隔药灸脐法治疗虚症失眠的临床研究
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摘要
目的
本临床随机对照研究评价隔药灸脐法对虚证失眠的临床疗效和安全性。
方法
研究对象为符合失眠中西医诊断标准的来自于台湾门诊的失眠患者,随机分为两组,一组采用隔药灸脐法治疗,另一组接受药物疗法。观察药物对睡眠质量、中医症候、PSQI指数和生活质量的改善作用。
结果
本研究最初纳入了226例病人,全部病例参与了安全性评价,可以参与疗效评价的有204例。治疗前两组病例的人口学特征(年龄、性别、体重、身高)、病例来源、生命体征(体温、心率、呼吸、血压)、药物过敏史、合并疾病、失眠程度、疗前病程等基线资料,经t检验或卡方检验差异无统计学意义(P>0.05),两组基线资料一致,具有可比性。
经过一个疗程的治疗,试验组在众多观察指标中均表现出优于对照组,具体表现在以下几个方面：
在改善睡眠质量方面,试验组和对照组均取得了良好的疗效,其中试验组有42.16%的病人其睡眠质量等级改善,对照组的改善率为27.45%,两组比较差异有统计学意义(P<0.05)。
在中医症候疗效方面,试验组和对照组的症候总积分由疗前的22.118±7.493和22.912±8.089下降到疗后的13.392±7.163和16.225±8.236,治疗前后差值分别为8.725±5.697和6.686±7.842,治疗前后中医症候积分的变化率分别为40.17%和25.48%,两组治疗后积分、治疗前后差值及变化率组间比较差异均有统计学意义(P<0.05)；试验组与对照组的中医证候疗效分别为71.59%和44.12%,组间差异有统计学意义(P<0.05)；治疗后试验组的单项症状包括多梦、心悸健忘和腹胀的评分等级均比疗前下降,各单项症状改善等级及消失率组间比较组间比较差异均有统计学意义(P<0.05)。
PSQI总分比较方面,试验组和对照组的PSQI总分由疗前的11.899±5.594和12.245±5.175下降到疗后的10.941±4.626和12.916±6.248,治疗前后差值分别为0.895±3.42和-0.67±4.05,治疗前后PSQI总分的变化率分别为40.17%和25.48%,两组治疗后积分、治疗前后差值及变化率组间比较差异均有统计学意义(P<0.05)；试验组与对照组的中医证候疗效分别为2.266%和-9.727%,组间差异有统计学意义(P<0.05)。试验组与对照组的中医证候疗有效率分别为77.45%和43.14%,组间差异有统计学意义(P<0.05)。
生活质量方面,治疗后试验组和对照组SF-36量表评分比疗前均无明显变化,试验组治疗前、后的SF-36量表评分分别为34.034±13.402和33.646±14.203；对照组治疗前、后的SF-36量表评分分别为31.276±12.038和30.434±13.63,前后差异均无统计学意义(P>0.05)。
本次试验过程中共出现33例39件不良事件,无严重不良事件发生。其中试验组出现18例22件,与药物相关的3例3件,对照组出现15例17件,与药物相关的3例3件,均表现为轻度腹泻。本试验无严重不良事件发生。除上述实验室检查异常已作为不良事件统计外,试验组和对照组其他受试者的血、尿常规及肝、肾功能和心电图等检查均未出现与试验药物相关的异常变化。
结论
隔药灸脐法对于治疗失眠症比口服药物具有更加安全、毒副作用小和患者无痛苦、适应性好的优点,且又有操作简便、节省药材等优点,故可广泛应用于临床。
Objective
In this randomized controlled clinical trial, we try to evaluate the clinical effect and safety of drug-separated moxibustion at the navel for insomnia with deficiency syndrome.
Method
Patients with insomnia who met diagnostic criteria of Traditional Chinese Medicine and Western Medicine from TaiWan outpatient department were recruited as research objects. They were randomly divided into two groups. One group (test group) was treated with drug-separated moxibustion at the navel and the other one (control group) was treated with drugs. The effect of Drugs for improving sleep quality, Traditional Chinese Medicine syndrome, index of PSQI and quality of life was observed.
Results
206 patients were recruited initially in this trial. All cases had involved in safety evaluation, yet 204 cases joined in effect evaluation. Baseline information including demography characteristic(age, gender, weight, stature), case source, vital signs (temperature, heart rate,respiratory rate, blood pressure), allergic history of drugs, accompanying diseases, insomnia severity, was analyzed by t test or chi-square test, and the result showed no significance statistically (P>0.05), indicating baseline information of the two groups was equivalent and comparable.
After a course of treatment, a number of indicators observed in the test group had shown more advantages than the control group, specifically on the following aspects:
The test and control group all made good effect in improving sleep quality. The test group had 42.16% of patients improved in the grade of their sleep quality while the control group had 27.45%.The difference was statistically significant (P<0.05).
