香莲方对咪康唑抗念珠菌增效作用的临床和实验研究
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摘要
目的：
1.临床观察香莲栓和咪康唑栓联合治疗单纯性VVC抗菌增效作用。同时观察单纯性外阴阴道念珠菌病的好发人群特征。
2.实验室观察香莲外洗液、黄连煎液和硝酸咪康唑溶液联用抗菌增效情况。
3.进一步完善香莲系列制剂外用治疗难治性皮肤黏膜真菌病的规范化方案。
4.初步探索中西医结合治疗VVC的优势。
方法：
临床研究：按照随机对照的原则,严格按照纳入标准,共纳入65例患者,分为试验组和对照组。试验组35例患者,对照组30例患者。试验组给予香莲栓和咪康唑栓,对照组给予咪康唑栓。共治疗7天。患者第一次就诊时,记录所有患者基本情况,复查的时间分别为治疗结束后三天,第一次月经干净后,第二次月经干净后,记录治疗前后积分,观察疗效,按照主要疗效标准、次要疗效标准进行疗效评价,有效率的比较用卡方检验。
实验研究：参照1997年CLSI(美国临床和实验室标准化协会)颁布的《肉汤稀释法酵母菌抗真菌药物敏感性试验参考方法》(M27一方案),采用微量液基稀释法分别测定香莲外洗液、硝酸咪康唑、香莲外洗液合用咪康唑、黄连煎液、黄连煎液合用硝酸咪康唑对15例白色念珠菌阴道分离株、15例光滑念珠菌的抑菌效果。采用联合抑菌指数对硝酸咪康唑+香莲外洗液、黄连煎液+咪康唑的最小抑菌浓度进行统计分析。采用独立样本t检验,对硝酸咪康唑、香莲外洗液、黄连煎液的MIC进行统计分析。
结果：
临床研究：65例女性患者中,年龄最小18岁,最大51岁,发病主要集中在20-40岁；其中27例患者未婚有性生活(41.54%),38例患者已婚,以已婚育龄期所占比例为多；饮食方面,16例患者喜食辛辣,6例喜食生冷,3例喜食甜食；学历方面,11例为初中,30例专科,22例本科,2例硕士；月经基本正常,均无明显烟酒嗜好；压力多为一般,舌苔脉象均表现为舌红苔腻微黄,辩证为湿热下注,湿重于热。
治疗结束后3天,试验组有效率57.1%,对照组有效率60.0%,两组有效率比较,P>0.05,二者疗效差异无统计学意义；真菌阴性者于治疗后第一次月经干净后复查,试验组有效率57.1%：对照组有效率53.3%,两组有效率比较,P>0.05,二者疗效差异无统计学意义；第二次月经干净后复查,试验组有效率57.1%,对照组有效率53.3%,两组有效率比较,P>0.05,二者疗效差异无统计学意义。
按照疗效指数评价其疗效,评价其治疗前后积分,治疗结束后三天,试验组有效率(60%),对照组有效率23.33%,二者均为有效治疗,但疗效差异有统计学意义,试验组的疗效明显优于对照组。
实验研究：作用于15株临床分离菌株白念珠菌：香莲外洗液的MIC均值为：13.54mg/ml,黄连煎液的MIC均值为：13.65mg/ml,和硝酸咪康唑溶液的MIC均值11.40ug/ml效果相当；
硝酸咪康唑合用香莲外洗液作用于白念珠菌,二者的联合抑菌指数1 硝酸咪康唑合用黄连煎液作用于白念珠菌,二者的联合抑菌指数为0.5 作用于15株光滑念珠菌的MIC值,香莲外洗液8.40mg/ml,黄连煎液9.38mg/ml和硝酸咪康唑14.88ug/ml的效果相当。
硝酸咪康唑合用香莲外洗液作用于光滑念珠菌,二者的联合抑菌指数1 硝酸咪康唑合用黄连煎液作用于光滑念珠菌,二者的联合抑菌指数为FICI=0.70≤0.5,表明硝酸咪康唑与黄连煎液联用作用于光滑念珠菌二者为相加作用。
对作用于白念珠菌和光滑念珠菌来讲,硝酸咪康唑、黄连煎液二者的MIC值差异无统计学意义,香莲外洗液对光滑念珠菌较白念珠菌的MIC值比较有统计学意义。香莲外洗液对光滑念珠菌更敏感。
结论：
临床研究：临床上咪康唑栓合用香莲栓治疗单纯性外阴阴道念珠菌病,较单纯用咪康唑栓可以较明显的改善临床症状,为临床治疗单纯性外阴阴道念珠菌病提供有效的临床研究依据。
实验室研究：香莲外洗液、黄连煎液和硝酸咪康唑作用于白念珠菌、光滑念珠菌均有抑菌作用。香莲外洗液、黄连煎液作用于白念珠菌、光滑念珠菌的敏感性无差异；硝酸咪康唑合用香莲外洗液无论是作用于白念珠菌还是光滑念珠菌,均为无关作用；硝酸咪康唑合用黄连煎液作用于白念珠菌,光滑念珠菌菌表现为相加作用。
Objective:
(1)To observe the antibacterial synergism of Xianglian suppository with Miconazole suppository in the treatment of the pure VVC clinically. At the same time to observe The characteristic of pure VVC.
(2)To observe the antibacterial synergism of Xianglian Lotion、huanglian ecoction solution with nitric acid Miconazole solution in the laboratory
(3)To further improve the standardization research of Xianglian Series square preparations in the topical treatment of refractory mucocutaneous fungal disease.
(4)To Preliminarily study the advantages of combining traditional Chinese and Western medicine treatment of VVC.
Methods:
