中医标本同治法治疗近端输卵管阻塞性不孕近期疗效的前瞻性研究
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摘要
[目的]前瞻性随机对照研究中医标本同治法治疗近端输卵管阻塞性不孕症的近期疗效。通过输卵管通畅度的评价及中医症状、体征的评分值变化探讨该方法的有效性和安全性,为临床治疗该病提供更有效的治疗方案。
[方法]2009年4月～2010年11月在广州中医药大学第一附属医院妇科门诊就诊的91例近端输卵管阻塞性不孕症患者(符合纳入标准),按照2：1比例完全随机分为试验组和对照组。所有患者均在广州中医药大学第一附属医院介入室行高压恒速的子宫输卵管造影。
试验组62例,年龄28.66±3.983(21-40)岁,病程3.17±2.144(1～12)年,随访时间6.82±3.165(1～18)月。中医辨证分型：气滞血瘀39例,湿热瘀结18例,寒湿瘀滞5例。原发不孕17例,继发不孕45例。双侧输卵管阻塞40例,单侧阻塞22例。输卵管阻塞部位：间质部74条,峡部24条,峡壶腹部交界处4条。对照组29例,年龄30.14±3.907(22～38)岁,病程3.66±2.581(1～12)年,随访时间7.14±2.601(3～14)月。中医辨证分型：气滞血瘀18例,湿热瘀结7例,寒湿瘀滞4例。原发不孕7例,继发不孕22例。双侧输卵管阻塞23例,单侧阻塞6例。输卵管阻塞部位：间质部38条,峡部11条,峡部与壶腹部交界处3条。
试验组采用中医标本同治法,在FTR术后行中医内外合治(内服、外敷、灌肠)1周,并在术后连续2月内行丹参注射液宫腔灌注(2次/月),术后行中医内外合治1周。对照组在FTR术后的连续2月内行庆大霉素、地塞米松、α-糜蛋白酶宫腔灌注(2次/月)。所有患者治疗前及治疗后进行慢性盆腔炎评分,术后随访1-2年,记录受孕情况或行子宫输卵管造影复查输卵管通畅情况。组间均衡性采用独立样本t检验或x2检验,通畅度的对比采用Wilcoxon秩和检验,失访病例疗效进行意图治疗分析。
[结果]试验组与对照组结果对比分别如下,手术成功率88.24%、92.31%；通畅率82.02%、64.29%；闭塞率17.98%、35.71%；再闭塞率12.66%、31.58%；宫内妊娠15(27.78%)例、4(16.67%)例；输卵管妊娠1(1.85%)例、3(12.5%)例；与FTR术后对比,仍保持通畅或通畅度有改善的输卵管共计68(76.40%)条、18(42.86%)条。
两组输卵管通畅度比较有显著差异(Z=-3.186,P=0.001)；气滞血瘀证型和寒湿瘀滞证型的输卵管通畅度比较有差异(Z=-2.276,P=0.023；Z=-2.975,P=0.003)；湿热瘀结证型的输卵管通畅度比较无差异(Z=-0.098,P=0.922)。
两组症状、体征积分值比较有显著差异(t=-8.851,P=0.000)；两组下腹疼痛、经行腹痛加重、带下量和腰骶胀痛、神疲乏力的症状、体征评分比较有显著差异(t=-6.223,P=0.000；t=-7.412,P=0.000；t=-3.052,P=0.004；t=-5.391,P=0.000；t=-2.816, P=0.009)。
[结论]中医标本同治法治疗近端输卵管阻塞性不孕症的近期疗效确切,输卵管通畅率高,术后再粘连率低。以中医整体辨证论治及中医标本兼治为原则制订的该方案,在解决输卵管局部梗阻的同时,积极治疗盆腔感染的根本问题,改善盆腔内大环境和输卵管的微环境,更好地恢复输卵管的功能和保持输卵管的通畅性,提高妊娠率。今后可作为近端输卵管阻塞性不孕症的常规治疗方法之一
Objective
To assess the short-term clinical efficacy of the protocol of treating both the primary and the secondary aspects for infertility induced by oviduct blockage, prospectively and randomly. Evaluate its safety and effectiveness according to patency testing and manifestation of the symptoms and syndromes.
