自拟理气疏肝方治疗慢性非细菌型前列腺炎的临床研究
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摘要
慢性前列腺炎是男性泌尿、生殖系统的常见病、多发病,本病症状复杂,病程较长,易于复发,给患者的身心健康带来较大危害,如伴有神经衰弱、性功能障碍或不育症等疾病,患者精神上的痛苦会远远超过疾病本身的痛苦。慢性前列腺炎(CP)主要分细菌性、非细菌性及前列腺痛3大类。临床上以慢性非细菌性前列腺炎占大多数。慢性非细菌性前列腺炎是男科、泌尿科、皮肤性病科、中医科常见病,多发于青壮年及中年男性,相当于祖国医学的“精浊”范畴,具有缠绵难愈、易复发的特点,不仅影响患者的生殖健康,而且日久易引起患者精神症状,是男科难治病之一,在美国患病率仅次于良性前列腺增生(BPH)和前列腺癌。因此积极有效地防治CNP,对于提高男性生活质量及生育能力有着十分重要的意义。由于中医治疗有辨证施治的优点,因此,采用中医疗法,发挥中医辨证施治的优点,从而能更好的改善症状,治愈本病。
目的
客观评价应用自拟理气疏肝方治疗慢性非细菌性前列腺炎的临床疗效及其安全性,为进一步开展临床及理论研究奠定基础。
方法
研究对象为符合中医主证为肝气郁结辨证标准,同时符合西医慢性非细菌型前列腺炎诊断标准的患者。随机分为两组,一组服用自拟理气疏肝方药,另一组服用前列康片,以临床综合疗效、NIH-CPSI积分、前列腺液常规积分、前列腺压痛积分、尿流率、前列腺超声为观察指标,评价自拟理气疏肝方的有效性和安全性。统计方法：分类资料用x2检验,等级资料用两样本比较Wilcoxon秩和检验(校正),两样本均数比较用t检验或Wilcoxon秩和检验,自身前后比较用配对t检验或Wilcoxon配对秩和检验。
结果
本研究最后符合纳入排除标准参与分析的有70例,自拟理气疏肝方治疗组和前列康片对照组分别35例。患者的平均年龄为36.7±5.9岁；平均病程为36.8±7.2月。从临床治疗总效果看,自拟理气疏肝方的愈显率为68.57%,而对照组为22.86%,差别有统计学意义(P<0.05),说明自拟理气疏肝方对于治疗慢性非细菌型前列腺炎有显著疗效。两组治疗前后NIH-CPIS症状积分均有所降低,但治疗组分值更低于对照组(P<0.05),可认为治疗组自拟理气疏肝方在改善前列腺症状方面要优于对照组前列康片。两组治疗前后客观指标(前列腺液常规EPS-WBC计数、卵磷脂小体及前列腺压痛)积分均下降(P<0.05),但治疗组自拟理气疏肝方在改善卵磷脂小体及前列腺压痛方面要更具优势(P<0.05)。对两组治疗前后尿流率进行比较,相比于对照组前列康片,治疗组自拟理气疏肝方在改善尿流率方面更具优势(P<0.05)。对慢性非细菌型前列腺炎的主要临床症状和体征消失率进行比较,提示治疗组自拟理气疏肝方在改善尿频、尿急、排尿费力、夜尿多症状和体征方面要优于对照组前列康片(P<0.05)。治疗期间两组患者均无明显的不良反应,治疗前后血、尿、便及肝肾功能检测结果均未见异常改变及毒副反应。临床观察表明两药均具有较高的安全性。
结论
本课题的临床研究表明运用中医疏肝理气方施治,此法有如下优势：明显改善疼痛或不适及排尿等症状体征及尿流动力学检查指标;对于治疗慢性非细菌型前列腺炎有其独特的优势与特点,未见明显的副作用；在提高慢性非细菌前列腺炎病人生活质量上优于对照组,并且安全有效。本课题研究提示中医药疏肝理气为慢性非细菌性前列腺炎的重要治疗法则,为中医中药治疗该病症的新途径。
Chronic prostatitis (CNP) was a common disease, also was a frequently encountered disease in the male urinary and genital system. CNP would harm to the patients'physical and mental health with complicated symptom and long course of disease,accompanying with neurastheria、sexual disturbance and barrenness, which given the patient more physical painful. CNP could be divided into three categories:bacterium type、nonbacterial type and prostatalgia type. Bacterium type was the main type in the clinic. Chronic prostatitis without inflammation was usually found in department of male、department of urology、department of skin and venereal disease and department of TCM which harmed mostly to young-aged and middle-aged man. It was belong to the category "Jingzhuo" in the TCM and was one of difficult treating disease, because it has characteristic of hard recovering and easy recurring and also hardly harm to the reproduction health. The case rate was only lower than benign prostatic hyperplasia (BPH) and carcinoma of prostate (CAP). So it has important significance for raising the quality of life and potentia generandi if the CNP was efficiently and positively prevented and cured. With the advantages of determine the treatment based on differentiation of symptoms and signs in TCM. The method of Chinese medicine treatment for CNP had superiority of improving the symptom and curing the disease.
