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参蛤细辛散时间给药法治疗小儿哮喘缓解期肾虚证的临床研究

Clinical Research on Time-Administration Therapy with Shen Ge Xi Xin San on Syndrome of Kidney Deficiency on the Remission Phase of Children Asthma

【作者】 郑雯

【导师】 汪受传;

【作者基本信息】 南京中医药大学 , 中医儿科学, 2009, 博士

【摘要】 哮喘是世界范围内的常见病、多发病,其患病率有逐年上升的趋势。全世界约有1.5亿哮喘患者,每年死于哮喘的人约18万之多,因此哮喘已成为严重威胁人类健康的一种主要慢性疾病。2000年调查结果显示,我国儿童平均累计哮喘患病率达到1.97%。因此,哮喘的防治引起了全世界的重视,世界卫生组织已将其列入全球防治战略。本病可分为急性发作期、慢性持续期和缓解期。在缓解期进行积极治疗,可预防和减少哮喘发作,是治疗儿童哮喘的重要环节。中医药在辨证论治原则指导下进行多环节调治,未病先防,具有独特的优势。本文在回顾哮喘缓解期相关文献的基础上,研究时间给药法在本病中的应用。通过对68例哮喘缓解期肾虚证患儿的临床观察,研究参蛤细辛散时间服药法治疗本证的疗效。通过对临床症状、体征积分的统计,比较每日辰时用药与辰时、酉时同时用药的疗效差异,同时观察参蛤细辛散的用药安全性,为临床减少服药次数提供依据,可增加儿童及家长的依从性,具有一定的临床推广价值。目的:在“子午流注”理论的指导下治疗小儿哮喘缓解期肾虚证,在不同时点给予参蛤细辛散,通过观察两组的临床疗效,说明时间给药法对疗效的影响。方法:本文以新加坡中华医院门诊、自然中医诊所的68例哮喘缓解期肾虚证患儿为研究对象,按盲法、随机的原则按1:1的比例分为试验组和对照组,两组均给予参蛤细辛散1~3个疗程,每个疗程12周,试验组每日于辰时给药1次,对照组每日于辰时和酉时给药2次,观察疗程结束后两组患儿主症、次症积分的变化,进行统计学处理,评判两种给药方法的疗效与安全性。结果:试验前两组患儿在年龄、性别、病程、病情均无显著性差异,两组具有可比性。研究结果显示:试验组经治疗后,在总积分、哮喘次数、哮喘发作程度、痰涎、汗出不温、气短、鼻痒喷嚏、鼻塞、面色、精神、惊恐、畏寒肢冷、夜尿、大便、舌象等情况改善方面明显优于治疗前,在感冒次数、过敏症情况改善方面无明显差异。对照组患儿在总积分、哮喘次数、哮喘发作程度、痰涎、汗出不温、气短、鼻痒喷嚏、鼻塞、面色、精神、惊恐、畏寒肢冷、夜尿、大便、舌象等情况改善方面明显优于治疗前,在感冒次数、过敏症改善情况方面无明显差异。两组间对比,经治疗后,对照组在畏寒肢冷情况改善方面优于试验组,在总积分、感冒次数、哮喘次数、哮喘发作程度、过敏症、痰涎、汗出不温、气短、鼻痒喷嚏、鼻塞、面色、精神、惊恐、夜尿、大便、舌象情况改善方面无明显差异。两组总疗效分析:试验组显效2例(5.9%)、有效21例(61.76%)、无效11例(32.35%),总有效率67.64%。B组显效2例(5.9%)、有效22例(64.10%)、无效10例(29.41%),总有效率70%。经统计学处理,两组有效率无明显差异。两组均未见临床不良反应。结论:在“子午流注”理论指导下,辰时给药的治疗方案与辰时、酉时给药的治疗方案疗效相似,从而为临床减少小儿服药次数提供了依据。运用时间给药法增强了小儿服药的依从性,具有一定的实用价值和操作性,值得临床推广。

