活血通絡(luò)顆粒對(duì)缺血性視神經(jīng)病變的臨床研究

朱成義,伊瓊,馬金力,韋企平

活血通絡(luò)顆粒對(duì)缺血性視神經(jīng)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(guó)北京市和平里醫(yī)院眼科;2(100078)中國(guó)北京市,北京中醫(yī)藥大學(xué)東方醫(yī)院眼科

目的:探討活血通絡(luò)顆粒對(duì)氣虛血瘀型非動(dòng)脈炎性前部缺血性視神經(jīng)病變的臨床療效。

視神經(jīng)病變;血流變學(xué);活血通絡(luò)顆粒

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

0 引言

非動(dòng)脈炎性前部缺血性視神經(jīng)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(jīng)病變,臨床上以無痛性突發(fā)視力障礙、視野缺損、視盤水腫或周圍神經(jīng)纖維層出血為主要表現(xiàn)[1-2]。該病發(fā)病急、短期內(nèi)視力急劇下降,嚴(yán)重者甚至失明[3]。目前,國(guó)內(nèi)在控制原發(fā)病的基礎(chǔ)上,對(duì)NAION治療多采用復(fù)方樟柳堿顳淺動(dòng)脈旁皮下注射,但療效尚不盡滿意。本研究結(jié)合中醫(yī)辯證思維,旨在探討復(fù)方樟柳堿治療的基礎(chǔ)上應(yīng)用活血通絡(luò)顆粒對(duì)氣虛血瘀型NAION的臨床療效。

1 對(duì)象和方法

1.1 對(duì)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(fā)病42例,單眼發(fā)病58例,共計(jì)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(dòng)脈硬化29例42眼,無明顯誘因13例18眼。納入標(biāo)準(zhǔn):符合以下診斷標(biāo)準(zhǔn),同時(shí)自愿配合該項(xiàng)目治療的患者被納入為研究對(duì)象。參照Hayreh等[4]制定的NAION診斷標(biāo)準(zhǔn):(1)突發(fā)視力下降,多在晨起時(shí)發(fā)生;(2)病史中急性期存在視盤水腫或相關(guān)的記錄;(3)存在與視盤病變相關(guān)的視野缺損;(4)排除其他可以導(dǎo)致視盤水腫和視力下降的神經(jīng)、系統(tǒng)或眼部疾病。氣虛血瘀證型診斷標(biāo)準(zhǔn)[5]:視力驟降,心煩郁悶,頭目隱痛,胸脅脹滿;舌質(zhì)紫暗或有瘀斑,脈弦數(shù)。采用隨機(jī)對(duì)照試驗(yàn),將100例隨機(jī)分為治療組和對(duì)照組,其中治療組51例72眼,對(duì)照組49例70眼。兩組患者的性別、年齡、病程的差異均無統(tǒng)計(jì)學(xué)意義(P＞0.05),見表1。

1.2 方法對(duì)照組采用復(fù)方樟柳堿注射液2mL顳淺動(dòng)脈旁注射,1次/d。在上述治療的基礎(chǔ)上,治療組根據(jù)韋企平[5]主編的《視神經(jīng)疾病中西醫(yī)結(jié)合診治》氣虛血瘀型方選活血通絡(luò)方,方藥組成:熟地15g、當(dāng)歸、芍藥、川芎、雞血藤、絲瓜絡(luò)、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(yī)藥大學(xué)東方醫(yī)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(guó)際標(biāo)準(zhǔn)對(duì)數(shù)視力表對(duì)患者的視力進(jìn)行檢查;采用靜態(tài)自動(dòng)電腦Octpus101型視野計(jì)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(cè)血液流變學(xué)指標(biāo);采用生化分析儀檢測(cè)血脂、血糖、肝腎功能等指標(biāo)。記錄兩組患者用藥前后上述指標(biāo)的變化,并對(duì)結(jié)果進(jìn)行比較分析。

