1.Efficacy and safety of telbivudine in pregnant women to prevent perinatal transmission of hepatitis B virus.
Guo-rong HAN ; Hong-xiu JIANG ; Geng-ju WANG ; Xin YUE ; Cui-min WANG ; Nan-ying KAN ; Min-min WU
Chinese Journal of Hepatology 2012;20(3):201-205
OBJECTIVETo evaluate the efficacy and safety of telbivudine use during the second and third trimester of pregnancy for reducing hepatitis B virus (HBV) transmission from highly viremic hepatitis B e antigen-positive (HBeAg+) mothers to their fetuses.
METHODSPregnant women, between weeks 20 to 32 of gestation, who were HBeAg+ and had HBV DNA more than 1.0*10(7) copies/mL were enrolled in our study. The women were offered inclusion into one of two treatment arms, based upon their personal preference: telbivudine or no telbivudine. The patients in the telbivudine treatment arm were administered 600 mg/d telbivudine at least until postpartum week 4. All delivered infants in both treatment arms were administered hepatitis B immune globulin (HBIG; 200 IU) within 12 hours of delivery and recombinant HBV vaccine (20 mug) at 0, 1 and 6 months. The HBV perinatal transmission rate was determined by measuring HBsAg and HBV DNA in infants at postpartum week 28.
RESULTSA total of 220 pregnant women were enrolled in our study, 120 chose the telbivudine arm and 100 chose the control arm. All telbivudine treated subjects were registered in the Antiretroviral Pregnancy Registry. Telbivudine treatment was associated with a marked reduction in the mothers' serum HBV DNA, HBeAg and ALT levels before delivery. A striking decline of HBV DNA levels in treated mothers was observed at week 2 of treatment, which was followed by a gradual and steady decrease that continued until delivery. Thirty-seven (31%) of the telbivudine-treated mothers and none (0%) of the untreated controls had polymerase chain reaction-undetectable viremia at delivery. At week 28, 0% of the infants delivered from telbivudine-treated mothers were HBsAg+ or HBV DNA+, as compared to 8% HBsAg+ or HBV DNA+ in the untreated control arm (P = 0.002). No telbivudine discontinuations occurred from adverse events, and no congenital deformities were observed in the infants delivered to telbivudine-treated mothers. Eighty mothers discontinued telbivudine at week 4 postpartum, and there were no cases of severe hepatitis. There were no significant differences between the two treatment arms for postpartum hemorrhage, adverse events during pregnancy, cesarean section, gestational age, or infants' height/weight or Apgar scores.
CONCLUSIONSTelbivudine use during the second and third trimester of pregnancy in HBeAg+ highly viremic mothers can safely reduce perinatal HBV transmission rates. Telbivudine was well-tolerated by our patient group. Furthermore, no safety concerns were observed in either the telbivudine-treated mothers or their delivered infants in short term follow-up.
Adult ; DNA, Viral ; Female ; Hepatitis B ; transmission ; virology ; Hepatitis B virus ; Humans ; Infectious Disease Transmission, Vertical ; prevention & control ; Nucleosides ; adverse effects ; therapeutic use ; Pregnancy ; Pregnancy Complications, Infectious ; prevention & control ; virology ; Pregnancy Trimester, Second ; Pregnancy Trimester, Third ; Pyrimidinones ; adverse effects ; therapeutic use ; Thymidine ; analogs & derivatives ; Viral Load ; Young Adult
2.Influences of warming kidney prescription on antiviral therapeutic efficacy and creatine kinase in telbivudine-treated HBeAg-positive chronic hepatitis B patients.
