1.A prospective study on association between sleep duration and the risk of chronic obstructive pulmonary disease in adults in Suzhou
Mengshi YANG ; Xikang FAN ; Jian SU ; Xinglin WAN ; Hao YU ; Yan LU ; Yujie HUA ; Jianrong JIN ; Pei PEI ; Canqing YU ; Dianjianyi SUN ; Jun LYU ; Ran TAO ; Jinyi ZHOU
Chinese Journal of Epidemiology 2024;45(3):331-338
Objective:To investigate the prospective association of sleep duration with the development of chronic obstructive pulmonary disease (COPD) in adults in Suzhou.Methods:The study used the data of 53 269 participants aged 30-79 years recruited in the baseline survey from 2004 to 2008 and the follow-up until December 31, 2017 of China Kadoorie Biobank (CKB) conducted in Wuzhong District, Suzhou. After excluding participants with airflow limitation, self-reported chronic bronchitis/emphysema/coronary heart disease history at the baseline survey and abnormal or incomplete data, a total of 45 336 participants were included in the final analysis. The association between daily sleep duration and the risk for developing COPD was analyzed by using a Cox proportional hazard regression model, and the hazard ratio ( HR) values and their 95% CI were calculated. The analysis was stratified by age, gender and lifestyle factors, and cross-analysis was conducted according to smoking status and daily sleep duration. Results:The median follow-up time was 11.12 years, with a total of 515 COPD diagnoses in the follow-up. After adjusting for potential confounders, multifactorial Cox proportional hazard regression analysis showed that daily sleep duration ≥10 hours was associated with higher risk for developing COPD ( HR=1.42, 95% CI: 1.03-1.97). The cross analysis showed that excessive daily sleep duration increased the risk for COPD in smokers ( HR=2.49, 95% CI: 1.35-4.59, interaction P<0.001). Conclusion:Longer daily sleep duration (≥10 hours) might increase the risk for COPD in adults in Suzhou, especially in smokers.
2.Prospective association study of sleep status and risk of coronary heart disease in adults in Suzhou
Jiang HUA ; Xikang FAN ; Jian SU ; Lulu CHEN ; Yan LU ; Yujie HUA ; Hongfu REN ; Pei PEI ; Dianjianyi SUN ; Canqing YU ; Jun LYU ; Jinyi ZHOU ; Ran TAO
Chinese Journal of Epidemiology 2024;45(7):914-922
Objective:To investigate the association between sleep status and the risk for coronary heart disease in adults in Suzhou.Methods:Using the baseline and follow up information of 53 269 local residents aged 30-79 years in China Kadoorie Biobank conducted in Wuzhong District, Suzhou, 51 929 subjects were included in this study after excluding those reporting coronary heart disease, stroke and cancer at the baseline survey. A Cox proportional hazards regression model was used to analyze the association of healthy sleep score (0-3 points) and sleep factors (snoring, insomnia, long sleep duration and nap) with the risk for coronary heart disease.Results:The median follow-up time was 11.12 years, and 1 304 individuals were diagnosed with coronary heart disease during the follow-up. After adjusting for potential confounders, occasional snoring ( HR=1.20, 95% CI: 1.04-1.38), usual snoring ( HR=1.17, 95% CI: 1.02-1.33), insomnia disorder ( HR=1.41, 95% CI: 1.12-1.78), daytime dysfunction ( HR=1.56, 95% CI: 1.20-2.03) and perennial nap ( HR=1.37, 95% CI: 1.19-1.59) were associated with increased risk of coronary heart disease. Compared with those with sleep score of 0 - 1 (low sleep quality), the people with sleep score of 3 had reduced risk of coronary heart disease by 26% ( HR=0.74, 95% CI: 0.63-0.87). Stratified analysis showed that the association of healthy sleep score 3 with risk of coronary heart disease was stronger in low physically active individuals (interaction P<0.05). Conclusions:Snoring, insomnia disorders, daytime dysfunction, and perennial napping were all associated with increased risk for coronary heart disease, and keep healthy sleep mode might reduce the risk for coronary heart disease in adults.
