1.Risk factors for bronchopulmonary dysplasia in twin preterm infants:a multicenter study
Yu-Wei FAN ; Yi-Jia ZHANG ; He-Mei WEN ; Hong YAN ; Wei SHEN ; Yue-Qin DING ; Yun-Feng LONG ; Zhi-Gang ZHANG ; Gui-Fang LI ; Hong JIANG ; Hong-Ping RAO ; Jian-Wu QIU ; Xian WEI ; Ya-Yu ZHANG ; Ji-Bin ZENG ; Chang-Liang ZHAO ; Wei-Peng XU ; Fan WANG ; Li YUAN ; Xiu-Fang YANG ; Wei LI ; Ni-Yang LIN ; Qian CHEN ; Chang-Shun XIA ; Xin-Qi ZHONG ; Qi-Liang CUI
Chinese Journal of Contemporary Pediatrics 2024;26(6):611-618
Objective To investigate the risk factors for bronchopulmonary dysplasia(BPD)in twin preterm infants with a gestational age of<34 weeks,and to provide a basis for early identification of BPD in twin preterm infants in clinical practice.Methods A retrospective analysis was performed for the twin preterm infants with a gestational age of<34 weeks who were admitted to 22 hospitals nationwide from January 2018 to December 2020.According to their conditions,they were divided into group A(both twins had BPD),group B(only one twin had BPD),and group C(neither twin had BPD).The risk factors for BPD in twin preterm infants were analyzed.Further analysis was conducted on group B to investigate the postnatal risk factors for BPD within twins.Results A total of 904 pairs of twins with a gestational age of<34 weeks were included in this study.The multivariate logistic regression analysis showed that compared with group C,birth weight discordance of>25%between the twins was an independent risk factor for BPD in one of the twins(OR=3.370,95%CI:1.500-7.568,P<0.05),and high gestational age at birth was a protective factor against BPD(P<0.05).The conditional logistic regression analysis of group B showed that small-for-gestational-age(SGA)birth was an independent risk factor for BPD in individual twins(OR=5.017,95%CI:1.040-24.190,P<0.05).Conclusions The development of BPD in twin preterm infants is associated with gestational age,birth weight discordance between the twins,and SGA birth.
2.Analysis of the causes of cage subsidence after oblique lateral lumbar interbody fusion
Zhong-You ZENG ; Ping-Quan CHEN ; Xing ZHAO ; Hong-Fei WU ; Jian-Qiao ZHANG ; Xiang-Qian FANG ; Yong-Xing SONG ; Wei YU ; Fei PEI ; Shun-Wu FAN ; Guo-Hao SONG ; Shi-Yang FAN
China Journal of Orthopaedics and Traumatology 2024;37(1):33-44
Objective To observe the cage subsidence after oblique lateral interbody fusion(OLIF)for lumbar spondylo-sis,summarize the characteristics of the cage subsidence,analyze causes,and propose preventive measures.Methods The data of 144 patients of lumbar spine lesions admitted to our hospital from October 2015 to December 2018 were retrospectively ana-lyzed.There were 43 males and 101 females,and the age ranged from 20 to 81 years old,with an average of(60.90±10.06)years old.Disease types:17 patients of lumbar intervertebral disc degenerative disease,12 patients of giant lumbar disc hernia-tion,5 patients of discogenic low back pain,33 patients of lumbar spinal stenosis,26 patients of lumbar degenerative spondy-lolisthesis,28 patients of lumbar spondylolisthesis with spondylolisthesis,11 patients of adjacent vertebral disease after lumbar internal fixation,7 patients of primary spondylitis in the inflammatory outcome stage,and 5 patients of lumbar degenerative scoliosis.Preoperative dual-energy X-ray bone mineral density examination showed 57 patients of osteopenia or osteoporosis,and 87 patients of normal bone density.The number of fusion segments:124 patients of single-segment,11 patients of two-seg-ment,8 patients of three-segment,four-segment 1 patient.There were 40 patients treated by stand-alone OLIF,and 104 patients by OLIF combined with posterior pedicle screw.Observed the occurrence of fusion cage settlement after operation,conducted monofactor analysis on possible risk factors,and observed the influence of fusion cage settlement on clinical results.Results All operations were successfully completed,the median operation time was 99 min,and the median intraoperative blood loss was 106 ml.Intraoperative endplate injury occurred in 30 patients and vertebral fracture occurred in 5 patients.The mean follow-up was(14.57±7.14)months from 6 to 30 months.During the follow-up,except for the patients of primary lumbar