1.Clinical observation on effects of Xuebijing injection on inflammatory mediators of patients with severe acute pancreatitis
Yongqing DUAN ; Ping GAN ; Jiahua ZHANG ; Chen LIAO ; Jin TANG ; Shicai XU
International Journal of Traditional Chinese Medicine 2011;33(2):104-106
Objective To evaluate the effects of Xuebijing injection on inflammatory mediators of patients with severe acute pancreatitis. Methods Using double blind method, 80 cases with severe acute pancreatitis were randomly divided into two groups, with 40 cases in each group. The control group was treated with conventional therapy such as: fasting, fluid replacement, acid inhibition and anti-infection, combined with the continuing injection with the growth hormone release inhibiting 6 mg, ulinastatin 200000u for 7 days. Based on the control group's treatment, the other group was added with Xuebijing injection 50 ml, twice a day for 7days. The plasma levels of prostaglandin Ⅰ2 (PGI2), thromboxane A2 (TXA2), tumor necrosis factor α (TNFα),interleukin-1,6,8 (IL-1,6,8) were compared before and after the treatment in each group and between two groups.Results Compared with the control group, Xuebijing injection group had marked effects on modulating the levels of inflammatory mediators. The levels of PGI2 and PGI2/TXA2 were increased significantly and the levels ofTXA2, TNF2, IL-1,6 and 8 were deceased(P<0.05)sharply after the treatment. Conclusion Combined with conventional western medicine therapy, Xuebijing injection has the effects of inhibiting and controlling the release of inflammatory mediators on patients with severe acute pancreatitis.
2.The W-shaped acetabular angular plate for the treatment of acetabular posterior wall fractures through the direct posterior approach
Fuming HUANG ; Wenquan XU ; Shibang LIN ; Haizhou HUANG ; Qiubao ZHENG ; Jianwen LIAO ; Shicai FAN
Chinese Journal of Orthopaedics 2021;41(24):1762-1769
Objective:To evaluate the follow-up clinical results of W-shaped acetabular angular plate for the treatment of acetabular posterior wall fractures through a direct posterior approach (DPA).Methods:Fifteen cases (10 males and 5 females, average aged 42.1±10.0 years) were involved in this study, with acetabular posterior wall fractures treated by using the W-shaped acetabular angular plate through a DPA between March 2017 and June 2019. Nine patients with fractures were injured by traffic accidents and the other 6 cases by falling. Based on the three-column classification for acetabular fractures, all of the cases belonged to posterior wall fractures (A2.1), which included 6 cases of simple fractures and 9 cases of comminuted fractures. The mean time interval between injury and surgery was 5.6±1.1 (range, 4-8) days. The DPA was adopted in all cases. The posterior wall fractures of the acetabulum were reduced and fixed with W-shaped acetabular angular plates. The reduction quality of the acetabulum was evaluated by X-ray and CT scan during follow-up visits according to the criteria proposed by Matta. The function of the hip joint was assessed by the Merle d'Aubigné-Posteal score modified by Matta.Results:The length of the surgical incision was 9.5±1.1 (range, 8-12) cm. The operation time was 45.3±10.1 (range, 35-75) mins. The amount of intraoperative blood loss was 248.0±94.7 (range, 100-380) ml. All the patients who were followed up for 20.5±6.3 (range, 16-38) months. All cases were evaluated according to Matta's reduction quality criteria, the satisfactory ratio of reduction was 100%. Among cases, 10 cases were matched the anatomic reduction, and the other 5 cases have belonged to satisfy. All cases of fractures had healed (the mean of healing time was 9.4±1.3 (range, 8-12 weeks). At the final follow-up visit, the mean of modified Merle d'Aubigne-Postel score was 16.9±1.6 (range, 13-18). Excellent clinical outcomes were obtained in 10 cases, good in 3 cases, and fair in 2 cases. One case had deep venous thrombosis of the lower extremities. The clots disappeared after anticoagulation treatment. One case had the heterotopic ossification, Brooker grade I, without any special treatment due to not affecting the hip joint activity in the follow-up visits. One patient had incision fat liquefaction and the wound healed after intensive dressing change. No internal fixation loosening or losing of fracture reduction was found at the follow-up visits.Conclusion:This study shows that using W-shaped acetabular angular plate for the treatment of acetabular posterior wall fractures through the DPA could obtain early satisfactory clinical outcomes.
