灵菇胶囊治疗功能性便秘的临床研究
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摘要
目的:通过对灵菇合剂剂型改良为胶囊剂型的临床病例观察,验证剂型改良后药物的临床疗效以及安全性及耐受性,并观察患者服用新剂型药物的情况,从而为功能性便秘(虚症型)患者提供一种新型的选择药物。方法:共观察68例,按1∶1比例将符合标准的受试对象随机分配入治疗组与对照组,最后合格入选者63例,其中治疗组32例、对照组31例。通过对一般体检项目及排便间隔时间、便质、排便费力情况,中医证候相关症状、舌象及脉象的变化,胃肠道反应等的临床观察而进行疗效评定。结果:灵菇胶囊组总有效率93.75%,灵菇合剂组总有效率90.32%,两组总体疗效相当,无明显差别。在临床观察过程中,发现灵菇胶囊改善患者大便干结、排便费力、排便不尽感等症状疗效比较明显,而且治疗组服药后无腹痛、恶心、头晕及水泻样大便等不良反应。结论:通过两组患者服用灵菇胶囊与灵菇合剂的临床观察,证明了剂型改良后药物疗效肯定,患者治疗过程中亦无明显的不良反应,然而胶囊型药物具有口味淡香,利于贮存、运输,方便携带及服用等特点,从而给便秘的立法组方用药探索了一条新的治疗途径。
Objective: The purpose of this research is to validate the clinical curative effect, the security, the patience, and the adverse reactions of the medicine by observing clinical cases in which the candidates take the medicine which has changed from mixture linggu into capsule linggu. So, the patients can elect a new medicine who come up against functional constipation (asthenic constipation). Method: 68 cases are observed, and finially 63 cases are suitable and elected. They are devided into two groups on average at random, which are treatment group and control group. We evaluate the curative effect by the clinical observation on normal items, the interval time, quantity and difficulty of the shit, the changes of the traditional Chinese medicine drome and the condition of the tonue and pulse, the gastro-intestinal side effects and so on. Result: the totally effective rate of treatment group is 93.75%, being similar to the control group, which is 90.32%, and there is no obvious difference. During the course of clinical observation, we find that capsule linggu has obvious curative effect on improving symptoms, such as stool being dry and hard, defecating strenuously, defecating endlessly and so on, and there are no adverse reactions after taking the capsule, for example, abdominal pain, nausea, dizziness and diarrhea, watery. Conclusion: the clinical observation of the groups who take mixture linggu and capsule linggu proves that the curative effect doesn’t reduce after the betterment of the form of a drug and there aren’t gastro-intestinal side effects during the dose process. As a result, it improves on the taste of medicine, makes for the stockpile, the transportation, the taking and the dosing, and searches after a new approach for treatment of constipation.
Objective: The purpose of this research is to validate the clinical curative effect, the security, the patience, and the adverse reactions of the medicine by observing clinical cases in which the candidates take the medicine which has changed from mixture linggu into capsule linggu. So, the patients can elect a new medicine who come up against functional constipation (asthenic constipation). Method: 68 cases are observed, and finially 63 cases are suitable and elected. They are devided into two groups on average at random, which are treatment group and control group. We evaluate the curative effect by the clinical observation on normal items, the interval time, quantity and difficulty of the shit, the changes of the traditional Chinese medicine drome and the condition of the tonue and pulse, the gastro-intestinal side effects and so on. Result: the totally effective rate of treatment group is 93.75%, being similar to the control group, which is 90.32%, and there is no obvious difference. During the course of clinical observation, we find that capsule linggu has obvious curative effect on improving symptoms, such as stool being dry and hard, defecating strenuously, defecating endlessly and so on, and there are no adverse reactions after taking the capsule, for example, abdominal pain, nausea, dizziness and diarrhea, watery. Conclusion: the clinical observation of the groups who take mixture linggu and capsule linggu proves that the curative effect doesn’t reduce after the betterment of the form of a drug and there aren’t gastro-intestinal side effects during the dose process. As a result, it improves on the taste of medicine, makes for the stockpile, the transportation, the taking and the dosing, and searches after a new approach for treatment of constipation.
引文
[1] 罗马Ⅱ标准 Drossman DA, Corazziari E,Talley NJ,et al. The functional gastrointestinal disorders ( 2nddition ) . Degnon Associates, Mclean,virgina,2000.
[2] 中药新药临床研究指导原则<第一辑>,中华人民共和国卫生部制定发布,1993;131～133.
[3] 徐方明.针药结合治疗原发性慢传输型便秘 40 例.广西中医学院学报,2005,(4):32-33.
[4] 徐建华,崔民英,胡占发.通三焦和脏腑治疗结肠慢传输型便秘的临床研究. 北京中医药大学报,2006,(2):31.