interstitial in-flammation and some patients of lumbar spondylolisthesis with spondylolisthesis,the others all had different degrees of cage subsidence.Cage subsidence classification:119 patients were normal subsidence,and 25 patients were abnormal subsidence(23 patients were grade Ⅰ,and 2 patients were grade Ⅱ).There was no loosening or rupture of the pedicle screw system.The height of the intervertebral space recovered from the preoperative average(9.48±1.84)mm to the postoperative average(12.65±2.03)mm,and the average(10.51±1.81)mm at the last follow-up.There were statistical differences between postop-erative and preoperative,and between the last follow-up and postoperative.The interbody fusion rate was 94.4%.The low back pain VAS decreased from the preoperative average(6.55±2.2 9)to the last follow-up(1.40±0.82),and there was statistically significant different.The leg pain VAS decreased from the preoperative average(4.72±1.49)to the final follow-up(0.60± 0.03),and the difference was statistically significant(t=9.13,P<0.000 1).The ODI index recovered from the preoperative av-erage(38.50±6.98)%to the latest follow-up(11.30±3.27)%,and there was statistically significant different.The complication rate was 31.3%(45/144),and the reoperation rate was 9.72%(14/144).Among them,8 patients were reoperated due to fusion cage subsidence or displacement,accounting for 57.14%(8/14)of reoperation.The fusion cage subsidence in this group had obvious characteristics.The monofactor analysis showed that the number of abnormal subsidence patients in the osteopenia or osteoporosis group,Stand-alone OLIF group,2 or more segments fusion group,and endplate injury group was higher than that in the normal bone mass group,OLIF combined with pedicle screw fixation group,single segment fusion group,and no endplate injury group,and the comparison had statistical differences.Conclusion Cage subsidence is a common phenomenon after 0-LIF surgery.Preoperative osteopenia or osteoporosis,Stand-alone OLIF,2 or more segments of fusion and intraoperative end-plate injury may be important factors for postoperative fusion cage subsidence.Although there is no significant correlation be-tween the degree of cage subsidence and clinical symptoms,there is a risk of cage migration,and prevention needs to be strengthened to reduce serious complications caused by fusion of cage subsidence,including reoperation.
3.Comparison of clinical effect and muscle injury imaging between oblique lateral lumbar interbody fusion and transforaminal lumbar interbody fusion in the treatment of single-segment degenerative lumbar spinal stenosis.
San-Biao LI ; Sheng-Qian MEI ; Wen-Bin XU ; Xiang-Qian FANG ; Shun-Wu FAN ; Li-Bin HUANG
China Journal of Orthopaedics and Traumatology 2023;36(5):420-427
OBJECTIVE:
To compare the efficacy and muscle injury imaging between oblique lateral lumbar interbody fusion (OLIF) and transforaminal lumbar interbody fusion (TLIF) in the treatment of single-segment degenerative lumbar spinal stenosis.
METHODS:
The clinical data of 60 patients with single-segment degenerative lumbar spinal stenosis who underwent surgical treatment from January 2018 to October 2019 was retrospectively analyzed. The patients were divided into OLIF groups and TLIF group according to different surgical methods. The 30 patients in the OLIF group were treated with OLIF plus posterior intermuscular screw rod internal fixation. There were 13 males and 17 females, aged from 52 to 74 years old with an average of (62.6±8.3) years old. And 30 patients in the TLIF group were treated with TLIF via the left approach. There were 14 males and 16 females, aged from 50 to 81 years old with an average of (61.7±10.4) years old. General data including operative time, intraoperative blood loss, postoperative drainage volume, and complications were recorded for both groups. Radiologic data including disc height (DH), the left psoas major muscle, multifidus muscle, longissimus muscle area, T2-weighted image hyperintensity changes and interbody fusion or nonfusion were observed. Laboratory parameters including creatine kinase (CK) values on postoperative 1st and 5th days were analyzed. Visual analogue scale(VAS) and Oswestry disability index(ODI) were used to assess clinical efficacy.
