| [Background]Huoxue, namely promoting blood circulation; Huayu, namely eliminating blood stasis obstruction. The meaning of Huoxuehuayu namely is promoting blood circulation and removing blood stasis. The method of Huoxuehuayu is an effective treatment for blood stasis syndrome by therapy of Huoxuehuayu. The method of Huoxuehuayu as a common means for treatment of diseases in Traditional Chinese Medicine (TCM) has an affirmative curative effect and a wide range in clinical application.Hypertensive Intracerebral Hemorrhage (HICH) belongs to the category of hemorrhagic apoplexy in TCM. TCM thinks abnormal flow of the blood namely is blood stasis, and the blood stasis pile up in head of patients with intracerebral hemorrhage. Blood stasis is not only pathological base of intracerebral hemorrhage, but also pathological product of intracerebral hemorrhage, which is the theoretical base of method of Huoxuehuayu to cure HICH. The Study of modern medicine also confirmed that the viscosity of whole blood was significantly increased in acute stage of HICH, which has closes relations with blood stasis syndrome of TCM.Because of blood stasis is important pathological change in acute stage of HICH, so for Huoxuehuayu providing an experimental basis in clinical application.To sum up. the nature of HICH is blood stasis, therapeutically emphasis of blood stasis is removing blood stasis, and removing blood stasis to produce new, so Huoxuehuayu is the essential method and effective measure for treatment of HICH, and impenetrate whole course of HICH.In recent years, with the development of theory and clinical research, some reports of using method of Huoxuehuayu to cure HICH are increasing gradually, the idea of using method of Huoxuehuayu for patient with HICH had be approved broadly, the positive effect of improving prognosis was confirmed constantly for patient with HICH, and treatment system is developing continually.Clinical reports demonstrate that the medicines of Huoxuehuayu can obviously control the initiation and development of cerebral edema and remarkably reduce duration time, so as to reduce the degree of brain injury from cerebral edema strip, which has important significance for ischemia area of around the hematoma, this is why the prognosis of patients with Huoxuehuayu are better than patients with a control group.Someone screened and analyzed178paper had published in recent years about compound Chinese medicinal preparation of Huoxuehuayu that aim at to cure acute cerebral hemorrhage, and affirming the medicines of Huoxuehuayu contribute to reduce the early mortality of acute cerebral hemorrhage.According to the physiopathology characteristic of HICH, and combined with the understanding of TCM for cerebral hemorrhage, this study establish therapeutic principle, namely is Huoxuehuayu and Buxuezhixu; And Selecting Huoxuehuayu prescription Annaohuoxue capsule to cure99patients with HICH, the capsule consist of Chinese herbal medicine salvia miltiorrhiza, panax notoginseng, angelica sinensis, crataegus pinnatifida, lycium barbarum, rhizoma dioscoreae. [Objectives]To observe the effects of Huoxuehuayu prescription Annaohuoxue capsule on hemorrheology, score of neurological impairment, Glasgow Coma Scale, and to assess the effectiveness and safety in patients with HIGH.[Objects&Methods]1. Clinical data1.1Data sourceSelecting99cases of patients with HICH, who admitted in the Department of Neurosurgery, Huadu hospital, the Southern Medical University, from April2010to January2012.57patients were male and42were female; age from40to75years, mean58.78±9.88years; most of they have a clear history of hypertension, the patients was diagnosed by brain CT or MRI when they reached hospital:1.2The case selection criteria①Accord with diagnostic code of hypertension②The bleeding in15mI-70ml③Age from40to75years④Course of disease from1to7days⑤Patients oneself or patients’ family agree to accept clinical observation⑥Bleeding site was diagnosed in basal ganglia, thalamus or capsula external by brain CT or MRI.1.3The case exclusion criteria①Gestational or breast feeding woman;②Patients is allergy for using drugs;③Endangered patients when they reached hospital;④Bleeding site was diagnosed in brainstem, cerebellum, ventricle or subarachnoid space; ⑤Patients who midway lost or did not take drugs on time can’t judge or affect efficacy and safety of drugs;⑥The patients who had serious underlying diseases, such as coronary heart disease, chronic bronchitis inflammation, diabetes, hepatic or renal failure and so on.2. Methods and materials2.1Grouping rulesPatients who accord with selection criteria were randomly divided into three groups----33cases of Annaohuoxue capsules treatment group (group A),34cases of tiandantongluo capsules (group B) and32cases of placebo control group (group C).2.2experimental materialsSelecting Annaohuoxue capsules and Tiandantongluo capsules as the interference factors, placebo as the control group.2.3Dose regimenThree groups of patients are given foundation treatment, such as decompression, nutrition support, protect brain cells and so on, after7days of onset, group A took Annaohuoxue capsules; group B and C were given Tiandantongluo capsules and placebo respectively; the course of treatment was21days. Relevant observation indexes were recorded and compared in these groups before and after treatment.3. Observation indexes3.1Curative effect evaluation indexHemorrheology, score of neurological impairment, GCS,ICP were recorded and compared in these groups before and after treatment.3.2safety index of drugThe indexes of hepatic or renal function(ALT、BUN、CR) were recorded and compared in these groups before and after treatment.4. Statistical analysis The date will be analyse by SPSS13.0statistical software. Measurement data were described as Mean±SD, and every group before and after treatment using Paired-Samples T Test to compare; Comparisons of among groups adopts One-Way ANOVA before or after treatment, equal variances not assumed uses Welch approximate F Test,(according to test of homogeneity of variances, equal variances assumed to adopt LSD method, equal variances not assumed to adopt Dunnett T3method); Enumeration data using2Independent Sample Chi-square Test; Ranked data using Kruskal-Wallis H Test.