川蛭通络胶囊联合西药治疗急性脑梗死气虚血瘀证临床研究

目的：观察川蛭通络胶囊联合西药治疗急性脑梗死气虚血瘀证的临床疗效。方法：采用随机数字表法将90 例急性脑梗死气虚血瘀证患者分为对照组和观察组各45 例。对照组给予常规西药治疗，观察组在对照组基础上加用川蛭通络胶囊治疗，2 组均连续治疗14 d。比较2 组治疗前后中医证候积分、美国国立卫生研究院卒中量表（NIHSS）、Barthel 指数（BI） 评分、脑血管储备功能（CVR） 值、脉动指数（PI） 值；比较2 组治疗前后血栓弹力图参数［血凝块增长曲线角度（Angle）、血凝块增长至20 mm 所需时间（K）、综合凝血指数（CI）、最大血凝块强度（MA）］、血清指标［白细胞介素-6（IL-6）、肿瘤坏死因子-α（TNF-α）、S100 钙结合蛋白β（S100β）、神经元特异性烯醇化酶（NSE）］；评估2 组临床疗效及不良反应发生情况。结果：治疗期间，对照组、观察组各脱落3 例，最终2 组各完成研究42 例。治疗后，对照组总有效率80.95%，观察组总有效率95.24%，2 组比较，差异有统计学意义（P＜0.05）。2 组治疗后BI 评分、CVR 值及血栓弹力图K 参数水平较治疗前升高（P＜0.05），中医证候积分、NIHSS 评分、PI 值及血栓弹力图Angle、CI、MA 参数水平降低（P＜0.05）；观察组治疗后BI 评分、CVR 值及血栓弹力图K 参数水平高于对照组（P＜0.05），中医证候积分、NIHSS 评分、PI 值及血栓弹力图Angle、CI、MA 参数水平低于对照组（P＜0.05）。2 组治疗后血清IL-6、TNF-α、NSE、S100β 水平低于治疗前（P＜0.05），且观察组治疗后上述血清指标水平低于对照组（P＜0.05）。治疗期间，2 组均无不良反应发生。结论：川蛭通络胶囊联合西药治疗急性脑梗死气虚血瘀证疗效确切，能够改善患者脑血管储备功能和凝血功能，减少炎症反应，加快神经功能恢复，安全性较高。

Clinical Study on Chuanzhi Tongluo Capsules Combined with Western Medicine forAcute Cerebral Infarction with Qi Deficiency with Blood Stasis Syndrome

Abstract： Objective： To observe the clinical effect of Chuanzhi Tongluo Capsules combined withwestern medicine for acute cerebral infarction with qi deficiency with blood stasis syndrome. Methods：Atotal of 90 cases of patients with acute cerebral infarction with qi deficiency with blood stasis syndromewere divided into the control group and the observation group， with 45 cases in each group. The controlgroup was treated with routine western medicine，and the observation group was additionally treated withChuanzhi Tongluo Capsules based on the treatment of the control group. Both groups were treated for14 days. The traditional Chinese medicine (TCM) syndrome scores， National Institutes of Health StrokeScale (NIHSS) scores，Barthel Index (BI) scores，cerebrovascular reserve function (CVR) values and pulseindexes (PI) values were compared before and after treatment between the two groups. Thrombelastographyparameters (angle of blood clot growth curve)，the time required for the blood clot to grow to 20 mm (K)，comprehensive coagulation index (CI)， maximum clot strength (MA) and serum indexes [interleukin- 6(IL-6)，tumor necrosis factor-α (TNF-α)，S100 calc-binding protein β (S100β)，neuron-specific enolase(NSE)] were compared before and after treatment between the two groups； the clinical effects and theincidence of adverse reactions in the two groups were evaluated. Results： During the treatment period，three cases were fallen off in the control group and the observation group respectively， and the studieswere completed on 42 cases in each group respectively. After treatment， the total effective rate was80.95% in the control group and 95.24% in the observation group， the difference being significant (P＜0.05). After treatment，BI scores，CVR values and the levels of thrombelastography parameter K in the twogroups were increased when compared with those before treatment (P＜0.05)， and TCM syndromescores， NIHSS scores， PI values and levels of thrombelastography parameters including Angle， CI andMA were decreased (P＜0.05). After treatment，BI score，CVR value and the level of thrombelastographyparameter K in the observation group were higher than those in the control group (P＜0.05)， and TCMsyndrome scores， NIHSS score， PI value， and the levels of thrombelastography parameters includingAngle， CI and MA were lower than those in the control group (P＜0.05). After treatment， the levels ofIL-6，TNF-α，NSE，and S100β in serum in the two groups were lower than those before treatment (P＜0.05)，and the above levels in the observation group were lower than those in the control group (P＜0.05).During treatment， no adverse reaction occurred in the two groups. Conclusion： Chuanzhi TongluoCapsules combined with western medicine has a definite curative effect in treating acute cerebral infarctionwith qi deficiency with blood stasis syndrome， which can improve cerebrovascular reserve function andcoagulation function，reduce inflammatory responses and accelerate the recovery of neurological function，with high safety.