补中益气丸辅助5-氨基酮戊酸光动力疗法治疗尖锐湿疣临床研究

Clinical Study on Buzhong Yiqi Pills Combined with 5-Aminolevulinic Acid Photodynamic Therapy for Condyloma Acuminatum

目的:观察补中益气丸辅助5-氨基酮戊酸光动力疗法(ALA-PDT)治疗尖锐湿疣(CA)的临床疗效。方法:选取CA患者82例,按随机数字表法分为研究组和对照组各41例。2组均暂停性生活,并采取常规西医治疗,对照组采取ALA-PDT,研究组在对照组基础上给予补中益气丸口服。比较2组临床疗效,检测治疗前后血清Th1/Th2型细胞因子[干扰素-γ(IFN-γ)、白细胞介素-10 (IL-10)、白细胞介素-2 (IL-2)]、淋巴细胞趋化因子(LTN)、转化生长因子-β1 (TGF-β1)含量及生活质量(CECA10)评分,并于治疗后3个月、6个月、9个月随访疾病复发率。结果:研究组总有效率为92.68%,高于对照组75.61%,差异有统计学意义(P<0.05)。治疗前,2组血清IFN-γ、IL-10、IL-2水平比较,差异无统计学意义(P>0.05)。治疗后,2组IFN-γ、IL-2、IL-10水平较治疗前改善(P<0.05);且研究组IFN-γ、IL-2水平高于对照组,IL-10水平低于对照组(P<0.05)。治疗前,2组血清LTN、TGF-β1水平比较,差异无统计学意义(P>0.05)。治疗后,2组血清LTN、TGF-β1水平较治疗前增高,且研究组高于对照组(P<0.05)。治疗前,2组CECA10量表评分比较,差异无统计学意义(P>0.05)。治疗后,2组CECA10量表评分较治疗前升高,且研究组高于对照组(P<0.05)。治疗后9个月,研究组复发率(11.11%)低于对照组(36.67%)(P<0.05)。结论:补中益气丸辅助ALA-PDT治疗CA患者疗效确切,可提高血清LTN、TGF-β1水平,增强机体免疫功能,改善生活质量,降低疾病复发率。

Objective: To observe the clinical effect of Buzhong Yiqi pills combined with 5-aminolevulinic acid photodynamic therapy(ALA-PDT) for condyloma acuminatum(CA). Methods:A total of 82 cases of CA patients were selected and divided into the study group and the control group according to the random number table method,41 cases in each group.Both groups suspended sexual life, and were given routine western medicine;the control group was additionally treated with ALA-PDT, and the study group was additionally given the oral administration of Buzhong Yiqi pills based on the treatment of the control group.The clinical effect was compared between the two groups. Contents of Th1/Th2 cytokines in serum [interferon-γ(IFN-γ), interleukin-10(IL-10), and interleukin-2(IL-2)], lymphotactin(LTN), and transforming growth factor-β1(TGF-β1),as well as score of Quality of Life Evaluation of condylomaacuminatum(CECA10) were detected before and after treatment.In the follow-up three months,six months,and nine months after treatment,recurrence rate of the disease was recorded. Results:The total effective rate was 92.68% in the study group,higher than that of 75.61% in the control group,the difference being significant(P<0.05). Before treatment,when compared levels of IFN-γ,IL-10,and IL-2 in serum between the two groups,there was no significance being found in the difference(P>0.05). After treatment,levels of IFN-γ,IL-2,and IL-10 in the two groups were improved when compared with those before treatment(P<0.05);levels of IFN-γ and IL-2 in the study group were higher than those in the control group,and the level of IL-10 was lower than that in the control group(P<0.05). Before treatment,when compared levels of LTN and TGF-β1 in serum between the two groups,there was no significance being found in the difference(P>0.05).After treatment,levels of LTN and TGF-β1 in serum in the two groups were increased when compared with those before treatment,and the two levels in the study group were higher than those in the control group(P<0.05).Before treatment,when compared score of CECA10 Scale between the two groups,there was no significance being found in the difference(P>0.05).After treatment,scores of CECA10 Scale in the two groups were increased when compared with those before treatment,and the score in the study group was higher than that in the control group(P<0.05).Nine months after treatment,the recurrence rate was 11.11% in the study group,lower than that of 36.67% in the control group(P<0.05). Conclusion: The therapy of Buzhong Yiqi pills combined with ALA-PDT has defined curative effect in the treatment of CA patients, which can increase levels of LTN and TGF-β1 in serum,enhance immune function of body,improve quality of life,and reduce recurrence rate of the disease.