Objective: To establish a method for determining the molecular weight and molecular weight distribution of Poly(Lactide-co-Glycolide Acid) (PLGA) using Size Exclusion Chromatography-Refractive Index-Multiangle Laser Light Scattering (SEC-RI-MALLS) and Size Exclusion Chromatography-Refractive Index (SEC-RID), and to compare the results obtained from these two methods.
Methods: For SEC-RI-MALLS, tetrahydrofuran was used as the mobile phase, Shodex GPC KF-803L was employed as the chromatographic column with a flow rate of 1 mL·min^-1, column temperature at 30 ℃, and an injection volume of 100 μL. For SEC-RID, tetrahydrofuran was also used as the mobile phase, Agilent PLgel 5 μm MIXD-D was used as the chromatographic column with a flow rate of 1 mL·min^-1, column temperature at 30 ℃, differential detector temperature at 35 ℃, and an injection volume of 20 μL. The molecular weight and molecular weight distribution were calculated using Agilent’s GPC software. The newly established methods were validated methodologically, and the molecular weight and molecular weight distribution of 13 batches of samples were determined.
Results: The precision, accuracy, stability, and repeatability tests for SEC-RI-MALLS showed RSD values of 1.35%, 1.58%, 1.53%, and 1.26%, respectively. The SEC-RID method exhibited good linearity (r=0.999 9), with RSD values for precision, accuracy, stability, and repeatability tests (n=6) of 2.05%, 1.62%, 1.30%, and 2.97%, respectively. The results obtained from SEC-RI-MALLS were lower than those from SEC-RID, and the molecular weight distribution coefficient was smaller, but the results from the paired T-test performed with the value measured by SEC-RID method and the value measured by SEC-RI-MALLS method multiplied a conversion coefficient of 1.5 showed no significant difference between the two methods.
Conclusion: Both methods are stable and reliable, and can be used for the determination of PLGA molecular weight and molecular weight distribution based on the specific situations.

Objective:To investigate the value of transanal multipoint full-layer puncture biopsy (TMFP) in predicting pathological complete response (pCR) after neoadjuvant radiotherapy and chemotherapy (nCRT) in patients with locally advanced rectal cancer (LARC) and to establish a predictive model for providing clinical guidance regarding the treatment of LARC.Methods:In this multicenter, prospective, cohort study, we collected data on 110 LARC patients from four hospitals between April 2020 and March 2023: Beijing Chaoyang Hospital of Capital Medical University (50 patients), Beijing Friendship Hospital of Capital Medical University (41 patients), Qilu Hospital of Shandong University (16 patients), and Zhongnan Hospital of Wuhan University (three patients). The patients had all received TMFP after completing standard nCRT. The variables studied included (1) clinicopathological characteristics; (2) clinical complete remission (cCR) and efficacy of TMFP in determining pCR after NCRT in LARC patients; and (3) hospital attended, sex, age, clinical T- and N-stages, distance between the lower margin of the tumor and the anal verge, baseline and post-radiotherapy serum carcinoembryonic antigen (CEA) and carbohydrate antigen (CA)19-9 concentrations, chemotherapy regimen, use of immunosuppressants with or without radiotherapy, radiation therapy dosage, interval between surgery and radiotherapy, surgical procedure, clinical T/N stage after radiotherapy, cCR, pathological results of TMFP, puncture method (endoscopic or percutaneous), and number and timing of punctures. Single-factor and multifactorial logistic regression analysis were used to determine the factors affecting pCR after NCRT in LARC patients. A prediction model was constructed based on the results of multivariat analysis and the performance of this model evaluated by analyzing subject work characteristics (ROC), calibration, and clinical decision-making (DCA) curves. pCR was defined as complete absence of tumor cells on microscopic examination of the surgical specimens of rectal cancer (including lymph node dissection) after NCRT, that is, ypT0+N0. cCR was defined according to the Chinese Neoadjuvant Rectal Cancer Waiting Watch Database Study Collaborative Group criteria after treatment, which specify an absence of ulceration and nodules on endoscopy; negative rectal palpation; no tumor signals on rectal MRI T2 and DWI sequences; normal serum CEA concentrations, and no evidence of recurrence on