3.Surgical technique and curative effect analysis of the lateral-rectus approach for acetabular fractures combined with ipsilateral greater sciatic notch fractures
Shicai FAN ; Kangshuai XU ; Qiguang MAI ; Tao LI ; Zhenhua ZHU ; Yuhui CHEN ; Yingze ZHANG
Chinese Journal of Orthopaedics 2022;42(18):1197-1203
Objective:To explore the surgical technique and clinical results of the lateral-rectus approach (LRA) for acetabular fractures combined with ipsilateral greater sciatic notch fractures.Methods:Nine cases of acetabular fractures combined with ipsilateral greater sciatic notch fractures treated by the LRA from January 2015 to January 2021 were involved in this study, including 7 males and 2 females with age of 39.8±15.4 years (range, 25-54 years). Six cases were injured by falling and the others by traffic accidents. There were 3 cases combined with pelvic fractures, 1 combined with craniocerebral injury, 3 combined with thoracic injury, 2 combined with closed abdominal injury, and 3 combined with other fractures of the extremities. Based on the Letournel-Judet classification, the cases were all classified as double-column acetabular fractures. The fractures of the greater sciatic notch are all fractures with obvious displacement from the lower part of the sacroiliac joint through the top of the greater sciatic notch to the posterior column of the acetabulum. Pelvic X-ray and CT examination were performed after operation. The reduction quality of the acetabulum and greater sciatic foramen was evaluated by Matta's criteria. The function of the hip joint was assessed by modified Merle D'Aubigné-Postel score.Results:All 9 patients were successfully completed the operation, and followed up. The operation time was 140.4±55.2 min (range, 110-190 min). The amount of intraoperative blood loss was 770.5±430.9 ml (range, 540-1,260 ml). All cases of fractures had healed in 7.7±3.4 weeks (range, 6-12 weeks) after operation. According to Matta's reduction quality criteria, the quality of fracture reduction after surgery was excellent in 7 cases and good in 2 cases. The follow-up period was 24.8±8.8 months (range, 6-12 months). Fractures of the acetabulum and greater sciatic foramen healed well, with the healing time of 6 to 12 weeks. There were no complications such as loss of fracture reduction, failure of internal fixation, traumatic arthritis or necrosis of femoral head. Matta's modified Merle d'Aubigne-Postel hip function score was 16.2±0.6 (range, 12-18) one year after surgery. There were excellent in 6 cases, good in 2 cases, fair in 1 case, with an excellent and good rate of 89%.Conclusion:Fractures of the acetabulum and ipsilateral greater sciatic notch are serious injuries with difficulty in surgical reduction and fixation. The LRA can better complete reduction and fixation of the above fractures, obtaining satisfactory clinical outcomes.
4.Clinical effects of direct posterior approach with the fixation of percutaneous tunnel screw and plate for acetabular posterior comminuted fractures
Qiguang MAI ; Yuhui CHEN ; Tao LI ; Hua WANG ; Qiubao ZHENG ; Xiaorui ZHAN ; Kangshuai XU ; Sheqiang CHEN ; Jiacheng LI ; Wenquan XU ; Shicai FAN
Chinese Journal of Orthopaedics 2021;41(19):1426-1433
Objective:To investigate the surgical technique and the clinical effects of direct posterior approach (DPA) with the fixation of percutaneous tunnel screw and plate for acetabular posterior comminuted fractures.Methods:Thirty-six cases with acetabular posterior comminuted fractures treated by this technique from January 2016 to July 2020 were retrospectively analyzed in this study. There were 28 males and 8 female, aged 42.0±12.1 (range 19-64) years. According to Letournel-Judet classification, there were 28 cases of transverse associated with posterior wall fractures, 6 cases of posterior column with posterior wall fractures and 2 cases of T shape with posterior wall fractures. DPA was adopted in prone position. The anterior and posterior column fractures of the acetabulum were reduced under direct vision and then fixed with percutaneous tunnel screw. Further, the posterior wall fractures of the acetabulum were reduced and fixed with plate and screws. The operation duration, intraoperative blood loss, incision length, fracture union time, fracture reduction quality, postoperative complications and hip function were recorded.Results:The incision was 9.8±1.2 (range 8-12) cm. The operation duration was 102.9±21.4 (range 65-145) min. Intraoperative bleeding was 214.0±116.9 (range 100-640) ml. Postoperative X-ray and CT examinations showed perfect reduction. All the patients