in 4 cases. All patients had over anteversion of the femoral neck, with the acetabular anteversion angle of (21.28 ± 4.87)°, the femoral neck anteversion angle of (59.06 ± 1.44)°, and combined anteversion angle of (80.33 ± 1.55)°. All the patients had limb-length discrepancy, ranged from 1.0 to 3.5 cm (mean, 2.5 cm). Before operation, gluteus medius muscle strength was grade 2 in 17 hips and grade 3 in 5 hips; severe or moderate claudication was observed in 13 and 5 patients, respectively. Trendelenburg sign was positive in all patients. Preoperative Harris score was 30.00 ± 6.32. Cementless prosthesis was used. Becker V-shaped lateral rotation osteotomy and subtrochanteric shortening with overlapping femoral resection were performed, and proximal femoral shaft splitting was performed on 21 hips having narrow bone marrow cavity. Results All the cases achieved primary healing of incision. No complication of anterior dislocation, deep infection, nerve traction injury, or femoral uncontrolled fracture occurred. All the cases were followed up 3-12 years (mean, 8 years). Postoperative X-ray films showed that the initial fixation result of femoral prosthesis was excellent in 18 hips and good in 4 hips. Bone healing of osteotomy stump was obtained at 3-6 months (mean, 5 months) after operation. Affected limb prolonged for 2.5-3.5 cm (mean, 3.0 cm ) at 1 year after operation; limb-length discrepancy was 0.5-1.5 cm (mean, 1.0 cm). The gluteus medius muscle strength was restored to grade 4 in 5 hips and grade 5 in 17 hips. At last follow-up, 13 patients had no claudication, and 5 patients had mild claudication; Trendelenburg sign was negative in 15 cases and was positive in 3 cases; the Harris score was significantly improved to 91.89 ± 3.22; all showing significant difference when compared with preoperative ones (P lt; 0.05). At last follow-up, the acetabular anteversion angle, the femoral neck anteversion angle, and combined anteversion angle were (19.33 ± 4.49), (13.33 ± 5.70), and (32.67 ± 5.35)°, respectively, all showing significant differences when compared with preoperative ones (P lt; 0.05). No aseptic loosening, osteolysis, or rediolucent line was found around the femoral component. No implant subsidence, stem varus, or revision occurred. Conclusion Becker V-shaped lateral rotation osteotomy is a safe and predictable method to treat type Crowe type IV DDH.