抗宫糜栓治疗慢性宫颈炎宫颈糜烂（湿热下注证）临床研究
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摘要
目的
对抗宫糜栓进行随机、盲法、平行对照临床试验研究,进一步评价抗宫糜栓治疗慢性宫颈炎宫颈糜烂(湿热下注证)的临床疗效,观察其安全性。
方法
1病例选择将符合西医慢性宫颈炎宫颈糜烂诊断标准,中医辨证为湿热下注的患者,共64例,随机分为治疗组和对照组,治疗组48例,对照组16例。连续用药14天为一疗程,用药结束后进行疗效评定。两组在年龄、治疗前中医证候积分、病情分级分布上基本均衡,经统计学分析,无显著性差异(P＞0.05),具有可比性。
2治疗方法治疗组给予抗宫糜栓,对照组给予苦参碱栓,月经干净3天后开始用药,晚睡前1粒,戴上指套,药栓尖端向内,用手指将药栓轻置于阴道后穹窿,每日1次,每次1粒,14天为一疗程。同时嘱患者用药期间禁止性生活。
3疗效及安全性观测观测治疗前后两组患者的宫颈糜烂面积、炎症程度、阴道清洁度及中医证候变化。治疗前后进行血、尿常规、肝功能(ALT)、肾功能(BUN、Cr)、心电图检测以及阴道分泌物检查;治疗前宫颈刷片检查。
4统计方法计量资料用t检验,计数资料用X~2检验,等级资料用Ridit分析。
结果
1研究结果显示治疗组总有效率93.33%,对照组总有效率83.33%。经统计学分析,两组痊愈率、愈显率和总有效率差别均无统计学意义(P＞0.05)。
2中医证候疗效比较:中医症候疗效比较无显著性差异(P＞0.05),治疗组痊愈15例,总有效率97.92%,对照组痊愈3例,总有效率93.75%。
3中医证候单项症状指标比较:治疗后两组中医证候单项症状(包括主要症状和次要症状)均有不同程度的改善。经统计学分析,对照组与治疗组药物在对中医主要症状的改善方面无显著性差异(P＞0.05)。
4局部体征(妇科检查)疗效比较:两组治疗前后宫颈糜烂面、炎症程度、阴道清洁度比较有显著性差异(P＜0.05)。两组宫颈糜烂面疗效比较有显著性差异(P＜0.05),治疗组痊愈5例,总有效率93.82%,对照组痊愈1例,总有效率77.62%。说明两组药均能有效改善宫颈糜烂(湿热下注证)的临床症状,缩小糜烂面,减轻炎症程度及清洁度。
5不良反应及毒副作用:试验期间,两组均未出现明显不良反应及毒副作用。两组实验室检查结果(三大常规、肝肾功能、心电图)在治疗后均未出现与治疗相关的异常改变。
结论
观察结果表明,经统计学分析,抗宫糜栓能有效治疗中医辨证为湿热下注的宫颈糜烂,明显改善宫颈局部病变糜烂面积、炎症程度、阴道清洁度及相关临床症状,无毒副作用,安全可靠,有较好的临床应用前景。
Objective
Through random,blind,contrasting clinic research of Anti - Gong Mi Suppository,preliminary evaluating the clinical effect and safety of Anti - Gong Mi Suppository treating chronic cervicitis and cervical erosion(syndrome of dampness-heat pouring downward).
Methods
1 Clinical data:The patients accorded with the diagnostic standard of cervical erosion of western medicine,and according to differentiation of syndromes in TCN it belonged to the type of damp invasion of lower energizer,64 cases were divided into treatment and control groups at random,the treatment group had 48 cases and control group had 16,both completed the study.For a consecutive 14-day drug treatment.Through statistical analysis,the age, scores of TCM Syndrome before treatment and classification of disease of the two groups are comparability.
2 Medical usage:Given Anti - Gong Mi Suppository and matrine suppository respectively,two groups began to use it just three days after the menstrual cleaning.Suppository sophisticated inwards, was pushed into the vaginal depths gently,1suppository daily,14 days a course Moreover,the patients are asked to prohibit sex life.
