慢盆逐瘀汤治疗慢性盆腔炎临床疗效及动物实验研究
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摘要
目的
1.通过观察慢盆逐瘀汤治疗慢性盆腔炎患者前后血流变学、血清前白蛋白、临床表现、安全性指标的变化,评价慢盆逐瘀汤对慢性盆腔炎的临床疗效及安全性。
2.通过研究慢盆逐瘀汤对机械损伤加混合菌感染法制备的慢性盆腔炎模型大鼠血流变学、血清前白蛋白、子宫病理组织学改变的影响,进一步验证其有效性。
3.通过研究慢盆逐瘀汤对动物模型血流变学、血清前白蛋白及子宫病理组织形态学的影响,探讨其治疗慢性盆腔炎的作用机理,并了解血清前白蛋白在慢性盆腔炎疗效判定中的价值。
方法
1.80例慢性盆腔炎患者随机分成慢盆逐瘀汤组、妇科千金胶囊组。慢盆逐瘀汤组给予口服慢盆逐瘀汤,对照组给予口服妇科千金胶囊,2个月为1疗程。治疗前后观察并记录患者临床症状、体征、检查室指标(子宫、双侧附件B超)、实验室指标(血流变学、血清前白蛋白),以及安全指标(血常规、肝肾功能等)变化,采取自身前后对照及组间对照的方法分析病情变化情况并进行统计学分析。
2.SPF级SD雌性大鼠62只,随机分成慢盆逐瘀汤高、中、低剂量组、妇科千金胶囊组、模型组、假手术组(模型组、假手术组各11只,其余组各10只)。其中假手术组仅常规开腹,对其子宫不予机械损伤及混合菌感染,其余各组用机械损伤加混合菌(大肠杆菌、乙型溶血性链球菌和金黄色葡萄球菌)感染法制备慢性盆腔炎大鼠模型。造模后12天在模型组和假手术组中各随机选取1只大鼠确定造模是否成功。造模成功即于造模后第14天按组别给予不同施加因素,各组灌胃14天,末次灌胃24小时后行心脏采血,锥板法检测大鼠血流变学指标、ELISA法测定大鼠血清前白蛋白水平,肉眼观察并摘取子宫,常规HE染色,光镜下观察各组大鼠子宫病理组织形态学改变。
结果
1.临床研究
1.1慢盆逐瘀汤组、妇科千金胶囊组治疗总有效率分别为96.88%、86.67%,中医证候总有效率分别为100.00%、90.00%,主要体征总有效率分别为93.75%、83.33%,组间比较均有统计学差异(P<0.05)。
1.2慢盆逐瘀汤治疗后中医证候、主要体征积分较前均有所改善,与治疗前比较有统计学差异(P<0.01)。
1.3两组慢性盆腔炎患者治疗后血流变学指标均较前有所下降,比较有统计学差异(P<0.05)。慢盆逐瘀汤组在全血高、中切粘度、血浆粘度、红细胞压积方面优于妇科千金胶囊组(P<0.05)。
1.4两组慢性盆腔炎患者治疗前后血清前白蛋白自身及组间均无明显变化,比较无统计学差异(P>0.05)。
1.5慢盆逐瘀汤组患者治疗后血常规较前好转(P<0.05),余肝功能、肾功能安全指标治疗前后比较无统计学差异(P>0.05)
2.实验研究
2.1模型组大鼠子宫宫腔粘连或扩张、腔壁结构病变、上皮变性坏死、慢炎症细胞浸润、内膜充血水肿、上皮细胞增生较假手术组明显,比较有统计学差异(P<0.05)。除慢盆逐瘀汤低剂量组外,慢盆逐瘀汤高、中剂量组、妇科千金胶囊组较模型组明显改善,比较有统计学差异(P<0.05),且慢盆逐瘀汤高剂量组优于妇科千金胶囊组(P<0.05)。
2.2模型组血流变学(全血高、中、低切粘度、血浆粘度、红细胞压积)较假手术组明显升高,比较有统计学差异(P<0.01)。给予不同施加因素,除慢盆逐瘀汤低剂量组全血高、中切粘度较模型组无明显改善(P>0.05)外,高、中剂量组血流变学较模型组均有明显改善,比较有统计学差异(P<0.05),且全血高切粘度、全血低切粘度、血浆粘度与中药灌胃剂量呈负相关关系(P<0.01)。高剂量组较妇科千金胶囊组改善明显,血浆粘度比较有统计学差异(P<0.01)。
2.3各组大鼠血清前白蛋白水平比较,组间无统计学差异(P>0.05),与中药灌胃剂量无明显相关性(P>0.05)。结论
1.慢盆逐瘀汤可降低慢性盆腔炎患者血流变学指标,对瘀血阻滞相关的临床症状有改善作用,且安全性高,但对治疗前后血清前白蛋白水平的变化无统计学意义。
2.慢盆逐瘀汤可降低慢性盆腔炎模型大鼠血流变学指标,改善大鼠子宫病理学损坏,进一步证明了该方的有效性,其机理可能与增加局部微循环,加强组织代谢,促进组织修复,加快增生性病变转化和吸收有关,而血清前白蛋白对慢性盆腔炎的疗效判定价值尚待进一步研究。
Objects
1. To evaluate the clinical effect and security of Manpen Zhuyu decoction on patients of chronic pelvic inflammatory disease, by observing the changes of indexes, including blood rheology, prealbumin, clinical manifestation and indicators of safety.