Xiao-Yu HU ; Yang ZHANG ; Guang-Wei LIU ; Hong-Ming NIE ; Xin-Jiang FAN ; Sen ZHONG
Chinese Journal of Hepatology 2012;20(2):93-97
To study the influences of warming kidney prescription on antiviral therapeutic efficacy and creatine kinase (CK) level in telbivudine-treated HBeAg-positive chronic hepatitis B patients with kidney yang deficiency syndrome. Ninety-six cases were enrolled and randomly divided into two groups (n=48 each): warming kidney prescription treatment or control. Both groups were treated for 52 weeks with telbivudine monotherapy, but the treatment group received additional treatment with the warming kidney prescription. Traditional Chinese medicine (TCM) syndrome score, biochemical response, virological response, serological response, CK level, and adverse reactions were recorded for each group in order to perform comparative analysis of the warming kidney prescription's effects. A total of 84 patients, including 43 cases in the treatment group, completed the study. The warming kidney prescription led to significantly improved total clinical syndrome efficacy, TCM syndrome score, biochemical response, virological response, and HBeAg serological responses, as evidenced by changes for each parameter observed in the treatment group versus the control group (respectively, 88.37% vs. 63.41%, 4.97+/-1.88 vs. 10.13+/-3.72, 95.35% vs. 75.61%, 81.40% vs. 56.10%, 48.84% vs. 26.83% (all, P less than 0.05)). No patient in either group experienced primary treatment failure. Seven cases, all from the control group, experienced virological breakthrough. Elevated CK was observed in both the treatment and control groups, but significantly more patients in the control group experienced this adverse reaction (respectively, 73.17% vs. 44.19%; P less than 0.01). The warming kidney prescription can increase telbivudine antiviral therapeutic efficacy and decrease the telbivudine-induced increase in creatine kinase in HbeAg-positive chronic hepatitis B patients with kidney yang deficiency syndrome.
Adult
;
Antiviral Agents
;
therapeutic use
;
Creatine Kinase
;
blood
;
Female
;
Hepatitis B, Chronic
;
blood
;
drug therapy
;
Humans
;
Male
;
Middle Aged
;
Nucleosides
;
therapeutic use
;
Phytotherapy
;
Pyrimidinones
;
therapeutic use
;
Thymidine
;
analogs & derivatives
3.Effect of Acid Pump Antagonist (Revaprazan, Revanex(R)) on Result of 13C Urea Breath Test in Patients with Helicobacter pylori Associated Peptic Ulcer Disease.
Ju Hyun OAK ; Woo Chul CHUNG ; Sung Hoon JUNG ; Kang Hyun CHOI ; Eun Jung KIM ; Bong Koo KANG ; Borami KANG ; Si Eun KONG ; Chang Nyol PAIK ; Kang Moon LEE
The Korean Journal of Gastroenterology 2011;57(1):8-13
BACKGROUND/AIMS: Revaprazan (Revanex(R)) is a novel proton pump inhibitor (PPI) that has a somewhat different effect on proton pump compared with the other PPI's, also (called as 'acid pump antagonist'). We aimed to examine the false negative rate of 13C-urea breath test (UBT) in the patients with Helicobacter pylori (H. pylori) associated peptic ulcer disease who were treated with revaprazan and evaluate the anti-urease activity of revaprazan. METHODS: Total 55 patients were enrolled in this study. They received EGD examination between January 2009 and December 2009 and diagnosed histologically as H. pylori associated peptic ulcer disease. All patients took revaprazan only. Three patients were excluded because of underlying chronic disease and inappropriate breath sampling. The remaining 52 patients had UBT at 0, 2 and 4 weeks of revaprazan use. After 2 weeks of the cessation of revaprazan, they had the fourth UBT. RESULTS: At 2 and 4 weeks, the false negative rates of UBT were 5.8% and 23.1%, respectively (p=0.05). After 2 weeks of the cessation, the cases of the false negative result were five. Four out of five patients had prolonged negative results on two or three successive tests, and baseline 13C difference value did not predict the false negative results. CONCLUSIONS: False negative results of UBT were common and increased with prolonged use of acid pump antagonist. As PPI, it had also anti-urease activity and most patients (47/52, 90.4%) reverted to positive results by 2 weeks after the cessation of taking the medication.
*Breath Tests
;
Carbon Isotopes
;
False Negative Reactions
;
Female
;
Helicobacter Infections/complications/*diagnosis
;
*Helicobacter pylori
;
Humans
;
Male
;
Middle Aged
;
Peptic Ulcer/*drug therapy/microbiology
;
Proton Pump Inhibitors/*therapeutic use
;
Pyrimidinones/*therapeutic use
;
Tetrahydroisoquinolines/*therapeutic use
;
Urea/*diagnostic use
4.Effect of Acid Pump Antagonist (Revaprazan, Revanex(R)) on the Result of 13C Urea Breath Test in the Patients with Helicobacter pylori Associated Peptic Ulcer Disease.
The Korean Journal of Gastroenterology 2011;57(1):1-2
No abstract available.
