1.Efficacy evaluation of extending or switching to tenofovir amibufenamide in patients with chronic hepatitis B: a phase Ⅲ randomized controlled study
Zhihong LIU ; Qinglong JIN ; Yuexin ZHANG ; Guozhong GONG ; Guicheng WU ; Lvfeng YAO ; Xiaofeng WEN ; Zhiliang GAO ; Yan HUANG ; Daokun YANG ; Enqiang CHEN ; Qing MAO ; Shide LIN ; Jia SHANG ; Huanyu GONG ; Lihua ZHONG ; Huafa YIN ; Fengmei WANG ; Peng HU ; Xiaoqing ZHANG ; Qunjie GAO ; Chaonan JIN ; Chuan LI ; Junqi NIU ; Jinlin HOU
Chinese Journal of Hepatology 2024;32(10):883-892
Objective:In chronic hepatitis B (CHB) patients with previous 96-week treatment with tenofovir amibufenamide (TMF) or tenofovir disoproxil fumarate (TDF), we investigated the efficacy of sequential TMF treatment from 96 to 144 weeks.Methods:Enrolled subjects who were previously assigned (2:1) to receive either 25 mg TMF or 300 mg TDF with matching placebo for 96 weeks received extended or switched TMF treatment for 48 weeks. Efficacy was evaluated based on virological, serological, biological parameters, and fibrosis staging. Statistical analysis was performed using the McNemar test, t-test, or Log-Rank test according to the data. Results:593 subjects from the initial TMF group and 287 subjects from the TDF group were included at week 144, with the proportions of HBV DNA<20 IU/ml at week 144 being 86.2% and 83.3%, respectively, and 78.1% and 73.8% in patients with baseline HBV DNA levels ≥8 log10 IU/ml. Resistance to tenofovir was not detected in both groups. For HBeAg loss and seroconversion rates, both groups showed a further increase from week 96 to 144 and the 3-year cumulative rates of HBeAg loss were about 35% in each group. However, HBsAg levels were less affected during 96 to 144 weeks. For patients switched from TDF to TMF, a substantial further increase in the alanine aminotransferase (ALT) normalization rate was observed (11.4%), along with improved FIB-4 scores.Conclusion:After 144 weeks of TMF treatment, CHB patients achieved high rates of virological, serological, and biochemical responses, as well as improved liver fibrosis outcomes. Also, switching to TMF resulted in significant benefits in ALT normalization rates (NCT03903796).
2.Safety profile of tenofovir amibufenamide therapy extension or switching in patients with chronic hepatitis B: a phase Ⅲ multicenter, randomized controlled trial
Zhihong LIU ; Qinglong JIN ; Yuexin ZHANG ; Guozhong GONG ; Guicheng WU ; Lvfeng YAO ; Xiaofeng WEN ; Zhiliang GAO ; Yan HUANG ; Daokun YANG ; Enqiang CHEN ; Qing MAO ; Shide LIN ; Jia SHANG ; Huanyu GONG ; Lihua ZHONG ; Huafa YIN ; Fengmei WANG ; Peng HU ; Xiaoqing ZHANG ; Qunjie GAO ; Peng XIA ; Chuan LI ; Junqi NIU ; Jinlin HOU
Chinese Journal of Hepatology 2024;32(10):893-903
Objective:In chronic hepatitis B (CHB) patients with previous 96-week treatment with tenofovir amibufenamide (TMF) or tenofovir disoproxil fumarate (TDF), we investigated the safety profile of sequential TMF treatment from 96 to 144 weeks.Methods:Enrolled subjects that previously assigned (2:1) to receive either 25 mg TMF or 300 mg TDF with matching placebo for 96 weeks received extending or switching TMF treatment for 48 weeks. Safety profiles of kidney, bone, metabolism, body weight, and others were evaluated.Results:666 subjects from the initial TMF group and 336 subjects from TDF group with at least one dose of assigned treatment were included at week 144. The overall safety profile was favorable in each group and generally similar between extended or switched TMF treatments from week 96 to 144. In subjects switching from TDF to TMF, the non-indexed estimated glomerular filtration rate (by non-indexed CKD-EPI formula) and creatinine clearance (by Cockcroft-Gault formula) were both increased, which were (2.31±8.33) ml/min and (4.24±13.94) ml/min, respectively. These changes were also higher than those in subjects with extending TMF treatment [(0.91±8.06) ml/min and (1.30±13.94) ml/min]. Meanwhile, switching to TMF also led to an increase of the bone mineral density (BMD) by 0.75% in hip and 1.41% in spine. On the other side, a slight change in TC/HDL ratio by 0.16 (IQR: 0.00, 0.43) and an increase in body mass index (BMI) by (0.54±0.98) kg/m 2 were oberved with patients switched to TMF, which were significantly higher than that in TMF group. Conclusion:CHB patients receiving 144 weeks of TMF treatment showed favorable safety profile. After switching to TMF, the bone and renal safety was significantly improved in TDF group, though experienceing change in metabolic parameters and weight gain (NCT03903796).