3.Observational study on perioperative outcomes of pelvic exenteration.
Hao YUAN ; Bing YAO ; Jun Tao LI ; Wen Liang ZHU ; Dong Lin REN ; Hui WANG ; Teng Hui MA ; Shu Qin CHEN ; Jian Jian WU ; Yi Ran TAO ; Lei YE ; Zhong Yang WANG ; Hu QU ; Bo MA ; Wen Wen ZHONG ; De Juan WANG ; Jian Guang QIU
Chinese Journal of Gastrointestinal Surgery 2023;26(3):260-267
Objective: To investigate the surgical indications and perioperative clinical outcomes of pelvic exenteration (PE) for locally advanced, recurrent pelvic malignancies and complex pelvic fistulas. Methods: This was a descriptive study.The indications for performing PE were: (1) locally advanced, recurrent pelvic malignancy or complex pelvic fistula diagnosed preoperatively by imaging and pathological examination of a biopsy; (2)preoperative agreement by a multi-disciplinary team that non-surgical and conventional surgical treatment had failed and PE was required; and (3) findings on intraoperative exploration confirming this conclusion.Contraindications to this surgical procedure comprised cardiac and respiratory dysfunction, poor nutritional status,and mental state too poor to tolerate the procedure.Clinical data of 141 patients who met the above criteria, had undergone PE in the Sixth Affiliated Hospital of Sun Yat-sen University from January 2018 to September 2022, had complete perioperative clinical data, and had given written informed consent to the procedure were collected,and the operation,relevant perioperative variables, postoperative pathological findings (curative resection), and early postoperative complications were analyzed. Results: Of the 141 included patients, 43 (30.5%) had primary malignancies, 61 (43.3%) recurrent malignancies, 28 (19.9%) complex fistulas after radical resection of malignancies,and nine (6.4%)complex fistulas caused by benign disease. There were 79 cases (56.0%) of gastrointestinal tumors, 30 cases (21.3%) of reproductive tumors, 16 cases (11.3%) of urinary tumors, and 7 cases (5.0%) of other tumors such mesenchymal tissue tumors. Among the 104 patients with primary and recurrent malignancies, 15 patients with severe complications of pelvic perineum of advanced tumors were planned to undergo palliative PE surgery for symptom relief after preoperative assessment of multidisciplinary team; the other 89 patients were evaluated for radical PE surgery. All surgeries were successfully completed. Total PE was performed on 73 patients (51.8%),anterior PE on 22 (15.6%),and posterior PE in 46 (32.6%). The median operative time was 576 (453,679) minutes, median intraoperative blood loss 500 (200, 1 200) ml, and median hospital stay 17 (13.0,30.5)days.There were no intraoperative deaths. Of the 89 patients evaluated for radical PE surgery, the radical R0 resection was achieved in 64 (71.9%) of them, R1 resection in 23 (25.8%), and R2 resection in two (2.2%). One or more postoperative complications occurred in 85 cases (60.3%), 32 (22.7%)of which were Clavien-Dindo grade III and above.One patient (0.7%)died during the perioperative period. Conclusion: PE is a valid option for treating locally advanced or recurrent pelvic malignancies and complex pelvic fistulas.
Humans
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Pelvic Exenteration/methods*
;
Pelvic Neoplasms/surgery*
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Retrospective Studies
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Neoplasm Recurrence, Local/surgery*
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Postoperative Complications
4.Effect of 28-day administration of Psoraleae Fructus water extract on early liver injury in rats.
