杞菊甘露饮及杞菊甘露饮配合针刺治疗肺肾阴虚型干眼的临床研究
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摘要
干眼是指因环境因素或机体因素而引起的泪液质和量异常或流体动力学异常导致的泪膜稳定性下降以及眼表组织损害为特征的眼病。干眼是临床最常见的眼表疾病之一,有文献报道其发病频率及症状已经明显影响到了患者的生活质量,严重者甚至难以维持正常工作。干眼治疗无论患者或政府医保方面所耗费的支出也很可观,据美国估计,医疗成本接近每千人一年一百万美金。
维护良好和舒适的双眼视觉是人类生存和从事各种职业最基本的需求。没有良好的双眼视觉,人们就不能从事许多精细或高难度的工作；同样,视力虽然正常,但因干眼而双眼长期处于干涩不适、疲劳、灼痛、异物感等,也会严重干扰工作和影响生活质量,甚至造成心理疾患。故干眼是目前临床研究工作的热点和重要课题之一。
干眼在全球有发展的趋势。最近国际干眼流行病学小组(2007)特别指出需要进一步研究干眼与糖尿病、抽烟者的相关性及将干眼对生活质量的真正影响数据化。
新加坡作为一个先进国家,关于干眼的科研,已经在新加坡眼科中心连续进行了15年,但由于中医西医治疗在新加坡属于两种不同体制的治疗系统,中医治疗干眼,在新加坡眼科常规治疗体系里,仍未被广泛应用。新加坡中华医院眼科组在临床工作上,虽然应用中药或中药加针灸综合治疗干眼发挥了其特长及优势,但在干眼的临床研究和确切疗效评价方面,还缺乏客观科学的临床研究。
本课题在中医脏腑理论及气血理论指导下,用前瞻性的随机、对照的研究方法,分别对韦企平教授验方“杞菊甘露饮”及“杞菊甘露饮配合针刺”治疗肺肾阴虚型干眼进行疗效评价,以获得临床证据。
论文包括文献综述和临床观察两部分。
文献综述：
包括：《新加坡对干眼的研究进展》和《针灸治疗干眼及干眼综合征的临床研究》两部分。在《新加坡对干眼的研究进展》中,主要对新加坡眼科中心近5年所做的干眼临床研究,对干眼的定义、分类、病因、组织病理学、临床特征、诊断与治疗等方面进行了简要评述。在《针灸治疗干眼及干眼综合征的临床研究》中,则对近年外国中国研究者采用针灸治疗干眼及干眼综合征的临床研究、中医学病名、病因病机、辩证论治、治疗思维及现代中医眼科对干眼的认识进行简要回顾。
临床观察部分：
目的：评价韦企平教授验方“杞菊甘露饮”和“杞菊甘露饮配合针刺”治疗中老年肺肾阴虚型干眼的临床疗效。干眼目前是全球常见眼科疾病,严重影响生活质量。常规干眼治疗通常以滴眼液治疗,但新加坡眼科中心提出的最新研究认为滴眼液对很多病人,尤其是中老年型病人,毫无作用,即使疗效有用也是短期效应,长期复诊造成了时间及资源上的浪费,因此提议应该寻求其他综合治疗方法,给予病人更好的治疗方案,从中减轻国家保健负担。导师韦企平曾在新加坡讲学期间实地考察了解到新加坡以潮湿炎热气候为主,通常室内长年开空调避热防潮,造成许多人有口鼻干燥,双眼干涩不适；个别人甚或出现恶寒、发热、头痛、干咳等秋燥病证。加上现代电脑办公、环境污染等,故许多新加坡人,尤其是中老年人多有不同程度眼干不适症状。据此,韦教授结合自己临床实践经验,组成“杞菊甘露饮”配方,用于治疗肺肾阴虚型干眼。为了获得“杞菊甘露饮”治疗肺肾阴虚型干眼的实际临床疗效及短期巩固疗效的证据,我们设计了该课题,开展中医治疗干眼临床研究的第一步。
方法：对2012年10月至2013年9月间不同原因所致中老年肺肾阴虚型干眼病人90例,年龄40-70岁,采用前瞻性的随机、双盲、对照研究方法,以自觉症状、检查体征、中医肺肾阴虚症状变化为评价指标进行临床疗效观察。具体方法为：中药治疗组(组1)和针药并用组(组2)入组比例为1：1。中药组仅给予“杞菊甘露饮”配方颗粒冲剂,早晚两次分服；中药加针刺则给予“杞菊甘露饮”配方颗粒冲剂早晚两次分服,另予一个星期两次的针刺治疗,留针20分钟,疗程30天。在治疗前后分别进行自觉症状SPEED(标准干眼测试量化评分,Standard Patient Evaluation of Eye Dryness Questionnaire)VAS(视觉模拟量表评分,Visual Analogue Scale Score)、中医肺肾阴虚型干眼评分,及客观的泪膜破裂时间(Tear Break Up Time, TBUT)、泪液分泌试验(Schirmer's Test1, SIt)、角膜荧光素染色(Corneal Staining)、睑板腺功能障碍的临床检查,并在停止治疗后的第2个月和第4个月分别进行随访。疗效标准参考中国国家中医管理局《中医病证诊断疗效标准》中疗效评价标准,综合主观和客观观察指标进行评价。计量数据符合正态分布的使用T-检验,不符合正态分布的采用秩和检验(两个独立样本的Mann-Whitney Test曼惠特尼U检验),计数数据应用x2检验。
结果：入组病例共90例,中药组和中药加针刺组各45例。中药组中1有1例脱落。两组治疗前的年龄、视力、自觉主观症状测值无显著差异,具有可比性(p>0.05)。治疗后中药组及中药加针刺组的自身治疗前后疗效皆有明显统计学差异(p=0.000、p<0.05)。两组间疗效比较除了在泪膜破裂时间上有差异,中药组疗效比中药加针刺组疗效佳(中药组p=0.000,中药甲针刺组p=0.099),两组组间治疗疗效在其他指标上的比较则没有统计学差异。(p>0.05)。在治疗停止后的第2、4个月随访时间里,中药组和中药加针刺组的治疗前后皆有统计学差异(p=0.000),但两组间比较疗效则无差异(p>0.05)。
