中医中药内外合治炎性慢性盆腔痛的临床随机对照研究
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摘要
目的
本研究旨在探讨盆炎方及盆炎方联合复方毛冬青液治疗炎性慢性盆腔痛的临床疗效及作用机理；评价其对焦虑和抑郁不良情绪、生存质量的影响。探讨抑郁及焦虑情绪与炎性慢性盆腔痛的相关性；并从外周神经递质的角度研究炎性慢性盆腔痛患者产生疼痛的可能机理。为有效治疗炎性慢性盆腔痛开辟新路径和方法。
方法
本研究采用前瞻性随机对照的临床试验设计,病例来源于2008年12月至2010年4月在广州市中医医院妇科门诊及住院就诊,符合诊断和纳入标准的气滞血瘀型炎性慢性盆腔痛患者90例,利用简单随机分组的方法,将其分为口服中药组(盆炎方口服)、内外合治组(盆炎方口服+复方毛冬青灌肠)和西药对照组(氧氟沙星片+甲硝唑片口服)。治疗前后及治疗后1月比较患者主要临床症状、体征改善情况；以及患者疼痛程度NRS评分、证候体征积分、汉密尔顿抑郁量表(HAMD)(17项)评分、汉密尔顿焦虑量表(HAMA)评分和健康状况调查问卷中文版(SF-36)评分的变化情况。并在治疗前后检测血浆5-羟色胺(5-HT)及β-内啡肽(β-EP)水平,记录不良反应的发生。
结果
1.三组疗效比较,差异有统计学意义(P<0.05),内外合治组优于口服中药组,优于西药对照组。
2.三组患者经治疗后及治疗后1月疼痛程度NRS评分均较治疗前有所下降；治疗后、治疗后1月与治疗前组内比较,差异均有统计学意义(P<0.01)；而治疗后、治疗后1月组间比较,差异亦有统计学意义(P<0.05)；治疗后、治疗后1月疼痛程度NRS评分分级组间比较也有统计学意义(P<0.05)。表明三组均能较低疼痛NRS评分,且内外合治组对镇痛疗效优于口服中药组,口服中药组优于西药对照组。
3.三组患者经治疗后及治疗后1月证候体征评分均较治疗前有所下降；治疗后、治疗后1月与治疗前组内比较,差异均有统计学意义(P<0.01)；而治疗后、治疗后1月组间比较,差异亦有统计学意义(P<0.05)。表明三组均能改善气滞血瘀证,且内外合治组对气滞血瘀证的改善优于口服中药组,口服中药组优于西药对照组。
4.三组患者治疗前HAMD评分高于7分,估计可能存在抑郁状态。
5.三组患者经治疗后及治疗后1月HAMD评分均有下降；治疗后、治疗后1月与治疗前组内比较,差异均有统计学意义(P<0.01)；而治疗后、治疗后1月组间比较,差异亦有统计学意义(P<0.05)；组间治疗后HAMD减分率比较,差异也有统计学意义(P<0.05)。表明三组均可降低HAMD评分,且内外合治组对抑郁情绪的改善优于口服中药组,口服中药组优于西药对照组。
6.三组患者治疗前HAMA评分高于7分,估计可能存在焦虑状态。
7.三组患者经治疗后及治疗后1月HAMA评分均有下降,治疗后、治疗后1月与治疗前组内比较,差异均有统计学意义(P<0.01)；而治疗后、治疗后1月组间比较,差异无统计学意义(P>0.05)；表明三组均能降低HAMA评分,对焦虑情绪均有改善作用,三组疗效相当。
8.对生存质量各维度积分值的影响：治疗后、治疗后1月口服中药组和内外合治组八个维度得分与治疗前比较,差异均有统计学意义(P<0.05),均高于治疗前。西医对照组八个维度积分较治疗前虽均有所提高,但仅BP维度积分一项治疗后、治疗后1月与治疗前比较,差异有统计学意义(P<0.01)；GH维度积分治疗后1月与治疗前比较,差异亦有统计学意义(P<0.01)。治疗后、治疗后1月,内外合治组PF、RP、BP、GH、VT、RE、MH七个维度积分高于西药对照组,各维度比较差异均有统计学意义(P<0.01)；内外合治组PF、RP、GH、VT、RE五个维度积分高于口服中药组,差异亦均有统计学意义(P<0.05)；口服中药组RP、BP、RE三个维度积分高于西药对照组,差异也有统计学意义(P<0.05)。治疗后内外合治组BP维度积分高于口服中药组,差异有统计学意义(P<0.05)。
9.三组患者经治疗后及治疗后1月血浆5-HT均有下降,治疗后、治疗后1月与治疗前组内比较,差异均有统计学意义(P<0.01)；而治疗后、治疗后1月组间比较,差异亦有统计学意义(P<0.05)。表明三组均可降低血浆5-HT水平,且内外合治组对血浆5-HT水平下降的影响大于口服中药组,口服中药组大于西药对照组。
10.三组患者经治疗后及治疗后1月血浆β-EP水平均有上升,治疗后、治疗后1月与治疗前组内比较,差异均有统计学意义(P<0.01)；而治疗后、治疗后1月组间比较,差异亦有统计学意义(P<0.01)；表明内外合治组对血浆β-EP水平上升的影响大于口服中药组,口服中药组大于西药对照组。
11.疼痛NRS评分与HAMD评分呈正相关(P<0.01),表明疼痛程度越高,则抑郁程度越严重；而随着疼痛的减轻,抑郁情绪亦有明显的改善。
12.疼痛NRS评分与生存质量BP积分呈负相关(P<0.05),提示两者对疼痛的观测结果有良好的一致性,保证了疼痛评估结果的可信性和准确性。可以认为应用疼痛程度NRS评分评估炎性慢性盆腔痛的疼痛程度是有效、可靠、准确的。
13.疼痛NRS评分与β-EP水平呈负相关(P<0.01),表明患者疼痛程度越高,则血浆β-EP水平越低。
结论
1.盆炎方能有效治疗炎性慢性盆腔痛,联合复方毛冬青液灌肠治疗可起协同作用,可提高临床疗效。
2.炎性慢性盆腔痛患者可能存在抑郁和焦虑状态。
3.盆炎方口服、盆炎方口服+复方毛冬青灌肠、氧氟沙星片+甲硝唑片口服对于气滞血瘀型炎性慢性盆腔痛患者的疼痛程度、中医临床证候及体征、抑郁症状、生存质量均有显著改善,且盆炎方口服+复方毛冬青灌肠优于盆炎方口服优于氧氟沙星片+甲硝唑片口服。
4.盆炎方口服、盆炎方口服+复方毛冬青灌肠、氧氟沙星片+甲硝唑片口服均能显著改善气滞血瘀型炎性慢性盆腔痛患者的焦虑症状,且三者疗效相当。
5.治疗前疼痛NRS评分与HAMD评分呈正相关,提示患者的疼痛程度可能与其抑郁程度密切相关,两者可能有协同作用。
6.治疗前疼痛NRS评分与SF-36的BP维度积分呈负相关,提示两者对疼痛程度的评价均具有较好的信度。
