Clinical Efficacy of Erdong Xiaoke Formula in Treating Type 2 Diabetes Dry Eyes with Yin Deficiency and Heat Excess Syndrome and Its Influence on Serum IL-17 and IL-1β
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摘要:
目的 观察二冬消渴方治疗阴虚热盛型2型糖尿病性干眼的临床疗效及对血清白细胞介素-17(IL-17)、白细胞介素-1β(IL-1β)的影响, 探讨二冬消渴方疗效机制。 方法 纳入江苏省中医院阴虚热盛证2型糖尿病性干眼患者110例, 随机分为治疗组及对照组各55例, 治疗组脱落5例, 对照组脱落4例。对照组予基本降糖方案联合玻璃酸钠滴眼液外用治疗, 治疗组在对照组治疗基础上加服二冬消渴方, 2组疗程均为4周。治疗前后观察2组患者中医证候积分变化情况并评估中医临床疗效, 检测血糖及胰岛功能相关指标[空腹血糖(FBG)、空腹胰岛素(FINS)、空腹C肽(FCP)、餐后2 h血糖(PBG)、胰岛素分泌功能指数(HOMA-β)、胰岛素抵抗指数(HOMA-IR)]、眼表指标[泪膜破裂时间(BUT)、角膜荧光素钠染色(FL)、Schirmer Ⅰ试验(SⅠT)]及炎症相关指标(IL-17、IL-1β)的变化情况, 治疗期间观察2组患者不良反应发生情况。 结果 治疗后, 2组患者中医证候总积分均明显减少(P < 0.01), 治疗组优于对照组(P < 0.01), 治疗组中医临床总有效率高于对照组(P < 0.01);2组患者SⅠT和BUT均明显增加(P < 0.01), 治疗组优于对照组(P < 0.05, P < 0.01);2组患者FL均显著降低(P < 0.01), 组间无显著差异; 治疗组患者血清IL-17、IL-1β均显著下降(P < 0.01), 明显优于对照组(P < 0.05)。治疗前后2组患者血糖及胰岛功能相关指标未见明显变化(P>0.05)。治疗期间, 2组患者均未见明显不良反应。 结论 二冬消渴方可改善糖尿病性干眼患者SⅠT、BUT、FL及眼部症状, 有效治疗糖尿病干眼, 减轻眼表炎症, 其机制可能与降低血清炎症因子IL-17、IL-1β有关。 Abstract:OBJECTIVE To observe the clinical efficacy of Erdong Xiaoke Formula in the treatment of type 2 diabetes dry eyes with yin deficiency and heat excess syndrome and its effect on serum interleukin 17 (IL-17) and interleukin 1β (IL-1β), and to explore the therapeutic mechanism of Erdong Xiaoke Formula. METHODS 110 cases of type 2 diabetes patients with dry eyes of yin deficiency and heat excess syndrome from Jiangsu Province Hospital of Chinese Medicine were enrolled and randomly divided into a treatment group and a control group, 55 cases each. 5 cases dropped out of the treatment group and 4 cases dropped out of the control group. The control group was given a basic hypoglycemic regimen combined with topical sodium hyaluronate eye drops. The treatment group was given Erdong Xiaoke Formula in addition to the treatment in the control group. The treatment course for both groups was 4 weeks. Changes in TCM syndrome scores of the two groups of patients were observed before and after treatment, and the clinical efficacy of TCM was evaluated. Blood glucose and pancreatic islet function-related indicators [fasting blood glucose (FBG), fasting insulin (FINS), fasting C-peptide (FCP), postprandial 2 h blood glucose (PBG), insulin secretion function index (HOMA-β), insulin resistance index (HOMA)-IR)], ocular surface indicators [tear break up time (BUT), corneal sodium fluorescein staining (FL), Schirmer Ⅰ test (SⅠT)], and inflammation-related indicators (IL-17, IL-1β) were detected. The occurrence of adverse reactions in the two groups of patients was observed during the treatment period. RESULTS After treatment, the total scores of TCM syndromes in both groups were significantly reduced (P < 0.01), the treatment group was better than the control group (P < 0.01), and the total effective rate of TCM syndromes in the treatment group was higher than that of the control group (P < 0.01); SⅠT and BUT of patients in both groups increased significantly (P < 0.01), and the treatment group was better than the control group (P < 0.05, P < 0.01); the FL of patients in both groups significantly reduced (P < 0.01), and there was no significant difference between the groups; the serum IL-17 and IL-1β of the patients in the treatment group decreased significantly (P < 0.01), which was significantly better than that of the control group (P < 0.05). There were no significant changes in blood glucose and pancreatic islet function-related indicators in the two groups before and after treatment (P>0.05). During the treatment, no obvious adverse reactions were observed in the two groups. CONCLUSION Erdong Xiaoke Formula can improve SⅠT, BUT, FL and eye symptoms in patients with diabetic dry eye, effectively treat diabetic dry eye, and reduce ocular surface inflammation. Its mechanism may be related to reducing serum inflammatory factors IL-17 and IL-1β. -
