1.Clinical observation on antiviral efficacy and blocking of mother-to-infant transmission by telbivudine in women with chronic hepatitis B throughout pregnancy
Fang CHEN ; Xianglin TU ; Chuanying CHEN ; Quanhong CHENG ; Xin LI ; Xue LIN ; Zebin XING
The Journal of Practical Medicine 2016;32(4):636-639
Objective To explore antiviral efficacy, safety and blocking of mother-to-infant transmission by administrating telbivudine in pregnant patients with chronic hepatitis B (CHB) throughout pregnancy. Methods Sixty-four cases of female patients were enrolled. The study participants were divided into the telbivudine treatment group (n = 31) and the control group (n = 33). Data were recorded from beginning of administration to ending pregnancy, as well as notation of any adverse reactions. The neonates and infants were evaluated in HBV infection, parameters of growth and development. Results The recovery rates of ALT, respectively, were 90.32% vs. 57.58% (P = 0.003), 93.55% vs. 62.50% (P = 0.003) at 24 weeks and ante partum and the HBVDNA-negative conversion rates, respectively, were 48.39% vs. 3.03% (P = 0.000), 83.87%vs. 6.06% (P = 0.000), 90.32% vs. 6.25% (P = 0.000) respectively, at 12, 24 weeks of pregnancy and at ante partum between the treatment and control groups. The HBsAg-positive and HBVDNA-positive rates of the infants, respectively, were 12.90% vs. 37.50% (P = 0.025) and 0 vs. 21.88% (P = 0.018) at birth, and respectively, were all 0 vs. 18.75% (P = 0.035) and 0 vs. 18.75% (P = 0.035) at 1, 6, 12 months old between the treatment and control groups. The treatment group showed lower incidence of intrauterine HBV infection (0 vs. 18.75%, P = 0.035). The gestational ages, fetal weights and Apgar scores were not significant different in the children born in the mothers from the two groups. Conclusions Telbivudine administration showed a good antiviral curative effect and effectively blocked mother-to-infant transmission in women with CHB. The treatment was safe and caused no obvious adverse reaction.
2.The characteristics of resilience and the relationships between resilience and social integration of disabled people
Yanzhang LI ; Dingjie XU ; Zhu ZHOU ; Quanhong HUANG ; Youping YANG ; Li HE ; Long CHENG
Chinese Journal of Behavioral Medicine and Brain Science 2015;24(8):732-734
Objective To explore the characteristics of resilience and the relationships between resilience and social integration of disabled people.Methods By convenient sampling,a total of 702 disabled people were investigated by Connor-Davidson Resilience Scale,Social Integration Scale of the Disabled and self-made general questionnaire.Results The score of resilience of disabled people(53.27± 18.21) was lower than chinese community people(65.4± 13.9,t=-13.19,P<0.01).The resilience scores were significantly lower of the disabled people who came from rural areas,younger(≤ 24 years old) or older(≥ 60 years old),and were disabled from birth had poor family economic conditions,and had no insurances(P<0.05,P<0.01).But the disabled people who had university degree or above,married,working,and had warm and harmonious family atmosphere,had significantly higher resilience scores (P<0.05,P<0.01).The vesilience and three sub-factors were significantly correlated with social integration (r=0.38-0.66,P<0.01).The high resilience group had higher score in integration and three dimensions compared with the low resilience group(t=11.60-19.02,P<0.01).Tenacity and strength directly influenced the three dimensions of social integration (the path coefficient were 0.18-0.46,P<0.01).Conclusion The resilience of the disabled people is lower,and there are close relationships between resilience and social integration.The training of tenacity and strength is beneficial to social integration of the disabled people.
3.Development of the social integration self-rating scale and the reliability, validity analysis of the disabled people
Zhu ZHOU ; Yanzhang LI ; Dingjie XU ; Quanhong HUANG ; Youping YANG ; Li HE ; Long CHENG
Chinese Journal of Behavioral Medicine and Brain Science 2015;24(3):270-272
Objective To develop social integration scale of the disabled,and to test the reliability and validity of the scale.Methods 511 disabled persons were investigated by self-made social integration scale and Chinese version of positive and negative affect schedule (PANAS-C).Results The Scale was composed of three factors:self integration,relationship integration and affection integration,and they explained 47.39% of variance.The theoretical model fit could be accepted (x2/df =2.051,P<0.001;RMSEA =0.046;GFI =0.884;CFI =0.926;IFI =0.927).The factors had significant correlated with positive affect (r=0.34-0.55,P<0.01)and positive affect (r=-0.12--0.32,P<0.01).The high score group and low score group of social integration had significant differences in positive affect (t=13.77,P<0.01)and negative affect(t=-7.58,P<0.01).The cronbach's alpha coefficients of the scale and the three factors were 0.94,0.92,0.87 and 0.89 respectively,and the seven sub-factors'cronbach 's alpha coefficients were from 0.76 to 0.87.Conclusion The theory construct of social integration of the disabled is multi-hierarchical and multi-dimensional.The scale has acceptable reliability and validity,and can be used to assess the degree of social integration of the disabled.
4.Clinical observation of telbivudine's antiviral efficacy and protection against mother-to-infant transmission of chronic hepatitis B during the first trimester of pregnancy.
Chuanying CHEN ; Xianglin TU ; Quanhong CHENG ; Fang CHEN ; Ying DAI ; Fanghua GONG ; Xue LIN
Chinese Journal of Hepatology 2015;23(1):9-12
OBJECTIVETo explore the antiviral efficacy, safety and protective ability against mother-to-infant transmission of telbivudine in pregnant patients with chronic hepatitis B (CHB) during the first trimester.
