| Objectives:To investigate the clinical efficacy and safety of hyperbaric oxygen assist therapy on patients with acute hypertensive cerebral hemorrhage.Methods:1.The randomized, double blind, placebo controlled clinical trial was measured. Patients with acute hypertensive cerebral hemorrhage who were admitted to department of Neurology of The Chengdu Military Command General Hospital in Kunming from March 2014 to January 2016 were retrospectively analyzed. According to the order of hospital admission, the patients were randomly divided into treatment group and control group by SPSS statistical software. The clinical data of patients were collected, which includes sex, age, delay time (hours), histories on hypertension and diabetes, hyperlipidemia, histories on stroke, smoking, drinking, and medication. In keeping with the diagnosis and treatment guidelines of cerebral hemorrhage in China in 2014, patients in treatment group were treated by hyperbaric oxygen therapy, and the control group was treated with normal pressure oxygen therapy.2.The laboratory test index of patients, neurological deficit scores (NIHSS), Glasgow coma scale score (GCS), Oxford disability scale score (OHS), and brain imaging examination were collected at the time of admission, the third day of disease onset, and the end of treatment, respectively. After 90 days of disease onset, we have been following these patients to record the whereabouts of them, the survival status, the death cause, NIHSS, OHS, the adverse outcome of cardiovascular, and the secondary preventive measures.3.The measurement data of this study indicated mean ± standard deviation (X±s). The dates following the normaldistribution all were analyzed by homogeneity test of variances, if it is significant difference, we used t-test between two groups, and differences among groups were compared with one-way analysis of variance (One-Way ANOVA), pairwise comparison in multiple groups was conducted with least significant difference method (LSD-test); if it is no significant difference, the t’-test was used. But if it did not follow the normal distribution, the rank-sum test was used to analyze the data. The count data use composition, count data between the two groups were compared with chi-square test, R × C table Chi-square test was used to compared multiple groups of data, and then splitting multiple count data into a number of four grid table data to be analyzed with multiple group chi-square test. The inspection standard of a= 0.05, p< 0.05 indicates statistics meanings. All the data of this study were statistically analyzed by SPSS17.0 statistics software.Results:1.Clinical 120 patients were selected in this study, and 23 cases were excluded, and finial 97 cases were enrolled. The study took the randomized trial methods and classified 48 cases into the treatment group, and 49 cases in to the controlled group. The lowest age is 49 years old, and the highest is 75 years old, and the average age is (58.38 ± 10.90). The baseline information of these two groups on the main indicators showed no statistical significance, which is comparable.2.The comparison of the volume of cerebral hematoma and brain edema around hematoma in these two groups. At the third day of disease onset, the volume of cerebral hematoma and brain edema around hematoma in the two groups had no significant difference (p> 0.05). At the end of treatment, the volume of hematoma had no statistical difference between treatment group and controlled group (3.98±3.08vs5.38±4.81,t=-1.690, P=0.094); and the volume of brain edema around hematoma in treatment group is less than that of the control group (2.86±2.76vs5.85±4.82,t=-3.730, P=0.000).3.The comparison of NIHSS scores between the two groups at each follow-up period. At the third day of disease onset, NIHSS scores had no obvious differences between treatment group and controlle group (8.98±4.11 vs 9.22±4.23, t=-0.293, P=0.770); Following up at the end of treatment and 90 days after the onset of disease, the NIHSS scores in treatment group were all lower than that of the control group (4.42±2.67vs5.82±3.27,t=-2.305,P=0.023; 1.44±1.35vs.3.92±2.22, t=-7.309,P-0.000).4.The comparison of disability status between the two groups. At the third day of disease onset, the disability status in treatment group and control group shared similar situation (72.92%vs67.35%, χ2=0.359,P=0.658); Following up at the end of treatment and 90 days after the onset of disease, the obtained data showed that the disability of treatment group was all lower than that of the control group (33.33%vs55.10%, χ2=4.602, P=0.042; 12.15%vs38.77,χ2=8.751, P=0.005).5. At 90 days after the onset of the disease, the comparison of recurrence rate and mortality between the two groups. There were no significant differences in the treatment group and control group (6.25%vsl0.20%, χ2=0.115, P=0.735; 4.17%vs6.12,χ2=0.000, P=1.000).6. After treatment, the laboratory data of patients in the two groups were compared. The fibrinogen (FIB) of treatment group was lower than control group (3.13±0.89 mg/dL vs.3.57±1.07 mg/dL, t=-2.215,P=0.029); the platelet counts of treatment group were lower than control group (202.23±53.87*109/L vs.254.55±72.66*107L, t=-4.022,P=0.000); the blood urea nitrogen (BUN) of treatment group was lower than control group (4.33±1.18 mmol/L vs 5.48±1.20 mmol/L, t=-4.775,P=0.000);the serum creatinine of treatment group was lower than control group (75.38±10.85μmol/L vs 81.55±9.78μmol/L, t=-2.919, P=0.004);the blood D-dimer(D-D) of treatment group was lower than control group(0.30±0.15 mg/L vs 0.53±0.21 mg/L, t=-6.347,P=0.000).7. The comparison of complication occurrence rate in the two groups during treatment. The complication occurrence rate of hyperbaric oxygen treatment group was lower than control group (18.75%vs44.90%, χ2=7.624, P=0.009).8. There were none death in the two groups during treatment. Only individual patients were with occasional ear discomfort in hyperbaric oxygen treatment, but the chewing and ear massage can relieve the symptoms.Conclusions:1.Applying the hyperbaric oxygen treat patients with acute hypertensive cerebral hemorrhage, which contributes to reduce cerebral edema around hematoma and improve the degree of neurological deficits and reduce disability rate, however, it may be fail to promote the absorption of cerebral hematoma.2.The hyperbaric oxygen therapy can not reduce recurrence rate and mortality of patients with hypertensive intracerebral hemorrhage at 90 days after the onset of the disease.3.The hyperbaric oxygen therapy can ease the laboratory data of FIB, PLT, BUN, Scr, and D-D in patients with hypertensive cerebral hemorrhage, and it can improve the laboratory data and not damage the renal function.4.The hyperbaric oxygen therapy can reduce the complications of patients with hypertensive cerebral hemorrhage at acute stage.5.The hyperbaric oxygen therapy has better security for patients with acute hypertensive intracerebral hemorrhage. |
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