| 1 PurposeAccording to the GCP standard,select the blood coagulation index,TCM syndrome(Symptoms)and livingquality through the central random,multi-center clinical trial method to evaluate the clinical effect of Xinjia Liangfu Granule in the treatment of advanced gastric cancer complicated with dysfunction of blood coagulation.2 MethodAccording to the criteria of diagnosis,curative effect and operation,patients with advanced gastric cancer with dysfunction of blood coagulationwere randomly divided into groups by central random system and treated clinically for 21 days.The researchers entered into the groups on the day 7(Visit 2)and day 21(Visit 4)to visit the subjects in order to collect test datas for effectiveness and safety assessment,fill out case observation forms(CRF).And the test data in the CRF table are entered into the database.Finally,the statistical analysis is carried out.3 Results3.1 Number of cases observedAccording to the clinical trial scheme,from July 2013 to August 2015,in the whole city totally 7 Grade 3 A medical units selected 180 subjects(Number of cases in which the number of cases has reached the number of cases determined by the plan)who met the entry criteria by competitive entry method.There were 120 cases in the test group and 60 cases in the control group.After repeatedly checking the clinical trial data and excluding many related interference factors,180 patients entered the FAS analysis set(120 cases in experimental group and 60 cases in control group).According to the clinical trial plan,30 cases dropped out and 150 cases entered the PPS analysis set(102 Cases in experimental group and 48 cases in control group).According to the clinical trial,the stragglers of the cases were analyzed,and 29 cases were natural falling off,and the rate of exfoliation was 16.11%.In the course of treatment,serious adverse events and complications were included in the number of exfoliated cases,and the rate of abscission was 16.67%.Two methods meet the requirements of clinical trial design.3.2 Change of hemagglutination indexAlthough there was no statistical significance(P>0.05)between the two groups in the comparison of the hemagglutination indexes at the critical point of visit to the baseline difference,there was significantchange of the hemagglutination single indexe,and the results of the analysis are as follows:? Compared with baseline value,thrombin time test group and control group,there was statistical significance(P<0.01)through the T checkout.The results of FAS and PPS analysis were consistent.?FAS analysis of prothrombin ratio showed that there was statistical significance(P<0.05)comparing the test group Visit 2,Visit 4 of PPS analysis with baseline.?There was statistical significance(P<0.001)of the percentage of prothrombin activity in the test group comparing the Visit 4 with the baseline.The results of FAS and PPS analysis were consistent.?There was statistical significance(P<0.01)comparing the international standardized ratio of prothrombin with the Visit 4 of the control group and the baseline in the test group.The results of FAS and PPS analysis were consistent.?Fibrinogen:There was significant significance(P<0.05)comparing the the Visit 2 of group after treatment and baseline;?D-dimer:There was significant significance(P<0.01)comparing the Visit 2 of the control group and the baseline.The results of FAS and PPS analysis were consistent.The above results show that the test group(New Jia Liang attached particles)could improve Thrombin time,prothrombin ratio,activity of prothrombin percentage,international standardized ratio of prothrombin,fibrinogen and D-dimer to the certain degree.lt is speculated that the therapeutic effect will be more obvious with the prolongation of treatment time.3.3 TCM syndrome indicatorsThere was statistical significance(P<0.01)comparing the Visit 2,of the test group of total integral of TCM syndromes based on FAS and PPS analysis with baseline.;Visit 4:There was statistical significance(P<0.01)comparing the the Visit 4 with the baseline total score..It shows that the experimental group is superior to the control group in improving the total integral of TCM syndromes.3.4 Single symptom indicatorThe FAS set statistics show that there was statistical significance(P<0.05)comparing the Visit 2 with the baseline.(Ecchymosis,numbness);Visit Point 4-baseline(Dull,tired body fatigue,body pain,ecchymosis,skin armour fault,numbness,dizziness).There was statistical significance(P<0.05)between groups.The result of PPS set analysis is consistent with that of FAS analysis set which indicates that the test group(Xinjialiangfu Granules)was superior to the control group in improving the single symptoms of dark complexion,fatigue,body pain,subcutaneous ecchymosis,skin armour error,limb numbness and head vertigo.3.5 Results of blood routine observationThe results of blood routine tests are as follows:?There was statistical significance(P<0.05)about the elevated blood cell count in the control group comparing the Visit 2 with the baseline;?Platelet distribution width:There was statistical significance(P<0.05)that the control group was higher than the experimental group with comparison between the two groups.3.6 Score of life qualityThere was statistical significance(P<0.01)to compare the life quality score with baseline with the FAS and PPS sets tested by rank sum test.The change of life quality score in the control group was not statistically significant compared with the baseline,and the improvement of the quality of life in the experimental group was better than that in the control group.4 ConclusionXinjialiangfu granule can partly improve the blood coagulation index,and can obviously improve the curative effect of TCM syndromes in patients with gastric cancer complicated with hypercoagulability.It can improve the single symptoms,such as dark complexion,fatigue,pain,subcutaneous ecchymosis,skin armour error,limb numbness,head dizziness,mental depression and so on,which shows the characteristics and advantages of traditional Chinese medicine.Based on the results of clinical trials,the Xinjialiangfu Granule was considered as warming-yang nourishing-qi and activating blood thereby it can improve the hypercoagulable state of advanced gastric cancer safely and effectively.The result can be further improved and applied in clinical practice. |
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