3 Observation of efficacy and safety:To observe the size of cervical erosion surface,the degree of inflammation,TCM syndrome and sign,clop-clearing grade before and after the treatment.Blood routine,urine routine,liver function(ALT),kidney function(Bun, Cr),electrocardiogram test and vaginal discharge inspection are taken before and after treatment.TCT before treatment.
4 Statistical methods:After treatment,we analyze the data.The Counting materials are examined with X~2,the measuring materials are examined with t-test and the grading materials are examined with Ridit-test.
Results
1 The total effective rate of the treatment group was 93.33%,While the control group was 83.33%,There was no significant difference between these two groups on the comprehensive efficacy(P＞0.05).
2 Individual symptoms of TCM Syndrome indicators:There is not significantly different between the two groups(P＞0.05).The total effective rates of TCN Syndrome are 97.92%and 93.75%in control group and treatment group.
3 Individual symptoms of TCM Syndrome indicators:Individual symptoms of TCM Syndrome(including the major symptoms and minor symptoms) have improved by different degrees.Through statistical analysis,the improvement of the major symptoms of TCM Syndrome is not significantly different between the two groups(P＞0.05).
4 Local signs(gynecological examinations) effects:Both could significantly depress the integral about the size of cervical erosion surface,the degree of inflammation,clop-clearing grade after the treatment(P＜0.05).There was significant difference between the two groups on the area of cervical erosion and the TCM syndrome and sign efficacy(P＞0.05),The total effective rates of TCM Syndrome are 93.82%and 77.62%in control group and treatment group.It stated that the two groups had significant effect on the symptoms.There was no significant difference between the two groups after treatment(P＞0.05).
5 Adverse reactions and side effects:no obvious adverse reactions and side effects in both groups during clinical study.All laboratory tests(Three conventional,liver and renal function,ECG)before and after the treatment had no treatment-related abnormalities.
Conclusion
Observations show that,through statistical analysis,Anti-Gong Mi Suppository could effectively treat chronic cervicitis and cervical erosion(syndrome of dampness-heat pouring downward), obviously improve erosion area,inflammation and the correlate symptoms,has no side effects.In a conclusion,Anti - Gong Mi Suppository also has a good foreground for clinic.
对抗宫糜栓进行随机、盲法、平行对照临床试验研究,进一步评价抗宫糜栓治疗慢性宫颈炎宫颈糜烂(湿热下注证)的临床疗效,观察其安全性。
方法
1病例选择将符合西医慢性宫颈炎宫颈糜烂诊断标准,中医辨证为湿热下注的患者,共64例,随机分为治疗组和对照组,治疗组48例,对照组16例。连续用药14天为一疗程,用药结束后进行疗效评定。两组在年龄、治疗前中医证候积分、病情分级分布上基本均衡,经统计学分析,无显著性差异(P＞0.05),具有可比性。
2治疗方法治疗组给予抗宫糜栓,对照组给予苦参碱栓,月经干净3天后开始用药,晚睡前1粒,戴上指套,药栓尖端向内,用手指将药栓轻置于阴道后穹窿,每日1次,每次1粒,14天为一疗程。同时嘱患者用药期间禁止性生活。
3疗效及安全性观测观测治疗前后两组患者的宫颈糜烂面积、炎症程度、阴道清洁度及中医证候变化。治疗前后进行血、尿常规、肝功能(ALT)、肾功能(BUN、Cr)、心电图检测以及阴道分泌物检查;治疗前宫颈刷片检查。
4统计方法计量资料用t检验,计数资料用X~2检验,等级资料用Ridit分析。
结果
1研究结果显示治疗组总有效率93.33%,对照组总有效率83.33%。经统计学分析,两组痊愈率、愈显率和总有效率差别均无统计学意义(P＞0.05)。
2中医证候疗效比较:中医症候疗效比较无显著性差异(P＞0.05),治疗组痊愈15例,总有效率97.92%,对照组痊愈3例,总有效率93.75%。
3中医证候单项症状指标比较:治疗后两组中医证候单项症状(包括主要症状和次要症状)均有不同程度的改善。经统计学分析,对照组与治疗组药物在对中医主要症状的改善方面无显著性差异(P＞0.05)。
4局部体征(妇科检查)疗效比较:两组治疗前后宫颈糜烂面、炎症程度、阴道清洁度比较有显著性差异(P＜0.05)。两组宫颈糜烂面疗效比较有显著性差异(P＜0.05),治疗组痊愈5例,总有效率93.82%,对照组痊愈1例,总有效率77.62%。说明两组药均能有效改善宫颈糜烂(湿热下注证)的临床症状,缩小糜烂面,减轻炎症程度及清洁度。
5不良反应及毒副作用:试验期间,两组均未出现明显不良反应及毒副作用。两组实验室检查结果(三大常规、肝肾功能、心电图)在治疗后均未出现与治疗相关的异常改变。
结论
观察结果表明,经统计学分析,抗宫糜栓能有效治疗中医辨证为湿热下注的宫颈糜烂,明显改善宫颈局部病变糜烂面积、炎症程度、阴道清洁度及相关临床症状,无毒副作用,安全可靠,有较好的临床应用前景。
Objective
Through random,blind,contrasting clinic research of Anti - Gong Mi Suppository,preliminary evaluating the clinical effect and safety of Anti - Gong Mi Suppository treating chronic cervicitis and cervical erosion(syndrome of dampness-heat pouring downward).
