The Study On Early Diagnosis Of Ectopic Pregnancy And "Chinese And Western Treatment Program Of Tubal Pregnancy"

In the recent years, with the increase of abortion and infections in the department of gynecology and obstetrics, the rate of ectopic pregnancy is rising. According to the statistics, the incidence of ectopic pregnancies among the all is about 1%[1], and the overwhelming majority of them are tubal pregnancies (95%). Although a part of the intrauterine gestational sacs can not be found within 6 weeks, do the women with pregnancies often appear positive in the early pregnancy test, the cases of ectopic pregnancy which cannot be excluded, is about 8%-31% among the all.Because the clinical treatments between ectopic pregnancy and the others are different, especially the threatened abortion,the early identification between two is of higher clinical significance. In order to identify ectopic pregnancy and threatened abortion, discriminant equation, basing on the admission clinical data which was diagnosed to be pregnancy of unknown location and providing the effective treatment to an early clinical reference program, will be established through bayes discriminant analysis.At present, many scholars advocate more use of non-surgical therapy as the treatment of early ectopic pregnancy, while some ertain indications and contraindications were found in the conservative treatment. Considering of the fertility, safety, and so on, choosing the best treatment is becoming priority in the therapy of ectopic pregnancy. Basing on differentiating diseases and zheng differentiation-treatment of tubal pregnancy, the "impact factor of tubal pregnancy condition integration" and "Chinese and western treatment of tubal pregnancy", aiming at the problems of drastic surgery or blind drug treatment which exit during the treatment of tubal pregnancy, is created after 718 cases of retrospective studies, prospective study of 150 cases and 706 cases of retrospective assessment according to nearly a decade of clinical studies and summaries.This project, solving many problems in clinical treatment of tubal pregnancy effectively, had been officially used in clinical since 2006. After four years of clinical application,the curative effects of "Chinese and western treatment of tubal pregnancy", the correlation factors of medical curative effects, the changing situations of serumβ-HCG working as the main observation index, and whether the surgical cases in stipulation really need surgery or not,require further more summaries and evaluations.Objective1. According to the diagnosis of the clinical data earlypregnancy on admission, the establishion of early pregnancy,sdiscriminant eqution by bayes discrimination, differs ectopic pregnancy between threatening miscarriage, providing reference for the early clinical disagnosis and effective treatment.2. Relative factors about drug therapy efficacy, can be learned by observing the drug therapy efficacies for tubal pregnancy with the use of the combination of the traditional Chinese and western medicine treatment for tubal pregnancy from 2006-2009 and analyzing the clinical history material of patients.3. According to observing the change trend and rules of serumβ-HCG of tubal pregnancy in the drug therapy process, the effects of tubal pregnancy patients, serumβ-HCG of different types for different drug treatment, can be known.4. Observe the intraoperative situations of case needing surgery in the combination of the traditional Chinese and western medicine treatment for tubal pregnancy, compare the intraoperative situations of cases suiting for drug therapy with thoese needing drug treatment while taking operations, discussing surgical treatment of rationality in the combination of the traditional Chinese and western medicine treatment for tubal pregnancy.According to the studies mentioned above, the strengthen of early diagnosis for tubal pregnancy and the further verification of rationality and utlity of the combination of the traditional Chinese and western medicine treatment for tubal pregnancy, promote and provide better clinical evidence.Research Contents and Research Methods1. Clinical data on admission which meets the case selection criteria should be collected. In order to determine the discriminant function coefficients and constants by using bayes discriminant analysis to select effective variables for the diagnostics,. and finally establish bayes discriminant function formula. It should be verified and the effect of discriminant function formula shall be expored through its own methods of validation and cross validation.2. After distinguishing the disease stages, syndrome differentiation of the tubal pregnancies from January 2006 to December 2009 and calculating the total score of illness impact factors, the cases that suit drug treatments, based on "Chinese and