1.Chinese expert consensus on blood support mode and blood transfusion strategies for emergency treatment of severe trauma patients (version 2024)
Yao LU ; Yang LI ; Leiying ZHANG ; Hao TANG ; Huidan JING ; Yaoli WANG ; Xiangzhi JIA ; Li BA ; Maohong BIAN ; Dan CAI ; Hui CAI ; Xiaohong CAI ; Zhanshan ZHA ; Bingyu CHEN ; Daqing CHEN ; Feng CHEN ; Guoan CHEN ; Haiming CHEN ; Jing CHEN ; Min CHEN ; Qing CHEN ; Shu CHEN ; Xi CHEN ; Jinfeng CHENG ; Xiaoling CHU ; Hongwang CUI ; Xin CUI ; Zhen DA ; Ying DAI ; Surong DENG ; Weiqun DONG ; Weimin FAN ; Ke FENG ; Danhui FU ; Yongshui FU ; Qi FU ; Xuemei FU ; Jia GAN ; Xinyu GAN ; Wei GAO ; Huaizheng GONG ; Rong GUI ; Geng GUO ; Ning HAN ; Yiwen HAO ; Wubing HE ; Qiang HONG ; Ruiqin HOU ; Wei HOU ; Jie HU ; Peiyang HU ; Xi HU ; Xiaoyu HU ; Guangbin HUANG ; Jie HUANG ; Xiangyan HUANG ; Yuanshuai HUANG ; Shouyong HUN ; Xuebing JIANG ; Ping JIN ; Dong LAI ; Aiping LE ; Hongmei LI ; Bijuan LI ; Cuiying LI ; Daihong LI ; Haihong LI ; He LI ; Hui LI ; Jianping LI ; Ning LI ; Xiying LI ; Xiangmin LI ; Xiaofei LI ; Xiaojuan LI ; Zhiqiang LI ; Zhongjun LI ; Zunyan LI ; Huaqin LIANG ; Xiaohua LIANG ; Dongfa LIAO ; Qun LIAO ; Yan LIAO ; Jiajin LIN ; Chunxia LIU ; Fenghua LIU ; Peixian LIU ; Tiemei LIU ; Xiaoxin LIU ; Zhiwei LIU ; Zhongdi LIU ; Hua LU ; Jianfeng LUAN ; Jianjun LUO ; Qun LUO ; Dingfeng LYU ; Qi LYU ; Xianping LYU ; Aijun MA ; Liqiang MA ; Shuxuan MA ; Xainjun MA ; Xiaogang MA ; Xiaoli MA ; Guoqing MAO ; Shijie MU ; Shaolin NIE ; Shujuan OUYANG ; Xilin OUYANG ; Chunqiu PAN ; Jian PAN ; Xiaohua PAN ; Lei PENG ; Tao PENG ; Baohua QIAN ; Shu QIAO ; Li QIN ; Ying REN ; Zhaoqi REN ; Ruiming RONG ; Changshan SU ; Mingwei SUN ; Wenwu SUN ; Zhenwei SUN ; Haiping TANG ; Xiaofeng TANG ; Changjiu TANG ; Cuihua TAO ; Zhibin TIAN ; Juan WANG ; Baoyan WANG ; Chunyan WANG ; Gefei WANG ; Haiyan WANG ; Hongjie WANG ; Peng WANG ; Pengli WANG ; Qiushi WANG ; Xiaoning WANG ; Xinhua WANG ; Xuefeng WANG ; Yong WANG ; Yongjun WANG ; Yuanjie WANG ; Zhihua WANG ; Shaojun WEI ; Yaming WEI ; Jianbo WEN ; Jun WEN ; Jiang WU ; Jufeng WU ; Aijun XIA ; Fei XIA ; Rong XIA ; Jue XIE ; Yanchao XING ; Yan XIONG ; Feng XU ; Yongzhu XU ; Yongan XU ; Yonghe YAN ; Beizhan YAN ; Jiang YANG ; Jiangcun YANG ; Jun YANG ; Xinwen YANG ; Yongyi YANG ; Chunyan YAO ; Mingliang YE ; Changlin YIN ; Ming YIN ; Wen YIN ; Lianling YU ; Shuhong YU ; Zebo YU ; Yigang YU ; Anyong YU ; Hong YUAN ; Yi YUAN ; Chan