针药并用对更年期综合征肝郁肾虚患者心身症状影响的临床研究
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摘要
目的
观察针药并用治疗更年期综合征肝郁肾虚患者的临床有效性和安全性。
方法
采用随机对照单盲的试验方法,将符合纳入标准的更年期综合征患者随机分配到治疗组和对照组,按照1：1的比例。治疗组采用针刺联合中药治疗,对照组采用针刺联合模拟中药治疗。以绝经综合征症状评定量表(KI)、更年期生存质量量表和中医证候评分量表的积分改善情况为疗效指标,观察针药并用治疗更年期综合征的有效性和安全性。
结果
本临床试验共入组更年期综合征病例64例,治疗组与对照组分别为32例,其中,治疗组组脱落1例,剔除1例,对照组脱落2例。两组最终纳入分析的病例数为每组30例。两组病例的年龄、体重、身高、生命体征、疗前KI积分、中医证候积分、生存质量评分、病程、初潮年龄、月经周期、经期、婚姻状况、既往治疗史、药物过敏史、合并疾病和疗前用药等疗前基线资料,经统计学检验,差异无统计学意义(P>0.05),两组基线资料一致,具有可比性。
疗效性结果：
①治疗组与对照组治疗前KI积分分别为32.36±13.51和30.89±11.56,治疗后KI积分均比治疗前低。两组治疗后的KI积分和治疗前后的KI积分差值,经t检验,组间比较差异均无统计学意义(P>0.05)。两组治疗前后KI积分组内比较,经配对t检验,组内比较差异均无统计学意义(P>0.05)。
②治疗组与对照组治疗前更年期生存质量积分分别为129.53±9.84和128.16±11.49,治疗后分别113.74±18.25和113.05±20.37,治疗前后差值分别为15.74±21.06和15.11±19.14,治疗后更年期生存质量积分均比治疗前低。两组治疗后的更年期生存质量积分和治疗前后的更年期生存质量积分差值,经t检验,组间比较差异均无统计学意义(P>0.05)。两组治疗前后更年期生存质量积分组内比较,经配对t检验,组内比较差异均有统计学意义(P<0.05)。
③治疗组与对照组治疗前中医证候量表积分分别为4.15±0.44和4.18±0.43,治疗后分别3.71±0.55和3.78±0.60,治疗前后差值分别为0.44±0.69和0.40±0.62,治疗后中医证候量表积分均比治疗前低。两组治疗后中医证候量表积分和治疗前后的中医证候量表积分差值,经t检验,组间比较差异均无统计学意义(P>0.05)。两组治疗前后中医证候量表积分组内比较,经配对t检验,组内比较差异均有统计学意义(P<0.05)。
④治疗组与对照组的中医证候总疗效分别为90%和70%,两组疗效等级分布和总有效率比较,经单向有序CHM检验或卡方检验,差异均有统计学意义(P<0.05)。
⑤治疗组与对照组的单项症状疗效分析显示,难入睡易醒这个症状的治疗后有效率比较,经四格表卡方检验,两组组间差异有统计学意义(P<0.05)。烘热汗出、腰酸,胸闷胁痛和口苦症状的有效率比较,治疗组均高于对照组,经四格表卡方检验,两组组间差异无统计学意义。
安全性结果：两组均未观察到不良事件。
结论
本试验研究结果显示,针药并用治疗更年期综合征有效安全。
Purpose
To observe the safety and clinical effect of treating menopausal syndrome of the liver qi stagnation and kidney deficiency syndrome with acupuncture and herbal application. Method
Using randomized controlled single blinded testing method, qualified menopause patients were divided into treatment and control groups with a one to one ratio. The treatment group was treated with acupuncture and herbal concoction, while the control group was treated with acupuncture and concoction made with simulated herbs. After treatment, the safety and curative effects were evaluated using the following indices:the Menopause Rating Scale (MRS), the Quality of Life Scale for menopause, and the Rating Scale of TCM syndromes. Results
A total of 64 patients were randomly divided into 2 groups, with each having 32 patients in each group. Throughout the course of treatment, one case was withdrawn and one was removed from the treatment group, and 2 were removed from the control group. The final count for both groups was 30. Before treatment, indices recorded include:age, weight, height, vital signs, KI score before treatment, TCM syndrome score, quality of life score, course of disease, age at menarche, menstrual cycle, menstrual symptoms, marital status, medical history, drug allergy history, concomitant disease and information regarding any taken medication. The above indices were not statistically significantly different (p>0.05) before treatment, thus, were comparable between the two groups.
