Effects of Butylphthalide Sodium Chloride Injection Combined with Edaravone Dexborneol on Neurological Function and Serum Inflammatory Factor Levels in Sufferers Having Acute Ischemic Stroke.

For investigating an influence on butylphthalide sodium chloride injection combined with edaravone dexborneol on neurological function and serum inflammatory factor levels in sufferers having acute ischemic stroke, 120 sufferers having acute ischemic stroke from September 2020 to September 2021 are chosen for the study subjects. In line with the diverse therapies, they took part in a control group and the study group, with 60 examples in each group. The control group is treated with edaravone dexborneol, and the study group is treated with butylphthalide sodium chloride injection, based on the control group. The posttreatment curative efficacy on the two groups is recorded, and treatment of both the two groups is compared. Before and after neurological function indexes (NIHSS and mRS), inflammatory factor indexes (IL-6, CRP, and TNF-α), life quality index (Barthel index), hemorheological indexes (plasma-specific viscosity), and neurological levels of NSE are logged and contrasted between the two groups of adverse reactions during therapy. Postcure, the overall response rate and Barthel index of the study group obviously overtop those of the control group (p < 0.05). IL-6, CRP, TNF-α, NSE, plasma specific viscosity, and NIHSS and mRS scores obviously hypodown those of the control group (p < 0.05), and untoward effects on the two groups during curing are lower, and the discrepancy is not obvious(p > 0.05). Butylphthalide sodium chloride injection combined with edaravone dexborneol can enhance curative efficacy on sufferers having acute ischemic stroke, improve neurological function, blood rheology, and quality of life, and decrease the secretion of cytokine, having a better effect and high medication safety.

1. Introduction

Acute ischemic stroke is the most common severe manifestation of cerebrovascular disease and a major cause of severe disability. It is the leading cause of hospitalization for neurological disorders. It is manifested as aphasia, dizziness, hemiplegia, and cerebral edema, seriously affecting the quality of life of patients [1]. The acute ischemic stroke is often accompanied with different degrees of neurological deficits. Studies have shown that the severity of neurological deficits on sufferers with acute ischemic stroke is strongly linked with density of inflammatory factors in patient's body [2]. The concentrated solution of edaravone and dexborneol for injection can effectively inhibit the lipid peroxidation of nerve cells and exert a protective effect on brain tissue. It is widely used, but its clinical effect has certain limitations [3, 4]. Butylphthalide sodium chloride can be used to improve the neurological deficit on acute ischemic stroke; in addition, it is a usual drug for curing acute ischemic stroke [5, 6].

In the context of the above research, this study used butylphthalide sodium chloride injection combined with edaravone dexborneol to cure sufferers having acute ischemic stroke to explore the effect of neural feature and serum inflammatory factor levels. The aim is to provide a new perspective for clinical treatment of acute ischemic stroke.

The rest of this study is organized as follows: Section 2 discusses treatment methods. Section 3 is the observation indicators. Section 4 shows the simulation experimental results, followed by the clinical result analysis in Section 5, and Section 6 concludes the study with summary and future research directions.

2. Treatment Methods

120 sufferers having acute ischemic stroke from September 2020 to September 2021 are chosen for the study subjects. They took part in a control group and the study group lining with the diverse therapies, with 60 examples in each group. This study was approved by the ethics committee of our hospital; in addition, informed consent was obtained from the patients and their relatives.

Sufferers with acute ischemic stroke facing clinical symptoms, signs, and imaging examinations are included [7]. Patients with other brain diseases except acute ischemic stroke, patients with a history of head injury, sufferers having a history of brain surgery, sufferers having serious underlying disease, patients with immunodeficiency, patients with coagulation dysfunction, combined with mental and cognitive dysfunction, and patients with incomplete clinical case data were excluded.

The control group is given concentrated solution of edaravone and dexborneol for injection (Nanjing Xiansheng TECO Pharmaceutical Co., Ltd., specification: 5 ml: 10 mg (edaravone): 2.5 mg (dexborneol), Chinese medicine accurate word: H20200007) intravenous infusion treatment, 15 ml each time (containing edaravone 30 mg, dexborneol 7.5 mg), 2 times a day. When in use, add it to 100 ml of normal saline to dilute it and then infuse it intravenously; finish the drip within 30 minutes and treat it continuously for 14 days.