*Breath Tests
;
Carbon Isotopes
;
False Negative Reactions
;
Helicobacter Infections/complications/*diagnosis
;
*Helicobacter pylori
;
Humans
;
Peptic Ulcer/*drug therapy/microbiology
;
Proton Pump Inhibitors/*therapeutic use
;
Pyrimidinones/*therapeutic use
;
Tetrahydroisoquinolines/*therapeutic use
;
Urea/*diagnostic use
5.Study on the efficacy and HBeAg seroconversion related factors of telbivudine and entecavir therapy in HBeAg positive chronic hepatitis B patients.
Jing HUANG ; Xiao-ping CHEN ; Xue-fu CHEN ; Wen-li CHEN ; Ren CHEN ; Xiao-jun MA ; Xiao-dan LUO
Chinese Journal of Hepatology 2011;19(3):178-181
OBJECTIVETo investigate the efficacy of Telbivudine and Entecavir for therapy of HBeAg positive chronic hepatitis B for 52 weeks.
METHODSIn this random and control study, the efficacy of Telbivudine and Entecavir treatments were compared in 180 patients with HBeAg positive chronic hepatitis B.The patients were randomly assigned to a daily 600 mg Telbivudine treatment group or daily 0.5 mg Entecavir group for 52 weeks.
RESULTSAt week 52, HBV DNA undetectable rate was better in the Entecavir-treated group than in the Telbivudine-treated group, but didn't reach statistical significance. The viral breakthrough rates were significantly lower in the Entecavir-treated group than in the Telbivudine-treated group (x2 = 4.09, P <0.05). The clearance and seroconversion of HBeAg and the mean reductions of HBeAg from baseline at week 52 were significantly greater in the telbivudine-treated group than in the entecavir-treated group (x(2) clearance = 4.63, x(2) seroconversion = 4.80, (t-mean) reductions = 2.02; P < 0.05). The HBeAg seroconversion rates were not associated with both baseline ALT and baseline HBV DNA in both groups (P more than 0.05). In Telbivudine-treated group, the HBeAg decline is more than 2 log at week 24, HBeAg decline is more than 1 log at week 12 and the HBeAg baseline were independent factors correlated to HBeAg seroconversion rates at week 52 by Binary Logistic analysis, and also in entecavir-treated group the HBeAg decline is more than 2 log at week 24, HBeAg decline is more than 2 log at week 36 and the HBeAg decline is more than 2 log at week 12 were independent factors correlated to HBeAg seroconversion rates at week 52.
CONCLUSIONSignificant difference of HBeAg seroconversion rates at week 52 existed between Telbivudine-treated group and Entecavir-treated group. Entecavir is significantly superior to Telbivudine with less resistance to nucleosides. HBeAg decline is more than 2 log at week 24 is the best predicting factor for HBeAg seroconversion at week 52.
Adolescent ; Adult ; Antiviral Agents ; therapeutic use ; DNA, Viral ; blood ; Female ; Guanine ; analogs & derivatives ; therapeutic use ; Hepatitis B e Antigens ; blood ; Hepatitis B, Chronic ; blood ; drug therapy ; Humans ; Male ; Middle Aged ; Nucleosides ; therapeutic use ; Pyrimidinones ; therapeutic use ; Thymidine ; analogs & derivatives ; Treatment Outcome ; Young Adult
6.Efficacy and safety of telbivudine in pregnant chronic hepatitis B patients.
Yue-jin ZHOU ; Jin-li ZHENG ; Hua-jiang PAN ; Shan JIANG
Chinese Journal of Hepatology 2011;19(11):861-862
Adult
;
Antiviral Agents
;
adverse effects
;
therapeutic use
;
Female
;
Hepatitis B, Chronic
;
drug therapy
;
Humans
;
Nucleosides
;
adverse effects
;
therapeutic use
;
Pregnancy
;
Pregnancy Complications, Infectious
;
drug therapy
;
Pyrimidinones
;
adverse effects
;
therapeutic use
;
Thymidine
;
analogs & derivatives
;
Treatment Outcome
;
Young Adult
7.New Insight for HBV DNA and HBsAg Quantitation during Antiviral Therapy in Patients with Chronic Hepatitis B.
