静阻一号方治疗视网膜静脉阻塞痰瘀阻络证的临床观察

发布时间：2018-05-07 16:05

本文选题：祛瘀化痰法 + 视网膜静脉阻塞　；参考：《中国中医科学院》2016年硕士论文

【摘要】：目的：科学、规范地评价静阻一号方(祛痰化瘀法)对于视网膜静脉阻塞(痰瘀阻络证)的有效性及安全性。方法：本课题采用随机、对照试验设计,按拟定的纳入和排除标准纳入视网膜静脉阻塞(RVO)患者,按照简单随机化方法随机分为试验组和对照组。对照组仅采用基础治疗,试验组在常规基础治疗上联合祛瘀化痰中药静阻一号方为治疗措施。治疗12周,观察两组患者治疗前后的视力、眼底出血情况、中医证候学变化,结合荧光素眼底血管造影(FFA)、眼底光学相干断层扫描(OCT)结果进行疗效评价。同时检测安全性指标包括生命体征、血尿便常规、肝肾功能、心电图,以进行药物安全性评价。结果：本研究共纳入77例符合纳排标准的RVO患者,因失访脱落10例。纳入统计的67例患者中试验组32例,对照组35例。两组患者性别、年龄、RVO分型等基线资料经统计学分析无显著性差异(P0.05),具有可比性。1.两组患者视力比较：试验组治愈21.88%(7/32),显效31.25%(10/32),有效25.00%(8/32),对照组治愈11.43%(4/35),显效8.57%(3/35),有效14.29%(5/35),组间比较P=0.001,差异有统计学意义。治疗后视力总有效率,试验组为78.12%(25/32),对照组为34.29%(12/35)。在4周、8周、12周时视力提高者试验组占59.38%(19/32)、87.50%(28/32)、81.25%(26/32)；对照组为31.43%(11/35)、48.57%(17/35)、57.14%(20/35)。在各个时间段,组间视力改善情况试验组优于对照组,差异有统计学意义(P0.05)。2.两组患者眼底出血面积比较：治疗前两组患者均存在眼底出血,出血面积≤10PD、10-20PD、20PD的患者,试验组分别为31.25%(10/32)、37.50%(12/32)、31.25%(10/32),对照组分别为51.43%(18/35)、34.29%(12/35)、14.29%(5/35),治疗前组间比较P=0.054,差异无统计学意义。治疗12周后试验组和对照组各有1例患者眼底出血全部吸收。治疗后眼底出血面积≤10PD、10-20PD、20PD的患者,试验组分别为75.00%(24/32)、18.75%(6/32)、3.13%(1/32),对照组分别为71.43%(25/35)、8.57%(3/35)、17.14%(6/35)。在治疗第12周时试验组、对照组出血面积较治疗前均明显减少,组内比较有统计学差异(试验组P0.001,对照组P=0.033)；组间比较无统计学差异(P=0.535)。3.两组患者视网膜循环时间比较：治疗前试验组和对照组视网膜循环时间分别为15.5(7)s、17(10)s,治疗后分别为14(7)s、13(5)s。两组患者治疗前后组间比较无统计学差异(治疗前P=0.338、治疗后P=0.431),治疗前后组内比较有统计学意义(试验组P=0.025、对照组P0.001)。4.两组患者黄斑水肿情况比较：治疗前后均无黄斑水肿者14例,试验组9例,对照组5例；治疗前无黄斑水肿,治疗后出现黄斑水肿者9例,试验组2例,对照组7例；治疗前有黄斑水肿,治疗后无黄斑水肿者16例,试验组5例,对照组11例。统计分析治疗前存在黄斑水肿的44例患者黄斑中心区视网膜厚度(CRT)情况,治疗前试验组和对照组CRT分别为449.43±132.83um.481.52±133.12um,治疗后CRT分别为341(232)um.302(175)um.治疗前后试验组组内比较无统计学差异(P=0.322),对照组组内比较有统计学差异(P0.05)；治疗前后两组患者组间CRT比较无明显统计学差异(P0.05)。5.新生血管评价：67例RVO患者治疗过程中对照组有1例BRVO患者发生新生血管,治疗结束后随访时行激光光凝治疗,其余患者治疗期间未见新生血管。6.两组患者中医证候比较：在4周、8周、12周时中医证候总有效率试验组为21.88%(7/32)、68.75%(22/32)、93.75%(30/32)；对照组为5.71%(2/35)、22.86%(8/35)、28.57%(10/35)。在治疗第8、12周时中医证候总有效率组间对比差异有统计学意义(8周P0.001,12周P0.0001)7.两组患者在用药过程中均未发生任何不良反应,治疗前后安全性化验指标无明显异常。结论：1.联合静阻一号方治疗RVO能有效的改善患者视力、促进眼底出血的吸收,并且在治疗周期内疗效与时间成正比。2.联合静阻一号方可以改善RVO视网膜循环时间,但治疗效果与基础治疗相比,无统计学意义：3.静阻一号方能明确改善痰瘀阻络证RVO患者的中医证候;4.静阻一号方在服用过程中未出现任何不良反应及不良事件,安全可靠。
[Abstract]:Objective : To evaluate the efficacy and safety of static resistance 1 prescription ( sputum removal and stasis removing method ) in the treatment of retinal vein occlusion ( RVO ) .
There was no significant difference between the two groups ( P = 0.054 , P = 0.054 , P = 0.054 , P = 0.054 ) .
The retinal circulation time of the two groups was 15.5 ( 7 ) s , 17 ( 10 ) s after treatment and 14 ( 7 ) s , 13 ( 5 ) s after treatment . There was no significant difference between the two groups ( P = 0.025 , P = 0.431 ) .
There were no macular edema before treatment , 9 cases with macular edema after treatment , 2 in trial group and 7 in control group .
There were 16 patients with macular edema after treatment , 5 in the experimental group and 11 in the control group . The CRT in 44 patients with macular edema before treatment was 449.43 卤 132.83um and 482.52 卤 133.12um , respectively . There was no statistical difference in the test group before and after treatment ( P = 0.322 ) .
There was no significant difference in CRT between the two groups before and after treatment ( P0.05 ) . In 67 patients with RVO treated , 1 case of BRVO was treated with laser photocoagulation , while the rest of the patients were treated with laser photocoagulation during the follow - up period . The total effective rate of TCM syndrome was 21.88 % ( 7 / 32 ) , 68.75 % ( 22 / 32 ) and 93.75 % ( 30 / 32 ) at 4 weeks , 8 weeks and 12 weeks .
Conclusion : 1 . The combination of the first prescription can improve the visual acuity of the patients and promote the absorption of fundus hemorrhage . Conclusion : 1 . The combination of the first prescription can improve the RVO retinal circulation time , but the effect is not significant compared with the basic therapy .

【学位授予单位】：中国中医科学院
【学位级别】：硕士
【学位授予年份】：2016
【分类号】：R276.7

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