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Objective To explore the short-term efficacy of Xiaoaiping injection assisted TP regimen (taxotere + paraplatin)in the treatment of advanced non-small cell lung cancer(NSCLC)and its effects on immune function,adverse reactions and quality of life. Methods One-hundred cases of patients with advanced NSCLC who were admitted to the Affiliated Hospital of Chengdu University of Traditional Chinese Medicine from October 2014 to October 2017 were selected as subjects,and they were randomly divided into Xiaoaiping group (n = 55)and TP group(n = 45)according to the random number table method. Patients in TP group were given TP regimen chemotherapy,and patients in Xiaoaiping group were added with Xiaoaiping injection on the basis of TP group. The short-term efficacy and changes of immune function,adverse reactions and quality of life were observed in the two groups,and statistical comparison was performed. Results After treatment,the response rates of patients in Xiaoaiping group and TP group were 49. 09％(27 / 55)and 28. 89％(13 / 45) respectively,with a significant difference(χ2 = 4. 209,P = 0. 040). After treatment,the disease control rates of patients in Xiaoaiping group and TP group were 83. 64％(46 / 55)and 73. 33％(33 / 45)respectively,with no significant difference(χ2 = 1. 584,P = 0. 208). The CD4 +(40. 98％ ± 5. 73％ vs. 33. 47％ ± 5. 06％ ), CD4 + / CD8 +(1. 53 ±0. 34 vs. 1. 25 ±0. 26)and nature killer(NK)cells(19. 59％ ± 4. 77％ vs. 17. 05％ ± 4. 12％ )in Xiaoaiping group after treatment were significantly higher than those in TP group(t = 6. 869,P <0. 001;t = 4. 542,P < 0. 001;t = 5. 609,P < 0. 001). And there was no significant difference in CD8 +between the two groups(26. 83％ ± 5. 21％ vs. 26. 58％ ± 5. 20％ ;t = 0. 239,P = 0. 812). The incidence rates of leucopenia(50. 91％ vs. 75. 56％ ),thrombocytopenia(38. 18％ vs. 66. 67％ )and hemoglobin re-duction(52. 73％ vs. 77. 78％ )in Xiaoaiping group were lower than those in TP group,with significant diffe-rences(χ2 = 6. 381,P = 0. 012;χ2 = 8. 306,P = 0. 005;χ2 = 6. 741,P = 0. 009). There were no significant differences in the incidence rates of nausea and vomiting(32. 73％ vs. 48. 89％ ),diarrhea constipation (45. 45％ vs. 60. 00％ )and liver damage(7. 27％ vs. 13. 33％ )between the two groups(χ2 = 2. 694,P =0. 101;χ2 = 2. 098,P = 0. 148;χ2 = 0. 449,P = 0. 503). After treatment,the Karnofsky functional status scores of patients in Xiaoaiping group and TP group were 81. 47 ± 11. 26 and 73. 38 ± 10. 45 respectively,and the stability rates of quality of life improvement were 78. 18％(43 / 55)and 57. 78％(26 / 45)respectively, with significant differences(t = 3. 691,P < 0. 001;χ2 = 4. 817,P = 0. 028). Conclusion Xiaoaiping injec-tion assisted TP regimen has a good short-term efficacy on advanced NSCLC,which can effectively improve immune function,reduce adverse reactions and improve the quality of life.
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Objective To observe the efficacy and safety of Xiaoaiping injection combined with chemotherapy for treatment of recurrent ovarian cancer. Methods Eighty-eight patients with recurrent epithelial ovarian cancer in the Affiliated Cancer Hospital of Shanxi Medical University from October 2014 to November 2016 were randomly divided into the test group (44 cases) and the control group (44 cases) according to the random number table method. The control group was treated with paclitaxel + platinum regimen chemotherapy, and the test group was treated with chemotherapy regimens combined with Xiaoaiping injection. The efficiency and adverse reactions of both groups were compared. Results Finally, 40 patients and 42 patients were enrolled in the test group and the control group respectively. The recent objective response rate (ORR) in the test group was higher than that in the control group [52.5 ％ (21/40) vs. 31.0 ％(13/42), respectively; χ2= 3.919, P= 0.048]. CA12550 ％ declining rate in the test group was higher than that in the control group [75.0％(30/40) vs. 57.1 ％ (24/42); χ2= 2.905, P= 0.088]; CA12575 ％ declining rate in the test group was higher than that in the control group [65.0％(26/40) vs. 28.6％(12/42);χ2=10.934, P=0.001]. The incidence of platelet decline in the test group was lower than that in the control group [7.5％(3/40) vs. 26.2％(11/42);χ2=6.138, P=0.046]. Conclusion Xiaoaiping injection combined with chemotherapy in treatment of recurrent ovarian cancer could increase the recent efficacy and reduce side effects.