pelvic computed tomography/magnetic resonance imaging.Results:Of the 110 patients, 45 (40.9%) achieved pCR after nCRT, which was combined with immune checkpoint inhibitors in 34 (30.9%). cCR was diagnosed before puncture in 38 (34.5%) patients, 43 (39.1%) of the punctures being endoscopic. There were no complications of puncture such as enterocutaneous fistulae, vaginal injury, prostatic injury, or presacral bleeding . Only one (2.3%) patient had a small amount of blood in the stools, which was relieved by anal pressure. cCR had a sensitivity of 57.8% (26/45) for determining pCR, specificity of 81.5% (53/65), accuracy of 71.8% (79/110), positive predictive value 68.4% (26/38), and negative predictive value of 73.6% (53/72). In contrast, the sensitivity of TMFP pathology in determining pCR was 100% (45/45), specificity 66.2% (43/65), accuracy 80.0% (88/110), positive predictive value 67.2% (45/67), and negative predictive value 100.0% (43/43). In this study, the sensitivity of TMFP for pCR (100.0% vs. 57.8%, χ 2=24.09, P<0.001) was significantly higher than that for cCR. However, the accuracy of pCR did not differ significantly (80.0% vs. 71.8%, χ 2=2.01, P=0.156). Univariate and multivariate logistic regression analyses showed that a ≥4 cm distance between the lower edge of the tumor and the anal verge (OR=7.84, 95%CI: 1.48-41.45, P=0.015), non-cCR (OR=4.81, 95%CI: 1.39-16.69, P=0.013), and pathological diagnosis by TMFP (OR=114.29, the 95%CI: 11.07-1180.28, P<0.001) were risk factors for pCR after NCRT in LARC patients. Additionally, endoscopic puncture (OR=0.02, 95%CI: 0.05-0.77, P=0.020) was a protective factor for pCR after NCRT in LARC patients. The area under the ROC curve of the established prediction model was 0.934 (95%CI: 0.892-0.977), suggesting that the model has good discrimination. The calibration curve was relatively close to the ideal 45° reference line, indicating that the predicted values of the model were in good agreement with the actual values. A decision-making curve showed that the model had a good net clinical benefit. Conclusion:Our predictive model, which incorporates TMFP, has considerable accuracy in predicting pCR after nCRT in patients with locally advanced rectal cancer. This may provide a basis for more precisely selecting individualized therapy.

Objective:To investigate the value of transanal multipoint full-layer puncture biopsy (TMFP) in predicting pathological complete response (pCR) after neoadjuvant radiotherapy and chemotherapy (nCRT) in patients with locally advanced rectal cancer (LARC) and to establish a predictive model for providing clinical guidance regarding the treatment of LARC.Methods:In this multicenter, prospective, cohort study, we collected data on 110 LARC patients from four hospitals between April 2020 and March 2023: Beijing Chaoyang Hospital of Capital Medical University (50 patients), Beijing Friendship Hospital of Capital Medical University (41 patients), Qilu Hospital of Shandong University (16 patients), and Zhongnan Hospital of Wuhan University (three patients). The patients had all received TMFP after completing standard nCRT. The variables studied included (1) clinicopathological characteristics; (2) clinical complete remission (cCR) and efficacy of TMFP in determining pCR after NCRT in LARC patients; and (3) hospital attended, sex, age, clinical T- and N-stages, distance between the lower margin of the tumor and the anal verge, baseline and post-radiotherapy serum carcinoembryonic antigen (CEA) and carbohydrate antigen (CA)19-9 concentrations, chemotherapy regimen, use of immunosuppressants with or without radiotherapy, radiation therapy dosage, interval between surgery and radiotherapy, surgical procedure, clinical T/N stage after radiotherapy, cCR, pathological results of TMFP, puncture method (endoscopic or percutaneous), and number and timing of punctures. Single-factor and multifactorial logistic regression analysis were used to determine the factors affecting pCR after NCRT in LARC patients. A prediction model was constructed based on the results of multivariat analysis and the performance of this model evaluated by analyzing subject work characteristics (ROC), calibration, and clinical decision-making (DCA) curves. pCR was defined as complete absence of tumor cells on microscopic examination of the surgical specimens of rectal cancer (including lymph node dissection) after NCRT, that is, ypT0+N0. cCR was defined according to the Chinese Neoadjuvant Rectal Cancer