Bo XU ; Guang-Tao YAO ; Jun XIE ; Lei RAN ; Xin-Yu A ; Lian-Bo XIAO
China Journal of Chinese Materia Medica 2023;48(16):4459-4466
This study aims to investigate the hepatotoxicity of Psoraleae Fructus water extract and the underlying mechanism in rats. Forty-eight rats were randomly assigned into four groups: a blank group and low-(BZGL, 6.25 g·kg~(-1)), medium-(BGZM, 12.5 g·kg~(-1)), and high-dose(BGZH, 25 g·kg~(-1)) Psoraleae Fructus water extract groups. The rats were treated for 28 days, and toxicity and mortality were observed daily. After 28 days, the rats were sacrificed, and the body weight, liver index, and liver-to-brain ratio were calculated. The morphological changes in the liver tissue were observed, and the serum levels of related biochemical indicators were measured. The results showed that compared with the blank group, Psoraleae Fructus water extracts of different doses decreased the body weight, increased the liver index and liver-to-brain ratio, and caused liver hypertrophy and pathological changes. Pathological examination revealed that the rats in Psoraleae Fructus water extract groups had bile duct hyperplasia, inflammatory cell infiltration, and liver cell fibrosis. Compared with the blank group, BGZL elevated the levels of alanine transaminase(ALT), α-glutathione S-transferase(α-GST), and total bile acid(TBA)(P<0.05), and BGZM and BGZH elevated the levels of ALT, TBA, α-GST, γ-glutamyl transferase(γ-GT), purine nucleoside phosphorylase(PNP), ornithine carbamoyltransferase(OCT), and arginase(ArgI)(P<0.05). Compared with the blank group, Psoraleae Fructus water extracts of different doses down-regulated the mRNA and protein levels of bile salt export pump(BSEP) and farnesoid X receptor(FXR) and up-regulated the mRNA and protein levels of tumor necrosis factor-α(TNF-α), nuclear factor kappaB(NF-κB), and cholesterol 7 alpha-hydroxylase(CYP7A1)(P<0.05). The results suggested that Psoraleae Fructus water extract caused toxicity in rats, showing a dose-toxicity relationship. Psoraleae Fructus water extract may cause liver damage, which may be due to its effect on liver bile acid secretion and induction of inflammation.
Rats
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Animals
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Water
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Rats, Sprague-Dawley
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Liver
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NF-kappa B
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Liver Cirrhosis
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Bile Acids and Salts
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Body Weight
;
RNA, Messenger
5.Incidence of chronic obstructive pulmonary disease and risk factors in the Suzhou cohort.
Meng Shi YANG ; Xi Kang FAN ; Jian SU ; Hao YU ; Yan LU ; Yu Jie HUA ; Pei PEI ; Jun LYU ; Ran TAO ; Jin Yi ZHOU ; Ming WU
Chinese Journal of Epidemiology 2023;44(6):868-876
Objective: To understand the incidence of chronic obstructive pulmonary disease (COPD) in the Suzhou cohort, and explore the risk factors for the development of COPD in Suzhou, and provide a scientific basis for COPD prevention. Methods: This study was based on the China Kadoorie Biobank project in Wuzhong District, Suzhou. After excluding individuals with airflow obstruction and self-reported chronic bronchitis, emphysema, or pulmonary heart disease at baseline, 45 484 individuals were finally included in the analysis. Cox proportional risk models were used to analyze risk factors of COPD and calculate hazard ratios and 95% confidence interval (CI) in the Suzhou cohort. The effect modifications of smoking on the association between other risk factors and COPD were evaluated. Results: Complete follow-up was available through December 31, 2017. Participants were followed up for a median of 11.12 years, and 524 individuals were diagnosed with COPD during the follow-up period; the incidence was 105.54 per 100 000 person-years. Multivariate Cox proportional risk regression models showed that age (HR=3.78, 95%CI:3.32-4.30), former smoking (HR=2.00, 95%CI:1.24-3.22), current smoking (<10 cigarettes/day, HR=2.14, 95%CI:1.36-3.35;≥10 cigarettes/day, HR=2.69, 95%CI:1.60-4.54), history of respiratory disease (HR=2.08, 95%CI:1.33-3.26), daily sleep duration ≥10 hours (HR=1.41, 95%CI:1.02-1.95) were associated with increased risk of COPD. However, education level of primary school and above (primary or junior high school, HR=0.65, 95%CI:0.52-0.81; high school and above, HR=0.54, 95%CI:0.33-0.87), consuming fresh fruit daily (HR=0.59, 95%CI:0.42-0.83) and consuming spicy food weekly (HR=0.71, 95%CI:0.53-0.94) were associated with reduced risk of COPD. Conclusions: The incidence of COPD is low in Suzhou. Older age, smoking, history of respiratory disease, and long sleep duration were risk factors for the development of COPD in the Suzhou cohort.
