| Purpose:By observing the coronary heart disease stable angina patients in the curative the change of autonomic neurotransmitter(ACh, NE),enteric neurotransmitter(5-HT),and analyzing the correlation between 5-HTand heart rate with the therapy of Replenishing qi to invigorate the spleen and nourishing blood to remove phlegm, to reveal neural regulation influence for CAD stable angina pectoris.Material and method:1.Experiment Object: CAD stable angina pectoris with spleen deficiency and phlegm syndrome.2. Study Design and Grouping method: The clinical trial design was carried out by using multi center, blind method, and randomized and parallel control group. According to the superiority trial design. Calculated the sample size for 160 cases, and then divided the 160 subjects into test and control group at a proportion of 1:1,80 cases in each group.3.Interventions:Test groups were given TCM granule which replenishing qi and strengthening the spleen and nourishing blood and eliminating phlegm, combining conventional western medicine;control groups were given placebo TCM granules(10% of the constituents of the test groups), combining conventional western medicine. The course of treatment is 12 weeks,followed up for 18 weeks.4.Observed indicator: The primary evaluation of efficacy include acetylcholine(ACh),Norepinephrine(NE), 5-hydroxy trypta- mine(5-HT),Heart Rate. Measurement time points are: 0 week, 4 weeks, 12 weeks; Indexes for evaluating safety include blood, liver function(alanine aminotransferase, aspartate aminotransferase), renal function(blood urea nitrogen,creatinine), measurements time points: 0 weeks, 12 weeks.5. Statistical methods: Application of SPSS for windows 17.0 collation and analysis of data.The measurement data were(-x±s), and p<0.05 was statistically significant.Results:The PPS data set was selected, and the finally finished cases are 75 in the test group and 70 in the control group.1.Heart Rate(HR):1) Comparing in the group: The test group was not statistically significant, comparing week 4 with week 0,(P>0.05). It was statistically significant, comparing week12 with week0,(P<0.05).The control group was not statistically significant, comparing week 4 and week 12 with week0,(P>0.05).2) Comparison among groups: It was not statistically significant, comparing week 4 of the two groups,(P>0.05). It was statistically significant, comparing the week 12,(P<0.05).The test group was better than the control group. Details are on the table5-7.2.Norepinephrine(NE):1) Comparing in the group: The test group was not statistically significant, comparing week 4 with week 0,(P>0.05). It was statistically significant, comparing week12 with week0,(P<0.05).The control group was not statistically significant, comparing week 4 and week 12 with week0,(P>0.05).2) Comparison among groups: It was not statistically significant, comparing week 4 of the two groups,(P>0.05). It was statistically significant, comparing the week 12,(P<0.05).The test group was better than the control group. Details are on the table 8-10.3.Acetylcholine(ACh):1) Comparing in the group: The test group was statistically significant, comparing week4 with week 0,(P<0.05). It was statistically significant, comparing week12 with week 0,(P<0.05).The control group was not statistically significant, comparing week 4 and week 12 with week0,(P>0.05).2) Comparison among groups: It was not statistically significant, comparing week 4 of the two groups,(P>0.05). It was statistically significant, comparing the week 12,(P<0.05).The test group was better than the control group. Details are on the table 11-13.4.5-hydroxy tryptamine(5-HT):1) Comparing in the group: The test group was not statistically significant, comparing week 4 with week 0,(P>0.05). It was statistically significant, comparing week12 with week0,(P<0.05).The control group was not statistically significant, comparing week 4 and week 12 with week 0,(P>0.05).2)Comparison among groups: At each point of time, there was no significant difference between the two groups(P>0.05).The test group and the control group had declined, but thecontrol group was not obvious. Details are on the table 14-16.5.Analyzing the correlation between 5-HT and heart rate:5-HT and heart rate had no linear correlation,(P>0.05).Details are on the table 17.Conclusion:1.The content of Norepinephrine and Acetylcholine had declined.The change of heart rate reflects the relationship between them.2.5-HT was not statistically significant, but had declined.had.5-HT and heart rate no linear correlation The reaction of Norepinephrine(NE), Acetylcholine(ACh),5-hydroxy tryptamine(5-HT),revealed the neural regulation mechanism of replenishing qi and strengthening the spleen and nourishing blood and eliminating phlegm for CAD stable angina pectoris. |
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