were followed up for 20.9±9.2 (range 10-38) months. The fracture healing time was 4.6±1.0 (range 3-6) months. There was no patient with damaged superior gluteal nerve and blood vessel. There were 2 cases of femoral head cystic changes without pain in walking, 1 case of postoperative infection and bacteremia who was cured at 1 month after debridement and anti-infection treatment, 1 case of sciatic nerve injury but recovered at 3 months after operation, and 1 case of heterotopic ossification at 3 months after surgery without affecting hip motion. According to the Matta's criteria, the reduction quality of the acetabular fracture was rated as excellent in 28 cases, good in 6 cases, fair in 2 cases. According to the modified Merle D'Aubigné and Postel scoring system, hip joint function was excellent in 24 cases, good in 10 cases and fair in 2 cases.Conclusion:DPA approach can directly reduce acetabular posterior comminuted fractures through a minimal incision. Combined with the technique of percutaneous tunnel screw, it displays great advantages of less trauma and with good clinical effects.
5.Classification system of sacroiliac joint dislocation with ipsilateral sacral wing fracture and its validity examination and clinical application evaluation
Kangshuai XU ; Cheng GU ; Jiacheng LI ; Sheqiang CHEN ; Yuhui CHEN ; Yan ZHUANG ; Zhiyong HOU ; Shicai FAN
Chinese Journal of Trauma 2022;38(3):234-239
Objective:To establish the classification system of sacroiliac joint dislocation with ipsilateral sacral wing fracture (SJDISWF), examine its reliability and evaluate the clinical application.Methods:A multi-center retrospective case series study was conducted to analyze the clinical data of 20 SJDISWF patients admitted to Third Affiliated Hospital of Southern Medical University, Honghui Hospital Affiliated to Xi′an Jiaotong University and Third Hospital of Hebei Medical University from January 2016 to December 2019. There were 8 males and 12 females, aged from 13-58 years[(34.7±13.2)years]. Based on the direction of sacral displacement, SJDISWF was divided into 3 types. Type I: the sacroiliac joint dislocated and the ipsilateral sacral wing fracture fragment was anteriorly prolapsed; Type II: the sacroiliac joint dislocated, the ipsilateral sacral wing fracture fragment was compressed or crushed, the anterior sacral foramen may fractured; Type III: the sacroiliac joint dislocated and the ipsilateral sacral wing fracture end was inserted into the sacral canal, causing an intra-sacral canal occupation. The reliability of the classification was performed based on the assessment results of two phases in four observers at 4-week intervals. Treatments were utilized based on the types I, II, III fractures, including anterior approach for open reduction and internal fixation, closed reduction and internal fixation or posterior approach for open reduction and internal fixation respectively. Postoperative fracture healing time was recorded. Quality of fracture reduction was graded according to Matta′s criteria. Majeed functional score was recorded at postoperative 3 months, 6 months and the final follow-up. Complications were detected as well.Results:The overall Kappa value of inter-observer reliability was 0.890. The overall Kappa value of intra-observer reliability was 0.854. There were 12 patients with type I, 7 with type II and 1 with type III. All patients went through the procedure uneventfully and were followed up for 6-36 months[(20.0±8.7)months]. All patients achieved clinical healing in 8-14 weeks[(10.2±1.7)weeks]. According to the Matta′s criteria for fracture reduction, the outcome was excellent or good in 83% (10/12) for type I, 71% (5/7) for type II and 0% (0/1) for type III, with the overall excellent rate of 75%. Majeed functional score was (74.6±5.2)points at postoperative 3 months and (84.4±5.8)points at postoperative 6 months ( P<0.01). According to Majeed functional score, the outcome was excellent or good in 75% (9/12) for type I, 100% (7/7) for type II and 0% (0/1) for type III at the final follow-up, with the overall excellent rate of 80%. There were no complications such as lateral femoral cutaneous nerve or sciatic nerve injury, lower extremity deep vein thrombosis, sacroiliac joint pain, failure of internal fixation or loss of fracture reduction during the follow-up. Conclusions:The SJDISWF classification has high reliability. The classification-oriented treatment strategy has achieved a relatively satisfactory restoration and functional recovery, indicating that the classification plays a certain role in guiding treatment selection for SJDISWF.