Basing on the control group, the study group is treated combined with butylphthalide sodium chloride injection (NBP Pharmaceutical Co, Ltd., of CSPC, specification: 100 ml, Chinese medicine approved word: H20100041) intravenous drip therapy, twice a day, 25 mg (100 ml) each time; each instillation time is not less than 50 min, the interval between the two administrations is not less than 6 h, and the course of treatment is 14 d.

3. Observation Indicators

3.1. Efficacy Evaluation

Cure: the patient's symptoms such as headache, dizziness, numbness, and weakness disappeared; furthermore, the National Institute of Health Stroke Scale (NIHSS) points decreased by >90%. Markedly effective: the patient had headache, dizziness, limb numbness, and weakness. Symptoms are relieved; furthermore the NIHSS points is decreased by > 45%. Effective: the symptoms such as headache, dizziness, numbness, and weakness of the patient are relieved, and the NIHSS score is reduced by > 17%; the overall response rate of treatment = healing ratio + markedly valid ratio + valid ratio.

3.2. Nerve Feature

NHISS and mRS scores are used for estimating the neurological feature of the two groups pretreatment as well as 90 days posttreatment. NHISS score [8]: the evaluation contents include neglect disorder, dysarthria, language, sensory, and mutual aid. Disorder, lower extremity movement, upper extremity movement, facial paralysis, visual field, level of consciousness, the higher the score, the more serious the nerve defect. mRS score [9]: 0 point represents completely asymptomatic; although there may be mild symptoms, the patient has not noticed any new functional limitations and symptoms since the stroke. 1 point represents the ability to carry out all usual duties and activities despite symptoms. 2 points represent mildly disabled; unable to carry out all normal activities, can dispose individual tasks in short of support. 3 points represent moderately disabled; some assistance is required, but no assistance is required to walk. 4 points represent severely disabled, unable to walk without the assistance of others and unable to take care of one's physical requirement. 5 points represent severely disabled; bedfast, incontinence, and calling for ongoing concern; although not requiring a trained nurse, but requiring someone to attend several times throughout the day and night.

3.3. Inflammatory Factors, Neuroenzymatic Indicators, and Hemorheological Indicators

Five ml of peripheral phlebo blood is collected from two groups, put in an anticoagulant tube for 1.5 h, and centrifuged with a centrifuge (Hettich, Germany, Rotofix 32A) for 10 min at a velocity of 3000r/min; separate the supernatant and save it for later use. The density of serum IL-6, CRP, TNF-α, and neuron-specific enolase (NSE) in the two groups of sufferers pretherapy and posttherapy is tested by ELISA assay mean to test plasma-specific viscosity before and after treatment in the two groups. The kits are purchased from Wuhan Boster Company, and the operating routines are rigorly going by the specifications of the reagents and instruments.

3.4. Quality of Life

Pre and posttreatment, use Barthel index to estimate quality of life from sufferers in the two groups [10]. Barthel index: divided into 4 grades. The overall points are one hundred points. Those with a point of 100 can take care of themselves in basic daily life, but they may not be able to live independently, cannot cook, or have contact with others. With a score of 60 or above, they can basically take care of themselves. Mild functional impairment, able to complete some daily activities independently. 60–41 points, need help in life. 40–20 points, need great help in life. Below 20 points, completely need help in life.

Record and compare the emergence of the untoward effect during treatment, containing vomiting, fever, disturbance of consciousness, convulsions, and mental symptoms.

SPSS 20.0 AutoCAD is employed for statistical analysis. GraphPad Prism 5 is employed for analyzing the datum of this research and make graphs. The metering datum is expressed (mean ± SD), and the comparison adopts Student' test. The count data are expressed in a form by n (%), and contrast is performed using the chi-square test. Discrepancy is considered statistically obvious at P < 0.05.

4. The Experimental Result

4.1. Contrast of Baseline Datum between the Two Groups

Discrepancy is not obvious between the two groups on gender, age, intravenous medication time window, BMI, history of diabetes, history of alcoholism, smoking history, and place of residence (p > 0.05), as given in Table 1.

Table 1

Ground line data (n (%), mean ± SD).

