1.Effects of Yupingfeng Powder on PD-L1 expression and T cell function in lung cancer cells
Zhen-Zhong YE ; Shi-Jie LI ; Cai-Qin NIU
Chinese Traditional Patent Medicine 2024;46(6):1850-1856
AIM To explore the effects of Yupingfeng Powder on the binding of programmed death receptor 1(PD-1)and programmed death ligand 1(PD-L1),and the growth of lung cancer cells in vitro and in vivo.METHODS Yupingfeng Powder extract had its effect on the growth of Lewis lung carcinoma(LLC)cells in mice detected by MTT assay;its effect on eliminating target cells in the co-culture of T cells and LCC cells detected by lactate dehydrogenase(LDH)release test;its effect on blocking the combination of PD-1 and PD-L1,and its influence on the levels of interferon-γ(IFN-γ)and tumor necrosis factor-α(TNF-α)release detected by enzyme-linked immunosorbent assay(ELISA);its inhibitory effect on the growth of LLC cells in vivo analyzed by homologous tumor model;its effect on the infiltration of CD4+T cells and CD8+T cells in tumor tissues investigated by immunohistochemical staining.RESULTS Yupingfeng Powder inhibited the growth of LLC cells and the expression of endogenous PD-L1 protein in a dose-dependent manner(P<0.05,P<0.01),competitively blocked the combination of PD-1 and PD-L1(P<0.05,P<0.01),and promoted the release of IFN-γ and TNF-α from T cells(P<0.05,P<0.01).Yupingfeng Powder inhibited the growth of LLC tumor(P<0.01),and increased the infiltration of CD4+T and CD8+T cells(P<0.01).CONCLUSION Yupingfeng Powder exhibits its in vitro capability in blocking the PD-L1 inhibition on T cells,and its in vivo anti-tumor effect in terms of the improvement of CD4+T cells and CD8+T cells in this homologous mouse tumor model.
2.Expert consensus on the diagnosis and treatment of osteoporotic proximal humeral fracture with integrated traditional Chinese and Western medicine (version 2024)
Xiao CHEN ; Hao ZHANG ; Man WANG ; Guangchao WANG ; Jin CUI ; Wencai ZHANG ; Fengjin ZHOU ; Qiang YANG ; Guohui LIU ; Zhongmin SHI ; Lili YANG ; Zhiwei WANG ; Guixin SUN ; Biao CHENG ; Ming CAI ; Haodong LIN ; Hongxing SHEN ; Hao SHEN ; Yunfei ZHANG ; Fuxin WEI ; Feng NIU ; Chao FANG ; Huiwen CHEN ; Shaojun SONG ; Yong WANG ; Jun LIN ; Yuhai MA ; Wei CHEN ; Nan CHEN ; Zhiyong HOU ; Xin WANG ; Aiyuan WANG ; Zhen GENG ; Kainan LI ; Dongliang WANG ; Fanfu FANG ; Jiacan SU
Chinese Journal of Trauma 2024;40(3):193-205
Osteoporotic proximal humeral fracture (OPHF) is one of the common osteoporotic fractures in the aged, with an incidence only lower than vertebral compression fracture, hip fracture, and distal radius fracture. OPHF, secondary to osteoporosis and characterized by poor bone quality, comminuted fracture pattern, slow healing, and severely impaired shoulder joint function, poses a big challenge to the current clinical diagnosis and treatment. In the field of diagnosis, treatment, and rehabilitation of OPHF, traditional Chinese and Western medicine have accumulated rich experience and evidence from evidence-based medicine and achieved favorable outcomes. However, there is still a lack of guidance from a relevant consensus as to how to integrate the advantages of the two medical systems and achieve the integrated diagnosis and treatment. To promote the diagnosis and treatment of OPHF with integrated traditional Chinese and Western medicine, relevant experts from Orthopedic Expert Committee of Geriatric Branch of Chinese Association of Gerontology and Geriatrics, Youth Osteoporosis Group of Orthopedic Branch of Chinese Medical Association, Osteoporosis Group of Orthopedic Surgeon Branch of Chinese Medical Doctor Association, and Osteoporosis Committee of Shanghai Association of Integrated Traditional Chinese and Western Medicine have been organized to formulate Expert consensus on the diagnosis and treatment of osteoporotic proximal humeral fracture with integrated traditional Chinese and Western medicine ( version 2024) by searching related literatures and based on the evidences from evidence-based medicine. This consensus consists of 13 recommendations about the diagnosis, treatment and rehabilitation of OPHF with integrated traditional Chinese medicine and Western medicine, aimed at standardizing, systematizing, and personalizing the diagnosis and treatment of OPHF with integrated traditional Chinse and Western medicine to improve the patients ′ function.
