| Subject:To observe the curative effect and safety of the Traditional Chinese Medicine huang qi injection on both types of deficiency of both vital energy and yin and deficiency of heart-qi of the cardiac arrhythmia disease, which is caused by viral myocarditis (VM), through comparing with acyclovir, and explore the mechanism and offer the scientific basis for the further clinic application.Method:1. These are a total of 100 VM inpatients of Cardiac internal medicine department in Hubei Traditional Chinese Medicine Hospital and Wuhan Xiehe Hospital from September, 2007 to March, 2009. All cases were randomly divided into two groups: the treatment group (50 cases) and the control group(50 cases). They referred to the diagnostic criteria of Disease Diagnosis and Treatment Routine of Internal Traditional Chinese Medicine , Practice of Internal Medicine and Clinical Electrocardiography. These 50 patients in each group without significant difference in Sex,Age,symptom pattern and basic diseases between two groups ( P>0. 05 ). Both groups were treated with conventional therapy including bed rest, oxygen uptake, vitamin(e) C, coenzyme Q10 and polarized solution. Treatment group added huang qi injection and the control group added acyclovir. Total was one period of treatment, two weeks.2. Observing the symptoms,signs ( for example, palpitation, shortness of breath, fatigue, insomnia, dizziness, annoyed, night sweat, dry mouth, dry tongue and so on) and life quality, then asking and recording the improvement in every three days, comparing the total effective ratios and the curative effect before and after the treatment ,making a statistical disposal .3. Making the Rest ECG and Holter ECG examination and recording data before the treatment, then making the Rest ECG once per week and Holter ECG once per two weeks, until the end of the treatment, in order to compare their changes before and after.4. Assay and recording indicators of cardiac enzymes and troponin I in order to compare their changes, deal with statistical treatment, evaluate relationship between medicines and myocardium protection.5. Examing immunologic function: including the nature killer cell (NK) activity, assay of cytokine and humoral immunity in order to compare their changes before and after and evaluate the immunoregulation of the medicine.6. The blood-routine, urine-routine, stool-routine,liver-function and kidney function were examined to judge the side-effect or toxicity of the injection of Traditional Chinese Medicine7. The statistical method: The data was analyze after observation. The count materials,the measuring materials and the grade materials were examined with X~2,T-test and Ridit respectively.Result:1.1 This test shows that the curative effect , Chinese traditionalmedicine symptoms , Holter ECG, indicators of cardiac enzymes and troponin I and immunologic function of the treatment group areimproved after the treatment and better than that of the controlgroup.1.2 The general curative effect: the huang qi injection treatmentgroup: 17 cases had marked effect, 29 cases were effective, 4 hadno effect, the total effective rate was 92%; the acyclovir controlgroup: 10 cases had marked effect, 28 were effective, 12 had noeffect, the total effective rate was 76%. The effect of the treatmentgroup was better than the control group(p<0. 05).1. 3 The effect of the treatment: After treatment , there were markedeffect in both groups, but the total effective rate of decreasingthe degree of VPB or PACs of treatment group was much better thanthat of the control group, meaning that there was significantdifference between two groups (p<0. 05).1. 4 The Holter ECG: After treatment , the degree of VPB of two groupswere decreasing (P<0. 05 ) , meaning that the treatment in both groupwas effective, but the treatment group was better than the controlgroup, as a result, there was significant difference between twogroups (P <0. 05) .1. 5 The symptom of the Traditional Chinese Medicine: After treatment,the symptom of two groups were improved(p<0. 05), meaning that thetreatment in both group was effective, but the effective percentageof the treatment group (87%) was better than that of the controlgroup (63%), as a result, there was significant difference betweentwo groups (p<0. 05).1. 6 After the treatment, indicators of cardiac enzymes and troponinI decreased in both groups, but that of the treatment groupdecreased more significantly than the control group, as a result, there was statistical significant difference (p<0. 05).1.7 After the treatment, cytokine, TNF-α,IL-1,IL-6 decreased in both groups, and indicators of the treatment group decreased significantly and there was statistical significant difference (p<0. 05). But comparing to the control group, the treatment group decreased more, as a result, there was significant difference between two groups (p<0. 05).1.8 After the treatment, the activity of killer cell (NK) was improved in both groups and there was statistical significant difference between two groups (p<0. 05). The humoral immunity, IgA,IgG,IgM were all increased comparing to the normal group and there was statistical significant difference (p<0.05). After two weeks, each indicator of treatment group decreased significantly and there was statistical significant difference between two groups (p<0. 05).2. Relevance analysis: This test shows that there is no overt relationship between the clinical effectiveness and patients' age, sex, course of disease and clinical manifestation, prompting that this medicine is applicable to patients with different age, sex, course of disease and clinical manifestation.3. Safety analysis: The blood-routine,urine-routine,stool-routine,liver-function and kidney function have no significant change before and after the 50 patients finish the treatment in the treatment group and prompting that this medicine has no obvious side-effect or toxicity.Conclusion:The study proved that huang qi injection may relieve symptoms of patients with cardiac arrhythmia caused by VM. It can decrease degree of VPB, improve the symptom, increase the NK activity and improve the cardiac enzymes indicators and shows that the clinical effectiveness of the treatment group is better than the control group. As a result, it is a safe and effective drug in treating patients with cardiac arrhythmia. |
PDF Full Text Request