| Background:Dry eye is a common disease of Ophthalmology.It is easier to diagnose,but the treatment effect is not satisfactory.Because the pathogenesis of dry eye is quite complicated,it leads to a variety of treatment methods.In the context of advocating a variety of comprehensive therapies for dry eye,it is particularly important to personalize a precise and simple treatment plan according to the type of dry eye.Compared with other types of dry eye,the treatment of pure Traditional Chinese Medicine for Aqueous deficient dry eye(ADDE)has a solid experimental foundation and was proved by hundreds of clinical research.Based on the concept of holism of Traditional Chinese Medicine,Chinese medicinal,acupuncture,moxibustion and other methods have been used to treat dry eye,and satisfactory results have been obtained.However,the clinical promotion lacks a strong evidence-based basis.There are mainly two issues that need to be solved urgently:The complexity and uncertainty of the role of Chinese medicinal in treating diseases.Second,dry eye,as a chronic disease,has its own complex pathogenesis and etiology,which make its treatment methods diversified and complicated.Therefore,it is of great clinical significance to accurately and scientifically find out the regularity of its treatment and study the types of dry eye and target populations suitable for Chinese medicinal treatment.Zhou Wanyu,Ophthalmologist,based on the theory of collateral disease,developed Tongluo Shumu Decoction for the treatment of ADDE and found that the clinical effect is quite satisfactory.She summed up the TCM pathogenesis of ADDE through many years of experience in the diagnosis and treatment of dry eye,and found that using the theory of collateral disease can better guide the clinical treatment of dry eye.She recognizes that the yin deficiency of the body is the root of the ADDE,the dryness toxin stasis which is both a pathogenic factor and a pathological product is the branch of ADDE,it can lead to collateral stasis.In turn,collateral stasis leads to the dryness toxin stasis.And it causes ADDE to linger and relapse.Finally,she proposes the principle of "resolve toxins,unblock the collateral" to cure ADDE.The regularity of treatment of Tongluo Shumu Decoction needs further exploration.The main purpose of collateral disease theory is to establish a pattern differentiation and treatment system for clinical syndrome differentiation and special medication for chronic complex diseases.Dry eye has been proposed as a chronic disease with complex pathogenesis and pathogenic factors.Moreover,the incidence rate of dry eye is increasing year by year,and the treatment methods of Western medicine are limited,which also affects the quality of life of patients.Based on this background,this study,a clinical observational trials,lays the foundation for future high-level evidence-based clinical trials by verifying the regularity and safety of Tongluo Shumu Decoction.Objective:1.To explore the effective target population of Tongluo Shumu Decoction for the treatment of ADDE.2.To explore the regularity of Tongluo Shumu Decoction for the treatment of ADDEMethods:This study is a prospective and observational study.Patients who were diagnosed with ADDE were collected in Xiyuan hospital from April 1,2019 to January 31,2020.Patients were treated with Tongluo Shumu Decoction for 1 month.General demographic data of patients and Tear Break-up Time(BUT),Schirmer I Test(S I T),Tear Meniscus Height(TMH),Cornea Fluorescein Staining(CFS),and subjective symptom score were collected before treatment,after 2 weeks of treatment,and after 4 weeks of treatment.And then Shapiro-Wilk test was performed,paired t test was used for data that fit the normal distribution,and rank sum test was used for grade data and those did not meet the normal distribution.P<0.05 is statistically different,P<0.01 is significantly statistically different.Results:A total of 161 patients were observed,101 cases of them took Tongluo Shumu Decoction for one month continuously and the information was complete.Among them,74 were female(73.3%).The 101 cases were between the ages of 24-70 years,with an average age of 44.69±14.02 years.There were 59 cases(58.4%)which course of disease was no more than 6 months,10 cases(9.9%)in 6-12 months,and 32 cases(31.7%)longer than 12 months.Sixty-eight cases(67.3%)had long-term use of video terminal products.Of the included cases,82 cases(81.1%)were not accompanied by other diseases of the whole body and the eye.Fifty-one cases(50.5%)had BUT ?5 seconds,and 