| Part 1 The relationship between the levels of serum testosterone and estradiol and syndrome elements with the hepatitis cirrhosisObjectiveAnalyzing the relationship between the levels of testosterone and estradiol and the syndrome elements in hepatitis cirrhosis.Methods1. Adopting the research method of clinical epidemiology investigation. The patients in the group were from nine hospitals across the country. Using the unified "hepatitis cirrhosis case survey form" formulated by research group, to collecting TCM symptoms and signs. Using the unified "Standards of hepatitis cirrhosis syndrome elements differentiation" formulated by research group, to identifying TCM syndrome elements. The levels of serum testosterone (male) and estradiol (female) were all detected uniformly in the patients.2. Adopting the unified data collecting platform to establish the database. Two individuals input data independently, for two-time checking. All data were analyzed by applying SPSS 20.0 statistical package. P<0.05 stands for a statistical difference, P<0.01 stands for a significantly statistical difference.ResultsThe study included 501 male patients and 145 female patients with menopause.1. The relationship between two indicators and the degree of disease:To male patients of hepatitis cirrhosis, the serum testosterone level was correlative negatively to either Child-Pugh score or MELD score(P<0.01,-1<r<0),and the serum testosterone levels were Child-Pugh A> Child-Pugh B> Child-Pugh C, compensatory period> decompensated period and rest period> active period(P<0.01). To menopause female patients of hepatitis cirrhosis, the serum estradiol level was correlative positively to MELD score(P<0.01,r=0.160),and the serum estradiol levels were Child-Pugh A< Child-Pugh B < Child-Pugh C, compensatory period<decompensated period and rest period< active period(P<0.01).2. The distribution of TCM syndrome elements:To male patients of hepatitis cirrhosi s:blood stagnation(17.53%)>qi deficiency(16.90%)>water retention(15.84%)>yan g deficiency(13.77%)>yin deficiency(13.61%)>qi stagnation(13.45%)>damp heat (8.90%),and in compensatory period, the most common syndrome element was bl ood stagnation(5.46%), however, in decompensated period, the most common syndr ome element was water retention(15.10%), on the whole, the TCM syndrome elem ents in decompensated period (1363(72.19%))were more than in compensatory per iod(525(27.81%)). To menopause female patients:yin deficiency(16.53%)>yang defi ciency(16.03%)>qi deficiency(15.69%)>qi stagnation/blood stagnation(14.86%) > water retention(13.86%)>damp heat(8.18%),and in compensatory period, the most common syndrome element were qi stagnation(6.51%) and yin deficiency(6.5 1%), however, in decompensated period, the most common syndrome element was water retention(12.85%), on the whole, the TCM syndrome elements in decompen sated period (414(69.12%))were more than in compensatory period(l85(30.88%)).3. The relationship between the level of testosterone and syndrome element to male p atients of hepatitis cirrhosis:the serum testosterone levels were qi deficiency group < non-qi deficiency group, yang deficiency group< non-yang deficiency group, a nd water retention group< non-water retention group(P<0.01), however, level of t estosterone of other syndrome elements were not significantly different from non-g roups(P>0.05). In compensatory period, testosterone levels of all the syndrome ele ments were not significantly different from non-groups(P>0.05). In decompensated period, the serum testosterone level was just qi deficiency group<non-qi deficienc y group(P<0.01).4. The relationship between the level of estradiol and syndrome element to menopaus e female patients of hepatitis cirrhosis:the serum estradiol levels were just qi defi ciency group>non-qi deficiency group, and water retention group>non-water rete ntion group(P<0.01). In compensatory period, estradiol levels of all the syndrome elements were not significantly different from non-groups(P>0.05), and so were e stradiol levels in decompensated period.Conclusions1. With the illness was more and more serious, the serum testosterone level of male patients with hepatitis cirrhosis would also show a trend of reducing, and the estradiol level of female patients with hepatitis cirrhosis would show a trend of rising.2. The blood stagnation and yin deficiency were more common syndrome elements to hepatitis cirrhosis patients, and the appearance of qi deficiency, yang deficiency and water retention may mean the aggravation of the patient’s condition. And the traditional Chinese medicine pathogenesis of patients during decompensated period may be often more complex than patients during compensation period, then, it is very necessary that taking "invigorating the circulation of blood(Huoxue)", "tonifying qi (Yiqi)" and "nourishing Yin(Ziyin)" and so on as the based TCM treatment methods for hepatitis cirrhosis.Part 2 The TCM intervention effects on serum testosterone and estradiol levels of patients with cirrhosis of hepatitis B in compensatory periodObjectiveTaking "Tonifying Qi and invigorating spleen", "soothing the liver or Qi", "invigorating the circulation of blood and dredging collaterals" and "nourishing Yin or blood" as the specific treatment means, and selecting patients with cirrhosis of hepatitis B in compensatory period to accepting test. Then, the main is to observing and analyzing the effects of TCM intervention on serum testosterone and estradiol levels of patients for provide some basis for TCM clinical intervention and scientific research for hepatitis cirrhosis.Methods1. During the TCM clinical intervention research, adopting the randomized, controlled and double-blind clinical trial design. The parents came from three hospitals considered owning the highest