療效標(biāo)準(zhǔn)[6]:以視力、視野的改善程度為標(biāo)準(zhǔn),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(shù)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(shù)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(shù)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(duì)照組總體治療效果的比較例(眼)

表3 治療組和對(duì)照組視力和視野平均敏感度的比較±s

表3 治療組和對(duì)照組視力和視野平均敏感度的比較±s

aP＜0.05 vs對(duì)照組治療后;cP＜0.05 vs對(duì)照組治療前;eP＜0.05 vs治療組治療前。

組別例數(shù)時(shí)間視力視野平均敏感度對(duì)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(tǒng)計(jì)學(xué)分析:采用SPSS 18.0軟件進(jìn)行統(tǒng)計(jì)學(xué)分析,活血通絡(luò)顆粒對(duì)氣虛血瘀型NAION的臨床總體療效采用Wilcoxon秩和檢驗(yàn);兩組的視力、視野、血脂和血液流變學(xué)指標(biāo)的治療前后比較分別采用配對(duì)t檢驗(yàn),兩組之間治療前后比較分別采用獨(dú)立樣本t檢驗(yàn),以±s表示, P＜0.05有統(tǒng)計(jì)學(xué)意義。

2 結(jié)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(duì)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(yàn)差異有統(tǒng)計(jì)學(xué)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(duì)照組比較,治療組患者的視力顯著提高,差異均有統(tǒng)計(jì)學(xué)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(tǒng)計(jì)學(xué)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(tǒng)計(jì)學(xué)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(tǒng)計(jì)學(xué)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(duì)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(jìn)行比較,均無顯著性差異(P＞0.05)。治療后,和對(duì)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(tǒng)計(jì)學(xué)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(tǒng)計(jì)學(xué)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(duì)照組患者的上述指標(biāo)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(duì)照組血脂水平的比較(±s,mmol/L)

表4 治療組與對(duì)照組血脂水平的比較(±s,mmol/L)

aP＜0.05 vs對(duì)照組治療后;cP＜0.05 vs治療組治療前。

組別例數(shù)時(shí)間TC TG HDL-C LDL-C對(duì)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(duì)照組血流變學(xué)指標(biāo)的比較±s

表5 治療組與對(duì)照組血流變學(xué)指標(biāo)的比較±s

aP＜0.05 vs對(duì)照組治療后;cP＜0.05 vs治療組治療前。

組別例數(shù)時(shí)間血漿黏度(mP/s)全血低切黏度(mP/s)全血高切黏(mP/s)紅細(xì)胞壓積(%)血漿纖維蛋白(mg/dL)對(duì)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(xué)的分析治療前,治療組與對(duì)照組患者的血漿黏度、全血高切黏度、低切黏度、紅細(xì)胞壓積指數(shù)及血漿纖維蛋白原水平進(jìn)行比較,均無顯著性差異(P＞0.05)。治療后,和對(duì)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(xì)胞壓積指數(shù)及血漿纖維蛋白原水平均下降,差異有統(tǒng)計(jì)學(xué)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(jìn)行自身比較,治療組患者的上述指標(biāo)較治療前均下降,差異有統(tǒng)計(jì)學(xué)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(duì)照組患者的上述指標(biāo)進(jìn)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(jīng)病變,血流動(dòng)力學(xué)異常、血液黏稠度改變、眼灌注壓較低為其病理生理學(xué)基礎(chǔ)[7-8]。活血通絡(luò)顆粒由熟地、當(dāng)歸、芍藥、川芎、雞血藤、絲瓜絡(luò)、路路通、女貞子、太子參、紅花、炒枳殼組成,具有益氣活血、通絡(luò)明目的功效。該配方符合氣虛血瘀型NAION患者的恢復(fù)期的證候特點(diǎn),具有多向調(diào)節(jié)功能。