Humans
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Incidence
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Pulmonary Disease, Chronic Obstructive/epidemiology*
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Risk Factors
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Smoking/epidemiology*
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Tobacco Smoking
6.Combination pattern of internal fixation for periprosthesis fractures of the proximal femur after hip replacement
Yake LIU ; Zhenyu ZHOU ; Ran TAO ; Yi CAO ; Jianwei ZHU ; Youhua WANG ; Yue LU ; Hua XU ; Xingli BAO ; Fan LIU ; Jining SHEN ; Xiaoliang SUN ; Yanglin GU ; Jian TANG ; Jun LIU ; Ranran ZHOU
Chinese Journal of Orthopaedics 2023;43(3):155-163
Objective:To investigate the combination of internal fixation for periprosthetic fractures of the proximal femur (PFFF) after hip arthroplasty.Methods:The data of 58 patients with periprosthetic fractures after hip arthroplasty from May 2008 to March 2022 were retrospectively analyzed, including 31 males and 27 females. The average age was 75.5±18.2 years (range, 35-95 years). There were 39 total hip arthroplasty and 19 hemiarthroplasty; 37 biological prosthesis and 21 cemented prosthesis. Intraoperative periprosthetic fractures occurred in 6 cases and 52 cases postoperatively. Unified classification system (UCS): UCS IV.3A1 type 2 cases, 3A2 type 1 case, 3B1.1 type 19 cases, 3B2.1 type 25 cases, 3B3 type 2 cases, 3C type 9 cases. Fracture site: 3 cases in zone A (greater trochanter), 46 cases in zone B (around the femoral stem), and 9 cases in zone C (distal to the tip of the femoral stem. Internal fixation is composed of primary and secondary fixation, the main fixation method was the cerclage of steel wire or titanium cable, locking compression plate, and locking attachment plate fixation. The secondary fixation method was the cerclage of titanium cable, which was required to cover three zones A, B and C to form an overall balanced fixation. The modified Harris hip scores (mHHS), plate length, working length and screw number of different internal fixation combinations were compared.Results:The follow-up time was 54.2±21.6 months (range, 11-86 months). All patients showed signs of fracture healing at 10.2±1.5 weeks (range, 7-13 weeks) after operation, and bony union was observed at 19.6±1.3 weeks (range, 17-22 weeks) after operation. No delayed union or nonunion was observed. After operation, one case had a stress fracture and was revised with double-plate internal fixation; one case had a failed internal fixation and was revised with double-plate internal fixation and a large allograft bone graft. The mHHS score of UCSIV.3B2.1 group (80.3±4.6) was the lowest at 6 months after operation, and the difference between the groups of different types was statistically significant ( F=256.72, P<0.001). The score of simple internal fixation group (91.6±4.2) was higher than that of revision combined with internal fixation group (81.9±4.1), and the difference was statistically significant ( t=8.32, P<0.001). The plate length and working length were 24.9±2.5 cm and 12.6±1.7 cm for UCS IV.3B1.1, 25.4±2.6 cm and 13.6±1.8 cm for 3B2.1 and 28.1±2.5 cm and 4.9±1.9 cm for 3C, respectively ( F=5.33, P=0.005; F=6.78, P<0.001). The number of screws in zone A was significant difference among different UCS types ( F=52.67, P<0.001); UCS IV.3B1.1 (6.5±2.3) and 3B2.1 (6.7±2.2) were more than 3B3 (3.5±1.5) and 3C (3.7±1.6). The number of screws in zone B was significant difference among different UCS types ( F=42.15, P<0.001); The number of UCS IV.3B1.1 (2.3±1.6) and 3B2.1 (2.8±1.9) were significantly more than that of 3B3 (1.0±0.5) and 3C (1.2±0.6). The number of screws in zone C was significant differences among different UCS types ( F=39.62, P<0.001); The number of UCS IV.3B1.1 (3.8±1.9) and 3B2.1 (3.9±1.7) were more than that of 3B3 (2.0±0.5), the difference was statistically significant ( P<0.05). Conclusion:The function of hip after simple internal fixation of proximal femoral periprosthetic fractures was better than that of those who underwent revision at the same time; the number of screws of UCSIV.B1 and B2 is more than that of B3.