level, who were randomly assigned to three groups, which were treatment group A(to "tonifying Qi and invigorating spleen"& "soothing the liver or Qi"& "invigorating the circulation of blood and dredging collaterals"), treatment group B(A plus "nourishing Yin or blood"), and simulation group C(simulative B), and the parents were all all treated by above drugs A or B or C, in the premise of the treatment with antiviral Western Medicine at the same time.2. The duration of the intervention lasted for up to six months. A total of two times(before and after the intervention), parents were all observed for their symptoms or physical signs by filling in "Symptom collection Form of Chinese Medicine", "Chronic liver disease Scale", and "Fatigue Scale", and they were uniformly tested serum testosterone and estradiol levels.3. Adopting the unified data collecting platform to establish the database. Two individuals input data independently, for two-time checking. By applying SPSS 20.0 statistical package to analyzing changes of patients’serum levels of testosterone and estradiol, intra-group and between the three groups, before and after the intervention. P< 0.05 stands for a statistical difference, P<0.01 stands for a significantly statistical difference.ResultsThis study included a total of 132 cases.1. Intervention effects on testosterone level(1) To male patients:①intra-group:Serum T levels were lower in patients with C after intervention(P<0.05).However, There were no significant differences in the serum testosterone levels between before and after intervention by A and B.②between the three groups:Before the intervention, there were no significant differences in the serum T between the three groups(P>0.05), which means the baseline levels of serum T in the three groups were comparable. Then, after the intervention, there were also no significant differences in the serum T between the three groups(P>0.05), but the trend of the rate of descend in the three groups was "C<B<A"(P>0.05).(2) To male patients in stationary phase and in active phase:①intra-group:In addition to patients from Group A in active phase, Serum T levels were lower after intervention(P<0.05), yet, to other patients, there were no significant differences in the serum T levels between before and after intervention by A,B and C in active or stationary phase(P>0.05).②between the three groups:Before the intervention, there were no significant differences in the serum T between the three groups(P>0.05), which means the baseline levels of serum T in the three groups were comparable. Then, after the intervention, there were also no significant differences in the serum T between the three groups(P>0.05), but the trend of the rate of descend in the three groups were "A<C<B"(to patients in stationary phase) and "B<C<A"(to patients in active phase)(P>0.05).2. Intervention effects on estradiol level(1) To male and female patients: ①intra-group:There were all no significant differences in the serum E2 levels between before and after intervention by A,B and C(P>0.05).② between the three groups:Before the intervention, there were no significant differences in the serum E2 between the three groups(P>0.05), which means the baseline levels of serum E2 in the three groups were comparable. Then, after the intervention, there were also no significant differences in the serum E2 levels or rate of change between the three groups(P>0.05), yet, to the trend of the rate of change, showing a trend of returning in group A, but a trend of increasing continuously in group B and C(to male patients), showing a trend of returning in group A and B, but a trend of increasing continuously in group C(to female patients).(2) To male patients in active or stationary phase, and to female patients in stationary phase and in menopausal phase:①intra-group:There were all no significant differences in the serum E2 levels between before and after intervention by A,B and C(P>0.05).②between the three groups:Before the intervention, there were no significant differences in the serum E2 between the three groups(P>0.05), which means the baseline levels of serum E2 in the three groups were comparable. Then, after the intervention, there were also no significant differences in the serum E2 levels between the three groups(P>0.05).But the trend of rising ratio of E2 in the three groups were "C<A<B"(for male patients in stationary phase) and "A<B<C"(for female patients in menopausal phase) (P>0.05). To male patients in active phase, the trend of rate of E2 change were returning in group A, and increasing continuously in group B and C(P>0.05). To female patients in stationary phase, the trend of rate of E2 change were returning in group B, and increasing continuously in group A and C (P>0.05).Conclusions1. To the hepatitis B cirrhosis with complicated pathogenesis, six months of clinical intervention may too short to see the effect by intervening of traditional Chinese medicine on the basis of antiviral treatment in western medicine.2. Integrating the changing trends between the three groups:To female patients, treatment group B("Tonifying Qi and invigorating spleen", "soothing the liver or Qi", "invigorating the circulation of blood and dredging collaterals" and "nourishing Yin or blood") was better than treatment group A("Tonifying Qi and invigorating spleen", "soothing the liver or Qi" and "invigorating the circulation of blood and dredging collaterals"). To male patients, treatment group A was better than treatment group B. In a word, Nourishing Yin(Ziyin) was better to female patients than to male patients for patients hepatitis B cirrhosis in stationary phase. Therefore, it needs considering patients gender and other individual differences to flexible treatment during the TCM clinical period. |
PDF Full Text Request