Project	Control group (n = 60)	Study group (n = 60)	χ 2/t	P
Gender			0.141	0.707
Male	36 (64.91)	38 (59.42)
Female	24 (35.09)	22 (40.58)
Average age (years)	60.30 ± 7.11	61.62 ± 6.02	1.098	0.275
Intravenous medication time window (h)	3.09 ± 0.51	3.14 ± 0.44	0.575	0.566
BMI (kg/m2)	22.42 ± 1.98	22.54 ± 2.51	0.291	0.772
Geschichte of diabetes			0.436	0.509
None	54 (47.37)	5 6 (44.93)
Have	6 (52.63)	4 (55.07)
History of alcoholism			0.154	0.695
None	42 (38.60)	40 (34.78)
Have	18 (61.40)	20 (65.22)
Smoking history			0.300	0.584
None	6 (49.12)	9 (42.03)
Have	54 (50.88)	5 1 (57.97)
Place of residence			0.853	0.356
Rural	37 (42.11)	32 (43.48)
City	23 (57.89)	28 (56.52)

4.2. Contrast of the Curative Effect

The overall effective ratio of patients in the study group is obvious higher than that in the control group (p < 0.05), as given in Table 2.

Table 2

Contrast of the curative effect (n (%)).

Group	Get well	Effective	Efficient	Invalid	Always valid
Control group (n = 60)	7 (11.67)	20 (33.33)	22 (36.67)	11 (18.33)	49 (81.67)
Study group (n = 60)	9 (15.00)	23 (38.33)	26 (43.33)	2 (3.33)	58 (96.67)
χ 2					6.988
P					0.008

4.3. Contrast of NIHSS and mRS Points between the Two Groups Pretherapy and Post Therapy

NIHSS and mRS points on the two groups posttherapy are obviously lower than those of the same group before treatment (p < 0.05), and the NIHSS and mRS points of the study group posttherapy are obviously lower than those of the control group (p < 0.05), as shown in Figure 1. In Figure 1, A denotes before treatment in the control group, B denotes pretherapy in the study group, C denotes posttherapy in the control group, and D denotes posttherapy in the study group.

Figure 1

Contrast of NIHSS and mRS points pretherapy and posttherapy on the two groups of sufferers.

4.4. Contrast of Serum Inflammatory Factors in the Two Groups of Patients Pretherapy and Posttherapy

The density of IL-6, CRP, and TNF-α in two groups after treatment are obviously lower than that before treatment on the same group (p< 0.05), and the density of IL-6, CRP, and TNF-α on the study group after treatment are obviously lower than the control group (p < 0.05), as given in Table 3.

Table 3

Contrast of serum inflammatory factors in the two groups of patients pretherapy and posttherapy (ng/L, mean ± SD).

Group	Time	TNF-α	IL-6	CRP
Study group (n = 60)	Before treatment	40.70 ± 7.88	38.78 ± 7.07	153.51 ± 16.79
	After treatment	15.47 ± 6.19∗#	17.62 ± 5.84∗#	101.36 ± 15.87∗#
Control group (n = 60)	Before treatment	41.90 ± 7.38	39.79 ± 6.36	148.59 ± 15.29
	After treatment	28.86 ± 8.53∗	36.57 ± 5.93∗	125.05 ± 16.30∗

Compared with the group before treatment, p < 0.05; Compared with the control group posttherapy, #p < 0.05.

4.5. Contrast of NSE Levels in the Two Groups Pretherapy and Posttherapy

Two groups after treatment are significantly lower than pretherapy in this group (p < 0.05); moreover, the level of NSE in the study group after treatment is significantly lower than that in the control group (p < 0.05), as shown in Figure 2. In Figure 2, A denotes before treatment in the control group, B denotes pretherapy in the study group, C denotes posttherapy in the control group, and D denotes after treatment in the study group.

Figure 2

Contrast of NSE levels in the two groups pretherapy and posttherapy.

4.6. Contrast of Hemorheological Indexes Pretherapy and Posttherapy in the Two Groups of Sufferers

Hemorheological indexes of sufferers are significantly lower than pretherapy on the same group (p < 0.05), as shown in Figure 3. In Figure 3, A denotes the pretherapy in the control group, B denotes the pretherapy in the study group, C denotes the posttherapy in the control group, and D denotes after treatment in the study group.

Figure 3

Contrast of hemorheological indexes pretherapy and posttherapy in the two groups of sufferers.

4.7. Comparison of Barthel Index before and after Treatment among Two Groups of Sufferers

Posttherapy, the Barthel index of two groups is obviously higher than pretherapy in the same group (p < 0.05), as shown in Figure 4. In Figure 4, A denotes before treatment in the control group, B denotes pretherapy in the study group, C denotes posttherapy in the control group, and D denotes after treatment in the study group.

Figure 4

Comparison of Barthel index before and after treatment among two groups of sufferers.