结论：“杞菊甘露饮”及“杞菊甘露饮配合针刺”对于治疗各种病因引起的肺肾阴虚型干眼具有较好的疗效,都可在一定程度上提高患者的泪液质量、泪液分泌量、减少干眼患者的自觉症状,缓解其肺肾阴虚的相关症状和体征。单用“杞菊甘露饮”和“杞菊甘露饮配合针刺”比较疗效并无明显差异,从而初步证明对中老年肺肾阴虚型干眼可用“杞菊甘露饮”口服治疗。
Dry eye is a major, common medical condition with significant health and economic burden in Singapore and worldwide. It is a holistic problem affected by living habits, nutrition and underlying systemic disease, inducing a significant decrease in quality-of-life. The hallmark of this disease is raised tear osmolarity and inflammation. There is no definitive cure for this condition, as treatment in the form of lubricants is only symptomatic and treatment with cyclosporine eyedrops is expensive and may not be well tolerated.
Following the rise in international interest in complementary medicine, randomized-controlled studies in dry eye using Traditional Chinese Medicine (TCM) have been published, with mixed results.
Therefore a clinical study was conducted involving herbal and acupuncture therapy on lung and kidney yin deficiency type of dry eye. This was only recently completed at Singapore Chung Hwa Medical Institution during the period from October2012-September2013, with support by the hospital administration, using prospective, randomized and controlled study, In the study, the aim was to evaluate the efficacy of TCM herbal medicine "qi ju gan lu yin" in treating dry eye, compared to the same herbal preparation with acupuncture and a total of89age-and gender-matched subjects were recruited.
This thesis consists of the literature review and clinical study.
The literature review includes two reports, in the first report, it mainliy reviewed the dry eye researches conducted by Singapore National Eye Centre in recent years which covers the etiology, histopathology, clinical features, diagnosis and treatment of the dry eye disease. In the second report, it mainly reviewed the TCM acupuncture and moxibustion dry eye treatment assessments conducted by overseas and Chinese researchers in recent years.
Clinical study:
Objective:to evaluate the efficacy of TCM herbal medicine "qi ju gan lu yin" in treating dry eye, compared to the same herbal preparation with acupuncture.
