ABSTRACT
Objective:
To observe effect of addition and subtraction
therapy of Huaihuasan combined with Taohuatang to
ulcerative colitis with
cold-
heat complicated
syndrome at active stage, and to study
regulation effect to immune function and inflammatory response.
Method:
One hundred and twelve
patients were randomly divided into
control group and
observation group by random number table.
Patients with
light and middle symptoms in
control group got
mesalazine slow release
tablets, 1.0 g/
time, 3 times/days,
patients with severe symptoms or whose symptoms were not changed after getting for 4 weeks in
control group got
prednisone acetate tablets, 0.75 mg·kg-1·d-1 for 3 times. Based on the
treatment in
control group,
patients in
observation group added Huaihuasan combined with Taohuatang, 1
dose/day. The
course of
treatment was 4 weeks. At remission period,
mesalazine slow release
tablets were used for maintain long-term
maintenance therapy, 0.5 g/times, 3 times/days. Scores of
disease activities were graded by improvement mayo, and clinical remission and
clinical efficacy were recorded, scores of
cold-
heat complicated
syndrome,
mucous membrane under enteroscopy and
histology of
mucosa belongs to Geboes were graded. And levels of
tumor necrosis factor-α(TNF-α) in peripheral
blood,
interleukin-8 (
IL-8),
IL-10,
T lymphocyte subsets (CD4+, CD8+), and adverse reactions, 6 months' follow-up and
recurrence were also be recorded.
Result:
Therapeutic effect of
traditional Chinese medicine syndromes were analyzed by rank sum test, which in
observation group was better than that in
control group (Z=1.915, P<0.05). Clinical effect in
observation group was 98.04%(50/51) higher than 84.00%(42/50) in
control group, clinical remission rate was 94.12%(48/51) higher than 78.00%(39/50) in
control group, and mucosal healing rate was 96.08%(49/51) higher than 82.00%(41/50) in
control group (P<0.05). Scores of mayo,
cold-
heat complicated
syndrome, colonic
mucosa and index scores of Geboes were all lower than those in
control group (P<0.01). And levels of TNF-α,
IL-8 and CD8+ were lower than those in
control group (P<0.01), and levels of
IL-10, CD4+ and CD4+ /CD8+ were higher than those in
control group (P<0.01).
Recurrence rate during 6 months in
observation group was 10.42%(5/48) lower than 30.77%(12/39) in
control group (χ2=5.669, P<0.05), as for adverse reactions, there was no significant difference between two groups.
Conclusion:
Huaihuasan combined with Taohuatang can induce UC to remission period, inhibit the activity of
disease, alleviate clinical symptoms, regulate immune function and expression of inflammatory factors, alleviate inflammatory reaction, promote intestinal mucosal healing, and can maintain clinical remission and reduce
recurrence. The
clinical efficacy is superior to that of 5-ASA/
glucocorticoid in Western
medicine.