| 1. Objectives1.1To provide clinical evidences of early prophylaxis and interventions for prostatitis type IIIB, the correlation between the symptom scale before intervention and density of cytokines lecithin body in express prostatic secretion, prostate tenderness, course of disease was under research.1.2To investigate the rule of symptom alleviation in varied time-points after intervention(compounded Tufuling tablet), the changes of the symptom scale and objective indicators in patients with prostatitis type IIIB before and after treatment (compounded Tufuling tablet) were researched.1.3To provide scientific evidences of Chinese herb medicine for prostatitis type IHB, the mechanism of compounded Tufuling tablet for the disease was investigated in the aspect of cytokine, tumor necrosis factor and Interleukin-10.2. Method The research is prospective randomized double-blinded paralleled controlledclinical trial.120patients with prostatitis type IIIB were randomly allocated intointervention group (compounded Tufuling tablet and standardized treatment of westernmedicine) and control group(standardized treatment of western medicine only). Theinterviews were made in run-in period,2nd and4th weeks after randomization. Thefollowings is the details:(1) Cross-sectional research The general information of120patients with prostatitis type IIIB was analyzedthrough frequency analysis method. The correlation between the symptom scalebefore intervention and density of cytokines lecithin body in express prostaticsecretion, prostate tenderness was under research.(2) Prospective research The efficacy was tested by analyzing the following indicators in2nd and4th weeksafter randomization:A. the scales of NIH-CPSI, B. the scales of symptoms based on traditional Chinese medicine, C. The rule of symptom alleviation in varied time-point was analyzed. The mechanism of compounded Tufuling tablet for the disease was investigated in the aspect of cytokine, tumor necrosis factor and Interleukin-10.3. Results3.1Cross-section research3.1.1The relation between scale of symptom and the number of varied lecithin body in expressed prostatic secretion, and prostate tenderness.There is no significant difference between the scale of NIH-CPSI, which is for the number of varied lecithin body in expressed prostatic secretion, and the scale of symptom based on traditional Chinese medicine(P>0.05). There is no significant difference between the scale of NIH-CPSI, which is for prostate tenderness, and the scale of symptom based on traditional Chinese medicine(P>0.05)3.1.2The relation between the level of cytokine and the number of lecithin body in expressed prostate secretion.There is no linear correlation between the level of TNF-a and the number of cytokine body in expressed prostate secretion.There is no linear correlation between the level of IL-10and the number of cytokine body in expressed prostate secretion.3.1.3The relation between the scale of symptom and the level of cytokine in expressed prostate secretion.There is no linear correlation between the level of TNF-a and the total scale of NIH-CPSI, the CPSI-scale for pain and urination, the scale of symptom based on traditional Chinese medicine(P>0.05).There is no linear correlation between the level of IL-10and the total scale of NIH-CPSI, the CPSI-scale for urination and life quality, the scale of symptom based on traditional Chinese medicine(P>0.05), whereas the linear correlation is shown between the level of IL-10and the CPSI-scale for pain (P＜0.05)3.1.4The relation between different cytokines in expressed prostate secretion.There is no linear correlation between the level of TNF-a and that of IL-10(P>0.05) 3.2The prospective research3.2.1Different interventions for the scale of symptomThe significant difference is shown on NIH-CPSI and the scale of symptom based on traditional Chinese medicine between two groups on the14th and28th days after randomization (favoured intervention group, compounded Tufuling tablet and standardized western medicine)(P<0.01)The response rate for NIH-CPSI is77.2%and6.9%on the14th day after randomization in the intervention and control group respectively, there is significant difference between groups (P＜0.01)The response rate for NIH-CPSI is84.2%and12.1%on the28th day after randomization in the intervention and control group respectively, there is significant difference between groups (P<0.01)The response rate for the scale of symptom based on traditional Chinese medicine is54.4%and8.6%on the14th day after randomization in the intervention and control group respectively, there is significant difference between groups (P＜0.001)The response rate for the scale of symptom based on traditional Chinese medicine is68.4%and13.8%on the28th day after randomization in the intervention and control group respectively, there is significant difference between groups (P＜0.01)3.2.2The rule of symptom alleviation in varied time-points3.2.2.1The scale of symptom and NIH-CPSI for urination descending trends are quickly first and slowly after.Compared with the score of symptom in run-in period, that was decreased significantly the difference of mean is15.27. Compared with the score on14th day after randomization, the same situation was observed, the difference of mean is4.34. The decrease range of symptom score between14th and28th day after randomization in intervention group show significant difference, the P value is less than0.05. however that value between the14th day after randomization and run-in period in control group is minus. That value between the28th and14th day after randomization in control group is distinct (7.68), which shows the significant difference (P<0.05) In intervention group, the mean difference value of NIH-CPSI for urination between14th day after randomization and that in run-in period is3.49, which shows the significant difference (P<0.05).The mean difference value of NIH-CPSI for urination between the28th day and14th after randomization is1.95which shows the significant difference (P<0.05)The mean difference value of NIH-CPSI for urination between the28th day and14after randomization in control group is0.18, no statistic difference was tested, whereas that values between the14th,28th days after randomization and run-in period is distinct and show significant difference (P<0.05)3.2.2.2The three highest response rates of CPSI on the14th28th day after randomization in intervention group are pain urgency high frequency of urination, discomfort or pain in perineum or in testicles, the rates reach77%,79%on14th28th days after randomization respectively.3.2.2.3The relation between the scale of symptom and different treatments and treatment timeThe generalized estimating equation models were made to investigate the relation. After adjustment of age and disease course, the influence was shown on the scale of CPSI in the field of scale of NIH-CPSI and of symptom based on traditional Chinese medicine (P<0.001),which indicates that the efficacy in intervention group is distinctly better than that in control group.3.2.3The relation between the level of WBC lecithin body in EPS and varied treatmentsNo difference was seen on the level of WBC lecithin body in EPS on the28th day after randomization between groups (P>0.05), the same result was shown on the prostate tenderness.3.2.4The relation between cytokines in EPS and varied treatmentsThe significant difference was observed in the level of TNF-a and IL-10on the28th day after randomization compared to run-in period in intervention group(P<0.01), whereas in control group, no statistic difference was tested (P>0.05)Compared with control group, the level of TNF-a is significant decreased in intervention group, statistic difference was tested (P<0.05),while there is no difference in IL-10level between groups(P>0.05). 4Conclusions4.1The positive correlation was observer between the score of NIH-CPSI and the level of cytokines(TNF-αIL-10) in prostatic fluid.4.2The efficacy of compounded tufuling tablet and standardized treatment of western medicine for symptom alleviation is better than standardized treatment of western medicine only.4.3The distinct rule of symptom alleviation is the followings:A. The trend is quick first and slow after. B. The three highest rate of alleviation are pain urgency high frequency of urination, discomfort or pain in perineum or in testicles. Different interventions and the time when patient receives the treatment on varied disease stage showed the most significant influences on the scale of symptom.4.4The distinct influence on the level of cytokines (IL-10) in prostatic fluid made by compounded tufuling was observed, the level was decreased significantly after intervention. |
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