RESULTS:
There was no significant difference in the operative time between two groups(P>0.05). The OLIF group had significantly less intraoperative blood loss and postoperative drainage volume compared to the TLIF group(P<0.01). The OLIF group also had DH better recovery compared to the TLIF group (P<0.05). There were no significant differences in left psoas major muscle area and the hyperintensity degree before and after the operation in the OLIF group (P>0.05). Postoperativly, the area of the left multifidus muscle and longissimus muscle, as well as the mean of the left multifidus muscle and longissimus muscle in the OLIF group, were lower than those in the TLIF group (P<0.05) .On the 1st day and the 5th day after operation, CK level in the OLIF group was lower than that in the TLIF group(P<0.05). On the 3rd day after operation, the VAS of low back pain and leg pain in the OLIF group were lower than those in the TLIF group (P<0.05). There were no significant differences in the ODI of postoperative 12 months, low back and leg pain VAS at 3, 6, 12 months between the two groups(P>0.05). In the OLIF group, 1 case of left lower extremity skin temperature increased after the operation, and the sympathetic chain was considered to be injured during the operation, and 2 cases of left thigh anterior numbness occurred, which was considered to be related to psoas major muscle stretch, resulting in a complication rate of 10% (3/30). In the TLIF group, one patient had limited ankle dorsiflexion, which was related to nerve root traction, two patients had cerebrospinal fluid leakage, and the dural sac was torn during the operation, and one patient had incision fat liquefaction, which was related to paraspinal muscle dissection injury, resulting in a complication rate of 13% (4/30). All patients achieved interbody fusion without cage collapse during the 6- month follow-up.
CONCLUSION
Both OLIF and TLIF are effective in the treatment of single-segment degenerative lumbar spinal stenosis. However, OLIF surgery has obviously advantages, including less intraoperative blood loss, less postoperative pain, and good recovery of intervertebral space height. From the changes in laboratory indexes of CK and the comparison of the left psoas major muscle, multifidus muscle, longissimus muscle area, and high signal intensity of T2 image on imaging, it can be seen that the degree of muscle damage and interference of OLIF surgery is lower than that of TLIF.
Male
;
Female
;
Humans
;
Middle Aged
;
Aged
;
Aged, 80 and over
;
Retrospective Studies
;
Spinal Stenosis/surgery*
;
Blood Loss, Surgical
;
Lumbar Vertebrae/surgery*
;
Spinal Fusion/methods*
;
Treatment Outcome
;
Pain, Postoperative
;
Muscles
;
Minimally Invasive Surgical Procedures/methods*
4.Epidemiological Survey of Hemoglobinopathies Based on Next-Generation Sequencing Platform in Hunan Province, China.
Hui XI ; Qin LIU ; Dong Hua XIE ; Xu ZHOU ; Wang Lan TANG ; De Guo TANG ; Chun Yan ZENG ; Qiong WANG ; Xing Hui NIE ; Jin Ping PENG ; Xiao Ya GAO ; Hong Liang WU ; Hao Qing ZHANG ; Li QIU ; Zong Hui FENG ; Shu Yuan WANG ; Shu Xiang ZHOU ; Jun HE ; Shi Hao ZHOU ; Fa Qun ZHOU ; Jun Qing ZHENG ; Shun Yao WANG ; Shi Ping CHEN ; Zhi Fen ZHENG ; Xiao Yuan MA ; Jun Qun FANG ; Chang Biao LIANG ; Hua WANG
Biomedical and Environmental Sciences 2023;36(2):127-134
OBJECTIVE:
This study was aimed at investigating the carrier rate of, and molecular variation in, α- and β-globin gene mutations in Hunan Province.
METHODS:
We recruited 25,946 individuals attending premarital screening from 42 districts and counties in all 14 cities of Hunan Province. Hematological screening was performed, and molecular parameters were assessed.
RESULTS:
The overall carrier rate of thalassemia was 7.1%, including 4.83% for α-thalassemia, 2.15% for β-thalassemia, and 0.12% for both α- and β-thalassemia. The highest carrier rate of thalassemia was in Yongzhou (14.57%). The most abundant genotype of α-thalassemia and β-thalassemia was -α 3.7/αα (50.23%) and β IVS-II-654/β N (28.23%), respectively. Four α-globin mutations [CD108 (ACC>AAC), CAP +29 (G>C), Hb Agrinio and Hb Cervantes] and six β-globin mutations [CAP +8 (C>T), IVS-II-848 (C>T), -56 (G>C), beta nt-77 (G>C), codon 20/21 (-TGGA) and Hb Knossos] had not previously been identified in China. Furthermore, this study provides the first report of the carrier rates of abnormal hemoglobin variants and α-globin triplication in Hunan Province, which were 0.49% and 1.99%, respectively.
