摘要
目的 观察疏肝养血润目针灸法治疗水样液缺乏性干眼(ATD)的临床疗效及安全性.方法 纳入2021年6月—2023年6月唐山市丰润区人民医院诊治的ATD肝肾阴虚证患者98例(196只眼),采用随机数字表法分成对照组和治疗组,最终每组纳入48例(96只眼).对照组予1.4%聚乙烯醇滴眼液治疗,治疗组在对照组基础上联合疏肝养血润目针灸法.2组均观察4周.分别于治疗前、后检测受试者的泪膜破裂时间(BUT)、泪液分泌试验(SⅠT)、角膜荧光染色(FL)、白细胞介素(IL)-1β、IL-6、金属基质蛋白酶-9(MMP-9)水平及中医证候积分.结果 (1)BUT:治疗前后比较,2组治疗后BUT均较治疗前延长,差异均有统计学意义(t治疗组=50.217、t对照组=40.909,均P=0.000).治疗组治疗后BUT长于对照组,差异有统计学意义(t=7.349,P=0.000).(2)SⅠT:治疗前后比较,2组治疗后SⅠT均较治疗前延长,差异均有统计学意义(t治疗组=46.149、t对照组=42.726,均P=0.000).治疗组治疗后SⅠT长于对照组,差异有统计学意义(t=7.078,P=0.000).(3)FL:治疗前后比较,2组治疗后FL均较治疗前降低,差异均有统计学意义(t治疗组=50.398、t对照组=42.955,均P=0.000).治疗组治疗后FL低于对照组,差异有统计学意义(t=8.688,P=0.000).(4)泪液炎症因子:治疗前后比较,2组治疗后IL-1β、IL-6及MMP-9水平均较治疗前降低,差异均有统计学意义(IL-1β:t治疗组=71.214、t对照组=51.982,均 P=0.000;IL-6:t治疗组=83.398、t对照组=70.133,均 P=0.000;MMP-9:t治疗组=673.908、t对照组=623.730,均P=0.000).治疗组治疗后IL-1β、IL-6及MMP-9均低于对照组,差异均有统计学意义(tIL-1β=10.708、tIL-6=9.689、tMMP-9=9.155,均P=0.000).(5)中医证候积分:治疗前后比较,2组治疗后中医证候积分均较治疗前降低,差异均有统计学意义(t治疗组=54.729、t对照组=46.822,均P=0.000).治疗组治疗后中医证候积分低于对照组,差异有统计学意义(t=11.622,P=0.000).(6)临床疗效:治疗组总有效率为92.71%,高于对照组的82.29%,差异有统计学意义(χ2=4.762,P=0.029).(7)不良反应:2组不良反应比较,差异无统计学意义(P>0.05).结论 对ATD患者实施疏肝养血润目针灸法联合人工泪液治疗,可有效缓解症状,明显改善FL等泪膜稳定性指标,且安全性高.
Abstract
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.