OBJECTIVE: To observe the efficacy of Chinese herbal medicine pacifying liver and benefiting essence formula in the treatment of dry eyes. METHODS: Sixty patients (120 eyes) with dry eye disease were selected and randomly divided into two groups. Patients in the herbal treatment group were treated with oral administration of the herbal formula of pacifying the liver and benefiting the essence and external fumigation of both eyes with the medicinal solution, and patients in the positive control group were treated with artificial tear drops for four weeks. The changes of subjective symptom scores and objective indexes of the patients before and four weeks after medication were observed. Results: The total effective rate of the Chinese medicine treatment group was 66.7%; the total effective rate of the patients in the positive control group was 56.7%, and the pacifying liver and benefiting essence formula significantly reduced the subjective symptom score of the patients (p<0.01< span="">), the objective index of tear secretion (SchirmertestI SIt) and tear film break up time (BUT) compared with the positive The control group improved significantly (p<0.05< span="">). Conclusion: The treatment of patients with dry eye syndrome with the Chinese herbal medicine Ping Liver Yi Jing formula not only relieves ocular symptoms, but also improves objective indicators such as tear secretion and tear film stability in patients, which has a better effect than the symptomatic treatment with artificial tears. Dry eye is a general term for a group of diseases characterized by reduced tear secretion or other causes of low tear film stability, which leads to ocular surface damage, with dry eye, visual fatigue and foreign body sensation as the main clinical symptoms. Dry eye can lead to corneal damage and even vision loss if not treated systematically. With the popularization of computer and internet, the incidence of this disease is increasing year by year, and according to statistics, the prevalence rate in our ophthalmology general outpatient clinic is 32.1%. Therefore, it is of great value to conduct clinical research on dry eye. We have been treating this disease with Chinese herbal medicine since 2007, using the formula of pacifying liver and benefiting essence, and have achieved certain effects, which are reported below. 1. Clinical data (1) General data: The cases in this study were all dry eye patients who attended the outpatient clinic of the Department of Traditional Chinese Medicine at Beijing Tongren Hospital from January 2007 to December 2008, a total of 60 cases, randomly divided into the herbal treatment group and the positive control group using the random number table method. There were 30 cases with 60 eyes in the Chinese medicine treatment group, with a mean age of 48.4±15.215 years; 30 cases with 60 eyes in the positive control group, with a mean age of 49.37±14.74 years. There was no statistical difference between the two groups in terms of gender, age and duration of disease, and they were comparable. (2) Diagnostic criteria: With reference to the diagnostic criteria formulated in the 2003 National Symposium on Ocular Surface Diseases and the 2004 National Symposium on Progress in Diagnosis and Treatment of Dry Eye, the diagnostic criteria for this clinical observation were determined as follows: ① Patients had obvious conscious symptoms: dryness, eye fatigue, foreign body sensation, burning sensation, eye swelling, eye pain, photophobia, and eye redness. The three symptoms of dryness, eye fatigue and foreign body sensation are necessary indicators; ② decreased tear secretion: tear secretion test Sit: ≤5mm/5min is a strong positive, 10< span="">mm/min is positive; ③ eye surface damage: discharge other external and injury-causing factors, corneal strips, lumpy staining or filaments are positive. (3) Inclusion criteria: ① meet the above diagnostic criteria; ② adhere to treatment for four weeks, there is a perfect examination to determine the efficacy. (4) Case exclusion criteria: ① do not meet the inclusion criteria, or meet the inclusion criteria but not according to the prescribed treatment, can not determine the efficacy or incomplete information, affecting the determination of efficacy. (2) This observation is limited to patients with simple dry eye disease, excluding dry eye disease caused by systemic diseases such as desiccation syndrome, or local diseases that destroy tear-secreting tissues, such as severe ocular thermal burns and chemical burns of the eye, resulting in partial or complete damage to the lacrimal gland. 2. Study method (1) Grouping method: A randomized controlled trial method was used to divide the subject patients who met the case inclusion criteria into the herbal treatment group and the artificial tear positive control group using a randomized table. (2) Treatment method: The Chinese herbal treatment group was given the formula of pacifying liver and benefiting essence (composition: 15g of raw stone cassia (first down), 15g of raw sea clam (first down), 15g of mother-of-pearl (first down), 10g of grain essence grass, 10g of wolfberry, 10g of silver flower, 10g of mimulus flower, 10g of chrysanthemum, 10g of celosia, 10g of salvia, 10g of salvia, 30g of fresh dendrobium, 20g of northern salvia, 10g of jiao yunqu, amber (3g cloth bag first), decoction of 200ml, taken twice a day, and external fumigation of both eyes with the herbal soup solution, twice a day. In the positive control group, artificial tear drops were applied topically, produced by the Belgium branch of Alcon Ophthalmology Factory. 