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Objective@#To evaluate the efficacy and safety of Xiaoaiping combined with chemotherapy in the treatment of advanced esophageal cancer.@*Methods@#This is a multi-center, randomized, open label and parallel controlled study. A total of 124 advanced esophageal cancer patients with Karnofsky Performance Status (KPS) score ≥60 and expected survival time≥3 months were enrolled. We adopted design and divided the patients into study and control group. The patients in study group received Xiaoaiping combined with S-1 and cisplatin. The control group received S-1 and cisplatin. Each group included 62 patients and 21 days as a treatment cycle. The efficacy and adverse events in patients of the two groups were observed and compared.@*Results@#57 patients in the study group and 55 in the control group were included in efficacy assessment. The response rate was 54.4% and 34.5% in the study group and control group, respectively(P<0.05). Disease control rates were 86.0% and 69.1%, respectively(P<0.05). The median progression-free survival (PFS) was 7.97 in the study group and 6.43 months in the control group(P<0.05). The median overall survival(OS) was 12.93 in the study group and 10.93 months in the control group(P<0.05). The most common adverse events in the two groups were nausea and vomiting, thrombocytopenia, anemia, neutropenia, liver damage, pigmentation, oral mucositis, renal impairment and diarrhea. The incidences of nausea, vomiting, thrombocytopenia, leukopenia, neutropenia and diarrhea in the study group were significantly higher than those in the control group(P<0.05).@*Conclusion@#Xiaoaiping combined with S-1 and cisplatin significantly increased response rate, and prolongedpatients′ survival in patients with advanced esophageal cancer.
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Objective To investigate the inhibitory effect of Xiaoaiping injection (XAP) combined with paclitaxel (PTX) on human ovarian cancer SK-OV-3 cells .Methods In vitro anti-proliferation activity study of XAP combined with PTX on hu-man ovarian cancer SK-OV-3 cells was performed using optical microscope and MTT assay .Human ovarian cancer SK-OV-3 cells were treated with PTX ,XAP ,PTX combined XAP or vehicle control .Each group of cells was treated with drugs for 24 h or 48 h .SK-OV-3 cell morphology was observed with optical microscope .MTT assay was used to detect the A value and cell vi-ability was calculated .In vivo effect of XAP combined with PTX on the growth of SK-OV-3 cells was determined in nude mice . In our study ,thirty-six mice were randomly divided into six groups :G1 (NS) ,G2 (PTX ,10 mg/kg) ,G3 (XAP ,20 ml/kg) , G4 (XAP ,50 ml/kg) ,G5 (PTX 10 mg/kg+XAP 20 ml/kg) and G6 (PTX 10 mg/kg+XAP 50 ml/kg) .Animals were trea-ted for 18 days .Body weight ,tumor volume and tumor inhibition rate were recorded and calculated .The results were analyzed by the SPSS 19 .0 software .Results In vitro study showed that SK-OV-3 cell viability decreased significantly in PTX com-bined XAP group compared to PTX group or XAP group ,in a time and dose-dependent manner .In vivo study showed that the combination of PTX and XAP resulted in decreased tumor weight significantly compared to the control or the PTX alone . Conclusion The combination of XAP and paclitaxel exhibited a synergistic effect both in vitro and in vivo in nude mouse tumor xenograft model .
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Objective To observe the clinical effect of Xiaoaiping Injection combined with gemcitabine and carboplatin in the treatment ofⅢB and Ⅳ non-small cell lung cancer (NSCLC).Methods Totally 106 NSCLC patients from Huangshi Central Hospital of Edong Medical Group were sellected in this study.The patients were divided into gemcitabine and carboplatin control group (n =53)and Xiaoaiping Injection combined with gemcitabine and carboplatin observation group (n =53).The clinical efficacy and adverse reactions were compared between two groups.Results After four cycles of treatment,the effective rate and control rate in observation group were 39.6％ and 77.4％,and those in control group were 35.8％ and 75.5％.There was no significant difference between the two groups.The decline rates of white blood cells,hemoglobin,and platelet in observation group were 41.5％,37.7％,and 45.3％,which were significantly lower than those of 64.2％,62.3％,and 69.8％ in control group (P ＜ 0.05).There was no significant difference of renal function injury,liver function damage,nausea,vomiting,dizziness,headache,diarrhea,and constipation between two groups.In observation group,the median survival time was 8.4 months,time to tumor progression was 5.3 months,and 1 year survival rate was 26.4％.In control group,the median survival time was 7.7 months,time to tumor progression was 4.2 months,and 1 year survival rate was 11.3％.There was significant difference between two groups (P ＜ 0.05).Conclusion Xiaoaiping Injection combined with gemcitabine and carboplatin can reduce the hematologic toxicity of chemotherapy drug in the treatment of ⅢB and Ⅳ NSCLC,and improve long-term clinical outcomes.combined with gemcitabine and carboplatin can reduce the hematologic toxicity of chemotherapy drug in the treatment ofⅢB and Ⅳ NSCLC,and improve long-term clinical outcomes.