本研究結(jié)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(duì)照組患者(71.4%)。該結(jié)果和常永業(yè)等[9]的研究結(jié)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(duì)照組顯著性提高。上述結(jié)果提示:在采用復(fù)方樟柳堿注射液治療的基礎(chǔ)上,聯(lián)合應(yīng)用活血通絡(luò)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(luò)顆粒的成分密切相關(guān)?；钛ńj(luò)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(diào)節(jié)多種血管活性物質(zhì)的釋放,對(duì)抗交感神經(jīng)的縮血管作用,有擴(kuò)張微血管、改善視網(wǎng)膜缺血后再灌注產(chǎn)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(duì)神經(jīng)均有一定的保護(hù)作用。

本研究結(jié)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(duì)照組均下降,高密度脂蛋白膽固醇水平較對(duì)照組升高,差異有顯著性意義。該結(jié)果可能與活血通絡(luò)顆粒組方中地黃[35]、紅花[36]、女貞子[37]、太子參[38]、和絲瓜絡(luò)[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(jié)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(duì)照組均顯著下降。該結(jié)果可能因?yàn)榛钛ńj(luò)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(xì)胞凝聚,降低血液黏滯度,促進(jìn)纖溶活性,抑制血管內(nèi)凝血,擴(kuò)張血管,改善微循環(huán)和細(xì)胞代謝,增加動(dòng)脈血流量,降低外周血管阻力的作用。

結(jié)合中醫(yī)辯證論治,活血通絡(luò)顆粒中熟地、當(dāng)歸、太子參養(yǎng)血活血,補(bǔ)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(luò),其辛香善行之力可直達(dá)頭目巔頂,雞血藤養(yǎng)血活血,紅花活血化瘀,通絡(luò)開閉,四藥同為輔藥;佐以枳殼調(diào)理氣機(jī),疏解氣滯,絲瓜絡(luò)味甘、辛平,路路通味苦、辛平,二藥合并可增強(qiáng)其通經(jīng)活絡(luò)功效,性味平緩,毒性小,可持久應(yīng)用;女貞子性味平和,可“強(qiáng)陰,健腰膝,變白發(fā),明目”,加入本方有滋陰增液,生津潤(rùn)絡(luò)之效,為使藥。全方以活為要,以補(bǔ)助通,藥性和緩,可長(zhǎng)服久用。以上諸藥具有益氣養(yǎng)陰、活血化瘀通絡(luò)的作用。

活血通絡(luò)顆粒以中醫(yī)辨證論治和整體觀念為指導(dǎo),對(duì)NAION患者視功能的保護(hù)作用可能是通過中藥內(nèi)多成分、多重途徑、多個(gè)靶點(diǎn)共同實(shí)現(xiàn)的?？傊?本研究采用復(fù)方樟柳堿注射液治療的基礎(chǔ)上,聯(lián)合應(yīng)用活血通絡(luò)顆粒,進(jìn)一步改善了NAION患者的視力、視野、血脂水平及血液流變學(xué)指標(biāo),在用藥過程中無明顯不良反應(yīng),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(yī)師,研究方向:中西醫(yī)結(jié)合治療眼底病、神經(jīng)眼科疾病的診療。

韋企平,主任醫(yī)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(jī)對(duì)照試驗(yàn),將100例非動(dòng)脈炎性前部缺血性視神經(jīng)病變患者隨機(jī)分為對(duì)照組和治療組,治療組51例72眼,對(duì)照組49例70眼。對(duì)照組給予復(fù)方樟柳堿注射液顳淺動(dòng)脈旁注射,2mL/次,1次/d。在上述治療的基礎(chǔ)上,治療組患者加用活血通絡(luò)顆粒(10g/次,口服,2次/d)進(jìn)行干預(yù)。3mo后,觀察并分析兩組患者視神經(jīng)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(xué)指標(biāo)的改善情況。

結(jié)果:治療后,治療組患者視神經(jīng)病變的總有效率為88.2%,顯著高于對(duì)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(tǒng)計(jì)學(xué)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(tǒng)計(jì)學(xué)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(jié)論:復(fù)方樟柳堿注射液聯(lián)合活血通絡(luò)顆?？娠@著改善NAION患者的視力、視野、血脂水平和血液流變學(xué)指標(biāo)。