| Transepithelial Photorefractive Keratectomy(T-PRK)is a laser surface refractive surgery,which uses excimer laser to get rid of the epithelium and to cut matrix by one-step form.Because without knife disc,let it hold more corneal tissue,which makes it become one of the mainstream operation for refractive surgery.But the postoperative symptoms including pain,photophobia,tears,foreign body sensation often lead to decreased satisfaction of patients,and affect its more widely being used in clinic.After the surgery of T-PRK,corneal epithelium being defected,nerve being cutted by laser,a large number of highly sensitive nerve endings being exposure,epithelial reactive secreting and releasing of various inflammatory factors,which all directly stimulu to the corneal infiltrates and cause pain,photophobia,tears,foreign body sensation,symptoms such as.In the clinical,the ways to improve postoperative discomfort symptoms of the surface cutting surgery are a lot,including nonsteroidal anti-inflammatory eye drops,glucocorticoid hormones eye drops,low temperature analgesia,corneal dressing mirror,oral nonsteroidal and opioid,western medicine such as.But all of them both have different degree of adverse reactions or side effects,including the corneal healing delay,infection,corneal drying,glucocorticoid-induced glaucoma and so on,and dizziness,nausea,vomiting,systemic symptoms such as skin rash,peptic ulcers,bleeding.In current clinic,only one article has reported that the use of the chufengyisun soup to improve the postoperative symptoms of PRK.It rarely reports to use of traditional chinese medicine(TCM)or proprietary Chinese medicine to improve postoperative discomfort of patients after the surgery of T-PRK by the local control.We observed that in clinic yiqiqufengzhitong granules could effectively reduce inflammation stimulation and alleviate symptoms of patients with postoperative discomfort,at the same time,promote the growth of corneal epithelium and shorten the wound healing time.However,there is a lack of scientific and objective clinical evidence to verify the efficacy of the chinese medicine.Therefore,this study is intended to be adopted randomized and blank controlled way.We hope that through this research,we can verify the alleviated effect to postoperative ocular self-conscious symptoms with yiqiqufengzhitong granules and discuss the possible mechanism.Objective:Through randomized and blank controlled clinical research,we can verify the alleviated effect to postoperative ocular self-conscious symptoms with yiqiqufengzhitong granules and discuss the possible mechanism.We hope to make this surgery perfect by the perioperative treatments with chinese traditional medicine,and to provide new options for refractive surgery doctors in terms of clinical drug use.Methods:Using randomized and blank controlled clinical research methods:according to the standard set,We select suitable 52 patients for T-PRK surgery,and randomly divide them into chinese traditional medicine group and blank control group.We should check routine inspection before corneal refractive surgery,including uncorrected vision、best corrected visual acuity of vision、corneal topography,ultrasonic corneal thickness,central corneal epithelial thickness,intraocular pressure and fundus.Since three days before surgery,two groups use levofloxacin eye drops by four times each day and diclofenac sodium eye drops by three times a day.On the day of surgery,We use the same preoperative medication and at the same time apply fluorine dragon eye drops four times a day.When it is on the third day of surgery,we apply fluorine dragon eye drops eight times a day.At the meantime,chinese traditional medicine group is given yiqiqufengzhitong granules by two times a day.That’s until total of Seven days.And we should record the score of the patient’s pain and other subjective symptoms in the first day,the third day,the fifth and seventh day after the surgery.In the fifth day,we should stain the corneal with fluorescein sodium.when the corneal is healed,we should pick the dressing mirror,otherwise keep it until the seventh day.When it is the seventh day,we should measure intraocular pressure and central corneal epithelial thickness.SPSS22.0 statistical software is used to do statistics.Eye pain scores and total subjective symptom scores are observed in the right eye or single eye surgery.The Chinese medicine group and blank control group both have 26 cases(26 eyes).Uncorrected vision、Corneal epithelium recovery condition、central cornea epithelial thickness and intraocular pressure are observed in the two eyes or single eye surgery.The Chinese medicine group have 26 cases(50 eyes)while blank control group have 26 cases(52 eyes).The measurement data is indicated by the mean number plus or minus standard deviation and we use t-test to do statistics.The enumeration data is indicated by rate and we useχ2-test to do statistics.The difference is statistically significant(P<0.05).Results:1.ocular self-conscious symptomsIn both groups,both of the symptoms and other eyes are less painful as time prolongs.Eye pain in different time points:Comparison between groups:in the first day,the third and the fifth day after the surgery:Pain symptom scores are 1.923±0.845、1.192±0.694、0.385±0.496 in chinese traditional medicine group while the one are 2.731±0.452、1.885±0.432、0.846±0.368 in blank control group.The difference between the two groups have statistical significance(P 均<0.05).In the seventh day:Pain symptom