| Objective:1.To explore the TCM syndrome characteristics of platinum-resistant recurrent ovarian cancer.2.To evaluate the clinical efficacy and safety of Yiqi Yangyin Tongluo Decoction in platinum-resistant recurrent ovarian cancer with syndrome of deficiency of both qi and yin complicated with phlegm and static blood.Methods:1.In this study,patients with platinum-resistant recurrent ovarian cancer were studied.Clinical data,such as general data and four diagnostic information were collected by means of questionnaire survey firstly.Next,the clinical data were verified and integrated before systematic cluster analysis was performed.Descriptive statistics were performed for each type of symptom and TCM syndrome were summarized.Finally factor analysis was carried out on tongue manifestation and pulse manifestation.The analysis results were summarized and explained clinically by clinical practice and TCM theory.2.In this study,patients with platinum-resistant recurrent ovarian cancer with syndrome of deficiency of both qi and yin complicated with phlegm and static blood were divided into a treatment group(Yiqi Yangyin Tongluo Decoction combined with bevacizumab and chemotherapy)and a control group(bevacizumab and chemotherapy)and compared at baseline.Each treatment cycle lasted 21 days.Evaluate the improvement of TCM syndrome scores,KPS scores,tumor markers and coagulation function-related indexes in the two groups after 2 cycles,as well as evaluate the clinical efficacy indicators DCR and ORR.The adverse events during the treatment were recorded.In addition,the PFS of the 2 groups was followed up and analyzed.Results:(1)A total of 104 patients with an average age of 55.35 ± 9.09 years were included in this study.There were 71 cases(68.3%)in stage IIIC and 33 cases(31.7%)in stage IV.The most common pathological type was high-grade serous carcinoma(72.1%).(2)The most common symptoms of TCM were spiritlessness and weakness(77.9%),panting and being taciturn(62.5%),emaciation(56.7%),soreness and weakness of waist and knees(52.9%),etc.Sublingual varicose vessel(90.4%),ecchymosis and petechia on tongue(59.6%),white fur(43.3%),little fur(36.5%),thready pulse(54.8%)and deep pulse(33.7%)were common in tongue manifestation and pulse manifestation.(3)According to cluster analysis and clinical practice,it is most appropriate to divide syndrome into 5 types,namely,deficiency of both qi and yin(35.6%),stagnation of qi and blood stasis(25.0%),phlegm-dampness amassment(16.4%),water overflowing due to yang deficiency(14.4%)and deficiency of qi and blood(8.7%).In addition to the qi stagnation and blood stasis,the sublingual varices in different syndrome types can be seen in the phlegm and dampness accumulation type(82.4%),the deficiency of both qi and yin type(89.2%),the deficiency of qi and blood type(88.9%),and the water overflowing due to yang deficiency(86.7%);Violet sublingual collaterals can be seen in the type of deficiency of both qi and blood(55.6%);Dark red can be seen in water overflowing due to yang deficiency(46.7%);The tongue with ecchymosis can be seen in the deficiency of both qi and yin(56.8%)and the deficiency of both qi and blood(44.4%).(4)Factor analysis was performed on the tongue and pulse.Combined with clinical practice,3 types of common factors were finally combined,corresponding to the TCM pathogenesis of deficiency(30.123%),static blood(22.811%),and phlegm(16.203%).1.A total of 64 patients were included in this study,including 33 in the treatment group and 31 in the control group.Statistical analysis showed that baseline data were comparable(P>0.05).After 2 cycles of treatment,patients in both groups were evaluated.(1)In terms of quality of life,the effective rate of TCM syndrome score in the treatment group was significantly improved compared with the control group(78.8% vs 48.4%,P= 0.029),among them,the symptoms of less abdominal pain,less food,lethargy,tiredness,five-heart fever,spontaneous sweating and night sweating improved more significantly.The effective rate of KPS score was also significantly improved compared with the control group(75.8% vs 48.4%,P= 0.024).(2)There was no significant difference in ORR(24.2% vs 22.6%)and DCR(78.8% vs 71.0%)between the treatment group and the control group(P>0.05).(3)In terms of tumor markers,compared with the same group,CA125 in the treatment group decreased significantly before and after treatment,with a statistically significant difference(P= 0.001),but there was no statistically significant difference in CA125 in the control group before and after treatment(P= 0.217).The comparison between the two groups showed that the decrease of CA125 in the treatment group was significantly greater than that in the control group(P= 0.042).There was no statistical difference in HE4 between the two groups and in the same group before and after treatment(P>0.05).(4)In terms of coagulation function,the FIB and D-dimer in the treatment group and the control group increased compared with those before treatment(P>0.05).However,the comparison between the two groups suggests that the increase of FIB and D-dimer in the treatment group is smaller than that in the control group(P<0.05).There was no significant difference in the levels of PT and APTT between the two groups and within the same group before and after treatment(P>0.05)(5)In terms of adverse reactions,compared with the control group,the incidence and severity of leukopenia,neutropenia,nausea,vomiting and loss of appetite in the treatment group decreased significantly(P<0.05).There was no significant difference in thrombocytopenia,constipation,liver and kidney function injury,albuminuria and hypertension(P>0.05).(6)survival analysis showed that the m PFS of the treatment group was 6.5±0.468(95%CI:5.58-7.41)months,and that of the control group was 5.7±0.905(95%CI:3.92-7.47)months.The difference was statistically significant(P= 0.033).Conclusions:1.The syndromes of patients with platinum-resistant recurrent ovarian cancer are deficiency of both qi and yin,stagnation of qi and blood stasis,phlegm-dampness amassment,water overflowing due to yang deficiency and deficiency of qi and blood,among which deficiency of both qi and yin and stagnation of qi and blood stasis are more common,and the clinical symptoms of individualized patients are complex,their TCM syndrome are not single.In addition,patients with different syndrome types have different degrees of blood stasis.The body stasis state is the common feature of platinum-resistant recurrent ovarian cancer.2.Through the factor analysis of tongue manifestation and pulse manifestation,it is concluded that deficiency,static blood and phlegm are the pathogenesis characteristics of platinum-resistant recurrent ovarian cancer.3.Yiqi Yangyin Tongluo Decoction combined with bevacizumab and chemotherapy in treating platinum-resistant recurrent ovarian cancer with syndrome of deficiency of both qi and yin complicated with phlegm and static blood has obvious advantages in improving TCM syndrome score,KPS score,CA125,and coagulation function compared with the simple treament of bevacizumab and chemotherapy.Meanwhile,the PFS of patients is prolonged to a certain extent.In addition,the incidence and severity of adverse events,including leukopenia and neutropenia,nausea,vomiting,loss of appetite were reduced. |
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