[5] 郭世宏.补中益气汤加减治疗混合型便秘 96 例.河南中医,2004,(2):67-68.
[6] 郭晓峰,柯美云,潘国宗,等.北京地区成年人慢性便秘流行病学调查及其相关因素分析[J] .基础医学与临床,2001,21[增刊]:18-20.
[7] 黄乃健.中国肛肠病学,济南:山东科学技术出版社,1996. 第 1 版:947.
[8] 严用和.济生方,北京:人民卫生出版社,1956. 第 1 版:146.
[9] 程士德.内经讲义,上海科学技术出版社,1984. 第 1 版:47.
[10] 刘珉.重用白术治疗便秘三十四例疗效观察.福建中医药,1981,(1):36.
[11] 丁曙晴,丁义江,张苏闽,等.白术水煎液治疗结肠慢传输性便秘 36 例疗效观察. 新中医,2005,9,(9):30-31.
[12] 郑开明,陈江宁.老年人习惯性便秘的辨证施治.河北中医,2006,(12):925.
[1] 郭晓峰,柯美云,潘国宗,等.北京地区成年人慢性便秘流行病学调查及其相关因素分析[J] .基础医学与临床,2001,21[增刊]:18-20.
[2] 张连阳.慢传输性便秘的临床研究进展.大肠肛门病外科杂志,2005,(1):1-2.
[3] 聂玉强,李瑜元.罗马Ⅱ功能性胃肠疾病分类及诊断标准.国外医学内科学分册,2001;28(4):147-150.
[4] 罗金燕. 慢性功能性便秘.中华内科杂志,2000;39(11):787-788.
[5] 霍岭霞.运脾润肠法治疗慢性传输型便秘的临床观察.四川中医,2006,(11):57-58.
[6] 季铁铮.辨证治疗老年虚性便秘 42 例总结.中医药导报,2006,(4):29-40.
[7] 丁曙晴,丁义江,张苏闽,等.白术水煎液治疗结肠慢传输性便秘 36 例疗效观察.新中医,2005,9,(9):30-31.
[8] 潘现甫.泰山磐石散加减治疗慢传输型便秘 61 例. 河南中医,2004,(5):78-79.
[9] 李绥军,宋琛虹.益气温阳养血生津治疗功能性便秘临床观察.中医药学刊,2005,(10):1913-1914.
[10] 郑开明,陈江宁.老年人习惯性便秘的辨证施治.河北中医,2006,(12):925.
[11] 张士金.中风患者虚证便秘 56 例.河南中医,2004,(8):37-39.
[12] 徐升.刘友章教授治疗糖尿病肠轻瘫经验介绍.新中医,2006,(9):14-15.
[13] 叶海东,刘宇.新加黄龙汤加减治疗老年性气阴两虚型便秘的体会.北京中医,2004,(5):297-299.
[14] 毛炯,杨伟明,李艳嫦.慎柔养真汤治疗老年脾阴虚型便秘 40 例.中医药学刊,2003,(10):18.
[15] 林锡芬,陈金泉,赖庆勇,等.术皮汤治疗虚证结肠慢传输便秘临床研究.国际医药卫生导报,2005,(16):119-120.
[16] 余日新.补运通便法治疗便秘经验.上海中医药杂志,2006,(10):32-33.
[17] 沈晓旭.耄塞通治疗功能性便秘 44 例观察及其对心绞痛的影响.齐齐哈尔医学院学报,2005,(6):634-636.
[18] 魏志军,张悦,张小惠,等.重用生白术治疗虚证便秘的临床及实验研究.中国中医药科技,2003,(4):196-197.
[19] 赵云燕,谢炜,陈宝田,等.便必清对虚证便秘患者结肠传输时间的影响.中国中西医结合杂志,2003,(11):862-863.
[20] 陈雪清,高记华,孙士然.运肠汤治疗结肠慢传输型便秘的疗效观察.临床荟萃,2006,(14):1501.
[21] 刘海.秘得康冲剂治疗老年习惯性便秘 90 例疗效观察.中国中医基础医学杂志,2004,(10):37-48.
[22] 赵宝林.益气运肠汤治疗功能性慢传输型便秘.河南中医,2004,(7):44-58.
[23] 郭世宏.补中益气汤加减治疗混合型便秘 96 例.河南中医,2004,(2):67-68.
[24] 汤善国.行气导滞润肠治疗慢传输型便秘 80 例.陕西中医,2004,(1):22-23.
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[2] 中药新药临床研究指导原则<第一辑>,中华人民共和国卫生部制定发布,1993;131～133.
