1.Efficacy of distracting external fixator for tibiofibular fractures combined with osteofascial compartment syndrome
Ying LI ; Junsheng YANG ; Zhiwei YANG ; Liangcheng TONG ; Lei ZHAO ; Jianling WANG ; Zhongyang SUN ; Qing XUE
Chinese Journal of Trauma 2021;37(12):1078-1082
Objective:To explore the efficacy of distracting external fixator for tibiofibular fractures combined with osteofascial compartment syndrome.Methods:A retrospective case-control study was conducted to analyze the clinical data of 62 patients with tibiofibular fractures combined with osteofascial compartment syndrome admitted to Air Force Hospital from Eastern Theater of PLA from March 2009 to March 2019, including 47 males and 15 females, aged 20-78 years[(47.1±13.4)years]. There were 30 patients with tibia shaft fractures, 17 with tibia plateau fractures and 15 with tibia distal fractures. The fractures were classified as type 4A in 18 patients, type 4B in 24 and type 4C in 20 according to AO/OT classification. Distracting external fixation was performed for 30 patients(Group A)and calcaneal tuberosity traction for 32 patients(Group B). Levels of alanine aminotransferase(ALT), urea nitrogen(BUN), creatine kinase(CK)and lactate dehydrogenase(LDH)of the injured limb were compared between the two groups during traction. Additionally, the fasciotomy rate, time of damage control treatment(observation interval from trauma to stage II definitive surgery), time of stage II definitive surgery, internal fixation modalities of stage II definitive surgery, rate of needle tract infection and rate of non-planned secondary surgery were compared between the two groups. The limb function was assessed using Johner-Wruhs scoring system at the last follow-up.Results:All patients were followed up for 12-22 months[(15.1±2.7)months]. Level of CK in Group A was 315.6(140.0, 531.5)U/L, significantly lower than that in Group B[465.5(277.0, 1240.5)U/L]( P<0.05). The two groups revealed no statistical differences in levels of BUN, CK and LDH( P>0.05). The fasciotomy rate in Group A[40%(12/30)]was higher than that in Group B[34%(11/32)], but the difference was statistically insignificant( P>0.05). The time of stage II definitive surgery in Group A was(68.5±17.1)minutes, significantly lower than that in Group B[(89.0±15.1)minutes]( P<0.05). The rate of non-planned secondary surgery in Group A[3%(1/30)]was lower than that in Group B[25%(8/32)]( P<0.05). There were no statistically significant differences in time of damage control treatment, internal fixation modalities of stage II definitive surgery and rate of needle infection between the two groups( P>0.05). According to Johner-Wruhs scoring system, the function in Group A were excellent in 17 patients, good in 5, fair in 2 and poor in 6 at the last follow-up, with the excellent rate of 73%. However, the difference was not statistically significant when compared to Group B: excellent in 13 patients, good in 3, fair in 7 and poor in 9, with the excellent rate of 50%( P>0.05). Conclusion:Compared with calcaneal tuberosity traction, the distracting external fixation of tibiofibular fractures combined with osteofascial compartment syndrome can attenuate soft tissue damage during the traction and shorten the time of stage II definitive surgery by maintaining intraoperative fracture reduction.
2.Classification of lower leg osteofacial compartment syndrome
Ying LI ; Junsheng YANG ; Zhiwei YANG ; Liangcheng TONG ; Lei ZHAO ; Jianling WANG ; Zhongyang SUN ; Qing XUE
Chinese Journal of Trauma 2022;38(5):458-461
Osteofacial compartment syndrome (OCS) is one of the serious complications in traumatic orthopedics. If not treated in time, OCS may result in irreversible damage to nerve and muscle,even amputation or death in serious condition. 5P presents to be the classic clinical diagnosis of OCS, but it is highly subjective and cannot timely and accurately judge the progression of the disease. Intracompartment pressure manometry is the main auxiliary method for the diagnosis of OCS. Although there are many manometry methods, there is still no authoritative pressure threshold as the diagnosis standard. Clinicians often aggressively perform fasciotomy to avoid serious complications, leading to unnecessary fasciotomy. The authors retrospectively reviewed the data of patients with OCS treated at Air Force Hospital of Eastern Theater of PLA from March 2010 to March 2020 and found that some patients with OCS had gradual alleviation of clinical symptoms after appropriate conservative treatments such as brace releasing, limb stabilization and swelling subsidence, with no need of fasciotomy. However, the symptoms of some patients progressively aggravated after the above-mentioned traditional treatments and timely fasciotomy was required. The authors graded the severity of OCS and proposed for the first time the OCS grading criteria according to quantitative clinical results and quantitative indicators such as ratio of mean blood flow velocity of bilateral arteries and pulse wave changes, aiming to take corresponding intervention measures for patients with different OCS classifications, carry out more precise treatment and avoid unnecessary fasciotomy.
