【摘要】：目的：本課題通過對中藥抗病毒制劑對比匹多莫德口服液(商品名：芙露飲)治療濕熱下注型年輕女性宮頸高危型人乳頭瘤病毒(high-risk Human Papilloma Virus, hrHPV)感染的臨床研究,以此來評價中藥抗病毒制劑臨床治療的有效性以及安全性。方法：選擇符合納入標準的于2015年6月-2015年12月在常州市中醫(yī)醫(yī)院婦科門診就診及住院的年齡為25-35歲之間的濕熱下注型hrHPV感染患者共60例,將病人隨機分為2組,對照組(芙露飲組),治療組(中藥抗病毒制劑組),每組30例,按研究方案進行治療,通過治療前后及兩組組間對比來評價中藥抗病毒制劑的臨床療效,并通過觀察治療組的臨床生化指標來評價中藥抗病毒制劑的安全性。結果：1.中醫(yī)臨床癥候積分的比較：(1)兩組治療前后各項中醫(yī)癥狀積分的比較：治療組在治療后對濕熱下注型年輕女性富頸hrHPV感染患者的各項臨床癥狀均有明顯改善。對照組在治療后對帶下情況及全身癥狀較前無或僅有輕微改善。(2)中醫(yī)臨床癥候總積分的比較：治療組的中醫(yī)臨床癥候總積分在治療前后的比較有顯著的統(tǒng)計學意義(p=0.00,p0.01),對照組在治療前后的臨床癥候積分方面意義不顯著,且兩組之間對比,差異具有統(tǒng)計學意義(p0.05)。2.hrHPV病毒載量及轉陰率的比較：(1)治療組與對照組在治療前后的病毒載量比較均具有顯著統(tǒng)計學意義,兩組病毒載量治療前后差值比較有統(tǒng)計學意義(p=0.01,p0.05),且治療組降低hrHPV病毒載量明顯優(yōu)于對照組,兩組對比具有明顯差異(p0.05)。(2)對照組在治療3個月、6個月后轉陰率為20%、33.3%,治療組在治療3個月、6個月后的轉陰率為36.7%、63.3%。兩組在治療3個月、6個月后的轉陰率的比較均具有統(tǒng)計學意義(p0.05)。3.治療前后總有效率的比較：對照組痊愈率為10%,總有效率63.3%,治療組痊愈率為26.7%,總有效率為86.7%。兩組總有效率的比較有顯著統(tǒng)計學意義(p=0.00,p0.01)。4.安全性觀察：治療組在治療3個月、6個月后查肝腎功能、血尿常規(guī)、凝血功能、血生化等指標未見明顯異常,兩組治療期間未出現(xiàn)與服用藥物明顯相關的不良反應。結論：中藥抗病毒制劑及芙露飲均能夠明顯縮短年輕女性宮頸hrHPV感染的臨床自愈時限,能夠清除hrHPV病毒,降低病毒載量,改善患者的臨床癥狀。中西藥及早干預治療有顯著的臨床治療意義,且中藥治療效果明顯優(yōu)于西藥治療。中藥經(jīng)濟實惠,安全無毒副作用。
[Abstract]:Objective: to study the clinical study on the treatment of high risk human papillomavirus (high-risk Human Papilloma Virus, hrHPV) infection of cervix of young women with dampness and heat by contrasting pidomod oral liquid (commercial name: Fructus decoction) with antiviral preparation of traditional Chinese medicine. To evaluate the efficacy and safety of traditional Chinese medicine antiviral preparations. Methods: a total of 60 patients with hrHPV infection, aged 25-35 years, who were admitted to the department of gynecology of Changzhou traditional Chinese Medicine Hospital from June 2015 to December 2015, were randomly divided into two groups. The control group (Flo Yin group) and the treatment group (traditional Chinese medicine antiviral preparation group), 30 cases in each group, were treated according to the research plan. The clinical efficacy of traditional Chinese medicine antiviral preparation was evaluated by comparison before and after treatment and between the two groups. The safety of traditional Chinese medicine antiviral preparations was evaluated by observing the clinical biochemical indexes of the treatment group. Results: 1. Comparison of TCM clinical symptom scores: (1) comparison of TCM symptom scores before and after treatment: after treatment, the clinical symptoms of young female patients with hrHPV infection with rich neck were obviously improved in the treatment group. In the control group, there was no or only slight improvement in the subband condition and systemic symptoms after treatment. (2) comparison of the total score of TCM clinical symptoms: the total score of TCM clinical symptoms in the treatment group was significantly different before and after treatment. Statistical significance (p0. 00. P0.01), the control group had no significant significance in the clinical symptom score before and after treatment, and the comparison between the two groups, The difference was statistically significant (p0. 05). The comparison of viral load and negative rate of 2.hrHPV: (1) the viral load of treatment group and control group were significantly different before and after treatment. The difference of viral load between the two groups before and after treatment was statistically significant (p0. 01% p0. 05), and the decrease of hrHPV viral load in the treatment group was significantly better than that in the control group. There was significant difference between the two groups (p0. 05). (2). In the control group, the rate of turning negative after 3 months and 6 months was 20 and 33. 3 respectively. In the treatment group, the rate of turning negative after 3 months and 6 months was 36. 7% and 63. 3% respectively. After 3 months and 6 months of treatment, there were significant differences in the rate of negative conversion between the two groups (p 0.05). Comparison of the total effective rate before and after treatment: the cure rate of the control group was 10, the total effective rate was 63.3, the cure rate of the treatment group was 26.7and the total effective rate was 86.7. The total effective rate of the two groups was significantly higher than that of the control group (p0. 00p 0. 01). 4. Safety observation: the liver and kidney function, blood and urine routine, coagulation function and blood biochemistry were not abnormal in the treatment group after 3 months and 6 months, and there were no obvious adverse reactions associated with taking drugs during the treatment period. Conclusion: both antiviral preparations and Fructus decoction can significantly shorten the time limit of self-healing of cervical hrHPV infection in young women, eliminate hrHPV virus, reduce viral load and improve the clinical symptoms of the patients. Early intervention of Chinese and western medicine has significant clinical significance, and the effect of traditional Chinese medicine is obviously better than that of western medicine. Traditional Chinese medicine is economical and safe without toxic side effects.
【學位授予單位】：南京中醫(yī)藥大學
【學位級別】：碩士
【學位授予年份】：2016
【分類號】：R271.9

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