3.Efficacy of Altemeier procedure in the treatment of rectal prolapse.
Yonglei CAO ; Yan ZHOU ; Congqing JIANG ; Guiyi YANG ; Hui SONG ; Lvfeng LIU ; Xu AI ; Jing ZHONG ; Zhilin GONG ; Jianhua DING ; Wei FU ; Qun QIAN
Chinese Journal of Gastrointestinal Surgery 2017;20(12):1370-1374
OBJECTIVETo evaluate the safety and efficacy of the perineal rectosigmoidectomy (Altemeier procedure) in the treatment of full thickness rectal prolapse.
METHODSClinical and follow-up data of 52 patients with full thickness rectal prolapse undergoing Altemeier procedure in 9 hospitals from September 2010 to July 2016 were analyzed retrospectively. Of which 38 cases were from Zhongnan Hospital of Wuhan University, 1 case from Suizhou Central Hospital of Hubei province, 1 case from Jingzhou Second People's Hospital of Hubei province, 3 cases from Wuxue First People's Hospital of Hubei province, 1 case from Jingmen First People's Hospital of Hubei province, 1 case from Tuanfeng County Hospital of Hubei province, 4 cases from Jingzhou Central Hospital of Hubei province, 2 from PLA Rocket Army General Hospital, 1 case from the Affiliated Hospital of Xuzhou Medical University in Jiangsu province. Altemeier operation steps: The line shaped teeth, the prolapsed rectum is first exposed to the anus. In the dentate line proximal 1-3 cm with ultrasonic knife or Ligasure ring outer rectal incision, using electric knife to mark pre resection line in rectal mucosa. Open down in front of the pelvic peritoneum. Incision of the outer intestine and the reduction of the internal rectum and part of sigmoid colon. To free and remove excess pelvic retroperitoneal, pelvic peritoneum and be at the top of the colon or rectum anterior pelvic reconstruction suture. The rear of the levator ani muscle forming rectum. Pull gently to the anus and rectum and sigmoid, in the absence of tension, 2-3 cm outside the anus was selected as the proximal inner bowel pre resection line, along the line of pre transection of proximal bowel resection, again the broken end of intestine full-thickness end-to-end anastomosis. Postoperative complication and recurrence were summarized. Gastrointestinal quality of life index (GIQLI), Wexner constipation score and Wexner fecal incontinence score were used to evaluate the efficacy.
RESULTSAll the 52 patients were beyond moderate full thickness rectal prolapse. Thirty-one were male and 21 were female with age ranging from 22 to 83 (average 53) years. The length of prolapsed rectum was 6 to 20 (average 9) cm and course of disease was 0.5 to 46(average 19.5) years. No perioperative death. Five patients (9.6%) had postoperative complications, including 2 anastomotic bleeding, 1 wall portion dehiscence of anastomosis, 1 anastomotic stenosis, and 1 malnutrition. Recurrence rate was 9.6%(5/52) within the long-term follow-up of 5 to 71 (median 40) years. Compared with the preoperative results, Wexner constipation score and Wexner fecal incontinence score decreased obviously (2.1±1.4 vs. 4.6±3.4, 4.8±4.1 vs. 6.8±4.1), and GIQLI significantly increased from 99.6±8.0 to 103.0±9.1 (all P<0.05) at 6-month after operation. Above 3 scores were sustained and continuously improved at 12-, 24-, and 36-month during the follow-up (all P<0.05).
CONCLUSIONAltemeier procedure possesses good efficacy with low morbidity of complication and recurrence in the treatment of full thickness rectal prolapse.