Waiting Watch Database Study Collaborative Group criteria after treatment, which specify an absence of ulceration and nodules on endoscopy; negative rectal palpation; no tumor signals on rectal MRI T2 and DWI sequences; normal serum CEA concentrations, and no evidence of recurrence on pelvic computed tomography/magnetic resonance imaging.Results:Of the 110 patients, 45 (40.9%) achieved pCR after nCRT, which was combined with immune checkpoint inhibitors in 34 (30.9%). cCR was diagnosed before puncture in 38 (34.5%) patients, 43 (39.1%) of the punctures being endoscopic. There were no complications of puncture such as enterocutaneous fistulae, vaginal injury, prostatic injury, or presacral bleeding . Only one (2.3%) patient had a small amount of blood in the stools, which was relieved by anal pressure. cCR had a sensitivity of 57.8% (26/45) for determining pCR, specificity of 81.5% (53/65), accuracy of 71.8% (79/110), positive predictive value 68.4% (26/38), and negative predictive value of 73.6% (53/72). In contrast, the sensitivity of TMFP pathology in determining pCR was 100% (45/45), specificity 66.2% (43/65), accuracy 80.0% (88/110), positive predictive value 67.2% (45/67), and negative predictive value 100.0% (43/43). In this study, the sensitivity of TMFP for pCR (100.0% vs. 57.8%, χ 2=24.09, P<0.001) was significantly higher than that for cCR. However, the accuracy of pCR did not differ significantly (80.0% vs. 71.8%, χ 2=2.01, P=0.156). Univariate and multivariate logistic regression analyses showed that a ≥4 cm distance between the lower edge of the tumor and the anal verge (OR=7.84, 95%CI: 1.48-41.45, P=0.015), non-cCR (OR=4.81, 95%CI: 1.39-16.69, P=0.013), and pathological diagnosis by TMFP (OR=114.29, the 95%CI: 11.07-1180.28, P<0.001) were risk factors for pCR after NCRT in LARC patients. Additionally, endoscopic puncture (OR=0.02, 95%CI: 0.05-0.77, P=0.020) was a protective factor for pCR after NCRT in LARC patients. The area under the ROC curve of the established prediction model was 0.934 (95%CI: 0.892-0.977), suggesting that the model has good discrimination. The calibration curve was relatively close to the ideal 45° reference line, indicating that the predicted values of the model were in good agreement with the actual values. A decision-making curve showed that the model had a good net clinical benefit. Conclusion:Our predictive model, which incorporates TMFP, has considerable accuracy in predicting pCR after nCRT in patients with locally advanced rectal cancer. This may provide a basis for more precisely selecting individualized therapy.

Objective:To compare the clinical efficacy of arthroscopy-assisted and open reduction and internal fixation in the treatment of Schatzker type I-III tibial plateau fractures.Methods:The data of patients with Schatzker type I-III tibial plateau fractures who were treated from August 2017 to July 2019 were retrospectively analyzed. According to the treatment, the patients were divided into the arthroscopic-assisted minimally invasive reduction and internal fixation group (arthroscopy group) and the conventional open reduction and internal fixation group (incision group). In the arthroscopy group, there were 30 patients, 19 males and 11 females were included; the age was 45.13±7.12 years old (range, 29-60 years). Among them, 13 cases were Schatzker type I fractures, 14 cases were Schatzker type II fractures, and 3 cases were Schatzker type III fractures. In the incision group, there were 30 patients, 17 males and 13 females were included; the age was 43.53±7.79 years old (range, 31-58 years). Among them, 11 cases were Schatzker type I fractures, 15 cases were Schatzker type II fractures, and 4 cases were Schatzker type III fractures. The operation time, intraoperative blood loss, postoperative ambulation time, postoperative complete weight-bearing time and postoperative complications were recorded. The degree of knee joint swelling, knee flexion and extension range of motion and the American knee society knee score (AKS score) were compared between the arthroscopy group and the incision group.Results:Both groups were followed up. The follow-up time of the arthroscopy group were 10-18 months, with an average of 14 months; the follow-up time in the incision group were 12-18 months, with an average of 15 months. In the arthroscopy group, the operation time (87.60±9.20 min vs. 94.33±10.65 min), intraoperative blood loss (57.16±9.63 ml vs. 71.93±11.15 ml), postoperative ambulation time (5.13±1.28 