| Objective:To study the clinical efficacy of traditional Chinese medicine combined with the control released tablet of Mesalazine to treat the ulcerative colitis(UC)in moderate activity,investigating the therapeutic mechanism of traditional Chinese medicine treat UC,and objectively evaluate the safety and effectiveness.Method:The study found 65 cases of the standard(moderate activity),and the differentiation syndrome of traditional Chinese medicine was dampness-heat stay inside.According to the doctor order,they were randomly divided into 2 groups,the control and the treatment group.There were 32 cases in the control group,and 33 cases in treatment group.Foundation treatment:Mesalazine.1g each time,4 times a day.Experimental group:The Qingchanghuashi granules: Rhizoma Coptidis 3g,radix scutellariae 10 g,Dahurian patrinia herb 15 g,Angelica 10 g,White paeony root 20 g,Sanguisorba officinalis 10 g,Lithospermum 10 g,Radix rubiae 20 g,Angelica dahurica 12 g,Costusroot 6g,Glycyrrhiza uralensis 6g Usage: Putting all granules into 200-300 warm water,mix evenly,then taking medicine two times one day.The control group:Placebo: The content was same as the Qingchanghuashi granules,but the drug concentration was only 1/40 of the experimental group.Usage: Use warm water 200 ml to 300 ml,put all granules into it,mix evenly,then take medicine two times one day.Two groups of drug were produced by Jiangyintianjiang limited liability company,the drug's appearance,shape and color were almost same.The course of treatment was 3 months.Followed-up visiting for 1 month after treatment,and observing the remission time.Results:1 Therapeutic evaluation1.1 The main indicators(1)Clinical effective rate: the control group was 62.5%(20/32),the treatment group was87.9%(29/33),(P = 0.018 < 0.05).(2)Clinical remission rate: the control group was 68.8%(22/32),the treatment group was90.9%(30/33),(P = 0.026 < 0.05).It indicated that the treatment group was superior to the control group in the clinical effective rate and the clinical remission rate.1.2 The secondary indicators1.2.1 Endoscopic response rate: The control group was 62.5%(20/32),while the treatment group was 93.9%(31/33)(P = 0.002 < 0.01).1.2.2 The intestinal mucosa healing rate: The control group was 50.0%(16/32),while the treatment group was 81.8%(27/33),(P = 0.007 < 0.01).It indicated that the treatment group was superior to the control group in the endoscopic response rate and the mucosal curative rate.1.3 The physical and chemical indicators1.3.1 Fecal occult blood test Before the treatment,the control group was 78.1%(25/32),and the treatment group was69.7%(23/33),(P = 0.440 ?0.05);It showed that the two groups were very comparable in Fecal occult blood test;After the treatment,the control group was 53.1%(17/32),while the treatment group was 27.3%(9/33),(P=0.033 <0.05);1.3.2 Erythrocyte sedimentation rate(ESR)Before the treatment,the ESR of the control group was 22.06 ± 2.35mm/h,while the treatment group was 22.09 ± 1.81mm/h,the two groups compared with each other(P=0.956 ? 0.05),however,was not statistically significant;After the treatment,the control group was 19.78 ± 2.45mm/h,the treatment group was 15.94 ± 1.83 mm/h,compared each other(P= 0.003 < 0.01).1.3.3 C-reactive protein Before the treatment,C-reactive protein of the control group was 14.50±1.85mg/L,the treatment group was 14.97±1.48 mg/L,the test result was(P = 0.260?0.05);It showed that the two groups are not statistically significant;After the treatment,C-reactive protein of the control group were 11.16±1.72mg/L,and the treatment group was 8.85±1.98mg/L, compared(P < 0.001);1.3.4 Fecal calprotectin(FC)Before the treatment,the FC of the control group was 342.28 ± 56.69ug/g,and the treatment group was 334.88±52.72ug/g,the test result was(P =0.585?0.05);It showed that the two groups were not statistically significant;After the treatment,the control group was 153.19±41.84ug/g,and the treatment group was 73.52±29.80ug/g,the test result was(P<0.01).The differences of four clinical physical and chemical indexes were statistically significant,It showed that the treatment group was superior to control group in relieving hematochezia and intestinal inflammation of UC patients.1.4 Efficacy evaluation of TCM syndrome There were 32 cases in the control group,and 10 cases were clinical remission,while 6cases were markedly effective,4 cases were effective,but 12 cases were ineffective;There were 33 cases in the treatment group,and 19 cases were clinical remission,while 7 cases were markedly effective,6 cases were effective,but 1 cases was ineffective(P = 0.004 <0.01),the difference was statistically significant,it illustrated that the efficacy evaluation of TCM syndrome was superior to the control group.1.5In reducing the abdominal pain,diarrhea,purulent blood integration of traditional Chinese medicine,the treatment group were superior to the control group.1.6 recurrence rate: The treatment group was 6.1%(2/33),the control group was 31.3%(10/32),(P <0.01),the difference was statistically significant,it indicated that the treatment group was superior to the control group in preventing recurrence.2.NO any obvious adverse reaction in the treatment,and laboratory tests were normal.Conclusion:In treating the UC,the treatment group(Mesalazine combined with the traditional Chinese medicine)was superior to the control group(western medicine)in reducing the inflammation of intestinal canal,accelerateing the healing of intestinal mucosal and the improvement of main clinical symptoms such as abdominal pian,diarrhea and purulent blood stool.It is definitely worth clinically popularizing and applying. |
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