2. To investigate the effects of Manpen Zhuyu decoction on pathobiology、blood rheology and prealbumin in the model rats with chronic pelvic inflammatory disease, that to prove its effectiveness.
3. To explore the therapeutic mechanism of Manpen Zhuyu decoction by investigating its influence on pathobiology、blood rheology and prealbumin of model rats with chronic pelvic inflammatory disease. And to understand the value of prealbumin in effect judgement.
Methods
1. 80 patients with chronic pelvic inflammatory disease were randomly divided into Manpen Zhuyu decoction group, Fuke Qianjin oblatum group.The patients in Manpen Zhuyu decoction group were treated by Manpen Zhuyu decoction. The patients in Fuke Qianjin oblatum group were treated by Fuke Qianjin oblatum. There were 2 months for a course of treatment. The clinical symptoms, physical signs、examination index (ultrasonic inspection)、laboratory data (blood rheology、prealbumin) and indicators of safety (blood routine, liver and renal functions test) before and after treatment were noted and compared.
2. 62 SD female rats of SPF grade were randomly divided into High-dose Manpen Zhuyu decoction group, Medium-dose Manpen Zhuyu decoction group, Low-dose Manpen Zhuyu decoction group, Fuke Qianjin oblatum group, Model group and Sham operation group (model group and Sham operation group contain 11 rats, other groups contain 10 rats). Sham operation group was just opened their abdomens without injecting mixed bacteria, other groups'rats were injected mixed bacteria (bacillus coli, beta-hemolytic streptococci, staphylococcus aureus)into two sides of the uterus to induce chronic pelvic inflammatory disease models. At the 12th days, in the model group and sham operation group, the rats were randomly selected to definite that the model with chronic pelvic inflammatory disease is succeeded. At the 14th days, the corresponding drugs were administrated, after 14 days the heart of rats were prick and the blood was obtained to detect blood rheology and determine prealbumin by ELISA method. To observe the uterus by naked eyes and check microscopic the pathological histology of uterus.
Results
1.Clinical research
1.1 The total effective rate was 96.88% in Manpen Zhuyu decoction group, 86.67% in Fuke Qianjin oblatum group, The total effective rate of TCM symptom-complex 100.00% in Manpen Zhuyu decoction group,90.00% in Fuke Qianjin oblatum group, The total effective rate of principal physical sign was 93.75% in Manpen Zhuyu decoction group,83.33% in Fuke Qianjin oblatum group, between two groups there were all significant differences statistically (P<0.05)
1.2 The TCM symptom-complex and principal physical sign were improved after Manpen Zhuyu decoction treatment, there were significant differences statistically (P<0.01)
1.3 After treatment, the two groups patients with chronic pelvic inflammatory disease'indexes of blood rheology were significantly decreased (P <0.05). Manpen Zhuyu decoction group decreased significantly more in high shear viscosity、medium shear viscosity、plasma viscosity and hematocrit (P<0.05)
1.4 After treatment, the prealbumin of two groups patients with chronic pelvic inflammatory disease did not change significantly, there were not significant differences statistically (P>0.05)
1.5 The indicators of safety of patients in Manpen Zhuyu decoction group, included blood routine, liver and kidney function (ALT, AST, and Cr, BUN)had no significant differences (P>0.05).
