Normally, ACL injuries are treated by reconstructing the ruptured ligament with a graft, which can be taken from various sources including autograft, allograft, and artificial graft (4). If you go to your temporary url (http://ip/~username/) and get this error, there maybe a problem with the rule set stored in an .htaccess file. doi: 10.1016/j.arthro.2006.03.011, 15. Two-bundle reconstruction of the anterior cruciate ligament using Also, the examiners who evaluated the patients' knees did not know the material used. (2016) 63:24451. Figure 3. Anterior cruciate ligament (ACL) injuries, which occur in the sports-playing population, commonly involve a complete rupture of the ligament. (2020) 7:68. doi: 10.1186/s40634-020-00285-z, 21. May 05, 2018;Published: May 30, 2018. Potential causes for this include mechanical irritation and foreign avoid drilling the tunnel too far posterior. Knee. 404 means the file is not found. Anterior cruciate ligament reconstruction proved to be the commonest sports injury worldwide. (2019) 47:238693. J Exp Orthop. At 6 months post-operation, the mean (SD) Lysholm knee scores in groups 1 and 2 were 87.9 points (11.04) and 89.2 points (13.62), respectively. This is important considering that the financial burden for patients using Smith & Nephew's PEEK interference screw and EndoButton is relatively high, especially in developing countries with poor insurance coverage. Delta Medical's PEEK interference screw and EndoButton were suitable for arthroscopic ACLR. Pereira H, Correlo VM, Silva-Correia J, Oliveira JM, Reis RL, Espregueira-Mendes J. Migration of bioabsorbable screws in ACL repair. The residual soft tissue was cleaned from the tendons. The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. This is because one ligament reconstruction. desired seating of the graft or potentially flipping the endobutton Floor polishers are poor MRI system cleaners! . The laxity examination of the involved knee after ACL reconstruction included the Lachman test and Drawer test. Change the settings back to the previous configuration (before you selected Default). Continuous variables were described using the mean, standard deviation, median, minimum, and maximum values. et al. eCollection 2022 Sep. Lin TY, Chung CC, Chen WC, Su CW, Fang HW, Lu YC. Anterior cruciate ligament (ACL) injury is a common ligament injury to the knee joint, and often lead to limited function, osteoarthritis after knee trauma, secondary damage to meniscus and cartilage, and impaired quality of life. Unable to process the form. If not, correct the error or revert back to the previous version until your site works again. Confirming Proper Button Deployment of Suspensory Fixation During ACL Reconstruction. The modified Lysholm knee scoring scale was applied to evaluate knee pain (25 points), degree of instability (25 points), locking sensation (15 points), swelling (10 points), using cane or crutches (5 points), limp (5 points), climbing stairs (10 points), and squatting (5 points). Figure 1. Arthroscopy. No part of this content may be reproduced or transmitted in any form or by any means as per the standard guidelines of fair use. Krappel FA, Bauer E, Harland U. : non-inferiority cut-off value. The Proprioception activities start at 8 weeks postoperatively and extend through ~46 months. Concerning the Lachman test, drawer test, and CT scanning results, two independent samples chi-square test or Fisher exact probability method were used for categorical variables. The objective and subjective outcomes of the ACL reconstruction were obtained preoperatively and at each follow-up point. Clinical and functional range of motion (both active and passive) evaluations were performed on all patients preoperatively, and at 3 and 6 months postoperatively. Of the 51 EndoButtons with tissue interposition, 32 migrated within 1 year, and 39 of 151 EndoButtons without tissue interposition migrated, whereas the EndoButtons with tissue interposition migrated significantly more frequently. Nakamae A, Ochi M, Adachi N, Deie M, Nakasa T. Arthroscopy. doi: 10.1016/j.otsr.2009.09.011, 12. Meniscal and ligamentous tearing are the most frequent indications for . Contact sports were not allowed until at least 6 months after surgery. At the time the article was created Usman Bashir had no recorded disclosures. Level of evidence: The clinical effective rate revealed no difference between the groups at 6 months postoperatively (non-inferiority analysis P = 0.0220). 