Long-term lamivudine for chronic hepatitis B and cirrhosis: A real-life cohort study

AIM: To investigate clinical outcomes of chronic hepatitis B(CHB) and liver cirrhosis(LC) patients under whole-course management with lamivudine(LAM). METHODS: This was a retrospective-prospective cohort study based on two nonrandom cohorts of Chinese patients(LAM group and history control group). Two hundred thirty-eight patients with LAM treatment for at least 12 mo under whole-course management were included in the LAM group. The management measures included regular follow-up and timely adjustment of the therapeutic regimen according to drug-resistance and relapse. Two hundred thirtyeight patients with CHB or LC without any antiviral treatment and with follow-up over 12 mo were included in the history control group. The LAM and control group patients were 1:1 matched by propensity score method to ensure both patients were similar in general datum,sex,age,E antigen,and diagnosis. The incidence rates of endpoint events [LC,hepatocellular carcinoma(HCC),and death] were compared between the LAM and control groups.RESULTS: Hepatitis B virus-DNA < 1000 copies per m L rate and rate of alanine transaminase < 1.3 of theupper normal limit in LAM and control groups were 89.1% vs 18.5%(P < 0.05) and 89.8% vs 31.1%(P < 0.05),respectively. Viral breakthrough occurred in 77 patients(32.4%); the one-,three-,and fiveyear cumulative rates were 6.8%,33.1%,and 41.3%,respectively. In total,44.5%(106/238) of patients had once stopped LAM,and 63(59.4%) of them developed virologic relapse; the relapse rate of patients with and without reaching Asian Pacific Association for the Study of the Liver endpoint criteria were 52.4% and 69.8%,respectively. Six CHB patients in the LAM group developed LC compared to 47 patients in the control group; the three-,and five-year cumulative rates of CHB at baseline of LAM were lower than those of the control group: 0.7% vs 12.0% and 1.8% vs 23.8%(P < 0.01),respectively. The incidence of HCC in CHB at baseline of LAM was lower than that of the control group; the three-,and five-year cumulative rates were 0% vs 3.2% and 1.1% vs 3.2%(P = 0.05),respectively. The incidence of HCC in LC at baseline of LAM was lower than that of the control group: 9.8%(5/51) vs 25.0%(12/48),and the three-,and five-year cumulative rates were 4.5% vs 20.7% and 8.1% vs 37.5%(P < 0.01),respectively. The mortality rate in the LAM group was lower than the control group. CONCLUSION: Standardized long-term LAM treatment in combination with comprehensive management can reduce the incidence rates of LC and HCC as well as hepatitis B virus-related deaths.

Observation on TCM syndromes effect of Shujinjianyao Pill in the Treatment of Lumbar Spinal Stenosis (Ganshenbuzu and Fengshiyuzu Syndrome)

Objective:To observe the TCM(Traditonal Chinese Medcine)syndromes effect and safety of Shujinjianyao Pill in the treatment of LSS(Lumbar Spinal Stenosis)(Ganshenbuzu and Fengshiyuzu Syndrome).Methods:120 LSS patients fit the inclusion criteria were separated into two groups,90 in the experimental group and 30 in the control group.No significant difference was existed in the basic data between the two groups.The experimental group was given Shujinjianyao Pill and Danlutongdu Tablet Simulator orally,while the control group was given Shujinjianyao Pill Simulator and Danlutongdu Tablet orally for 4 weeks.The VAS score,total TCM(Traditonal Chinese Medcine)syndrome score and single TCM symptom score on day 0,14 and 28 were observed,and adverse reactions were recorded.Result:There were significant differences in total TCM syndrome score between the two groups at baseline,14 day and 28 day(P<0.01).There was a significant difference in total TCM syndrome score between the two groups at 28 day(P<0.05).Significant differences were existed between this two groups in total effective rate of total TCM syndromes and waist-knee pain-weak in single TCM syndromes on the 28 day(P<0.05).There was no significant difference in the incidence of adverse events and serious adverse events between the two groups(P>0.05).Conclusion:Shujinjianyao Pill is effective on TCM syndromes in the treatment of Ganshenbuzu and fengshiyuzu syndrome LSS,especially in improving the score of total TCM syndromes and waist-knee pain-weak of single TCM syndrome,and has high safety.