7.Application of three-dimensional printed endoprosthesis for reconstruction after metaphysis-involved intercalary tumor resection
Ran WEI ; Haijie LIANG ; Jun WANG ; Yi YANG ; Tao JI ; Xiaodong TANG ; Wei GUO
Chinese Journal of Orthopaedics 2023;43(14):969-977
Objective:To describe the design, manufacture and use of three-dimensional (3D)-printed endoprosthesis for reconstruction after metaphysis-involved intercalary tumor resection and to evaluate its outcome.Methods:Forty-three patients who received metaphysis-involved intercalary tumor resection followed by 3D-printed endoprosthetic reconstruction in Musculoskeletal Tumor Center, Peking University People's Hospital between January 2018 and December 2021 were retrospectively reviewed. There were 25 males and 18 males with an average age of 20.1±15.2 years (range, 4-58 years). The pathological diagnosis included 24 cases of osteosarcomas, 6 cases of Ewing sarcomas, 5 cases of chondrosarcomas, 2 cases of pleomorphic undifferentiated sarcomas, 3 cases of soft-tissue sarcomas (liposarcoma, synovial sarcoma, malignant peripheral nerve sheath tumor for each) and 3 others (adamantinoma, recurrent aneurysmal bone cyst and recurrent osteofibrous dysplasia for each). The tumors located at femur in 25 patients (58%), including 14 lesions involving distal femoral metaphysis and 11 lesions involving both proximal and distal metaphysis; the tumors located at tibia in 11 patients (26%), including 4 lesions involving distal tibial metaphysis, 5 lesions involving proximal tibial metaphysis and 2 lesions involving both proximal and distal tibial metaphysis; the tumors located at humerus in 7 patients (16%), including 1 lesion involving distal humeral metaphysis, 3 lesions involving proximal humeral metaphysis and 3 lesions involving both proximal and distal humeral metaphysis. The endoprosthesis was designed in a semi-modular fashion and consisted of three parts: a diaphysis-fixing component, a semi-modular lap joint component, and a custom-made 3D-printed metaphysis-fixing component which was designed as two types with 3D-printed porous bone-contacting surfaces according to the osteotomy plane (Type I on meta-diaphyseal region, Type II on meta-epiphyseal region). The functional outcome was assessed using Musculoskeletal Tumor Society (MSTS) 93 system.Results:All surgeries were accomplished sucessfully. The median resection length and the distance from osteotomy plane to adjacent joint was 16.0 (13.0, 22.0) cm and 4.5 (3.5, 6.0) cm, respectively. 59 metaphysis-fixing components were installed in 43 patients. Type I components were used in single and dual ends of endoprosthesis in 12 and 6 cases respectively. Type II components were used in single and dual ends in 15 and 5 cases respectively. Hybrid endoprosthesis with Type I and II components were used in 5 cases. The mean follow-up time was 26.0 (17, 37) months (range, 12-54 months). The mean MSTS 93 score was 29.0 (28.0, 30.0) points (range, 21-30 points). Implant failures were found in 5 patients, including 2 cases of aseptic loosening (loosening was observed in the cementing diaphysis-fixing stems while no evidence of loosening in metaphysis-fixing components) and 3 cases of local tumor progression. The 2-year implant survival rate was 90.3% (95% CI: 0.81, 0.99). Conclusion:Using 3D-printed intercalary endoprosthesis for reconstruction after intercalary resection of metaphysis-involved bone tumor shows satisfactory functional outcome and implant survival. Moreover, by assembling endoprosthetic components according to the different osteotomy plane, the semi-modularized endoprosthesis also provids a comprehensive and individualized reconstruction for patients with metaphysis-involved intercalary tumor.