ZHANG ; Jinjun ZHANG ; Jun ZHANG ; Kai ZHANG ; Leibing ZHANG ; Quan ZHANG ; Rongjiang ZHANG ; Sanming ZHANG ; Shengji ZHANG ; Shuo ZHANG ; Wei ZHANG ; Weidong ZHANG ; Xi ZHANG ; Xingwen ZHANG ; Guixi ZHANG ; Xiaojun ZHANG ; Guoqing ZHAO ; Jianpeng ZHAO ; Shuming ZHAO ; Beibei ZHENG ; Shangen ZHENG ; Huayou ZHOU ; Jicheng ZHOU ; Lihong ZHOU ; Mou ZHOU ; Xiaoyu ZHOU ; Xuelian ZHOU ; Yuan ZHOU ; Zheng ZHOU ; Zuhuang ZHOU ; Haiyan ZHU ; Peiyuan ZHU ; Changju ZHU ; Lili ZHU ; Zhengguo WANG ; Jianxin JIANG ; Deqing WANG ; Jiongcai LAN ; Quanli WANG ; Yang YU ; Lianyang ZHANG ; Aiqing WEN
Chinese Journal of Trauma 2024;40(10):865-881
Patients with severe trauma require an extremely timely treatment and transfusion plays an irreplaceable role in the emergency treatment of such patients. An increasing number of evidence-based medicinal evidences and clinical practices suggest that patients with severe traumatic bleeding benefit from early transfusion of low-titer group O whole blood or hemostatic resuscitation with red blood cells, plasma and platelet of a balanced ratio. However, the current domestic mode of blood supply cannot fully meet the requirements of timely and effective blood transfusion for emergency treatment of patients with severe trauma in clinical practice. In order to solve the key problems in blood supply and blood transfusion strategies for emergency treatment of severe trauma, Branch of Clinical Transfusion Medicine of Chinese Medical Association, Group for Trauma Emergency Care and Multiple Injuries of Trauma Branch of Chinese Medical Association, Young Scholar Group of Disaster Medicine Branch of Chinese Medical Association organized domestic experts of blood transfusion medicine and trauma treatment to jointly formulate Chinese expert consensus on blood support mode and blood transfusion strategies for emergency treatment of severe trauma patients ( version 2024). Based on the evidence-based medical evidence and Delphi method of expert consultation and voting, 10 recommendations were put forward from two aspects of blood support mode and transfusion strategies, aiming to provide a reference for transfusion resuscitation in the emergency treatment of severe trauma and further improve the success rate of treatment of patients with severe trauma.
2.FMO3-TMAO axis modulates the clinical outcome in chronic heart-failure patients with reduced ejection fraction: evidence from an Asian population.