7.治疗前β-EP水平与疼痛程度NRS评分呈负相关,而盆炎方口服、盆炎方口服+复方毛冬青灌肠、氧氟沙星片+甲硝唑片口服均能提高血浆β-EP水平,提示三者可能通过提高血浆β-EP水平而起到镇痛作用,且盆炎方口服+复方毛冬青灌肠优于盆炎方口服优于氧氟沙星片+甲硝唑片口服。
8.盆炎方口服、盆炎方口服+复方毛冬青灌肠、氧氟沙星片+甲硝唑片口服均能减低血浆5-HT水平,提示三者可能通过减低血浆5-HT水平而起到镇痛作用。且盆炎方口服+复方毛冬青灌肠优于盆炎方口服优于氧氟沙星片+甲硝唑片口服。
9.HAMD评分、SF-36的BP维度积分值、血浆β-EP水平可作为评估炎性慢性盆腔痛患者疼痛程度的参考指标之一,可协作本病的诊断和观察疗效,具有一定的实用价值。
10.血浆5-HT水平升高、β-EP水平下降可能是炎性慢性盆腔痛患者产生疼痛的原因。
Object ives
The main purposes of the trial were to explore the clinical efficacy and mechanism of Pen Yan Fang (hereinafter referred to as "PYF") and PYF combined with Fu Fang Mao Dong Qi liquid(hereinafter referred to as "FFMDQL") on Inflammatory Chronic Pelvic Pain(hereinafter referred to as "CPP"); to evaluate the influence of the above therapies on depression、anxiety and quality of life; to investigate the correlation between depression、anxiety and Inflammatory Chronic Pelvic Pain; to analyze the possible occurrence mechanism of pain in Inflammatory Chronic Pelvic Pain through peripheral neurotransmitters. Thus to find a new way and a new method to treat the Inflammatory Chronic Pelvic Pain effectively.
Methods
The study was a prospective clinical randomized controlled trial. We choosed 90 female patients who were out-and in-patients of Guangzhou Hospital of Traditional Chinese Medicine suffering from inflammatory CPP with qi stagnation and blood stasis Syndrome from December 2008 to April 2010. And the patients were all according with the diagnosis and inclusion criteria. The all participants were equally and randomly divided into three groups. One group was oral Traditional Chinese Medicine group(hereinafter referred to as "oral TCM group") received PYF by oral administration. One group was combined internal-external therapy of Traditional Chinese Medicine group (hereinafter referred to as "combined internal-external therapy group") received PYF by oral administration and FFMDQL by retention enema. One group was west medicine control group(hereinafter referred to as "WM control group") received ofloxacin tablets and metronidazole tablets by oral administration. Before、 after and 1 month after treatment, we compared the improvement of the main symptoms and signs, the vary scores of Numerical Rating Scale of pain, the vary scores of symptom and sign cumulative scores, the vary scores of Hamilton Depression Scale, the vary scores of Hamilton Anxiety Scale and the Short Form-36 Health Survey (hereinafter referred to as "SF-36"). We also assayed the levels of plasma 5-hydroxytryptamine andβ-endorphin at the beginning and end of the treatment. At last the changes of various indices were respectively compared among the three groups and within group. We recorded the occurrence of adverse reactions as well.