3.Improvement of Core Behavior in Autism Spectrum Disorder Mice by 8-Week Aerobic Exercise
Niu LIU ; Ya-Qi XUE ; Shi-Jiao WANG ; Zhi-Ping ZHEN
Progress in Biochemistry and Biophysics 2024;51(9):2168-2181
ObjectiveTo investigate the effect of 8-week aerobic exercise on the improvement of core behaviors of male and female autistic mice induced by valproic acid (VPA). MethodsExperimental mice were randomly divided into the control group (CTL), VPA-induced autism group (VPA) and VPA+aerobic exercise group (VEX), with 10 mice in each group. The pregnant mice were injected with VPA intraperitoneally at E12.5, and their offspring were used as autistic mice. Pups were weaned 28 d after birth and began an 8-week aerobic exercise intervention. The day after exercise, mice were tested in behavioral experiments to detect exploratory behavior, social skills, repetitive stereotypic behavior, cognitive ability and mood. The mice were tested for social skills, repetitive stereotyped behaviors, cognitive and learning memory abilities, exploratory behaviors, and emotions by behavioral assays on the following day after the exercise. ResultsBoth male and female mice in the CTL group showed a significant decrease in the total distance and percentage of time spent in the interaction zone in the 4th socialization compared to the 1st socialization (P<0.01); the total distance and percentage of time spent in the interaction zone in the 5th socialization was significantly increased compared to the 4th socialization (P<0.01); in VPA group, both male and female mice showed no significant change in the total distance and percentage of time spent in the interaction zone in the 4th and 5th socialization; in the VEX group, the total distance and percentage of time spent in the interaction zone by male mice in the 4th socialization was significantly decreased compared to the 1st socialization (P<0.01, P<0.05); and in the VEX group the total distance and percentage of time spent in the social interaction zone by both male and female mice in the 5th socialization was significantly increased compared to the 4th socialization (P<0.01, P<0.05). The results of the first phase of three-box socialization experiment showed that male and female mice in the CTL group spent more time socializing with their social partners than in contact with the empty cages (P<0.01); there was no difference in the time spent by male and female mice in the VPA group in socializing with their social partners and the empty cages; and male and female mice in the VEX group spent a longer time socializing with their social partners(P<0.01). The results of the second phase of three-box test showed that male and female mice in the CTL group showed a significant tendency to socialize with new social partners (P<0.01), whereas no significant changes were observed in the mice of VPA group; aerobic exercise significantly ameliorated this deficit in male and female mice with autism. Compared with the CTL group, VPA-induced significant decreases were observed in the total distance freely moved in the central area of the open field, the time and percentage of time spent in the open arm of cross maze, and the distance and time spent in the white box in both male and female autistic mice (P<0.01); a significant increase in the number of bead burials and time spent in self-grooming (P<0.01); a significant decrease in the cognitive index (P<0.01); a significantly longer latency to find the platform, and significantly decreased the percentage of time spent in the target quadrant and the number of times they traversed the platform (P<0.01). Compared with the VPA group, after 8 weeks of aerobic intervention, male and female mice in the VEX group showed a significant increase in total distance, open-arm dwell time, and percentage of free movement in the central area of the empty field (P<0. 05), and a trend toward a decrease in the dwell time of females in the white box was not significant, the number of beads burying and the time of self-combing were significantly lower(P<0.01, P<0.05); and a significant increase in cognitive index (P<0.05), a significantly shorter time to find the platform, and significantly increased percentage of time spent in the target quadrant and the number of times they traversed the platform (P<0.01), showing excellent learning memory. ConclusionAutistic mice severely suffer from social and cognitive impairments, repetitive stereotyped behaviors, decreased activity level, and the exhibition of anxiety. 8 weeks of aerobic exercise can improve the social and cognitive abilities, alleviate the stereotyped repetitive behaviors, increase the activity level, and positively regulate the anxiety in autistic mice. It is hypothesized that aerobic exercise has an important role in motor rehabilitation of autism, in order to provide a theoretical basis for clinical research.