Methods
91 consectuive patients with infertility induced by oviduct blockage defined according to the inclusion and exclusion criteria were divided into two groups-experimental group and controls by 2:1 ratio from Apr.2009 to Nov. 2010, randomly. All of patients received HSG in the first affiliated Hospital of Guangzhou University of TCM.
Experimental group data:62 patients with mean age of 28.66±3.983 years (range 21 to 40), course of 3.17±2.144 years (range 1 to 12) and fllowed for a median of 6.82±3.165 months (range 1 to 18). There were divided into three syndromes including qi stagnation and blood stasis, stagnation of damp and heat and stagnation of cold and damp(39、18、5 respentively) according to the syndrome differentiation of TCM. There were 17 patients of primary infertility and 45 of secondary infertility, 40 bilateral obstructed oviducts and 22 unilateral ones. Anatomically, the position of oviduct blockage include uterine part, isthmus and junction between isthmus and ampulla, which the sum of affected position is 74,24 and 4, respectively.
Controls data:29 patients with mean age of 30.14±3.907 years (range 22 to 38), course of 3.66±2.581 years(range 1 to 12) and fllowed for a median of 7.14±2.601 months (range 3 to 14). There were divided into three syndromes including qi stagnation and blood stasis, stagnation of damp and heat and stagnation of cold and damp(18、7、4 respentively) according to the syndrome differentiation of TCM. There were 7 patients of primary infertility and 22 of secondary infertility, 23 bilateral obstructed oviducts and 6 unilateral ones. Anatomically, the position of oviduct blockage include uterine part, isthmus and junction between isthmus and ampulla, which the sum of affected position is 38, 11 and 3, respectively.
All of the patients were received fallopian tube recanalization. The patients of experimental group were received the treatment of Chinese herbs by oral, enema and external application according to syndrome differentiation of TCM about one week per month in 3 months after fallopian tuberecanalization. Perfuse the drugs which are different in two groups into uterine cavity about two times per month in 2 months after operation. The drugs include Radix Salvia Miltiorrhiza and gentamycin、dexamethasone、α-chymotrypsin in experimental and control groups, respectively. Observe the clinical symptoms and sign of chronic pelvic inflammation and record findings in two groups. The patients were regularly followed up for 2 years. The patient which is not perceived during follow-up will be tested on HSG. The findings before operation were compared between two groups by independent-samples t test and x2 test. The statistic method was respectively adopted the matched t-test、and of measurement data and the Wilcoxon test to analyse by SPSS 13.0 statistic software.
Result
There were successful rate of 88.24%、92.31%, patent rate of 82.02%、64.29%, oviduct obstructed rate of 17.98%、35.71%, re-adhesion rate of 12.66%. 31.58%, intrauterine pregnant rate of 27.78%、16.67%, ectopic pregnant rate of 1.85%、12.5%, response rate of 76.40%、42.86% in experimental and control groups, respectively.
The patent rate of oviduct in experimental group was higher than that of the control group, the obvious significant between two groups in statistic (P<0.01). The patent rate of oviduct in experimental group was higher than that of the control group in the syndrome of qi stagnation and blood stasis and stagnation of cold and damp, the obvious significant between two groups in statistic(P<0.001). The patent rate of oviduct in two groups was not different significantly in the syndrome of stagnation of damp and heat. The improvement of symptoms and signs on chronic pelvic inflammation (such as lower quadrant abdominal pain、menstruating abdominal pain and CTB) in experimental group was obviously than that of the control group, the obvious significant between two groups in statistic(P<0.01).