Result
1. Comparison of the clinical effects, our results showed significant differences between both treatment groups and the WM control group, as well as significant differences between the oral TCM group and the combined internal-external therapy group(P<0.05).
2. After and 1 month after the treatment the scores of Numerical Rating Scale of pain were all declined in the three groups than that before treatment. Within-group comparisons showed significant differences between before and after treatment, as well as significant differences between before treatment and 1 month after treatment (P<0.01). While comparisons among the three groups on the time of after treatment and 1 month after treatment, there also had significant differences(P<0.05). Furthermore, comparison of the grade of Numerical Rating Scale of pain on the time of after treatment and 1 month after treatment, there were significant differences among the three groups as well (P <0.05). It indicated that the treatments of the three groups all could reduce the scores of Numerical Rating Scale of pain. The effects of analgesia was best in the combined internal-external therapy group, followed by the oral TCM group, while those were better in the oral TCM group than the WM control group.
3. after and 1 month after treatment, the symptom and sign cumulative scores of the three groups were all decreased than pre-treatment; intra-group comparisons showed significant differences between before and after treatment, as well as significant differences between before treatment and 1 month after treatment (P<0.01). While post-treatment and 1 month after treatment, inter-group comparisons also showed significant differences too(P<0.05). It demonstrated that the therapies of the three groups all could improve the qi stagnation and blood stasis syndrome. The combined internal-external therapy group outperformed the oral TCM group, and the oral TCM group was better than the WM control group.
4. The scores of three groups patients'Hamilton Depression Scale were all higher than seven points. So we estimated that the patients might be in depression state.
5.When afer and 1 month after treatment, the scores of three groups patients'Hamilton Depression Scale were all dropped. We compared the scores of Hamilton Depression Scale within group, there were significant differences between before and after treatment, as well as significant differences between before treatment and 1 month after treatment (P<0.01). We compared those among the three groups on the time of after treatment and 1 month after treatment, there were significant differences likewise (P<0.05). Simultaneously we compared the reducing score rate of Hamilton depression scale among inter-groups, it showed significant differences too(P<0.05). It proved that the therapies of the three groups all could reduced the scores of the patients' Hamilton Depression Scale. The combined internal-external therapy group excelled the oral TCM group, while the oral TCM group was superior to the WM control group.
6. The scores of the three groups patients'Hamilton Anxiety Scale were all more than seven points. So we considered that the patients might be in anxiety state.
7. When afer and 1 month after treatment, the scores of three groups patients'Hamilton Anxiety Scale were all declined. Comparisons within group showed significant differences between before and after treatment, as well as significant differences between before treatment and 1 month after treatment(P<0.01). When we compared the scores of Hamilton Anxiety Scale among the three groups, there is no significant difference(P>0.05). It indicated that the therapies of the three groups all could reduce the scores of the patients'Hamilton Anxiety Scale and improve the feeling of anxiety. The above effects of the three groups were almost the same.
8. Before、after and 1 month after treatment, the influences of quality of life was evaluated by SF-36 in different dimensions. In the oral TCM group and the combined internal-external therapy group, the scores of the eight dimensions after and 1 month after treatment were all higher than those before treatment, there were significant differences(P<0.05). In the WM control group, the scores of the eight dimensions after and 1 month after treatment were all higher than those before treatment too. But only the varied scores of the Body Pain dimension after and 1 month after treatment compared to those before treatment have significant differences (P<0.01). In additional, in the WM control group, the varied scores of the General Health dimension 1 month after treatment compared to that before treatment also has a significant difference (P<0.01). On the time of after and 1 month after treatment, the scores of the Physical Functioning、Role Physical、Body Pain、General Health、Vitality、Role Emotional and Mental Health dimensions in the combined internal-external therapy group were higher than those in the WM control group, there were significant differences (P<0.01). At the same time, the scores of the Physical Functioning、Role Physical、General Health、Vitality and Role Emotional dimensions in the combined internal-external therapy group were higher than those in the oral TCM group, there were significant differences too(P<0.05). Meanwhile, the scores of the Role Physical、Body Pain and Role Emotional dimensions in the oral TCM group were higher than those in the WM control group, there were significant differences as well (P<0.05). After treatment, the scores of the Body Pain dimension in the combined internal-external therapy group were higher than those in the oral TCM group, there were significant differences (P<0.05).
9.As compared with pretherapy, the level of plasma 5-hydroxytryptamine in the three groups significantly was decreased after treatment and 1 month after treatment. Within-group comparisons showed significant differences between before and after treatment, as well as significant differences between before treatment and 1 month after treatment (P<0.01). While comparisons among the three groups on the time of after treatment and 1 month after treatment also had significant differences(P<0.05). It manifested that the treatments of the three groups all could reduce the level of plasma 5-hydroxytryptamine. The combined internal-external therapy group was superior to the oral TCM group, while the oral TCM group was better than the WM control group.