score is 0.000±0.000 in chinese traditional medicine group while the one is 0.038±0.196 in blank control group.The difference between the two groups hasn’t statistical significance(t=1.000,P>0.05).In group comparison,chinese traditional medicine group:in the first day,the third,the fifth and seventh day after the surgery:scores are 1.923±0.845、1.192±0.694、0.385±0.496 and 0.000±0.000.The score is compared with each other on every time point,and the difference is statistically significant(P<0.05).Blank control group:in the first day,the third,the fifth and seventh day after the surgery:scores are 2.731 ±0.452、1.885±0.432、0.846±0.368 and 0.038±0.196.The score is compared with each other on every time point,and the difference is statistically significant(P<0.05).Total subjective symptom scores:Comparison between groups:in the first day,the third and the fifth day after the surgery:scores are 10.038±3.117、5.615±2.787、2.500±2.337 in chinese traditional medicine group while the one are 13.577±3.177、9.038±3.243、4.462±2.044 in blank control group.The difference between the two groups has statistical significance(P 均<0.05).In the seventh day:Pain symptom score is 0.923±1.412 in chinese traditional medicine group while the one is 1.269±1.151 in blank control group.The difference between the two groups hasn’t statistical significance(t=0.969,P>0.05).In group comparison,chinese traditional medicine group:in the first day,the third,the fifth and seventh day after the surgery:scores are 10.038±3.117.5.615±2.787.2.500±2.337 and 0.923±1.412.The score is compared with each other on every time point,and the difference is statistically significant(P<0.05).Blank control group:in the first day,the third,the fifth and seventh day after the surgery:scores are 13.577±3.177、9.038±3.243、4.462±2.044 and 1.269±1.151.The score is compared with each other on every time point,and the difference is statistically significant(P<0.05).2.uncorrected vision:With the extension of time,postoperative uncorrected vision in the two groups begins to gradually return to preoperative best corrected vision.Comparison between groups:in the first day,the third and the fifth day after the surgery:the difference between the two groups has statistical significance(P=0.045、0.010.0.008,均<0.05).In the seventh day:the difference between the two groups hasn’t statistical significance(P=0.799>0.05).In group comparison,the uncorrected vision in seventy-eight point percent of the patients has reached or exceeded preoperative best corrected vision in the third day.It has reached to ninety-four point percent in the fifth day,while ninety-eight point percent in the seventh day in chinese traditional medicine group.But in blank control group,the uncorrected vision in fifty-three point eight percent of the patients has reached or exceeded preoperative best corrected vision in the third day.It has reached to seventy-five percent in the fifth day,while ninety-six point two percent in the seventh day in blank control group.The uncorrected vision is compared with each other on every time point,and the difference is statistically significant(P<0.05)in each group.3.corneal epithelium recovery condition:The corneal epithelial is well-healed in Chinese traditional medicine group and blank control group in the seventh day after surgery.They are both picked the mirror.Comparison between groups:In the fifth day the proportion of the corneal epithelium recovery is one-hundred percent in chinese traditional medicine group while ninety-two piont three percent in blank control group.The difference between the two groups has statistical significance(P=0.045<0.05).4.central corneal epithelial thickness:Comparison between groups:In the seventh day after surgery,the difference between the two groups has statistical significance(t=-2.895,P=0.005<0.05).The difference between the two groups in Postoperation and preoperation has statistical significance(t=-3.113,P=0.002<0.05).In group comparison,the value of central corneal epithelial thickness in chinese traditional medicine group is 42.019±7.014 and 46.160±7.430 in the seventh day and preoperation while 45.600±7.467、45.788±4.984 in blank control group.The difference between the two groups has statistical significance(t=-1.191,2.422,P 均<0.05).5.intraocular pressure:Comparison between groups:The intraocular pressure is 15.108±2.321 in chinese traditional medicine group while the one is 14.796±2.923 in blank control group.The difference between the two groups hasn’t statistical significance in the seventh day after surgery(t=-0.914,P=0.365>0.05).In group comparison,the value of intraocular pressure in chinese traditional medicine group is 15.108±2.321 and 14.550±2.565 in the seventh day and preoperation while 14.796±2.923 and 14.175±2.439 in blank control group.The difference between the two groups hasn’ t statistical significance(P 均>0.05).ConclusionYiqiqufengzhitong granules could effectively reduce inflammation stimulation and alleviate symptoms of patients with postoperative discomfort,promote corneal epithelial recovery、shorten the time of wound healing and promote uncorrected vision recovery.There is no adverse effect of intraocular pressure.It provides theoretical basis for its application in clinic.The mechanism that granules can reduce the postoperative pain and other symptoms is associated with the growth of corneal epithelium.Whether it is related to relieve pain and anti-inflammatory effects of some traditional Chinese medicine is still to be studied. |