Yoo Kyung CHO ; Byung Cheol SONG
The Korean Journal of Gastroenterology 2011;57(3):144-149
Over the past decade, advances in the antiviral therapy in patients with chronic hepatitis B have enabled the sustained suppression of hepatitis B viral replication and the prevention of progressive liver disease. Hepatitis B surface antigen (HBsAg) has been used to diagnose patients with hepatitis B virus infection. Recently, test for quantitative HBsAg titers are available and on-treatment HBsAg quantitations are used to predict treatment outcome. Serum HBV DNA levels have been shown to predict natural course of chronic hepatitis B infection. The HBV DNA levels have been reported to be positively correlated with the development of cirrhosis, hepatocellular carcinoma and related death. The baseline and on-treatment levels of HBV DNA are important factors for predicting treatment outcomes. In this article, we will discuss the role of HBV DNA and HBsAg quantitation during antiviral therapy.
Antiviral Agents/*therapeutic use
;
Carcinoma, Hepatocellular/etiology
;
DNA, Viral/*blood
;
Hepatitis B Surface Antigens/*blood
;
Hepatitis B virus/*genetics
;
Hepatitis B, Chronic/complications/*drug therapy
;
Humans
;
Lamivudine/therapeutic use
;
Liver Cirrhosis/etiology
;
Liver Neoplasms/etiology
;
Nucleosides/therapeutic use
;
Pyrimidinones/therapeutic use
8.Effects of Ucf-101 on expression of Omi/HtrA2 in kidneys of postasphyxial neonatal rats.
Bing HUA ; Wen-Bin DONG ; Qing-Ping LI ; Zhi-Qiang FENG ; Hong YU ; Xue-Song ZHAI ; Xiao-Ping LEI
Chinese Journal of Contemporary Pediatrics 2010;12(8):658-661
OBJECTIVETo investigate the expression of serine protease Omi/HtrA2 in kidneys of postasphyxial neonatal rats, and to study the effects of Ucf-101 on apoptosis and the expression of Omi/HtrA2 in these rats.
METHODSSeventy-two neonatal Wistar rats of 7-10 days old were randomly divided into 3 groups: control, postasphyxial model, Ucf-101-treated postasphyxialThe postasphyxial model was established by normobaric asphyxiaExpression of Omi/HtrA2 was determined with streptavidin-peroxidase immunohistochemistry 2, 24 and 48 hrs after asphyxia. Terminal deoxynuleotidyl-mediated nick end labeling (TUNEL) was used to ascertain the apoptosis of renal cells.
RESULTSCompared with the control group, OmiHtrA2 expression in renal cells began to increase 2 hrs after asphyxia and peaked at 24 hrs. The expression of Omi/HtrA2 in the Ucf-101-treated postasphyxial group was significantly lower than that in the postasphyxial model group (P<0.01). TUNEL-positive cells began to increase 2 hrs after asphyxia and peaked at 24 hrs in the postasphyxial model group when compared with the control group. The number of TUNEL-positive cells in the Ucf-101-treated postasphyxial group was significantly lower than that in the postasphyxial model group at all time points (P<0.01).
CONCLUSIONSThe expression of Omi/HtrA2 in kidneys is increased in postasphyxial neonatal rats. The increased Omi/HtrA2 expression may play an important role in the development of postasphyxial renal injury. Treatment with Ucf-101 can reduce the expression of Omi/HtrA2 in kidneys of postasphyxial neonatal rats and thus reduce renal tububar epithelial cell apoptosis.
Animals ; Animals, Newborn ; Apoptosis ; drug effects ; Asphyxia Neonatorum ; drug therapy ; metabolism ; pathology ; Female ; High-Temperature Requirement A Serine Peptidase 2 ; Humans ; Immunohistochemistry ; In Situ Nick-End Labeling ; Infant, Newborn ; Kidney ; chemistry ; Male ; Mitochondrial Proteins ; analysis ; antagonists & inhibitors ; Pyrimidinones ; pharmacology ; therapeutic use ; Rats ; Rats, Wistar ; Serine Endopeptidases ; analysis ; Thiones ; pharmacology ; therapeutic use
9.Nifekalant hydrochloride terminating sustained ventricular tachycardia accompanied with QT dispersion prolongation.