Methods:At Singapore Chung Hwa Medical Institution during the period from October2012-September2013, a total of89age-and gender-matched subjects were recruited. This included44in Group1, the oral TCM Herbal Medicine Group, and45in Group2, the TCM Combined Herbal and acupuncture Group. Acupuncture was performed twice a week,20minutes each session, for a period of30days.
All participants had dry eyes as the main complaint and were aged40-70years old. All subjects had good general health, no ocular disease, were non-smokers and did not wear contact lenses. The inclusion criteria include a positive score in the SPEED Questionnaire (Standard Patient Evaluation for Eye Dryness Questionnaire).
Results:Pre-and post-treatment measurements of Schirmer1test (Sit) and TBUT test were performed. Sit (mm/5min) was improved in Group1(p=0.04) but not2(p=0.668). The interventions were more effective with regard to Tear Break-Up Time (TBUT) on group1(p=0.001) compared to Group2(p=0.099).
At the post treatment visit, Group1had significantly higher TBUT than Group2(Z=7.013p=0.001for Group1; Z=1.650, p=0.099in Group2). However, no significant differences were found in Sit readings between the two groups (Z=-1.441, p=0.150).
in terms of symptoms, the total%improvement in SPEED was similar at54.4%and53.3%for Groups1and2respectively. The actual improvement in SPEED score was3.58±5.40and4.40±7.82in the two groups respectively. There was no significant difference between the two groups (t=0.520, p=0.604).
To increase the validity of the study, a different method of assessing symptoms based on the visual analog scale was also used (SANDE)(published previously by Schaumberg DAet al.,2007). The percentage improvement in the SANDE in Group1and2was61%and55.5%respectively. Actual SANDE improvement for Groups1and2were24.01±23.99and22.70±24.33respectively (t=-0.252, p=0.802).
Furthermore the TCM lung and kidney yin deficiency score aggregates for Group1was68.18%and for Group2was71.11%.These scores were similarly improved by treatment in both Groups by3.76±6.04and4.50±5.81(t=-0.205, p=0.838).
Conciusion:The findings demonstrate the potential usefulness of TCM treatment in commonly seen dry eye disease in Singapore. In this study, acupuncture does not demonstrate any additional therapeutic effect over and above herbal medication alone. In fact, for TBUT, Group1(TCM Herbal Medicine alone) has in fact shown a better result than the combined TCM methods. The result findings suggest that with more research, TCM herbal medicine may be used as an alternative approach to treat dry eyes in Singapore.
维护良好和舒适的双眼视觉是人类生存和从事各种职业最基本的需求。没有良好的双眼视觉,人们就不能从事许多精细或高难度的工作；同样,视力虽然正常,但因干眼而双眼长期处于干涩不适、疲劳、灼痛、异物感等,也会严重干扰工作和影响生活质量,甚至造成心理疾患。故干眼是目前临床研究工作的热点和重要课题之一。