Clinical research:According to the principle of randomized single blind,65patients were divided into test group and control group who were included accordding to the strict standards with the.35patients of test group and30patients of is35and control group. The test group was given the Xianglian suppository and miconazole suppository, The control group was treated with miconazole suppository, A total of7days for the treatment. Observed the basic conditions of all patients, When the patient came to see thedoctor for the first time. The review time is the following:three days after the end of treatment, after the first menstrual clean, after the secede menstrual clean. Recorded the score before and behind the treatment. According to the main effect, therapeutic index, to evaluate the curative effect. Compared with the efficiency of the chi-square test.
laboratory procedure:According to the1997CLSI (American clinical and Laboratory Standards Institute) broth microdilution antifungal susceptibility testing of yeasts reference methods promulgated the "(M27 program)", Using the broth microdilution method, The MIC of theXianglian lotion、nitric acid Miconazole solution、huanglian lotion、xianglian lotion with nitric acid miconazole solution、huanglian lotion with nitric acid miconazole effecting on Candida albicans and Candida glabrata were determined. Combined antibacterial index effect were used to analysis of the application of drugs; Using the independent samples t test, to analysis of the MIC of nitric acid Miconazole solution、xianglian lotion、huanglian lotion.
Results:
Clinical study results:
For the65patients, the age is the smallest17years old, the biggest51years old, mainly concentrated in the20-40years old this stage. The27patients with unmarried sexual life(41.54%),38patients with married, most of were married and childbearing age. In the diet,16cases of patients with eating spicy,6cases of eating cold,3cases of eating sweets; In the education,11cases of junior high school,30cases of college,22cases of undergraduate,2cases of master. Menstruation is normal; There were no obvious tobacco and alcohol addiction; pressure for general pulse, tongue coating showed a red tongue greasy yellowish, dialectic is damp, wet weight in the heat.
A week after treatment, observation of curative effect,3days after the end of treatment, the test group was57.1%, the effective rate was60%in the control group, no significant difference in efficacy between the two groups; after the first menstrual clean, the test group was57.1%:the effective rate of control group53.3%, there were no statistically significant differences effect of the two; after thesecond menstrual clean, the test group was57.1%, the control group was53.3%, there was no statistically significant difference in efficacy between the two.