2. Basic research
2.1 Compare with the Sham operation group in high shear viscosity、medium shear viscosity、low shear viscosity of whole blood, plasma viscosity and hematocrit, the model group was increased significantly, and there were significant differences statistically (P<0.01). Imposed by different factors to each group, In addition to Low-dose Manpen Zhuyu decoction group, High-dose Manpen Zhuyu decoction group. Medium-dose Manpen Zhuyu decoction group have improved the indexes of blood rheology significantly(P<0.05), and there is negative correlation significantly between dose of Chinese materia medica and blood rheology(high shear viscosity、low shear viscosity of whole blood, plasma viscosity).Compare with Fuke Qianjin oblatum group in plasma viscosity, High-dose Manpen Zhuyu decoction group is improved significantly (P<0.01)
2.2 Compared with the Sham operation group in intrauterine adhesions or expansion of the uterus、parietal structural lesions、epithelial degeneration and necrosis、chronic inflammatory cell infiltration、intimal edema, epithelial cell proliferation, the damage of model group is severe significantly(P<0.05). In addition to Low-dose Manpen Zhuyu decoction group, High-dose Manpen Zhuyu decoction group. Medium-dose Manpen Zhuyu decoction group and Fuke Qianjin oblatum group improved significantly more (P<0.05), and High-dose Manpen Zhuyu decoction group is better than Fuke Qianjin oblatum group (P<0.05).
2.3 The level of prealbumin is not significant difference in the six groups (P>0.05), And there is not significant correlation between dose of Chinese materia medica (P>0.05).
Conclusions
1. Manpen Zhuyu decoction could reduce the indexes of blood rheology and improve clinical symptoms effectively in patients with chronic pelvic inflammatory disease, and it is safety. But before and after treatment the prealbumin of two groups did not change significantly, there were not ignificant differences statistically (P>0.05)
2. Manpen Zhuyu decoction could reduce effectively the model rats'indexes of blood rheology, improve the damage of uterus. The mechanism migth be related to Increasing local microcirculation, strengthening the tissue metabolism, promoting tissue repair and regeneration, to speed up the transformation and absorption of proliferative lesions. But in determination chronic pelvic inflammatory disease the value of the prealbum to be studied further still.
1.通过观察慢盆逐瘀汤治疗慢性盆腔炎患者前后血流变学、血清前白蛋白、临床表现、安全性指标的变化,评价慢盆逐瘀汤对慢性盆腔炎的临床疗效及安全性。
2.通过研究慢盆逐瘀汤对机械损伤加混合菌感染法制备的慢性盆腔炎模型大鼠血流变学、血清前白蛋白、子宫病理组织学改变的影响,进一步验证其有效性。
3.通过研究慢盆逐瘀汤对动物模型血流变学、血清前白蛋白及子宫病理组织形态学的影响,探讨其治疗慢性盆腔炎的作用机理,并了解血清前白蛋白在慢性盆腔炎疗效判定中的价值。
方法
1.80例慢性盆腔炎患者随机分成慢盆逐瘀汤组、妇科千金胶囊组。慢盆逐瘀汤组给予口服慢盆逐瘀汤,对照组给予口服妇科千金胶囊,2个月为1疗程。治疗前后观察并记录患者临床症状、体征、检查室指标(子宫、双侧附件B超)、实验室指标(血流变学、血清前白蛋白),以及安全指标(血常规、肝肾功能等)变化,采取自身前后对照及组间对照的方法分析病情变化情况并进行统计学分析。