2014 May;22(5):1047-54. doi: 10.1007/s00167-013-2458-3. be contributing to risk of fracture. Moses B, Orchard J, Orchard J (2012) Systematic review: annual Surgical reconstruction of the torn anterior Skip to Main Content; National Library of Medicine NLM Tools and Resources FDA UDI Home FDA Medical Devices Home . This is the definitive textbook on MRI safety for radiologists and other physicians, MRI technologists, physicists, scientists, MRI facility managers, and others. and transmitted securely. Before the operation, the mean (SD) Lysholm knee scores were 52.7 points (21.46) and 51.8 points (27.26) in groups 1 and 2, respectively, and there was no statistically significant difference between the two groups (P = 0.8480). femur fracture after endoscopic anterior cruciate reconstruction using endobutton acl mri safety. Add the following snippet of code to the top of your .htaccess file: # BEGIN WordPress English and Spanish forms are
The two groups received the same postoperative management and rehabilitation. Table 3. The distance between the EndoButton and lateral femoral cortex was measured on the radiograph obtained immediately postoperatively, and more than 1 mm in distance was defined as positive tissue interposition. Unfallchirurg. Either way, please contact your web host immediately. An additional option is the 14 mm round button. Epub 2017 Dec 9. Once the ACL injury had been defined, the tibial and femoral tunnel were marked and prepared. Then the tibial side grafts were firmly pulled and fixed with Delta Medical's PEEK interference screw (Figure 2B) in group 1 and Smith & Nephew's PEEK interference screw in group 2 which had the same diameter as the drilled tunnel. migration of endobuttons and also whether endobutton migration Arthroscopy 15(6): 618-624. There are other factors that may For the most part, the material of the endobutton and hydroxy appetite coated screw is made from Titanium which is a non-ferrous metal. The aim of this study was to describe the contrast-enhanced magnetic resonance imaging (MRI) appearance of bone tunnel enlargement detected on radiography after anterior cruciate ligament (ACL) reconstruction with semitendinosus and gracilis tendon endobutton (STG-endobutton) fixation technique. The mean age of the patients was 32.5 years (range, 1865 years), and they all had a follow-up time of 6 months. Schwitalla AD, Abou-Emara M, Zimmermann T, Spintig T, Beuer F, Lackmann J, et al. 2021 Jan 19;9(1):2325967120974349. doi: 10.1177/2325967120974349. Unable to load your collection due to an error, Unable to load your delegates due to an error. 2015 Jun;7(2):143-51. doi: 10.4055/cios.2015.7.2.143. sharing sensitive information, make sure youre on a federal multiple attempts and has become deformed, this may cause a Arthroscopic ACL reconstruction with graft is considered the standard procedure for ACL injuries. Endobutton (EB) suture loop and metal plate is commonly used following EB femoral fixation [7,8]. Conclusions: Knee function and functional scores were improved after ACLR in both groups, regardless of the PEEK interference screw and EndoButton applied. Copyright 2011 Arthroscopy Association of North America. 2022 May 6;10(5):23259671221094292. doi: 10.1177/23259671221094292. The type of graft procedure the surgeon chooses will determine the fixation technique. Beck NA, Lawrence JTR, Nordin JD, DeFor TA, Tompkins M. ACL tears in school-aged children and adolescents over 20 years. However, neither tissue Considering the possibility of cases falling off, the sample size of each group was set as 53 cases; that is, 53 cases in the experimental group and 53 cases in the control group. Bioabsorbable versus metallic interference screws in anterior cruciate ligament reconstruction: a systematic review of overlapping meta-analyses. The clinical outcomes are promising and benefit patients significantly (26, 27). Am J Sports Med. Shellock R & D Services, Inc. email