10. The level of plasmaβ-endorphin were all increased in three groups after treatment and 1 month after treatmen than those before treatment. Intra-group comparisons showed significant differences between before and after treatment, as well as significant differences between before treatment and 1 month after treatment(P<0.01). Inter-group comparisons at post-treatment and 1 month after treatment showed significant differences too(P<0.01). It indicated that the influences on elevation of plasmaβ-endorphin were best in the combined internal-external therapy group, followed by the oral TCM group, while those were better in the oral TCM group than the WM control group.
11. There was a significant positive correlation between the scores of Numerical Rating Scale of pain and the Hamilton Depression Scale (P<0.01) It suggested that the higher extent of pain was, then the more severe degree of depression was. On the other hand, with the relief of pain, the depression emotion also had been significant improved.
12.There was a significant negative correlation between the scores of Numerical Rating Scale of pain and the Body Pain dimension of quality of life (P<0.05). It suggested that both of them had good consistency in assessing the severity of pain, so that it could ensure the evaluation result of pain credible and accurate. It considered that assessment on the degree of pain by applying the scores of Numerical Rating Scale of pain is effective、reliable and accurate.
13. The scores of Numerical Rating Scale of pain were significant negatively associated with the level of plasmaβ-endorphin (P<0.01).It showed that the higher extent of pain was, then the lower level of plasmaβ-endorphin was. Conclusion
1.Our research provides evidence that Pen Yan Fang can effectively treat Inflammatory Chronic Pelvic Pain. Our research also suggests that combining Pen Yan Fang by oral administration and Fu Fang Mao Dong Qi liquid by retention enema play a role of synergistic action in curing inflammatory CPP, and which can improve the clinical effect.
2. The patients who suffering from inflammatory CPP may be in depression and anxiety state.
3. The treatments by oral administration of Pen Yan Fang, by combining oral administration of Pen Yan Fang with Fu Fang Mao Dong Qi liquid by retention enema, by oral administration of ofloxacin tablets and metronidazole tablets all can significant ease pain, relieve the traditional chinese medicine clinical symptoms and signs, ameliorate depression symptoms, improve the quality of life of the patients who are suffering from inflammatory CPP with qi stagnation and blood stasis Syndrome. Moreover the treatment which combining Pen Yan Fang by oral administration with Fu Fang Mao Dong Qi liquid by retention enema is better than the treatment only with Pen Yan Fang by oral administration. And the therapy only with Pen Yan Fang by oral administration is in turn better than the therapy with ofloxacin tablets and metronidazole tablets by oral administration.
4.The treatments by oral administration of PYF, by combining oral administration of PYF with FFMDQL by retention enema, by oral administration of ofloxacin tablets and metronidazole tablets all can improve the symptoms of the anxiety. The three kinds of treatments show comparable effects on easing anxiety.
5.There was a significant positive correlation between the scores of Numerical Rating Scale of pain and the Hamilton Depression Scale before treatment. It shows that the level of pain may closely related to the degree of depression. They may have synergetic effects.
6.There was a significant negative correlation between the scores of Numerical Rating Scale of pain and the Body Pain dimension of the SF-36 before treatment. It indicates that both of them have better reliability in evaluation on the severity of pain.
7.There was a significant negative correlation between the scores of Numerical Rating Scale of pain and the level of plasmaβ-endorphin before treatment. The treatments by oral administration of PYF, by combining oral administration of PYF with FFMDQL by retention enema, by oral administration of ofloxacin tablets and metronidazole tablets all can significant increase the level of plasmaβ-endorphin. It indicates that-the three kinds of treatments all have analgesic effects possibly by increasing the level of plasmaβ-endorphin. Furthermore the treatment which combining with PYF by oral administration and FFMDQL by retention enema is superior to the treatment with PYF by oral administration only.And the therapy with PYF by oral administration only is in turn better than the therapy with ofloxacin tablets and metronidazole tablets by oral administration.
8.The treatments by oral administration of PYF, by combining oral administration of PYF with FFMDQL by retention enema, by oral administration of ofloxacin tablets and metronidazole tablets all can significant decrease the level of plasma 5-hydroxytryptamine. It indicates that the three kinds of treatments all have analgesic effects possibly by decreasing the level of plasma 5-hydroxytryptamine. Furthermore the treatment which combining PYF by oral administration with FFMDQL by retention enema excels the treatment with PYF by oral administration only. And the therapy with PYF by oral administration only is superior to the therapy with ofloxacin tablets and metronidazole tablets by oral administration.
9. It is suggested that the scores of the Hamilton Depression Scale、the scores of the Body Pain dimension of the SF-36 and the level of plasmaβ-endorphin can be regarded as reference indices to evaluate the degree severity of pain in patients with inflammatory CPP. These indices are practical and valuable not only to help the diagnosis of inflammatory CPP but also to observe the effects.
10. The occurrence mechanism of pain may related with the rising level of plasma 5-hydroxytryptamine and the declining level ofβ-endorphin.