4.Analysis of influencing factors and clinical value of anterior peritoneal reflection for patients with rectal cancer.
Hua Qing ZHANG ; Shi Tian WANG ; Zhen SUN ; Guo Le LIN ; Bin WU ; Bei Zhan NIU ; Jun Yang LU ; Lai XU ; Yi XIAO
Chinese Journal of Surgery 2023;61(9):791-797
Objectives: To investigate the factors influencing the height of anterior peritoneal reflection (APR) for patients with rectal cancer, and to analyze the relationship between the APR and the lateral lymph node metastasis. Methods: Clinical data of 432 patients with tumor located within and below APR were retrospectively collected from the rectal cancer database at the Department of General Surgery, Peking Union Medical College Hospital from August 2020 to September 2022. Ninty-eight non-rectal cancer patients were also enrolled as a control group. There were 308 males and 124 females in the tumor group, aged (M(IQR)) 62 (16) years (range: 24 to 85 years) and 53 males and 45 females in the control group, aged 60 (22) years (range: 27 to 87 years). The APR height, pelvis, and tumor-related parameters were measured by MRI. A multifactor linear regression model was established to analyze the dependent correlation factors of APR height. These factors of the two groups were matched by propensity score matching and their APR heights were compared after matching. An ordinal Logistic regression model was established to explore the relationship between APR-related parameters and radiographic lateral lymph node metastasis. Results: The APR height of the tumor group was (98.7±14.4) mm (range: 43.3 to 154.0 mm) and the control group was (95.1±12.7) mm (range: 68.0 to 137.9 mm). Multivariable linear regression revealed that the greater the weight (B=0.519, 95%CI: 0.399 to 0.640, P<0.01), the anterior pelvic depth (B=0.109, 95%CI: 0.005 to 0.213, P=0.039) and the smaller the bi-ischial diameter (B=-0.172, 95%CI:-0.294 to -0.049, P=0.006), the higher the APR height. The tumor group had a higher APR height than the control group after propensity score matching ((98.3±14.2) mm vs. (95.1±12.7) mm, t=-1.992, P=0.047). Ordinal Logistic regression indicated that the longer segment of the tumor invade the nonperitoneal rectum was an independent influencing factor of radiographic lateral lymph node metastasis (OR=1.016, 95%CI: 1.002 to 1.030, P=0.021), while the distance between the anal verge and the tumor was not (OR=0.986, 95%CI: 0.972 to 1.000, P=0.058). Conclusions: The higher the weight, the deeper and narrower the pelvis, the higher the APR height. There is a certain relationship between APR and lateral lymph node metastasis on imaging.
5.Effects of short-segment pedicle screw internal fixation surgery combined with hyperbaric oxygen treatment for acute spinal injury on the morphology and function of the spine.
Shi-Zhen NIU ; Tong NIU ; Yong NI ; Jian-Wen GAO ; Feng-Qing YANG
China Journal of Orthopaedics and Traumatology 2022;35(8):785-789
OBJECTIVE:
To explore effect of short-segment pedicle screw internal fixation combined with hyperbaric oxygen in treating acute spinal fractures and its influence on recovery of spinal nerve function.
