OBJECTIVE To observe the clinical efficacy and safety of Shugan Yangxue Runmu acupuncture method in treating aqueous deficient dry eye(ATD).METHODS A total of 98 ATD patients(196 eyes)treated at Tangshan Fengrun People's Hospital from June 2021 to June 2023 were included.They were randomly divided into a control group(CG)and a treatment group(TG)using a random number table,with 48 patients(96 eyes)in each group.The control group received 1.4% polyvinyl alcohol eye drops,while the treatment group received Shugan Yangxue Runmu acupuncture method in addition to the control group treatment.Both groups were observed for four weeks.The tear film break-up time(BUT),SchirmerⅠ test(SⅠT),corneal fluorescein staining(FL),the level of interleukin(IL)-1β,IL-6 and matrix metalloproteinase-9(MMP-9),and Traditional Chinese Medicine(TCM)symptom scores were measured before and after treatment.RESULTS(1)BUT:After treatment,BUT in both groups was significantly longer than before treatment(tTG=50.217,tCG=40.909,both P=0.000).The treatment group's BUT was longer than the control group's after treatment,with a statistically significant difference(t=7.349,P=0.000).(2)SⅠT:After treatment,SⅠT in both groups was significantly longer than before treatment(tTG=46.149,tCG=42.726,both P=0.000).The treatment group's SⅠT was longer than the control group's after treatment,with a statistically significant difference(t=7.078,P=0.000).(3)FL:After treatment,FL in both groups was significantly lower than before treatment(tTG=50.398,tCG=42.955,both P=0.000).The treatment group's FL was lower than the control group's after treatment,with a statistically significant difference(t=8.688,P=0.000).(4)Tear inflammatory factors:After treatment,IL-1β,IL-6,and MMP-9 levels in both groups were significantly lower than before treatment(IL-1β:tTG=71.214,tCG=51.982,both P=0.000;IL-6:tTG=83.398,tCG=70.133,both P=0.000;MMP-9:tTG=673.908,tCG=623.730,both P=0.000).The treatment group's IL-1β,IL-6,and MMP-9 levels were lower than the control group's after treatment,with statistically significant differences(tIL-1β=10.708,tIL-6=9.689,tMMP-9=9.155,all P=0.000).(5)TCM syndrome scores:After treatment,TCM symptom scores in both groups were significantly lower than those before treatment(tTG=54.729,tCG=46.822,both P=0.000).The treatment group's TCM symptom scores were lower than those in the control group's after treatment,with a statistically significant difference(t=11.622,P=0.000).(6)Clinical efficacy:The overall effective rate was 92.71% in the treatment group,higher than 82.29% in the control group,with a statistically significant difference(χ2=4.762,P=0.029).(7)Adverse effects:There was no statistically significant difference in adverse reactions between the two groups(P>0.05).CONCLUSIONS For ATD patients,Shugan Yangxue Runmu acupuncture method combined with artificial tears can effectively alleviate symptoms,significantly improve tear film stability indicators such as FL,and has high safety.