On the Effective of TCM syndrome aspect, the total score of the syndrome were 22.118±7.493 in test group and 22.912±8.089 in control group before treatment and decreased to 13.392±7.163 and 16.225±8.236 respectively after treatment. The differences were 8.725±5.697 and 6.686±7.842. The variation rate of TCM syndrome scores were 40.17% and 25.48%. Comparing the two groups in total score after treatment, difference and the change rate before and after treatment, there were significant differences (P<0.05).
The therapeutic effect of TCM syndrome were 71.59% in test group and 44.12% in control group, showing statistically significant difference between the two groups (P<0.05);scoring single symptom including insomnia, palpitations, morbid forgetfulness and abdominal distension, the grades decreased than that of pre-treatment. Comparing the two groups of the improved grade at all single symptoms and disappearance rate, the differences were statistically significant (P<0.05).
PSQI total scores were 11.899±5.594 in test group and 12.245±5.175 in control group before treatment and decreased to 10.941±4.626 and 12.916±6.248 respectively after treatment.The differences were 0.895±3.42 and-0.67±4.05. The variation rate on PSQI total score were 40.17% and 25.48% before and after treatment. Comparing the total score after treatment, difference and the variation rate between the two groups before and after treatment, there were significant differences (P<0.05).
The effectiveness of TCM syndromes were 2.266% in test group and-9.727% in control group, showing statistically significant difference between the two groups (P<0.05).
The effective rate of TCM syndromes were 77.45% and 43.14%, meaning there was statistically significant difference in the two groups (P<0.05).
In the Quality of life, comparing the SF-36 scale scores in the two groups before and after treatment, there was no significant change. In test group, the SF-36 scale scores were 34.034±13.402 before treatment and 33.646±14.203 after treatment:in control group, they were 31.276±12.038 and 30.434±13.63, indicating that the differences were not statistically significant (P> 0.05).
In this study, we found 39 adverse events of 33 cases, but no severe adverse events. Test group had 22 adverse events of 18 cases, and 3 drug-related events of 3 cases. The control group had 15 adverse events of 15 cases, and 3 drug-related events of 3 cases, among whom all had mild diarrhea. In this trial,no serious adverse event was found.. In addition to these laboratory abnormalities treated as adverse events statistics, blood test, urine test, liver, renal function, ECG and other tests of other study subjects in the two groups showed no abnormal changes related to the test drug. Conclusion
Drug-separated moxibustion at the navel for treatment of insomnia is a therapy with more security.fewer toxic and side effect than the oral drugs. That Patients received this treatment have no pain and good adaptability.It's a simply and convenient method, with the advantages of saving medical material, so It can be applied in clinical.
本临床随机对照研究评价隔药灸脐法对虚证失眠的临床疗效和安全性。
方法
研究对象为符合失眠中西医诊断标准的来自于台湾门诊的失眠患者,随机分为两组,一组采用隔药灸脐法治疗,另一组接受药物疗法。观察药物对睡眠质量、中医症候、PSQI指数和生活质量的改善作用。
结果
本研究最初纳入了226例病人,全部病例参与了安全性评价,可以参与疗效评价的有204例。治疗前两组病例的人口学特征(年龄、性别、体重、身高)、病例来源、生命体征(体温、心率、呼吸、血压)、药物过敏史、合并疾病、失眠程度、疗前病程等基线资料,经t检验或卡方检验差异无统计学意义(P>0.05),两组基线资料一致,具有可比性。
经过一个疗程的治疗,试验组在众多观察指标中均表现出优于对照组,具体表现在以下几个方面：
在改善睡眠质量方面,试验组和对照组均取得了良好的疗效,其中试验组有42.16%的病人其睡眠质量等级改善,对照组的改善率为27.45%,两组比较差异有统计学意义(P<0.05)。
在中医症候疗效方面,试验组和对照组的症候总积分由疗前的22.118±7.493和22.912±8.089下降到疗后的13.392±7.163和16.225±8.236,治疗前后差值分别为8.725±5.697和6.686±7.842,治疗前后中医症候积分的变化率分别为40.17%和25.48%,两组治疗后积分、治疗前后差值及变化率组间比较差异均有统计学意义(P<0.05)；试验组与对照组的中医证候疗效分别为71.59%和44.12%,组间差异有统计学意义(P<0.05)；治疗后试验组的单项症状包括多梦、心悸健忘和腹胀的评分等级均比疗前下降,各单项症状改善等级及消失率组间比较组间比较差异均有统计学意义(P<0.05)。
PSQI总分比较方面,试验组和对照组的PSQI总分由疗前的11.899±5.594和12.245±5.175下降到疗后的10.941±4.626和12.916±6.248,治疗前后差值分别为0.895±3.42和-0.67±4.05,治疗前后PSQI总分的变化率分别为40.17%和25.48%,两组治疗后积分、治疗前后差值及变化率组间比较差异均有统计学意义(P<0.05)；试验组与对照组的中医证候疗效分别为2.266%和-9.727%,组间差异有统计学意义(P<0.05)。试验组与对照组的中医证候疗有效率分别为77.45%和43.14%,组间差异有统计学意义(P<0.05)。
生活质量方面,治疗后试验组和对照组SF-36量表评分比疗前均无明显变化,试验组治疗前、后的SF-36量表评分分别为34.034±13.402和33.646±14.203；对照组治疗前、后的SF-36量表评分分别为31.276±12.038和30.434±13.63,前后差异均无统计学意义(P>0.05)。
本次试验过程中共出现33例39件不良事件,无严重不良事件发生。其中试验组出现18例22件,与药物相关的3例3件,对照组出现15例17件,与药物相关的3例3件,均表现为轻度腹泻。本试验无严重不良事件发生。除上述实验室检查异常已作为不良事件统计外,试验组和对照组其他受试者的血、尿常规及肝、肾功能和心电图等检查均未出现与试验药物相关的异常变化。
结论
隔药灸脐法对于治疗失眠症比口服药物具有更加安全、毒副作用小和患者无痛苦、适应性好的优点,且又有操作简便、节省药材等优点,故可广泛应用于临床。
Objective
In this randomized controlled clinical trial, we try to evaluate the clinical effect and safety of drug-separated moxibustion at the navel for insomnia with deficiency syndrome.