western treatment of tubal pregnancy", will be taken group therapies according to different treatments, the clinical outcomes of each treated group will be observed, the differences of efficacy in each will be compared by each year, the equilibrium and stability of clinical efficacy between groups of the program will be evaluated.At the same time, via making multivariate logistic regression analysis of the related clinical data for each treated group,we will explore the correlation between the clinical data and the efficacy of treatment group patients. It will provide reference to the efficacy predicting of clinical drug treatment of tubal pregnancy.3. Analyzing serumβ-HCG of the cases of tubal pregnancy succeeding in drug treatment by "Chinese and western treatment of tubal pregnancy", drawing the curve of serumβ-HCG according to the serumβ-HCG changes in each time point, comprehending the Serumβ-HCG changes in the course of drug treatment, provide important reference to the use of conservative treatments of tubal pregnancy by "Chinese and western treatment of tubal pregnancy"in clinical.4. According to"Chinese and western treatment of tubal pregnancy", compare the conditions in surgery of each group by selecting the cases demanding surgery and suiting drug treatment while requiring surgery as the observations of objects, such as the comparisons of the intraoperative pelvic bleeding, the mass size of the lesion site, the site of lesion, whether there were tubal ruptures or active bleedings or not and so on, by the ways those above, the necessities of the cases demanding surgery in the program can be evaluated.Results1. Establish discriminant formula as for early pregnancy:(1) Early threatened abortion:Yl=-51.8050+2.4640* X1+2.5804* X2+9.0985* X3+2.0742* X4+1.3489* X5+3.5299* X6+2.9579* X7+0.0836* X8+2.1086* X9-0.000056* X10+1.0492* X11-2.6068* X12(2)Early tubal pregnancy:Y2=-65.2017+2.8745* X1+4.6113* X2+7.3590* X3+0.3337* X4+3.4951* X5+3.5299* X6+1.1739* X7+0.0398* X8+3.1716* X9-0.000209* X10+7.0776* X11-1.2064* X12Among the total, X1=amenorrhea by time (the actual value), X2= irregular vaginal bleeding(0=no, l=yes), X3=menstrual whether rules(1=regular,2=irregular), X4=history of spontaneous abortion(0=no, 1=yes),X5=history of ectopic pregnancy(0=no,1=yes), X6=history of pelvic inflammatory disease(0=no, l=yes), X7= IUD history(0=no, 1=yes), X8= initial P value(nmol/L) (the actual value),X9=abdominal pain situation(0=no, 1=yes), X10= initial HCG value (IU /L) (the actual value), X11=uterine mass under type-B ultrasonic(0=no, 1=yes), X12= pelvic fluid under type-B ultrasonic(0=no, 1=yes).2. The observation of curative effect in the combination of traditional Chinese and western treatment for tubal pregnancy297 cases of drug treatment of tubal pregnancy were collected from January 2006 to December 2009.(1) 218 cases were Fetus-collateral-blockage type among the total,159 cases were treated by pure traditional Chinese medicine, the effective rate was 82.39%,59 cases were treated by conbined treatment of traditional Chinese medicine and western medicine, the effective rate was 81.82%.79 cases were Vitality-deficiency and Blood stasis type,57 cases were treated by pure traditional Chinese medicine, the effective rate was 80.70%,22 cases were treated by conbined treatment of traditional Chinese medicine and western medicine, the effective rate was 79.66%. It, P=0.971>0.05, has no statistical significance by using X2 test to compare the effective rate of all cases in different syndromes in 4 years.(2)65 cases were treated by drug treatment in 2006, the effective rate was 89.23%; 52 cases were treated by drug treatment in 2007, the effective rate was 78.85%;78 cases were treated by drug treatment in 2008, the effective rate was 73.08%; 102 cases were treated by drug treatment in 2009, the effective rate was 84.31%. It, P=0.071>0.05, has no statistical significance by using X2 test to compare the effective rate of all cases in diffrent years. (3) It, P> 0.05, has statistical significance by using exact propability to compare the effective rate of different treatment groups in the year of 2006,2007,2008 and 2009. So, no differences in the effective rate between each treatment groups can be considered.(4) It, P>0.05, has no statistical significance by using X2 test and exact propability to compare the effective rate of Fetus-collateral-blockage type treated by traditional Chinese drug treatment, Fetus-collateral-blockage type treated by conbined treatment of traditional Chinese medicine and western medicine, Vitality-deficiency and blood stasis type treated by traditional Chinese drug treatment, Vitality-deficiency and blood stasis type treated byconbined treatment of traditional Chinese medicine and western medicine.3. Analyzing the relative historical factors that impact the drugs clinincal curative effect.