Haoran WEI ; Mingming ZHAO ; Man HUANG ; Chenze LI ; Jianing GAO ; Ting YU ; Qi ZHANG ; Xiaoqing SHEN ; Liang JI ; Li NI ; Chunxia ZHAO ; Zeneng WANG ; Erdan DONG ; Lemin ZHENG ; Dao Wen WANG
Frontiers of Medicine 2022;16(2):295-305
The association among plasma trimethylamine-N-oxide (TMAO), FMO3 polymorphisms, and chronic heart failure (CHF) remains to be elucidated. TMAO is a microbiota-dependent metabolite from dietary choline and carnitine. A prospective study was performed including 955 consecutively diagnosed CHF patients with reduced ejection fraction, with the longest follow-up of 7 years. The concentrations of plasma TMAO and its precursors, namely, choline and carnitine, were determined by liquid chromatography-mass spectrometry, and the FMO3 E158K polymorphisms (rs2266782) were genotyped. The top tertile of plasma TMAO was associated with a significant increment in hazard ratio (HR) for the composite outcome of cardiovascular death or heart transplantation (HR = 1.47, 95% CI = 1.13-1.91, P = 0.004) compared with the lowest tertile. After adjustments of the potential confounders, higher TMAO could still be used to predict the risk of the primary endpoint (adjusted HR = 1.33, 95% CI = 1.01-1.74, P = 0.039). This result was also obtained after further adjustment for carnitine (adjusted HR = 1.33, 95% CI = 1.01-1.74, P = 0.039). The FMO3 rs2266782 polymorphism was associated with the plasma TMAO concentrations in our cohort, and lower TMAO levels were found in the AA-genotype. Thus, higher plasma TMAO levels indicated increased risk of the composite outcome of cardiovascular death or heart transplantation independent of potential confounders, and the FMO3 AA-genotype in rs2266782 was related to lower plasma TMAO levels.
Carnitine
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Choline/metabolism*
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Chronic Disease
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Heart Failure/genetics*
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Humans
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Methylamines
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Oxygenases
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Prospective Studies
3.Correlation between postpartum pelvic floor dysfunction and vaginal microecological imbalance in late pregnancy.
Chunxia CHENG ; Boyang GUO ; Ruizhen LI ; Wen WU ; Chunmei MI ; Xuhong LI
Journal of Central South University(Medical Sciences) 2022;47(11):1608-1614
OBJECTIVES:
Pelvic floor dysfunction (PFD) seriously affects women's physical and mental health. Pregnancy and childbirth are recognized as high-risk factors for PFD, and studies have shown that vaginal microenvironmental disorders can promote the development of pelvic organ prolapse. In this study, we intend to investigate whether the changes in vaginal microecology during pregnancy affect the pelvic floor function and participate in the development of postpartum PFD, and provide a basis for the prevention and treatment of PFD.
METHODS:
A total of 358 full-term mothers who delivered in Third Xiangya Hospital, Central South University from November 2019 to April 2020 were selected and underwent review 6 to 8 weeks after delivery. The pelvic floor structures were examined using pelvic floor ultrasound, and ultrasound values were measured at rest and at maximum Valsalva maneuver. One hundred and seventy women with PFD were assigned in a PFD group, and 188 women without PFD were assigned in a control group. The clinical data of all mothers were collected, and the clinical data and the results of microecological testing for vaginal secretions after 36 weeks of gestation and before delivery were compared between the 2 groups. The correlation of PFD with leucorrhoea cleanliness, lactobacillus level, bacterial vaginosis (BV), and vulvovaginal candidiasis (VVC) was analyzed, and logistic regression analysis was used to screen for independent risk factors for PFD.
RESULTS:
The incidences of VVC, BV, Lactobacillus vaginalis deficiency, and leucorrhoea cleanliness ≥III° were all higher in the PFD group than those in the control group (P<0.05). Among them, leukocyte cleanliness ≥III°and lack of Lactobacilli in the vagina were independent risk factors for the development of PFD, while VVC and BV were not independent risk factors for the development of PFD.
CONCLUSIONS
Postpartum PFD is related to vaginal microecological imbalance in late pregnancy, among which Lactobacillus vaginalis deficiency and leucorrhoea cleanliness ≥III° are independent risk factors for the occurrence of PFD. Therefore, pregnant women with Lactobacillus vaginalis deficiency and leucorrhoea cleanliness ≥III° in late pregnancy should pay attention to the occurrence of postpartum PFD, and early diagnosis and effective intervention of postpartum PFD should be enhanced.