2.SPF级SD雌性大鼠62只,随机分成慢盆逐瘀汤高、中、低剂量组、妇科千金胶囊组、模型组、假手术组(模型组、假手术组各11只,其余组各10只)。其中假手术组仅常规开腹,对其子宫不予机械损伤及混合菌感染,其余各组用机械损伤加混合菌(大肠杆菌、乙型溶血性链球菌和金黄色葡萄球菌)感染法制备慢性盆腔炎大鼠模型。造模后12天在模型组和假手术组中各随机选取1只大鼠确定造模是否成功。造模成功即于造模后第14天按组别给予不同施加因素,各组灌胃14天,末次灌胃24小时后行心脏采血,锥板法检测大鼠血流变学指标、ELISA法测定大鼠血清前白蛋白水平,肉眼观察并摘取子宫,常规HE染色,光镜下观察各组大鼠子宫病理组织形态学改变。
结果
1.临床研究
1.1慢盆逐瘀汤组、妇科千金胶囊组治疗总有效率分别为96.88%、86.67%,中医证候总有效率分别为100.00%、90.00%,主要体征总有效率分别为93.75%、83.33%,组间比较均有统计学差异(P<0.05)。
1.2慢盆逐瘀汤治疗后中医证候、主要体征积分较前均有所改善,与治疗前比较有统计学差异(P<0.01)。
1.3两组慢性盆腔炎患者治疗后血流变学指标均较前有所下降,比较有统计学差异(P<0.05)。慢盆逐瘀汤组在全血高、中切粘度、血浆粘度、红细胞压积方面优于妇科千金胶囊组(P<0.05)。
1.4两组慢性盆腔炎患者治疗前后血清前白蛋白自身及组间均无明显变化,比较无统计学差异(P>0.05)。
1.5慢盆逐瘀汤组患者治疗后血常规较前好转(P<0.05),余肝功能、肾功能安全指标治疗前后比较无统计学差异(P>0.05)
2.实验研究
2.1模型组大鼠子宫宫腔粘连或扩张、腔壁结构病变、上皮变性坏死、慢炎症细胞浸润、内膜充血水肿、上皮细胞增生较假手术组明显,比较有统计学差异(P<0.05)。除慢盆逐瘀汤低剂量组外,慢盆逐瘀汤高、中剂量组、妇科千金胶囊组较模型组明显改善,比较有统计学差异(P<0.05),且慢盆逐瘀汤高剂量组优于妇科千金胶囊组(P<0.05)。
2.2模型组血流变学(全血高、中、低切粘度、血浆粘度、红细胞压积)较假手术组明显升高,比较有统计学差异(P<0.01)。给予不同施加因素,除慢盆逐瘀汤低剂量组全血高、中切粘度较模型组无明显改善(P>0.05)外,高、中剂量组血流变学较模型组均有明显改善,比较有统计学差异(P<0.05),且全血高切粘度、全血低切粘度、血浆粘度与中药灌胃剂量呈负相关关系(P<0.01)。高剂量组较妇科千金胶囊组改善明显,血浆粘度比较有统计学差异(P<0.01)。
2.3各组大鼠血清前白蛋白水平比较,组间无统计学差异(P>0.05),与中药灌胃剂量无明显相关性(P>0.05)。结论
1.慢盆逐瘀汤可降低慢性盆腔炎患者血流变学指标,对瘀血阻滞相关的临床症状有改善作用,且安全性高,但对治疗前后血清前白蛋白水平的变化无统计学意义。
2.慢盆逐瘀汤可降低慢性盆腔炎模型大鼠血流变学指标,改善大鼠子宫病理学损坏,进一步证明了该方的有效性,其机理可能与增加局部微循环,加强组织代谢,促进组织修复,加快增生性病变转化和吸收有关,而血清前白蛋白对慢性盆腔炎的疗效判定价值尚待进一步研究。
Objects
1. To evaluate the clinical effect and security of Manpen Zhuyu decoction on patients of chronic pelvic inflammatory disease, by observing the changes of indexes, including blood rheology, prealbumin, clinical manifestation and indicators of safety.
2. To investigate the effects of Manpen Zhuyu decoction on pathobiology、blood rheology and prealbumin in the model rats with chronic pelvic inflammatory disease, that to prove its effectiveness.
3. To explore the therapeutic mechanism of Manpen Zhuyu decoction by investigating its influence on pathobiology、blood rheology and prealbumin of model rats with chronic pelvic inflammatory disease. And to understand the value of prealbumin in effect judgement.
Methods
1. 80 patients with chronic pelvic inflammatory disease were randomly divided into Manpen Zhuyu decoction group, Fuke Qianjin oblatum group.The patients in Manpen Zhuyu decoction group were treated by Manpen Zhuyu decoction. The patients in Fuke Qianjin oblatum group were treated by Fuke Qianjin oblatum. There were 2 months for a course of treatment. The clinical symptoms, physical signs、examination index (ultrasonic inspection)、laboratory data (blood rheology、prealbumin) and indicators of safety (blood routine, liver and renal functions test) before and after treatment were noted and compared.
