Abstract:

Objective　To investigate the effects of acupuncture using the Tongyang Kaiqiao method combined with Tongluo Mingmu decoction on visual function and microvascular parameters in the macular region after laser surgery for diabetic retinopathy. Methods　A total of 172 patients who underwent laser surgery for diabetic retinopathy at Jinan Second People's Hospital from January 2022 to May 2024 were selected for a prospective randomized controlled trial, divided into four groups using a random number table. The control group comprised 20 males and 23 females, with an average age of (65.77±8.10) years and a diabetes duration of (10.07±2.15) years, involving 78 affected eyes. Group A consisted of 22 males and 21 females, with an average age of (66.05±8.26) years and a diabetes duration of (10.12±2.10) years, involving 76 affected eyes. Group B included 21 males and 22 females, with an average age of (65.53±8.07) years and a diabetes duration of (10.16±2.08) years, involving 75 affected eyes. Group C comprised 19 males and 24 females, with an average age of (65.44±8.12) years and a diabetes duration of (10.21±2.18) years, involving 76 affected eyes. The control group received basic supportive treatment, while Group A received acupuncture using the Tongyang Kaiqiao method plus basic supportive treatment, Group B received Tongluo Mingmu decoction plus basic supportive treatment, and Group C received acupuncture using the Tongyang Kaiqiao method plus Tongluo Mingmu decoction plus basic supportive treatment. All groups were treated for 2 weeks. The changes in Traditional Chinese Medicine (TCM) symptom scores, visual function, and microvascular parameters in the macular region before and after treatment were compared, along with adverse reactions. Statistical analysis was performed using One-way ANOVA and χ² tests. Results　After 2 weeks of treatment, the main symptom scores, secondary symptom scores, total scores, retinal neovascularization (RNV) leakage area, and central macular thickness (CMT) in Group C were lower than those in Groups A, B, and the control group [(3.15±0.75) points vs. (5.12±1.01) points, (5.02±1.00) points, (7.35±1.20) points; (2.24±0.41) points vs. (3.45±0.71) points, (3.26±0.68) points, (4.09±0.81) points; (5.39±1.05)points vs. (8.57±1.75) points, (8.29±1.69) points, (10.95±2.01) points; (221.04±19.60) mm² vs. (261.20±21.32) mm², (259.74±20.53) mm², (281.75±25.66) mm²; (422.17±35.88) µm vs. (455.86±37.64) µm, (451.33±38.76) µm, (474.82±39.41) µm], with statistically significant differences (all P<0.05). Groups A and B also had lower scores compared to the control group, with significant differences (all P<0.05). The best corrected visual acuity (BCVA) and deep capillary plexus blood flow density (DCP-BD) in Group C were higher than those in Groups A, B, and the control group [(0.78±0.14)° vs. (0.62±0.11)°, (0.64±0.12)°, (0.55±0.10)°; (45.07±2.04)% vs. (43.10±2.05)%, (43.12±2.07)%, (41.03±2.01)%], with significant differences (all P<0.05). The incidence of adverse reactions in the control, A, B, and C groups was 4.65% (2/43), 9.52% (4/42), 11.90% (5/42), and 14.63% (6/41), respectively, with no statistically significant difference (corrected χ²=0.448, P=0.569). Conclusion　Both acupuncture using the Tongyang Kaiqiao method and Tongluo Mingmu decoction can alleviate symptoms after laser surgery for diabetic retinopathy, improve visual function, and enhance DCP-BD in the macular region. Their combined application yields even better results and is safe and reliable.

Key words: Acupuncture,  , Tongluo Mingmu , decoction,  , Diabetes retinopathy,  , Laser technology,  , Visual function,  , Microvasculature in macular area

摘要：

目的　探讨通阳开窍法针刺联合通络明目汤对糖尿病视网膜病变激光术后视功能、黄斑区微血管的影响。方法　选取济南市第二人民医院2022年1月至2024年5月收治的糖尿病视网膜病变激光术后患者共172例开展前瞻性随机对照试验，根据随机数字表法分为4组，各43例。对照组男20例、女23例，年龄（65.77±8.10）岁，糖尿病病程（10.07±2.15）年，患眼78只；A组男22例、女21例，年龄（66.05±8.26）岁，糖尿病病程（10.12±2.10）年，患眼76只；B组男21例、女22例，年龄（65.53±8.07）岁，糖尿病病程（10.16±2.08）年，患眼75只；C组男19例、女24例，年龄（65.44±8.12）岁，糖尿病病程（10.21±2.18）年，患眼76只。对照组予以基础支持治疗，A组予以通阳开窍法针刺+基础支持治疗，B组予以通络明目汤+基础支持治疗，C组予以通阳开窍法针刺+通络明目汤+基础支持治疗。4组均治疗2周。比较各组治疗前后中医症状评分、视功能、黄斑区微血管参数变化及不良反应。采用One-way ANOVA检验、χ2检验对数据进行统计学分析。结果　治疗2周后，C组中医症状评分的主症评分、次症评分、总分以及视网膜新生血管（RNV）渗漏面积、黄斑中心凹厚度（CMT）均低于A、B、对照组［（3.15±0.75）分比（5.12±1.01）分、（5.02±1.00）分、（7.35±1.20）分；（2.24±0.41）分比（3.45±0.71）分、（3.26±0.68）分、（4.09±0.81）分；（5.39±1.05）分比（8.57±1.75）分、（8.29±1.69）分、（10.95±2.01）分；（221.04±19.60）mm2比（261.20±21.32）mm2、（259.74±20.53）mm2、（281.75±25.66）mm2；（422.17±35.88）µm比（455.86±37.64）µm、（451.33±38.76）µm、（474.82±39.41）µm］，A、B组均低于对照组，差异均有统计学意义（均P<0.05）；C组的最佳矫正视力（BCVA）、深层毛细血管丛血流密度（DCP-BD）均高于A、B、对照组［（0.78±0.14）°比（0.62±0.11）°、（0.64±0.12）°、（0.55±0.10）°；（45.07±2.04）%比（43.10±2.05）%、（43.12±2.07）%、（41.03±2.01）%］，A、B组均高于对照组，差异均有统计学意义（均P<0.05）。对照组、A、B、C组不良反应发生率分别为4.65%（2/43）、9.52%（4/42）、11.90%（5/42）、14.63%（6/41）］，差异无统计学意义（校正χ2=0.448，P=0.569）。结论　通阳开窍法针刺、通络明目汤均可减轻糖尿病视网膜病变激光术后患者的临床症状，并改善视功能和黄斑区DCP-BD，二者联合治疗效果更理想，且安全可靠。

关键词: 针刺, 通络明目汤, 糖尿病视网膜病变, 激光术, 视功能, 黄斑区微血管