Clinical Efficacy of Wandai Decoction in Preventing and Treating VVC with Spleen Deficiency-Dampness Abundance Syndrome and Its Impact on DNA Damage
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摘要:
目的 探讨完带汤治疗脾虚湿盛型外阴阴道假丝酵母菌病(Vulvovaginal candidiasis, VVC)的临床疗效及对DNA损伤的影响。 方法 将符合纳入标准的70例脾虚湿盛VVC患者随机分为完带汤组和氟康唑组各35例，治疗期间2组各脱落5例。氟康唑组采用150 mg氟康唑口服一次；完带汤组采用完带汤口服14 d。治疗后比较2组患者中医证候积分变化情况；评估2组患者临床治愈(Test of cure, TOC)率及临床缓解(Clinical improvement, CI)率；比色法检测阴道灌洗液中8-羟基脱氧鸟苷(8-hydroxydeoxyguanosine, 8-OHDG)水平变化以评估DNA损伤情况；治疗后3月评估患者访视临床完全缓解(Follow up, FU)、真菌学转阴及复发率。 结果 治疗后，2组患者中医证候积分均呈现不同程度改善(P < 0.05，P < 0.01)；完带汤组优于氟康唑组(P < 0.05，P < 0.01); 完带汤组TOC、CI、真菌学转阴率与氟康唑组未见明显差异(P＞0.05)；但完带汤组FU及复发率均显著优于氟康唑组(P < 0.05，P < 0.01)。治疗后，氟康唑组阴道灌洗液中8-OHDG表达显著增加(P < 0.001)，完带汤组未见明显变化，显著低于氟康唑组(P < 0.001)。 结论 完带汤总体临床疗效与氟康唑相当，但在改善中医证候、防止复发方面优于氟康唑，同时具有不加剧阴道细胞DNA损伤的优势。 -
关键词:
- 完带汤 /
- 外阴阴道假丝酵母菌病 /
- DNA损伤 /
- 临床疗效
Abstract:OBJECTIVE To explore the clinical efficacy of Wandai Decoction in the treatment of vulvovaginal candidiasis (VVC) with spleen deficiency-dampness abundance and its effect on DNA damage. METHODS 70 VVC patients with spleen deficiency-dampness abundance who met the inclusion criteria were randomly divided into Wandai Decoction and fluconazole groups, 35 cases each. The fluconazole group took 150 mg fluconazole orally once; the Wandai Decoction group took Wandai Decoction orally for 14 d. After treatment, changes in TCM syndrome scores of the two groups of patients were compared; the clinical cure (test of cure, TOC) rate and clinical improvement (CI) rate of the two groups of patients were evaluated; 8-hydroxydeoxyguanosine (8-OHDG) in the vaginal lavage fluid was detected by colorimetry to assess DNA damage; clinical complete remission (follow up, FU), mycological negative conversion and recurrence rate were evaluated 3 months after treatment. RESULTS After treatment, the TCM syndrome scores of the two groups of patients were improved to varying degrees (P < 0.05, P < 0.01); the Wandai Decoction group was superior to the fluconazole group (P < 0.05, P < 0.01); there was no significant difference in TOC, CI, mycology negative conversion between the Wandai Decoction group and the fluconazole group (P>0.05); however, the FU and recurrence rate of the Wandai Decoction group were significantly better than those of the fluconazole group (P < 0.05, P < 0.01). After treatment, the expression of 8-OHDG in the vaginal lavage fluid of the fluconazole group increased significantly (P < 0.001), while there was no significant change in the Wandai Decoction group, which was significantly lower than that of the fluconazole group (P < 0.001). CONCLUSION The overall clinical efficacy of Wandai Decoction is equivalent to that of fluconazole, but it is better than fluconazole in improving TCM syndromes and preventing recurrence, with the advantage of not aggravating DNA damage in vaginal cells. -
