Study On Syndrome Drift In Syndrome Of Liver Depression And Spleen Deficiency In Chronic Hepatitis B

Objective:To recognize syndrome drift in syndrome of liver depression and spleen deficiency in chronic hepatitis B (CHB) and in turn to improve the approach to syndrome efficacy evaluation.Methods:A total of169HBeAg-positive chronic hepatitis B (CHB) patients with syndrome of liver depression and spleen deficiency were recruited in this study. Of them,56patients served as controls (untreated group) who did not receive any treatment according to their conditions and intentions,113received Huo Zhi Tang treatment based on syndrome differentiation for3months (differential treatment group). All the patients in the2groups were followed up weekly for at least3months. Emerging syndromes were registered. Syndrome drift was defined as that new syndrome(s) is (are) emerging but any syndrome type else could not yet be diagnosed as because of inadequate syndromes emerged. Severity of every syndrome was scored blindly by using a semiquantitative scoring system at baseline and every follow-up. The current Nimodipine method and a modified Nimodipine method were used to separately evaluate syndrome efficacy. Post-treatment syndrome scores in the former was the sum of scores of the baseline syndromes presented at the end of treatment and in the latter was the sum of scores of all the syndromes presented at the end of treatment, including both the baseline syndromes and the emerging syndromes. All data was analyzed by intention to treat analysis. Statistical analysis of the data was performed by using the SPSS16.0for Windows, except that95%confidence interval (95%CI) for a rate was computed by using MedCalc software (Version12.2.1.0).Marginal Homogeneity Test was used to determine the significance between syndrome efficacies, and McNemar Test was used to test the significance between overall rates of syndrome efficacy, resulted from the current Nimodipine method and the modified Nimodipine method respectively, respectively.Results:Syndrome drift was observed in24(42.9%,95%CI:27.5%,63.8%) of56patients in untreated group, and in29(25.7%,95%CI:17.2%,36.9%) of113patients in differential treatment group (χ2=5.142, p=0.023). Both syndrome efficacy (Std. MH Statistic=-3.207, p=0.001) and overall rate of syndrome efficacy (57.5%versus49.6%, p=0.004) resulted from the current Nimodipine method were significantly higher than that resulted from the modified Nimodipine method respectively, respectively.Conclusion:Syndrome drift is common in syndrome of liver depression and spleen deficiency in CHB, and syndrome drift induces a biased estimate (overestimation) of syndrome efficacy of treatment based on syndrome differentiation if evaluated by using the current Nimodipine method.