Methods
1 Clinical data:The patients accorded with the diagnostic standard of cervical erosion of western medicine,and according to differentiation of syndromes in TCN it belonged to the type of damp invasion of lower energizer,64 cases were divided into treatment and control groups at random,the treatment group had 48 cases and control group had 16,both completed the study.For a consecutive 14-day drug treatment.Through statistical analysis,the age, scores of TCM Syndrome before treatment and classification of disease of the two groups are comparability.
2 Medical usage:Given Anti - Gong Mi Suppository and matrine suppository respectively,two groups began to use it just three days after the menstrual cleaning.Suppository sophisticated inwards, was pushed into the vaginal depths gently,1suppository daily,14 days a course Moreover,the patients are asked to prohibit sex life.
3 Observation of efficacy and safety:To observe the size of cervical erosion surface,the degree of inflammation,TCM syndrome and sign,clop-clearing grade before and after the treatment.Blood routine,urine routine,liver function(ALT),kidney function(Bun, Cr),electrocardiogram test and vaginal discharge inspection are taken before and after treatment.TCT before treatment.
4 Statistical methods:After treatment,we analyze the data.The Counting materials are examined with X~2,the measuring materials are examined with t-test and the grading materials are examined with Ridit-test.
Results
1 The total effective rate of the treatment group was 93.33%,While the control group was 83.33%,There was no significant difference between these two groups on the comprehensive efficacy(P＞0.05).
2 Individual symptoms of TCM Syndrome indicators:There is not significantly different between the two groups(P＞0.05).The total effective rates of TCN Syndrome are 97.92%and 93.75%in control group and treatment group.
3 Individual symptoms of TCM Syndrome indicators:Individual symptoms of TCM Syndrome(including the major symptoms and minor symptoms) have improved by different degrees.Through statistical analysis,the improvement of the major symptoms of TCM Syndrome is not significantly different between the two groups(P＞0.05).
4 Local signs(gynecological examinations) effects:Both could significantly depress the integral about the size of cervical erosion surface,the degree of inflammation,clop-clearing grade after the treatment(P＜0.05).There was significant difference between the two groups on the area of cervical erosion and the TCM syndrome and sign efficacy(P＞0.05),The total effective rates of TCM Syndrome are 93.82%and 77.62%in control group and treatment group.It stated that the two groups had significant effect on the symptoms.There was no significant difference between the two groups after treatment(P＞0.05).
5 Adverse reactions and side effects:no obvious adverse reactions and side effects in both groups during clinical study.All laboratory tests(Three conventional,liver and renal function,ECG)before and after the treatment had no treatment-related abnormalities.
Conclusion
Observations show that,through statistical analysis,Anti-Gong Mi Suppository could effectively treat chronic cervicitis and cervical erosion(syndrome of dampness-heat pouring downward), obviously improve erosion area,inflammation and the correlate symptoms,has no side effects.In a conclusion,Anti - Gong Mi Suppository also has a good foreground for clinic.
引文
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[3]陈自明.宋·妇人大全良方[M].北京:中国中医药出版社,1996:33.
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