消朦灵片联合激光治疗糖尿病性视网膜黄斑水肿的临床研究
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摘要
研究目的:评价消朦灵片联合全视网膜激光光凝术(PRP)治疗糖尿病性黄斑水肿(气阴两虚、目络瘀阻型)的疗效,观察消朦灵片对全视网膜激光光凝术后的DME患者视力、黄斑水肿以及气阴两虚、目络瘀阻证候改善的影响。
方法:采用前瞻性随机、对照试验,对2006年12月—2007年12月期间在我院就诊的糖尿病视网膜病变(Ⅲ～Ⅴ期)黄斑水肿患眼(气阴两虚、目络瘀阻型)46眼(30例)进行研究。将上述纳入病例随机分为2组,其中对照组22眼(15例),观察组24眼(15例)。对上述纳入患者的患眼均行全视网膜激光光凝术治疗,观察组在行全视网膜激光光凝术后口服中药制剂消朦灵片(主要由党参、蒺藜、密蒙花、五味子等组成),疗程为12周,治疗后行眼底镜、FFA、黄斑部OCT、视力等专科检查,以视力、黄斑水肿程度以及中医证候改变为疗效评价指标。随访期间,记录治疗1周、4周时患者视力变化情况。
结果:两组比较:治疗1周后观察组视力改善的总有效率为91.3%,对照组总有效率为88.89%,P＞0.05,2组1周后视力改善疗效相当,差异无统计学意义;4周后观察组视力改善总有效率为86.95%,对照组总有效率为72.22%,P＞0.05,2组4周后视力改善疗效相当,差异无统计学意义;12周后观察组视力改善总有效率为86.95%,对照组总有效率为66.67%,两组比较P＜0.05,观察组优于对照组,差异有统计学意义;12周后观察组黄斑水肿改善的有效率为91.3%,对照组的有效率为38.89%,两组比较P＜0.05,观察组优于对照组,差异有统计学意义。12周后对照组与观察组对黄斑区渗出、出血、微血管瘤疗效的总有效率分别为55.56%和91.3%,对中医证候疗效的总有效率分别为26.67%和86.67%,观察组疗效优于对照组,P＜0.05,差异有统计学意义。各组组内治疗前后比较:对照组治疗前平均视力为0.38±0.06,治疗1周后平均视力为0.46±0.07,P＜0.05,1周后视力较治疗前提高,差异有统计学意义;治疗4周后平均视力为0.37±0.06,P＞0.05,4周后视力与治疗前相当,差异无统计学意义;治疗12周后平均视力为0.36±0.06,P＞0.05,12周后视力与治疗前相当,差异无统计学意义;对照组治疗前黄斑中心凹OCT平均值为250.55±18.16(um),治疗后OCT平均值为260.83±16.41(um),治疗前后比较P＞0.05,差异无统计学意义。观察组治疗前平均视力为0.29±0.05,治疗1周、4周、12周后平均视力分别为0.39±0.06,0.36±0.05,0.35±0.05,均较治疗前提高(P＜0.05),差异有统计学意义;治疗前平均OCT值为330.70±45.20(um),治疗12周后平均OCT值为275.13±30.75(um),P＜0.05,治疗后黄斑水肿改善,差异有统计学意义。两组病例不同程度黄斑水肿治疗后疗效比较:轻、中、重度黄斑水肿在视力改善方面的总有效率分别为83.33%、78.95%、60%,两两比较,P＞0.05,差异无统计学意义。轻、中、重度黄斑水肿在水肿程度改善方面的总有效率分别为66.67%、57.89%、50%,两两比较,P＞0.05,差异无统计学意义。
结论:治疗12周后,观察组对改善视力、黄斑水肿程度以及气阴两虚、目络瘀阻中医证候的疗效优于对照组,P＜0.05,差异有统计学意义。在改善黄斑区渗出、出血、微血管瘤方面的疗效优于对照组,P＜0.05,差异有统计学意义。单纯全视网膜激光光凝术治疗DR(Ⅲ～Ⅴ期)黄斑水肿效果不明显。消朦灵片联合全视网膜光凝术能够改善DME(气阴两虚、目络瘀阻证)患眼的视力、黄斑水肿的程度,可缩短全视网膜激光光凝术后的DME(气阴两虚、目络瘀阻证)患眼视力改善、黄斑水肿消退的时间,可以改善患者气阴两虚、目络瘀阻的中医证候。2组治疗12周后,视力以及黄斑水肿程度改善的疗效随着黄斑水肿程度的加重而呈下降趋势,故对DME患者应尽量早期治疗,以提高疗效。
Objective:To observe the clinical efect of the union of laser therapy and Chinese TraditionaI Medicine(xiao meng ling tables)to treat diabetic macuIar edema.