【Abstract】 Asthma, a common medical condition, is on the rise. Globally, there are approximately 150 million asthmatic patients. Amongst which 180 thousand die from the illness each year. Based on these figures, it is clear that asthma is a chronic medical condition that threatens the well-being of human health. In the year 2000, asthmatic analytical research report had recorded that 1.97% of Singaporean children were asthmatic. Therefore, the prevention of asthma has become a global issue. World Health Organization (WHO) has also classified the fight against asthma on a global scale.Asthma can be categorised into acute attack, chronic duration and the remission phase. It is crucial for asthmatic children to engage proactively in the various phases of the treatment. The treatment of asthma during the remission phase in order to prevent and reduce the attacks is deemed very important. The Chinese medicine is superior in regulating the overall health of a person. Depending on the principle of differentiation and treatment,it is very effective in the various stages of treatment as well as the prevention of asthma. Based on the existing knowledge on the remission phase of asthmatic treatment, this thesis analysed the effects of consuming the medicine at different timings of the day. Through close observation of 68 cases of child asthmatic patients with weak kidney function, detailed analysis on the effects of consuming "Shen Ge Xi Xin San" at different timings of the day was performed. The results that the medicine had on the patients were tabulated and analysed based on short-term and long-term recoveries. A point system was applied to classify and grade the effects of the administration of the medicine on 2 different sets of timing - Morning only ; Both morning and evening. During the study, the safety aspects of using the medicine was also closely followed and recorded. From the study, medical effects and the safety of the medicine was observed, analysed and recorded. In addition, other beneficial effects of the medicine was also noted.Objective: To investigate the time administration effect of "Shen Ge Xi Xin San" on the remission phase of asthma affecting children with weak kidney function based on the "Zi Wu Liu Zhu" logic.Method: The experimental subjects to this research were 68 asthmatic children with weak kidney function. They were the patients at the Singapore Chung Hwa Medical Institution and Natural TCM Clinic. Based on the concept of a blocked and randomized statistical model with a ratio of 1:1, the subjects were divided into 2 groups, namely the experimental group and the control group. Each group of patients was administered with the "Shen Ge Xi Xin San" with 1 to 3 courses at 12 weeks duration for each course. The experimental group was administered with the medicine each morning whereas the control group was administered both mornings and evenings. The results were obtained by applying a point system. The findings were concluded by analysing the points using specific statistical models, thus commenting on the effect of the different methods of administering the medicine as well as the safety aspects.Result: Based on the concept of a randomized statistical model with a ratio of 1:1, 68 sick children were administered with "Shen Ge Xi Xin San". The experimental group was administered with the medicine each morning whereas the control group was administered both mornings and evenings. Results of the 2 groups were analysed. The analysis between the 2 groups was plausible because both groups observed similar characteristics in age, sex,condition and course of the illness.Post-treatment results displayed significant improvements for most of the symptoms of the illness. However for both groups, no significant improvements were observed for flu and allergic symptoms. Post-treatment analysis displayed better results for the control group than the experimental group in the tolerance to cold. For the rest of the symptoms, both groups displayed similar results. The experimental group concluded with 2 significant success cases (5.9%), 21 success cases (61.76%) and 11 status-quo cases (32.35%) resulting an overall success rate of 67.64%. The control group concluded with 2 significant success cases (5.9%), 22 success cases (64.10%) and 10 status-quo cases (29.41%) resulting an overall success rate of 90%. There were no significant differences between the results of both groups and it was possible to achieve a success rate of 70.59%. In addition, no side-effects were noted.Conclusion:Under the concept of "Zi Wu Liu Zhu", the administering of the medicine only in the morning or both morning and evening displayed similar results. Therefore it provided the basis for the reduction of the frequency of consuming the medicine. By applying the time administration of the medicine, it enhanced the compliance and medicinal effect on the patient. This method is thus effective and worth to be implemented clinically.

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