Pregnancy
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Female
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Humans
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Pelvic Floor
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Mothers
4.Activating transcription factor 4 protects mice against sepsis-induced intestinal injury by regulating gut-resident macrophages differentiation
Zhenliang WEN ; Xi XIONG ; Dechang CHEN ; Lujing SHAO ; Xiaomeng TANG ; Xuan SHEN ; Sheng ZHANG ; Sisi HUANG ; Lidi ZHANG ; Yizhu CHEN ; Yucai ZHANG ; Chunxia WANG ; Jiao LIU
Chinese Medical Journal 2022;135(21):2585-2595
Background::Gut-resident macrophages (gMacs) supplemented by monocytes-to-gMacs differentiation play a critical role in maintaining intestinal homeostasis. Activating transcription factor 4 (ATF4) is involved in immune cell differentiation. We therefore set out to investigate the role of ATF4-regulated monocytes-to-gMacs differentiation in sepsis-induced intestinal injury.Methods::Sepsis was induced in C57BL/6 wild type (WT) mice and Atf4-knockdown ( Atf4+/-) mice by cecal ligation and puncture or administration of lipopolysaccharide (LPS). Colon, peripheral blood mononuclear cells, sera, lung, liver, and mesenteric lymph nodes were collected for flow cytometry, hematoxylin and eosin staining, immunohistochemistry, quantitative reverse transcription polymerase chain reaction, and enzyme-linked immunosorbent assay, respectively. Results::CD64, CD11b, Ly6C, major histocompatibility complex-II (MHC-II), CX3CR1, Ly6G, and SSC were identified as optimal primary markers for detecting the process of monocytes-to-gMacs differentiation in the colon of WT mice. Monocytes-to-gMacs differentiation was impaired in the colon during sepsis and was associated with decreased expression of ATF4 in P1 (Ly6C hi monocytes), the precursor cells of gMacs. Atf4 knockdown exacerbated the impairment of monocytes-to-gMacs differentiation in response to LPS, resulting in a significant reduction of gMacs in the colon. Furthermore, compared with WT mice, Atf4+/- mice exhibited higher pathology scores, increased expression of inflammatory factor genes ( TNF-α, IL-1β), suppressed expression of CD31 and vascular endothelial-cadherin in the colon, and increased translocation of intestinal bacteria to lymph nodes and lungs following exposure to LPS. However, the aggravation of sepsis-induced intestinal injury resulting from Atf4 knockdown was not caused by the enhanced inflammatory effect of Ly6C hi monocytes and gMacs. Conclusion::ATF4, as a novel regulator of monocytes-to-gMacs differentiation, plays a critical role in protecting mice against sepsis-induced intestinal injury, suggesting that ATF4 might be a potential therapeutic target for sepsis treatment.
5.Safety evaluation on different ventilation strategies set for neonatal respiratory distress syndrome: a network Meta-analysis
Jing WU ; Zihao WEN ; Dandan LIU ; Chenfei WU ; Yong ZHANG ; Lan ZHANG ; Youlan XU ; Guang YANG ; Chunxia JING
Chinese Journal of Epidemiology 2020;41(2):249-260
Objective To evaluate the relative safety of different ventilation methods regarding mortality and rates of complication,on neonatal respiratory distress syndrome (NRDS).Methods Network Meta-analysis was used to collect data on randomized controlled trials of pulmonary ventilation strategies in preterm infants with a mean gestational age of less than 32 weeks.Diagnostic criteria on NRDS were published in the PubMed,Cochrane,Web of Science,EBSCO,and Springer Link databases from January 1986 to June 2018.Revman 5.3 software was used to evaluate the quality of studies,based on the Cochrane quality assessment tool.Data were analyzed by Bayesian and frequency methods,using both Win BUGS 1.4.3 and STATA 13.0 software.Safety of different ventilation strategies for NRDS mortality and complications would include intraventficular hemorrhage (IVH),patent ductus arteriosus (PDA) and retinopathy of prematurity (ROP) and were evaluated.Counted data was displayed by OR and 95%CI.Results A total of 31 RCTs were included in this paper,including 5 827 preterm infants and 11 ventilation strategies.There were no statistically significant differences appearing in 11 ventilation strategies on mortality,PDA or ROE IVH results were reported in 28 studies.Compared with nasal intermittent positive pressure ventilation (NIPPV),both high-frequency oscillation ventilation (HFOV) (OR=3.33,95% CI:1.08-16.67,P<0.05) and synchronized intermittent mechanical ventilation (SIMV) (OR=8.22,95%CI:1.25-29.44,P<0.05) schemes seemed to have increased the risk of IVH in preterm infants with NRDS.NIPPV appeared the optimal ventilation strategy in the rankings of cumulative probability.Results on clustering showed that NIPPV was probably the best ventilation strategy for children with NRDS after considering the orders of IVH,PDA and ROP on mortality,respectively.However,HFOV,IMV,and SIMV did not seem to be the ideal ventilated strategies.Conclusions Most of the clinical decision makers might prefer using NIPPV in the treatment of children with NRDS through mechanical ventilation systems to reduce both the incidence and death caused by IVH,PDA and ROP.It was not recommended to use HFOV,SIMV and IMV in treating NRDS with gestational less than 32 weeks.We suggested that larger numbers of multi-center RCTs ba carried out to make the above conclusions more convincing.
