| ObjectiveThe main side effects of pemetrexed and nedaplatin in the treatment of lung adenocarcinoma are myelosuppression and digestive tract reaction.From the perspective of TCM syndrome differentiation,the patients with Spleen Yang deficiency type have a large proportion in the chemotherapy of pemetrexed and nedaplatin.Through clinical observation,Jiawei Lizhong pill can improve the symptoms and syndromes of patients.In order to evaluate the therapeutic effect of jiaweilizhong Pill on the toxic and side effects of chemotherapy patients with lung adenocarcinoma of spleen yang deficiency type and the improvement effect of TCM syndrome,the clinical trial is designed to provide data support for jiaweilizhong pill to participate in the adjuvant chemotherapy of lung cancer.MethodsAccording to the standard,60 patients who received chemotherapy for lung adenocarcinoma and met the syndrome of spleen yang deficiency were included in the pulmonary Department of Qingdao Haici medical group from November 2018 to February 2020.They were randomly divided into control group(chemotherapy+western medicine for prevention of side effects+western medicine for symptomatic treatment),treatment group(chemotherapy+western medicine for prevention of side effects+western medicine for symptomatic treatment+Jiawei Lizhong pill),30 cases each.The treatment group began to use Jiawei Lizhong Pill on the first day of chemotherapy,and the other treatment methods were the same as the control group.Each group was given a course of treatment according to 14 days.Blood routine examination was carried out on the first day,the seventh day and the fourteenth day of chemotherapy.Liver and kidney function examination was carried out on the first day and the fourteenth day of chemotherapy,and the clinical symptoms of the patients were observed and recorded.According to the guiding principles of clinical research on new drugs of traditional Chinese medicine(Trial)(2002 version)[1],the symptoms of traditional Chinese medicine were scored,and the side effects of Hematology and liver and kidney function were evaluated.After collecting the above data,the statistical differences of each index before and after treatment between the two groups were compared.Results(1)Effect on clinical symptoms:① On the first day of treatment,by rank sum test analysis:the scores of each symptom in the two groups were compared,the level was similar,the difference was not statistically significant(P>0.05).② On the 14th day of treatment,the score of each symptom in the two groups was compared with that in the first day,and the difference was statistically significant(P<0.05).③On the 14th day of the treatment,the score of each symptom in the two groups was compared by rank sum test.The improvement degree of the treatment group was higher than that of the control group,and the difference was statistically significant(P<0.05).(2)Effect on spleen yang deficiency syndrome① On the 14th day of treatment,the analysis of variance was carried out according to the total effective rate:the total effective rate of the two groups was calculated according to the ratio of changes before and after treatment(Day 1 total points-Day 14 total points/Day 1 total points*100%),and the difference between the treatment group and the control group was statistically significant(P<0.05).(3)Effects on myelosuppression:① On the first day of treatment,t-test analysis showed that the blood routine level of the two groups was similar,and the difference was not statistically significant(P>0.05).② On the 7th day of treatment,t-test analysis:compared with the first day,the blood routine level of the two groups decreased significantly(P<0.05);among them,compared with the first day,the blood routine level of the control group decreased significantly(P<0.01),③ On the 7th day of treatment,t-test analysis:the blood routine level of the two groups were compared,the difference was statistically significant(P<0.05).④ On the 14th day of treatment,the blood routine level of the two groups was significantly higher than that of the 7th day(P<0.05).⑤ On the 14th day of treatment,t-test analysis:compared the blood routine level of the two groups,the improvement degree of the treatment group was higher than that of the control group,the difference was statistically significant(P<0.05).(4)Safety evaluation:① On the first day of treatment,t-test analysis showed that the liver and kidney function levels of the two groups were similar,and the difference was not statistically significant(P>0.05).② On the 14th day of treatment,t-test analysis:compared with the first day,the liver function level of the treatment group decreased,but the difference was not statistically significant(P>0.05);compared with the first day,the liver function level of the control group decreased,the difference was statistically significant(P<0.05);compared with the first day,the renal function level of the two groups decreased,but the difference was poor The difference was not statistically significant(P>0.05).③ On the 14th day of treatment,t-test analysis:the liver function level of the two groups was compared,the difference was statistically significant(P<0.05);the renal function level of the two groups was compared,the difference was slightly higher than that of the control group,but the difference was not statistically significant(P>0.05).ConclusionJiawei Lizhong pill has a significant effect on the improvement of clinical symptoms,TCM syndrome conditioning and bone marrow inhibition level of patients with lung adenocarcinoma of spleen yang deficiency type.It has a certain preventive effect on liver function damage,and has the safety of clinical use. |
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