3.Influence of PVE and PVE combined with TACE on secondary hepatectomy and prognosis of hepatocellular carcinoma
Junsheng NI ; Yao LI ; Xue LIU ; Guojun HOU ; Linghao ZHAO ; Yuan YANG ; Yefa YANG ; Weiping ZHOU
Chinese Journal of Digestive Surgery 2024;23(2):257-264
Objective:To investigate the influencing of portal vein embolization (PVE) and PVE combined with transcatheter arterial chemoembolization (TACE) on secondary hepatectomy and prognosis of patients with initially unresectable hepatocellular carcinoma (HCC).Methods:The retrospective cohort study was conducted. The clinicopathological data of 102 patients with initially unresectable HCC who were admitted to the Third Affiliated Hospital of Naval Medical University from October 26,2015 to December 31,2022 were collected. There were 82 males and 20 females, aged 52(range,25?73)years. Of 102 patients, 72 cases undergoing PVE combined with TACE were set as the PVE+TACE group, and 30 cases undergoing PVE were set as the PVE group. Observation indicators: (1) surgical resection rate of secondary hepatectomy and increase of future liver remnant (FLR); (2) situations of secondary hepatectomy; (3) follow-up. Measurement data with normal distribution were represented as Mean± SD, and comparison between groups was conducted using the independent sample t test. Measurement data with skewed distribution were represented as M(range), and comparison between groups was conducted using the Mann-Whitney U test. Count data were described as absolute numbers, and comparison between groups was conducted using the chi-square test or Fisher exact probability. Comparison of ordinal data was conducted using the Mann-Whitney U test. The Kaplan-Meier method was used to calculate survival rate and draw survival curve, and Log-Rank test was used for survival analysis. Results:(1) Surgical resection rate of secondary hepatectomy and increase of FLR. The surgical resection rate of secondary hepatectomy in the PVE+TACE group and the PVE group were 72.2%(52/72) and 53.3%(16/30), respectively, showing no significant difference between the two groups ( χ2=3.400, P>0.05). The surgical waiting time, increasing volume of FLR, growth rate of FLR in the 52 patients of PVE+TACE group receiving secon-dary hepatectomy were 20(range, 14?140)days, 140(range, 62?424)mL, 9.8(range, 1.5?26.5)mL/day, respectively. The above indicators in the 16 patients of PVE group receiving secondary hepatectomy were 16(range, 12?35)days, 160(range, 95?408)mL, 10.5(range, 1.2?28.0)mL/day, respectively. There was no significant difference in the above indicators between the 52 patients of PVE+TACE group and the 16 patients of PVE group ( Z=1.830, 1.498, 1.266, P>0.05). (2) Situations of secondary hepatectomy. The operation time, rate of tumor necrosis (>90%, 60%?90%,<60%), cases with complications ≥ grade Ⅲa in the 52 patients of PVE+TACE group receiving secondary hepatectomy were 200(range, 125?420)minutes, 8, 4, 40, 28, respectively. The above indicators in the 16 patients of PVE group receiving secondary hepatectomy were 170(range, 105?320)minutes, 0, 0, 16, 4, respectively. There were significant differences in the above indicators between the 52 patients of PVE+TACE group and the 16 patients of PVE group ( Z=2.132, ?2.093, χ2=4.087, P<0.05). (3) Follow-up. Sixty-eight patients who completed the surgery were followed up for 40(range, 10?84)months. The 1-, 3-, 5-year recurrence free survival rate in the 52 patients of PVE+TACE group receiving secondary hepatectomy were 73.0%, 53.3%, 35.4%, respectively. The above indicators in the 16 patients of PVE group were 62.5%, 37.5%, 18.8%, respectively. There was a significant difference in the recurrence free survival rate between the 52 patients of PVE+TACE group and the 16 patients of PVE group ( χ2=4.035, P<0.05). The 1-, 3-, 5-year overall survival rate in the 52 patients of PVE+TACE group receiving secondary hepatectomy were 82.5%, 61.2%, 36.6%, respectively. The above indica-tors in the 16 patients of PVE group receiving secondary hepatectomy were 68.8%, 41.7%,20.8%, respectively. There was a significant difference in the overall survival rate between the 52 patients of PVE+TACE group and the 16 patients of PVE group ( χ2=4.767, P<0.05). Conclusion:Compared with PVE, PVE+TACE as stage Ⅰ surgery can increase the surgical resection rate of secondary hepatec-tomy and the recurrence free survival rate of patients with initially unresectable HCC, prolong the long-term survival time, but not influence the growth rate of FLR.