CONCLUSION
Our study demonstrates the high complexity and diversity of thalassemia gene mutations in the Hunan population. The results should facilitate genetic counselling and the prevention of severe thalassemia in this region.
Humans
;
beta-Thalassemia/genetics*
;
alpha-Thalassemia/genetics*
;
Hemoglobinopathies/genetics*
;
China/epidemiology*
;
High-Throughput Nucleotide Sequencing
5.Application of oblique lateral interbody fusion in the treatment of lumbar intervertebral disc degeneration in patients with Modic change and endplate sclerosis.
Ping-Quan CHEN ; Zhong-You ZENG ; Xing ZHAO ; Shi-Yang FAN ; Hong-Fei WU ; Wei YU ; Jian-Qiao ZHANG ; Yong-Xing SONG ; Shun-Wu FAN ; Xiang-Qian FANG ; Fei PEI ; Guo-Hao SONG
China Journal of Orthopaedics and Traumatology 2023;36(1):29-37
OBJECTIVE:
To explore the feasibility and clinical effect of Stand-alone oblique lateral interbody fusion (OLIF) in the treatment of lumbar intervertebral disc degeneration with Modic changes and endplate sclerosis.
METHODS:
A retrospective analysis was performed on 16 cases with lumbar intervertebral disc degeneration with Modic changes and endplate sclerosis admitted to three medical centers from January 2015 to December 2018. There were 6 males and 10 females, the age ranged from 45 to 67 years old with an average of (55.48±8.07) years old, the medical history ranged from 36 to 240 months with an average of (82.40±47.68) months. The lesion sites included L2,3 in 2 cases, L3,4 in 5 cases, and L4,5 in 9 cases. All patients presented with chronic low back pain with lower limb neurological symptoms in 3 cases. All patients were treated by Stand-alone oblique lateral lumbar interbody fusion. Clinical and radiological findings and complications were observed.
RESULTS:
There was no vascular injury, endplate injury and vertebral fracture during the operation. The mean incision length, operation time, and intraoperative blood loss were(4.06±0.42) cm, (45.12±5.43) min, (33.40±7.29) ml, respectively. The mean visual analogue scale (VAS) of the incision pain was (1.14±0.47) at 72 hours after operation. There was no incision skin necrosis, poor incision healing or infection in patients. Sympathetic chain injury occurred in 1 case, anterolateral pain and numbness of the left thigh in 2 cases, and weakness of the left iliopsoas muscle in 1 case, all of which were transient injuries with a complication rate of 25%(4/16). All 16 patients were followed up from 12 to 36 months with an average of (20.80±5.46) months. The intervertebral space height was significantly recovered after operation, with slight lost during the follow-up. Coronal and sagittal balance of the lumbar spine showed good improvement at the final follow-up. There was no obvious subsidence or displacement of the cage, and the interbody fusion was obtained. At the final follow-up, Japanese Orthopaedic Association(JOA) score and Oswestry disability index(ODI) were significantly improved.
CONCLUSION
As long as the selection of case is strict enough and the preoperative examination is sufficients, the use of Stand-alone OLIF in the treatment of lumbar intervertebral disc degeneration with Modic changes and endplate sclerosis has a good results, with obvious clinical advantages and is a better surgical choice.