Jing WANG ; Wei HUA ; Jun ZHU ; Yan-Min YANG ; Fang-Zheng WANG ; Jie-Lin PU ; Ke-Ping CHEN ; Shu ZHANG
Chinese Medical Journal 2010;123(15):2028-2033
BACKGROUNDVentricular tachycardia (VT) and ventricular fibrillation are the main reasons causing sudden cardiac death. This study aimed to investigate the effects of nifekalant hydrochloride (NIF) on QT dispersion (QTd) in treating VT.
METHODSA total of 16 consecutive patients suffered sustained VT was included and then randomly divided into two groups according to the administration duration of NIF. In long-time group (group L), patients were injected with NIF continuously for at least 12 hours after a bolus dose. The patients in short-time group (group S) were injected with NIF just for 1 hour.
RESULTSThere were 7 of all 10 episodes of VT which were terminated by NIF, including 4 episodes in group L were stopped over 1 hour after continuous infusion of NIF. One patient suffered from torsade de pointes. Electrocardiography analysis indicated that QTd was significantly decreased 12 hours after stopping of infusing NIF compared with that when VT stopped ((45.4 +/- 22.1) ms vs. (73.4 +/- 33.2) ms, P < 0.01), and the corrected QTd (QTcd) decreased too ((47.8 +/- 22.9) ms vs. (78.3 +/- 36.5) ms, P < 0.01). There was a positive correlation between the increase in QTd and dose of administrating NIF (P < 0.01), so was QTcd (P < 0.01).
CONCLUSIONSMore administration of NIF indicates higher terminating rate of VT and more QTd prolongation. However, the safety is acceptable if several important issues were noticed in using NIF, such as serum potassium concentration, stopping side-effect related agents, and carefully observing clinical responses.
Adult ; Anti-Arrhythmia Agents ; therapeutic use ; Electrocardiography ; Female ; Humans ; Long QT Syndrome ; drug therapy ; pathology ; Male ; Middle Aged ; Pyrimidinones ; therapeutic use ; Tachycardia, Ventricular ; drug therapy ; pathology ; Treatment Outcome
10.Clinical antiviral effects of telbivudine in patients with chronic hepatitis B.
Yan XU ; Jiang-bin WANG ; Shang-wei JI ; Yong-gui ZHANG ; Na-la SIQINGTU ; Ping ZHAO ; Hong-hua GUO ; Yan LI ; Jian JIAO ; Chang-yu ZHOU
Chinese Journal of Hepatology 2010;18(4):259-262
OBJECTIVETo analyze antiviral effects of telbivudine in patients with chronic hepatitis B.
METHOD72 chronic hepatitis B patients without prior history of antiviral therapy were treated with telbivudine 600mg once daily.
RESULTSAt week 4, 37.5% of the patients achieved undetectable HBV DNA, and 33.3% achieved ALT normalization. At week 108, 87.5% of the patients achieved undetectable HBV DNA, and 91.7% achieved ALT normalization. HBeAg seroconversion occurred in 23.9% of the 46 HBeAg positive patients. The rates of undetectable HBV DNA and HBeAg seroconversion at week 108 in the patients with HBV DNA < 3 log(10) copies/ml at week 12 were significant higher than those in patients with HBV DNA >or= 3 log(10) copies/ml. The rate of undetectable HBV DNA at week 108 in the patients with HBV DNA < 3 log(10) copies/ml at week 24 was significantly higher than that in patients with HBV DNA >or= 3 log(10) copies/ml, and the rate of antiviral resistance rate at week 108 in the patients with HBV DNA < 3 log(10) copies/ml at week 24 was significantly lower than that in patients with HBV DNA >or= 3 log(10) copies/ml. Antiviral therapy could significantly improve Child-Pugh score in patients with liver cirrhosis.
CONCLUSIONTelbivudine treatment results in suppression of HBV and high HBeAg seroconversion, and improvement of Child-Pugh score in the patients with liver cirrhosis.
Adult ; Antiviral Agents ; therapeutic use ; DNA, Viral ; blood ; Female ; Hepatitis B e Antigens ; blood ; Hepatitis B virus ; genetics ; physiology ; Hepatitis B, Chronic ; drug therapy ; virology ; Humans ; Male ; Middle Aged ; Nucleosides ; therapeutic use ; Pyrimidinones ; therapeutic use ; Thymidine ; analogs & derivatives ; Treatment Outcome ; Virus Replication

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