1.Rapid on-site detection of methamphetamine using surface-enhanced raman spectroscopy
Caiyun LIAO ; Yating ZHANG ; Rongji YANG ; Liu YANG ; Guojuan LI ; Chenxi LIU ; Wen REN ; Zhou YANG
Chinese Journal of Forensic Medicine 2025;40(4):459-462
Objective To establish a rapid on-site detection method for methamphetamine(MA)based on surface-enhanced Raman spectroscopy(SERS).Methods Laboratory-synthesized colloidal silver nanoparticles(AgNPs)were employed as SERS substrates to rapidly detect methamphetamine in typical crime scene matrices,including beer,cigarette ash,and plastic containers.Results The method requires no sample pretreatment,is simple to operate,and offers high sensitivity with fast detection speed.The limit of detection(LOD)reached 10 ppb(signal-to-noise ratio,S/N>3).The qualitative results of methamphetamine analysis from forensic case samples were highly consistent with gas chromatography-mass spectrometry(GC-MS)findings.Conclusion Methamphetamine is frequently encountered in illicit settings and criminal activities.This study achieved rapid detection of methamphetamine in complex matrices(beer,cigarette ash,and plastic containers),demonstrating good application prospects in practice and providing important value for law enforcement,public safety,and criminal investigation.
2.Digital technology-assisted debridement and bone and soft tissue reconstruction for the treatment of chronic osteomyelitis of the tibia
Hongying HE ; Weidong SHI ; Wenxing HAN ; Li HAN ; Huhu WANG ; Jianwen ZHAO ; Zhuo WU ; Shaoguang LI ; Rongji ZHANG ; Yanhui GUO ; Jianzheng ZHANG
Chinese Journal of Orthopaedics 2025;45(8):500-507
Objective:To evaluate the safety and efficacy of digital technology-assisted debridement and bone and soft tissue reconstruction in the treatment of chronic osteomyelitis of the tibia.Methods:This retrospective study analyzed clinical data from 38 patients (26 males, 12 females; mean age 45.61±18.36 years, range 16-83 years) with chronic post-traumatic osteomyelitis complicated by soft tissue defects in the tibia, treated at the Department of Orthopaedics, Fourth Medical Center of PLA General Hospital between June 2021 and June 2023. There were 18 cases of traffic accidents, 6 cases of high-altitude falls, 6 cases of heavy objects and 6 cases of low-energy falls. Lesion sites: 12 cases in the upper segment of the tibia, 12 cases in the middle segment, and 14 cases in the lower segment. According to the Cierny-Mader classification, there were 24 cases of type III and 14 cases of type IV. Before the operation, the "3D point cloud technology" was used to plan the debridement range of bone and soft tissue. During the operation, the optical navigation system was used to monitor the debridement range in real time. The flap was designed by combining "Reading Tablet Treasure" with CT angiography, and the amount of bone graft was predicted by AI algorithm. The surgical method adopted is the Masquelet technique, namely thorough debridement, bone cement occupation and soft tissue repair in the first stage, and bone reconstruction in the second stage. Comparing the calculated bone defect amount and soft tissue defect area before the operation with the actual measured values after debridement. The cure rate of infection was evaluated by using the McKee bone infection treatment criteria after the operation. The visual analogue scale (VAS) for pain, lower extremity functional scale (LEFS), and self-rating anxiety scale (SAS) were used to evaluate the improvement of the quality of life of postoperative patients.Results:38 patients were followed up with a mean follow-up of 13.53±2.37 months. 37 patients' infections were effectively controlled, and 1 patient had a recurrence of infection, with an effectiveness rate of 97% for the treatment of McKee's infections. The preoperative calculated bone defect amount and soft tissue defect area were 51.05±26.31 cm 3 and 68.42±43.45 cm 2 respectively, and the actual measured values after debridement during the operation were 51.66±26.35 cm 3 and 68.82±43.76 cm 2 respectively. There was no statistically significant difference before and after the operation ( P>0.05). The interval between the first and second stage surgeries was 10.36±1.61 weeks, and all flaps survived after the first stage surgery. Two months after the operation, one case had recurrent osteomyelitis. After palliative treatment, sinus tracts were formed at the infection site. At the 12-month regular dressing change follow-up, there were still purulent secretions in the sinus tracts. There was no recurrence of infection after primary debridement in 37 cases, and the bone grafts healed. The bone healing time was 3.58±0.97 months. The postoperative VAS, LEFS, and SAS scores were 1.00±0.91, 66.68±7.91, and 34.30±4.29, respectively, which were significantly improved compared with the preoperative scores of 7.54±1.52, 21.22±4.29, and 52.70±6.74, respectively, and the difference was statistically significant ( P<0.05). Conclusions:The application of digital technology to precisely design the debridement range of bone and soft tissue, and the real-time holographic visualization monitoring of the debridement range during the operation can achieve precise debridement of bone and soft tissue and personalized and precise repair of soft tissue defects. It is a safe and effective technique for the treatment of chronic osteomyelitis of the tibia.