Objective
To observe the clinical effect and safety and found the base for the further clinical and theoretical development by evaluating the effect of Ziniliqishuganfang (ZNF) treating the Chronic prostatitis without inflammation.
Methods
The candidates that were consisted with the standard of depression of liver-QI in TCM and Chronic prostatitis without inflammation in western medicine divided into two groups. The one group was treated by ZNF, the other group was treated by Qianliekang Tablets (QLT). To observe the clinical effect and safety with the observation index of curative effect、NIH-CPSI score、liquor prostaticus routine score、prostate tenderness score、flow rate of urine and prostate hypersound test. Statistical methods:The classification data was observed usingχ2 test and the ranked data by Wilcoxon rank-sum test. T-test or Wilcoxon rank-sum test was applied for group comparison. Matched t-test or Wilcoxon matched-rank-sum test was applied for self-AP:PA comparison. Results
The 70patients that were consistent with standard of diagnostic criteria were divided into ZNF group and QLT group in random. Each group was 35 cases. General investigation data showed that the average of patients'age was 36.7±5.9years old and the course of disease was 36.8±7.2 months. Compared with the curative effect on symptom of Chinese medicine within two groups, it was showed that the clinical recovery rate of the treatment group was 68.57%. While in the control group, the clinical recovery rate of the treatment group was 22.86%. There was significant difference between two groups(P<0.05). It showed that ZNF group had good effective for treating Chronic prostatitis without inflammation. Both two groups had significant difference between before and after treatment for decreasing NIH-CPIS score, and the NIH-CPIS score of ZNF group was lower than the control group (P<0.05). It was considered that the ZNF group was better than the control group. And also were the prostate tenderness score and the flow rate of urine. To compared the improving rate of symptom and physical sign for the disease, it was presented that the ZNF group had better curative effect on improving the frequent micturition、urgency、hard to urinate and frequent nocturia than the control group. Both two groups had no evident adverse effect. Blood test、urine test、stool test and liver-renal function test had no abnormal change and adverse reaction. It was presented that these two groups treatment was safe.
Conclusion
The clinical study was showed that the method of regulate QI and disperse the depressed liver-energy has advantage as follows:the treatment group could improve the symptom of Chronic prostatitis without inflammation and the index of urodynamic study; The treatment group had the advantage for treating the Chronic prostatitis without inflammation and had not significant adverse reaction; The treatment group could improve the quality of life and better than the control group and was safe. The study was presented that the method of regulate QI and disperse the depressed liver-energy for treating the Chronic prostatitis without inflammation disease was an important therapeutics and was a new way of treating the disease.
目的
客观评价应用自拟理气疏肝方治疗慢性非细菌性前列腺炎的临床疗效及其安全性,为进一步开展临床及理论研究奠定基础。
方法
研究对象为符合中医主证为肝气郁结辨证标准,同时符合西医慢性非细菌型前列腺炎诊断标准的患者。随机分为两组,一组服用自拟理气疏肝方药,另一组服用前列康片,以临床综合疗效、NIH-CPSI积分、前列腺液常规积分、前列腺压痛积分、尿流率、前列腺超声为观察指标,评价自拟理气疏肝方的有效性和安全性。统计方法：分类资料用x2检验,等级资料用两样本比较Wilcoxon秩和检验(校正),两样本均数比较用t检验或Wilcoxon秩和检验,自身前后比较用配对t检验或Wilcoxon配对秩和检验。
结果
本研究最后符合纳入排除标准参与分析的有70例,自拟理气疏肝方治疗组和前列康片对照组分别35例。患者的平均年龄为36.7±5.9岁；平均病程为36.8±7.2月。从临床治疗总效果看,自拟理气疏肝方的愈显率为68.57%,而对照组为22.86%,差别有统计学意义(P<0.05),说明自拟理气疏肝方对于治疗慢性非细菌型前列腺炎有显著疗效。两组治疗前后NIH-CPIS症状积分均有所降低,但治疗组分值更低于对照组(P<0.05),可认为治疗组自拟理气疏肝方在改善前列腺症状方面要优于对照组前列康片。两组治疗前后客观指标(前列腺液常规EPS-WBC计数、卵磷脂小体及前列腺压痛)积分均下降(P<0.05),但治疗组自拟理气疏肝方在改善卵磷脂小体及前列腺压痛方面要更具优势(P<0.05)。对两组治疗前后尿流率进行比较,相比于对照组前列康片,治疗组自拟理气疏肝方在改善尿流率方面更具优势(P<0.05)。对慢性非细菌型前列腺炎的主要临床症状和体征消失率进行比较,提示治疗组自拟理气疏肝方在改善尿频、尿急、排尿费力、夜尿多症状和体征方面要优于对照组前列康片(P<0.05)。治疗期间两组患者均无明显的不良反应,治疗前后血、尿、便及肝肾功能检测结果均未见异常改变及毒副反应。临床观察表明两药均具有较高的安全性。
结论
本课题的临床研究表明运用中医疏肝理气方施治,此法有如下优势：明显改善疼痛或不适及排尿等症状体征及尿流动力学检查指标;对于治疗慢性非细菌型前列腺炎有其独特的优势与特点,未见明显的副作用；在提高慢性非细菌前列腺炎病人生活质量上优于对照组,并且安全有效。本课题研究提示中医药疏肝理气为慢性非细菌性前列腺炎的重要治疗法则,为中医中药治疗该病症的新途径。
