| Objective: The study aims to evaluate the safety and effectiveness of Tongyouheji by treating childhood functional constipation of excess-heat syndrome.Methods: 1.Experimental design: The design uses the randomized and controlled method. Firstly, to selecte 60 cases of children who range from 1 to 14 years old with FC of excess-heat syndrome in Hubei Provincial Hospital of Traditional Chinese Medicine and divided them into two groups randomly. And then to Observe the efficacy and the safety index before and after the treatment at 7 days and 14 days respecttively and followed up for 28 days. 2.Therapeutic method:In the basic treatment at the same time, giving two groups oral drugs. Control group: Maren runchang bowel, 1 to 3 years old,half a bowel each time, 2 times a day;4 to 6 years old,1 bowel each time,2 times a day;7 years old and above,1 bowel each time,3 times a day.Treatment group: Tongyouheji, flushing it with boiling water and take it warm for 3 times one day,1 to 3 yearsold,take half a dose;4 to 6 years old, one dose a day;7 years old and above,1 and a half dose a day.All children took drugs at the first day after they bowel by themselves or with the help of drug.Oral drug treatment:14 days(plus or minus 2 days). 3.Observing methods:We have interviewed all patients before treatment,at 7 days、14 days、28 days respectively and recorded the main symptom integral、secondary symptom integral as well as filling in the CRF table timely.Results : 1.Onset time: Compared with control group, the difference was statistically significant for onset time(p<0.05)。 2.The curative effect of main symptoms: At 7 days after treatment, the total cure rate was 28.57% and the markedly effective rate was 71.42%. For the treatment group, the total cure rate was 13.79% and the markedly effective rate was 41.38%. For the control group, meanwhile, at 14 days after treatment, the total cure rate was 50% and the markedly effective rate was 78.57%. For the treatment group, the total cure rate was 24.14% and the markedly effective rate was 55.17%.For the control group, the difference was statistically significant(p<0.05). 3.The curative effect of TCM Syndrome: 7 days after treatment,the markedly effective rate was 39.29% and the total effective rate was 89.29% of the treatment group,the markedly effective rate was 24.14% and the total effective rate was 75.86% of control group.14 days after treatment, the markedly effective rate was 71.43% and the total effective rate was 96.43% of the treatment group,the markedly effective rate was 51.72% and the total effective rate was 86.21% of control group.The differences were statistically signi-ficant(p<0.05). 4.The main symptoms: Compared with prior treatment,the main symptoms of two groups after treatment were statistically significant(p<0.01).Compared with the control group,the defecation interval time and bowel problems of the treatment group were statistically significant(p<0.05),the problem of dry stool has no difference(p>0.05). 5.The secondary symptoms: Compared with prior treatment,the secondary symptoms of two groups both have difference(p<0.05);compared between groups,they have no difference at defecating time、lip dry、heat of foot and hands、red face and lip and yellow urine(p>0.05),but they have difference at abdominal heaviness、loss of appetite and bad breath(p<0.05). 6.Long-dated curative effect: The total effective cases were 27 of treatment group, the recurrence rate was 29.63% after followed up for 28 days,the total effective cases were 25 of control group,the recurrence rate was 56% after followed up for 28 days, the recurrence rate were statistically significant between the two groups(p<0.05).Conclusion: The clinical curative effect is distinct by treating the children with functional constipation of excess-heat syndrome with Tongyouheji, and has no adverse reaction. In conclusion, it is worthy of clinical promotion. |
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