| Objectives1.Investigate application of NAs in antiviral treatment of chronic hepatitis B,HBV cirrhosis and HBV associated liver cancer(include drug selection and treatment mode);2.Explore the efficacy of NAs in treating CHB patients so that to serve as a guideline for clinical antiviral treatment.Methods1.Retrospectively analyzed 2504 outpatients and inpatients of Department of Infectious Diseases,the First Hospital of Kunming Medical University who have used nucleos(t)ide analogues in treating CHB,HBV cirrhosis and HBV associated liver cancer.Clinical data of these patients were recorded in detail,include age,gender,medical history of HBV,family history of HBV,current disease state,and selection,course,dosage as well as usage mode of antiviral drugs.2.Randomly included patients who treated CHB initially with nucleos(t)ide analogues alone from these 2504 cases for curative effect analysis.Baseline information of each patient was recorded in detail,include(1)age,gender,medical history of HBV,family history of HBV infection,current disease state and selection of antiviral drugs.(2)Level of ALT,HBV DNA,HBsAg,HBsAb,HBeAg,HBeAb,HBcAb,and ALT normalization rate,HBV DNA negative rate,HBeAg seroconversion rate at 12 weeks,24 weeks,48 weeks and 96 weeks after treatment.(3)Examination like Ultrasound B,CT,MRI and transient elastography of the liver.3.Established database with SPSS 2.0,and conducted statistical analysis after all data was included in the database.Results1.Application of nucleos(t)ide analogues in antiviral treatment of chronic hepatitis B patients.(1)Altogether data of 2504 patients using nucleos(t)ide analogues in antiviral treatment were collected.There were 1748 inpatients and 1705 of them used single drug therapy,accounting for 97.5%,and 43 of them used combination therapy,accounting for 2.5%.756 outpatients,671 used single drug therapy(88.8%)and 85 used combination therapy(11.2%).In all 1292 CHB patients,1201 treated with single drug(93.0%)and 91 with combination therapy(7.0%).806 cases of hepatitis B cirrhosis(compensation/decompensation stage),786 single drug therapy(97.5%)and 20 combination therapy(2.5%).406 cases of hepatitis B related liver cancer,389 single drug therapy(95.8%)and 17 combination therapy(4.2%).(2)In total,2376 patients treated with single drug(94.9%),among which there were 260 cases of LAM(10.9%),261 cases of ADV(11.0%),1556 cases of ETV(65.5%),139 cases of LdT(5.9%)and 160 cases of TDF(6.7%).And 128 patients used combination therapy,among which 95 cases of LAM + ADV(74.2%),15 cases of LdT+ADV(11.7%),18 cases of ETV + ADV(14.1%).2.Curative effect analysis of nucleos(t)ide analogues in treating CHB patients alone(1)Patients informationInitially 348 CHB patients were entered,and 86 patients were excluded due to lost to follow up or loss of case data,there 262 patients were included finally.The patients aged from 18-67 years old,38.05±10.96 in average,and were divided into group of LAM(n = 49),ADV(n=64),ETV(n = 68),LdT(n = 41)and TDF(n = 40).178 males(67.9%)and 84 females(32.1%).In addition,the patients had hepatitis B for 0.5-30 year,and 8.74±5.94 in average.(2)ALT normalization rateALT normalization rate in 12 weeks:15 cases in LAM(30.6%),17 in ADV(26.6%),47 in ETV(69.1%),13 in LdT(31.7%),and 22 in TDF(55.0%).The rate of ETV and TDF was significantly higher than that of LAM,ADV and LdT(P<0.05),and no significant difference was observed between any other two groups.ALT normalization rate in 24 weeks:18 cases in LAM(36.7%),23 in ADV(35.9%),55 in ETV(80.9%),17 in LdT(41.5%),and 28 in TDF(70.0%).The rate of ETV and TDF was significantly higher than that of LAM,ADV and LdT(P<0.05),and no significant difference was observed between any other two groups.ALT normalization rate in 48 weeks:24 cases in LAM(49.0%),34 in ADV(53.1%),64 in ETV(94.1%),24 in LdT(58.5%),and 32 in TDF(80.0%).The rate of ETV and TDF was significantly higher than that of LAM,ADV and LdT,ETV higher than TDF(P<0.05),and no significant difference was observed between any other two groups.ALT normalization rate in 98 weeks:33 cases in LAM(67.3%),48 in ADV(75.0%),65 in ETV(95.6%),30 in LdT(73.2%),and 37 in TDF(92.5%).The rate of ETV and TDF was significantly higher than that of LAM,ADV and LdT(P<0.05),and no significant difference was observed between any other two groups.