Methods:According to the fundus fluorescein angiography and optical coherence tomography,we chose 30 patients,46 eyes with diabetic(Ⅲ～Ⅴ)macular edema(Qi-yin deficiency and stasis blocking eye collaterals ),and randomly divided them into the observation group and control group.Both of these two groups received the treatment of panretinal photocoagulation(PRP).After that,the observation group was given the Chinese Traditional Medicine treatment,taking orally xiaomengling tables.Twelve weeks for a course.The effectiveness indexes were the vision、the thicness of the macular central fovea and the symptom of TCM.Meanwhile we record the vision of one-week and four-weeks during the follow up pariod.
Results:The total effectiveness of the vision enhancement of the observation group for one-week and four-weeks was respectively 91.3%and 86.95%,while the control group was respectively 88.89%and 72.22%.The difference of the two group was not statistically significant.Twelve weeks later,the total effectiveness of the vision enhancement and macular edema improvement of the observation group were 86.95%and 96.65%,while the control group were 66.67%and 38.89%.The difference of them was statistically significant.The total effect of TCM symptom and diabetic microangiopathy of the observation group was respectively 86.67%and 91.3%,while the control group was respectively 26.67%and 55.56%.The difference of them was statistically significant.The results of therapy effect of pre and post treatment for every groups:(1)control group:The average visual acuity pre treatment was 0.38±0.06.One-week、four-weeks and twelve-weeks later it was respectively 0.46±0.07(P＜0.05)、0.37±0.06(P＞0.05)and 0.36±0.06(P＞0.05).The results suggest that the difference of average visual acuity was statistically significant in a week,but was not statistically significant in four-weeks and twelve-weeks. The mean thicness of macular fovea detected by OCT pre and post treatment were 250.55±18.16(um)and 260.83±16.41(um),P＞0.05,so the difference was not statistically significant.(2)observation group:The average visual acuity pre treatment was 0.29±0.05.One-week、four-weeks and twelve-weeks later it was respectively 0.39±0.06(P＜0.05),0.36±0.05(P＜0.05)and 0.35±0.05(P＜0.05).The results suggest that the difference of average visual acuity was statistically significant in one-week、four-weeks and twelve-weeks.The mean thicness of macular fovea detected by OCT pre and post treatment were 330.70±45.20(um)and 275.13±30.75(um)(P＜0.05),so the difference was statistically significant.(3)The therapy effect for different classification macular edama:The total effectiveness of the vision enhancement for mild、moderate and severe macular edama was respectively 83.33%、78.95%and 60%(P＞0.05). The total effective rate on the improvement of macular edema for that three different classification macular edama was respectively 66.67%、57.89%、50%(P＞0.05).
Conclusions:The effect of the union of panretinal photocoagulation(PRP) and Chinese Traditional Medicine(Xiaomengling tablets)to treat diabetic macular edema is better than the treatment of panretinal photocoagulation,the difference was statistically significant.The union of PRP and Xiaomengling tablets can improve the vision、the diabetic microangiopathy、the degree of the macular edema and the symptom of TCM,can shorten the time of vision enhancement and macular edema retrogression.The effect of different degree of macular edema is decreasing whith increasing of the severity of the macular edema,It suggest that early treatment can improve the curative effect of DME.