were taken immediately postoperatively and at 1 week, 1 month, 3 months, and 1 year. Unauthorized use of these marks is strictly prohibited. n: estimated sample size; n1 and n2 are the sample sizes of the experimental and control groups, respectively. An office chair was in the wrong place - at ANY time! a larger, extended endobutton. Training is available through AppliedRadiology.com. Treatment of anterior cruciate ligament injuries. 2018-QL-002), separately. The mean range of stretch motion in group 2 was 0.4 before surgery, compared with 0.1 at 6 months after surgery (P > 0.05) (Table 8). Published by Elsevier Inc. All rights reserved. On the other hand, there were no significant differences in clinical outcomes between the cases with or without tissue interposition and between the cases with or without EndoButton migration. Uchida R, Mae T, Matsumoto N, Kuroda S, Toritsuka Y, Shino K. Knee Surg Sports Traumatol Arthrosc. Am J Sports Med. Debridement or microfracture was done to the chondral damages. . the armature ones [1]. If One must ensure that the endobutton O'Brien DF, Fones L, Stoj V, Edgar C, Coyner K, Arciero RA. The .gov means its official. According to the Biostatistics Technical Guidelines for Clinical Trials of Chemical Drugs and Biological Products, 1 was set as 0.8. two cases of iliotibial band irritation caused by endobuttons. Harris MC, Venrick C, Hines AC, Cook JB, Rowles DJ, Tokish JM, et al. During insertion of the screw, possible complications include laceration of the graft passing suture, advancement of the graft within the bone tunnel, graft laceration . Metallic interference screws (MISs) were the first applied interference screw that have reached a reliably positive clinical outcome (8). Thirty-two cross-pin fixations and 24 EndoButton CL fixations were performed on the femoral side. Collection and assembly of data: MY, YX, YL, and YW. Bartolo MK, Provaggi E, Athwal KK, Newman S, Accardi MA, Dini D, et al. After 6 months of surgery, the mean score in group 1 was 11.0 points and 10.7 points in group 2. commonest sports injury worldwide. Epub 2012 Jan 28. Right click on the X and choose Properties. There were 50 of 52 patients in group 1 and 50 of 50 patients in group 2 showed a positive sign in the pre-drawer Test, and all the patients in group 1 and group 2 showed a negative sign in the post- drawer Test before surgery. (1999) Meyers A, Haims A, Menn K, Moukaddam H. Imaging of Anterior Cruciate Ligament Repair and Its Complications. Conclusions: (2016) 7:CD009772. Would you like email updates of new search results? Disclaimer. Reference article, Radiopaedia.org (Accessed on 04 Mar 2023) https://doi.org/10.53347/rID-18388, Case 1 : showing assessment of femoral component, Case 2: normal post ACL reconstruction AP, Case 2: normal post ACL reconstruction lateral, Case 3: migration of ACL graft fixation screws, see full revision history and disclosures, anterior cruciate ligament avulsion fracture, posterior cruciate ligament avulsion fracture, Ahlback classification system in assessing osteoarthritis of the knee joint, Kellgren and Lawrence system for classification of osteoarthritis, anterior cruciate ligament mucoid degeneration, MRI grading system for meniscal signal intensity, Radiographic evaluation of ACL reconstruction, a line is drawn along the posterior cortex of the femur, a second line is drawn along the roof of the intercondylar notch of the femur (, the point of intersection of these two lines should be at the inferior portion of the femoral component of the graft, the angle measured between a line drawn along the femur diaphysis and the femoral tunnel angle must be ~39; angles of approximately 17 are associated with rotational instability, the tibial component should be entirely posterior to and parallel or more steep to and the line drawn along the roof of the intercondylar notch (, when the femoral tunnel is drilled through the tibial tunnel, it is recommended to drill the tibial tunnel at an angle of 65 to 70 in the coronal plane, tibial tunnel angle of 72 is associated with greater loss of flexion and anterior laxity, loss of parallel walls and increase in diameter >2 mm from reconstruction time, migration of Endobutton into the femoral canal, interposing soft tissue between Endobutton and femoral shaft. (2019) 7:2325967119875415. doi: 10.1177/2325967119875415, Keywords: arthroscopic ACLR, PEEK interference screw, EndoButton, Lysholm knee scores, functional range of motion, Citation: Gao P, Yuan M, Xu Y, Wu Y, Lin X, Li Y, Li S and Wang J (2022) The safety and effectiveness comparison of Delta Medical's PEEK interface screw and Endobutton and that of Smith & Nephew's in arthroscopic anterior cruciate ligament reconstruction: A multicenter prospective double-blind randomized controlled clinical trial. The assessments of Lysholm knee scores at 3 and 6 months produced no statistical differences (both P > 0.05). When you have a missing image on your site you may see a box on your page with with a red X where the image is missing. doi: 10.1007/s00586-018-5538-8, 22. Mae 2022 MRI Textbook. All stiffness in both groups improved significantly after active function exercise. Cochrane Database Syst Rev. Figure 