| ObjectiveTo 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.Methods91 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.ResultThere 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).ConclusionThe 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.
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