| Objective:The incidence rate of Condyloma Acuminatum(CA) is rising year by year, which is characterised by long incubation period, high infection, high recurrence rate, and probability of tumorigenesis,especially in anal and vaginal (including cervix uteri). High recurrence rate of CA has been a research hotspot and difficulty. This study discusses the clinical efficacy of the treatment of Youdujing capsule and Youdujing suppository for CA in anal and vaginal, aiming to reduce the recurrence rate and the treatment cost of CA.Method:The anal or vaginal CA patients that were diagnosed by dermatology department of Guangdong Provincial Hospital of TCM during the period from April2012to October2013were randomly divided into experimental group and control group according to the treatment sequence. Each group consists of45patients. For all patients whose pre-treatment inspection results of serum RPR, TPPA and HIV antibodies were negative,901C-ⅡCO2laser therapy instrument was used to gasify or remove visible wart and the lesion tested positive by acetic acid white test, with gasification depth about1~2mm, the therapeutic range of the lesion area expanded to around2~3mm. Administration of anti-inflammatory drugs was used to prevent infection after operation, and diluted potassium permanganate solution (concentration of1:8000) was used to soak and clean the infected parts until scabbing occurs. In the experimental group, patients took Youdujing capsules (5capsules, TID) orally after operation; and pluged Youdujing suppository into anal (for anal CA patients) or vaginal (for vaginal CA patients) after wound healing (one pill of suppository every other night after washing hands with soap and cleaning the lesion). Youdujing capsule and Youdujing suppository were provided by Preparation Room of Guangdong Provincial Hospital of TCM. For patients in the control group, no oral administration or external treatment was given in addition to anti-inflammatory drugs. Both of the two groups took medicine one month being a therapeutic course for two consecutive therapeutic courses and the clinical efficacy was determined after1-month follow-up. Patient were reminded to pay attention to personal hygiene and prevent impurity sexual behaviour during the treatment and observation period; and record untoward effect truthfully during the treatment period.Youdujing capsule was provided by Preparation Room of Guangdong Provincial Hospital of TCM, with instrument of approval No. Yue Yao Zhi Zi E0302004. The main components include Gentian, Radix, Bolbostemma, Polygonum cuspidatum, Coix, Curcuma, Lithospermum Radix Astragali, Atractylodes, Licorice, each capsule containing1.49g of crude drug.Youdujing suppository was provided by Preparation Room of Guangdong Provincial Hospital of TCM. The main components include:Berberine, Lithospermum, Asarum, Sophora, Bupleurum, each suppository containing2g of crude drug.Results:1. The comparison results of general information:a total of90patients, among which two cases in the experimental group and five cases in the control group were dropped out during the test and a total of83patients completed clinical observation. The statistical results of sex comparison between the experimental group and the control group is P=0.829. The average age of the experimental group and the control group was29.36±8.863and28.04±7.255respectively; the average number of wart before treatment was4.11±2.259in the experimental group and3.96±1.580in the control group. The comparison of gender, age and number of wart between the experimental group and the control group were not statistically significant (P>0.05).2. The comparison results of clinical efficacy:(1) After3months clinical treatment of observation, the cure rate o f the experimental group was higher than that of the control group (the c ure rates of the experimental group and the control group were60.5%and32.5%respectively). The recurrence rate of the experimental group was lo wer than that of the control group (the recurrence rates of the control g roup and the experimental group were67.5%and39.5%respectively). Compar ison of efficacy between the two groups was statistical significant (P<0.05).(2) The treatment for multiple warts (>4) of the experimental group w as same as the that of the control group, but with higher recurrence rate and higher efficacy in treatment of single or scattered warts (≤4).(3) Influence factors, including gender and age, have no effect on cl inical efficacy.(4) The number of warts of the patients with recurrence were reduced in the experimental group, which was statistical significant compared wit h the control group.(5) Efficacy in the long term (more than6months) was similar between the two groups.3. Untoward effects recorded:one case in the experimental group had a partial mild itching in the process of using suppositories and such symptoms disappeared after stopping usage of the medicine. The rest of the trial patients had no any untoward effects.Conelusion:This study demonstrates that the application of Youdujing capsule and Youdujing suppository for anal and vaginal CA after operation can achieve better efficacy than no treatment after operation, and also can reduce t he number of the warts in the patients with recurrence. There were no sev ere adverse reactions in the treatment. Therefore, the combination treatm ent of Youdujing capsule and Youdujing suppository for CA can be consider ed with good efficacy, well tolerated, safety, convenient and affordable, and is worthily recommended in the clinical application. |