d vs. 6.17±1.53 d) and postoperative complete weight-bearing time (12.83±1.68 weeks vs. 14.23±1.77 weeks) were superior to the incision group, and the differences were statistically significant ( t=2.62, 5.49, 2.83, 3.94; all P<0.05). The healing time was 13.33±1.37 weeks in the arthroscopy group and 14.86±1.63 weeks in the incision group, and the difference was statistically significant ( t=3.94, P<0.001). At 1 year after surgery, the range of flexion and extension of knee joint in the arthroscopy group was 116.77°±12.46°, which was better than that in the incision group, which was 109.13°±9.89°, and the difference was statistically significant ( t=2.63, P=0.011). The AKS score in the arthroscopy group was 164.57±11.16 points, and the score in the incision group was 149.53±14.77 points, and the difference was statistically significant ( t=4.45, P<0.001). There were no malunion or compartment syndrome in the arthroscopy group and the incision group. The total incidence of complications in the arthroscopy group was 13% (4/30), including 2 cases of poor wound healing, 2 of poor knee range of motion after operation. The total incidence of complications in the incision group was 23% (7/30), including 4 cases of poor wound healing, 1 of wound infection, 2 of poor knee range of motion after operation. And the difference between the two groups in complication incidence was not statistically significant (χ 2=1.00, P=0.317). Conclusion:Arthroscopic-assisted reduction and internal fixation in the treatment of Schatzker I-III tibial plateau fractures has the advantages of less trauma, less bleeding, early mobility, fewer complications, and better knee joint function, and there are no obvious arthroscopic-related complications, which is a safe and reliable treatment method.

Due to the complex components of polysorbate 80, analysis is time-consuming and labor-intensive, so there is an urgent need to find a method for rapid analysis of polysorbate 80 components.In this study, 10 batches of samples collected from 3 domestic and foreign enterprises were analyzed by UHPLC-HRMS, with the being further results were analyzed by the ExcipientProfiler software and supplemented by the extended database.The results showed that the ExcipientProfiler software could quickly identify the [M+Na]+ peak in the mass spectrogram, and obtain the information of component distribution, the numbers of components and the degree of polymerization of the sample.Meanwhile, the numbers of components obtained by the ExcipientProfiler software could be used to distinguish the injection grade samples from the ordinary grade samples by systematic clustering analysis.In addition, it was found through further supplement that the sample contained other fatty acid ester components by manually searching the relevant extended database.The polyoxyethylene sorbitan tetraoleate components were found in the sample according to the analysis of mass spectrum data.Therefore, although this method is fast and simple, it is necessary to add polyoxyethylene sorbitan tetraoleate components and other fatty acid ester components to further supplement the information in the ExcipientProfiler software, so that it can be better used for the analysis of polysorbate 80.

Non-small cell lung cancer (NSCLC) is the most common pathological type of lung cancer. The systemic antitumor therapy of advanced NSCLC has undergone renovations of chemotherapy, targeted therapy and immunotherapy, which results in greatly improved survival for patients with advanced NSCLC. Immune checkpoint inhibitors (ICIs), especially targeting programmed cell death protein 1 (PD-1)/programmed death-ligand 1 (PD-L1), has changed the treatment paradigm of NSCLC. ICIs have become the standard treatment for advanced NSCLC without epidermal growth factor receptor(EGFR) mutation or anaplastic lymphomakinase(ALK) translocation in the first- or second-line setting, and for locally advanced NSCLC following concurrent radiotherapy and chemotherapy. ICIs are also promising in adjuvant/neoadjuvant therapy. More and more ICIs have been approved domestically for the treatment of NSCLC. Led by the NSCLC expert committee of Chinese Society of Clinical Oncology (CSCO), this consensus was developed and updated based on thoroughly reviewing domestic and foreign literatures, clinical trial data, systematic reviews, experts' discussion and the consensus(2019 version). This consensus will aid domestic clinicians in the treatment of NSCLC with ICIs.