(1) Considering efficacy of 297 cases of tubal pregnancy mentioned above using drug treatment as the dependent variable, while the clinical data on admission as the independent variable, establish Multivariate Logistic Regression Equation and use the forward method to filter out significant variables, results are as follows:the history of spontaneous abortion, infertility and pelvic inflammatory disease are the three impacting factors on efficacy. Among them, the history of spontaneous abortion(ORO.30)and history of pelvic inflammatory disease(ORO.13)are the risks on curative effect, while the history of infertility (0R18.10) is the protective factor.(2)Considering Fetus-collateral-blockage type as the object of study, establish Multivariate Logistic Regression Equation of efficacy and clinical data and use the forward method to filter out significant variables, results are as follows:the history of ectopic pregnancy, infertility and pelvic inflammatory disease are the three factors on efficacy. Among them, the history of ectopic pregnancy (ORO.18) and pelvic inflammatory disease(OR2O.44)are the risk factors while history of infertility (0R20.44) is a protective factor on curative effect.(3)Consider Vitality-deficiency and blood stasis type as the object of study, establish Multivariate Logistic Regression Equation of efficacy and clinical data and use the forward method to filter out significant variables, results are as follows:the history of pelvic inflammatory disease and pelvic surgeryare the 2 factors on efficacy. Between them, the history of pelvic inflammatory disease (OR0.03) is a risk factor while the history of pelvic surgery(OR30.33) is protective on curative effect.4.Curve analysis of serumβ-HCG in the drug treatment process(1)By the ways of analyzing serumβ-HCG of the cases of tubal pregnancy which were succeeded in drug treatment by "Chinese and Western treatment of tubal pregnancy", and using multivariate analysis of variances to compareβ-HCG levels and the decline in the percentage change of each time point, groups and time points are different,P≤0.05 shows that the decline in the amount and the percentage ofβ-HCG in different groups and different time points are different.(2) With the absolute value of serumβ-HCG and the decline in percentage as ordinate, with each time point as x-coordinate, draw the curves of the serumβ-HCG of each drug treatment groups, among them, the curve of serumβ-HCG of the group of Fetus-collateral-blockage type treated by traditional Chinese drug treatment goes down smoothly, there were no significant differences in each adjacent time point with some occasional fluctuations but stable, the curve decreasing gradually was about 87.7%, the serumβ-HCG decline curve in percentage also showed a gradually descending curve of trapezoidal shape, among them, the time declining by more than 50% was 6.25±3.69 days, declining by more than 90% was 11.29±6.11 days. The curve of serumβ-HCG of Fetus-collateral-blockage type treated by conbined treatment of traditional Chinese medicine and western medicine, significantly higher than the groups of Fetus-collateral-blockage type and the groups of Vitality-deficiency and blood stasis type treated by traditional Chinese drug, P≤0.05, was of great fluctuation, among them, there were more cases of peak-shaped curve accounted for 31.82%. When comparing serumβ-HCG decline in the percentage of time, the treatment from 6 to 9 days got a greater change in the 4-5 time points, it had statistical difference in the percentage of the decline between the two points. The time of Serumβ-HCG dropping by more than 50% was 8.39±4.52 days, declining by more than 90% was 14.53±6.51 days. The curve of serumβ-HCG of the group of Vitality-deficiency and blood stasis type treated by traditional Chinese drug treatment, most of which gradually decreasing as a trapezoidal shape, went down smoothly,there was no significant difference in the percentage of decline between adjacent time points, the time of Serumβ-HCG dropping by more than 50% was 6.95±3.12 days, and the declining by more than 90% was 11.78±5.42 days. The curve of serumβ-HCG of Fetus-collateral-blockage type treated by Chinese medicine and western medicine, the overall of which gradually decreasing as a trapezoidal shape, was of a slight fluctuation. When analyzing the decline of the percentage, the serumβ-HCG was found to decrease significantly at the 5 to 6 time points from the 8 to 11 days, the time dropping by more than 50% was 9.55±5.37 days, the declining by more than 90% was 16.64+7.34 days.5. Discussing the rationality of surgical treatment in "the combination of Chinese and western treatment for tubal pregnancy"Study the cases of tubal surgery from amount of pelvic hemorrhage, maximum diameter of lesion site, lesion location with ruptures and active bleedings or not,etc,results are as follows:Pelvic cavity hemorrhage:①The collapse of both qi and:blood type was significantly more than the other types.