2. 62 SD female rats of SPF grade were randomly divided into High-dose Manpen Zhuyu decoction group, Medium-dose Manpen Zhuyu decoction group, Low-dose Manpen Zhuyu decoction group, Fuke Qianjin oblatum group, Model group and Sham operation group (model group and Sham operation group contain 11 rats, other groups contain 10 rats). Sham operation group was just opened their abdomens without injecting mixed bacteria, other groups'rats were injected mixed bacteria (bacillus coli, beta-hemolytic streptococci, staphylococcus aureus)into two sides of the uterus to induce chronic pelvic inflammatory disease models. At the 12th days, in the model group and sham operation group, the rats were randomly selected to definite that the model with chronic pelvic inflammatory disease is succeeded. At the 14th days, the corresponding drugs were administrated, after 14 days the heart of rats were prick and the blood was obtained to detect blood rheology and determine prealbumin by ELISA method. To observe the uterus by naked eyes and check microscopic the pathological histology of uterus.
Results
1.Clinical research
1.1 The total effective rate was 96.88% in Manpen Zhuyu decoction group, 86.67% in Fuke Qianjin oblatum group, The total effective rate of TCM symptom-complex 100.00% in Manpen Zhuyu decoction group,90.00% in Fuke Qianjin oblatum group, The total effective rate of principal physical sign was 93.75% in Manpen Zhuyu decoction group,83.33% in Fuke Qianjin oblatum group, between two groups there were all significant differences statistically (P<0.05)
1.2 The TCM symptom-complex and principal physical sign were improved after Manpen Zhuyu decoction treatment, there were significant differences statistically (P<0.01)
1.3 After treatment, the two groups patients with chronic pelvic inflammatory disease'indexes of blood rheology were significantly decreased (P <0.05). Manpen Zhuyu decoction group decreased significantly more in high shear viscosity、medium shear viscosity、plasma viscosity and hematocrit (P<0.05)
1.4 After treatment, the prealbumin of two groups patients with chronic pelvic inflammatory disease did not change significantly, there were not significant differences statistically (P>0.05)
1.5 The indicators of safety of patients in Manpen Zhuyu decoction group, included blood routine, liver and kidney function (ALT, AST, and Cr, BUN)had no significant differences (P>0.05).
2. Basic research
2.1 Compare with the Sham operation group in high shear viscosity、medium shear viscosity、low shear viscosity of whole blood, plasma viscosity and hematocrit, the model group was increased significantly, and there were significant differences statistically (P<0.01). Imposed by different factors to each group, In addition to Low-dose Manpen Zhuyu decoction group, High-dose Manpen Zhuyu decoction group. Medium-dose Manpen Zhuyu decoction group have improved the indexes of blood rheology significantly(P<0.05), and there is negative correlation significantly between dose of Chinese materia medica and blood rheology(high shear viscosity、low shear viscosity of whole blood, plasma viscosity).Compare with Fuke Qianjin oblatum group in plasma viscosity, High-dose Manpen Zhuyu decoction group is improved significantly (P<0.01)
2.2 Compared with the Sham operation group in intrauterine adhesions or expansion of the uterus、parietal structural lesions、epithelial degeneration and necrosis、chronic inflammatory cell infiltration、intimal edema, epithelial cell proliferation, the damage of model group is severe significantly(P<0.05). In addition to Low-dose Manpen Zhuyu decoction group, High-dose Manpen Zhuyu decoction group. Medium-dose Manpen Zhuyu decoction group and Fuke Qianjin oblatum group improved significantly more (P<0.05), and High-dose Manpen Zhuyu decoction group is better than Fuke Qianjin oblatum group (P<0.05).
2.3 The level of prealbumin is not significant difference in the six groups (P>0.05), And there is not significant correlation between dose of Chinese materia medica (P>0.05).
Conclusions
1. Manpen Zhuyu decoction could reduce the indexes of blood rheology and improve clinical symptoms effectively in patients with chronic pelvic inflammatory disease, and it is safety. But before and after treatment the prealbumin of two groups did not change significantly, there were not ignificant differences statistically (P>0.05)
2. Manpen Zhuyu decoction could reduce effectively the model rats'indexes of blood rheology, improve the damage of uterus. The mechanism migth be related to Increasing local microcirculation, strengthening the tissue metabolism, promoting tissue repair and regeneration, to speed up the transformation and absorption of proliferative lesions. But in determination chronic pelvic inflammatory disease the value of the prealbum to be studied further still.
引文
[1]梁菁.慢性盆腔炎的中医辨证分型探讨[J].时珍国医国药,2007,18(12)：3113-3114.
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