6.Isolation, identification and genetic evolution analysis of Coxsackievirus A group 2 type
Ziwei LIU ; Chunxia LI ; Jing JI ; Shaoxia SONG ; Li ZHAO ; Zhiyu WANG ; Hongling WEN
Chinese Journal of Experimental and Clinical Virology 2020;34(2):160-164
Objective:To isolate and identify the virus from stool samples of children with hand, foot and mouth disease (HFMD) in Linyi City, Shandong Province in 2017, and analyze its genetic characteristics.Methods:Nucleic acid was detected in fecal specimens of children with hand, foot and mouth disease. Human rhabdomyosarcoma cells were used for virus isolation. The whole genome of the virus was sequenced, and the phylogenetic analysis and gene recombination analysis of the isolates were carried out by comparing with human enterovirus.Results:A coxsackievirus A group 2 type(CoV-A2), named SD17-430, was successfully isolated from fecal specimens of children with severe HFMD. Phylogenetic analysis further confirmed that the coxsackievirus genotype belonged to D2 genotype. The coding region of SD17-430 capsid protein had high homology with CoV-A2 international original strain, while the coding region of non-structural protein had high homology with CoV-A4 (MH086949) and CoV-A14 (KP036482).Conclusions:Compared with the original strain, CoV-A2 SD17-430 strain has a greater degree of genetic variation, and may have genetic recombination with multiple enteroviruses during its evolution. We should continue to strengthen the overall monitoring of HFMD pathogens in order to further understand the changes of pathogen spectrum and provide data reference for formulating more effective strategies for HFMD prevention and control.
7.Long term follow-up results of anlotinib in the treatment of advanced renal cell carcinoma
Yan SONG ; Chi YIHEBALI ; Lin YANG ; Chengxu CUI ; Wen ZHANG ; Yongkun SUN ; Chunxia DU ; Aiping ZHOU ; Jinwan WANG
Chinese Journal of Oncology 2020;42(9):765-770
Objective:Anlotinib is an oral multi-target tyrosine kinase inhibitor (TKI) with dual effects of anti-proliferation and anti-angiogenesis. Phase Ⅰ clinical trials showed anlotinib was well tolerated and had therapeutic effects on a variety of tumors. The aim of this study is to explore the safety and efficacy of anlotinib in the treatment of metastatic renal cell carcinoma.Methods:Between January 2014 and November 2015, a single-center data was obtained from a phase Ⅱ clinical study of anlotinib versus sunitinib on advanced renal cell carcinoma and a phase Ⅱ clinical study of anlotinib on advanced renal cell carcinoma which failed to respond to TKI treatment. Kaplan-Meier method was used for survival analysis, while Log-rank test was used to compare the survival rates.Results:A total of 36 patients with advanced renal cell carcinoma were enrolled in this study, including 19 patients without any target drug treatment, 12 patients with sunitinib treatment and 5 patients with sorafenib treatment. The median number of treatment cycle was 16. Partial response (PR) was obtained in 11 patients (30.6%) and stable disease (SD) was obtained in 24 patients (66.7%). The disease control rate (DCR) was 97.2%. The median progression free survival (PFS) was 12.6 months, the 1-year survival rate was 80.6%, and the median survival time was 22.2 months. Up to the follow-up deadline, 3 patients still received treatment, the PFSs were 52.6 months, 65.0 months, and 66.7 months. The most common treatment-related adverse events of grade 3 or 4 included hypertension (19.4%), hand-foot skin reaction (11.1%), proteinuria (5.6%) and anemia (5.6%).Conclusions:Anlotinib shows good anti-tumor activity and is generally well-tolerated in the treatment of advanced renal cell carcinoma. The adverse reactions of anlotinib are milder than sunitinib or pazopanib.
