| Objective: To evaluate the clinical safety and efficacy of Shenqitongluo capsuleto the treatment of acute ischemic cerebral stroke; to reveal the mechanism of actionof Shenqitongluo capsule from its effect on serum TNF-α, thus provide acomparatively objective basis for clinical application of Shenqitongluo capsule.Methods: Adopting the randomized and controlled clinical study method divided60cases of ischemic cerebral stroke patients with acute stroke into30cases ofShenqitongluo capsule treatment group (treatment group) and30cases ofconventional treatment control group (control group). The control group receivedroutine medical treatment while the treatment group took Shenqitongluo capsule onthe basis of conventional treatment. The two groups were treated for28days. After28days treatment, grade two groups of patients’ serum TNF-α content, NeurologicDeficit Scale(NDS) and Chinese medicine symptoms, and do statistics of patients’activities of daily living, adopting the computer spass18.0statistical analysis softwareto process data.Results:①The comparison of the two groups of patients’ general information:adapting chi-square test and t-test analyzed the two groups of patients’ gender, age,co-morbidity and past history of illness. The results showed no significant differencebetween the two groups and were comparable (P>0.05).②The comparison of twogroups of patients’ Neurologic Deficit Scale (NDS) and Chinese medicine syndromescore before treatment: compared by t-test,P>0.05, so two groups were comparable.③The comparison of two groups of patients’ Neurologic Deficit Scale (NDS) andactivities of daily living after treatment: the treatment group was superior to that inthe control group and there were significant differences (P <0.05).(4) Experimentaltest results showed that at7days and14days after treatment, the serum TNF-α oftreatment group significantly increased compared with the control group(P <0.05).⑤Safety observation: there were no obvious adverse reactions and the patients couldtolerate; patients in both groups completed the trial and no case of treatment interruption for serious adverse events.Conclusion:①The Shenqitongluo capsule can inhibit the formation of brainedema after acute ischemic cerebral stroke and promote the recovery of neurologicfunction of acute ischemic cerebral stroke patients. Besides, the clinical study foundno significant adverse reactions and side effects but safety.②Studies showed thatMMP-9level in the serum of patients with ischemic cerebral stroke significantlyincreased at three days after the onset of illness, but significantly decreased after theShenqitongluo capsule treatment group receiving treatment, suggesting theShenqitongluo capsule could improve patients’ condition through affecting theexpression of MMP-9and TNF-α. |