肾虚血瘀型子宫内膜异位症痛经的临床研究
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摘要
目的
本试验采用临床随机对照的方法,评价加味罗氏田七痛经散治疗肾虚血瘀型子宫内膜异位症痛经的临床有效性和安全性。
方法
研究对象为符合西医子宫内膜异位症痛经和中医辨证属于肾虚血瘀的患者。将患者随机分为试验组和对照组,试验组服用加味罗氏田七痛经散,对照组服用失笑散,两组药物均口服3个疗程。以月经周期、经量、经色、经质的变化,尤其是经期疼痛程度及伴随症状变化为疗效观察目标。
结果
本研究共有合格受试者80例,试验组40例,对照组40例,均为门诊病人。西医诊断为痛经,中医辨证均属于肾虚血瘀证。两组治疗前年龄、病程、病情程度、疾病分期、异位部位、月经情况、临床症状、基础体温、舌象、脉象及病灶大小、CA-125等比较,差异均无统计意义,两组具有可比性。
经过3个疗程的治疗,试验组临床痊愈率为62.5%,显效率为17.5%,有效率为12.5%,临床痊愈率及显效率为80.0%,总有效率为92.5%；对照组临床痊愈率为40.0%,显效率为20.0%,有效率为27.5%,临床痊愈率及显效率为60.0%,总有效率为87.5%。两组比较,差异有统计意义。试验组治疗3个疗程后痛经消失率为65.0%,对照组为42.5%,两组比较,差异有统计意义。
试验组和对照组巧克力囊肿平均直径由治疗前的4.32±1.26(cm)和3.88±1.35(cm),治疗3月后,缩小至2.79±1.03(cm)和3.14±1.15(cm)。两组囊肿大小改善情况组间比较,差异有统计意义(P<0.05)。试验组和对照组治疗前后组内比较,差异均有统计意义(P<0.01)。提示：加味罗氏田七痛经散组和失笑散组患者卵巢巧克力囊肿较治疗前均明显缩小,而加味罗氏田七痛经散能显著缩小巧克力囊肿。
试验组和对照组结节病灶平均直径由治疗前的3.17±1.54(cm)和2.96±1.30(cm),治疗3月后,缩小至1.97±0.75(cm)和2.23±0.88(cm)。两组结节大小改善情况组间比较,差异无统计意义(P>0.05)。试验组和对照组治疗前后组内比较,差异均有统计意义(P<0.01)。提示：加味罗氏田七痛经散和失笑散均可明显缩小结节病灶。
试验组血清CA-125从治疗前56.26±8.71(ug／L),在治疗后第1个月经周期、第2个月经周期、第3个月经周期比治疗前分别下降23.17±7.32、34.17±7.23、40.53±6.46(ug／L)。对照组血清CA-125从治疗前54.30±7.65(ug／L),在治疗后第1个月经周期、第2个月经周期、第3个月经周期分别下降18.81±6.88、28.84±7.06、36.12±6.72(ug／L)。两组血清CA-125改善情况组间比较,差异有统计意义。试验组和对照组治疗前后组内比较,差异均有统计意义。
整个临床试验过程中未发现任何实验室指标异常,也未发现任何不良反应。结论
1.加味田七痛经散治疗肾虚血瘀型子宫内膜异位症具有显著疗效,能明显缓解痛经,并改善其他临床症状。治疗3个月经周期后的痛经消失率为65.0%,与对照组比较,差异有显著性。
2.以加味田七痛经散治疗3个月经周期后,盆腔子宫内膜异位症病灶(卵巢巧克力囊肿和结节病灶)得到控制,血清CA-125水平下降,月经周期与经期、经量趋于正常。提示加味田七痛经散治疗过程对卵巢功能没有影响。
加味罗氏田七痛经散治疗子宫内膜异位症痛经具有显著疗效,能明显减轻患者的临床症状,缩小囊肿、结节病灶,毒副反应少,值得临床广泛推广。
Objective
Using a randomized controlled method, the study observes the safety and therapeutic effect of taking Luo's jiawei tianqi tongjing san in the treatment of endometriosis-related dysmenorrhea of the kidney deficient and blood stasis syndrome.
Method
Patients in the study must qualify the Western medicine diagnosis of endometriosis-related dysmenorrhea and the TCM diagnosis of the kidney deficient and blood stasis syndrome. They were randomly divided into treatment and control group. The patients in the treatment group were prescribed Luo's tianqi tongjing san, while those in the control group were given shixiao san. The prescriptions were to be taken for 3 courses of treatment. The patients'menstrual cycle, volume, color, and change in menstruation, especially the level of menstrual pain and any accompanying symptoms were monitored.
Results
The study had a total of 80 qualified patients from the out-patients department; each group contained 40 subjects. Before treatment, their age, course, severity, staging of disease, the site and volume of endometriosis, menstrual condition, basal body temperature, tongue and pulse diagnosis, and blood CA-125 level were assessed, and found that there was no significant group difference; thus, the groups were comparable.