METHODSEighty four gravid women who were diagnosed with CHB, in their first trimester of pregnancy, and had refused to terminate their pregnancies were enrolled; all study participants were clinically classified as active hepatitis cases with positivity for both hepatitis B surface antigen (HBsAg) and hepatitis B e antigen (HBeAg), HBV DNA more than or equal to 107 copies/mL and serum level of alanine aminotarnsferase (ALT) of more than or equal to 4 ULN.Patients with YMDD mutations were excluded from the study. The study participants were divided into a telbivudine treatment group (n=43; administered in the first trimester of pregnancy) and a control group (n=41, consisting of patients who refused to take antivirals). All babies bom to the women in both groups of the study received standard immune prevention (anti-hepatitis B immunoglobulin plus hepatitis B vaccine) and artificial feeding.Data recorded for the women during pregnancy included clinical findings for tests of hepatic and renal function, myocardial enzymes, blood and urine clinical parameters, hepatitis B virus makers and HBV DNA, as well as notation of any adverse reactions. The neonates were evaluated for presence of HBV infection, parameters of growth and development, presence of complications, and Apgar score. At 6 and 12 months old, all infants were evaluated for HBV DNA level and HBsAg presence.
RESULTSThe genetic variant rtM204I was detected in one of the women in the treatment group at 36 weeks of pregnancy. One woman in the control group developed severe hepatitis at 28 weeks of pregnancy and was put on the telbivudine treatment The treatment group showed greater recovery rates of ALT than the control group at 12 weeks of pregnancy (62.8% vs.29.3%, P=0.002), 24 weeks of pregnancy (76.7% vs.46.3%, P=0.000), and at ante partum (88.1% vs.60.0%, P=0.004). The treatment group also showed greater HBV DNA-negative conversion rates at 12 weeks of pregnancy (20.9% vs.0, P=0.006), at 24 weeks of pregnancy (37.2% vs.0, P=0.001) and at ante partum (78.6% vs.0, P=0.000), and greater HBeAg seroconversion rates at 12 weeks of pregnancy (2.3% vs.0, P=1.000), at 24 weeks of pregnancy (9.3% vs.0, P=0.116) and at ante partum (2 1.4% vs.0, P=0.002). The HBsAg-positive rates and HBV DNA-positive rates among the infants born to the mothers in the treatment and control groups, respectively, were 2.4% vs.17.5% (P=0.027) at birth, 0 vs.17.5% (P=0.005)at 6 months old and 0 vs.17.5% (P=0.005) at 12 months old. The Apgar scores were not significantly different for the children born to the mothers from the two groups, and all the children showed parameters of growth development within normal limits.
CONCLUSIONTelbivudine administration in the first trimester had a good antiviral curative effect and effectively blocked mother-to-infant transmission in women with CHB. The treatment was safe, causing no obvious adverse reaction in the gravid women or developmental effects on the infants.
Antiviral Agents ; DNA, Viral ; Female ; Hepatitis A Vaccines ; Hepatitis B Vaccines ; Hepatitis B e Antigens ; Hepatitis B virus ; Hepatitis B, Chronic ; Humans ; Infant ; Infant, Newborn ; Infectious Disease Transmission, Vertical ; Mother-Child Relations ; Mutation ; Pregnancy ; Pregnancy Complications, Infectious ; Pregnancy Trimester, First ; Thymidine ; analogs & derivatives ; Vaccines, Combined
5.Chemotherapy initiation with single-course methotrexate alone or combined with dactinomycin versus multi-course methotrexate for low-risk gestational trophoblastic neoplasia: a multi-centric randomized clinical trial.
Lili CHEN ; Ling XI ; Jie JIANG ; Rutie YIN ; Pengpeng QU ; Xiuqin LI ; Xiaoyun WAN ; Yaxia CHEN ; Dongxiao HU ; Yuyan MAO ; Zimin PAN ; Xiaodong CHENG ; Xinyu WANG ; Qingli LI ; Danhui WENG ; Xi ZHANG ; Hong ZHANG ; Quanhong PING ; Xiaomei LIU ; Xing XIE ; Beihua KONG ; Ding MA ; Weiguo LU
Frontiers of Medicine 2022;16(2):276-284
We aimed to evaluate the effectiveness and safety of single-course initial regimens in patients with low-risk gestational trophoblastic neoplasia (GTN). In this trial (NCT01823315), 276 patients were analyzed. Patients were allocated to three initiated regimens: single-course methotrexate (MTX), single-course MTX + dactinomycin (ACTD), and multi-course MTX (control arm). The primary endpoint was the complete remission (CR) rate by initial drug(s). The primary CR rate was 64.4% with multi-course MTX in the control arm. For the single-course MTX arm, the CR rate was 35.8% by one course; it increased to 59.3% after subsequent multi-course MTX, with non-inferiority to the control (difference -5.1%,95% confidence interval (CI) -19.4% to 9.2%, P = 0.014). After further treatment with multi-course ACTD, the CR rate (93.3%) was similar to that of the control (95.2%, P = 0.577). For the single-course MTX + ACTD arm, the CR rate was 46.7% by one course, which increased to 89.1% after subsequent multi-course, with non-inferiority (difference 24.7%, 95% CI 12.8%-36.6%, P < 0.001) to the control. It was similar to the CR rate by MTX and further ACTD in the control arm (89.1% vs. 95.2%, P =0.135). Four patients experienced recurrence, with no death, during the 2-year follow-up. We demonstrated that chemotherapy initiation with single-course MTX may be an alternative regimen for patients with low-risk GTN.
Antineoplastic Combined Chemotherapy Protocols/adverse effects*
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Dactinomycin/adverse effects*
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Female
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Gestational Trophoblastic Disease/drug therapy*
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Humans
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Methotrexate/therapeutic use*
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Pregnancy
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Retrospective Studies