RESUMO
Human papillomavirus (HPV) infection is an important factor that causes cervical cancer and non-melanoma skin cancer (NMSC), while HSV-2 plays an important role when HR-HPV triggers the cancer. Thus, a quick and convenient assay in the detection of HPV and HSV-2in the screening of HPV and HSV-2 infection is required. Two respective HPV and HSV-2 detection methods were established based on loop-mediated isothermal amplification (LAMP) assay. Specific outer primers, inner primers, and loop primers were designed according to the conserved domains of HPV and HSV-2 genomes, respectively, while degenerate primers were used for HPV assay. After optimizing the reaction conditions, the results were observed by LAMP Tubidimeter real-time LA-320. Standard plasmids HPV-L-P and HSV-2-L-P were cloned and used in sensitivity tests of HPV LAMP and HSV-2 LAMP, respectively. Fifty samples of actinic keratosis (AK), 20 samples of squamous cell carcinoma (SCC), 50 samples of basal cell carcinoma (BCC) and 20 samples of seborrheic keratosis (SK) were detected by HPV assay. Seventy three clinical samples of vaginitis, chronic cervicitis, cervical intraepithelial neoplasias and cervical cancer level positive were detected with HPV and HSV-2 assays. The reaction conditions of two assays were the same with a reaction temperature of 63 °C and a reaction time of 45 min. The sensitivity of HPV LAMP assay was 10 copies/µL, while that of the HSV-2 LAMP assay was 100 copies/µL. No cross-reactivity was observed. The HPV positive rates of AK, SCC, BCC and SK samples were 80% (40/50), 75% (15/20), 44% (22/50) and 21% (15/72), respectively. As an economic and quick diagnostic tool, LAMP assay is conducive to the extensive screening of HPV and HSV-2 and has huge potential to be promoted in resource-limited hospitals.
Assuntos
Herpes Genital/diagnóstico , Herpesvirus Humano 2/isolamento & purificação , Técnicas de Diagnóstico Molecular/métodos , Técnicas de Amplificação de Ácido Nucleico/métodos , Papillomaviridae/isolamento & purificação , Infecções por Papillomavirus/diagnóstico , Reações Cruzadas , Feminino , Herpes Genital/virologia , Herpesvirus Humano 2/genética , Humanos , Papillomaviridae/genética , Infecções por Papillomavirus/virologia , Sensibilidade e Especificidade , Temperatura , Fatores de TempoRESUMO
OBJECTIVE: To assess the efficacy and safety of Xiaozheng pills in treating mastoplasia. METHOD: Clinical trials were carried out by five hospitals. In each hospital, patients were divided into two groups with one group 24 patients (trial group) and the other 24 patients (control group). Total 240 patients were included in the study. According to randomized, double-blinded and placebo-controlled clinical study, the trial groups were treated by Xiaozheng pills with Rujiekang mimetic (placebo) and the control groups were treated by Rujiekang with Xiaozheng pills mimetic (placebo). Symptoms, laboratory test results as well as ADR were evaluated after 1 period of treatment. RESULT: The overall response rates of trial group and control group were 93.8% and 88.6% respectively, no statistic difference between the two groups. No deleterious effect in both groups and the indexes of safety were normal. CONCLUSION: These results suggest that Xiaozheng pills are effective and safe in treating mastoplasia caused by qi stagnation, blood stasis or/and stagnation of phlegm.