METHODS:
A total of 96 patients with acute spinal fracture admitted from February 2017 to March 2020 were divided into combined group and control group, with 48 cases in each group. Both groups were treated with short-segment pedicle screw internal fixation. The combined group was given hyperbaric oxygen after surgery. The operation time, surgical blood loss, incision length and other general operation conditions between two groups were recorded. The differences in spinal morphology and function, Ameraican Spinal Injury Assiciation(ASIA) neurological function grade, serum inflammatory factors and ability of daily living activities were observed before and after surgery.
RESULTS:
There was no significant difference in operation time, surgical blood loss, and incision length between combined group and control group(P>0.05). There were no significant differences in anterior height ratio and Cobb angle between two groups before surgery, 1 week and 6 months after surgery(P>0.05). The height ratio of anterior margin of the injured spine was significantly improved in both groups at 1 week and 6 months after surgery compared with preoperative period (P<0.05), and Cobb angle was significantly reduced in both groups compared with preoperative period (P<0.05). There was no statistically significant difference in serum interleukin-6(IL-6), interleukin-8(IL-8), and tumor necrosis factor-α(TNF-α) levels between two groups at 1 d after surgery(P>0.05);the serum IL-6, IL-8, and TNF-α levels of combined group were lower than those of control group at 1 week after surgery (P<0.05). At 6 months after surgery, ASIA neurological function grade of combined group was C grade in 2 cases, D grade in 23 cases, E grade in 22 cases. In control group, 7 cases was grade C, 26 cases was grade D, 13 cases was grade E, and the difference between two groups was statistically significant(P<0.05). The Barthel score of combined group was higher than that of control group at 1 month and 3 months after surgery, and the difference was statistically significant (P<0.05);at 6 months after surgery, there was no significant difference in Barthel score between two groups(P>0.05).
CONCLUSION
Short-segment pedicle screw internal fixation combined with hyperbaric oxygen for the treatment of acute spinal fractures is beneficial to the recovery of spinal nerve function after surgery, and has a certain effect on the early improvement of the patients' activities of daily living.
Activities of Daily Living
;
Blood Loss, Surgical
;
Fracture Fixation, Internal
;
Humans
;
Hyperbaric Oxygenation
;
Interleukin-6
;
Interleukin-8
;
Lumbar Vertebrae/surgery*
;
Oxygen
;
Pedicle Screws
;
Retrospective Studies
;
Spinal Fractures/surgery*
;
Thoracic Vertebrae/injuries*
;
Treatment Outcome
;
Tumor Necrosis Factor-alpha
6.COVID-19 treated with oral Nirmatrelvir-Ritonavir in 3 children.
Shuang SHI ; Na DONG ; Ying DING ; Chao WANG ; Lang YUAN ; Yong Shuang FANG ; Bing Jie WANG ; Yan Hua NIU ; Zhen Zhen WEI ; Tian PU ; Xiao Yan DONG ; Quan LU
Chinese Journal of Pediatrics 2022;60(11):1168-1171
Objective: To summarize the application experience and the therapeutic effect of Nirmatrelvir-Ritonavir (trade name: Paxlovid) for COVID-19 in children. Methods: A retrospective analysis was performed on the clinical data, including collecting the clinical manifestations and clinical outcomes, dynamically monitoring the blood routine, hepatic and renal function and SARS-CoV-2 nucleic acid results, and observing the related side effects during the treatment, etc, of 3 cases with COVID-19 treated with Paxlovid admitted to Shanghai Children's Hospital (designated referral hospital for SARS-CoV-2 infection in Shanghai) from May 1st to June 1st, 2022. Results: The 3 cases were 12, 14, 17 years of age, among which 2 cases were males, 1 case was female. All 3 cases were mild cases with underlying diseases and risk of developing into severe COVID-19, with symptoms of high fever, sore throat and dry cough. The treatment of Paxlovid at 3rd day of symptom onset contributed to the symptom-free after 1-2 days and negative results of SARS-CoV-2 nucleic acid after 2-4 days. All patients had no adverse manifestations of gastrointestinal tract and nervous system but a case had little skin rashes, which recovered after the withdrawal of Paxlovid. Three cases had normal hepatic and renal function during the Paxlovid treatment. At 3 months after discharge, no clinical manifestations of post-COVID syndrome were found in all 3 cases. Conclusion: Paxlovid was effective and relatively safe in the treatment of 3 children with COVID-19.