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Objective:To observe the compatibility of Xiaoaiping injection and insulin for injection in glucose infusion. Methods:The changes in appearance, particles and pH of the mixture in 24h at ambient temperature were observed. The concentration of chloro-genic acid and insulin were determined by HPLC. Results:There were no obvious changes in appearance, pH, precipitation or turbidi-ty generation, and the contents of insulin and chlorogenic acid kept stable in 12 h. The number of insoluble particles was stable in 12 h, and then gradually increased in 24 h. Conclusion:Xiaoaiping injection and insulin in 5％ glucose infusion is stable in 12h under the testing conditions.
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Objective To explore the treatment for patients with advanced gastric cancer, the use of xiaoaiping injection combined with FOLFOX6 chemotherapy intervention. Methods 40 cases of patients with advanced gastric cancer for the implementation of FOLFOX6 chemotherapy intervention, at the same time as the control group, the other 40 patients in the control group based on the use of xiaoaiping injection, and classified as the observation group, two groups of patients were in our hospital from March 2015 to January 2017 . Results Comparing the two groups of patients with the treatment efficiency, the patients in the observation group were higher obviously; the observation group patients nursing satisfaction rate was significantly higher (P<0.05) shows significant differences. Compared two groups of patients with adverse reactions, found in the two groups were different, but the difference was not obvious. Conclusion The visible analysis of the effect of xiaoaiping injection combined with FOLFOX6 chemotherapy in the treatment of advanced gastric cancer, compared with chemotherapy and intervention The utility model has the advantages that the patient can be improved in time, and the clinical treatment effect can be improved, so that the utility model is worthy of clinical reference.
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OBJECTIVE:To evaluate therapeutic efficacy and safety of chemotherapy combined with Xiaoaiping injection in the treatment of elderly patients with advanced gastric cancer. METHODS:60 elderly patients with advanced gastric cancer were collected from our department during 2012-2014,and then divided into union group and single group with 30 cases in each group. Single group was given irinotecan(CPT-11)150 mg/m2 added into 0.9%Sodium Chloride injection,and union group was addition-ally given Xiaoaiping injection 80 ml,qd,on the basis of single group. A treatment course lasted for 14 days,and both groups re-ceived 4 courses of treatment. The tumor markers,disease single rate,progression-free survival (PFS) and the incidence of ADR were compared between 2 groups. RESULTS:After treatment,the levels of CEA,CA199 and CA242 in 2 groups were significant-ly lower than before;the union group was significantly lower than the single group,with statistical significance(P<0.05). The dis-ease single rate of union group was 70.00%,which was significantly higher than that of single group (33.33%). PFS of union group was(11.23±2.17)months,which was significantly longer that of single group [(9.36±0.84)months],with statistical signif-icance(P<0.05). The incidence of leucopenia,alanine aminotransferase elevation,diarrhea,stomatitis and hand-foot syndrome in union group was significantly lower than in single group,with statistical significance(P<0.05). CONCLUSIONS:Xiaoaiping in-jection combined with irinotecan chemotherapy for advanced gastric cancer has obvious effect with a low incidence of ADR.
