Randomized Controlled Trial On Chuanjiao Decoction For Prevention And Treatment Of Patients With Allergic Conjunctivitis

Objective:To evaluate the efficacy and safety of Chuanjiao Decoction in the treatment and prevention of allergic conjunctivitis, and to provide a new proposal and scientific foundation for the clinical application.Methods:Our research included therapeutic research and relapse prevention research. Therapeutic research:One hundred and two patients(two hundred and four eyes) with allergic conjunctivitis, including seasonal allergic conjunctivitis and vernal keratoconjunctivitis according to the inclusion criteria, were randomly divided into two groups (group of Chuanjiao Decoction and group of Olopatadine eye drops).These patients were treated for twenty-eight days. The eye and other allergic symptoms and signs were evaluated before and after the treatment at7d,14d and28d, and we analyzed the efficacy between the two groups. We also detected the level of substance p and IgE in serum and substance p in tear before and after the treatment at28d.Relapse prevention research:(1)All patients were followed up for two years, and the relapse or the symptoms and signs after relapse were observed in the second year;(2)The patients in our study were received Chuanjiao Decoction or Olopatadine eye drops seven days before the onset of allergic symptoms, continuous medication for14d.If relapsed, the symptoms and signs were observed, and analyzed in order to know the recurrence.Results:1.therapeutic research:(1)The baseline:The general were no difference between the two groups (p>0.05), and the symptoms and signs were no difference too (p>0.05).(2)The improvement of eye symptoms and signs compared:The contrast in the two groups:The eye symptoms and signs were improved significantly after treatment, the difference was significant (p<0.05).The contrast between the two groups:After four weeks, the scores of eye symptoms in group of Chuanjiao Decoction were significantly lower than the Olopatadine group(p<0.05),while there was no significant difference after one week and two weeks(p>0.05).After two weeks and four weeks, the improvement of eye signs in group of Chanjiao Decoction were significantly better than the Olopatadine group, the difference was significant(p<0.05), while there was no significant difference after one week(p>0.05).(3)The total score of eye(symptoms and signs) compared:After two weeks and four weeks, the overall improvement of eye in group of Chanjiao Decoction were significantly better than the Olopatadine group, the difference was significant(p<0.05), while there was no significant difference after one week(p>0.05).(4)As to the overall efficacy of eye, there was significantly difference between the two groups in different times (p<0.05), and the Chuanjiao Decoction group was better than the Olopatadine group.(5)The score for nose symptoms in Chuanjiao Decoction group was significantly decreased after treatment compared with baseline, the difference was significant (all p<0.05), otherwise, there was no significant difference in Olopatadine group. The improvement of nose symptoms in group of Chuanjiao Decoction was significantly better than the Olopatadine group (all p<0.05).(6)Compared with the baseline, the tear level of substance P was significantly suppressed after treatment in both groups (all p<0.05).In Chuanjiao Decoction group, the serum level of substance P and IgE were significantly lower as compare to baseline (p<0.05),but there was no significantly difference in the Olopatadine group (p>0.05).2. relapse prevention research:(1)Second year without advance medication:The recurrence rate was61.1%in group of Chuanjiao Decoction,88%in Olopatadine group in the second year. The difference was significantly (p<0.05).(2)Second year with advance medication All scores of eye symptoms and signs in Chuanjiao Decoction group were lower than the year before, the difference was significantly (p<0.05).While there was no significantly difference in Olopatadine group (p>0.05).The recurrence (treatment in advance) rate was55.6%in group of Chuanjiao Decoction,53.8%in Olopatadine group in the second year. But there was no significantly difference between the two groups (p=0.776). 3. safety evaluation:there was no significant adverse drug reaction in both groups in the course of treatment.Conclusion:1. Chuanjiao Decoction is an effective and safety drug in treatment of allergic conjunctivitis (SAC and VKC), better than Olopatadine eye drops.2. Chuanjiao Decoction can effectively suppress the recurrent symptoms and signs of allergic conjunctivitis and play a role in suppressing the relapse of allergic conjunctivitis.3. Chuanjiao Decoction can effectively relieve the symptoms of allergic rhinitis associated with allergic conjunctivitis.4. Both Chuanjiao Decoction and Olopatadine eye drops can reduce the tear level of substance P. Chuanjiao Decoction also can reduce the serum level of substance p and IgE.