本研究旨在探讨盆炎方及盆炎方联合复方毛冬青液治疗炎性慢性盆腔痛的临床疗效及作用机理；评价其对焦虑和抑郁不良情绪、生存质量的影响。探讨抑郁及焦虑情绪与炎性慢性盆腔痛的相关性；并从外周神经递质的角度研究炎性慢性盆腔痛患者产生疼痛的可能机理。为有效治疗炎性慢性盆腔痛开辟新路径和方法。
方法
本研究采用前瞻性随机对照的临床试验设计,病例来源于2008年12月至2010年4月在广州市中医医院妇科门诊及住院就诊,符合诊断和纳入标准的气滞血瘀型炎性慢性盆腔痛患者90例,利用简单随机分组的方法,将其分为口服中药组(盆炎方口服)、内外合治组(盆炎方口服+复方毛冬青灌肠)和西药对照组(氧氟沙星片+甲硝唑片口服)。治疗前后及治疗后1月比较患者主要临床症状、体征改善情况；以及患者疼痛程度NRS评分、证候体征积分、汉密尔顿抑郁量表(HAMD)(17项)评分、汉密尔顿焦虑量表(HAMA)评分和健康状况调查问卷中文版(SF-36)评分的变化情况。并在治疗前后检测血浆5-羟色胺(5-HT)及β-内啡肽(β-EP)水平,记录不良反应的发生。
结果
1.三组疗效比较,差异有统计学意义(P<0.05),内外合治组优于口服中药组,优于西药对照组。
2.三组患者经治疗后及治疗后1月疼痛程度NRS评分均较治疗前有所下降；治疗后、治疗后1月与治疗前组内比较,差异均有统计学意义(P<0.01)；而治疗后、治疗后1月组间比较,差异亦有统计学意义(P<0.05)；治疗后、治疗后1月疼痛程度NRS评分分级组间比较也有统计学意义(P<0.05)。表明三组均能较低疼痛NRS评分,且内外合治组对镇痛疗效优于口服中药组,口服中药组优于西药对照组。
3.三组患者经治疗后及治疗后1月证候体征评分均较治疗前有所下降；治疗后、治疗后1月与治疗前组内比较,差异均有统计学意义(P<0.01)；而治疗后、治疗后1月组间比较,差异亦有统计学意义(P<0.05)。表明三组均能改善气滞血瘀证,且内外合治组对气滞血瘀证的改善优于口服中药组,口服中药组优于西药对照组。
4.三组患者治疗前HAMD评分高于7分,估计可能存在抑郁状态。
5.三组患者经治疗后及治疗后1月HAMD评分均有下降；治疗后、治疗后1月与治疗前组内比较,差异均有统计学意义(P<0.01)；而治疗后、治疗后1月组间比较,差异亦有统计学意义(P<0.05)；组间治疗后HAMD减分率比较,差异也有统计学意义(P<0.05)。表明三组均可降低HAMD评分,且内外合治组对抑郁情绪的改善优于口服中药组,口服中药组优于西药对照组。
6.三组患者治疗前HAMA评分高于7分,估计可能存在焦虑状态。
7.三组患者经治疗后及治疗后1月HAMA评分均有下降,治疗后、治疗后1月与治疗前组内比较,差异均有统计学意义(P<0.01)；而治疗后、治疗后1月组间比较,差异无统计学意义(P>0.05)；表明三组均能降低HAMA评分,对焦虑情绪均有改善作用,三组疗效相当。
8.对生存质量各维度积分值的影响：治疗后、治疗后1月口服中药组和内外合治组八个维度得分与治疗前比较,差异均有统计学意义(P<0.05),均高于治疗前。西医对照组八个维度积分较治疗前虽均有所提高,但仅BP维度积分一项治疗后、治疗后1月与治疗前比较,差异有统计学意义(P<0.01)；GH维度积分治疗后1月与治疗前比较,差异亦有统计学意义(P<0.01)。治疗后、治疗后1月,内外合治组PF、RP、BP、GH、VT、RE、MH七个维度积分高于西药对照组,各维度比较差异均有统计学意义(P<0.01)；内外合治组PF、RP、GH、VT、RE五个维度积分高于口服中药组,差异亦均有统计学意义(P<0.05)；口服中药组RP、BP、RE三个维度积分高于西药对照组,差异也有统计学意义(P<0.05)。治疗后内外合治组BP维度积分高于口服中药组,差异有统计学意义(P<0.05)。
9.三组患者经治疗后及治疗后1月血浆5-HT均有下降,治疗后、治疗后1月与治疗前组内比较,差异均有统计学意义(P<0.01)；而治疗后、治疗后1月组间比较,差异亦有统计学意义(P<0.05)。表明三组均可降低血浆5-HT水平,且内外合治组对血浆5-HT水平下降的影响大于口服中药组,口服中药组大于西药对照组。
10.三组患者经治疗后及治疗后1月血浆β-EP水平均有上升,治疗后、治疗后1月与治疗前组内比较,差异均有统计学意义(P<0.01)；而治疗后、治疗后1月组间比较,差异亦有统计学意义(P<0.01)；表明内外合治组对血浆β-EP水平上升的影响大于口服中药组,口服中药组大于西药对照组。
11.疼痛NRS评分与HAMD评分呈正相关(P<0.01),表明疼痛程度越高,则抑郁程度越严重；而随着疼痛的减轻,抑郁情绪亦有明显的改善。
12.疼痛NRS评分与生存质量BP积分呈负相关(P<0.05),提示两者对疼痛的观测结果有良好的一致性,保证了疼痛评估结果的可信性和准确性。可以认为应用疼痛程度NRS评分评估炎性慢性盆腔痛的疼痛程度是有效、可靠、准确的。
13.疼痛NRS评分与β-EP水平呈负相关(P<0.01),表明患者疼痛程度越高,则血浆β-EP水平越低。
结论
1.盆炎方能有效治疗炎性慢性盆腔痛,联合复方毛冬青液灌肠治疗可起协同作用,可提高临床疗效。
2.炎性慢性盆腔痛患者可能存在抑郁和焦虑状态。
3.盆炎方口服、盆炎方口服+复方毛冬青灌肠、氧氟沙星片+甲硝唑片口服对于气滞血瘀型炎性慢性盆腔痛患者的疼痛程度、中医临床证候及体征、抑郁症状、生存质量均有显著改善,且盆炎方口服+复方毛冬青灌肠优于盆炎方口服优于氧氟沙星片+甲硝唑片口服。
4.盆炎方口服、盆炎方口服+复方毛冬青灌肠、氧氟沙星片+甲硝唑片口服均能显著改善气滞血瘀型炎性慢性盆腔痛患者的焦虑症状,且三者疗效相当。
5.治疗前疼痛NRS评分与HAMD评分呈正相关,提示患者的疼痛程度可能与其抑郁程度密切相关,两者可能有协同作用。
6.治疗前疼痛NRS评分与SF-36的BP维度积分呈负相关,提示两者对疼痛程度的评价均具有较好的信度。
7.治疗前β-EP水平与疼痛程度NRS评分呈负相关,而盆炎方口服、盆炎方口服+复方毛冬青灌肠、氧氟沙星片+甲硝唑片口服均能提高血浆β-EP水平,提示三者可能通过提高血浆β-EP水平而起到镇痛作用,且盆炎方口服+复方毛冬青灌肠优于盆炎方口服优于氧氟沙星片+甲硝唑片口服。