Child
;
Male
;
Humans
;
Female
;
COVID-19
;
SARS-CoV-2
;
Ritonavir/therapeutic use*
;
Retrospective Studies
;
China
;
Nucleic Acids
;
COVID-19 Drug Treatment
7.Clinical application value of transthoracic echocardiography during perioperative period in patients undergoing left ventricular assist device implantation.
Yi Sheng SHI ; Li Li NIU ; Zhen Hui ZHU ; Yu LIANG ; Hao WANG ; Juan DU ; Xian Qiang WANG ; Hai Bo CHEN ; Sheng Shao HU
Chinese Journal of Cardiology 2021;49(6):610-614
Objective: To observe the changes of parameters derived from transthoracic echocardiography (TTE) before and after left ventricular assist device (LVAD) implantation, and to evaluate the clinical value of TTE in the perioperative period of LVAD implantation. Methods: This is a retrospective study. The data of patients who underwent LVAD implantation in Fuwai Hospital from January 2018 to December 2020 were analyzed retrospectively. The TTE parameters, N-terminal pro-B-type natriuretic peptide (NT-proBNP) and total bilirubin (TBil) before and 1 month after LVAD implantation were collected and analyzed. Results: A total of 12 male patients undergoing LVAD implantation were included in this study. The mean age was (43.3±8.6) years. The left atrial volume index ((41.4±12.8)ml/m2 vs. (74.9±30.7)ml/m2, P<0.001), left ventricular end-diastolic volume index ((152.1±35.3)ml/m2 vs. (205.5±35.7)ml/m2, P<0.001), left ventricular end-systolic volume index ((112.5±27.9)ml/m2 vs. (155.1±29.1)ml/m2, P<0.001), right atrial diameter index ((23.7±3.5)mm/m2 vs. (27.2±5.8)mm/m2, P=0.023), right ventricular internal diameter at end-diastole ((24.6±2.7)mm vs. (30.0±4.8)mm, P<0.001), tricuspid annular plane systolic excursion ((11.5±2.9)mm vs. (14.6±2.8)mm, P=0.007), systolic pulmonary arterial pressure ((29.2±4.8) mmHg vs. (55.1±19.3) mmHg, P<0.001, 1 mmHg=0.133 kPa) were significantly reduced at 1 month post LVAD implantation as compared to before LVAD implantation. The aortic sinus diameter ((33.8±4.7)mm vs. (31.6±5.1)mm, P=0.007), left ventricular ejection fraction ((26.3±3.0)% vs. (23.8±4.4)%, P=0.016), right ventricular fractional area change ((31.0±8.6)% vs. (23.8±5.5)%, P=0.004) at 1 month post LVAD implantation were significantly higher than before LVAD implantation. The degree of mitral and tricuspid regurgitation decreased, and the inspiratory collapse rate of inferior vena cava increased (all P<0.05). NT-proBNP ((1 418.4±812.6)ng/L vs. (5 097.5±3 940.4)ng/L, P=0.004) and TBil ((12.4±5.4)μmol/L vs. (27.5±14.0)μmol/L, P=0.001) decreased significantly at 1 month post LVAD implantation. Conclusions: TTE results show that LVAD could effectively relieve left ventricular load and improve right ventricular function. TTE can monitor the cardiac structural and functional changes during the perioperative period of LVAD implantation, and provide the imaging evidence for clinical evaluation of the therapeutic effect of LVAD.
Adult
;
Echocardiography
;
Heart Failure/surgery*
;
Heart-Assist Devices
;
Humans
;
Male
;
Middle Aged
;
Perioperative Period
;
Retrospective Studies
;
Stroke Volume
;
Ventricular Function, Left
8.Three-year Follow-up on the Safety and Effectiveness of Rituximab Plus Chemotherapy as First-Line Treatment of Diffuse Large B-Cell Lymphoma and Follicular Lymphoma in Real-World Clinical Settings in China: A Prospective, Multicenter, Noninterventional Study.