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OBJECTIVE To study the antitumor activity and underlying mechanisms of Xiaoaiping injection(Xap)combined with gefitinib(Gef)in nude mice bearing resistant non-small cell lung cancer (NSCLC) cells H460 or H975. METHODS BALB/c nude mice were inoculated with human NSLCL cells H460 or H1975 and the drug treatment did not start until the tumor volume reached 50-100 mm3. The tumor bearing mice were divided into four groups:control group,Xap group(5 g · kg-1,ip),Gef group (50 mg · kg-1,ig),and Xap plus Gef group. All the administration lasted for 21 d continuous. Tumor volumes were measured two or three times per week,and the body weight of animals was re-corded. At the end of the test,tumors were weighed after the sacrifice of mice. Tumor inhibition rate and relative tumor proliferation rate were calculated based on tumor weight and tumor volume. The related biomarkers and proteins in tumor tissues were detected by immunohistochemistry and Western blot assay, respectively. RESULTS Compared with the control group,no significant effect was observed on the growth of H460 and H1975 xenografts in groups of Xap or Gef alone in nude mice. However,the two-drug combination significantly suppressed tumor volume,with (1103 ± 340) versus (3020 ± 450) mm3 for H460 and(487 ± 153)versus(1269 ± 161)mm3 for H1975,respectively(P<0.05). The combined Xap and Gef application also significantly reduced the tumor weight,with(1.20±0.52)versus(2.78± 0.93)g for H460 and(0.52 ± 0.32)versus(0.92 ± 0.42)g for H1975,respectively(P<0.05). The relative tumor proliferation rate and inhibition rate in the combination group was 42.1%and 43.5%for H460(P<0.01),43.0%and 52.5% for H1975(P<0.01). Compared with Xap and Gef drug alone,their combination showed significant difference in reducing tumor weight,suppressing tumor proliferation rate and increasing tumor inhibition rate(P<0.05). Immunohistochemistry results showed that each drug alone had no effect on tumor angiogenesis markers of vascular endothelial growth factor(VEGF)and CD105 expression,or on drug resistance related proteins of p-ERK,p-Akt and p-mTOR,whereas the combination of Xap and Gef obviously reduced the expression of these biomarkers in H460 and H1975 tumor tissues. The decreased drug resistance related proteins of p-PI3K and its downstream molecules p-Akt,p-ERK and p-mTOR by the two-drug combination were also confirmed by Western blot results(P<0.01,compared with control), and showed significant difference compared with each single treatment(P<0.05). CONCLUSION The addition of Xap significantly improves the antitumor activity of Gef in H460 and H1975 xenografts,and this synergistic effect may be ascribed to the inhibition of tumor angiogenesis,the down-regulation of PI3K and its downstream signaling molecules which are associated with drug resistance.
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OBJECTIVE:To observe clinical efficacy and safety of Xiaoaiping injection with rectum administration combined with conventional chemotherapy in the treatment of epithelial ovarian tumor. METHODS:60 patients diagnosed as epithelial ovari-an tumor were divided into observation group and control group according to the actual order,with 30 cases in each group. AU pa-tients received TC chemotherapy,4-6 cycles in total;And patients in control group received TC chemotherapy for 3 weeks,i.e. pa-clitaxel 175 mg/m2,3 h,i.v.+carboplatin AUC=5-7.5,1 h,i.v.. Based on this,observation group was additionally given Xiaoaip-ing injection with rectum administration,20-30 ml each time,once a day,2 weeks as a treatment course. Clinical effective rate, 1-year progression-free survival rate and median progression free survival and the incidence of adverse events were compared be-tween 2 groups. RESULTS:Effective rate of observation group was 83.33%,and higher than that of control group (53.33%);there was statistically significant difference (χ2=13.20,P<0.05);1-year progression-free survival rate of observation group was 86.67%,and median progression free survival was 11.3 months;those of control group were 63.33% and 7.2 months;there was statistically significant difference between 2 groups (P<0.01 or P<0.05). There was no significant difference in the incidence of ADR between 2 groups(χ2=0.53,P=0.47). CONCLUSIONS:Xiaoaiping injection with rectum administration combined with con-ventional chemotherapy in the treatment of epithelial ovarian cancer show good curative effect and safety,high 1-year progres-sion-free survival rate and long median progression-free survival.
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Objective To study the effect of Xiaoaiping injection on Caov-3 human ovarian cancer cells and its mechanisms. Methods After treatment with Xiaoaiping injection, viability of Caov-3 cells determined by MTT method. Phase contrast microscopy was used to observed the morphological changes of Caov-3 cells. Cell cycle was assessed by FACS. Cell signaling pathway protein-Akt and pAkt, and cell cycle associated protein-p27 were measured by western blot. Results Xiaoaiping injection inhibited the growth of Caov-3 human ovarian cancer cells in a dose and time dependent manner. Xiaoaiping injection induced G0/G1 phase arrest of Caov-3 cells, accompanied by pAkt down-regulation and p27 up-regulation. Conclusion Xiaoaiping injection can inhibit the proliferation of Caov-3 human ovarian cancer cells by inhibiting PI3K/Akt signaling pathway.
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Objective To develop a HPLC method for the determination of chlorogenic acid in xiaoaiping injection in human plasma.Methods The analytical column was packed with Hypersil ODS C18 (250 mm×4.6 nm,5 μm).The mobile phase was acetonitrile-0.4% phosphoric acid solution(13:87).The flow rate was 1 ml/min,and detection wave length was set at 327 nm.Results The linear ranges were 2.5～60.0 mg/L chlorogenic acid in human plasma,with the correlation coefficients of 0.9996.The Low limit of detection was 0.25 μg/ml.The method and extraction recovery were 100.1%～102.6%and 78.6%～80.3%.The relative standard deviation value for the within-day and between-day precision were less than 3.9%.Conclusion The method is simple,sensitive for the determination of chlorogenic acid in xiaoaiping injection in human plasma.