6.Correlation between intervertebral disc degeneration and hyperuricemia
Yang LI ; Fei MA ; Yebo LENG ; Shicai XU ; Baoqiang HE ; Jiajun ZHOU ; Yehui LIAO ; Qiang TANG ; Chao TANG ; Qing WANG ; Dejun ZHONG
Chinese Journal of Tissue Engineering Research 2024;28(32):5091-5096
BACKGROUND:Hyperuricemia is a common metabolic disease,and the main clinical manifestation of patients with hyperuricemia is the formation of uric acid crystals leading to gout.Previous studies have only reported that uric acid crystals lead to intervertebral disc degeneration,but there are fewer studies on the correlation between hyperuricemia and intervertebral disc degeneration. OBJECTIVE:To retrospectively analyze the characteristics of intervertebral disc degeneration in patients with hyperuricemia and the correlation between serum uric acid level and intervertebral disc degeneration. METHODS:A retrospective analysis was performed in all patients diagnosed with intervertebral disc degeneration admitted at the Department of Orthopedics,the Affiliated Hospital of Southwest Medical University from January 2021 to December 2022.There were 97 hyperuricemia patients in the hyperuricemia group and 194 non-hyperuricemia patients in the control group according to sex and age in a ratio of 1:2.Blood uric acid test results were collected,and Pfirrmann scoring was performed for the degree of disc degeneration in patients based on the whole spinal MRI images.The difference in the degree of disc degeneration between the two groups was compared,and the correlation between the serum uric acid level and the degree of intervertebral disc degeneration was analyzed. RESULTS AND CONCLUSION:The Pfirrmann score in the hyperuricemia group was higher than that in the control group,and the total number of disc degeneration in the hyperuricemia group was also significantly higher than that in the control group(P<0.05).Spearman correlation analysis showed that the degree of disc degeneration in male patients was positively correlated with serum uric acid level at many spinal segments in the hyperuricemia group(C3/4:r=0.317,C4/5:r=0.333,C5/6:r=0.309,L2/3:r=0.443,P<0.05);the degree of disc degeneration in female patients was also positively correlated with serum uric acid level(C3/4:r=0.354,C4/5:r=0.388,C6/7:r=0.312,T7/8:r=0.282,T9/10:r=0.305,T11/12:r=0.277,L4/5:r=0.319,L5-S1:r=0.367,P<0.05).In the control group,there was no significant correlation between the degree of disc degeneration and serum uric acid level in male and female patients(P>0.05).To conclude,in patients with hyperuricemia,the higher serum uric acid level indicates the more serious intervertebral disc degeneration.Therefore,hyperuricemia is one of the risk factors for intervertebral disc degeneration.