Key words:
- Wandai Decoction /
- vulvovaginal candidiasis /
- DNA damage /
- clinical efficacy
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图 1 2组患者治疗前后阴道灌洗液中8-OHDG水平比较
注: Pre-C.氟康唑组治疗前; Post-C.氟康唑组治疗后; Pre-T.完带汤组治疗前; Post-T.完带汤组治疗后。***P < 0.001，n=10。
Figure 1. Comparison of 8-OHDG levels in vaginal lavage fluid of the two groups of patients before and after treatment
表 1 中医证候评分量表
Table 1. Scoring standards for TCM syndrome
项目 0分 1分 2分 3分 带下量 无增多 稍有增多 较病前增多1~2倍 较病前增多2倍以上 带下色 无色透明 白色 淡黄色 黄色 带下质 不稀不稠 稀薄 稍有黏稠 黏稠 面色㿠白或萎黄 无 轻 中 重 四肢倦怠或浮肿 无 轻 中 重 纳少 无 较病前减少1/3 较病前减少1/2 较病前减少2/3 便溏 无 每日1~2次 每日3~4次 每日>4次 脘胁不舒 无 轻 中 重 
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表 2 VSS评分标准
Table 2. VSS scoring criteria
项目 0分 1分 2分 3分 瘙痒 无 偶有发作, 可被忽略 能引重视 持续发作, 坐立不安 疼痛 无 轻 中 重 充血、水肿 无 轻 中 重 抓痕、皲裂、糜烂 无 - - 有 分泌物量 无 较正常稍多 量多, 无溢出 量多, 有溢出
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表 3 2组患者治疗前后中医证候积分比较(x±s, n=30)
Table 3. Comparison of TCM symptoms between the two groups of patients before and after treatment(x±s, n=30)
组别 时间 带下量 带下色 带下质 面色㿠白或萎黄 四肢倦怠或浮肿 完带汤组 治疗前 2.60±0.50 0.93±0.45 1.01±0.46 2.80±0.41 2.43±0.78 治疗后 1.30±0.22**## 0.28±0.13**## 0.35±0.17**## 0.77±0.39**## 0.98±0.47**## 氟康唑组 治疗前 2.67±0.48 1.00±0.46 1.03±0.41 2.67±0.48 2.73±0.58 治疗后 1.78±0.31** 0.61±0.24** 0.63±0.33** 1.89±0.68** 2.12±0.38** 组别 时间 纳少 便溏 脘胁不舒 总积分 完带汤组 治疗前 0.77±0.73 0.57±0.57 0.37±0.49 11.23±1.87 治疗后 0.42±0.18*## 0.25±0.12**## 0.13±0.28*# 3.18±0.33**## 氟康唑组 治疗前 0.80±0.66 0.53±0.51 0.33±0.48 12.05±1.52 治疗后 0.68±0.43 0.39±0.25 0.25±0.15 7.84±0.56** 注: 组内比较, *P < 0.05, **P < 0.01;组间比较, #P < 0.05, ##P < 0.01。
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表 4 2组患者VSS评分比较(x±s，n=30)
Table 4. Comparison of VSS scores between the two groups of patients (x±s, n=30)
组别 时间 VSS评分 完带汤组 治疗前 8.73±1.41 治疗后 1.13±1.48** 随访 0.33±0.92**## 氟康唑组 治疗前 8.80±0.92 治疗后 1.23±1.46** 随访 1.83±0.20** 注: 与治疗前比较，**P < 0.01，与氟康唑组比较，##P < 0.01。
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表 5 2组患者终点指标比较(%, n=30)
Table 5. Comparison of outcome between the two groups(%, n=30)
组别 TOC率 CI率 FU率 完带汤组 53.30 90.00 83.33# 氟康唑组 46.70 76.67 53.33 注: 组间比较, χFU2=10.76, #P < 0.05。
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表 6 2组患者真菌学转阴率和复发率比较(%, n=30)
Table 6. Comparison of mycological negative conversion rate and recurrence rate between the two groups of patients (%, n=30)
组别 真菌学转阴率 复发率 完带汤组 93.33 6.67## 氟康唑组 83.33 43.33 注: 组间比较, χ复发率2=10.76, ##P < 0.01。
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