(3)HBV DNA negative rateHBV DNA negative rate in 12 weeks:12 cases in LAM(24.5%),8 in ADV(12.5%),29 in ETV(42.6%),13 in LdT(31.7%),and 19 in TDF(47.5%).The rate of ETV and TDF was significantly higher than that of LAM and ADV,LdT higher than ADV(P<0.05),and no significant difference was observed between any other two groups.HBV DNA negative rate in 24 weeks:20 cases in LAM(40.8%),15 in ADV(23.4%),45 in ETV(66.2%),19 in LdT(46.3%),and 34 in TDF(85.0%).The rate of ETV and TDF was significantly higher than that of LAM,ADV and LdT,LAM and LdT higher than ADV,TDF higher than ETV(P<0.05),and no significant difference was observed between any other two groups.HBV DNA negative rate in 48 weeks:25 cases in LAM(51.0%),20 in ADV(31.3%),59 in ETV(86.8%),28 in LdT(68.3%),and 38 in TDF(95.0%).The rate of ETV and TDF was significantly higher than that of LAM and LdT,ADV lower than other four single drug groups(P<0.05),and no significant difference was observed between any other two groups.HBV DNA negative rate in 96 weeks:30 cases in LAM(61.2%),29 in ADV(45.3%),64 in ETV(94.1%),33 in LdT(80.5%),and 39 in TDF(97.5%).The rate of ETV and LdT and TDF was significantly higher than that of LAM and ADV,ETV and TDF higher than LdT(P<0.05),and no significant difference was observed between any other two groups.(4)HBeAg seroconversion rateHBeAg seroconversion rate in 12 weeks:2 cases in ETV(5.7%),and 0 in other groups.There was no significant difference between any two groups.HBeAg seroconversion rate in 24 weeks:3 cases in ETV(8.6%),4 in LdT(14.8%).and 0 in other groups.There was no significant difference between any two groups.HBeAg seroconversion rate in 48 weeks:3 cases in LAM(9.1%),2 in ADV(6.7%),5 in ETV(14.3%),10 in LdT(37.0%),3 in TDF(11.5%).The rate of LdT was significantly higher than that of LAM,ADV,ETV and TDF(P<0.05),and no significant difference was observed between any other two groups.HBeAg seroconversion rate in 96 weeks:5 in LAM(15.2%),4 cases in ADV(13.3%),7 in ETV(20.0%),12 in LdT(44.4%),6 in TDF(23.1%).The rate of LdT was significantly higher than that of LAM,ADV and ETV(P<0.05),and no significant difference was observed between any other two groups.(5)Drug-resistance mutation rate:13 cases in LAM(26.5%),2 in ADV(13.1%),and 0 in ETV,LdT and TDF.(6)Progression of cirrhosis and liver cancerCirrhosis progression during treatment:2 cases in LAM(4.1%),2 in ADV(3.1%),3 in ETV(4.4%),2 in LdT(4.9%),and 0 in TDF.Liver cancer progression during treatment:3 in LAM(6.1%),2 in ADV(3.1%),2 in ETV(2.9%),1 in LdT(2.4%),and 0 in TDF.(7)Adverse events presented mainly as headache,upper respiratory infect,cough,nasopharyngitis,fatigue,dizziness,epigastric pain and nausea,and these events were proven irrelevant to drug administration.No serious adverse events and ensuing drug withdrawn was observed.Conclusions1.At present,the nucleos(t)ide analogues is used in antiviral treatment in form of single drug or combination therapy,and single drug accounts for 94.9%.The most preferred antiviral drug is Entecavir due to its high efficacy,short reaction time and low resistance rate,followed by cheaper Lamivudine and Adefovir dipivoxil.While combination therapy is less common,and the most preferred combination is Lamivudine and Adefovir dipivoxil.2.ETV,TDF was significantly superior than LAM,ADV and LdT in HBV DNA negative rate,and ADV is the least effective one.3.LdT was significantly superior than LAM,ADV,ETV and TDF in HBeAg seroconversion rate.There was no significant difference between HBeAg seroconversion rate at 48 weeks and 96 weeks after treated with ETV and TDF.4.ETV,TDF was significant better than LAM,ADV,LdT,ETV in normalizing ALT.5.CHB patients treated initially with ETV and TDF had higher HBV DNA negative rate and ALT normalization rate in 48 weeks.As for seroconversion rate,there was no significant difference. |
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