Curative Effects:
1. Before treatment, the KI score of the treatment and control groups were 32.36±13.51 and 30.89±11.56 respectively. The scores for both groups dropped after treatment. The score differences before and after treatment for both treatment and control groups were analyzed using the t test, and found that they were not significantly different (p>0.05). Likewise, comparing the group differences in the before and after treatment scores using the paired (?) test, the result showed no significant difference (p>0.05)
2. The menopause quality of life score for the treatment and control groups before treatment were 129.53±9.84 and 128.16±11.49, and those after treatment were 113.74±18.25 and 113.05±20.37, respectively. The differences before and after treatment for the two groups were 15.74±21.06 and 15.11±19.14, respectively. The scores were lower after treatment in both groups. The difference before and after treatment for both groups were analyzed using the t test, and found that they were not significantly different (p>0.05). When comparing the group differences using the paired t test, however, the results were statistically significant (p<0.05)
3. The TCM syndrome scores for the treatment and control group before treatment were 4.15±0.44 and 4.18±0.43, and those after treatment were 3.71±0.55 and 3.78±0.60, respectively. The differences before and after treatment for the two groups were 0.44±0.69 and 0.40±0.62, respectively. The scores lowered after treatment for both groups. The differences before and after treatment for both groups were analyzed using the t test, and found that they were not significantly different (p>0.05). When comparing the group differences using the paired t test, however, the results were statistically significant (p<0.05)
4. The TCM syndrome total effective rate for the treatment and control groups were 90% and 70%, respectively. Using the Chi-square test, the group differences in effectiveness distribution and total effective rate were analyzed, and found that the results were significantly different (p<0.05)
5. Analyzing individual symptom between treatment and control groups using the chi-square test, light sleep patients found there was significant improvement after treatment (p<0.05). The effective rates regarding symptoms such as hot flashes, soreness in the lower back, tightness in the chest, hypochondriac pain, and bitterness in the mouth were higher for the treatment group; the group difference was analyzed using the chi-square test, the results showed no significant difference. No abnormal clinical observations or adverse reactions recorded. Conclusion
Treatment of menopause of the stagnation of liver qi and kidney deficiency syndrome using acupuncture and herbal intake is safe and effective.
观察针药并用治疗更年期综合征肝郁肾虚患者的临床有效性和安全性。
方法
采用随机对照单盲的试验方法,将符合纳入标准的更年期综合征患者随机分配到治疗组和对照组,按照1：1的比例。治疗组采用针刺联合中药治疗,对照组采用针刺联合模拟中药治疗。以绝经综合征症状评定量表(KI)、更年期生存质量量表和中医证候评分量表的积分改善情况为疗效指标,观察针药并用治疗更年期综合征的有效性和安全性。
结果
本临床试验共入组更年期综合征病例64例,治疗组与对照组分别为32例,其中,治疗组组脱落1例,剔除1例,对照组脱落2例。两组最终纳入分析的病例数为每组30例。两组病例的年龄、体重、身高、生命体征、疗前KI积分、中医证候积分、生存质量评分、病程、初潮年龄、月经周期、经期、婚姻状况、既往治疗史、药物过敏史、合并疾病和疗前用药等疗前基线资料,经统计学检验,差异无统计学意义(P>0.05),两组基线资料一致,具有可比性。
疗效性结果：
①治疗组与对照组治疗前KI积分分别为32.36±13.51和30.89±11.56,治疗后KI积分均比治疗前低。两组治疗后的KI积分和治疗前后的KI积分差值,经t检验,组间比较差异均无统计学意义(P>0.05)。两组治疗前后KI积分组内比较,经配对t检验,组内比较差异均无统计学意义(P>0.05)。
②治疗组与对照组治疗前更年期生存质量积分分别为129.53±9.84和128.16±11.49,治疗后分别113.74±18.25和113.05±20.37,治疗前后差值分别为15.74±21.06和15.11±19.14,治疗后更年期生存质量积分均比治疗前低。两组治疗后的更年期生存质量积分和治疗前后的更年期生存质量积分差值,经t检验,组间比较差异均无统计学意义(P>0.05)。两组治疗前后更年期生存质量积分组内比较,经配对t检验,组内比较差异均有统计学意义(P<0.05)。
③治疗组与对照组治疗前中医证候量表积分分别为4.15±0.44和4.18±0.43,治疗后分别3.71±0.55和3.78±0.60,治疗前后差值分别为0.44±0.69和0.40±0.62,治疗后中医证候量表积分均比治疗前低。两组治疗后中医证候量表积分和治疗前后的中医证候量表积分差值,经t检验,组间比较差异均无统计学意义(P>0.05)。两组治疗前后中医证候量表积分组内比较,经配对t检验,组内比较差异均有统计学意义(P<0.05)。
④治疗组与对照组的中医证候总疗效分别为90%和70%,两组疗效等级分布和总有效率比较,经单向有序CHM检验或卡方检验,差异均有统计学意义(P<0.05)。
⑤治疗组与对照组的单项症状疗效分析显示,难入睡易醒这个症状的治疗后有效率比较,经四格表卡方检验,两组组间差异有统计学意义(P<0.05)。烘热汗出、腰酸,胸闷胁痛和口苦症状的有效率比较,治疗组均高于对照组,经四格表卡方检验,两组组间差异无统计学意义。
安全性结果：两组均未观察到不良事件。
结论
本试验研究结果显示,针药并用治疗更年期综合征有效安全。
Purpose
To observe the safety and clinical effect of treating menopausal syndrome of the liver qi stagnation and kidney deficiency syndrome with acupuncture and herbal application. Method
