| abstractObserve the efficacy and adverse pregnancy late pregnant women with chronic hepatitis B, telbivudine applied to investigate the application of antiviral drugs in late pregnancy to reduce vertical transmission probability of high hepatitis B viral load in pregnant women, chronic hepatitis B for clinical comprehensive treatment in late pregnancy pregnant women to provide new ways to bring the Gospel to the third trimester of pregnancy in pregnant women with chronic hepatitis B.MethodThis study used parallel controlled clinical trial, will take place from May1,2008to March1,2010in Taiyuan City Third People’s Hospital, clinical diagnosis of chronic hepatitis B in the third trimester of pregnancy in pregnant women, according to the condition of patients into mild, moderate, severe. The case according to the informed patient choice s divided into the experiment group and the control group, the test group was given antiviral and liver protection therapy, oral antiviral therapy for biff tablet, once daily, one tablet each time, and liver protection therapy with hepatocyte growth promoting factors injection120g, in10%glucose injection200ml, once a day, static point. The control group was only given a treatment, i.e. hepatocyte growth promoting factors injection120g, in10%glucose injection200ml, once a day, the static point. Randomly selected140cases, respectively:70cases of test group, in which mild in30cases, moderate in30cases, severe in10cases;70cases in the control group, in which mild in30cases, moderate in30cases,10cases of serious. Before the experiment, test after4weeks and8weeks after the test, respectively, from the clinical symptoms, liver function, serum HBsAg, serum HBeAg, serum HBVDNA and adverse reactions and other indicators to compare changes. In0,1years of age on neonatal serum HBsAg, serum HBeAg, serum HBVDNA and bad results of examination were compared. Analysis of telbivudine efficacy, adverse reactions and to block the vertical transmission of hepatitis B virus has no effect.Select case diagnosis standard in2000September by the Chinese Medical Association, infectious diseases and parasites, Association for the study of liver diseases, liver cirrhosis hepatitis combined with revised diagnostic standard [9], as well as the2010Revision of the" guide" the prevention and treatment of chronic hepatitis. All participants in the study of gestational hepatitis patients were told that gestational hepatitis the harm may occur, as well as the two therapeutic methods, taking telbivudine Group signed informed consent, comply with ethical requirements.Laboratory tests were the third people’s Hospital of Taiyuan City laboratory equipment Liver function testing apparatus of Beckman Coulter DXC-800, transaminase determination using enzyme rate method, reagent system for the analysis of the SYNCHRON reagent; bilirubin determination using2-4-dichloro aniline diazonium method, Desai diagnostic system kit. Hepatitis B virus quantitative take automatic fluorescence quantitative PCR method, apparatus using Step one plus, Shanghai Shen You reagent. Hepatitis B five by E601instrument, chemiluminescence method.Results using SPSS16.0statistical analysis of measurement data, using t test, count data by using χ2test.ResultTelbivudine (1) used in the treatment of chronic hepatitis B in late pregnancy, pregnant women are as follows. Clinical symptoms:mild group does not have clinical symptoms, not done; moderate group test4weeks after the clinical symptoms of the experimental group improved rate of95.8%,90%of the control group, no significant difference between the two groups (χ2=584, P<0.445).8weeks after the test, the test group and control group of clinical symptoms improvement rate was100%, improved clinical symptoms of two groups close; severe group test4weeks after the clinical symptoms of the experimental group improved90%,80%of the control group, two group of people the clinical symptoms improved situation was no significant difference (P=1). Eight weeks after the test, the clinical symptoms improvement rate of the test and control groups were100%, and improved clinical symptoms of the two groups close.Biochemical indicators refers to the main liver function:mild group, four weeks after the test, the test group improvement rate was83.3%,60%of the control group, and the difference was statistically significant (χ2=4.022, P=0.045), test8weeks later, the experimental group improved rate of100%,93.3%of the control group, but the difference was not statistically significant,(χ2=2.069, P=0.150); moderate group, after4weeks of treatment, the experimental group improved56.7%,43.3%of the control group, the difference was not statistically significant (χ2=1.067, P=0.302), treatment After eight weeks, the experimental group improved rate of100%,93.3%of the control group, the difference