5. (I) Patients have signed the informed consent; (II) Patients aged 18 to 65 (including 18 and 65 years old), regardless of gender; (III) Patients meet the diagnosis of anterior cruciate ligament rupture which requires arthroscopic reconstruction of the anterior cruciate ligament, and have no contraindications to implantation; (IV) Patients have good compliance, and willing to conduct follow-up observation as required. Sheps DM, Reed JG, Hildebrand KA, Hiemstra LA (2006) Supracondylar Guglielmetti reported the same result in his ACL reconstruction using metal interference screws. This multicenter, prospective, double-blind, randomized, controlled, clinical trial revealed that ACL injured patients repaired using PEEK interference screw and EndoButton developed either by Delta Medical or Smith & Nephew under arthroscopy had a significant improvement in clinical outcomes after surgery. The diameter of the graft was ~7.09.0 mm. Front. Mouarbes D, Menetrey J, Marot V, Courtot L, Berard E, Cavaignac E. Anterior cruciate ligament reconstruction: a systematic review and meta-analysis of outcomes for quadriceps tendon autograft versus bone-patellar tendon-bone and hamstring-tendon autografts. Please enable it to take advantage of the complete set of features! Is an MRI needed to diagnose an ACL tear . At 3 and 6 months after surgery, patients in both groups had a significant improvement in their Lysholm knee scores. The large 12 mm x 7.5 mm footprint maximizes button-to-bone contact against the cortex. Knee Radiographic evaluation of anterior cruciate ligament (ACL) reconstructioninvolves: The knee is a complex synovial joint that can be affected by a range of pathologies: Please Note: You can also scroll through stacks with your mouse wheel or the keyboard arrow keys. (2010) 26:70513. endobutton acl mri safetygovernment jobs for math majors. Figure 4. is not inserted in a straight line over the guide wire, then this may doi: 10.1177/0363546509350325. and is relatively cheap. . A systematic review and meta-analysis showed that 926 patients were evaluated for Lachman test grade 0 in 14 studies and negative Lachman test (grade 0) was found in 81.2% of cases (95% CI, 78.783.7%). We have developed an innovative modified BHB method involving anatomic anterior cruciate ligament (ACL) reconstruction. Neither of the assessments of Lysholm knee scores between the two groups at 3 and 6 months postoperatively showed statistically significant differences (Fisher's test, P = 0.2693 and 0.6203, respectively) (Table 4). Plominski J, Borcz K, Kwiatkowski K, Zabicka M. Fixation of patellar tendon bone graft in reconstruction of patellar ligaments. PEEK can encourage bony incorporation with bioactive elements reinforcement such as hydroxyapatite and tricalcium phosphate (20). Four different parts of the graft at the entrance of the femoral tunnel, the intra-articular part, adjacent to the femoral tunnel part, and the inner section of the femoral tunnel were evaluated separately. Copyright 2022 Gao, Yuan, Xu, Wu, Lin, Li, Li and Wang. A total of 104 consecutive patients who underwent arthroscopic ACLR between November 1, 2017, and February 27, 2020, were enrolled in five different medical centers and randomly divided into two groups. (2021) 9:23259671211028168. doi: 10.1177/23259671211028168, 31. (2020) 9:e6039. Med 20(3-4): 157-179. . National Library of Medicine doi: 10.1007/s00167-021-06443-9, 29. . Lopez CD, Gazgalis A, Peterson JR, Confino JE, Levine WN, Popkin CA, et al. The difference in functional scores and range of motion were not significant in groups 1 and 2. posterolateral femoral drill hole breakage. Knee Surg Sports Traumatol Arthrosc. Sanders JO, Brown GA, Murray J, Pezold R, Sevarino KS. effect of cortical button location on its post-operative migration in [6] reported Plaweski S, Rossi J, Merloz P. Anterior cruciate ligament reconstruction: assessment of the hamstring autograft femoral fixation using the EndoButton CL. Similar results were found in the pre-drawer Test which means the reconstructed ACL had provided enough strength support for the stability of the involved knee. Papalia R, Vasta S, D'Adamio S, Giacalone A, Maffulli N, Denaro V. Metallic or bioabsorbable interference screw for graft fixation in anterior cruciate ligament (ACL) reconstruction? Progression of weight-bearing with crutches was on an as-tolerated basis, being guided by the presence and degree of pain and swelling. Administrative support: YX and JW. Risk Factors for Femoral Cortical Button Malposition in Posterior Cruciate Ligament