Conclusion
The treatment focusing on relieving the primary and the secondary aspects is quite effective for infertility due to tubal obstruction. It can improve the tubal patency and decrease the recurrence of fallopian tube adhesion and be treated as one of the routine therapy for infertility due to proximal tubal obstruction.
[方法]2009年4月～2010年11月在广州中医药大学第一附属医院妇科门诊就诊的91例近端输卵管阻塞性不孕症患者(符合纳入标准),按照2：1比例完全随机分为试验组和对照组。所有患者均在广州中医药大学第一附属医院介入室行高压恒速的子宫输卵管造影。
试验组62例,年龄28.66±3.983(21-40)岁,病程3.17±2.144(1～12)年,随访时间6.82±3.165(1～18)月。中医辨证分型：气滞血瘀39例,湿热瘀结18例,寒湿瘀滞5例。原发不孕17例,继发不孕45例。双侧输卵管阻塞40例,单侧阻塞22例。输卵管阻塞部位：间质部74条,峡部24条,峡壶腹部交界处4条。对照组29例,年龄30.14±3.907(22～38)岁,病程3.66±2.581(1～12)年,随访时间7.14±2.601(3～14)月。中医辨证分型：气滞血瘀18例,湿热瘀结7例,寒湿瘀滞4例。原发不孕7例,继发不孕22例。双侧输卵管阻塞23例,单侧阻塞6例。输卵管阻塞部位：间质部38条,峡部11条,峡部与壶腹部交界处3条。
试验组采用中医标本同治法,在FTR术后行中医内外合治(内服、外敷、灌肠)1周,并在术后连续2月内行丹参注射液宫腔灌注(2次/月),术后行中医内外合治1周。对照组在FTR术后的连续2月内行庆大霉素、地塞米松、α-糜蛋白酶宫腔灌注(2次/月)。所有患者治疗前及治疗后进行慢性盆腔炎评分,术后随访1-2年,记录受孕情况或行子宫输卵管造影复查输卵管通畅情况。组间均衡性采用独立样本t检验或x2检验,通畅度的对比采用Wilcoxon秩和检验,失访病例疗效进行意图治疗分析。
[结果]试验组与对照组结果对比分别如下,手术成功率88.24%、92.31%；通畅率82.02%、64.29%；闭塞率17.98%、35.71%；再闭塞率12.66%、31.58%；宫内妊娠15(27.78%)例、4(16.67%)例；输卵管妊娠1(1.85%)例、3(12.5%)例；与FTR术后对比,仍保持通畅或通畅度有改善的输卵管共计68(76.40%)条、18(42.86%)条。
两组输卵管通畅度比较有显著差异(Z=-3.186,P=0.001)；气滞血瘀证型和寒湿瘀滞证型的输卵管通畅度比较有差异(Z=-2.276,P=0.023；Z=-2.975,P=0.003)；湿热瘀结证型的输卵管通畅度比较无差异(Z=-0.098,P=0.922)。
两组症状、体征积分值比较有显著差异(t=-8.851,P=0.000)；两组下腹疼痛、经行腹痛加重、带下量和腰骶胀痛、神疲乏力的症状、体征评分比较有显著差异(t=-6.223,P=0.000；t=-7.412,P=0.000；t=-3.052,P=0.004；t=-5.391,P=0.000；t=-2.816, P=0.009)。
[结论]中医标本同治法治疗近端输卵管阻塞性不孕症的近期疗效确切,输卵管通畅率高,术后再粘连率低。以中医整体辨证论治及中医标本兼治为原则制订的该方案,在解决输卵管局部梗阻的同时,积极治疗盆腔感染的根本问题,改善盆腔内大环境和输卵管的微环境,更好地恢复输卵管的功能和保持输卵管的通畅性,提高妊娠率。今后可作为近端输卵管阻塞性不孕症的常规治疗方法之一
Objective
To assess the short-term clinical efficacy of the protocol of treating both the primary and the secondary aspects for infertility induced by oviduct blockage, prospectively and randomly. Evaluate its safety and effectiveness according to patency testing and manifestation of the symptoms and syndromes.