7.Treatment of pelvic fractures complicated with urethral rupture via lateral-rectus approach and Pfannenstiel approach
Qiguang MAI ; Yuhui CHEN ; Zhenhua ZHU ; Tao LI ; Hua WANG ; Kangshuai XU ; Hai HUANG ; Cheng YANG ; Jianwen LIAO ; Shicai FAN
Chinese Journal of Orthopaedic Trauma 2022;24(12):1016-1023
Objective:To investigate the safety and clinical efficacy of the lateral-rectus approach combined with the Pfannenstiel approach in the treatment of pelvic fractures complicated with urethral rupture.Methods:From January 2013 to June 2021, 20 patients with pelvic fracture complicated with urethral rupture were surgically managed through the lateral-rectus approach and the Pfannenstiel approach at Department of Traumatic Surgery, Center for Orthopaedic Surgery, the Third Hospital Affiliated to Southern Medical University. They were 15 males and 5 females, with an average age of 42 years (from 18 to 55 years). By the Tile classification, there were 11 cases of type B and 9 cases of type C. The first-stage urethral realignment was performed via the Pfannenstiel approach in the supine position after general anesthesia in conjunction with an urologist; at the second-stage, the lateral-rectus approach was used to reduce and fixate the acetabular or pelvic fractures. The operation time, intraoperative blood loss, fracture reduction quality, pelvic functional recovery and complications were documented.Results:In this cohort, the operation time ranged from 80 to 240 min, averaging 140.5 min; the time for simple urethral convergence ranged from 20 to 30 min; the intraoperative blood loss ranged from 400 mL to 2,000 mL, averaging 730 mL. According to the Mears andVelyvis evaluation for fracture reduction quality, anatomical reduction was achieved in 13 cases, satisfactory reduction in 6 cases, and unsatisfactory reduction in one. The 20 patients were followed up for 12 to 68 months (mean, 37 months) after surgery. One fracture got nonunited but the other fractures got united after 3.0 to 4.5 months (mean, 3.5 months). According to the Majeed scoring system, the pelvic function at 12 months after surgery was excellent in 12 cases, good in 6 and fair in 2, giving an excellent and good rate of 90% (18/20). Screw loosening was found in one patient, traction injury to the lumbosacral trunk nerve in another patient, varying degrees of dysuria which responded to periodic urethral dilation in 8 patients, urethral stricture in 3 patients and erectile dysfunction in 5 patients. No abdominal hernia or pelvic infection was observed.Conclusions:The lateral-rectus approach combined with the Pfannenstiel approach can be used effectively to reduce and fixate the pelvic and acetabular fractures, and to repair the urethral rupture in one stage as well. They are also safe due to a low incidence of such complications as abdominal wall hernia and pelvic infection.
8.Surgical methods and treatment effects of the adult anterior dislocation of the sacroiliac joint
Shicai FAN ; Zhiyong HOU ; Yan ZHUANG ; Gang LYU ; Shuquan GUO ; Kangshuai XU ; Qiguang MAI ; Tao LI ; Yuhui CHEN ; Zhenhua ZHU ; Yingze ZHANG
Chinese Journal of Orthopaedics 2023;43(8):477-483
Objective:To explore the surgical methods and treatment effects of adult anterior dislocation of the sacroiliac joint (AADSJ).Methods:A multi-center retrospective case series study was conducted to analyze the clinical data of 25 cases admitted in 5 clinical centers (affiliations of authors in this article) from January 2016 to January 2021. There were 18 males and 7 females, aged 38.8±15.5 years (range, 18-83 years). The AADSJ clinical classification system was formulated based on the radiographic morphology of anterior dislocation of the sacroiliac joint, which includes two types. Type I: complete anterior dislocation of the sacroiliac joint, and displacement of the entire iliac auricular surface to the front of the sacrum. Type II: fracture of the sacroiliac joint combined with anterior dislocation, subdivided into 3 subtypes. Type IIa: iliac fracture involves the anterior 1/3 of the sacroiliac joint, and dislocation of the ilium anterior to the sacrum. Type IIb: iliac fracture involves the posterior 2/3 of the sacroiliac joint, and dislocation of the ilium anterior to the sacrum. Type IIc: iliac fracture involves the posterior 2/3 of the sacroiliac joint, and dislocation of the ilium anteromedial to the sacrum. The reliability and repeatability of the clinical classification, Tile classification and Young-Burgess classification were performed based on the results of two-phase assessments in four observers. The operations were performed by the lateral-rectus approach and the ilioinguinal approach. The operation time and intraoperative bleeding were recorded. Pelvic X-ray and CT scan were rechecked after the operation. The quality of fracture reduction was evaluated according to Matta score. The postoperative functional rehabilitation was evaluated according to the Majeed rehabilitation standard at one-year follow-up.Results:Among 25 cases in this study, there were 3 cases of Type I, 5 cases of Type IIa, 9 cases of Type IIb and 8 cases of Type IIc according to the clinical classification system. The Kappa values of reliability tests for the clinical classification, Tile classification and Young-Burgess classification were 0.681, 0.328 and 0.383, respectively. The Kappa values of repeatability tests for the clinical classification, Tile classification and Young-Burgess classification were 0.690, 0.221 and 0.395, respectively. The reliability and repeatability of the AADSJ clinical