[Results]13cases of patients lost in treatment process, others86cases of patients complete the prescribed course of treatment; the clinical data of every point-in-time collecting and entering without missing.1. Comparison of basal indexesThe sex ratio of three groups of patients were compared by the Chi-Square Test, the result showed that the difference has no statistically significant,(χ2=0.870, P值=0.647,);the age were compared by the One-Way ANOVA, the result showed that the difference has no statistically significant,(F值=1.466, P值=0.237).2. Curative effect evaluation index2.1Hemorrheology indexes2.1.1Plasma viscosity, blood high sheer viscosity, blood middle sheer viscosity, blood low sheer viscosity, erythrocyte aggregation index and ESR of three groups of patients were compared by Paired-Samples T Test before and after treatment, the result showed that the difference has statistically significant (P<0.01), Casson viscosity and relative viscosity has no statistically significant(P>0.05).2.1.2The hemorrheology indexes of three groups of patients were compared before treatment by the One-Way ANOVA, the result showed that the difference has no statistically significant (P>0.05)Plasma viscosity, blood high sheer viscosity, blood middle sheer viscosity, blood low sheer viscosity, erythrocyte aggregation index and ESR of three groups of patients were compared after treatment by the One-Way ANOVA, the result showed that the difference has statistically significant (P<0.05)2.2Score of Neurological ImpairmentThe score of neurological impairment of every groups were compared by Paired-Samples T Test before and after treatment, the result showed that the difference has statistically significant (P<0.01).The score of neurological impairment of group A, group B and group C before treatment were compared by the one-way ANOVA, the result showed that the difference has no statistically significant (P>0.05),and the contrastive result of after treatment showed that the difference has statistically significant (P<0.05)2.3Glasgow Coma ScaleThe GCS of every groups of patients were compared by Paired-Samples T Test before and after treatment, the result showed that the difference has statistically significant (P<0.05).The GCS of three groups of patients after treatment were compared by the One-Way ANOVA, the result showed that the difference has statistically significant (P<0.05)After3weeks, Prognosis classification of three groups of patients were compared by Kruskal-Wallis H test, the result showed that the difference has statistically significant P<0.05),according to Mean Rank,The Prognosis of group A and group B are better than group C.2.4Intracranial PressureThe ICP of every groups of patients were compared by Paired-Samples T Test before and after treatment, the result showed that the difference has statistically significant (P<0.01); The ICP of three groups after treatment were compared by the One-Way ANOVA, the result showed that the difference has no statistically significant (P>0.05)3. Safety index of drugPatients of three groups do not appear any discomfort or untoward effect, and the indexes of hepatic or renal function(ALT、BUN、CR) were normal; ALT、 BUN and CR of three groups of patients before and after treatment were compared by the Paired-Samples T Test, the result showed that the difference has no statistically significant (P>0.05);ALT、BUN and CR of three groups before and after treatment were compared by the One-Way ANOVA, the result showed that the difference has no statistically significant (P>0.05)[Conclusions]1. Through Huoxuehuayu prescription Annaohuoxue capsules and Tiandantongluo capsules to regulate the hemorrheology indexes, So as to improving blood physical and chemical properties, reducing blood viscosity, which can be propitious to increase cerebral blood flow, improve cerebral circulation and protect brain tissue.2. By to analysis and compare the score of neurological impairment and GCS before and after treatment, the patients of Annaohuoxue capsules groups and Tiandantongluo capsules groups had an obvious improvement, and is better than placebo group.3. This study demonstrated that the prognosis of Huoxuehuayu groups is superior to placebo group, so we think that Huoxuehuayu prescription is mainly through promoting absorption of intracerebral hematoma, improving the cerebrovascular microcirculation, reducing the brain cells toxicity by thrombin and vasoactive substances, improving the general condition and other aspects to play a role.4. Our clinical study discovered that the curative effect of Annaohuoxue capsules is better than Tiandantongluo capsules for patients with HICH, and the costs of Annaohuoxue capsules was lower than Tiandantongluo capsules, so the social and economic value of Annaohuoxue capsules was higher. |
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