To observe the efficacy index, evaluating scores before and after the treatment. After the three days of treatment, the test group was (60%), the control group was23.33%, two groups were the effective treatment, but there were significant differences between the experimental group effect, curative effect is better than that of the control group.
The results of laboratory research:
For the effect on Candida albicans:nitric acid miconazole solution MIC value was:14. Oug/ml; Xianglian lotion MIC value was13.54mg/ml; Huanglian lotion MIC value was13.65mg/ml; We can said that for the inhibition of Candida albicans in vitro MIC value, Xianglian lotion13.54mg/ml, a considerable effect of Coptis Decoction13.65mg/ml and nitric acid miconazole solution14. Oug/ml. Huanglian lotion is more sensitive than Xianglian lotion on Candida albicans.
Nitric acid Miconazole solution with Xianglian lotion effect on Candida albicans, two combined antibacterial index1 Nitric acid Miconazole solution and huanglian lotion on Candida albicans, combined inhibition index of the two is0.5 The effect on Candida glabrata:Nitric acid Miconazole solution MIC value was:14.88ug/ml, the average MIC of Xianglian lotion:8.40mg/ml, Huanglian lotion;MIC means:9.38mg/ml; can be said for the in vitro inhibition of Candida glabrata MIC value, Nitric acid Miconazole solution14.88ug/ml, quite effect of Coptis Decoction9.38mg/ml and miconazole nitrate14.88ug/ml. No differences in sensitivity to unilateral Coptis Decoction and Fufang Xianglian lotion of Candida glabrata.
Nitric acid Miconazole solution with Xianglian lotion on Candida glabrata, two combined antibacterial index1 Nitric acid Miconazole solution and huanglian lotion on Candida glabrata, combined inhibition index of the two is FICI=0.70≤0.5, that of miconazole nitrate and Coptis decoction combined with effects on Candida glabrata two synergistic action.
The effect on Candida albicans and Candida glabrata, Nitric acid Miconazole solution, huanglian lotion were no significant difference. But for the effect on Candida albicans and Candida glabrata, The Xianglian lotion is more sensitive to Candida glabrata.
Conclusion:
Clinical results show that:In the treatment of simple vulvovaginal candidiasis, Xianglian suppository combined miconazole suppository can obviously improve the clinical symptoms, and provide clinical efficiency.