Jian-Qiu WU ; Yong-Ping SONG ; Li-Ping SU ; Ming-Zhi ZHANG ; Wei LI ; Yu HU ; Xiao-Hong ZHANG ; Yu-Huan GAO ; Zuo-Xing NIU ; Ru FENG ; Wei WANG ; Jie-Wen PENG ; Xiao-Lin LI ; Xue-Nong OUYANG ; Chang-Ping WU ; Wei-Jing ZHANG ; Yun ZENG ; Zhen XIAO ; Ying-Min LIANG ; Yong-Zhi ZHUANG ; Ji-Shi WANG ; Zi-Min SUN ; Hai BAI ; Tong-Jian CUI ; Ji-Feng FENG
Chinese Medical Journal 2018;131(15):1767-1775
Background:
Prospective real-life data on the safety and effectiveness of rituximab in Chinese patients with diffuse large B-cell lymphoma (DLBCL) or follicular lymphoma (FL) are limited. This real-world study aimed to evaluate long-term safety and effectiveness outcomes of rituximab plus chemotherapy (R-chemo) as first-line treatment in Chinese patients with DLBCL or FL. Hepatitis B virus (HBV) reactivation management was also investigated.
Methods:
A prospective, multicenter, single-arm, noninterventional study of previously untreated CD20-positive DLBCL or FL patients receiving first-line R-chemo treatment at 24 centers in China was conducted between January 17, 2011 and October 31, 2016. Enrolled patients underwent safety and effectiveness assessments after the last rituximab dose and were followed up for 3 years. Effectiveness endpoints included progression-free survival (PFS) and overall survival (OS). Safety endpoints were adverse events (AEs), serious AEs, drug-related AEs, and AEs of special interest. We also reported data on the incidence of HBV reactivation.
Results:
In total, 283 previously untreated CD20-positive DLBCL and 31 FL patients from 24 centers were enrolled. Three-year PFS was 59% (95% confidence interval [CI]: 50-67%) for DLBCL patients and 46% (95% CI: 20-69%) for FL patients. For DLBCL patients, multivariate analyses showed that PFS was not associated with international prognostic index, tumor maximum diameter, HBV infection status, or number of rituximab treatment cycles, and OS was only associated with age >60 years (P < 0.05). R-chemo was well tolerated. The incidence of HBV reactivation in hepatitis B surface antigen (HBsAg)-positive and HBsAg-negative/hepatitis B core antibody-positive patients was 13% (3/24) and 4% (3/69), respectively.
Conclusions:
R-chemo is effective and safe in real-world clinical practice as first-line treatment for DLBCL and FL in China, and that HBV reactivation during R-chemo is manageable with preventive measures and treatment.
Trial Registration
ClinicalTrials.gov, NCT01340443; https://clinicaltrials.gov/ct2/show/NCT01340443.
Aged
;
Aged, 80 and over
;
Antineoplastic Combined Chemotherapy Protocols
;
therapeutic use
;
China
;
Cyclophosphamide
;
administration & dosage
;
Doxorubicin
;
administration & dosage
;
Female
;
Follow-Up Studies
;
Humans
;
Lymphoma, Follicular
;
drug therapy
;
Lymphoma, Large B-Cell, Diffuse
;
drug therapy
;
Male
;
Middle Aged
;
Prospective Studies
;
Rituximab
;
therapeutic use
;
Vincristine
;
administration & dosage
9.Correlation analysis between position of head, cervical curvature classification and balance of cervical spine through lateral plain radiograph measurement.
Kuan WANG ; Zhen DENG ; Hui-Hao WANG ; Zheng-Yan LI ; Wen-Xin NIU ; Bo CHEN ; Ming-Cai ZHANG ; Wei-An YUAN ; Hong-Sheng ZHAN
China Journal of Orthopaedics and Traumatology 2017;30(5):458-462
OBJECTIVETo analyze the relationship between position of head, cervical curvature type and associated cervical balance parameters in a neutral looking-forward posture.