8.盆炎方口服、盆炎方口服+复方毛冬青灌肠、氧氟沙星片+甲硝唑片口服均能减低血浆5-HT水平,提示三者可能通过减低血浆5-HT水平而起到镇痛作用。且盆炎方口服+复方毛冬青灌肠优于盆炎方口服优于氧氟沙星片+甲硝唑片口服。
9.HAMD评分、SF-36的BP维度积分值、血浆β-EP水平可作为评估炎性慢性盆腔痛患者疼痛程度的参考指标之一,可协作本病的诊断和观察疗效,具有一定的实用价值。
10.血浆5-HT水平升高、β-EP水平下降可能是炎性慢性盆腔痛患者产生疼痛的原因。
Object ives
The main purposes of the trial were to explore the clinical efficacy and mechanism of Pen Yan Fang (hereinafter referred to as "PYF") and PYF combined with Fu Fang Mao Dong Qi liquid(hereinafter referred to as "FFMDQL") on Inflammatory Chronic Pelvic Pain(hereinafter referred to as "CPP"); to evaluate the influence of the above therapies on depression、anxiety and quality of life; to investigate the correlation between depression、anxiety and Inflammatory Chronic Pelvic Pain; to analyze the possible occurrence mechanism of pain in Inflammatory Chronic Pelvic Pain through peripheral neurotransmitters. Thus to find a new way and a new method to treat the Inflammatory Chronic Pelvic Pain effectively.
Methods
The study was a prospective clinical randomized controlled trial. We choosed 90 female patients who were out-and in-patients of Guangzhou Hospital of Traditional Chinese Medicine suffering from inflammatory CPP with qi stagnation and blood stasis Syndrome from December 2008 to April 2010. And the patients were all according with the diagnosis and inclusion criteria. The all participants were equally and randomly divided into three groups. One group was oral Traditional Chinese Medicine group(hereinafter referred to as "oral TCM group") received PYF by oral administration. One group was combined internal-external therapy of Traditional Chinese Medicine group (hereinafter referred to as "combined internal-external therapy group") received PYF by oral administration and FFMDQL by retention enema. One group was west medicine control group(hereinafter referred to as "WM control group") received ofloxacin tablets and metronidazole tablets by oral administration. Before、 after and 1 month after treatment, we compared the improvement of the main symptoms and signs, the vary scores of Numerical Rating Scale of pain, the vary scores of symptom and sign cumulative scores, the vary scores of Hamilton Depression Scale, the vary scores of Hamilton Anxiety Scale and the Short Form-36 Health Survey (hereinafter referred to as "SF-36"). We also assayed the levels of plasma 5-hydroxytryptamine andβ-endorphin at the beginning and end of the treatment. At last the changes of various indices were respectively compared among the three groups and within group. We recorded the occurrence of adverse reactions as well.