3.Masquelet technique for different types of chronic tibial osteomyelitis
Yanhui GUO ; Jianzheng ZHANG ; Li HAN ; Rongji ZHANG ; Ji SHI ; Hongying HE ; Xianyong MENG
Chinese Journal of Orthopaedic Trauma 2025;27(4):341-347
Objective:To evaluate the efficacy and safety of the Masquelet technique on the basis of characterization of hematogenous and traumatic chronic osteomyelitis of the tibia.Methods:A retrospective analysis was conducted with chronic tibial osteomyelitis who had been treated by the Masquelet technique at Department of Orthopedic Surgery, The Fourth Medical Center, PLA General Hospital from February 2021 to June 2023. The patients were classified into 2 groups based on the underlying etiology of their conditions: a hematogenous group and a traumatic group. Treatment efficacy was evaluated in terms of infection control rate, bone graft healing time, visual analog scale (VAS) pain score, anxiety measured by the self-rating anxiety scale (SAS), and lower limb function assessed by the lower extremity functional scale (LEFS).Results:A total of 66 patients with chronic tibial osteomyelitis were included in the study. There were 17 cases in the hematogenous group. They were 11 males and 6 females with a median age of 31.0 (15.0, 45.0) years and a median disease duration of 3.0 (1.5, 8.0) months. The median interval between the first and second-stage surgeries was 11.5 (8.0, 13.0) weeks, the median volume of bone defect 25.0 (15.0, 40.0) cm 3, and the median bone graft healing time 4.0 (3.0, 4.0) months. No bacteria were detected in secretion culture in 6 cases and Staphylococcus aureus was found in 6 cases. At 12 months postoperatively, the median VAS score was 1.0 (0.0, 2.0) point, the median SAS score 27.0 (20.0, 32.0) points, and the median LEFS score 78.0 (75.0, 80.0) points. There were 49 cases in the traumatic group. They were 36 males and 13 females with a median age of 52.0 (42.0, 63.0) years and a median disease duration of 6.0 (3.0, 36.0) months. The median interval between the first and second-stage surgeries was 10.0 (8.0, 17.0) weeks, the median volume of bone defect 30.0 (22.0, 53.0) cm 3, and the median bone graft healing time 3.5 (3.0, 4.5) months. No bacteria were detected in secretion culture in 10 cases and Staphylococcus aureus was found in 19 cases. At 12 months postoperatively, the median VAS score was 2.0 (1.0, 3.0) points, the median SAS score 35.0 (28.0, 42.0) points, and the median LEFS score 54.0 (42.0, 60.0) points. According to the McKee criteria for infection treatment, 14 cases achieved complete recovery, 2 ones showed improvement, and 1 case experienced recurrence in the hematogenous group, while 44 cases achieved complete recovery, 4 ones showed improvement, and 1 case experienced recurrence in the traumatic group. Conclusions:Although hematogenous and traumatic cases of chronic osteomyelitis of the tibia differ in terms of age of onset, disease duration, and lesion extent, Staphylococcus aureus is the predominant pathogen in both conditions. Application of the Masquelet technique has proven to be an effective treatment for both conditions with comparable bone graft healing time.