METHODSCervical lateral X-rays of 60 patients with cervical spondylosis were selected from January to December 2015. There were 22 males and 38 females with an average age of (35.5±10.9) years old. The measured parameters included cervical curvature type, McGregor slope, C2 lower end plate slope, T1 slope, center of gravity to C7 sagittal vertical offset (CG-C7 SVA), and C2 to C7 sagittal vertical offset (C2-C7 SVA). The parameters were analyzed using Spearman correlation.
RESULTSThe cervical curvature type was significantly correlated with C2 lower endplate slope, C0-C2 angle (total degree of C2 lower endplate slope plus McGregor slope), CG-C7 SVA and T1 slope (<0.05), but it was not significantly correlated McGregor slope (>0.05). C2 lower endplate slope and C2-C7 SVA (r=0.87) were significantly (<0.05) correlated with CG-C7 SVA (<0.05).
CONCLUSIONSThere was certain some relationship among position of head, cervical curvature type and associated cervical balance parameters in a neutral looking-forward posture. The center of gravity of the head would backwards shift following faced upward. A position of extension with posterior-shifting of the head would suggest that it may be accompanied with a relatively normal lordosis of the cervical spine. Some patients with abnormal curvature showed slightly bended head in the natural posture. Health education toward these people would be meaningful to restore the balance of their neck.
10. Efficacy and safety of pegylated interferon α-2b injection (Y shape, 40 kD) in treatment of patients with genotype 1/6 chronic hepatitis C
Bo FENG ; Jia SHANG ; Shuhuan WU ; Hong CHEN ; Ying HAN ; Yueqi LI ; Dazhi ZHANG ; Longfeng ZHAO ; Shaofeng WEI ; Qing MAO ; Zhibiao YIN ; Tao HAN ; Maorong WANG ; Shijun CHEN ; Jun LI ; Qing XIE ; Zhen ZHEN ; Zhiliang GAO ; Yuexin ZHANG ; Guozhong GONG ; Dongliang YANG ; Chen PAN ; Jifang SHENG ; Hong TANG ; Qin NING ; Guangfeng SHI ; Junqi NIU ; Guanghan LUO ; Yongtao SUN ; Hong YOU ; Guiqiang WANG ; Lunli ZHANG ; Jie PENG ; Qin ZHANG ; Jiajun LIU ; Chengwei CHEN ; Xinyue CHEN ; Wei ZHAO ; Runhua WANG ; Li SUN ; Lai WEI
Chinese Journal of Hepatology 2017;25(3):187-194
Objective:
To investigate the efficacy and safety of the new investigational drug pegylated interferon α-2b (Peg-IFN-α-2b) (Y shape, 40 kD) injection (180 µg/week) combined with ribavirin in the treatment of patients with genotype 1/6 chronic hepatitis C (CHC), with standard-dose Peg-IFN-α-2a combined with ribavirin as a positive control.
Methods:
A multicenter, randomized, open-label, and positive-controlled phase III clinical trial was performed. Eligible patients with genotype 1/6 CHC were screened out and randomly divided into Peg-IFN-α-2b(Y shape, 40kD) group and Peg-IFN-α-2a group at a ratio of 2:1. The patients in both groups were given oral ribavirin for 48 weeks in addition and then followed up for 24 weeks after drug withdrawal. Abbott Real Time HCV Genotype II was used to determine HCV genotype, and Cobas TaqMan quantitative real-time PCR was used to measure HCV RNA level at 0, 4, 12, 24, 48, and 72 weeks. Adverse events were recorded in detail. The primary efficacy endpoint was sustained virological response (SVR), and a non-inferiority test was also performed.
Results:
A total of 561 patients with genotype 1/6 CHC were enrolled, among whom 529 received treatment; 90.9% of these patients had genotype 1 CHC. The data of the full analysis set showed that SVR rate was 69.80% (95%

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