78 cases(77.2%)had TMH between 0.1-0.2mm,and 86 cases(85.1%)had S I T ?5 mm/5 minutes,only 30 cases(29.7%)had mild to moderate corneal staining.In the SS group,after 2 weeks of treatment,there was a statistically different improvement in SIT and systemic subjective symptom score compared with before treatment(P<0.05),after 4 weeks of treatment,there was a statistically significant improvement(P<0.01).After 4 weeks of treatment,there was a statistically difference in OSDI compared with before treatment(P<0.05),the improvement in OSDI and SIT was statistically significant compared with after 2 weeks of treatment.In the group without any systemic diseases such as SS,systemic subjective symptom and OSDI score,BUT,TMH,S I T,and CFS were significantly improved after treatment(P<0.01).There was also a significant difference between after 4 weeks of treatment and after 2 weeks of treatment(P<0.01).The total effective rate was 85.15%.Among the 8 subjective symptoms of dry eye,dryness,foreign body sensation,pain or irritation,burning or tearing,bloating,and eye fatigue were statistically differently(P<0.05)improved compared with those before treatment.According to the severity of dry eye,it was divided into mild(39 cases,38.6%),moderate(22 cases,21.8%),and severe(40 cases,39.6%)dry eye.Prolonged BUT was a statistically significant difference after 2 weeks and 4 weeks treatment compared with before treatment for mild dry eye(P<0.01),and for moderate and severe dry eye,the prolonged BUT was statistically different after 2 weeks treatment(P<0.05),and there was a significantly statistical difference after 4 weeks treatment(P<0.01).There was a significantly statistical difference in the increase of S I T after 2 weeks and 4 weeks treatment for mild,moderate,and severe dry eye(P<0.01).For mild and severe dry eye,there was a statistically significant difference in the increase of TMH after 2 weeks and 4 weeks of treatment compared with that before treatment(P<0.01),but in moderate dry eye,only 4 weeks later there was a statistically significant difference(P<0.01).CFS decreased significantly after 2 weeks and 4 weeks treatment compared with before for mild,moderate,and severe dry eye(P<0.01)Of the 101 cases,there were 86 cases that the treatment was effective,grouped by gender,age,course of disease,occupation,presence or absence of concomitant diseases,BUT,S I T,TMH,CFS,pre-treatment medication history,and combined medication,the subjective recognition effectiveness of each group was extremely higher than 80%.Among them,the subjective e ffective rates of patients with systemic diseases such as Sjogren's syndrome are equivalent to those without basic diseases,which are 87.5%and 87.0%respectively.The subjective effective rates of video terminal product occupations are as high as 89.1%.The longer BUT,the higher S I T and TMH,and the lower CFS at baseline,the higher subjective effective rates could be confirmed.Of the 15 ineffective cases,14 cases were not accompanied by any systemic and ocular diseases,and 1 case of retinopathy after laser surgery.Nine young patients,4 middle-aged patients,2 elderly patients who with extremely dry eye,except for one case of middle-aged and young patient,all the rest are long-term users of video terminal products.The 161 cases observed in the study did not show any adverse reactions caused by drugs.Conclusion:In the study,Tongluo Shumu Decoction is effective in treating patients with ADDE,and there is no adverse events.The target population of Tongluo Shumu Decoction for the treatment of ADDE is those who have subjective symptoms of dry eye and abnormalities in BUT,TMH,S I T,and CFS without any systemic diseases,and those who have subjective symptoms of dry eye and abnormalities in S I T with SS.In particular,dryness,foreign body sensation,pain or irritation,burning or tearing sensation,eye bloating,and eye fatigue are the six main complaints of dry eye.The regularity of Tongluo Shumu Decoction on the treatment of ADDE is to treat patients by improving the subjective symptoms and signs of patients.The improvement of indicators for ADDE patients without any disease is better than that with systemic diseases such as SS.The effect of prolonging the BUT of patients with mild dry eye is more significant than that of moderate and severe patients.Continuous using(4 weeks)of Tongluo Shumu Decoction is more effective than short-term(2 weeks).Lack of sleeping is a key factor leading to poor efficacy in the ine ffective cases. |
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