4.Digital technology-assisted debridement and bone and soft tissue reconstruction for the treatment of chronic osteomyelitis of the tibia
Hongying HE ; Weidong SHI ; Wenxing HAN ; Li HAN ; Huhu WANG ; Jianwen ZHAO ; Zhuo WU ; Shaoguang LI ; Rongji ZHANG ; Yanhui GUO ; Jianzheng ZHANG
Chinese Journal of Orthopaedics 2025;45(8):500-507
Objective:To evaluate the safety and efficacy of digital technology-assisted debridement and bone and soft tissue reconstruction in the treatment of chronic osteomyelitis of the tibia.Methods:This retrospective study analyzed clinical data from 38 patients (26 males, 12 females; mean age 45.61±18.36 years, range 16-83 years) with chronic post-traumatic osteomyelitis complicated by soft tissue defects in the tibia, treated at the Department of Orthopaedics, Fourth Medical Center of PLA General Hospital between June 2021 and June 2023. There were 18 cases of traffic accidents, 6 cases of high-altitude falls, 6 cases of heavy objects and 6 cases of low-energy falls. Lesion sites: 12 cases in the upper segment of the tibia, 12 cases in the middle segment, and 14 cases in the lower segment. According to the Cierny-Mader classification, there were 24 cases of type III and 14 cases of type IV. Before the operation, the "3D point cloud technology" was used to plan the debridement range of bone and soft tissue. During the operation, the optical navigation system was used to monitor the debridement range in real time. The flap was designed by combining "Reading Tablet Treasure" with CT angiography, and the amount of bone graft was predicted by AI algorithm. The surgical method adopted is the Masquelet technique, namely thorough debridement, bone cement occupation and soft tissue repair in the first stage, and bone reconstruction in the second stage. Comparing the calculated bone defect amount and soft tissue defect area before the operation with the actual measured values after debridement. The cure rate of infection was evaluated by using the McKee bone infection treatment criteria after the operation. The visual analogue scale (VAS) for pain, lower extremity functional scale (LEFS), and self-rating anxiety scale (SAS) were used to evaluate the improvement of the quality of life of postoperative patients.Results:38 patients were followed up with a mean follow-up of 13.53±2.37 months. 37 patients' infections were effectively controlled, and 1 patient had a recurrence of infection, with an effectiveness rate of 97% for the treatment of McKee's infections. The preoperative calculated bone defect amount and soft tissue defect area were 51.05±26.31 cm 3 and 68.42±43.45 cm 2 respectively, and the actual measured values after debridement during the operation were 51.66±26.35 cm 3 and 68.82±43.76 cm 2 respectively. There was no statistically significant difference before and after the operation ( P>0.05). The interval between the first and second stage surgeries was 10.36±1.61 weeks, and all flaps survived after the first stage surgery. Two months after the operation, one case had recurrent osteomyelitis. After palliative treatment, sinus tracts were formed at the infection site. At the 12-month regular dressing change follow-up, there were still purulent secretions in the sinus tracts. There was no recurrence of infection after primary debridement in 37 cases, and the bone grafts healed. The bone healing time was 3.58±0.97 months. The postoperative VAS, LEFS, and SAS scores were 1.00±0.91, 66.68±7.91, and 34.30±4.29, respectively, which were significantly improved compared with the preoperative scores of 7.54±1.52, 21.22±4.29, and 52.70±6.74, respectively, and the difference was statistically significant ( P<0.05). Conclusions:The application of digital technology to precisely design the debridement range of bone and soft tissue, and the real-time holographic visualization monitoring of the debridement range during the operation can achieve precise debridement of bone and soft tissue and personalized and precise repair of soft tissue defects. It is a safe and effective technique for the treatment of chronic osteomyelitis of the tibia.
5.Rapid on-site detection of methamphetamine using surface-enhanced raman spectroscopy
Caiyun LIAO ; Yating ZHANG ; Rongji YANG ; Liu YANG ; Guojuan LI ; Chenxi LIU ; Wen REN ; Zhou YANG
Chinese Journal of Forensic Medicine 2025;40(4):459-462
Objective To establish a rapid on-site detection method for methamphetamine(MA)based on surface-enhanced Raman spectroscopy(SERS).Methods Laboratory-synthesized colloidal silver nanoparticles(AgNPs)were employed as SERS substrates to rapidly detect methamphetamine in typical crime scene matrices,including beer,cigarette ash,and plastic containers.Results The method requires no sample pretreatment,is simple to operate,and offers high sensitivity with fast detection speed.The limit of detection(LOD)reached 10 ppb(signal-to-noise ratio,S/N>3).The qualitative results of methamphetamine analysis from forensic case samples were highly consistent with gas chromatography-mass spectrometry(GC-MS)findings.Conclusion Methamphetamine is frequently encountered in illicit settings and criminal activities.This study achieved rapid detection of methamphetamine in complex matrices(beer,cigarette ash,and plastic containers),demonstrating good application prospects in practice and providing important value for law enforcement,public safety,and criminal investigation.