干眼在全球有发展的趋势。最近国际干眼流行病学小组(2007)特别指出需要进一步研究干眼与糖尿病、抽烟者的相关性及将干眼对生活质量的真正影响数据化。
新加坡作为一个先进国家,关于干眼的科研,已经在新加坡眼科中心连续进行了15年,但由于中医西医治疗在新加坡属于两种不同体制的治疗系统,中医治疗干眼,在新加坡眼科常规治疗体系里,仍未被广泛应用。新加坡中华医院眼科组在临床工作上,虽然应用中药或中药加针灸综合治疗干眼发挥了其特长及优势,但在干眼的临床研究和确切疗效评价方面,还缺乏客观科学的临床研究。
本课题在中医脏腑理论及气血理论指导下,用前瞻性的随机、对照的研究方法,分别对韦企平教授验方“杞菊甘露饮”及“杞菊甘露饮配合针刺”治疗肺肾阴虚型干眼进行疗效评价,以获得临床证据。
论文包括文献综述和临床观察两部分。
文献综述：
包括：《新加坡对干眼的研究进展》和《针灸治疗干眼及干眼综合征的临床研究》两部分。在《新加坡对干眼的研究进展》中,主要对新加坡眼科中心近5年所做的干眼临床研究,对干眼的定义、分类、病因、组织病理学、临床特征、诊断与治疗等方面进行了简要评述。在《针灸治疗干眼及干眼综合征的临床研究》中,则对近年外国中国研究者采用针灸治疗干眼及干眼综合征的临床研究、中医学病名、病因病机、辩证论治、治疗思维及现代中医眼科对干眼的认识进行简要回顾。
临床观察部分：
目的：评价韦企平教授验方“杞菊甘露饮”和“杞菊甘露饮配合针刺”治疗中老年肺肾阴虚型干眼的临床疗效。干眼目前是全球常见眼科疾病,严重影响生活质量。常规干眼治疗通常以滴眼液治疗,但新加坡眼科中心提出的最新研究认为滴眼液对很多病人,尤其是中老年型病人,毫无作用,即使疗效有用也是短期效应,长期复诊造成了时间及资源上的浪费,因此提议应该寻求其他综合治疗方法,给予病人更好的治疗方案,从中减轻国家保健负担。导师韦企平曾在新加坡讲学期间实地考察了解到新加坡以潮湿炎热气候为主,通常室内长年开空调避热防潮,造成许多人有口鼻干燥,双眼干涩不适；个别人甚或出现恶寒、发热、头痛、干咳等秋燥病证。加上现代电脑办公、环境污染等,故许多新加坡人,尤其是中老年人多有不同程度眼干不适症状。据此,韦教授结合自己临床实践经验,组成“杞菊甘露饮”配方,用于治疗肺肾阴虚型干眼。为了获得“杞菊甘露饮”治疗肺肾阴虚型干眼的实际临床疗效及短期巩固疗效的证据,我们设计了该课题,开展中医治疗干眼临床研究的第一步。
方法：对2012年10月至2013年9月间不同原因所致中老年肺肾阴虚型干眼病人90例,年龄40-70岁,采用前瞻性的随机、双盲、对照研究方法,以自觉症状、检查体征、中医肺肾阴虚症状变化为评价指标进行临床疗效观察。具体方法为：中药治疗组(组1)和针药并用组(组2)入组比例为1：1。中药组仅给予“杞菊甘露饮”配方颗粒冲剂,早晚两次分服；中药加针刺则给予“杞菊甘露饮”配方颗粒冲剂早晚两次分服,另予一个星期两次的针刺治疗,留针20分钟,疗程30天。在治疗前后分别进行自觉症状SPEED(标准干眼测试量化评分,Standard Patient Evaluation of Eye Dryness Questionnaire)VAS(视觉模拟量表评分,Visual Analogue Scale Score)、中医肺肾阴虚型干眼评分,及客观的泪膜破裂时间(Tear Break Up Time, TBUT)、泪液分泌试验(Schirmer's Test1, SIt)、角膜荧光素染色(Corneal Staining)、睑板腺功能障碍的临床检查,并在停止治疗后的第2个月和第4个月分别进行随访。疗效标准参考中国国家中医管理局《中医病证诊断疗效标准》中疗效评价标准,综合主观和客观观察指标进行评价。计量数据符合正态分布的使用T-检验,不符合正态分布的采用秩和检验(两个独立样本的Mann-Whitney Test曼惠特尼U检验),计数数据应用x2检验。
结果：入组病例共90例,中药组和中药加针刺组各45例。中药组中1有1例脱落。两组治疗前的年龄、视力、自觉主观症状测值无显著差异,具有可比性(p>0.05)。治疗后中药组及中药加针刺组的自身治疗前后疗效皆有明显统计学差异(p=0.000、p<0.05)。两组间疗效比较除了在泪膜破裂时间上有差异,中药组疗效比中药加针刺组疗效佳(中药组p=0.000,中药甲针刺组p=0.099),两组组间治疗疗效在其他指标上的比较则没有统计学差异。(p>0.05)。在治疗停止后的第2、4个月随访时间里,中药组和中药加针刺组的治疗前后皆有统计学差异(p=0.000),但两组间比较疗效则无差异(p>0.05)。
结论：“杞菊甘露饮”及“杞菊甘露饮配合针刺”对于治疗各种病因引起的肺肾阴虚型干眼具有较好的疗效,都可在一定程度上提高患者的泪液质量、泪液分泌量、减少干眼患者的自觉症状,缓解其肺肾阴虚的相关症状和体征。单用“杞菊甘露饮”和“杞菊甘露饮配合针刺”比较疗效并无明显差异,从而初步证明对中老年肺肾阴虚型干眼可用“杞菊甘露饮”口服治疗。
Dry eye is a major, common medical condition with significant health and economic burden in Singapore and worldwide. It is a holistic problem affected by living habits, nutrition and underlying systemic disease, inducing a significant decrease in quality-of-life. The hallmark of this disease is raised tear osmolarity and inflammation. There is no definitive cure for this condition, as treatment in the form of lubricants is only symptomatic and treatment with cyclosporine eyedrops is expensive and may not be well tolerated.
