活血通絡顆粒對缺血性視神經病變的臨床研究

朱成義,伊瓊,馬金力,韋企平

活血通絡顆粒對缺血性視神經病變的臨床研究

朱成義1,伊瓊1,馬金力1,韋企平2

作者單位:1(100013)中國北京市和平里醫院眼科;2(100078)中國北京市,北京中醫藥大學東方醫院眼科

目的:探討活血通絡顆粒對氣虛血瘀型非動脈炎性前部缺血性視神經病變的臨床療效。

視神經病變;血流變學;活血通絡顆粒

引用:朱成義,伊瓊,馬金力,等.活血通絡顆粒對缺血性視神經病變的臨床研究.國際眼科雜志2015;15(11):1945-1948

0 引言

非動脈炎性前部缺血性視神經病變(non arteritic anterior ischemic opticneuropathy,NAION)是一種50歲以上人群中最常見的急性視神經病變,臨床上以無痛性突發視力障礙、視野缺損、視盤水腫或周圍神經纖維層出血為主要表現[1-2]。該病發病急、短期內視力急劇下降,嚴重者甚至失明[3]。目前,國內在控制原發病的基礎上,對NAION治療多采用復方樟柳堿顳淺動脈旁皮下注射,但療效尚不盡滿意。本研究結合中醫辯證思維,旨在探討復方樟柳堿治療的基礎上應用活血通絡顆粒對氣虛血瘀型NAION的臨床療效。

1 對象和方法

1.1 對象選取2014-02/10在我院眼科門診及住院的患者100例,其中雙眼發病42例,單眼發病58例,共計142眼;男性患者51例,女性患者49例。伴隨的全身疾病包括高血壓31例44眼,糖尿病27例38眼,冠狀動脈硬化29例42眼,無明顯誘因13例18眼。納入標準:符合以下診斷標準,同時自愿配合該項目治療的患者被納入為研究對象。參照Hayreh等[4]制定的NAION診斷標準:(1)突發視力下降,多在晨起時發生;(2)病史中急性期存在視盤水腫或相關的記錄;(3)存在與視盤病變相關的視野缺損;(4)排除其他可以導致視盤水腫和視力下降的神經、系統或眼部疾病。氣虛血瘀證型診斷標準[5]:視力驟降,心煩郁悶,頭目隱痛,胸脅脹滿;舌質紫暗或有瘀斑,脈弦數。采用隨機對照試驗,將100例隨機分為治療組和對照組,其中治療組51例72眼,對照組49例70眼。兩組患者的性別、年齡、病程的差異均無統計學意義(P＞0.05),見表1。

1.2 方法對照組采用復方樟柳堿注射液2mL顳淺動脈旁注射,1次/d。在上述治療的基礎上,治療組根據韋企平[5]主編的《視神經疾病中西醫結合診治》氣虛血瘀型方選活血通絡方,方藥組成:熟地15g、當歸、芍藥、川芎、雞血藤、絲瓜絡、路路通、女貞子各10g、太子參15g、紅花、炒枳殼各6g。上方由北京中醫藥大學東方醫院制劑室制成配方顆粒,每次10g,每天2次早晚飯后服用。兩組療程均為3mo。釆用國際標準對數視力表對患者的視力進行檢查;采用靜態自動電腦Octpus101型視野計檢查患者60°范圍的視野;眼底熒光血管造影(Fundus fluoresecine angiography,FFA)觀察眼底血管情況;采用血液流變儀檢測血液流變學指標;采用生化分析儀檢測血脂、血糖、肝腎功能等指標。記錄兩組患者用藥前后上述指標的變化,并對結果進行比較分析。

療效標準[6]:以視力、視野的改善程度為標準,將療效分為以下4類:(1)臨床治愈:視力≥1.0或增加4行,從光感提高至0.1,從眼前指數提高至0.2,從0.02提高至0.3,或從0.05提高至0.4,視野缺損面積減少40%以上,或平均視野閾值增加30%以上;(2)顯效:視力增加3行,從光感提高至0.05,從眼前指數提高至0.1,從0.01提高至0.2,從0.05提高至0.3,視野缺損面積減少15%～40%或平均視野閾值增加10%～30%;(3)有效:視力增加2行或1行,從光感提高至0.02,從眼前指數提高至0.02～0.05,從0.02提高至0.05～0.1,從0.05提高至0.12～0.2,視野缺損面積減少15%以下,或平均視野閾值增加10%以下;(4)無效:視力無變化或下降,視野缺損面積不變或增大,或平均視野閾值不變或下降。

表1 患者的一般情況比較

表2 治療組和對照組總體治療效果的比較例(眼)