3-6 times/day. Both the treatment group and the positive control group were summarized after 4 weeks of treatment. (1) Observation indexes and measurement methods (1) Observation indexes: ①Subjective indexes: the change of clinical symptom score before and after treatment was compared by questionnaire; ②Objective indexes: 1) change of tear secretion; 2) change of tear film stability; 3) change of corneal fluorescein staining. (2) Measurement method ① Questionnaire items and scoring method: common clinical symptoms (1) dryness (2) foreign body sensation (3) eye fatigue (4) burning sensation (5) eye distension (6) eye pain (7) photophobia (8) eye redness, divided into no, light (occasional), medium (frequent), and heavy (continuous) degree, corresponding to the score 0-3; ② Basic tear secretion test ( SIt: the method was: 0.4% oxybuprocaine hydrochloride (Japan Sento Pharmaceutical) was dropped into the conjunctival sac once; after 5 min, the residual fluid in the conjunctival sac was aspirated; one end of 5×35 mm tear detection test paper (Tianjin Jingming Pharmaceutical Co., Ltd.) was folded back 5 mm along the mark and gently clamped in the conjunctival sac in the outer and outer 1/3 of the lower lid, and the other end was draped over the outer part of the lower lid; the filter paper strip was removed at 5 min, and 2 m The length of the wetted filter paper strip was observed after 2m in. ③ tear film rupture time (BUT): after sodium fluorescein corneal staining, the patient was instructed to blink and then look forward, under the slit lamp, observed with a cobalt blue filter, and the rupture time was calculated from the time the eye was opened after the last transient until the first black spot tear film defect appeared in the cornea. 4.Clinical efficacy criteria Refer to the “Diagnostic and efficacy criteria for Chinese medicine diseases” promulgated by the State Administration of Traditional Chinese Medicine [. ①Cured: symptoms disappeared, corneal staining subsided, Schirmer test repeatedly measured more than 10mm/5min. ②Good: symptoms reduced, corneal staining decreased, Schirmer test repeatedly measured tear secretion increased. ③ not healed: no improvement in symptoms, no change or increase in corneal staining, no increase in tear secretion as measured by Schirmer test several times 5, statistical analysis: spss11.5 software, statistical analysis of measurement data described by mean ± standard deviation, paired t-test before and after treatment in the same group, independent t-test for comparison between different groups; count data described by frequency, percentage, chi-square test for Comparisons were made. 6. Results (1) Comparison of the efficacy of the two groups after treatment After four weeks of treatment, the Chinese medicine treatment group improved in 20 cases with 40 eyes and failed to heal in 10 cases with 20 eyes, with an effective rate of 66.7%; the positive control group improved in 17 cases with 34 eyes and failed to heal in 13 cases with 26 eyes, with an effective rate of 56.7%, and the difference in the effective rate between the two groups by chi-square test was not statistically significant. (2) Changes in subjective symptoms of the two groups There was no difference in subjective symptoms between the two groups before treatment, indicating that the subjective symptoms of the two groups were comparable. After treatment, the subjective symptom scores of the two groups were significantly improved compared with those before treatment, and the difference was statistically significant (p<0.01). After treatment, the subjective symptom scores of both groups were better than those of the positive control group, and the scores decreased, and the difference was statistically significant (p<0 .01) (3) Distribution of symptoms before and after treatment in both groups Before and after treatment, the distribution of patients' subjective symptoms changed, and by chi-square test, the five symptoms of dryness, eye fatigue, foreign body sensation, photophobia and eye redness in patients after treatment were significantly improved compared with those before treatment, and the difference was statistically significant (p<0 .01). (4) Changes in objective indexes of the two groups There were no differences between the two groups in BUT, SIt test and corneal fluorescence staining before treatment, which indicated that the two groups were well balanced and comparable. Self-comparison: All three objective indexes in the herbal treatment group improved significantly after treatment compared with those before treatment, with statistically significant differences (P<0.01 P<0. 