Following the rise in international interest in complementary medicine, randomized-controlled studies in dry eye using Traditional Chinese Medicine (TCM) have been published, with mixed results.
Therefore a clinical study was conducted involving herbal and acupuncture therapy on lung and kidney yin deficiency type of dry eye. This was only recently completed at Singapore Chung Hwa Medical Institution during the period from October2012-September2013, with support by the hospital administration, using prospective, randomized and controlled study, In the study, the aim was to evaluate the efficacy of TCM herbal medicine "qi ju gan lu yin" in treating dry eye, compared to the same herbal preparation with acupuncture and a total of89age-and gender-matched subjects were recruited.
This thesis consists of the literature review and clinical study.
The literature review includes two reports, in the first report, it mainliy reviewed the dry eye researches conducted by Singapore National Eye Centre in recent years which covers the etiology, histopathology, clinical features, diagnosis and treatment of the dry eye disease. In the second report, it mainly reviewed the TCM acupuncture and moxibustion dry eye treatment assessments conducted by overseas and Chinese researchers in recent years.
Clinical study:
Objective:to evaluate the efficacy of TCM herbal medicine "qi ju gan lu yin" in treating dry eye, compared to the same herbal preparation with acupuncture.
Methods:At Singapore Chung Hwa Medical Institution during the period from October2012-September2013, a total of89age-and gender-matched subjects were recruited. This included44in Group1, the oral TCM Herbal Medicine Group, and45in Group2, the TCM Combined Herbal and acupuncture Group. Acupuncture was performed twice a week,20minutes each session, for a period of30days.
All participants had dry eyes as the main complaint and were aged40-70years old. All subjects had good general health, no ocular disease, were non-smokers and did not wear contact lenses. The inclusion criteria include a positive score in the SPEED Questionnaire (Standard Patient Evaluation for Eye Dryness Questionnaire).
Results:Pre-and post-treatment measurements of Schirmer1test (Sit) and TBUT test were performed. Sit (mm/5min) was improved in Group1(p=0.04) but not2(p=0.668). The interventions were more effective with regard to Tear Break-Up Time (TBUT) on group1(p=0.001) compared to Group2(p=0.099).
At the post treatment visit, Group1had significantly higher TBUT than Group2(Z=7.013p=0.001for Group1; Z=1.650, p=0.099in Group2). However, no significant differences were found in Sit readings between the two groups (Z=-1.441, p=0.150).
in terms of symptoms, the total%improvement in SPEED was similar at54.4%and53.3%for Groups1and2respectively. The actual improvement in SPEED score was3.58±5.40and4.40±7.82in the two groups respectively. There was no significant difference between the two groups (t=0.520, p=0.604).
To increase the validity of the study, a different method of assessing symptoms based on the visual analog scale was also used (SANDE)(published previously by Schaumberg DAet al.,2007). The percentage improvement in the SANDE in Group1and2was61%and55.5%respectively. Actual SANDE improvement for Groups1and2were24.01±23.99and22.70±24.33respectively (t=-0.252, p=0.802).
Furthermore the TCM lung and kidney yin deficiency score aggregates for Group1was68.18%and for Group2was71.11%.These scores were similarly improved by treatment in both Groups by3.76±6.04and4.50±5.81(t=-0.205, p=0.838).
Conciusion:The findings demonstrate the potential usefulness of TCM treatment in commonly seen dry eye disease in Singapore. In this study, acupuncture does not demonstrate any additional therapeutic effect over and above herbal medication alone. In fact, for TBUT, Group1(TCM Herbal Medicine alone) has in fact shown a better result than the combined TCM methods. The result findings suggest that with more research, TCM herbal medicine may be used as an alternative approach to treat dry eyes in Singapore.
引文
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