表3 治療組和對照組視力和視野平均敏感度的比較±s

表3 治療組和對照組視力和視野平均敏感度的比較±s

aP＜0.05 vs對照組治療后;cP＜0.05 vs對照組治療前;eP＜0.05 vs治療組治療前。

組別例數時間視力視野平均敏感度對照組49治療前0.29±0.09 16.81±3.15治療后0.35±0.06c21.89±3.36c治療組51治療前0.28±0.08 16.24±2.84治療后0.43±0.09a,e24.24±2.22a,e

統計學分析:采用SPSS 18.0軟件進行統計學分析,活血通絡顆粒對氣虛血瘀型NAION的臨床總體療效采用Wilcoxon秩和檢驗;兩組的視力、視野、血脂和血液流變學指標的治療前后比較分別采用配對t檢驗,兩組之間治療前后比較分別采用獨立樣本t檢驗,以±s表示, P＜0.05有統計學意義。

2 結果

2.1 總體療效的分析治療后,治療組患者臨床治愈12例15眼(23.5%),顯效15例21眼(29.4%),有效18例25眼(35.3%),無效6例11眼(11.8%),有效率為88.2%;對照組患者臨床治愈5例7眼(10.2%),顯效8例11眼(16.3%),有效22例29眼(44.9%),無效14例23眼(28.6%),有效率為71.4%。兩組臨床總體療效比較用Wilcoxon秩和檢驗差異有統計學意義(Z=2.890,P= 0.004,表2)。

2.2 視力和視野的改善情況治療后,和對照組比較,治療組患者的視力顯著提高,差異均有統計學意義(t=-4.65, P＜0.01);治療組患者的視野平均敏感度顯著提高,差異均有統計學意義(t=-3.69,P=0.0004)。治療后和治療前比較,兩組患者的視力均提高,差異有統計學意義(t= -3.86,P=0.0002;t=-7.68,P＜0.01);兩組患者的視野平均敏感度均提高,差異有統計學意義(t=-6.98,P＜0.01;t=-14.03,P＜0.0001),見表3。

2.3 血脂的分析治療前,治療組與對照組患者的血清總膽固醇(TC)、甘油三脂(TG)、高密度脂蛋白膽固醇(HDL-C)、低密度脂蛋白膽固醇(LDL-C)水平進行比較,均無顯著性差異(P＞0.05)。治療后,和對照組比較,治療組患者的TC、TG、LDL-C水平較治療前均下降,HDL-C水平較治療前升高,差異均有統計學意義(t=6.25,P＜0.01;t=4.14,P＜0.01;t=4.48,P＜0.01;t=3.76,P= 0.0003;t=-4.31,P＜0.01)。治療后,和治療前自身比較,治療組患者的TC、TG、LDL-C水平較治療前均下降,HDL-C水平較治療前升高,差異有統計學意義(t=9.83,P＜0.01; t=4.78,P＜0.01;t=4.58,P＜0.01;t=7.22,P＜0.01);對照組患者的上述指標比較,無顯著性差異(t=1.77,P= 0.0807;t=1.25,P=0.2153;t=1.04,P=0.3038;t=-1.89,P= 0.0629),表4。

表4 治療組與對照組血脂水平的比較(±s,mmol/L)

表4 治療組與對照組血脂水平的比較(±s,mmol/L)

aP＜0.05 vs對照組治療后;cP＜0.05 vs治療組治療前。

組別例數時間TC TG HDL-C LDL-C對照組49治療前8.07±1.07 2.43±0.82 1.44±0.30 4.48±1.19治療后7.59±1.32 2.25±0.48 1.59±0.35 4.25±0.75治療組51治療前8.18±0.93 2.48±0.78 1.40±0.30 4.57±1.08治療后5.84±1.18a,c1.79±0.46a,c1.89±0.30a,c3.50±1.01a,c

表5 治療組與對照組血流變學指標的比較±s

表5 治療組與對照組血流變學指標的比較±s

aP＜0.05 vs對照組治療后;cP＜0.05 vs治療組治療前。

組別例數時間血漿黏度(mP/s)全血低切黏度(mP/s)全血高切黏(mP/s)紅細胞壓積(%)血漿纖維蛋白(mg/dL)對照組49治療前1.67±0.29 12.52±1.97 5.66±1.25 47.17±3.30 3.87±0.89治療后1.55±0.27 11.76±2.84 5.62±1.29 46.12±3.32 3.67±0.90治療組51治療前1.73±0.25 12.43±1.90 5.68±1.25 47.22±3.18 3.92±0.81治療后1.39±0.15a,c8.81±1.57a,c4.77±0.74a,c41.19±4.63a,c3.10±0.71a,c