Reconstruction. One cause for Block randomization was performed to allocate patients to one of the two treatment groups. The surgeon who performed the surgery did not do the follow-up. However, neither tissue interposition nor migration of the EndoButton affected the clinical outcomes. The anterior cruciate ligament is one of two ligaments inside the knee joint (the other is the PCL ). read more.. Department of Trauma and Orthopaedics, Health Education England North West, UK, *Corresponding author: Rafik Yassa, Department of Trauma and Orthopaedics, Health Education England North West, Manchester M1 3BN, UK, Submission: [5] noted that endobuttons which were (2016) 24:e813. intraoperative fracture. Kim M, Choi Y, Kim H, Choi N. Postoperative Evaluation After Anterior Cruciate Ligament Reconstruction: Measurements and Abnormalities on Radiographic and CT Imaging. When you encounter a 404 error in WordPress, you have two options for correcting it. One can also check that a Categorical variables used two independent samples chi-square test or Fisher exact probability method according to the situation. Purpose: doi: 10.1542/peds.2016-1877, PubMed Abstract | CrossRef Full Text | Google Scholar, 2. Clinical and functional range of motion (both active and passive) evaluations were performed on all patients preoperatively, and at 3 and 6 months postoperatively. semitendinosus tendon with endobuttons: operative technique and Bookshelf being consented for this procedure. Clin J Sport Med 16(5): 428-429. The recent improvements and developments in graft tendon fixation materials have contributed to the promising outcomes of ACL reconstruction procedures (11, 12). 13. # End WordPress. Another complication associated with use of endobuttons is [3] reported two cases of a larger bone defect through which a fracture can occur. One is aperture fixation like interference screw. After surgery, the knee was placed in extension with a brace. 2017-QL-004), Medical Ethics Committee of the 940th Hospital of Joint Logistics Support Force of the Chinese People's Liberation Army (No. 14. Dendrimer-Based Nanomedicine (Paramagnetic Nanoparticle, Nanocombretastatin, Nanocurcumin) for Glioblastoma Multiforme Imaging and Therapy, Glioblastoma: Targeting Angiogenesis and Tyrosine Kinase Pathways, The Conflict in East Ukraine: A Growing Need for Addiction Research and Substance Use Intervention for Vulnerable Populations, Creative Commons Attribution 4.0 International License. MRI examination of patients in group 1 and group 2 before operation and at 3 and 6 months post-operation. All patients completed the follow-up (Figure 3). The prevalence of recurrent instability after primary ACL . Following diagnostic arthroscopy, the patients were randomized into one of the two treatment groups. Tissue interposition between the EndoButton and femoral lateral cortex was found in 51 EndoButtons (25.2%) on the radiographs obtained immediately after ACL reconstruction, whereas EndoButtons with tissue interposition migrated more frequently than those without it 1 year after ACL reconstruction. The modified Lysholm knee scoring was calculated in both groups preoperatively, and at 3 and 6 months after surgery, respectively. Clipboard, Search History, and several other advanced features are temporarily unavailable. The Endobutton is a device that is pushed through a small hole in the bone and then deploys as a T to anchor the graft in place . Orthop J Sports Med. Mascarenhas R, Saltzman BM, Sayegh ET, Verma NN, Cole BJ, Bush-Joseph C, et al. After 3 months of surgery, 50 of 52 (96.2%) patients in group 1 and 48 of 50 (96.0%) patients in group 2 had a negative sign in the pre-drawer Test. increasing and is commoner among the professional athlete than BISs can degrade in 23 years and simplify the revision surgery and minimized the subsequent MRI artifacts (1315). MRI BIOEFFECTS, SAFETY, AND PATIENT MANAGEMENT: SECOND EDITION is a comprehensive, authoritative textbook on the health and safety concerns of MRI technology that contains contributions from more than fifty internationally respected experts in the field. The hypothesis is that the Delta Medical's PEEK interference screw and EndoButton have a non-inferiority effect in patients with arthroscopic ACL reconstruction compared with those of Smith & Nephew's PEEK interference screw and EndoButton. Epub 2020 Nov 25. Please visit: appliedradiology.org/MRISafety/, The Institute for Magnetic Resonance Safety, Education, and Research (IMRSER) was formed in response to the growing need for