Male
;
Female
;
Humans
;
Child, Preschool
;
Intervertebral Disc Degeneration/surgery*
;
Retrospective Studies
;
Sclerosis
;
Treatment Outcome
;
Lumbar Vertebrae/surgery*
;
Spinal Fusion/methods*
6.Radiomics based on three-dimensional high-resolution MR vessel wall imaging for identification of culprit plaques in symptomatic patients with middle cerebral artery atherosclerosis
Guiling ZHANG ; Jicheng FANG ; Zhenxiong WANG ; Yiran ZHOU ; Di WU ; Jun LU ; Su YAN ; Hongquan ZHU ; Shun ZHANG ; Wenzhen ZHU
Chinese Journal of Radiology 2023;57(1):27-33
Objective:To investigate the value of radiomics based on three-dimensional high resolution MR vessel wall imaging (3D HRMR-VWI) for identifying culprit plaques in symptomatic patients with middle cerebral atherosclerosis.Methods:The clinical and imaging features of 117 patients (139 middle cerebral artery plaques) with cerebrovascular diseases in Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology from October 2018 to October 2020 were respectively reviewed. Stratified random sampling was used to divide 139 plaques into training set (97 plaques) and validation set (42 plaque) at the ratio of 7∶3. The plaques were divided into 69 culprit plaques and 70 non-culprit plaques based on plaque MR features and clinical symptoms. The clinical and imaging characteristics of culprit plaques and non-culprit plaques were compared by independent sample t-test, Mann-Whitney U test and χ 2 test, and factors with significant difference between two groups in univariate analysis were further analyzed by multivariate logistic regression to find out the independent predictors of culprit plaques. Radiomics features were extracted, screened and radiomics model was constructed using pre-and post-contrast 3D HRMR-VWI based on the training set. The combined model was constructed by combining the independent predictors and radiomics model. Receiver operating characteristic curve and area under curve (AUC) were used to evaluate the efficacy of each model, and DeLong test was used to compare the efficacy of different models. Results:Significant difference was found in intraplaque hemorrhage, lumen area of stenosis, stenosis diameter, stenosis rate, plaque burden and enhancement rate between culprit and non-culprit plaques (all P<0.05). Multivariate logistic regression analysis confirmed that only intraplaque hemorrhage was the independent predictor for culprit plaques (OR=7.045,95%CI 1.402-35.397, P=0.018). In the validation set, the AUC of the pre-contrast 3D HRMR-VWI model was lower than that of the post-contrast 3D HRMR-VWI model ( Z=-2.01, P=0.044). The AUC of pre+post-contrast 3D HRMR-VWI model was not significantly different from that of post-contrast 3D HRMR-VWI model ( Z=0.79, P=0.427). The AUC showed no significant difference between combined model and pre+post-contrast 3D HRMR-VWI model ( Z=-0.59, P>0.05). The combined model showed the best performance in predicting culprit plaques of middle cerebral artery (AUC=0.939), with the sensitivity, specificity and accuracy of 95.24%, 76.19% and 85.71%. Conclusion:Radiomics based on 3D HRMR-VWI has potential values in identifying culprit plaques in symptomatic patients with middle cerebral atherosclerosis.
7.Modified Chevron osteotomy in the treatment of moderate and severe hallux valgus.
Jian-Hua YU ; Tian-Shun FANG ; Tao SONG ; Meng WU ; Xiong-Feng LI
China Journal of Orthopaedics and Traumatology 2022;35(1):90-94
OBJECTIVE:
To investigate the method and clinical effect of modified Chevron osteotomy of the distal end of the first metatarsal in the treatment of moderate and severe hallux valgus.
METHODS:
From January 2015 to January 2019, 28 patients(30 feet) with moderate and severe hallux valgus were treated with modified Chevron osteotomy combined with lateral soft tissue release of the first metatarsophalangeal joint, including 2 males (2 feet) and 26 females (28 feet). The age ranged from 35 to 74 (57.3±9.3) years;10 feet on the left, 16 feet on the right, 2 cases on both sides(4 feet);the course of disease was 3 to 12 (9.32±3.89) years. The changes of hallux valgus angle(HVA), intermetatarsal angle(IMA) between the first and second metatarsals and distal metatarsal articular angle(DMAA) of the first metatarsal were measured and compared before and 6 months after operation. The American Orthopaedic Foot and Ankle Society(AOFAS) thumb joint scoring system was used to evaluate the curative effect.
RESULTS:
All 28 patients were followed up for 8 to 16 (11.28±3.42) months. The incision healed well in all patients, and there were no complications such as incision infection and metatarsal head necrosis. The healing time of osteotomy site was 6 to 10(7.12±1.34) weeks. Preoperative HVA, IMA, DMAA and AOFAS were (36.06±6.02) °, (21.78±4.16) °, (8.21±2.65) ° and (52.90±10.97) respectively, at six months after operation, they were (8.87±2.46) °, (11.66±2.84) °, (3.65±1.00) ° and (87.45±10.55) respectively, there was significant difference between preoperative and 6 months after operation(P<0.05). At 6 months after operation, AOFAS score was excellent in 20 feet, good in 7 feet and poor in 3 feet. Among the 3 patients with poor scores, 2 were excellent after revision, and 1 was significantly improved after using custom insoles.