4.8. Contrast of the Untoward Effect in Two Groups of Suffers during Treatment

During the therapy stage, the incidence of the untoward effect on the two groups is little, and there is no obvious difference (p > 0.05), as given in Table 4.

Table 4

Contrast of the untoward effect in two groups of suffers during treatment (n (%)).

Group	Vomit	Fever	Disturbance of consciousness	Twitch	Mental symptoms	Total incidence
Study group (n = 60)	0 (0.00)	1 (1.67)	0 (0.00)	0 (0.00)	1 (1.67)	2 (3.33)
Control group (n = 60)	1 (1.67)	1 (1.67)	0 (0.00)	0 (0.00)	1 (1.67)	3 (5.00)
χ 2						0.209
P						0.648

5. The Clinical Result Analysis

Acute ischemic stroke is a type disease in which the emboli formed by various factors in blood turn into the cerebral vessel with the blood cycle to block blood supply to the brain and lead to lacking blood thanatosis of the cerebrum tissue [11]. After emboli block the cranic vessel, the collateral circulation cannot be compensation, causing lacking blood thanatosis of the cerebrum tissue in arterial blood supply area, resulting in focal neurological deficits, which can lead to hemianopia and hemiplegia, cerebral herniation, coma, sudden death, and other serious consequences [12]. Butylphthalide sodium chloride injection and edaravone dexborneol are both commonly used drugs for the clinical treatment of acute ischemic stroke, and the efficacy of a single drug is positive. The clinical efficacy of butylphthalide sodium chloride injection combined with edaravone dexborneol in the treatment of acute ischemic stroke is better than that of single drug.

Consequence of this research manifested that after treatment, overall valid ratio and Barthel index of this study group are obviously higher than those of the control group, IL-6, CRP, TNF-α, NSE, plasma specific viscosity, and NIHSS. The mRS score is obviously lower than those of the control group, and the discrepancy are statistically meaningful, suggesting that butylphthalide sodium chloride injection combined with edaravone dexborneol can enhance the curative effect of sufferers from acute ischemic stroke, improve neurological function, blood rheology, and quality of life, and reduce serum inflammatory factor levels. To explore its mechanism, patients with cerebral infarction are often in an ischemic and hypoxic environment due to the obstruction on blood provision to the encephalon tissue, on which turn induces brain tissue inflammation and oxidative stress damage and, meanwhile, releases plentiful TNF-α, IL-6, and CRP inflammatory factors; these inflammatory factors can further aggravate the inflammatory damage and neurotoxicity of brain tissue, forming a vicious circle [13, 14]. Butylphthalide can act on the brain by increasing the levels of NO and PGI2 in the cerebral vascular endothelium, reducing the intracellular calcium ion concentration, inhibiting the release of glutamate, reducing the generation of arachidonic acid, scavenging oxygen free radicals, and improving the activity of antioxidant enzymes [15-17]. Multiple pathological links of ischemia play a role in reducing inflammatory response of brain tissue and improving the curative effect. Animal pharmacodynamic studies showed that butylphthalide has a strong anticerebral ischemia effect and can significantly improve microcycle and blood flow in the lacking blood district, aggrandize the amount of microvessel in the lacking blood district, restore blood provision to the encephalon tissue, relieve encephalon edema, reduce volume of cerebral infarction in rats, improve the brain energy metabolism, reduce nerve cell apoptosis, improve neurological function, and promote blood circulation [18, 19]. Clinical studies have shown that butylphthalide has a significant therapeutic effect on ischemic cerebrovascular disease and can accelerate recovery on damaged nerve feature on sufferers. Above research reports support the consequence of this research [6]. Furthermore, consequence of this research showed untoward effects on the two groups during curing are lower, and the discrepancy is not obvious, suggesting that this efficacy has a high drug safety.

6. Conclusions

This study innovatively combines butylphthalide sodium chloride injection and edaravone dexborneol to treat patients with acute ischemic stroke. A new path has been opened. In addition, this study is a regression study, there may be retrospective bias, and the swatch scale on this research is diminutive; moreover, the Swatch origin is relatively single, more objective, and accurate conclusions need further multicenter, large-sample prospective studies.

Butylphthalide sodium chloride injection combined with edaravone dexborneol can enhance curative efficacy on sufferers having acute ischemic stroke, improve neurological function, blood rheology, and quality of life and decrease the secretion of cytokine, with a better effect and high medication safety.