8.Long term follow-up results of anlotinib in the treatment of advanced renal cell carcinoma
Yan SONG ; Chi YIHEBALI ; Lin YANG ; Chengxu CUI ; Wen ZHANG ; Yongkun SUN ; Chunxia DU ; Aiping ZHOU ; Jinwan WANG
Chinese Journal of Oncology 2020;42(9):765-770
Objective:Anlotinib is an oral multi-target tyrosine kinase inhibitor (TKI) with dual effects of anti-proliferation and anti-angiogenesis. Phase Ⅰ clinical trials showed anlotinib was well tolerated and had therapeutic effects on a variety of tumors. The aim of this study is to explore the safety and efficacy of anlotinib in the treatment of metastatic renal cell carcinoma.Methods:Between January 2014 and November 2015, a single-center data was obtained from a phase Ⅱ clinical study of anlotinib versus sunitinib on advanced renal cell carcinoma and a phase Ⅱ clinical study of anlotinib on advanced renal cell carcinoma which failed to respond to TKI treatment. Kaplan-Meier method was used for survival analysis, while Log-rank test was used to compare the survival rates.Results:A total of 36 patients with advanced renal cell carcinoma were enrolled in this study, including 19 patients without any target drug treatment, 12 patients with sunitinib treatment and 5 patients with sorafenib treatment. The median number of treatment cycle was 16. Partial response (PR) was obtained in 11 patients (30.6%) and stable disease (SD) was obtained in 24 patients (66.7%). The disease control rate (DCR) was 97.2%. The median progression free survival (PFS) was 12.6 months, the 1-year survival rate was 80.6%, and the median survival time was 22.2 months. Up to the follow-up deadline, 3 patients still received treatment, the PFSs were 52.6 months, 65.0 months, and 66.7 months. The most common treatment-related adverse events of grade 3 or 4 included hypertension (19.4%), hand-foot skin reaction (11.1%), proteinuria (5.6%) and anemia (5.6%).Conclusions:Anlotinib shows good anti-tumor activity and is generally well-tolerated in the treatment of advanced renal cell carcinoma. The adverse reactions of anlotinib are milder than sunitinib or pazopanib.
9. Cost-effectiveness analysis of cervical cancer screening strategies in urban China
Jieru PENG ; Siyuan TAO ; Ying WEN ; Xue YANG ; Jianqiao MA ; Fei ZHAO ; Zhiyu CHEN ; Guiting ZHANG ; Youlin QIAO ; Fanghui ZHAO ; Chunxia YANG
Chinese Journal of Oncology 2019;41(2):154-160
Objective:
To explore the most economically feasible cervical cancer screening strategies in urban China.
Methods:
A series of Markov models were constructed to evaluate health and economic outcomes of different screening strategies. There were 24 screening strategies including four screening methods: liquid-based cytology (LBC), human papillomavirus (HPV) DNA genotyping, HPV DNA genotyping with LBC triage (HPV DNA+ LBC), HPV DNA genotyping and LBC co-testing (HPV DNA-LBC), along with three intervals (every 1, 3 or 5 years) and two starting age for screening (30 or 35 years old) were compared. Models parameters were obtained from a cervical cancer screening study in urban China and literature reviews.