CONCLUSION
Modified Chevron can effectively correct HVA, IMA and DMAA and improve functional recovery. The modified Chevron osteotomy increases the moving distance and the contact of the osteotomy surface. It can be fixed with multiple screws, has strong correction ability, and can exercise early. It is one of the optional methods for the treatment of moderate and severe hallux valgus.
Adult
;
Aged
;
Female
;
Hallux Valgus/surgery*
;
Humans
;
Male
;
Metatarsal Bones/surgery*
;
Metatarsophalangeal Joint/surgery*
;
Middle Aged
;
Osteotomy
;
Radiography
;
Treatment Outcome
8.Factors related to false negative results of interferon-γ release test in patients with confirmed pulmonary tuberculosis
Ling YE ; Jianhua LAN ; Min FANG ; Shun WANG ; Zhiyu WU ; Shugen WU ; Chunxian PENG ; Weili LU ; Tao LU
Chinese Journal of Clinical Infectious Diseases 2022;15(6):454-458
Objective:To analyze the influencing factors related to false-negative results of interferon-γ release assay (IGRA) QFT-GIT in patients with confirmed pulmonary tuberculosis.Methods:Clinical data of 389 patients with bacteriologically confirmed pulmonary tuberculosis who underwent QFT-GIT in Quzhou Hospital Affiliated to Wenzhou Medical University between January 1 and December 31 2020 were retrospectively analyzed. Univariate and multivariate logistic regression were used to analyze the influencing factors related to the false-negative results of QFT-GIT.Results:Among 389 confirmed patients, 347 cases had positive QFT-GIT results and 42 cases had negative results. Univariate analysis showed that the false-negative results of QFT-GIT were associated with low BMI, reduced CD4 + T lymphocyte count, decreased lymphocyte count, increased C-reactive protein, negative sputum smear, anemia, diabetes mellitus, malignant tumor and sepsis ( P<0.05 or P<0.01). Multivariate conditional logistic regression analysis showed that BMI <18.5 kg/m 2( OR=1.585, 95% CI 1.076-2.336), complicated with diabetes( OR=5.157, 95% CI 2.340-11.365), malignant tumors ( OR=5.596, 95% CI 2.048-15.295)and sepsis ( OR=4.141, 95% CI 1.042-16.459) were independent risk factors for the false-negative results of QFT-GIT ( P<0.05 or P<0.01). Conclusion:When the pulmonary tuberculosis patients are extreme emaciation, complicated with diabetes, malignant tumor or sepsis, the QFT-GIT results will be false negative.
9.Sofosbuvir/velpatasvir plus ribavirin for Child-Pugh B and Child-Pugh C hepatitis C virus-related cirrhosis
Chen-Hua LIU ; Chi-Yi CHEN ; Wei-Wen SU ; Chun-Jen LIU ; Ching-Chu LO ; Ke-Jhang HUANG ; Jyh-Jou CHEN ; Kuo-Chih TSENG ; Chi-Yang CHANG ; Cheng-Yuan PENG ; Yu-Lueng SHIH ; Chia-Sheng HUANG ; Wei-Yu KAO ; Sheng-Shun YANG ; Ming-Chang TSAI ; Jo-Hsuan WU ; Po-Yueh CHEN ; Pei-Yuan SU ; Jow-Jyh HWANG ; Yu-Jen FANG ; Pei-Lun LEE ; Chi-Wei TSENG ; Fu-Jen LEE ; Hsueh-Chou LAI ; Tsai-Yuan HSIEH ; Chun-Chao CHANG ; Chung-Hsin CHANG ; Yi-Jie HUANG ; Jia-Horng KAO
Clinical and Molecular Hepatology 2021;27(4):575-588
Background/Aims:
Real-world studies assessing the effectiveness and safety of sofosbuvir/velpatasvir (SOF/VEL) plus ribavirin (RBV) for Child-Pugh B/C hepatitis C virus (HCV)-related cirrhosis are limited.
Methods:
We included 107 patients with Child-Pugh B/C HCV-related cirrhosis receiving SOF/VEL plus RBV for 12 weeks in Taiwan. The sustained virologic response rates at off-treatment week 12 (SVR12) for the evaluable population (EP), modified EP, and per-protocol population (PP) were assessed. Thesafety profiles were reported.