2.4 血流變學的分析治療前,治療組與對照組患者的血漿黏度、全血高切黏度、低切黏度、紅細胞壓積指數及血漿纖維蛋白原水平進行比較,均無顯著性差異(P＞0.05)。治療后,和對照組比較,治療組患者的血漿黏度、全血高切黏度、低切黏度、紅細胞壓積指數及血漿纖維蛋白原水平均下降,差異有統計學意義(t=3.40,P=0.0011;t=5.75, P＜0.01;t=3.61,P=0.0005;t=6.78,P＜0.01;t=3.13,P= 0.0025)。治療后,和治療前進行自身比較,治療組患者的上述指標較治療前均下降,差異有統計學意義(t= 7.51,P＜0.01;t=9.30,P＜0.01;t=3.98,P=0.0002;t= 6.78,P＜0.01;t=4.79,P＜0.01);對照組患者的上述指標進行比較,無顯著性差異(t=1.90,P=0.0606;t=1.40,P= 0.1660;t=0.16,P=0.8744;t=1.42,P=0.1602;t=1.02, P=0.3120),見表5。

3 討論

NAION是50歲以上人群中最常見的急性視神經病變,血流動力學異常、血液黏稠度改變、眼灌注壓較低為其病理生理學基礎[7-8]?；钛ńj顆粒由熟地、當歸、芍藥、川芎、雞血藤、絲瓜絡、路路通、女貞子、太子參、紅花、炒枳殼組成,具有益氣活血、通絡明目的功效。該配方符合氣虛血瘀型NAION患者的恢復期的證候特點,具有多向調節功能。

本研究結果顯示:治療組患者的視力、視野改善情況總有效率(88.2%)高于對照組患者(71.4%)。該結果和常永業等[9]的研究結果基本一致。另外,治療組患者視力和視野平均敏感度均較對照組顯著性提高。上述結果提示:在采用復方樟柳堿注射液治療的基礎上,聯合應用活血通絡顆粒,在一定程度上可以改善NAION患者的視力、視野。該治療效果與活血通絡顆粒的成分密切相關。活血通絡顆粒中的多種成分:地黃[10-11]、川芎[12-13]、芍藥[14]、雞血藤[15]和枳殼[16]中有效成分可以調節多種血管活性物質的釋放,對抗交感神經的縮血管作用,有擴張微血管、改善視網膜缺血后再灌注產生的損傷。川芎中川芎嗪[17-18]、地黃中梓醇和毛蕊花糖苷[19-21]、紅花中紅花黃色素[22-24]和羥基紅花黃色素A[25-26]、芍藥中芍藥苷[27-30]、太子參中皂苷[31]以及枳殼中柚皮素[32]和橙皮苷[33-34]均對神經均有一定的保護作用。

本研究結果顯示:治療組患者的血清總膽固醇、甘油三脂、低密度脂蛋白膽固醇水平較對照組均下降,高密度脂蛋白膽固醇水平較對照組升高,差異有顯著性意義。該結果可能與活血通絡顆粒組方中地黃[35]、紅花[36]、女貞子[37]、太子參[38]、和絲瓜絡[39]中多種有效成分均可以降低血清膽固醇、甘油三脂、低密度脂蛋白的水平和升高密度脂蛋白的水平。

另外,本研究結果顯示:治療組患者的血漿黏度、全血高切黏度、低切黏度和血漿纖維蛋白原水平較對照組均顯著下降。該結果可能因為活血通絡顆粒配方中地黃的有效成分5-羥甲基糠醛[40-41]、川芎和赤芍中有效成分[42]、枳殼中柚皮素[16]、雞血藤和紅花中有效成分[43]均具有抑制血小板及紅細胞凝聚,降低血液黏滯度,促進纖溶活性,抑制血管內凝血,擴張血管,改善微循環和細胞代謝,增加動脈血流量,降低外周血管阻力的作用。

結合中醫辯證論治,活血通絡顆粒中熟地、當歸、太子參養血活血,補氣生津,使脈充血行,共為主藥;赤芍活血化瘀,白芍柔肝益陰,川芎為血中氣藥,可行氣走竄通絡,其辛香善行之力可直達頭目巔頂,雞血藤養血活血,紅花活血化瘀,通絡開閉,四藥同為輔藥;佐以枳殼調理氣機,疏解氣滯,絲瓜絡味甘、辛平,路路通味苦、辛平,二藥合并可增強其通經活絡功效,性味平緩,毒性小,可持久應用;女貞子性味平和,可“強陰,健腰膝,變白發,明目”,加入本方有滋陰增液,生津潤絡之效,為使藥。全方以活為要,以補助通,藥性和緩,可長服久用。以上諸藥具有益氣養陰、活血化瘀通絡的作用。

活血通絡顆粒以中醫辨證論治和整體觀念為指導,對NAION患者視功能的保護作用可能是通過中藥內多成分、多重途徑、多個靶點共同實現的?？傊?本研究采用復方樟柳堿注射液治療的基礎上,聯合應用活血通絡顆粒,進一步改善了NAION患者的視力、視野、血脂水平及血液流變學指標,在用藥過程中無明顯不良反應,具有一定的臨床借鑒意義。