方法:采用前瞻性随机、对照试验,对2006年12月—2007年12月期间在我院就诊的糖尿病视网膜病变(Ⅲ～Ⅴ期)黄斑水肿患眼(气阴两虚、目络瘀阻型)46眼(30例)进行研究。将上述纳入病例随机分为2组,其中对照组22眼(15例),观察组24眼(15例)。对上述纳入患者的患眼均行全视网膜激光光凝术治疗,观察组在行全视网膜激光光凝术后口服中药制剂消朦灵片(主要由党参、蒺藜、密蒙花、五味子等组成),疗程为12周,治疗后行眼底镜、FFA、黄斑部OCT、视力等专科检查,以视力、黄斑水肿程度以及中医证候改变为疗效评价指标。随访期间,记录治疗1周、4周时患者视力变化情况。
结果:两组比较:治疗1周后观察组视力改善的总有效率为91.3%,对照组总有效率为88.89%,P＞0.05,2组1周后视力改善疗效相当,差异无统计学意义;4周后观察组视力改善总有效率为86.95%,对照组总有效率为72.22%,P＞0.05,2组4周后视力改善疗效相当,差异无统计学意义;12周后观察组视力改善总有效率为86.95%,对照组总有效率为66.67%,两组比较P＜0.05,观察组优于对照组,差异有统计学意义;12周后观察组黄斑水肿改善的有效率为91.3%,对照组的有效率为38.89%,两组比较P＜0.05,观察组优于对照组,差异有统计学意义。12周后对照组与观察组对黄斑区渗出、出血、微血管瘤疗效的总有效率分别为55.56%和91.3%,对中医证候疗效的总有效率分别为26.67%和86.67%,观察组疗效优于对照组,P＜0.05,差异有统计学意义。各组组内治疗前后比较:对照组治疗前平均视力为0.38±0.06,治疗1周后平均视力为0.46±0.07,P＜0.05,1周后视力较治疗前提高,差异有统计学意义;治疗4周后平均视力为0.37±0.06,P＞0.05,4周后视力与治疗前相当,差异无统计学意义;治疗12周后平均视力为0.36±0.06,P＞0.05,12周后视力与治疗前相当,差异无统计学意义;对照组治疗前黄斑中心凹OCT平均值为250.55±18.16(um),治疗后OCT平均值为260.83±16.41(um),治疗前后比较P＞0.05,差异无统计学意义。观察组治疗前平均视力为0.29±0.05,治疗1周、4周、12周后平均视力分别为0.39±0.06,0.36±0.05,0.35±0.05,均较治疗前提高(P＜0.05),差异有统计学意义;治疗前平均OCT值为330.70±45.20(um),治疗12周后平均OCT值为275.13±30.75(um),P＜0.05,治疗后黄斑水肿改善,差异有统计学意义。两组病例不同程度黄斑水肿治疗后疗效比较:轻、中、重度黄斑水肿在视力改善方面的总有效率分别为83.33%、78.95%、60%,两两比较,P＞0.05,差异无统计学意义。轻、中、重度黄斑水肿在水肿程度改善方面的总有效率分别为66.67%、57.89%、50%,两两比较,P＞0.05,差异无统计学意义。
结论:治疗12周后,观察组对改善视力、黄斑水肿程度以及气阴两虚、目络瘀阻中医证候的疗效优于对照组,P＜0.05,差异有统计学意义。在改善黄斑区渗出、出血、微血管瘤方面的疗效优于对照组,P＜0.05,差异有统计学意义。单纯全视网膜激光光凝术治疗DR(Ⅲ～Ⅴ期)黄斑水肿效果不明显。消朦灵片联合全视网膜光凝术能够改善DME(气阴两虚、目络瘀阻证)患眼的视力、黄斑水肿的程度,可缩短全视网膜激光光凝术后的DME(气阴两虚、目络瘀阻证)患眼视力改善、黄斑水肿消退的时间,可以改善患者气阴两虚、目络瘀阻的中医证候。2组治疗12周后,视力以及黄斑水肿程度改善的疗效随着黄斑水肿程度的加重而呈下降趋势,故对DME患者应尽量早期治疗,以提高疗效。
Objective:To observe the clinical efect of the union of laser therapy and Chinese TraditionaI Medicine(xiao meng ling tables)to treat diabetic macuIar edema.