8.Clinical observation on the efficacy and safety of dupilumab in the treatment of moderate to severe atopic dermatitis.
Cheng Yuan LI ; Shuang CHEN ; Wei Lu QIAN ; Liu YANG ; Qiu ZHENG ; Ai Jun CHEN ; Jin CHEN ; Kun HUANG ; Sheng FANG ; Ping WANG ; Li HU ; Xin Ran LIU ; Xiao Qin ZHAO ; Na TAN ; Tao CAI
Chinese Journal of Preventive Medicine 2023;57(10):1590-1595
To investigate the clinical efficacy and safety of dupilumab in the treatment of moderate to severe atopic dermatitis (AD) in China. A small sample self-controlled study before and after treatment was conducted to retrospective analysis patients with moderate to severe AD treated with dupilumab in the department of dermatology of the First Affiliated Hospital of Chongqing Medical University from July 2020 to March 2022. Dupilumab 600 mg was injected subcutaneously at week 0, and then 300 mg was injected subcutaneously every 2 weeks. The condition was evaluated by SCORAD(severity scoring of atopic dermatitis), NRS(numerical rating scale), DLQI(dermatology life quality index) and POEM(patient-oriented eczema measure). The improvement of SCORAD, NRS, DLQI and POEM was analyzed by paired t test and non-parametric paired Wilcoxon. The results showed that a total of 67 patients with moderate to severe AD received dupilumab treatment, of which 41 patients (the course of treatment was more than 6 weeks) had reduced the severity of skin lesions, improved quality of life and reduced pruritus. A total of 23 patients completed 16 weeks of treatment. At 4, 8, 12 and 16 weeks, SCORAD, NRS, DLQI and POEM decreased compared with the baseline, and the differences were statistically significant. SCORAD (50.13±15.19) at baseline, SCORAD (36.08±11.96)(t=6.049,P<0.001) at week 4,SCORAD (28.04±11.10)(t=10.471,P<0.001) at week 8, SCORAD (22.93±9.72)(t=12.428,P<0.001) at week 12, SCORAD (16.84±7.82)(t=14.609,P<0.001) at week 16, NRS 7(6,8) at baseline, NRS 4(3,5)(Z=-3.861,P<0.001) at week 4, NRS 2(1,4)(Z=-4.088,P<0.001) at week 8, NRS 1(0,2)(Z=-4.206,P<0.001) at week 12, NRS 2(0,2)(Z=-4.222,P<0.001) at week 16, DLQI (13.83±5.71) at baseline, DLQI (8.00±4.02)(t=6.325,P<0.001) at week 4, DLQI (5.61±3.50)(t=8.060,P<0.001) at week 8, DLQI (3.96±1.99)(t=8.717,P<0.001) at week 12, DLQI (2.70±1.89)(t=10.355,P<0.001) at week 16, POEM (18.04±6.41) at baseline, POEM (9.70±4.70)(t=7.031,P<0.001) at week 4, POEM (7.74±3.48)(t=8.806,P<0.001) at week 8, POEM (6.35±3.33)(t=10.474,P<0.001) at week 12, POEM (4.26±2.51)(t=11.996,P<0.001) at week 16. In the 16th week, 100%(23 patients), 91.3%(21 patients), 34.8%(8 patients) and 8.7%(2 patients) of 23 patients reached SCORAD30, SCORAD50, SCORAD70, and SCORAD90 statuses, respectively. There were 82.6%(19 patients), 95.7%(22 patients) and 95.7%(22 patients) of 23 patients with NRS, DLQI and POEM improved by≥4 points compared with baseline. Twelve patients with AD who continued to receive dupilumab after 16 weeks showed further improvement in skin lesions. The adverse events were conjunctivitis and injection site reaction. In conclusion, dupilumab is an effective and safe treatment for moderate and severe AD. However, the longer-term efficacy and safety require further studies involving larger sample sizes and a longer follow-up time.
