| OBJECTIVE:First part:Through clinical retrospective analysis,to find a kind of laboratory diagnostic criteria to identify the hypercoagulable state related to cancer. Furthermore to value the TEG indicators,CBC and blood coagulation test relevant indicators in diagnosing the hypercoagulable state caused by malignant tumor.Second part:Though randomized clinical trials,to evaluate and compare the effectiveness of two kinds of Chinese herbal compounds:Qilong granule and Qizhi granule, which are used to treat the hypercoagulable state related to NSCLC, and the blood stasis due to qi deficiency syndrome, which is one TCM syndrome types of NSCLC.METHODS:First part:Select hospitalized patients who got cancer, design CRF to collect their laboratory test results such as TEG indicators, CBC and blood coagulation test relevant indicators. Compare the incidence, sensitivity and specificity of different kinds of diagnostic criteria of hypercoagulable state related to cancer and choose the most effective, easily used ones. Calculate the weight coefficient of each laboratory indicator through Fisher discriminant analysis.Second part:Selected outpatients and hospitalized patients who are met to inclusion criteria and divided those patients into three groups by the radio of1:1:1, that are Qilong group, Qizhi group and blank control group. Value the observing indicators such as PLT and blood coagulation test relevant indicators, TEG indicators, the scoring of symptoms of blood stasis due to qi deficiency syndrome, and the KPS at the fisrt day and14days later.RESULTS:First part:There are132patients who are included in statistical analysis.(1) According to TEG, the incidence of hypercoagulable state related to cancer is37.12%.(2)①PT shorten>3s;②APTT shorten>3s;③FIB>4g/dL;④DD>300ug/L;⑤PLT>300×109/L. Reaching2and more than2items of the above are used to diagnose the hypercoagulable state related to cancer.According to that, we got the incidence is38.64%, the sensitivity is71.4%, and the specificity is80.7%.(3)Using Fisher discriminant statistical method to analyse the whole laboratory indicators such as R、K、ANG、MA、CI、WBC、HGB、PLT、MPV、 PDW, PT、APTT、TT、FIB、 DD, we got the diagnostic equation as following:6.8×K+1.8×MA-3.3×R>100. According to the equation, we got the incidence is38.64%, the sensitivity is91.8%, and the specificity is92.8%.(4) Using Fisher discriminant statistical method to analyse the laboratory indicators besides TEG indicators such as WBC、HGB、PLT、MPV、PDW、PT、APTT、TT、FIB、DD, we got the diagnostic equation as following:8.1×PLT+0.7×DD-36.8×APTT>1000. According to the equation, we got the incidence is32.58%, the sensitivity is63.3%, and the specificity is85.5%.Second part:There are61patients who are collected in statistical analys is, including21cases in Qilong group,20cases in Qizhi group, and20cases in blank control group.(1)In Qilong group, there are no statistical difference of the whole observing laboratory indicators and the KPS between pre-treatment and post-treatment (P>0.05).The scoring of blood stasis due to qi deficiency syndrome and symptoms as fatigue, encrusted skin, numbness of limbs of post-treatment in Qilong group are lower than those of pre-treatment (P<0.05) The efficiency of Qilong granule in treating blood stasis due to qi deficiency syndrome is66.7%, and the therapeutic effect of life qualities of the whole21cases are stable.(2)After14days treating with Qizhi granule, the patients’ laboratory indicators such as DD, PDW, ANG, CI are lower, the indicator K is longer, the scoring of blood stasis due to qi deficiency syndrome and symptoms as dim complexion, fatigue, pain, encrusted skin, numbness of limbs, dizziness or blurred vision are lower, and the KPS is higer than those of pre-treatment (P<0.05).But the rising KPS show no clinical significance. The efficiency of Qizhi granule to treat blood stasis due to qi deficiency syndrome is60%. The therapeutic effect of life qualities of the whole20cases in Qizhi group, one of those is improved, and the other19of those are stable.(3) The indicators as FIB, DD, and the scoring of blood stasis due to qi deficiency syndrome of post-treatment in Qilong and Qizhi group are both lower than those of in blank control group (P<0.05).The KPS of post-treatment in Qilong group is no statistical difference from that of in blank control group (P>0.05), while the KPS of post-treatment in Qizhi goup is higher than that of in blank control group (P<0.05). But the higer KSP show no clinical significance.(4) There are no statistical difference of all observing laboratory indicators, scoring of blood stasis due to qi deficiency syndrome, and the KPS of post-treatment between Qilong group and Qizhi group (P>0.05).CONCLUSIONS:First part:(1)To diagnose the hypercoagulable state related to cancer through TEG:①R<5min;②K<lmin;③ANG>72°;④MA>70mm. To meet any of the above is recommended as the diagnostic criteria.(2)To diagnose the hypercoagulable state related to cancer through CBC and blood coagulation test:①PT shorten>3s;②PTT shorten>3s;③FIB>4g/dL;④DD>300ug/L;⑤PLT>300×109/L. Reaching2and more than2items of the above are suggested as the diagnostic criteria.(3)To diagnose the hypercoagulable state related to cancer through diagnostic equation:8.1×PLT+0.7×DD-36.8×APTT>1000. Meeting the above equation is advised as the diagnostic criteria as well.(4)In diagnosing the hypercoagulable state related to malignancy, the TEG indicators are better than those in CBC and blood coagulation tests. The indicators such as K, R, MA are better than those as ANG, CI in TEG indicators. While the indicators such as APTT, PLT, DD are better than those as FIB, WBC, HGB, MPV, PDW, PT, TT in CBC and blood coagulation tests.Second part:(1)Qilong granule and Qizhi granule can both alleviate the hypercoagulable state related to NSCLC, modify the blood stasis due to qi deficiency syndrome, and relieve the relevant symptoms.(2)Qizhi granule is better than Qilong granue in treating hypercoagulable state and blood stasis due to qi deficiency syndrome related to NSCLC.(3)Qilong granue and Qizhi granule had no effect on the life qualities of those patients who are got hypercoagulable state related to NSCLC.(4) The Chinese hebal which is able to benefit qi and activate blood circulation can be used for treating hypercoagulable state related to NSCLC. |
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