| Objective:The operation method of cohort study with Rhizoma coptidis decoction with wash out for the intervention of the infants and specification of Rhizoma coptidis with external "eliminating fetal toxins" to prevent the infantile eczema was adopted and the clinical effect of Rhizoma coptidis with external "eliminating fetal toxins" to prevent the infantile eczema was evaluated so as to provide a simple, convenient, effective and cheap method for the prevention of infantile eczema and reduce the mental and financial burden that the infantile eczema brings to the children and families.Methods1) With the method of cohort study, the maternal and children health hospital of Xicheng district as the experimental group and the hospital of Pinggu district as the control group,115 cases of patients were included in each group, sample size:experimental group:control group=1:1. There were actually total 230 patients included,3 patients falling off and 206 patients completing the follow-up. The experimental group had 98 patients and the control group had 108 patients.2) Intervention method:experimental group:Rhizoma coptidis decoction with wash out+ maternal and child care guidance; control group:conventional bath+maternal and child care guidance. Maternal and children care guidance:refer to the postpartum maternal and child care guidance handbook of Beijing maternal and child care hospital. The wash-out method of experimental group:Rhizoma coptidis was produced into the packages of 1g/ml、10ml/pc. 15000 ml and 38-39℃ warm water was poured into the bathtub of the infants and 3 pcs of prepared Rhizoma coptidis decoction (10ml) were poured into the bathtub with 1 minute of stirring, and it was configured into the liquid of 2/1000 concentration, the newborns had bathing 3 minutes/time and 1 time/day with three days as a course. The observation period lasted for 1 year. All the newborns were tracked and followed up until one year old. The follow-up was conducted once per month to record if there was the occurrence of eczema or other disease and make timely treatment.3) Main outcome measures:end point-the occurrence of eczema; secondary outcome measures:the time, frequency and severity of eczema (SCORAD scoring).4) The western medicine diagnostic criteria of infantile eczema and the TCM diagnostic criteria of infantile eczema were based on the diagnostic standards of "Practical Surgery of Traditional Chinese Medicine", "Surgery of Chinese Medicine" and "Practical Integration of Chinese and Western medicine with Dermatology".5) Safety evaluation:record the adverse reaction levels and handle according to the levels.6) The record of adverse reaction and reporting method:record in the observation table and evaluate its correlation with the experimental drugs.7) Compliance evaluation:the compliance of the experimental group:the drug counting method was adopted to measure the compliance of the subjects and the compliance was good if the control group could contact the guardians.Result1) It’s preliminarily assumed that the effect of the Rhizoma coptidis decoction with wash out to prevent the infantile eczema had no significant differences between the subjects of different genders through the research (P<0.05)2) The attacks of infantile eczema in the head and face were the most, followed by the attack in trunk and then the attack in limbs and other parts.3) The incidence rate of the experimental group and the control group was respectively 64.29% and 69.44%, and the Rhizoma coptidis decoction with wash out had no significant improvement for the incidence of infantile eczema. (P<0.05)4) The experimental group had most incidence patients within 42 days, accounting for 76.2% in the patients of the group and 34.7% in the total incidence, followed by the patients within 42 days of the control group, accounting for 44% in the patients of the group and 23.9% in the total incidence(P<0.05). The children patients within 42 days concentrated in the experimental group, accounting for 44.2% in the total number of patients; the patients after 42 days mainly concentrated in the control group, accounting for 25.4% in the total patients. The method had a certain prevention effect for the infantile eczema after 42 days but could bring forward the incidence time of eczema. The recurrence rate of the experimental group was 0 and the recurrence rate of the control group was 9.3%(P<0.05), but it had a certain preventing role for the recurrence of infantile eczema.5) There was one patient in the experimental group who had the incidence of eczema for more than 3 months and there were total 15 patients in the control group who had the incidence of eczema for more than 3 months, which had statistic significance (P<0.05). The method had significant shortening effect for the lasting time of infantile eczema attack within one year old, and could make the eczema achieve clinical cure in about 3 months.6) There were 7 subjects with medication treatment in the experimental group and 48 subjects with medication treatment in the control group. The number of subjects with medication treatment in the experimental group was smaller (P<0.05), after rhizoma coptidis decoction can reduce infant eczema attack of the number of drug treatment.7) There was no one case with medication and combination treatment in the experimental group and there were 20 subjects with medication and combination in the control group (P<0.05), and the number of subjects with eczema medication and medication combination treatment was smaller.8) The eczema severity score of the control group was 20.3 (15.2,26.4) points and the experimental group was 9.8(9.2,17.6) points, which had significant statistic difference (P<0.01), and the scores of the experimental group were significantly lower than the control group; when the severity of eczema was highest, the score of the control group was 23.5(15.8,29.3) points and the score of the experimental group was 11.2(9.4,18.5) points, which both had significant statistic difference (P<0.01). It had a certain relieving effect for the primary attack and most severe attack of infantile eczema.9) The subjects had good compliance to the method for the prevention of infantile eczema.10) This method also had very high security for the prevention of infantile eczema.ConclusionThe Rhizoma coptidis decoction with wash out has a certain clinical significance for the prevention of infantile eczema, which could reduce the severity of eczema for infants and has advantages for the relapse and could play a supplementary role in the treatment of infantile eczema. The Rhizoma coptidis decoction with wash out has no significant side effect and could ensure drug safety. |
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