Humans
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Dermatitis, Atopic/drug therapy*
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Quality of Life
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Retrospective Studies
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Severity of Illness Index
;
Treatment Outcome
9.Bioequivalence of lamivudine tenofovir tablets in Chinese healthy subjects
Ran MA ; Xin SUI ; Xiu-Jun WU ; Hua-Wei WANG ; Chun-Lei TAO ; Yang XU ; Xiao-Bin LI
The Chinese Journal of Clinical Pharmacology 2023;39(24):3643-3647
Objective To evaluate the bioequivalence of lamivudine tenofovir tablets in Chinese healthy volunteers.Methods A randomized,open,single-dose,two-period,double-crossover drug trial design was conducted.24 subjects were randomly divided into two groups,and administered orally one tablet of test preparation or one tablet of each reference preparation per period under fasting and fed condition respectively.The concentrations of lamivudine and tenofovir in plasma were determined by HPLC-MS/MS.The pharmacokinetic parameters were calculated and the bioequivalence was compared by non-compartment model of WinNonlin 7.0 program.Results The pharmacokinetic parameters of test and reference preparations after fasting oral administration:lamivudine Cmax were(2 777.74±702.55)and(2 985.00±979.23)ng·mL-1,AUC0-t were(11 977.14±2 550.67)and(12 450.22±2 336.41)ng·h·mL-1,AUC0-∞ were(12 177.69±2 526.02)and(12 660.98±2 333.30)ng·h·mL-1,respectively;tenofovir Cmax were(316.72±63.79)and(301.46±79.82)ng·mL-1,AUC0-t were(2 584.72±619.04)and(2 474.94±636.05)ng·h·mL-1,AUC0-∞ were(2 789.87±701.97)and(2 666.35±676.21)ng·h·mL-1,respectively.The pharmacokinetic parameters of test and reference preparations after fed oral administration:lamivudine Cmax were(2 079.46±583.92)and(2 084.28±517.59)ng·mL-1,AUC0-t were(10 628.86±1 751.63)and(10 573.70±2 059.54)ng·h·mL-1,AUC0-∞ were(10 827.86±1 734.39)and(10 791.93±2 098.91)ng·h·mL-1,respectively;tenofovir Cmax were(286.97±85.91)and(271.79±63.64)ng·mL-1,AUC0-t were(3 087.01±707.76)and(3 023.48±612.46)ng·h·mL-1,AUC0-∞ were(3 307.08±746.76)and(3 221.56±672.44)ng·h·mL-1,respectively.The statistical results of the 90%confidence intervals of the geometric mean ratios of Cmax,AUC0-t and AUC0-∞(test preparation/reference preparation)were all within the equivalent range of 80.00%-125.00%.Conclusion The test and reference preparations of lamivudine tenofovir tablets were bioequivalent in healthy Chinese subjects under fasting and fed conditions.
10.Clinical observation on the efficacy and safety of dupilumab in the treatment of moderate to severe atopic dermatitis.