Method
Patients with insomnia who met diagnostic criteria of Traditional Chinese Medicine and Western Medicine from TaiWan outpatient department were recruited as research objects. They were randomly divided into two groups. One group (test group) was treated with drug-separated moxibustion at the navel and the other one (control group) was treated with drugs. The effect of Drugs for improving sleep quality, Traditional Chinese Medicine syndrome, index of PSQI and quality of life was observed.
Results
206 patients were recruited initially in this trial. All cases had involved in safety evaluation, yet 204 cases joined in effect evaluation. Baseline information including demography characteristic(age, gender, weight, stature), case source, vital signs (temperature, heart rate,respiratory rate, blood pressure), allergic history of drugs, accompanying diseases, insomnia severity, was analyzed by t test or chi-square test, and the result showed no significance statistically (P>0.05), indicating baseline information of the two groups was equivalent and comparable.
After a course of treatment, a number of indicators observed in the test group had shown more advantages than the control group, specifically on the following aspects:
The test and control group all made good effect in improving sleep quality. The test group had 42.16% of patients improved in the grade of their sleep quality while the control group had 27.45%.The difference was statistically significant (P<0.05).
On the Effective of TCM syndrome aspect, the total score of the syndrome were 22.118±7.493 in test group and 22.912±8.089 in control group before treatment and decreased to 13.392±7.163 and 16.225±8.236 respectively after treatment. The differences were 8.725±5.697 and 6.686±7.842. The variation rate of TCM syndrome scores were 40.17% and 25.48%. Comparing the two groups in total score after treatment, difference and the change rate before and after treatment, there were significant differences (P<0.05).
The therapeutic effect of TCM syndrome were 71.59% in test group and 44.12% in control group, showing statistically significant difference between the two groups (P<0.05);scoring single symptom including insomnia, palpitations, morbid forgetfulness and abdominal distension, the grades decreased than that of pre-treatment. Comparing the two groups of the improved grade at all single symptoms and disappearance rate, the differences were statistically significant (P<0.05).
PSQI total scores were 11.899±5.594 in test group and 12.245±5.175 in control group before treatment and decreased to 10.941±4.626 and 12.916±6.248 respectively after treatment.The differences were 0.895±3.42 and-0.67±4.05. The variation rate on PSQI total score were 40.17% and 25.48% before and after treatment. Comparing the total score after treatment, difference and the variation rate between the two groups before and after treatment, there were significant differences (P<0.05).
The effectiveness of TCM syndromes were 2.266% in test group and-9.727% in control group, showing statistically significant difference between the two groups (P<0.05).
The effective rate of TCM syndromes were 77.45% and 43.14%, meaning there was statistically significant difference in the two groups (P<0.05).
In the Quality of life, comparing the SF-36 scale scores in the two groups before and after treatment, there was no significant change. In test group, the SF-36 scale scores were 34.034±13.402 before treatment and 33.646±14.203 after treatment:in control group, they were 31.276±12.038 and 30.434±13.63, indicating that the differences were not statistically significant (P> 0.05).
In this study, we found 39 adverse events of 33 cases, but no severe adverse events. Test group had 22 adverse events of 18 cases, and 3 drug-related events of 3 cases. The control group had 15 adverse events of 15 cases, and 3 drug-related events of 3 cases, among whom all had mild diarrhea. In this trial,no serious adverse event was found.. In addition to these laboratory abnormalities treated as adverse events statistics, blood test, urine test, liver, renal function, ECG and other tests of other study subjects in the two groups showed no abnormal changes related to the test drug. Conclusion
Drug-separated moxibustion at the navel for treatment of insomnia is a therapy with more security.fewer toxic and side effect than the oral drugs. That Patients received this treatment have no pain and good adaptability.It's a simply and convenient method, with the advantages of saving medical material, so It can be applied in clinical.
引文
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