was not statistically significant (χ2=2.069, P=0.150); severe group, four weeks after the test, the experimental group improved rate of70%in the control50%of the group, the difference was not statistically significant (P=0.65) trial of eight weeks after the experimental group improved rate of100%,80%of the control group, no significant difference between the two groups (P=0.474).The etiology index refers to the hepatitis B virus DNA quantitative (FQHBVDNA,):mild group, four weeks after the test, the test group in serum hepatitis B viral load improvement rate was80%, improved in the control group was0, two groups in lowering serum hepatitis B viral load difference was statistically significant (χ2=40.0, P <0.001), eight weeks after the test, the test group in serum hepatitis B viral load improvement rate was100%in the control group, the improvement rate was0, the two groups in the reduction of serum hepatitis B virus in the amount of difference statistically significant (χ2=60.0, P<0.001); moderate group, four weeks after the test, the test serum hepatitis B viral load improvement rate was83.3%in the control group, the two groups in the reduction of serum of hepatitis B viral load difference was statistically significant (χ2=42.86, P<0.001), eight weeks after the test, the test group in serum hepatitis B viral load improved rate of100%, control group0, the two groups in the reduction of serum hepatitis B virus The amount of difference was statistically significant (χ2=60.0, P. <0.001); severe group4weeks after the test, the test group to reduce the quantitative improvement in the rate of hepatitis B virus in the serum of60%, control group0, the two groups in the reduction of serum hepatitis B viral load difference was statistically significant (x-=8.571, P=0.011), eight weeks after the test, the experimental group in reducing hepatitis B virus in serum quantitative improvement in the rate of90%in the control group, the two groups in reducing the amount of serum hepatitis B virus The difference was statistically significant (χ2=16.364, P<0.001). Serological markers of hepatitis B five of HBsAg, HBeAg, none appear in the grouping of HBsAg and of HBeAg seroconversion, the difference was not statistically significant.(2) telbivudine treatment in late pregnancy, pregnant women with chronic hepatitis B observation, application of a total of70cases, patients with symptoms associated with the disease itself, in line with the disease, the development outcome of the case. One cases of muscle soreness, limb numbness and related symptoms of chronic hepatitis B do not match, and the patient nervous system disease, arthritis, diabetes, calcium deficiency, edema may be the symptoms of the disease, consider this adverse reaction and for more than telbivudine. By the observation of pregnant women does not appear premature labor, premature rupture of membranes, postpartum hemorrhage, puerperal infection, amniotic fluid bolt race, and other adverse outcomes, good general condition after birth, the Apgar score greater than9points, but found no deformity any reproductive toxicity.(3) In this observation in patients with chronic hepatitis B in late pregnancy, pregnant women, newborns, the serum of HBsAg, HBeAg, HBVDNA results:birth trial group with positive HBsAg positive cases HBeAg43, HBVDNA positive; control group1cases HBsAg positive cases positive HBeAg61, and HBVDNA3cases were positive. HBsAg positive rate in the experimental group and control group difference was not statistically significant (P=0.361), HBeAg-positive rate in the experimental group and control group difference was statistically significant (χ2=12.115, P=0.001). HBVDNA positive rate in the test group and control group difference was not statistically significant (x-=3.066, P=0.080). Neonatal1-year-old review HBsAg test group of HBeAg and HBV DNA compared to the situation:birth HBsAg positive, HBeAg positive, HBVDNA positive; control group,2cases of HBsAg positive, cases positive HBeAg1HBVDNA in positive HBsAg positive rate in the experimental group and control group difference was not statistically significant (χ2=2.021, P=1), HBeAg-positive rate in the experimental group and control group difference was not statistically significant (P=1). HBVDNA positive rate in the test and control groups showed no difference.ConclusionTelbivudine is used in late pregnant women in treatment of chronic hepatitis B, in this experiment, the liver function, serum HBsAg, serum HBeAg index and vertical transmission, the test group and the control group had no significant difference, clinical symptoms only in the mild group test after4weeks there was significant difference between two groups. Hepatitis B virus DNA quantitative test group was better thar control group. Good safety. |
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