6.Masquelet technique for different types of chronic tibial osteomyelitis
Yanhui GUO ; Jianzheng ZHANG ; Li HAN ; Rongji ZHANG ; Ji SHI ; Hongying HE ; Xianyong MENG
Chinese Journal of Orthopaedic Trauma 2025;27(4):341-347
Objective:To evaluate the efficacy and safety of the Masquelet technique on the basis of characterization of hematogenous and traumatic chronic osteomyelitis of the tibia.Methods:A retrospective analysis was conducted with chronic tibial osteomyelitis who had been treated by the Masquelet technique at Department of Orthopedic Surgery, The Fourth Medical Center, PLA General Hospital from February 2021 to June 2023. The patients were classified into 2 groups based on the underlying etiology of their conditions: a hematogenous group and a traumatic group. Treatment efficacy was evaluated in terms of infection control rate, bone graft healing time, visual analog scale (VAS) pain score, anxiety measured by the self-rating anxiety scale (SAS), and lower limb function assessed by the lower extremity functional scale (LEFS).Results:A total of 66 patients with chronic tibial osteomyelitis were included in the study. There were 17 cases in the hematogenous group. They were 11 males and 6 females with a median age of 31.0 (15.0, 45.0) years and a median disease duration of 3.0 (1.5, 8.0) months. The median interval between the first and second-stage surgeries was 11.5 (8.0, 13.0) weeks, the median volume of bone defect 25.0 (15.0, 40.0) cm 3, and the median bone graft healing time 4.0 (3.0, 4.0) months. No bacteria were detected in secretion culture in 6 cases and Staphylococcus aureus was found in 6 cases. At 12 months postoperatively, the median VAS score was 1.0 (0.0, 2.0) point, the median SAS score 27.0 (20.0, 32.0) points, and the median LEFS score 78.0 (75.0, 80.0) points. There were 49 cases in the traumatic group. They were 36 males and 13 females with a median age of 52.0 (42.0, 63.0) years and a median disease duration of 6.0 (3.0, 36.0) months. The median interval between the first and second-stage surgeries was 10.0 (8.0, 17.0) weeks, the median volume of bone defect 30.0 (22.0, 53.0) cm 3, and the median bone graft healing time 3.5 (3.0, 4.5) months. No bacteria were detected in secretion culture in 10 cases and Staphylococcus aureus was found in 19 cases. At 12 months postoperatively, the median VAS score was 2.0 (1.0, 3.0) points, the median SAS score 35.0 (28.0, 42.0) points, and the median LEFS score 54.0 (42.0, 60.0) points. According to the McKee criteria for infection treatment, 14 cases achieved complete recovery, 2 ones showed improvement, and 1 case experienced recurrence in the hematogenous group, while 44 cases achieved complete recovery, 4 ones showed improvement, and 1 case experienced recurrence in the traumatic group. Conclusions:Although hematogenous and traumatic cases of chronic osteomyelitis of the tibia differ in terms of age of onset, disease duration, and lesion extent, Staphylococcus aureus is the predominant pathogen in both conditions. Application of the Masquelet technique has proven to be an effective treatment for both conditions with comparable bone graft healing time.
