An Exploratory Clinical Study On The Effect Of Xiaoganping Injection On Bone Marrow Toxicity Induced By Chemotherapy

PURPOSEBased on theories of toxicity stasis bone marrow, removing blood stasis and promoting tissue regeneration and the function of Wuguteng, we investigate the influence of Xiaoaiping to marrow toxicity actions in the peripheral blood caused by chemotherapy.METHODSIn this multi-center randomized, open, parallel controlled and competing enrollment clinical trial, advanced lung cancer patients and gastric patients who were undergoing chemotherapy and met the enrollment criterion were randomly allocated via envelop method and received a 28-day treatment and observation. Strict diagnostic, efficacy and operational standards were followed according to the experimental scheme by all clinical units. Researchers visited to the subjects on the day they were enrolled, and 7th,14th,21st day after treatment (visit on day 0, day 7, day 14 and day 21). All the data for efficacy and safety assessment were collected, filled into the case report form (CRF), input into the database, and statistically analyzed by a third party.RESULTSAccording to traditional Chinese medicine, the glaucescent fissistigma root, indigenous medicinal materials of Xiaoaiping injection, has the functiuon to detoxify, promote blood circulation and stop bleeding, In clinical experimental scheme design, we therefore took blood platelet count and its parameters and hemorrhage improvement as main observation indexes, hemoglobin, white blood cell, neutrophil and coagulation function as secondary indexes, cardiac, liver and renal functions as safety indexes. Major positive results made from clinical trial data are shown as follows:1 Changes of major indexesBlood platelet count and parameter changes of overall cases: ①Both the platelet count values on day 21 and the platelet count changes between day 21 and baseline in the experimental group were significantly different from the control group by t-test (P=0.012, 0.022). ② Plateletcrit changes between day 7 and baseline in the experimental group was of statistical significance by t-test (P=0.049) compared to that of the control group. ③The blood platelet count sensitivity analysis after eliminating tumor hypercoagulability (PLT>400×109/L) suggested that values on day 21 and changes between day 21 and baseline in the experimental group were significantly different from the control group by t-test (P=0.011,0.017).Blood platelet count and parameter changes of stratified cases:① Statistics of different types of cancers showed that in lung cancer patients, both the platelet count values on day 21 and the platelet count changes between day 21 and baseline in the experimental group were significantly different from the control group by t-test (P=0.002,0.012). While in gastric cancer patients, there was significant difference between the two groups. ②In patients with or without previous radiotherapy history, both the platelet count values on day 21 and the platelet count changes between day 21 and baseline in the experimental group were significantly different from the control group by t-test (P=0.012,0.022,0.012,0.024), which indicating Xiaoaiping injection’s effects on chemotherapy-induced thrombocytopenia was not influenced by radiotherapy history. ③ In patients received chemotherapy, both the platelet count values on day 21 and the platelet count changes between day 21 and baseline in the experimental group were significantly different from the control group by t-test (P=0.002,0.009). The platelet classification stability ratio of cases between two groups on day 21 was of statistical differences by x2 test (P=0.024), by contrast, no positive results were observed on patients without previous chemotherapies.2 Secondary index changesHemoglobin series:① overall case statistics:There were no statistically significant differentce between experimental group and control group (P>0.05) in terms of hemoglobin (HGB), differentials of HGB before and after treatment, red blood cell (RBC) count, differentials of RBC before and after treatment, hemoglobin-related parameters, hemoglobin classification stability ratio, and red blood cell count. ② stratified case statistics:HGB statistical results of different tumors suggested that the comparison in HGB between the two groups of lung cancer patients on day 21 by t-test was of statistical significance (P=0.033), by contrast, that of gastric cancer patients was of no statistical significance (P>0.05). Statistical result according to patients with or without previous chemotherapies indicated that the comparison in HGB changes on day 7 (values on day 7 minus baseline) between two groups was of statistical differences by t-test (P=0.041).White blood cell (WBC) series:① overall analysis results showed that WBC values on day 7 and changes between day 7 and baseline in the experimental group were significantly different from those of the control group (P=0.032,0.026); while neutrophil count on day 7 between the two groups of patients was of statistical significance by t-test (P=0.009). ②In different types of cancers, there were significant difference between two groups of patients with gastric cancer on day 7 (P=0.042), while no statistical significance of patients with lung3 Safety index changesIt was revealed by cardiac, liver and renal function tests that, after Xiaoaiping injection, the cardiac AST anomaly classification stability ratio was 100% in the experimental group and 88.24% in the control group, and that the comparison between two groups of cases by x2 test was of statistical significance (P=0.015). In terms of the comparison between two groups in other test indexes, no statistical significance (P>0.05) was shown.CONCLUSIONThis clinical trial concludes:① Xiaoaiping injection has effect preventing and treating platelet decline in lung cancer and gastric cancer patients undergoing chemotherapy regardless of past radiotherapy history, with an optimal effects in lung cancer patients with previous chemotherapy history. ② Xiaoaiping has effect treating white blood cell decline in lung cancer and gastric cancer after chemotherapy, especially effective in gastric cancer③ Xiaoaiping injection reduces the hematologic toxicities of chemotherapy in patients with lung cancer or gastric cancer, yet it does not add to the toxicity of chemotherapeutics to the heart, liver and kidney.Xiaoaiping injection played a role in reducing AST after receiving chemotherapies.We, on the strength of aforementioned research findings, have reached a conclusion that Xiaoaiping injection plays a dual role in treating tumors and preventing hematologic toxicities after receiving chemotherapy, as a result of which, it is worth clinical promoting.