Chronic prostatitis (CNP) was a common disease, also was a frequently encountered disease in the male urinary and genital system. CNP would harm to the patients'physical and mental health with complicated symptom and long course of disease,accompanying with neurastheria、sexual disturbance and barrenness, which given the patient more physical painful. CNP could be divided into three categories:bacterium type、nonbacterial type and prostatalgia type. Bacterium type was the main type in the clinic. Chronic prostatitis without inflammation was usually found in department of male、department of urology、department of skin and venereal disease and department of TCM which harmed mostly to young-aged and middle-aged man. It was belong to the category "Jingzhuo" in the TCM and was one of difficult treating disease, because it has characteristic of hard recovering and easy recurring and also hardly harm to the reproduction health. The case rate was only lower than benign prostatic hyperplasia (BPH) and carcinoma of prostate (CAP). So it has important significance for raising the quality of life and potentia generandi if the CNP was efficiently and positively prevented and cured. With the advantages of determine the treatment based on differentiation of symptoms and signs in TCM. The method of Chinese medicine treatment for CNP had superiority of improving the symptom and curing the disease.
Objective
To observe the clinical effect and safety and found the base for the further clinical and theoretical development by evaluating the effect of Ziniliqishuganfang (ZNF) treating the Chronic prostatitis without inflammation.
Methods
The candidates that were consisted with the standard of depression of liver-QI in TCM and Chronic prostatitis without inflammation in western medicine divided into two groups. The one group was treated by ZNF, the other group was treated by Qianliekang Tablets (QLT). To observe the clinical effect and safety with the observation index of curative effect、NIH-CPSI score、liquor prostaticus routine score、prostate tenderness score、flow rate of urine and prostate hypersound test. Statistical methods:The classification data was observed usingχ2 test and the ranked data by Wilcoxon rank-sum test. T-test or Wilcoxon rank-sum test was applied for group comparison. Matched t-test or Wilcoxon matched-rank-sum test was applied for self-AP:PA comparison. Results
The 70patients that were consistent with standard of diagnostic criteria were divided into ZNF group and QLT group in random. Each group was 35 cases. General investigation data showed that the average of patients'age was 36.7±5.9years old and the course of disease was 36.8±7.2 months. Compared with the curative effect on symptom of Chinese medicine within two groups, it was showed that the clinical recovery rate of the treatment group was 68.57%. While in the control group, the clinical recovery rate of the treatment group was 22.86%. There was significant difference between two groups(P<0.05). It showed that ZNF group had good effective for treating Chronic prostatitis without inflammation. Both two groups had significant difference between before and after treatment for decreasing NIH-CPIS score, and the NIH-CPIS score of ZNF group was lower than the control group (P<0.05). It was considered that the ZNF group was better than the control group. And also were the prostate tenderness score and the flow rate of urine. To compared the improving rate of symptom and physical sign for the disease, it was presented that the ZNF group had better curative effect on improving the frequent micturition、urgency、hard to urinate and frequent nocturia than the control group. Both two groups had no evident adverse effect. Blood test、urine test、stool test and liver-renal function test had no abnormal change and adverse reaction. It was presented that these two groups treatment was safe.
Conclusion
The clinical study was showed that the method of regulate QI and disperse the depressed liver-energy has advantage as follows:the treatment group could improve the symptom of Chronic prostatitis without inflammation and the index of urodynamic study; The treatment group had the advantage for treating the Chronic prostatitis without inflammation and had not significant adverse reaction; The treatment group could improve the quality of life and better than the control group and was safe. The study was presented that the method of regulate QI and disperse the depressed liver-energy for treating the Chronic prostatitis without inflammation disease was an important therapeutics and was a new way of treating the disease.
引文
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