Cheng Yuan LI ; Shuang CHEN ; Wei Lu QIAN ; Liu YANG ; Qiu ZHENG ; Ai Jun CHEN ; Jin CHEN ; Kun HUANG ; Sheng FANG ; Ping WANG ; Li HU ; Xin Ran LIU ; Xiao Qin ZHAO ; Na TAN ; Tao CAI
Chinese Journal of Preventive Medicine 2023;57(10):1590-1595
To investigate the clinical efficacy and safety of dupilumab in the treatment of moderate to severe atopic dermatitis (AD) in China. A small sample self-controlled study before and after treatment was conducted to retrospective analysis patients with moderate to severe AD treated with dupilumab in the department of dermatology of the First Affiliated Hospital of Chongqing Medical University from July 2020 to March 2022. Dupilumab 600 mg was injected subcutaneously at week 0, and then 300 mg was injected subcutaneously every 2 weeks. The condition was evaluated by SCORAD(severity scoring of atopic dermatitis), NRS(numerical rating scale), DLQI(dermatology life quality index) and POEM(patient-oriented eczema measure). The improvement of SCORAD, NRS, DLQI and POEM was analyzed by paired t test and non-parametric paired Wilcoxon. The results showed that a total of 67 patients with moderate to severe AD received dupilumab treatment, of which 41 patients (the course of treatment was more than 6 weeks) had reduced the severity of skin lesions, improved quality of life and reduced pruritus. A total of 23 patients completed 16 weeks of treatment. At 4, 8, 12 and 16 weeks, SCORAD, NRS, DLQI and POEM decreased compared with the baseline, and the differences were statistically significant. SCORAD (50.13±15.19) at baseline, SCORAD (36.08±11.96)(t=6.049,P<0.001) at week 4,SCORAD (28.04±11.10)(t=10.471,P<0.001) at week 8, SCORAD (22.93±9.72)(t=12.428,P<0.001) at week 12, SCORAD (16.84±7.82)(t=14.609,P<0.001) at week 16, NRS 7(6,8) at baseline, NRS 4(3,5)(Z=-3.861,P<0.001) at week 4, NRS 2(1,4)(Z=-4.088,P<0.001) at week 8, NRS 1(0,2)(Z=-4.206,P<0.001) at week 12, NRS 2(0,2)(Z=-4.222,P<0.001) at week 16, DLQI (13.83±5.71) at baseline, DLQI (8.00±4.02)(t=6.325,P<0.001) at week 4, DLQI (5.61±3.50)(t=8.060,P<0.001) at week 8, DLQI (3.96±1.99)(t=8.717,P<0.001) at week 12, DLQI (2.70±1.89)(t=10.355,P<0.001) at week 16, POEM (18.04±6.41) at baseline, POEM (9.70±4.70)(t=7.031,P<0.001) at week 4, POEM (7.74±3.48)(t=8.806,P<0.001) at week 8, POEM (6.35±3.33)(t=10.474,P<0.001) at week 12, POEM (4.26±2.51)(t=11.996,P<0.001) at week 16. In the 16th week, 100%(23 patients), 91.3%(21 patients), 34.8%(8 patients) and 8.7%(2 patients) of 23 patients reached SCORAD30, SCORAD50, SCORAD70, and SCORAD90 statuses, respectively. There were 82.6%(19 patients), 95.7%(22 patients) and 95.7%(22 patients) of 23 patients with NRS, DLQI and POEM improved by≥4 points compared with baseline. Twelve patients with AD who continued to receive dupilumab after 16 weeks showed further improvement in skin lesions. The adverse events were conjunctivitis and injection site reaction. In conclusion, dupilumab is an effective and safe treatment for moderate and severe AD. However, the longer-term efficacy and safety require further studies involving larger sample sizes and a longer follow-up time.
Humans
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Dermatitis, Atopic/drug therapy*
;
Quality of Life
;
Retrospective Studies
;
Severity of Illness Index
;
Treatment Outcome

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