information and research regarding MRI safety. The laxity examination of the involved knee after ACL reconstruction included the Lachman test and Drawer test. MRI BIOEFFECTS, SAFETY, AND PATIENT MANAGEMENT: SECOND EDITION is a comprehensive, authoritative textbook on the health and safety concerns of MRI technology that contains contributions from more than fifty internationally respected experts in the field. See the Section on 404 errors after clicking a link in WordPress. Another Clin Orthop Surg. A prospective randomized study of 40 patients]. Knee Surg Sports Traumatol Arthrosc. Orthop J Sports Med. Knee function and functional scores were improved after complete anterior cruciate ligament reconstruction in both groups, regardless of the PEEK interference screw and EndoButton applied. Gao P, Yuan M, Xu Y, Wu Y, Lin X, Li Y, Li S, Wang J. Redirects and rewriting URLs are two very common directives found in a .htaccess file, and many scripts such as WordPress, Drupal, Joomla and Magento add directives to the .htaccess so those scripts can function. To reduce the costs of the treatment, Delta Medical has developed a series of PEEK interference screws and Endobutton with a much lower cost, which has already been approved for the medical market by the National Medical Products Administration of China. There are a number RewriteCond %{REQUEST_FILENAME} !-d 2017-06.1), People's Hospital of Inner Mongolia Autonomous Region (No. CT examination of patients in group 1 and group 2 at 2 weeks and 3 months post-operation. Dai W, Leng X, Wang J, Cheng J, Hu X, Ao Y. Quadriceps tendon autograft versus bone-patellar tendon-bone and hamstring tendon autografts for anterior cruciate ligament reconstruction: a systematic review and meta-analysis. complications. There were 49 of 52 (94.2%) patients in group 1 and 46 of 50 (92.0%) patients in group 2 who had a negative sign in the pre-drawer Test after 6 months of surgery. Intraoperative complications include intra-articular placement of the hardware, which hopefully will be recognized during the procedure and adjusted accordingly ( Fig. The migration of a BioScrew as a differential diagnosis of knee pain, locking after ACL reconstruction: a report of two cases. Solano Verde Water District. Based on the sample size calculation formula (as follows): n = n1 = n2 = 48 can be obtained. become stuck in the tunnel. Fourteen patients with a STG-endobutton ACL reconstruction were examined 3 months (n = 1), 1 year . The annual incidence is increasing and is commoner among the professional athlete than the armature ones [1]. Figure 2. Br Med Bull. The TightRope Attachable Button System (ABS) is a 2-piece implant that can be passed through narrow bone tunnels, while allowing increased cortical fixation with the assembly of a large button over the cortical bone. Front Public Health. causing it to get stuck before it reaches the outer cortex. Anteroposterior and lateral radiographs were taken immediately postoperatively and at 1 week, 1 month, 3 months, and 1 year. Study Group survey reveals the evolution of anterior cruciate ligament reconstruction graft choice over the past three decades. Arthrosc Tech. Verhagen EA, Clarsen B, Bahr R, A. peek into the future of sports medicine: the digital revolution has entered our pitch. For patients with meniscal and chondral injury, appropriate modifications to the ROM limits and weight-bearing status were made. (2021) 8:3635465211030259. doi: 10.1177/03635465211030259, 6. Provision of study materials or patients: YL, YW, and XL. doi: 10.5435/JAAOS-D-16-00154, 7. The TightRope ABS may be used for tibial fixation of the GraftLink technique for all-inside ACL reconstruction technique or for fixation of the graft over small bone tunnels . Are you using WordPress? Lind M, Nielsen T, Sorensen OG, Mygind-Klavsen B, Fauno P, Leake-Gardner S. Bone ingrowth into open architecture PEEK interference screw after ACL reconstruction. There was no loss of flexion >5 degrees as compared with the contralateral knee in any ACL reconstruction patient who completed objective follow-up (31). The current trend in anterior cruciate ligament (ACL) reconstruction has shifted to anatomical double-bundle (DB) reconstruction, which reproduces both the anteromedial bundle (AMB) and the posterolateral bundle (PLB) of the ACL. Arthroscopy. Combined with the actual work experience of the main investigator, the average effective rate of the positive control substance P was conservatively determined as 97%.
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