After 3 courses of treatment, the treatment group resulted in a curative rate of 62.5%, very effective rate of 17.5%, effective of 12.5%, the curative and very effective rate amount to 80.0%, and the total effective rate was 92.5%; for the control group, the curative rate was 40.0%, very effective rate of 20.0%, effective of 27.5%, the curative and very effective rate amount to 60.0%, and the total effective rate was 87.5%. The group difference was statistically significant. The rate of improvement after 3 courses of treatment for the treatment group was 65.0%, and that for the control group was 42.5%; their group difference was also statistically significant.
The average diameter of the endometrial cyst for the treatment and control group was 4.32±1.26cm and 3.88±1.35, respectively before treatment, and they respectively shrunk to 2.79±1.03cm and 3.14±1.15cm after 3 courses of treatment. The group difference was statistically significant (p<0.05), and the difference within each group showed statistical significance as well (p<0.01). Both Luo's jiawei tianqi tongjing san and shixiao san were effective in reducing the size of the endometrial cyst, but the former was more effective than the latter.
Before treatment, the average diameter of the endometrial lesions for the treatment and control group was 3.17±1.54cm and 2.96+1.30cm, respectively; after 3 courses of treatment however, the lesions decreased to 1.97±0.75cm and 2.23±0.88cm for the two groups. The change was not significantly different between the groups. However, the change within the groups showed significant difference (p<0.01), which demonstrates that both Luo's jiawei tianqi tongjing san and shixiao san were effective in reducing the size of the endometrial lesions.
The serum CA-125 level for the treatment group was 56.26±8.71μg/L before treatment, and after one, two and three courses of treatment, the level dropped to 23.17±7.32μg/L,34.17±7.23μg/L and 40.53±6.46μg/L, respectively. As for the control group, it was 54.30±7.65μg/L before treatment, and after 1,2 and 3 courses, the level dropped to 18.81±6.88μg/L,28.84±7.06μg/L, 36.12±6.72μg/L, respectively. The group difference and the difference with each group showed statistical significance.
The study did not encounter any abnormal lab readings or adverse reactions in patients. Conclusion
Luo's jiawei tianqi tongjing san was effective in treating endometriosis-related dysmenorrhea. It improved clinical symptoms, reduced the dimension of both endometrial cyst and lesion. It was both safe and effective for common practice.
本试验采用临床随机对照的方法,评价加味罗氏田七痛经散治疗肾虚血瘀型子宫内膜异位症痛经的临床有效性和安全性。
方法
研究对象为符合西医子宫内膜异位症痛经和中医辨证属于肾虚血瘀的患者。将患者随机分为试验组和对照组,试验组服用加味罗氏田七痛经散,对照组服用失笑散,两组药物均口服3个疗程。以月经周期、经量、经色、经质的变化,尤其是经期疼痛程度及伴随症状变化为疗效观察目标。
结果
本研究共有合格受试者80例,试验组40例,对照组40例,均为门诊病人。西医诊断为痛经,中医辨证均属于肾虚血瘀证。两组治疗前年龄、病程、病情程度、疾病分期、异位部位、月经情况、临床症状、基础体温、舌象、脉象及病灶大小、CA-125等比较,差异均无统计意义,两组具有可比性。
经过3个疗程的治疗,试验组临床痊愈率为62.5%,显效率为17.5%,有效率为12.5%,临床痊愈率及显效率为80.0%,总有效率为92.5%；对照组临床痊愈率为40.0%,显效率为20.0%,有效率为27.5%,临床痊愈率及显效率为60.0%,总有效率为87.5%。两组比较,差异有统计意义。试验组治疗3个疗程后痛经消失率为65.0%,对照组为42.5%,两组比较,差异有统计意义。
试验组和对照组巧克力囊肿平均直径由治疗前的4.32±1.26(cm)和3.88±1.35(cm),治疗3月后,缩小至2.79±1.03(cm)和3.14±1.15(cm)。两组囊肿大小改善情况组间比较,差异有统计意义(P<0.05)。试验组和对照组治疗前后组内比较,差异均有统计意义(P<0.01)。提示：加味罗氏田七痛经散组和失笑散组患者卵巢巧克力囊肿较治疗前均明显缩小,而加味罗氏田七痛经散能显著缩小巧克力囊肿。
试验组和对照组结节病灶平均直径由治疗前的3.17±1.54(cm)和2.96±1.30(cm),治疗3月后,缩小至1.97±0.75(cm)和2.23±0.88(cm)。两组结节大小改善情况组间比较,差异无统计意义(P>0.05)。试验组和对照组治疗前后组内比较,差异均有统计意义(P<0.01)。提示：加味罗氏田七痛经散和失笑散均可明显缩小结节病灶。
试验组血清CA-125从治疗前56.26±8.71(ug／L),在治疗后第1个月经周期、第2个月经周期、第3个月经周期比治疗前分别下降23.17±7.32、34.17±7.23、40.53±6.46(ug／L)。对照组血清CA-125从治疗前54.30±7.65(ug／L),在治疗后第1个月经周期、第2个月经周期、第3个月经周期分别下降18.81±6.88、28.84±7.06、36.12±6.72(ug／L)。两组血清CA-125改善情况组间比较,差异有统计意义。试验组和对照组治疗前后组内比较,差异均有统计意义。
整个临床试验过程中未发现任何实验室指标异常,也未发现任何不良反应。结论
1.加味田七痛经散治疗肾虚血瘀型子宫内膜异位症具有显著疗效,能明显缓解痛经,并改善其他临床症状。治疗3个月经周期后的痛经消失率为65.0%,与对照组比较,差异有显著性。
2.以加味田七痛经散治疗3个月经周期后,盆腔子宫内膜异位症病灶(卵巢巧克力囊肿和结节病灶)得到控制,血清CA-125水平下降,月经周期与经期、经量趋于正常。提示加味田七痛经散治疗过程对卵巢功能没有影响。