7.A risk model of postoperative 3-year all-cause mortality for the elderly patients with hip fracture: development and validation
Ji SHI ; Yanhui GUO ; Rongji ZHANG ; Xinming YANG ; Xiaowei WANG ; Jianzheng ZHANG
Chinese Journal of Orthopaedic Trauma 2024;26(11):948-955
Objective:To develop and validate a risk model of postoperative 3-year all-cause mortality for the elderly patients with hip fracture.Methods:A retrospective study was conducted to analyze the clinical data of 325 elderly patients with hip fracture who had been treated at The Fourth Medical Center, The General Hospital of PLA from January 2020 to December 2021. There were 90 men and 235 women with an age of (80.9±8.9) years, and 191 intertrochanteric fractures and 134 femoral neck fractures. The patients with hip fractures admitted from January 2020 to June 2021 were assigned to a modeling group (244 cases), and those admitted from July to December 2021 to a validation group (81 cases). Recorded were age, gender, fracture type, pre-injury disease, hematological indicators, time from injury to surgery, previous use of anticoagulant drugs, bone density, American Society of Anesthesiologists (ASA) grading, body mass index, and blood transfusion volume in the 2 groups of patients. The data in the modeling group were used to screen the independent risk factors for the postoperative 3-year all-cause mortality in the elderly patients with hip fracture through logistic regression analysis and receiver operating characteristic (ROC) curve analysis and consequently to construct a prediction model. The data in the validation group were used to analyze the predictive performance of the model through the ROC curve, and the fitting degree of the model was evaluated using the Hosmer-Lemeshow goodness-of-fit test.Results:Respectively, 75 cases in the modeling group and 29 cases in the validation group died 3 years after surgery. There was no statistically significant difference in the baseline data between the 2 groups, indicating comparability ( P>0.05). Logistic univariate analysis showed that gender, age, coronary atherosclerotic heart disease before injury, stroke before injury, pulmonary infection before injury, hemoglobin, albumin, high-density lipoprotein, body mass index, time from injury to surgery and ASA grade were related to the mortality of patients 3 years after surgery ( P<0.05). The ROC curve analysis showed that the variables with predictive ability included age, hemoglobin, albumin, body mass index, and time from injury to surgery. Logistic multivariate analysis showed male, age ≥ 83 years, pre-injury stroke, time from injury to surgery ≥ 4.5 days, ASA grade Ⅲ, and ASA grade Ⅳ were significantly related to the postoperative 3-year all-cause mortality in the elderly patients with hip fracture ( P<0.05). In the prediction model based on the above indicators, the area under the ROC curve was 0.792 (95% CI: 0.730 to 0.855, P<0.001), the cutoff value 0.459, sensitivity 56%, and specificity 90.5%, showing a good fit of the model ( χ2=5.818, P=0.668). Conclusions:Male, age ≥ 83 years, pre-injury stroke, time from injury to surgery ≥ 4.5 days, and ASA grades Ⅲ and Ⅳ are risk factors for postoperative 3-year all-cause mortality in the elderly patients with hip fracture. The risk prediction model based on these indicators demonstrates good predictive efficacy.
8.Progress of research on the technology of preservation and repair of severed limbs
Rongji ZHANG ; Ji SHI ; Jianwen ZHAO ; Qing LI ; Jianzheng ZHANG ; Wei CHAI ; Tiansheng SUN
Chinese Journal of Orthopaedics 2024;44(22):1503-1508
Limb preservation techniques of severed limbs play an important role in autologous replantation or allografting. At present, static cold storage (SCS) remains the gold standard for the in vitro preservation of severed limbs, which minimizes oxygen and energy metabolism. However, with a relatively short time window of 4-6 hours, SCS is insufficient for clinical transfer, injury management and other medical resources. To address this issue, researchers have initiated investigations into alternative methods of supplying oxygen and nutrients to severed limbs, leading to the development of mechanical perfusion technology and per-sufflation technology. Mechanical perfusion technology aims to clear metabolic waste and provide essential nutrients by mimicking a physiological state, thereby prolonging the preservation time and improving the outcome of the repair. Per-sufflation technology aims to deliver oxygen directly to the tissue using a vascular system to maintain tissue integrity. With these emerging technologies showing great promise, further exploration and refinement are needed to address their time constraints and complexity in clinical work. Furthermore, for severed limbs that are not suitable for immediate reimplantation, autologous heterotopic parasitism techniques and temporary endovascular shunts offer promising avenues for preservation. Autologous heterotopic parasitism techniques maintain tissue viability by constructing a temporary parasitic environment, while temporary endovascular shunts establish a temporary vascular access at the damaged site to deliver donor blood, thereby maintaining blood flow and promoting repair. Xenogeneic cross-circulation techniques combine recent advances from multiple disciplines and demonstrate remarkable potential; however, they currently face challenges such as ethics, immune rejection, and technical complexity. The combination of these novel techniques has led to a significant advancement in the field of limb preservation and repair. This article aims to provide an overview of the current research status and development of static cold storage, pre-sufflation, mechanical perfusion preservation and temporary ectopic parasitic preservation techniques in limb preservation over recent years, providing information for clinical work, promoting the development of limb reimplantation and transplantation techniques in China and further consolidating China's leadership in the field of amputation reimplantation and allograft transplantation.