[3] 徐方明.针药结合治疗原发性慢传输型便秘 40 例.广西中医学院学报,2005,(4):32-33.
[4] 徐建华,崔民英,胡占发.通三焦和脏腑治疗结肠慢传输型便秘的临床研究. 北京中医药大学报,2006,(2):31.
[5] 郭世宏.补中益气汤加减治疗混合型便秘 96 例.河南中医,2004,(2):67-68.
[6] 郭晓峰,柯美云,潘国宗,等.北京地区成年人慢性便秘流行病学调查及其相关因素分析[J] .基础医学与临床,2001,21[增刊]:18-20.
[7] 黄乃健.中国肛肠病学,济南:山东科学技术出版社,1996. 第 1 版:947.
[8] 严用和.济生方,北京:人民卫生出版社,1956. 第 1 版:146.
[9] 程士德.内经讲义,上海科学技术出版社,1984. 第 1 版:47.
[10] 刘珉.重用白术治疗便秘三十四例疗效观察.福建中医药,1981,(1):36.
[11] 丁曙晴,丁义江,张苏闽,等.白术水煎液治疗结肠慢传输性便秘 36 例疗效观察. 新中医,2005,9,(9):30-31.
[12] 郑开明,陈江宁.老年人习惯性便秘的辨证施治.河北中医,2006,(12):925.
[1] 郭晓峰,柯美云,潘国宗,等.北京地区成年人慢性便秘流行病学调查及其相关因素分析[J] .基础医学与临床,2001,21[增刊]:18-20.
[2] 张连阳.慢传输性便秘的临床研究进展.大肠肛门病外科杂志,2005,(1):1-2.
[3] 聂玉强,李瑜元.罗马Ⅱ功能性胃肠疾病分类及诊断标准.国外医学内科学分册,2001;28(4):147-150.
[4] 罗金燕. 慢性功能性便秘.中华内科杂志,2000;39(11):787-788.
[5] 霍岭霞.运脾润肠法治疗慢性传输型便秘的临床观察.四川中医,2006,(11):57-58.
[6] 季铁铮.辨证治疗老年虚性便秘 42 例总结.中医药导报,2006,(4):29-40.
[7] 丁曙晴,丁义江,张苏闽,等.白术水煎液治疗结肠慢传输性便秘 36 例疗效观察.新中医,2005,9,(9):30-31.
[8] 潘现甫.泰山磐石散加减治疗慢传输型便秘 61 例. 河南中医,2004,(5):78-79.
[9] 李绥军,宋琛虹.益气温阳养血生津治疗功能性便秘临床观察.中医药学刊,2005,(10):1913-1914.
[10] 郑开明,陈江宁.老年人习惯性便秘的辨证施治.河北中医,2006,(12):925.
[11] 张士金.中风患者虚证便秘 56 例.河南中医,2004,(8):37-39.
[12] 徐升.刘友章教授治疗糖尿病肠轻瘫经验介绍.新中医,2006,(9):14-15.
[13] 叶海东,刘宇.新加黄龙汤加减治疗老年性气阴两虚型便秘的体会.北京中医,2004,(5):297-299.
[14] 毛炯,杨伟明,李艳嫦.慎柔养真汤治疗老年脾阴虚型便秘 40 例.中医药学刊,2003,(10):18.
[15] 林锡芬,陈金泉,赖庆勇,等.术皮汤治疗虚证结肠慢传输便秘临床研究.国际医药卫生导报,2005,(16):119-120.
[16] 余日新.补运通便法治疗便秘经验.上海中医药杂志,2006,(10):32-33.
[17] 沈晓旭.耄塞通治疗功能性便秘 44 例观察及其对心绞痛的影响.齐齐哈尔医学院学报,2005,(6):634-636.
[18] 魏志军,张悦,张小惠,等.重用生白术治疗虚证便秘的临床及实验研究.中国中医药科技,2003,(4):196-197.
[19] 赵云燕,谢炜,陈宝田,等.便必清对虚证便秘患者结肠传输时间的影响.中国中西医结合杂志,2003,(11):862-863.
[20] 陈雪清,高记华,孙士然.运肠汤治疗结肠慢传输型便秘的疗效观察.临床荟萃,2006,(14):1501.
[21] 刘海.秘得康冲剂治疗老年习惯性便秘 90 例疗效观察.中国中医基础医学杂志,2004,(10):37-48.
[22] 赵宝林.益气运肠汤治疗功能性慢传输型便秘.河南中医,2004,(7):44-58.
[23] 郭世宏.补中益气汤加减治疗混合型便秘 96 例.河南中医,2004,(2):67-68.
[24] 汤善国.行气导滞润肠治疗慢传输型便秘 80 例.陕西中医,2004,(1):22-23.
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