Drift Of Syndrome Of Dampness-Heat Obstruction In Middle Energizer And Its Effect On Efficacy Evaluation Of The Syndrome In Chronic Hepatitis B

Background:Everything flows, nothing remains the same. Constant moving ideas of Traditional Chinese Medicine (TCM) holds that syndromes keep changing due to the changes in location or in nature of a disease and the resultant evolution of the disease, and thereby dynamic changes of the original syndromes as well as emerging symptoms during the disease course must be taken into account in clinical practice. However, both transmission and transformation, the currently only available terms regarding syndrome changes, means the final results of syndrome changes instead of the dynamic course of syndrome changing. It is a pity there is as yet no definite term to describe the dynamic course of syndromes. For example, a patient with anorexia, nauseas, tired of oil and dark yellow urine at the first visit, over a period of time, other new symptom such as mild lumbago emerge, however, the emergence of new symptom neither change the former syndrome pattern, nor form a new syndrome pattern. How to describe the dynamic course like this?"Syndrome drift" based on the basic theory of TCM,the result of previous research and "genetic drift" is defined as that the emergence of new syndrome(s) neither change the original syndrome pattern, nor form any other syndrome pattern. In addition, the current assessment approach of syndrome involve only the changes of original syndromes at the end of treatment. Does the emergence of new symptom impact the syndrome efficacy evaluation?Objective:To recognize the syndrome drift in the syndrome of dampness-heat obstruction in middle energizer in CHB and in turn to improve the approach to syndrome efficacy evaluation.Methods:According to their conditions and intention, all patients divided into the differential treatment group and the untreated group. All patients in differential treatment group received JieDuZhiZiGen Decoction treatment based on syndrome differentiation for3months, the untreated group who did not receive any treatment. All patients followed up weekly to biweekly at least3months. Syndrome, syndrome score and syndrome severity were recorded at each visit. If the new syndrome emerge, the time and duration of it are recorded. At the end of treatment, the current Nimodipine method and the modified Nimodipine method were used to evaluate syndrome efficacy separately. All of the data was analyzed by statistical software SPSS16.0. According to the sort of the information and data characteristics,χ2test, Kaplan-Meier test, Log-Rank test, the Mann-Whitney U test, Marginal homogeneity test and McNemar test were used.Results:A total of315CHB patients with syndrome of dampness-heat obstruction in middle energizer were recruited in this study, Of them,117patients were excluded from statistical analysis because of the time of research less than three months.124patients received JieDuZhiZiGen Decoction treatment based on syndrome differentiation for3months in differential treatment group,74patients were served as untreated group who did not receive any treatment according to their conditions and intention.73(58.9%,95%CI:49.7%,67.7%) cases in differential treatment group,40(54.1%,95%CI:42.1%,65.8%)(χ2=0.439,p=0.508) cases in control group emerged syndrome drift during research.72(58.1%,95%CI:48.9%,66.9%) cases in differential treatment group,37(55.1%,95%CI:43.1%,66.7%)(χ2=1.218, p=0.27) cases in control group emerged syndrome drift at the end of the research. The current Nimodipine method and a modified Nimodipine method were used to evaluate syndrome efficacy which syndrome drift occurs at the end of treatment:The clinical cure rate is0.0%versus0.0%, the marked effect rate is5.6%versus0.0%, the effective percentage is33.3%versus20.8%, and the rate of invalid is61.1%versus79.2%(Std. MH Statistic=-4.123,p=0.000). The overall rate of syndrome efficacy is38.7%versus28.2%(p=0.000) and the result of the current Nimodipine method was significantly overvalued.Conclusion:Syndrome drift is common in syndrome of dampness-heat obstruction in middle energizer in CHB and induces a biased estimate (overvalue) at the evaluation of syndrome efficacy.