05). In the positive control group, the BUT value was prolonged after treatment compared with that before treatment (P<0 05), while Sit and corneal fluorescein staining were slightly improved compared with that before, with no statistical significance; intergroup comparison: all three objective indexes in the herbal treatment group were significantly improved after treatment compared with the positive control group, among which BUT was significantly better than that in the positive control group (P<0 05), while SIt and corneal fluorescein staining were not statistically significant between the two groups. (5) The distribution of various examination results before and after treatment in the two groups By chi-square test, SIt in the treatment group showed significant improvement compared with that before treatment, and the difference was statistically significant (P<0. 05), and the difference was statistically significant (P<0. 05) compared with the control group; BUT showed significant improvement advantage compared with the control group, and the difference was statistically significant (P<0. 05) 7. Discussion: With the change of modern people's work and life style, the The popularity of computer and network, people use their eyes excessively, which leads to the incidence of dry eye disease increasing year by year, and the age of onset gradually younger, becoming a common and prevalent disease in modern society. At present, the more common treatment for dry eye is artificial tear replacement therapy, but artificial tears only have the effect of symptomatic treatment, and because they contain preservatives and other excipients, long-term use will lead to the occurrence of dry eye, which becomes a contradiction in the treatment of this disease. In contrast, Chinese medicine has a great advantage in treating this disease, "dry eye" is similar to the Chinese medicine "white astringent disease", the "review of the Yaohuan" volume 5 cloud: dry astringent unpleasant, miao steam is not comfortable, but because of the water less fluid failure, do not wait for the dry light damage, the disease described The classic Chinese medical text "Huangdi Neijing" laid down the programmatic guiding principles for the treatment of eye diseases: "the eye gets blood and can see", "the liver opens the orifice in the eye", pointing out that the key to normal function of the eye is the nourishment of the essence of the five viscera and six internal organs In clinical practice, we also found that patients with dry eyes do not have obvious clinical signs of Qi and blood deficiency, but often suffer from deficiency of liver and kidney yin and inflammation of deficiency fire, resulting in fluid deficiency and astringency of Qi and blood, resulting in a series of symptoms of dry eyes such as dryness, dysfunction and uncomfortable eye grinding. Therefore, in clinical practice, we mainly use the formula of pacifying liver and benefiting essence, together with clearing heat and activating blood, to form the formula of pacifying liver and benefiting essence to be taken orally, together with the fumigation of medicinal liquid to treat dry eyes, and the results showed that the effect was better in improving the subjective symptoms of patients, and after statistics, the clinical symptoms of the herbal treatment group itself were significantly better than before the treatment, and had a significant advantage over the positive control group in improving the clinical symptoms, and this advantage was also confirmed in the objective index The improvement was also confirmed by the fact that SIt, BUT and corneal fluorescence staining were significantly better in the Chinese herbal treatment group after its own comparative treatment than before treatment, and also had an improvement effect compared with the positive control group, indicating that Chinese herbal treatment is practically effective in improving tear secretion and tear film stability. According to Kongmen medicine, the salty and cold products of the mesocarpus class are sentient to blood and flesh, good at entering the yin division of the lower jiao, pacifying the liver and benefiting the essence, nourishing the kidney and brightening the eyes, nourishing the yin without hindering the stomach and helping dampness, therefore, the formula applies the mesocarpus class drugs such as raw stone cassia, raw sea clam and mother-of-pearl, together with grain essence grass and wolfberry to nourish the liver and kidney; silver flower, mimosa and chrysanthemum have the effect of clearing lung heat and draining liver wind; salvia, cyperus, northern sage, amber and fresh dendrobium can invigorate the blood and generate fluid, nourish the blood and brighten the eyes. The combination of all the medicines can nourish the blood and promote the vitality of the blood, nourish the blood and brighten the eyes. The combination of all the medicines can nourish the deficiency and dispel the evil, and the formula is comprehensive and targeted, and combined with the characteristics of ophthalmology, and the external fumigation of the liquid, the combination of internal and external use is effective.