Result
1. Comparison of the clinical effects, our results showed significant differences between both treatment groups and the WM control group, as well as significant differences between the oral TCM group and the combined internal-external therapy group(P<0.05).
2. After and 1 month after the treatment the scores of Numerical Rating Scale of pain were all declined in the three groups than that before treatment. Within-group comparisons showed significant differences between before and after treatment, as well as significant differences between before treatment and 1 month after treatment (P<0.01). While comparisons among the three groups on the time of after treatment and 1 month after treatment, there also had significant differences(P<0.05). Furthermore, comparison of the grade of Numerical Rating Scale of pain on the time of after treatment and 1 month after treatment, there were significant differences among the three groups as well (P <0.05). It indicated that the treatments of the three groups all could reduce the scores of Numerical Rating Scale of pain. The effects of analgesia was best in the combined internal-external therapy group, followed by the oral TCM group, while those were better in the oral TCM group than the WM control group.
3. after and 1 month after treatment, the symptom and sign cumulative scores of the three groups were all decreased than pre-treatment; intra-group comparisons showed significant differences between before and after treatment, as well as significant differences between before treatment and 1 month after treatment (P<0.01). While post-treatment and 1 month after treatment, inter-group comparisons also showed significant differences too(P<0.05). It demonstrated that the therapies of the three groups all could improve the qi stagnation and blood stasis syndrome. The combined internal-external therapy group outperformed the oral TCM group, and the oral TCM group was better than the WM control group.
4. The scores of three groups patients'Hamilton Depression Scale were all higher than seven points. So we estimated that the patients might be in depression state.
5.When afer and 1 month after treatment, the scores of three groups patients'Hamilton Depression Scale were all dropped. We compared the scores of Hamilton Depression Scale within group, there were significant differences between before and after treatment, as well as significant differences between before treatment and 1 month after treatment (P<0.01). We compared those among the three groups on the time of after treatment and 1 month after treatment, there were significant differences likewise (P<0.05). Simultaneously we compared the reducing score rate of Hamilton depression scale among inter-groups, it showed significant differences too(P<0.05). It proved that the therapies of the three groups all could reduced the scores of the patients' Hamilton Depression Scale. The combined internal-external therapy group excelled the oral TCM group, while the oral TCM group was superior to the WM control group.
6. The scores of the three groups patients'Hamilton Anxiety Scale were all more than seven points. So we considered that the patients might be in anxiety state.
7. When afer and 1 month after treatment, the scores of three groups patients'Hamilton Anxiety Scale were all declined. Comparisons within group showed significant differences between before and after treatment, as well as significant differences between before treatment and 1 month after treatment(P<0.01). When we compared the scores of Hamilton Anxiety Scale among the three groups, there is no significant difference(P>0.05). It indicated that the therapies of the three groups all could reduce the scores of the patients'Hamilton Anxiety Scale and improve the feeling of anxiety. The above effects of the three groups were almost the same.
8. Before、after and 1 month after treatment, the influences of quality of life was evaluated by SF-36 in different dimensions. In the oral TCM group and the combined internal-external therapy group, the scores of the eight dimensions after and 1 month after treatment were all higher than those before treatment, there were significant differences(P<0.05). In the WM control group, the scores of the eight dimensions after and 1 month after treatment were all higher than those before treatment too. But only the varied scores of the Body Pain dimension after and 1 month after treatment compared to those before treatment have significant differences (P<0.01). In additional, in the WM control group, the varied scores of the General Health dimension 1 month after treatment compared to that before treatment also has a significant difference (P<0.01). On the time of after and 1 month after treatment, the scores of the Physical Functioning、Role Physical、Body Pain、General Health、Vitality、Role Emotional and Mental Health dimensions in the combined internal-external therapy group were higher than those in the WM control group, there were significant differences (P<0.01). At the same time, the scores of the Physical Functioning、Role Physical、General Health、Vitality and Role Emotional dimensions in the combined internal-external therapy group were higher than those in the oral TCM group, there were significant differences too(P<0.05). Meanwhile, the scores of the Role Physical、Body Pain and Role Emotional dimensions in the oral TCM group were higher than those in the WM control group, there were significant differences as well (P<0.05). After treatment, the scores of the Body Pain dimension in the combined internal-external therapy group were higher than those in the oral TCM group, there were significant differences (P<0.05).
9.As compared with pretherapy, the level of plasma 5-hydroxytryptamine in the three groups significantly was decreased after treatment and 1 month after treatment. Within-group comparisons showed significant differences between before and after treatment, as well as significant differences between before treatment and 1 month after treatment (P<0.01). While comparisons among the three groups on the time of after treatment and 1 month after treatment also had significant differences(P<0.05). It manifested that the treatments of the three groups all could reduce the level of plasma 5-hydroxytryptamine. The combined internal-external therapy group was superior to the oral TCM group, while the oral TCM group was better than the WM control group.