9.Formulation and Analysis on the Standard of Off-label Drug Use
Rongji LIU ; Wei ZUO ; Jiancun ZHEN ; Wei ZHANG ; Ling JIANG ; Xiaoyang LU ; Qianzhou LYU ; Zhiqing ZHANG ; Ying CHEN ; Bo ZHANG
Herald of Medicine 2024;43(7):1065-1069
Off-label use means that the intended use of the drug is not included in the instructions approved by the National Medical Products Administration,including unapproved indication,dosage,the course of treatment,route of administration,or population.The formulation of Pharmaceutical Supply Services-Key Medications Management-Off-label Uses is based on relevant laws,regulations,normative documents,guidelines,literatures,and expert opinions,and follows the principles of scientificity,versatility,instructiveness,and operability.This standard regulates and standardizes the institutional and organizational construction,process management,and the whole process of quality management and evaluation improvement of off-label uses,which is the basis for medical institutions to carry out off-label uses management.This article introduced the formulation process of the off-label uses standard and analyzed the key contents of the standard,which would help medical institutions to better comply with and meet the requirements of this standard in the practice of off-label use management.
10.Efficacy and safety evaluation of insulin degludec and insulin glargine U100 in the treatment for type 2 diabetes mellitus
Xinyu WANG ; Yundi ZHANG ; Yue LI ; Huiying ZONG ; Wenqian HAN ; Lun LIU ; Qian WANG ; Lubo GUO ; Huifeng DI ; Xiaohui ZHEN ; Deqing SUN ; Ying SU ; Zonglin ZHANG ; Jing PENG ; Xiaofu CAO ; Ning LIU ; Jian LIU ; Cuicui LU ; Li WANG ; Tao GENG ; Rongji LI ; Guodong SUN ; Fan ZHANG ; Lin ZHANG ; Chuanjiang MA ; Siyuan TAN ; Dongfang QIAN ; Yan LI
Adverse Drug Reactions Journal 2023;25(11):649-655
Objective:To compare the efficacy and safety of insulin degludec and insulin glargine U100 in patients with type 2 diabetes mellitus.Methods:This study was a retrospective cohort study. The subjects were patients with type 2 diabetes mellitus who were hospitalized in 13 3A-level general hospitals in Shandong Province from September 2018 to December 2021. According to the type of basal insulin used, the patients were divided into insulin degludec group and insulin glargine U100 group. The basic information and laboratory test results in patients in the 2 groups were collected, the differences of fasting blood glucose level and incidence of hypoglycemia between the 2 groups were compared. The patients with complete blood glucose monitoring data in the 2 groups were selected and their blood glucose fluctuations were compared.Results:A total of 1 152 patients were entered in the study, including 552 patients in the insulin degludec group and 600 patients in the insulin glargine U100 group. The difference in the basic conditions in patients in the 2 groups was not statistically significant (all P>0.05). After treatment, the fasting blood glucose levels in patients in the 2 groups were lower than those before treatment, with statistically significant differences [10.2 (8.8, 12.5) mmol/L vs. 7.5 (6.6, 8.7) mmol/L, Z=-19.443, P<0.001; 10.0 (8.6, 11.7) mmol/L vs. 7.8 (6.6, 9.0) mmol/L, Z=-15.449, P<0.001], but the difference in fasting blood glucose levels between the 2 groups after treatment was not statistically significant ( Z=-1.427, P>0.05). The incidence of hypoglycemia in the insulin degludec group was lower than that in the insulin glargine U100 group [1.09% (6/552) vs. 2.83% (17/600), Z=4.481, P=0.032]. The intraday blood glucose standard deviation, maximum blood glucose fluctuation range, postprandial blood glucose fluctuation range, and average blood glucose fluctuation range in patients with complete blood glucose monitoring data in the insulin degludec group were significantly lower than those in the insulin glargine U100 group [(1.7±0.6) mmol/L vs. (2.4±1.0) mmol/L, (4.5±1.6) mmol/L vs. (6.7±2.9) mmol/L, (1.8±1.0) mmol/L vs. (3.3±1.2) mmol/L, (2.9±1.3) mmol/L vs. (4.6±2.1) mmol/L; all P<0.001]. Conclusion:The efficacy of insulin degludec in the treatment of type 2 diabetes mellitus is equivalent to that of insulin glargine U100, but the risk of hypoglycemia and blood glucose fluctuation is lower.

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