4. Interpretation of pharmacokinetic-based criteria for supporting alternative dosing regimens of programmed cell death receptor-1 (PD-1) or programmed cell death-ligand 1 (PD-L1) blocking antibodies for treatment of patients with cancer guidance for industry
Wei LIU ; Ziyu WANG ; Junsheng XUE ; Rong CHEN ; Tianyan ZHOU ; Zhiheng YU
Chinese Journal of Clinical Pharmacology and Therapeutics 2022;27(1):86-94
In recent years, modeling and simulation technology based on pharmacometrics has received increasing attention in the development of innovation drugs. In August of 2021, FDA issued a guidance named Pharmacokinetic-Based Criteria for Supporting Alternative Dosing Regimens of Programmed Cell Death Receptor-1 (PD-1) or Programmed Cell Death-Ligand 1 (PD-L1) Blocking Antibodies for Treatment of Patients with Cancer Guidance for Industry, claiming the necessity of using population PK-based simulation method for the optimization of dosing regimens, and the corresponding implementation standards. This article first summarized the existing therapeutic regimens of PD-1/PD-L1 blocking antibodies in clinic as well as the main content of the guidance, and then cited some actual examples where population PK-based simulation method did contribute to the approval of the alternative dosing regimens. Besides, some critical considerations for the dosing regimen optimization of PD-1/PD-L1 blocking antibodies were also analyzed. In our view, this guidance would have positive impacts on the development of PD-1/PD-L1 blocking antibodies in the future. We hope that this article may provide some references for the colleagues in China.
5.Application of Wall Thickness Analysis in Estimating the Degree of Tibial Fracture Bone Healing
Ying LI ; Liangcheng TONG ; Qing XUE ; Zhiwei YANG ; Chao XIA ; Junsheng YANG ; Jianling WANG ; Jianxin XING
Journal of Medical Biomechanics 2021;36(3):E365-E370
Objective To quantitatively judge the degree of tibial bone healing using the finite element wall thickness analysis method, so as to provide an intuitive diagnostic basis for clinical judgment of tibial union and delayed bone healing. Methods After three-dimensional (3D) modeling for the affected and healthy limb side of 48 patients, the maximum wall thickness (MWT) was calculated, and the ratio (B value) was used as a quantitative index of bone healing. When both BMWT2 and BMWT1 were greater than 0.9, bone healing could be judged. When BMWT2 was between 0.9 and 0.7, bone union was judged to be poor, and there was no significant increase in this value after regular reexamination. When BMWT3 was above 0.9 while both BMWT1 and BMWT2 were smaller than 0.7, it could be judged as internal fixation failure, which should be replaced during the second operation. The clinical diagnosis was revised twice, and the final clinical healing results were observed. Results Clinical diagnosis analysis and finite element wall thickness analysis were carried out in 48 patients during each review period, and 21 cases of delayed bone healing and 27 cases of bone nonunion were judged clinically. Among them, 2 cases were judged to be ineffective, and bone grafting intervention was adopted to replace the internal fixation, 12 cases were judged to be still effective, and all cases were finally healed by surgical intervention of bone grafting alone. By Bowker test, P=0.094 was obtained, indicating that the wall thickness analysis method was consistent with the clinical diagnosis. Conclusions The wall thickness analysis method can be used to quantitatively analyze the degree of bone healing at fracture end and realize the rapid calculation of bone healing degree. The case results in this study show that the finite element wall thickness analysis method is superior to the simple clinical diagnosis method, and has better differential diagnostic significance for early diagnosis of poor bone healing.