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Clinical studies of Huoxuetongluo granula on the treatment of ischemicoptic neuropathy

Cheng-YiZhu1,Qiong Yi1,Jin-Li M a1,Qi-Ping Wei2

1Department of Ophthalmology,Hepingli Hospital,Beijing 100013,China;2Department of Ophthalmology,Dongfang Affiliated Hospital of Beijing University of Chinese Medicine,Beijing 100078,China

Qi-Ping Wei.Department of Ophthalmology, Dongfang Affiliated Hospital of Beijing University of Chinese Medicine,Beijing 100078,China.wei_dfyy@yahoo.com.cn

·AIM:To evaluate the clinical efficacy of Huoxuetongluo granula on the treatment of qideficiency and blood stasis type of non-arteritic anterior ischemic optic neuropathy (NAION).·METHODS:A total of 100 patients with NAION were enrolled in the randomized controlled trial.They were divided in to control group(49 cases with 70 eyes)and treatment group(51 cases with 72 eyes).The patients in control group were treated with only injections of compound anisodine(CA)beside superficial temporal artery,2m l each time,once per day.The patients in treatment group received huoxuetongluo granula,10g each time,twice per days,besides CA.Patients were followed up for 3m o,and the overall cure effect,visual acuity,mean sensitivity(MS),serum lipid levels and hemorheology indicators were measured and analyzed.·RESULTS:After treatments,the total effective rate of treatment group were 88.2%,which was significantly higher than that of the control group(71.4%)(Z=2.890, P=0.004).Com pared with the control group,the visual acuity and MS of treatment group were significantly higher and the differences were statistical(t=-4.65,P＜0.0001;t=-3.69,P=0.0004).The TC,TG and lowdensity lipoprotein cholesterol(LDL-C)levels were significantly lower,the high-density lipoprotein cholesterol(HDL-C)significantly increased than those before treatments(t=6.25,P＜0.01;t=4.14,P＜0.01;t= 4.48,P＜0.01;t=3.76,P=0.0003;t=-4.31,P＜0.01).After treatments,the whole blood high shear viscosity,low shear viscosity,plasma viscosity and fibrinogen of the treatment group were significantly lower than those of control group(t=3.40,P=0.0011;t=5.75;P＜0.01;t=3.61, P=0.0005;t=6.78,P＜0.01;t=3.13,P=0.0025).·CONCLUSION:The combination of CA and huoxuetongluo granula can improve the visual acuity, MS,serum lipid levels and hemorheology indicators significantly.

optic neuropathy;hemorheology; huoxuetongluo granula

朱成義,碩士,主治醫師,研究方向:中西醫結合治療眼底病、神經眼科疾病的診療。

韋企平,主任醫師,研究方向:眼底病.wei_dfyy@ yahoo.com.cn

2015-08-04

2015-10-22

:Zhu CY,Yi Q,Ma JL,et al.Clinical studies of Huoxuetongluo granula on the treatment of ischemic optic neuropathy. Guoji Yanke Zazhi(Int Eye Sci)2015;15(11):1945-1948

10.3980/j.issn.1672-5123.2015.11.29

Received:2015-08-04 Accepted:2015-10-22

方法:采用隨機對照試驗,將100例非動脈炎性前部缺血性視神經病變患者隨機分為對照組和治療組,治療組51例72眼,對照組49例70眼。對照組給予復方樟柳堿注射液顳淺動脈旁注射,2mL/次,1次/d。在上述治療的基礎上,治療組患者加用活血通絡顆粒(10g/次,口服,2次/d)進行干預。3mo后,觀察并分析兩組患者視神經病變的總體療效、視力、視野平均光敏感度、血脂水平及血液流變學指標的改善情況。

結果:治療后,治療組患者視神經病變的總有效率為88.2%,顯著高于對照組71.4%(Z=2.890,P=0.004);治療組患者的視力和視野平均敏感度均顯著性提高,差異有統計學意義(t=-4.65,P＜0.01;t=-3.69,P= 0.0004);治療組患者的血清總膽固醇、甘油三脂、低密度脂蛋白膽固醇水平較治療前均下降,高密度脂蛋白膽固醇較治療前升高,差異有統計學意義(t=6.25,P＜0.01;t= 4.14,P＜0.01;t=4.48,P＜0.01;t=3.76,P= 0.0003;t=-4.31,P＜0.01);治療組患者的全血高切黏度、低切黏度、血漿黏度和血漿纖維蛋白原均顯著降低(t= 3.40,P=0.0011;t=5.75,P＜0.01;t=3.61,P=0.0005;t= 6.78,P＜0.01;t=3.13,P=0.0025)。

結論:復方樟柳堿注射液聯合活血通絡顆?？娠@著改善NAION患者的視力、視野、血脂水平和血液流變學指標。