Results:
The cumulative incidence and mortality risk of cervical cancer declined over 69% and 82% respectively for each screening strategy as compared with the no screening scenario. LBC every five years starting from 35 years old strategy cost the least (RMB 690 per capita) and could save life years compared with no screening. The cost effectiveness ratios of 24 strategies ranged from -10 903 to 117 992 RMB per life year saved. All strategies were cost-effective compared to no screening. In the incremental cost-effectiveness analysis, LBC every 5 years starting from 30 strategy, HPV DNA genotyping every 3 years starting from 30 strategy, LBC every 3 years starting from 30 strategy and LBC every year starting from 30 strategy were dominant strategies.
Conclusions
Screening can effectively prevent cervical cancer. In urban Chinese areas with insufficient socioeconomic resources, LBC every 5 years from 35 years old strategy is recommended. In relatively more affluent areas, LBC every 5 years from 30 years old strategy, LBC every 3 years from 30 years old strategy, HPV DNA genotyping every 3 years from 30 years old strategy, and LBC every year from 30 years old strategy are recommended successively.
10. A phase II, single-arm, open-label, multicenter clinical study to evaluate the efficacy and safety of sofosbuvir combined with ribavirin in patients with genotype 2 chronic hepatitis C virus infection
Yinghui GAO ; Guangming LI ; Qinglong JIN ; Yingren ZHAO ; Zhansheng JIA ; Xiaorong MAO ; Yongfeng YANG ; Jia SHANG ; Gongchen WANG ; Wen XIE ; Shanming WU ; Mingxiang ZHANG ; Jinlin HOU ; Dongliang LI ; Yuemin NAN ; Yujuan GUAN ; Chunxia ZHU ; Yangzhou YUAN ; Lai WEI
Chinese Journal of Hepatology 2019;27(5):352-357
Objective:
To evaluate the efficacy and safety of sofosbuvir (Nanjing Zhengda Tianqing Pharmaceutical Co., Ltd.) combined with ribavirin in patients with genotype 2 chronic hepatitis C virus infection.
Methods:
Treatment-naïve or treatment experienced genotype 2 chronic hepatitis C patients from sixteen research centers of China were screened. All subjects received once-daily dose of sofosbuvir (400 mg) combined with ribavirin (body weight < 75 kg, 1 000 mg/day, 400 mg in the morning and 600 mg in the evening; body weight > 75 kg, 1 200 mg/d, 600 mg in the morning and 600 mg in the evening) for 12 weeks. Patients were followed-up for a period of 12 weeks after discontinuation of treatment. Continuous variables were expressed as mean ± standard deviation. The proportion of subjects with virologic response at different follow-up time points and 95% confidence intervals were estimated by maximum likelihood ratio and Clopper-Pearson interval.
Results:
132 cases with genotype 2 chronic hepatitis C virus infection from sixteen research centers of China were included, 12 cases of whom were associated with cirrhosis, and the remaining 120 cases were not associated with cirrhosis. One hundred and thirty-one cases completed the study, and one patient lost to follow-up at week 4 after the end of treatment. The sustained virological response rate was 96.2% (95% confidence interval: 92.37% - 99.16%) after 12 weeks of drug withdrawal. Virological relapse occurred in four cases. Of the 132 subjects enrolled in the study, 119 (90.2%) reported 617 adverse events during treatment, of which 359 (76.5%) were TEAE related to sofosbuvir and/or ribavirin. There were nine TEAEs of grade 3 and above, and six cases (4.5%) of them had six severe adverse events. Only one serious adverse event was associated with sofosbuvir and ribavirin (unstable angina pectoris). There were no adverse events leading to drug discontinuation or death.
Conclusion
Sofosbuvir combined with ribavirin has a high SVR rate in the treatment of genotype 2 chronic hepatitis C virus infection, and most of the adverse events occurred were mild with acceptable safety profile.

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