②It is P≤0.05 in the comparison of surgically treated cases of the group of Vitality-deficiency and blood stasis type and for drug treatment while surgically treated cases of the group of Fetus-collateral-blockage type, pelvic hemorrhage volume differed.③It has no statistical significance in camparisons of pelvic cavity hemprrhage in each other treatment groups.(2)The maximum diameter of lesion sites:①lesion sites occurred, Fetus-collateral-blockage type requiring surgery was the largest among all, significantly differing from each group suiting drug therapy.②The maximum diameter of lesion sites of Vitality-deficiency and blood stasis type, requiring surgery, was longer than Fetus-collateral-blockage type suitable for drug therapy and Fetus-collateral-blockage type, suiting herbal treatment.③In the groups of Vitality-deficiency and blood stasis type with pharmacotherapy, the diameter of cases with Chinese and Western treatment was greater than those with pure traditional Chinese medicine.(3) Lesions occur:the number of pregnancies in tubal isthmus of Collapse of both qi and blood type was more than the other groups except the group of Fetus-collateral-blockage type with surgery.(4)In the tubal ruptures and active bleedings or not:①The group of Collapse of both qi and blood type was higher than the others in statistics.②The operation group of Vitality-deficiency and blood stasis type was significantly more than the groups of conservative treatment for drugs in the area of tubal rupture and so it is with each other group in the area of the active bleeding (except the group of Collapse of both qi and blood type).Research Conclusion1.Use Bayesian discriminant equation established for early pregnancy to check itseft, the results showed:the rate of identificated exactitude was 98.08% for threatened abortion,93.12% for ectopic pregnancy and was 95.6% for the overall. The results of alternation tests showed, the rate of identificated exactitude was 97.44% for threatened abortion,90.48% for ectopic pregnancy, and was 93.36% for the overall. This showed that the discriminant formula established was of good effect.2. Chinese and Western treatment of tubal pregnancy"studied and formulated by tutor was of good stability in drug treatment of tubal pregnancy. Moreover, the treatment is effective, reasonable and balanced, there are no significant differences in efficacy rate between groups. The efficacy in using drug treatment of "Tubal pregnancy treatments" is reliable.3. In the medication process of tubal pregnancy:①History of spontaneous abortion and pelvic inflammatory disease are the risk factors for success rate of the drug treatment, while history of infertility is protective for conservative therapy.②Toward to Fetus-collateral-blockage type, history of ectopic pregnancy and pelvic inflammatory disease are the risk factors for success rate of the drug treatment, while infertility history is the protective factor.③For Vitality-deficiency and blood stasis type, history of pelvic inflammatory disease is the risk factor for success rate of the drug treatment, but history of pelvic surgery is protective for conservative therapy.4. In the medication process of tubal pregnancy:①Serumβ-HCG of the group of Fetus-collateral-blockage type treated by traditional Chinese drug treatment decreased smoothly, among them, the time declining by more than 50% of was 6.25±3.69 days, while declining by more than 90% was 11.29±6.11 days.②Serumβ-HCG of the group of Fetus-collateral-blockage type treated by conbined treatment of traditional Chinese medicine and Western medicine is of a greater fluctuation. Serumβ-HCG decreased more sharplier in the treatment during the time of 6-9 days, the time declining by more than 50% was 8.39±4.52 days, while was 14.53±6.51 days by more than 90%.③Serumβ-HCG of the group of Vitality-deficiency and blood stasis type treated by traditional Chinese drug treatment decreased more smoothlier, among them, the time of serumβ-HCG declining by more than 50% was 6.95±3.12 days, declining by more than 90% was 11.78±5.42 days.④serumβ-HCG of Vitality-deficiency and blood stasis type treated by Chinese medicine and western medicine is of a slight fluctuation, it decreased significantly from 8 to 11 days, its time of dropping by more than 50% was 9.55±5.37 days, while declining by more than 90% was 16.64±7.34 days.5.The combination of traditional Chinese western medicine treatment for tubal pregnancy in the operation part,maded by the tutor in the early studies, suppling the time to take surgical treatment of tubal pregnancy with guidance and reference and avoiding choosing the treatments blindly, is reasonable and is of higher value for clinical applications.