Using randomized controlled single blinded testing method, qualified menopause patients were divided into treatment and control groups with a one to one ratio. The treatment group was treated with acupuncture and herbal concoction, while the control group was treated with acupuncture and concoction made with simulated herbs. After treatment, the safety and curative effects were evaluated using the following indices:the Menopause Rating Scale (MRS), the Quality of Life Scale for menopause, and the Rating Scale of TCM syndromes. Results
A total of 64 patients were randomly divided into 2 groups, with each having 32 patients in each group. Throughout the course of treatment, one case was withdrawn and one was removed from the treatment group, and 2 were removed from the control group. The final count for both groups was 30. Before treatment, indices recorded include:age, weight, height, vital signs, KI score before treatment, TCM syndrome score, quality of life score, course of disease, age at menarche, menstrual cycle, menstrual symptoms, marital status, medical history, drug allergy history, concomitant disease and information regarding any taken medication. The above indices were not statistically significantly different (p>0.05) before treatment, thus, were comparable between the two groups.
Curative Effects:
1. Before treatment, the KI score of the treatment and control groups were 32.36±13.51 and 30.89±11.56 respectively. The scores for both groups dropped after treatment. The score differences before and after treatment for both treatment and control groups were analyzed using the t test, and found that they were not significantly different (p>0.05). Likewise, comparing the group differences in the before and after treatment scores using the paired (?) test, the result showed no significant difference (p>0.05)
2. The menopause quality of life score for the treatment and control groups before treatment were 129.53±9.84 and 128.16±11.49, and those after treatment were 113.74±18.25 and 113.05±20.37, respectively. The differences before and after treatment for the two groups were 15.74±21.06 and 15.11±19.14, respectively. The scores were lower after treatment in both groups. The difference before and after treatment for both groups were analyzed using the t test, and found that they were not significantly different (p>0.05). When comparing the group differences using the paired t test, however, the results were statistically significant (p<0.05)
3. The TCM syndrome scores for the treatment and control group before treatment were 4.15±0.44 and 4.18±0.43, and those after treatment were 3.71±0.55 and 3.78±0.60, respectively. The differences before and after treatment for the two groups were 0.44±0.69 and 0.40±0.62, respectively. The scores lowered after treatment for both groups. The differences before and after treatment for both groups were analyzed using the t test, and found that they were not significantly different (p>0.05). When comparing the group differences using the paired t test, however, the results were statistically significant (p<0.05)
4. The TCM syndrome total effective rate for the treatment and control groups were 90% and 70%, respectively. Using the Chi-square test, the group differences in effectiveness distribution and total effective rate were analyzed, and found that the results were significantly different (p<0.05)
5. Analyzing individual symptom between treatment and control groups using the chi-square test, light sleep patients found there was significant improvement after treatment (p<0.05). The effective rates regarding symptoms such as hot flashes, soreness in the lower back, tightness in the chest, hypochondriac pain, and bitterness in the mouth were higher for the treatment group; the group difference was analyzed using the chi-square test, the results showed no significant difference. No abnormal clinical observations or adverse reactions recorded. Conclusion
Treatment of menopause of the stagnation of liver qi and kidney deficiency syndrome using acupuncture and herbal intake is safe and effective.
引文
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