Methods
91 consectuive patients with infertility induced by oviduct blockage defined according to the inclusion and exclusion criteria were divided into two groups-experimental group and controls by 2:1 ratio from Apr.2009 to Nov. 2010, randomly. All of patients received HSG in the first affiliated Hospital of Guangzhou University of TCM.
Experimental group data:62 patients with mean age of 28.66±3.983 years (range 21 to 40), course of 3.17±2.144 years (range 1 to 12) and fllowed for a median of 6.82±3.165 months (range 1 to 18). There were divided into three syndromes including qi stagnation and blood stasis, stagnation of damp and heat and stagnation of cold and damp(39、18、5 respentively) according to the syndrome differentiation of TCM. There were 17 patients of primary infertility and 45 of secondary infertility, 40 bilateral obstructed oviducts and 22 unilateral ones. Anatomically, the position of oviduct blockage include uterine part, isthmus and junction between isthmus and ampulla, which the sum of affected position is 74,24 and 4, respectively.
Controls data:29 patients with mean age of 30.14±3.907 years (range 22 to 38), course of 3.66±2.581 years(range 1 to 12) and fllowed for a median of 7.14±2.601 months (range 3 to 14). There were divided into three syndromes including qi stagnation and blood stasis, stagnation of damp and heat and stagnation of cold and damp(18、7、4 respentively) according to the syndrome differentiation of TCM. There were 7 patients of primary infertility and 22 of secondary infertility, 23 bilateral obstructed oviducts and 6 unilateral ones. Anatomically, the position of oviduct blockage include uterine part, isthmus and junction between isthmus and ampulla, which the sum of affected position is 38, 11 and 3, respectively.
All of the patients were received fallopian tube recanalization. The patients of experimental group were received the treatment of Chinese herbs by oral, enema and external application according to syndrome differentiation of TCM about one week per month in 3 months after fallopian tuberecanalization. Perfuse the drugs which are different in two groups into uterine cavity about two times per month in 2 months after operation. The drugs include Radix Salvia Miltiorrhiza and gentamycin、dexamethasone、α-chymotrypsin in experimental and control groups, respectively. Observe the clinical symptoms and sign of chronic pelvic inflammation and record findings in two groups. The patients were regularly followed up for 2 years. The patient which is not perceived during follow-up will be tested on HSG. The findings before operation were compared between two groups by independent-samples t test and x2 test. The statistic method was respectively adopted the matched t-test、and of measurement data and the Wilcoxon test to analyse by SPSS 13.0 statistic software.
Result
There were successful rate of 88.24%、92.31%, patent rate of 82.02%、64.29%, oviduct obstructed rate of 17.98%、35.71%, re-adhesion rate of 12.66%. 31.58%, intrauterine pregnant rate of 27.78%、16.67%, ectopic pregnant rate of 1.85%、12.5%, response rate of 76.40%、42.86% in experimental and control groups, respectively.
The patent rate of oviduct in experimental group was higher than that of the control group, the obvious significant between two groups in statistic (P<0.01). The patent rate of oviduct in experimental group was higher than that of the control group in the syndrome of qi stagnation and blood stasis and stagnation of cold and damp, the obvious significant between two groups in statistic(P<0.001). The patent rate of oviduct in two groups was not different significantly in the syndrome of stagnation of damp and heat. The improvement of symptoms and signs on chronic pelvic inflammation (such as lower quadrant abdominal pain、menstruating abdominal pain and CTB) in experimental group was obviously than that of the control group, the obvious significant between two groups in statistic(P<0.01).
Conclusion
The treatment focusing on relieving the primary and the secondary aspects is quite effective for infertility due to tubal obstruction. It can improve the tubal patency and decrease the recurrence of fallopian tube adhesion and be treated as one of the routine therapy for infertility due to proximal tubal obstruction.
引文
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