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Objective:To explore the morphological characteristics, treatment strategies and clinical results of complex hyperextension tibial plateau fractures.Methods:From October 2017 to January 2019, data of 27 patients with complex hyperextension tibial plateau fractures were retrospectively analyzed. There were 19 males and 8 females with an average age of 43.4 years (range, 23-68 years). According to Schatzker classification of tibial plateau fractures: there are 8 cases of type IV, 5 of type V, and 14 of type VI; according to the three-column theory classification: there are 8 cases of two-column fracture and 19 cases of three-column fracture. Bicondylar fractures were treated with medial Tomofix locking plate and anterolateral L-shaped locking plate through medial and anterolateral approach; tibialmedial condylar fractures was treated with T-shaped plate and posteromedial locking plate through extended medial approach. Patients with anterior tibial fractures were treated with horizontal strip plate through modified anterior median approach. Combined soft tissue or bone injury was repaired. The fracture healing and reduction were evaluated by X-ray and CT scan. The reduction of tibial plateau fracture was evaluated by Rasmussen radiology standard, and the knee joint function was evaluated 12 months after the operation by the score of American hospital for special surgery (HSS).Results:All the 27 surgeries were performedsuccessfully. The operation time was 130-350 minutes, with an average time of 165 minutes. Twenty-seven cases were followed up for 12-24 months, with an average period of 15.8 months. All fractures were healed. The average clinical healing time was 13.5 weeks (range, 10-18 weeks). Twelve months after operation, Rasmussen's radiology score was 13-18, with an average of 16.7 points, among them there were 19 excellent and 8 good. Twelve months after the operation, the score of HSS knee joint was 82-98, with an average score of 93.2 points, and there were 22 cases excellent, 4 cases good and 1 case fair. The excellent and good rate was 96.2% (26/27).Conclusion:Complex hyperextension tibial plateau fractures often combined with tibial bicondylar, medial tibial condyle or anterior tibial fractures. According to the morphological characteristics of complex hyperextension tibial plateau fractures, using appropriate surgical approach and internal fixation, repairing ligament soft tissue structure and reconstructing knee joint stability can achieve satisfactory results.

Objective:To discuss how to make the surgical strategy for tibial tubercle fracture associated with bicondylar tibial plateau fracture.Methods:Data of thirty-five patients of tibial tubercle fractures associated with bicondylar tibial plateau fractures who were treated from October 2014 to May 2018 were retrospectively analyzed. There were 26 males and 9 females with an average age of 37.6 years (range, 21-68 years). According to Schatzker classification in tibial plateau fracture, 16 cases were type V and 19 cases were type VI. According to the integrity of tibial tubercle fracture and cortical bone of the proximal tibia in bicondylar tibial plateau fracture, they were divided into four types: type A, tibial tubercle fracture fragment and cortical bone of the proximal tibia are both complete; type B, tibial tubercle fracture fragment is complete but cortical bone of the proximal tibia is comminuted; type C, tibial tubercle fracture fragment is comminuted but cortical bone of the proximal tibia is complete; type D, both of them are comminuted. The surgical approaches and fixation methods of all the tibial tubercle fractures were according to the four different types. There were 22 cases with type A and B that were treated via an anterolateral and a medial incision, 13 cases with type C and D were treated via an anterior midline and a medial incision. There were 4 cases belonging to type A fixed with lag screws singly, 18 cases with type B fixed with 1/4 tubular plates, 7 cases with type C and 6 cases with type D fixed by 1/4 tubular plates combined with lag screws.Results:Thirty-five patients were followed up for 16.8 months (range, 12-24 months). All fractures healed with an average time of 4.7 months (range, 3-6 months). Loss of reduction didn’t occur in 34 cases except one. According to Rasmussen radiographic evaluation, the average score was 14.1 (range, 10-18) and clinical outcomes were rated with excellent in 11 cases, good in 19, fair in 5. The excellent and good rate was 85.7% (30/35) . The mean Hospital for Special Surgery (HSS) scores of all cases were 86.8 (range, 64-98) and the functional scores were excellent in 22 cases, good in 10 cases and fair in 3 cases with the excellent and good rate of 91.4% (32/35) . Surgical complications included fat liquefaction in 2 cases, superficial wound infection in 1, loosening of implant in 1and traumatic arthritis in 1.Conclusion:This kind of tibial tubercle fracture associated with bicondylar tibial plateau fracture is rare and special. Therefore, the preoperative plan should be made by considering the morphological features of the tibial tubercle fragments and the cortical bone of the proximal tibia. The middle longitude approach is the best way to expose tibial tubercle fragments which should be fixed with 1/4 tubularplate and/or lag screws.