加味罗氏田七痛经散治疗子宫内膜异位症痛经具有显著疗效,能明显减轻患者的临床症状,缩小囊肿、结节病灶,毒副反应少,值得临床广泛推广。
Objective
Using a randomized controlled method, the study observes the safety and therapeutic effect of taking Luo's jiawei tianqi tongjing san in the treatment of endometriosis-related dysmenorrhea of the kidney deficient and blood stasis syndrome.
Method
Patients in the study must qualify the Western medicine diagnosis of endometriosis-related dysmenorrhea and the TCM diagnosis of the kidney deficient and blood stasis syndrome. They were randomly divided into treatment and control group. The patients in the treatment group were prescribed Luo's tianqi tongjing san, while those in the control group were given shixiao san. The prescriptions were to be taken for 3 courses of treatment. The patients'menstrual cycle, volume, color, and change in menstruation, especially the level of menstrual pain and any accompanying symptoms were monitored.
Results
The study had a total of 80 qualified patients from the out-patients department; each group contained 40 subjects. Before treatment, their age, course, severity, staging of disease, the site and volume of endometriosis, menstrual condition, basal body temperature, tongue and pulse diagnosis, and blood CA-125 level were assessed, and found that there was no significant group difference; thus, the groups were comparable.
After 3 courses of treatment, the treatment group resulted in a curative rate of 62.5%, very effective rate of 17.5%, effective of 12.5%, the curative and very effective rate amount to 80.0%, and the total effective rate was 92.5%; for the control group, the curative rate was 40.0%, very effective rate of 20.0%, effective of 27.5%, the curative and very effective rate amount to 60.0%, and the total effective rate was 87.5%. The group difference was statistically significant. The rate of improvement after 3 courses of treatment for the treatment group was 65.0%, and that for the control group was 42.5%; their group difference was also statistically significant.
The average diameter of the endometrial cyst for the treatment and control group was 4.32±1.26cm and 3.88±1.35, respectively before treatment, and they respectively shrunk to 2.79±1.03cm and 3.14±1.15cm after 3 courses of treatment. The group difference was statistically significant (p<0.05), and the difference within each group showed statistical significance as well (p<0.01). Both Luo's jiawei tianqi tongjing san and shixiao san were effective in reducing the size of the endometrial cyst, but the former was more effective than the latter.
Before treatment, the average diameter of the endometrial lesions for the treatment and control group was 3.17±1.54cm and 2.96+1.30cm, respectively; after 3 courses of treatment however, the lesions decreased to 1.97±0.75cm and 2.23±0.88cm for the two groups. The change was not significantly different between the groups. However, the change within the groups showed significant difference (p<0.01), which demonstrates that both Luo's jiawei tianqi tongjing san and shixiao san were effective in reducing the size of the endometrial lesions.
The serum CA-125 level for the treatment group was 56.26±8.71μg/L before treatment, and after one, two and three courses of treatment, the level dropped to 23.17±7.32μg/L,34.17±7.23μg/L and 40.53±6.46μg/L, respectively. As for the control group, it was 54.30±7.65μg/L before treatment, and after 1,2 and 3 courses, the level dropped to 18.81±6.88μg/L,28.84±7.06μg/L, 36.12±6.72μg/L, respectively. The group difference and the difference with each group showed statistical significance.
The study did not encounter any abnormal lab readings or adverse reactions in patients. Conclusion
Luo's jiawei tianqi tongjing san was effective in treating endometriosis-related dysmenorrhea. It improved clinical symptoms, reduced the dimension of both endometrial cyst and lesion. It was both safe and effective for common practice.
引文
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