Clinical Trial On Recombinant Interferon α Treatment Of Genital Herpes

Genital herpes(GH) is a sexually transmitted disease, which is familiar, recurrent and difficult healing. It transmit by sex contact. Its pathogen is herpes- simplex virus(HSV).HSV have two types that are HSV-Ⅰand HSV-Ⅱ.GH is caused by HSV-Ⅱ mainly, but recent years that HSV-Ⅰ causes GH has increased gradually. Interferon can induce cell to produce some proteins which have activities like enzyme. By those proteins interferon can restrain virus coping and damage virus. Interferon also have anti- tumor activities and immune-regulated function. Recombinant Interferon α is a product of modern medical biologic technique . Large quantities of clinical trial in domestic and international proved that Interferon α in curing GH was effective and safe. Objective: Applying Recombinant Interferon α-2a cream and Recombinant Interferon α-2b cream to cure GH. Observe the clinic effect and safety of the two medicines. Compare the effect of the two medicines.Method: A randomized, double-blind, placebo-controlled, comparative trial method was used. Choose 88 patients with GH in March of 2002 to 2003 April in the second hospital of JiLin University. Among them there are 65 males and 23 females. Average age is 33.58 ±s 8.62 years olds. There are 10 persons whose course of disease <12h and 78 persons whose course of disease is in 12-24h.Divide the 88 patients into two groups randomly. One group named A which has 48 patients, and divide these 48 patients into two groups named Aa and Ab. Aa group is test group which is applied with Interferon α-2a cream, and Ab group is control group which is applied with placebo. Aa group has 24 cases as many as Ab group. Another group named B which has 40 patients, and divide these 40 patients into two groups named Ba and Bb. Ba group is test group which is applied with Interferon α-2b cream, and Bb group is control group which is applied with placebo. Ba group has 20 cases as many as Bb group. Suffer the medicine to draw 5 times everyday on the infected part, continue to use 7 days. In the 3rd,5th,7th days after using the medicine we observe and record the ameliorative degree of the clinical symptom. according to the changes of integral calculus between the front and back of the trial, apply the t examination and χ2 examinations to analyze the parameter. Result: ameliorative degree of condition integral become distinct in the 3rd day after treatment. After trial Aa group had higher significantly cure and efficiency rate than Ab group, they were 56.62%, 95.65% versus 20.83%, 66.67% correspondingly(P<0.05). Ba group were the same, the cure and efficiency rate were 65%,85% versus 25%,50% correspondingly(P<0.05). The treatment was well tolerated by all patients. Contrasting Aa group and Ba group, the difference of cure rate and efficiency rate is not distinct(P>0.05).Conclusion: Recombinant Interferon α-2a cream and Recombinant Interferon α-2b cream are effective and safe in treatment for patients afflicted with genital herpes. The difference of cure rate and efficiency rate of these two medicine is not distinct, and the medicine can be used consider the feeling.