Laboratory results show that:Xianglian lotion, huanglian lotion and Nitric acid Miconazole solution effect on Candida albicans, Candida glabrata have bacteriostasis. For Candida albicans, huanglian lotion is more sensitive than Xianglian lotion; Nitric acid Miconazole solution in Xianglian lotion both acting on Candida albicans and Candida glabrata, were unrelated effect; miconazole nitrate and Coptis Decoction on Candida albicans showed an additive effect, effect on Candida glabrata were synergistic.
1.临床观察香莲栓和咪康唑栓联合治疗单纯性VVC抗菌增效作用。同时观察单纯性外阴阴道念珠菌病的好发人群特征。
2.实验室观察香莲外洗液、黄连煎液和硝酸咪康唑溶液联用抗菌增效情况。
3.进一步完善香莲系列制剂外用治疗难治性皮肤黏膜真菌病的规范化方案。
4.初步探索中西医结合治疗VVC的优势。
方法：
临床研究：按照随机对照的原则,严格按照纳入标准,共纳入65例患者,分为试验组和对照组。试验组35例患者,对照组30例患者。试验组给予香莲栓和咪康唑栓,对照组给予咪康唑栓。共治疗7天。患者第一次就诊时,记录所有患者基本情况,复查的时间分别为治疗结束后三天,第一次月经干净后,第二次月经干净后,记录治疗前后积分,观察疗效,按照主要疗效标准、次要疗效标准进行疗效评价,有效率的比较用卡方检验。
实验研究：参照1997年CLSI(美国临床和实验室标准化协会)颁布的《肉汤稀释法酵母菌抗真菌药物敏感性试验参考方法》(M27一方案),采用微量液基稀释法分别测定香莲外洗液、硝酸咪康唑、香莲外洗液合用咪康唑、黄连煎液、黄连煎液合用硝酸咪康唑对15例白色念珠菌阴道分离株、15例光滑念珠菌的抑菌效果。采用联合抑菌指数对硝酸咪康唑+香莲外洗液、黄连煎液+咪康唑的最小抑菌浓度进行统计分析。采用独立样本t检验,对硝酸咪康唑、香莲外洗液、黄连煎液的MIC进行统计分析。
结果：
临床研究：65例女性患者中,年龄最小18岁,最大51岁,发病主要集中在20-40岁；其中27例患者未婚有性生活(41.54%),38例患者已婚,以已婚育龄期所占比例为多；饮食方面,16例患者喜食辛辣,6例喜食生冷,3例喜食甜食；学历方面,11例为初中,30例专科,22例本科,2例硕士；月经基本正常,均无明显烟酒嗜好；压力多为一般,舌苔脉象均表现为舌红苔腻微黄,辩证为湿热下注,湿重于热。
治疗结束后3天,试验组有效率57.1%,对照组有效率60.0%,两组有效率比较,P>0.05,二者疗效差异无统计学意义；真菌阴性者于治疗后第一次月经干净后复查,试验组有效率57.1%：对照组有效率53.3%,两组有效率比较,P>0.05,二者疗效差异无统计学意义；第二次月经干净后复查,试验组有效率57.1%,对照组有效率53.3%,两组有效率比较,P>0.05,二者疗效差异无统计学意义。
按照疗效指数评价其疗效,评价其治疗前后积分,治疗结束后三天,试验组有效率(60%),对照组有效率23.33%,二者均为有效治疗,但疗效差异有统计学意义,试验组的疗效明显优于对照组。
实验研究：作用于15株临床分离菌株白念珠菌：香莲外洗液的MIC均值为：13.54mg/ml,黄连煎液的MIC均值为：13.65mg/ml,和硝酸咪康唑溶液的MIC均值11.40ug/ml效果相当；
硝酸咪康唑合用香莲外洗液作用于白念珠菌,二者的联合抑菌指数1
硝酸咪康唑合用香莲外洗液作用于光滑念珠菌,二者的联合抑菌指数1
对作用于白念珠菌和光滑念珠菌来讲,硝酸咪康唑、黄连煎液二者的MIC值差异无统计学意义,香莲外洗液对光滑念珠菌较白念珠菌的MIC值比较有统计学意义。香莲外洗液对光滑念珠菌更敏感。
结论：
临床研究：临床上咪康唑栓合用香莲栓治疗单纯性外阴阴道念珠菌病,较单纯用咪康唑栓可以较明显的改善临床症状,为临床治疗单纯性外阴阴道念珠菌病提供有效的临床研究依据。
实验室研究：香莲外洗液、黄连煎液和硝酸咪康唑作用于白念珠菌、光滑念珠菌均有抑菌作用。香莲外洗液、黄连煎液作用于白念珠菌、光滑念珠菌的敏感性无差异；硝酸咪康唑合用香莲外洗液无论是作用于白念珠菌还是光滑念珠菌,均为无关作用；硝酸咪康唑合用黄连煎液作用于白念珠菌,光滑念珠菌菌表现为相加作用。
Objective:
(1)To observe the antibacterial synergism of Xianglian suppository with Miconazole suppository in the treatment of the pure VVC clinically. At the same time to observe The characteristic of pure VVC.
(2)To observe the antibacterial synergism of Xianglian Lotion、huanglian ecoction solution with nitric acid Miconazole solution in the laboratory
(3)To further improve the standardization research of Xianglian Series square preparations in the topical treatment of refractory mucocutaneous fungal disease.
(4)To Preliminarily study the advantages of combining traditional Chinese and Western medicine treatment of VVC.