Results:
The SVR12 rates in the EP, modified EP and PP were 89.7% (95% confidence interval [CI], 82.5–94.2%), 94.1% (95% CI, 87.8–97.3%), and 100% (95% CI, 96.2–100%). Number of patients who failed to achieve SVR12 were attributed to virologic failures. The SVR12 rates were comparable regardless of patient characteristics. One patient discontinued treatment because of adverse events (AEs). Twenty-four patients had serious AEs and six died, but none were related to SOF/VEL or RBV. Among the 96 patients achieving SVR12, 84.4% and 64.6% had improved Child-Pugh and model for endstage liver disease (MELD) scores. Multivariate analysis revealed that a baseline MELD score ≥15 was associated with an improved MELD score of ≥3 (odds ratio, 4.13; 95% CI, 1.16–14.71; P=0.02). Patients with chronic kidney disease (CKD) stage 1 had more significant estimated glomerular filtration rate declines than patients with CKD stage 2 (-0.42 mL/min/1.73 m2/month; P=0.01) or stage 3 (-0.56 mL/min/1.73 m2/month; P<0.001).
Conclusions
SOF/VEL plus RBV for 12 weeks is efficacious and well-tolerated for Child-Pugh B/C HCV-related cirrhosis.
10.Sofosbuvir/velpatasvir plus ribavirin for Child-Pugh B and Child-Pugh C hepatitis C virus-related cirrhosis
Chen-Hua LIU ; Chi-Yi CHEN ; Wei-Wen SU ; Chun-Jen LIU ; Ching-Chu LO ; Ke-Jhang HUANG ; Jyh-Jou CHEN ; Kuo-Chih TSENG ; Chi-Yang CHANG ; Cheng-Yuan PENG ; Yu-Lueng SHIH ; Chia-Sheng HUANG ; Wei-Yu KAO ; Sheng-Shun YANG ; Ming-Chang TSAI ; Jo-Hsuan WU ; Po-Yueh CHEN ; Pei-Yuan SU ; Jow-Jyh HWANG ; Yu-Jen FANG ; Pei-Lun LEE ; Chi-Wei TSENG ; Fu-Jen LEE ; Hsueh-Chou LAI ; Tsai-Yuan HSIEH ; Chun-Chao CHANG ; Chung-Hsin CHANG ; Yi-Jie HUANG ; Jia-Horng KAO
Clinical and Molecular Hepatology 2021;27(4):575-588
Background/Aims:
Real-world studies assessing the effectiveness and safety of sofosbuvir/velpatasvir (SOF/VEL) plus ribavirin (RBV) for Child-Pugh B/C hepatitis C virus (HCV)-related cirrhosis are limited.
Methods:
We included 107 patients with Child-Pugh B/C HCV-related cirrhosis receiving SOF/VEL plus RBV for 12 weeks in Taiwan. The sustained virologic response rates at off-treatment week 12 (SVR12) for the evaluable population (EP), modified EP, and per-protocol population (PP) were assessed. Thesafety profiles were reported.
Results:
The SVR12 rates in the EP, modified EP and PP were 89.7% (95% confidence interval [CI], 82.5–94.2%), 94.1% (95% CI, 87.8–97.3%), and 100% (95% CI, 96.2–100%). Number of patients who failed to achieve SVR12 were attributed to virologic failures. The SVR12 rates were comparable regardless of patient characteristics. One patient discontinued treatment because of adverse events (AEs). Twenty-four patients had serious AEs and six died, but none were related to SOF/VEL or RBV. Among the 96 patients achieving SVR12, 84.4% and 64.6% had improved Child-Pugh and model for endstage liver disease (MELD) scores. Multivariate analysis revealed that a baseline MELD score ≥15 was associated with an improved MELD score of ≥3 (odds ratio, 4.13; 95% CI, 1.16–14.71; P=0.02). Patients with chronic kidney disease (CKD) stage 1 had more significant estimated glomerular filtration rate declines than patients with CKD stage 2 (-0.42 mL/min/1.73 m2/month; P=0.01) or stage 3 (-0.56 mL/min/1.73 m2/month; P<0.001).
Conclusions
SOF/VEL plus RBV for 12 weeks is efficacious and well-tolerated for Child-Pugh B/C HCV-related cirrhosis.

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