Methods:According to the fundus fluorescein angiography and optical coherence tomography,we chose 30 patients,46 eyes with diabetic(Ⅲ～Ⅴ)macular edema(Qi-yin deficiency and stasis blocking eye collaterals ),and randomly divided them into the observation group and control group.Both of these two groups received the treatment of panretinal photocoagulation(PRP).After that,the observation group was given the Chinese Traditional Medicine treatment,taking orally xiaomengling tables.Twelve weeks for a course.The effectiveness indexes were the vision、the thicness of the macular central fovea and the symptom of TCM.Meanwhile we record the vision of one-week and four-weeks during the follow up pariod.
Results:The total effectiveness of the vision enhancement of the observation group for one-week and four-weeks was respectively 91.3%and 86.95%,while the control group was respectively 88.89%and 72.22%.The difference of the two group was not statistically significant.Twelve weeks later,the total effectiveness of the vision enhancement and macular edema improvement of the observation group were 86.95%and 96.65%,while the control group were 66.67%and 38.89%.The difference of them was statistically significant.The total effect of TCM symptom and diabetic microangiopathy of the observation group was respectively 86.67%and 91.3%,while the control group was respectively 26.67%and 55.56%.The difference of them was statistically significant.The results of therapy effect of pre and post treatment for every groups:(1)control group:The average visual acuity pre treatment was 0.38±0.06.One-week、four-weeks and twelve-weeks later it was respectively 0.46±0.07(P＜0.05)、0.37±0.06(P＞0.05)and 0.36±0.06(P＞0.05).The results suggest that the difference of average visual acuity was statistically significant in a week,but was not statistically significant in four-weeks and twelve-weeks. The mean thicness of macular fovea detected by OCT pre and post treatment were 250.55±18.16(um)and 260.83±16.41(um),P＞0.05,so the difference was not statistically significant.(2)observation group:The average visual acuity pre treatment was 0.29±0.05.One-week、four-weeks and twelve-weeks later it was respectively 0.39±0.06(P＜0.05),0.36±0.05(P＜0.05)and 0.35±0.05(P＜0.05).The results suggest that the difference of average visual acuity was statistically significant in one-week、four-weeks and twelve-weeks.The mean thicness of macular fovea detected by OCT pre and post treatment were 330.70±45.20(um)and 275.13±30.75(um)(P＜0.05),so the difference was statistically significant.(3)The therapy effect for different classification macular edama:The total effectiveness of the vision enhancement for mild、moderate and severe macular edama was respectively 83.33%、78.95%and 60%(P＞0.05). The total effective rate on the improvement of macular edema for that three different classification macular edama was respectively 66.67%、57.89%、50%(P＞0.05).
Conclusions:The effect of the union of panretinal photocoagulation(PRP) and Chinese Traditional Medicine(Xiaomengling tablets)to treat diabetic macular edema is better than the treatment of panretinal photocoagulation,the difference was statistically significant.The union of PRP and Xiaomengling tablets can improve the vision、the diabetic microangiopathy、the degree of the macular edema and the symptom of TCM,can shorten the time of vision enhancement and macular edema retrogression.The effect of different degree of macular edema is decreasing whith increasing of the severity of the macular edema,It suggest that early treatment can improve the curative effect of DME.
引文
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