保妇康栓治疗混合性阴道感染的临床研究

Clinical Study of Baofukangshuan in the Treatment of Bacterial Vaginosis

目的:研究中成药保妇康栓调节阴道微生态平衡对治疗外阴阴道假丝酵母菌病(VVC)合并细菌性阴道病(BV)的临床意义。方法:采用前瞻性、随机、剂量组平行对照临床实验,将51例VVC合并BV的患者,分为保妇康栓组26例,甲硝唑联合硝酸咪康唑栓组(联合组)25例,分析两组患者在停药第7±3天和第28±5天的症状改善及实验室检查方面的变化,采用Nugent评分进行BV诊断及疗效评价。结果:第1次随访:保妇康栓组与联合组Nugent评分、减分率比较差异有统计学意义(P<0.05),两组p H值、乳杆菌分级差异无统计学意义(P>0.05);保妇康栓组与联合组患者外阴瘙痒、白带异味、白带增多不适症状比率较入组时均下降,但两组比较差异无统计学意义(P>0.05);此外,两组患者VVC痊愈率(76.92%vs 88.00%)比较差异无统计学意义(P>0.05),而BV痊愈率(38.46%vs 76.00%)差异有统计学意义(P<0.05)。第2次随访:保妇康栓组较联合组p H值、Nugent评分及减分率差异均无统计学意义(P>0.05);保妇康栓组15例患者的乳杆菌分级均达到Ⅰ级或Ⅱ级,恢复到正常水平,而联合组仍有2例未达到正常水平,但两组比较差异无统计学意义(P>0.05);保妇康栓组患者外阴瘙痒、白带异味、白带增多不适症状比率较第1次随访时进一步下降,而联合组外阴瘙痒、白带异味、白带增多症状比例上升,其中联合组有2例外阴瘙痒、1例白带异味可能有复发情况发生,但两组比较差异不显著(P>0.05);保妇康栓组与联合组患者BV均100%痊愈,保妇康栓组VVC复发率(6.67%)低于联合组(11.76%),两组比较差异无统计学意义(P>0.05)。结论:保妇康栓能有效治疗VVC合并BV,能恢复阴道微生态平衡,作用较抗生素和缓、复发率低,值得在临床全面推广应用。

Objective： To study the clinical efficacy of Baofukangshuan in the treatment of vulva vagina candida disease combing bacterial vaginal disease. M ethods： A prospective,randomized,case control clinical study was carried out. The study groups included Baofukangshuan group（ treat by Baofukangshuan,26 cases） and the joint group（ treat metronidazole and miconazole nitrate suppositories,25 cases）. In the withdrawal of（ 7 ± 3） days and（ 28 ± 5） days,respectively,patients were followed up,to observe the changes in the patient＇s symptoms and laboratory examination. Nugent score was used to diagnose BV and evaluate its curative effect. Results： The drug discontinuation（ 7 ± 3） day in the first follow-up： there was significant difference in Nugent score between the Baofukangshuan and joint groups（ P〈 0. 05）. There was no significant difference in p H value and grade of lactobacillus between the two groups（ P〉0. 05）; In both Baofukangshuan and joint group＇s patients,the genital itching,leucorrhea odor,increased leucorrhea uncomfortable symptom ratio all decreased,but between the two groups there was no significant differences（ P〉 0. 05）; There was no significant difference on VVC recovery rate between the two groups（ 76. 92% vs 88. 00% in Baofukangshuan and joint groups respectively）（ P〉 0. 05）,There was significant difference on BV recovery rate between the two groups（ 38. 46% vs 76. 00% in Baofukangshuan and joint groups respectively）（ P〈0. 05）. The second follow-up drug withdrawal（ 28 ± 5） days： There was no significant difference on vagina p H value and Nugent scores between the two groups（ P〉0. 05）,In Baofukangshuan group,15 patients＇ lactobacillus classification were atⅠorⅡnormal levels,but the joint group＇s two patients of lactobacillus classification did not return to normal levels,but in joint group,2 patients＇ lactobacillus classification was not turn normal,but there was no significant difference between the two groups（ P〉0. 05）. In Baofukangshuan group,genital itching,leucorrhoea peculiar smell,and leucorrhea increased uncomfortable percentage further to fall,but the joint group with genital itching,leucorrhoea peculiar smell the proportion increased,Among the joint group＇s two cases with genital itching,one case with leucorrhoea peculiar smell was possible recurrence happens,but there was no significant difference compared between two groups（ P〉0. 05）. Both in Baofukangshuan group and joint group,all BV patients were 100% recovery. Baofukangshuan VVC recurrence rate（ 6. 67%） was lower than the joint group（ 11. 76%）,and there was no significant difference（ P〉0. 05）. Conclusions： Baofukangshuan can be used for treating vulva vagina candida disease combined bacterial vaginal disease,improving the vagina micro ecological balance,and Baofukangshuan relatively more gentle and lower recurrence rate than antibiotics,which is worth spreading in the clinic.