classification were significantly better than other classifications. There were 14 cases underwent lateral rectus abdominis approach and 11 cases underwent ilioinguinal approach. The operative time for managing anterior dislocation of the sacroiliac joint was 122.0±50.7 min (range, 65-148 min) through the lateral rectus abdominis approach, and through the ilioinguinal approach was 178.0±49.9 min (range, 110-270 min), with a significant difference ( t=2.76, P=0.011). The amount of intraoperative blood loss through the lateral rectus approach was 680±330 ml (range, 350-2,120 ml), which was significantly less than that through the ilioinguinal approach (1,660±968 ml, 680-3,300 ml), with a significant difference ( t=3.55, P=0.002). The follow-up period was 1-3 years. At one week after surgery, the quality of fracture reduction evaluated by Matta score showed that the excellent and good reduction rate of the lateral-rectus approach was 79% (11/14), and that of the ilioinguinal approach was 73% (11/14), with no statistically significant difference ( P=1.000). At a one-year follow-up, according to Majeed's criteria, the overall excellent and good rate of the lateral-rectus approach was 64% (9/14), which is similar to 64% (7/11) of that of the ilioinguinal approach. No fracture reduction loss or internal fixation loosening failure occurred. Conclusion:The AADSJ clinical classification system can accurately describe the imaging features and clinical manifestations of AADSJ, with high reliability and repeatability. The AADSJ can be treated by the lateral-rectus approach or the ilioinguinal approach, with similar therapeutic effects but the former having less trauma.
9.Surgical method and clinical effect of modified LC-II screws for fragility fractures of the pelvis in the elderly
Tao LI ; Kangshuai XU ; Jiacheng LI ; Zhenhua ZHU ; Qiguang MAI ; Yuhui CHEN ; Jianwen LIAO ; Shicai FAN
Chinese Journal of Orthopaedics 2023;43(12):805-812
Objective:To investigate the surgical method of LC-II screws for fragility fractures of the pelvis (FFP) in the elderly and evaluate its clinical efficacy.Methods:A retrospective analysis was performed on 45 patients with FFPs operated in our department from January 2011 to January 2022. The clinical information was as follows. The FFP classification of pelvic fracture was IIIA in 26 cases and IIIB in 19 cases. Among them, 22 cases were fixed with closed reduction and modified LC-II screws (experimental group), and 23 cases were fixed with open reduction and reconstruction plates (control group). In the experimental group, there were 6 males and 16 females. The age range was 62-90 years, with an average of 73.2±9.2 years. The FFP classification of pelvic fracture was IIIA in 12 cases and IIIB in 10 cases. In the control group, there were 8 males and 15 females. The age range was 60-87 years, with an average of 72.8±6.6 years. FFP classification of pelvic fracture was IIIA in 14 cases and IIIB in 9 cases. After admission, pelvic X-ray and CT scan were performed, and the surgery was prepared. In the experimental group, after closed reduction of the posterior ring, the modified LC-II screw was inserted below the anterior inferior iliac spine (AIIS) toward the sacroiliac joint and penetrated the sacroiliac joint. For combined anterior ring fractures, the INFIX was used for anterior ring fixation. In the control group, the posterior ring was fixed with a reconstruction plate and/or sacroiliac screw after open reduction through the lateral rectus approach (LRA). The clinical efficacy was evaluated between the experimental group and the control group.Results:All 45 patients were successfully operated and followed up for 6 months to 3 years. All the pelvic fractures healed. In the experimental group of 22 cases, the time from injury to operation was 3-9 days, with an average of 5.8±1.9 days; the operation time was 25-70 min, with an average of 42.0±12.9 min. The intraoperative bleeding was 20-40 ml, with an average of 29.1±6.7 ml. According to the X-ray reduction evaluation criteria of Matta, 7 cases were excellent, 11 cases were good and 4 cases were medium, with an excellent and good rate of 81.8%. According to rehabilitation criteria of Majeed, 10 cases were excellent, 6 cases were good and 6 cases were fair, with a total excellent and good rate of 72.7%. At the last follow-up, sacroiliac joint pain was evaluated by VAS score: 0 in 10 cases, <3 in 7 cases, and 4-6 in 5 cases. No internal fixation loosening occurred. In the control group, the time from injury to operation was 5-20 days, with an average of 9.9±3.8 days; the operation time was 50-150 min, with an average of 89.1±29.5 min; the intraoperative bleeding was 220-1 000 ml, with an average of 509.2±214.3 ml. According to the X-ray reduction evaluation criteria of Matta, 16 cases were excellent, 4 cases were good and 3 cases was medium, with an excellent and good rate of 87.0%. According to rehabilitation criteria of Majeed, 12 cases were excellent, 6 cases were good and 7 cases were fair, with a total excellent and good rate of 78.3%. At the last follow-up, sacroiliac joint pain was evaluated by VAS score: 0 in 14 cases, <3 in 6 cases, and 4-6 in 3 cases. In the control group, posterior ring plate loosening was found in 2 cases and anterior ring pubic ramus plate and screw loosening was found in 4 cases, but there was no reduction loss.Conclusion:The modified LC-II screw is theoretically feasible in the treatment of FFP. Preliminary clinical results show good safety and efficacy, providing a new idea for minimally invasive treatment of FFP.