Key words:
- dry eye /
- diabetes /
- Erdong Xiaoke Formula /
- inflammation /
- IL-17 /
- IL-1β
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表 1 2组患者基本资料比较
Table 1. Comparison of basic information between the two groups of patients
组别 性别 年龄/岁 病程/a BMI/(kg·m-2) 男 女 治疗组 33 17 60.76±9.98 10.64±6.80 24.21±3.39 对照组 35 16 59.75±10.81 11.86±7.42 23.40±2.11 
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表 2 阴虚热盛证主症评分标准
Table 2. Scoring criteria for main symptoms of yin deficiency and heat excess
项目 0分 2分 4分 6分 眼球干涩 无 偶有干涩 常有干涩不爽 干涩难忍, 反复发作 白睛微红 无 白睛淡红 白睛深红 白睛红赤肿胀 灼热 无 偶有轻微烧灼感 烧灼感次数频繁, 欲闭眼 每日出现, 发作时如有辣物在眼, 无法睁眼 磨痛 无 轻微疼痛 明显疼痛 疼痛难忍 眼痒 无 微痒 痒时用手揉眼 痒极难忍 视物模糊 无 轻度视物模糊 中度视物模糊 严重视物模糊
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表 3 阴虚热盛证次症评分标准
Table 3. Scoring criteria for secondary symptoms of yin deficiency and heat excess
项目 0分 1分 2分 3分 口咽干燥 无 口微干 口干饮水 口渴思饮 失眠 无 睡眠稍有减少 时见失眠 难以入睡 心烦 无 夜间手足心微热 手足心灼热心烦 五心烦热，不欲衣被 潮热盗汗 无 偶尔潮热盗汗 经常潮热盗汗 持续潮热盗汗 大便干结 无 大便干, 每日1行 大便秘结, 2~3日1行 大便艰难, 3日以上1行 小便短黄 无 小便微黄 小便黄 小便黄赤
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表 4 2组患者治疗前后中医证候积分比较(x±s)
Table 4. Comparison of TCM syndrome scores between the two groups of patients before and after treatment (x±s)
组别 例数 时间 眼球干涩 白睛微红 灼热 磨痛 眼痒 视物模糊 治疗组 50 治疗前 1.80±1.28 1.00±1.08 1.00±1.08 0.76±1.19 1.08±1.21 1.84±1.43 50 治疗后 0.20±0.60**## 0.04±0.28**## 0.08±0.39**## 0.20±0.60** 0.24±0.76** 0.28±0.69** 对照组 51 治疗前 2.00±1.55 1.10±1.35 1.06±1.35 0.63±1.09 0.98±1.22 1.45±1.38 51 治疗后 0.98±1.09** 0.63±0.94** 0.67±0.95** 0.35±0.77** 0.51±1.88** 0.55±0.90** 组别 例数 时间 口咽干燥 失眠 心烦 潮热盗汗 大便干结 小便短黄 总积分 治疗组 50 治疗前 1.34±0.84 1.30±0.98 1.14±0.87 0.98±0.79 1.02±0.67 0.72±0.80 13.98±5.20 50 治疗后 0.44±0.57**## 0.48±0.64**## 0.32±0.55**## 0.30±0.50**## 0.24±0.43**## 0.24±0.47**## 3.06±2.46**## 对照组 51 治疗前 1.24±0.95 1.31±1.03 1.14±1.00 0.90±0.85 1.10±1.08 0.65±0.72 13.55±5.39 51 治疗后 1.00±0.77** 1.22±0.90 1.00±0.94** 0.76±0.76* 1.00±0.98 0.65±0.74 9.31±3.98** 注: 组内比较, *P < 0.05, * *P < 0.01;组间比较, ##P < 0.01。
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表 5 2组患者中医临床疗效比较
Table 5. Comparison of TCM syndrome efficacy between the two groups
组别 例数 治愈 显效 有效 无效 总有效率/% 治疗组 50 13 25 12 0 100.00## 对照组 51 0 0 26 25 50.98 注: 组间比较, χ2=32.572, ##P < 0.01。
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表 6 2组患者治疗前后眼表指标比较(x±s)
Table 6. Comparison of ocular surface examination indexes between the two groups of patients before and after treatment (x±s)
组别 例数 时间 BUT/s FL SⅠT/mm 治疗组 50 治疗前 3.59±1.08 1.08±1.25 3.16±2.74 50 治疗后 4.73±1.34**## 0.49±0.73** 6.02±3.90**# 对照组 51 治疗前 3.72±1.03 1.03±1.56 3.54±2.75 51 治疗后 4.09±1.26** 0.58±1.05** 5.04±3.10** 注: 组内比较, * *P < 0.01;组间比较, #P < 0.05, ##P < 0.01。
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表 7 2组患者治疗前后血糖及胰岛功能比较(x±s)
Table 7. Comparison of blood glucose and pancreatic islet function between the two groups of patients before and after treatment (x±s)
组别 例数 时间 FCP/(ng·mL-1) FINS/(μU·mL-1) FBG/(mmol·L-1) PBG/(mmol·L-1) HOMA-β HOMA-IR 治疗组 50 治疗前 1.36±0.88 10.91±7.51 5.82±1.09 10.57±2.42 122.20±141.69 2.82±1.99 50 治疗后 1.37±0.87 10.59±7.29 5.98±1.13 8.44±2.29 115.16±136.96 2.75±1.83 对照组 51 治疗前 1.27±0.82 10.96±8.10 5.95±1.51 10.48±2.42 149.13±213.68 2.99±2.76 51 治疗后 1.26±0.82 10.16±6.44 6.52±1.66 9.71±3.04 107.72±138.49 2.91±2.03
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表 8 2组患者治疗前后血清炎症指标比较(x±s, pg·mL-1)
Table 8. Comparison of serum inflammatory indexes between the two groups of patients before and after treatment (x±s, pg·mL-1)
组别 例数 时间 IL-17 IL-1β 治疗组 50 治疗前 30.92±30.89 60.51±41.03 50 治疗后 14.89±13.34**# 21.98±14.35**# 对照组 51 治疗前 28.28±30.89 60.24±27.15 51 治疗后 23.72±23.71 41.71±17.83 注: 组内比较, * *P < 0.01;组间比较, #P < 0.05。
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