10. The level of plasmaβ-endorphin were all increased in three groups after treatment and 1 month after treatmen than those before treatment. Intra-group comparisons showed significant differences between before and after treatment, as well as significant differences between before treatment and 1 month after treatment(P<0.01). Inter-group comparisons at post-treatment and 1 month after treatment showed significant differences too(P<0.01). It indicated that the influences on elevation of plasmaβ-endorphin were best in the combined internal-external therapy group, followed by the oral TCM group, while those were better in the oral TCM group than the WM control group.
11. There was a significant positive correlation between the scores of Numerical Rating Scale of pain and the Hamilton Depression Scale (P<0.01) It suggested that the higher extent of pain was, then the more severe degree of depression was. On the other hand, with the relief of pain, the depression emotion also had been significant improved.
12.There was a significant negative correlation between the scores of Numerical Rating Scale of pain and the Body Pain dimension of quality of life (P<0.05). It suggested that both of them had good consistency in assessing the severity of pain, so that it could ensure the evaluation result of pain credible and accurate. It considered that assessment on the degree of pain by applying the scores of Numerical Rating Scale of pain is effective、reliable and accurate.
13. The scores of Numerical Rating Scale of pain were significant negatively associated with the level of plasmaβ-endorphin (P<0.01).It showed that the higher extent of pain was, then the lower level of plasmaβ-endorphin was. Conclusion
1.Our research provides evidence that Pen Yan Fang can effectively treat Inflammatory Chronic Pelvic Pain. Our research also suggests that combining Pen Yan Fang by oral administration and Fu Fang Mao Dong Qi liquid by retention enema play a role of synergistic action in curing inflammatory CPP, and which can improve the clinical effect.
2. The patients who suffering from inflammatory CPP may be in depression and anxiety state.
3. The treatments by oral administration of Pen Yan Fang, by combining oral administration of Pen Yan Fang with Fu Fang Mao Dong Qi liquid by retention enema, by oral administration of ofloxacin tablets and metronidazole tablets all can significant ease pain, relieve the traditional chinese medicine clinical symptoms and signs, ameliorate depression symptoms, improve the quality of life of the patients who are suffering from inflammatory CPP with qi stagnation and blood stasis Syndrome. Moreover the treatment which combining Pen Yan Fang by oral administration with Fu Fang Mao Dong Qi liquid by retention enema is better than the treatment only with Pen Yan Fang by oral administration. And the therapy only with Pen Yan Fang by oral administration is in turn better than the therapy with ofloxacin tablets and metronidazole tablets by oral administration.
4.The treatments by oral administration of PYF, by combining oral administration of PYF with FFMDQL by retention enema, by oral administration of ofloxacin tablets and metronidazole tablets all can improve the symptoms of the anxiety. The three kinds of treatments show comparable effects on easing anxiety.
5.There was a significant positive correlation between the scores of Numerical Rating Scale of pain and the Hamilton Depression Scale before treatment. It shows that the level of pain may closely related to the degree of depression. They may have synergetic effects.
6.There was a significant negative correlation between the scores of Numerical Rating Scale of pain and the Body Pain dimension of the SF-36 before treatment. It indicates that both of them have better reliability in evaluation on the severity of pain.
7.There was a significant negative correlation between the scores of Numerical Rating Scale of pain and the level of plasmaβ-endorphin before treatment. The treatments by oral administration of PYF, by combining oral administration of PYF with FFMDQL by retention enema, by oral administration of ofloxacin tablets and metronidazole tablets all can significant increase the level of plasmaβ-endorphin. It indicates that-the three kinds of treatments all have analgesic effects possibly by increasing the level of plasmaβ-endorphin. Furthermore the treatment which combining with PYF by oral administration and FFMDQL by retention enema is superior to the treatment with PYF by oral administration only.And the therapy with PYF by oral administration only is in turn better than the therapy with ofloxacin tablets and metronidazole tablets by oral administration.
8.The treatments by oral administration of PYF, by combining oral administration of PYF with FFMDQL by retention enema, by oral administration of ofloxacin tablets and metronidazole tablets all can significant decrease the level of plasma 5-hydroxytryptamine. It indicates that the three kinds of treatments all have analgesic effects possibly by decreasing the level of plasma 5-hydroxytryptamine. Furthermore the treatment which combining PYF by oral administration with FFMDQL by retention enema excels the treatment with PYF by oral administration only. And the therapy with PYF by oral administration only is superior to the therapy with ofloxacin tablets and metronidazole tablets by oral administration.
9. It is suggested that the scores of the Hamilton Depression Scale、the scores of the Body Pain dimension of the SF-36 and the level of plasmaβ-endorphin can be regarded as reference indices to evaluate the degree severity of pain in patients with inflammatory CPP. These indices are practical and valuable not only to help the diagnosis of inflammatory CPP but also to observe the effects.
10. The occurrence mechanism of pain may related with the rising level of plasma 5-hydroxytryptamine and the declining level ofβ-endorphin.
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