10.Analytic performance validation of laboratory-developed real-time quantitative PCR (RQ-PCR) test for BCR::ABL1 p210 transcript in chronic myeloid leukemia
Cong HAN ; Ge SONG ; Jiao MA ; Shicai XU ; Qi SUN ; Huijun WANG ; Zhijian XIAO ; Yao YAO
Chinese Journal of Laboratory Medicine 2023;46(10):1040-1047
Objective:To establish and validate analytic performance of laboratory-developed real-time quantitative polymerase chain reaction (RQ-PCR) test (LDT) for BCR::ABL1 p210 transcript.Methods:Using the primes and probes released by the Europe Against Cancer Program(EAC), we have established BCR::ABL1 p210 RQ-PCR test. The laboratory-specific conversion factor (CF) was determined by the WHO 1 st International Genetic Reference Panel, and a two-level internal control is developed using a mixture of K562 and HL60 cell lines was created to ensure traceability. Analytical performance, including analytical accuracy, analytical precision, linearity range, analytic sensitivity and specificity of RQ-PCR LDT test for BCR::ABL1 p210 transcript were validated according to CLIS guidelines. Furthermore, a comparison was made with an FDA-cleared RQ-PCR in vitro diagnostics (IVD) kit by Bland-Altman analysis. Results:The laboratory specific conversion factor (CF) for LDT RQ-PCR was determined to be 0.535 based on WHO 1 st International Genetic Reference Panel, which can be used to convert to the BCR::ABL international scale (BCR::ABL1 IS) reliably. The repeatability of BCR::ABL1 IS results at 4 different molecular response (MR0.5,MR1.5,MR2.5,MR3.5) levels are 7.44%, 5.33%, 9.12% and 18.06%, respectively, with total precision of 7.99%, 5.49%, 10.95% and 17.99%. The previous CAP proficiency test (PT) results from our laboratory were within the acceptable range of variation. MR results of our laboratory and MR mean value of all CAP-PT laboratory is highly correlated ( r=0.999, P<0.01), and consistent according to Bland-Altman analysis. Furthermore, the LDT method in our laboratory has a high correlation with the test results of FDA-cleared Qiagen IVD kit ( r=0.997, P<0.01). BCR::ABL1 IS results of BCR::ABL1 e13a2 transcript showed linearity within the range of 0.001%-7.454%, with a maximum coefficient of variation (% CV) 64.09%. The linearity range of e14a2 transcript BCR::ABL1 IS was 0.002%-12.398%, with a maximum % CV of 43.37%. The test has a limit of detection (LoD) of MR5.0 (0.001% IS) for e13a2 and MR4.8 (0.002% IS) for e14a2 transcript, respectively. The limit of quantitation (LoQ) for both e13a2 and e14a2 transcripts was MR4.7 (0.002% IS). The test exhibited 100% specificity, with no cross-reactivity observed between the p190 transcript and p210. Conclusions:The analytic performance of BCR::ABL1 p210 LDT RQ-PCR test from our laboratory is excellent, which can meet the clinical needs of BCR::ABL1 detection in patients with chronic myeloid leukemia.