Objective:To investigate the correlation between urinary 8-oxo-7, 8-dihydroguanosine(8-oxo-Gsn)and physical function in community-dwelling elderly people.Methods:A total of 210 community-dwelling elderly people aged 75 years and over were enrolled in this cross-sectional analysis.According to the scores of short physical performance battery(SPPB), subjects were divided into three groups: the high performance group(summary score 10-12), the intermediate performance group(summary score 7-9)and the low performance group(summary score 0-6). All participants received a comprehensive geriatric assessment.Urinary 8-oxo-dGsn, serum high-sensitivity C-reactive protein(hs-CRP)and white blood cell count were measured.The correlation between urinary 8-oxo-Gsn and physical function was analyzed by using Pearson correlation analysis and the ordered Logistic regression model.Results:The scores of activities of daily living(ADL), instrumental activities of daily living(IADL), grip strength and gait speed were lower in the low performance group than in the other two groups( H=47.002, 110.902, F=11.962, 235.952, all P<0.001). Levels of urinary 8-oxo-Gsn and serum hs-CRP were higher in the low performance group than in the other two groups( F=23.780 and 13.259, both P<0.001). There was no significant difference in levels of urinary 8-oxo-dGsn or white blood cell count between the three groups(both P>0.05). Urinary 8-oxo-Gsn was negatively correlated with gait speed, grip strength and SPPB score( r=-0.559, -0.302 and-0.450, all P<0.001)and was positively correlated with the time of five-times-sit-to-stand test( r=0.290, P<0.001). Adjusting for age, gender and Charlson comorbidity index, the ordered Logistic regression analysis showed that elevated levels of urinary 8-oxo-Gsn( OR=1.38, 95% CI: 1.06-1.77, P<0.05)and hs-CRP( OR=1.23, 95% CI: 1.04-1.48, P<0.05)decreased physical function. Conclusions:Urinary 8-oxo-Gsn is independently associated with the decline of physical function in community-dwelling elderly adults, suggesting that the oxidative stress level is increased in the elderly with poor physical function.

Objective: To evaluate the long-term healing rate of transsphincteric anal fistula treated with anal fistula plug procedure and the risk factors affecting the healing of anal fistula. Methods: A retrospective case-control study was conducted to analyze the clinical data of 207 patients with transsphincteric anal fistulas who received anal fistula plug procedure at the Department of General Surgery, Beijing Chaoyang Hospital of Capital Medical University from August 2008 to September 2012. Inclusion criteria: (1) consistent with the diagnosis of transsphincteric anal fistula: the anal fistula passed through the internal and external sphincter; (2) complete data; (3) initial treatment with anal fistula plug procedure. Exclusion criteria: (1) acute rectal or perianal infection or poorly controlled focal infection; (2) recent incision and drainage of perianal abscess or spontaneous rupture of abscess; (3) patients with malignant tumor; (4) patients with Crohn′s disease or ulcerative colitis; (5) patients with heart, liver, brain, lung or renal insufficiency; (6) cachexia due to various chronic wasting diseases; (7) patients could not tolerate surgery. Patients were followed up for anal fistula healing. The cumulative healing rate of patients with transsphincteric anal fistula was plotted using the Kaplan-Meier method, and the factors affecting anal fistula healing were explored by univariate and multivariate logistic regression analysis. Results: There were 186 males and 21 females with age of 15 to 69 (mean 38) years. The duration of anal fistula was 3-60 (mean 15) months. Three patients had a history of previous episodes of perianal abscess and underwent incision and drainage of perianal abscess (all more than 3 months). During follow-up ending on October 31, 2018, 72 patients (34.8%) were lost to follow-up. Among 135 patients who were successfully followed up, the average follow-up period was 96 (75-124) months. Seventy-five patients had anal fistula healing, with healing rate of 55.6%. Kaplan-Meier survival curve showed that the healing time of anal fistula was prolonged and finally stabilized at 55.6%. In the patients who failed initial treatment with anal fistula plug packing, there were 6 cases whose anal fistula healed spontaneously without other treatment. Among them, 3 cases healed spontaneously 2 years and 3 cases 3 years after operation without recurrence. From 2008 to 2012, the annual healing rates of anal fistula plug treatment were 3/6, 61.5% (24/39), 42.1% (24/57), 12/15 and 12/18, respectively. Multivariate logistic regression analysis showed that the duration of anal fistula≥6 months (OR=3.187, 95% CI: 1.361-7.466, P=0.008) was an independent risk factor for anal fistula healing after treatment with anal fistula plug. Conclusion The long-term efficacy of anal fistula plug procedure in the treatment of transsphincteric anal fistula is positive, and this procedure should be implemented as soon as possible.