Methods:
Clinical research:According to the principle of randomized single blind,65patients were divided into test group and control group who were included accordding to the strict standards with the.35patients of test group and30patients of is35and control group. The test group was given the Xianglian suppository and miconazole suppository, The control group was treated with miconazole suppository, A total of7days for the treatment. Observed the basic conditions of all patients, When the patient came to see thedoctor for the first time. The review time is the following:three days after the end of treatment, after the first menstrual clean, after the secede menstrual clean. Recorded the score before and behind the treatment. According to the main effect, therapeutic index, to evaluate the curative effect. Compared with the efficiency of the chi-square test.
laboratory procedure:According to the1997CLSI (American clinical and Laboratory Standards Institute) broth microdilution antifungal susceptibility testing of yeasts reference methods promulgated the "(M27 program)", Using the broth microdilution method, The MIC of theXianglian lotion、nitric acid Miconazole solution、huanglian lotion、xianglian lotion with nitric acid miconazole solution、huanglian lotion with nitric acid miconazole effecting on Candida albicans and Candida glabrata were determined. Combined antibacterial index effect were used to analysis of the application of drugs; Using the independent samples t test, to analysis of the MIC of nitric acid Miconazole solution、xianglian lotion、huanglian lotion.
Results:
Clinical study results:
For the65patients, the age is the smallest17years old, the biggest51years old, mainly concentrated in the20-40years old this stage. The27patients with unmarried sexual life(41.54%),38patients with married, most of were married and childbearing age. In the diet,16cases of patients with eating spicy,6cases of eating cold,3cases of eating sweets; In the education,11cases of junior high school,30cases of college,22cases of undergraduate,2cases of master. Menstruation is normal; There were no obvious tobacco and alcohol addiction; pressure for general pulse, tongue coating showed a red tongue greasy yellowish, dialectic is damp, wet weight in the heat.
A week after treatment, observation of curative effect,3days after the end of treatment, the test group was57.1%, the effective rate was60%in the control group, no significant difference in efficacy between the two groups; after the first menstrual clean, the test group was57.1%:the effective rate of control group53.3%, there were no statistically significant differences effect of the two; after thesecond menstrual clean, the test group was57.1%, the control group was53.3%, there was no statistically significant difference in efficacy between the two.
To observe the efficacy index, evaluating scores before and after the treatment. After the three days of treatment, the test group was (60%), the control group was23.33%, two groups were the effective treatment, but there were significant differences between the experimental group effect, curative effect is better than that of the control group.
The results of laboratory research:
For the effect on Candida albicans:nitric acid miconazole solution MIC value was:14. Oug/ml; Xianglian lotion MIC value was13.54mg/ml; Huanglian lotion MIC value was13.65mg/ml; We can said that for the inhibition of Candida albicans in vitro MIC value, Xianglian lotion13.54mg/ml, a considerable effect of Coptis Decoction13.65mg/ml and nitric acid miconazole solution14. Oug/ml. Huanglian lotion is more sensitive than Xianglian lotion on Candida albicans.
Nitric acid Miconazole solution with Xianglian lotion effect on Candida albicans, two combined antibacterial index1
Nitric acid Miconazole solution with Xianglian lotion on Candida glabrata, two combined antibacterial index1
The effect on Candida albicans and Candida glabrata, Nitric acid Miconazole solution, huanglian lotion were no significant difference. But for the effect on Candida albicans and Candida glabrata, The Xianglian lotion is more sensitive to Candida glabrata.
Conclusion:
Clinical results show that:In the treatment of simple vulvovaginal candidiasis, Xianglian suppository combined miconazole suppository can obviously improve the clinical symptoms, and provide clinical efficiency.
Laboratory results show that:Xianglian lotion, huanglian lotion and Nitric acid Miconazole solution effect on Candida albicans, Candida glabrata have bacteriostasis. For Candida albicans, huanglian lotion is more sensitive than Xianglian lotion; Nitric acid Miconazole solution in Xianglian lotion both acting on Candida albicans and Candida glabrata, were unrelated effect; miconazole nitrate and Coptis Decoction on Candida albicans showed an additive effect, effect on Candida glabrata were synergistic.
引文
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