自拟益气养阴方辅助治疗气阴两虚型白血病化疗后发热的临床研究
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摘要
目的
     为了使益气养阴方辅助治疗白血病化疗后发热的临床研究建立在更为严谨的科学基础上,本课题主要采用临床流行病学、临床科研方法学及数理统计分析方法,进行临床随机对照研究,对益气养阴法辅助治疗白血病化疗后发热的临床疗效及安全性进行客观评价,以期进一步规范临床疗效,获得较好的社会效益。方法
     选取2008年3月至2009年12月期间在陈宥任门诊治疗的,符合病例筛选标准的70例白血病患者。按1:1的比例随机分配至试验组(常规方案化疗+抗生素升白药物+益气养阴中药)和对照组(常规方案化疗+抗生素升白药物)两组,每组各有35例。中药水煎服,每日一剂,治疗3周,3周为1疗程,观察1个疗程。治疗前后记录患者白细胞计数(WBC)、血红蛋白(Hb)、血小板的数值(PLT),化疗后出现的不良反应如感染性发热、恶心、出血等的发生率。两组患者均采用腋窝体温测定10min,分别于用药后0.5h,1.0h,2.0h,24h行腋温测定并观察临床症状。
     用EPIDATA3.1软件建立数据库,用SPSS15.0软件进行统计分析。计量资料用均数±标准差(x±S)表示,计数资料用构成比(%)表示。计量资料组间比较采用t检验(方差不齐采用t’检验或秩和检验),自身前后比较用配对t检验或Wilcoxon配对秩和检验。分类资料组间比较采用x2检验,等级资料组间比较采用Wilcoxon秩和检验。统计图形的制作采用软件Graph Pad Prism 4.03完成。
     结果
     本研究共收到合格病例70例,均为门诊病人。年龄12-55岁,病理类型为急性淋巴细胞白血病55例,急性髓系白血病7例,急性杂合性白血病3例,慢性粒细胞白血病5例,慢性淋巴细胞白血病2例。其中试验组和对照组各35例,试验组男20例,女15例,平均年龄为25.83±5.85岁,采用常规方案化疗同时给予抗生素升白药物+益气养阴中药治疗;对照组男22例,女13例,平均年龄为27.27±4.97岁,采用常规方案化疗同时给予抗生素升白药物治疗。
     患者基线特征的可比性分析中,两组性别、年龄、病理类型、治疗前血液WBC、HB、PLT计数及不良反应情况,经分析均无统计学意义,说明两组间的基线资料具有可比性。
     血象检查方面:一疗程后,两种治疗方法均可提高白血病患者的WBC、HB、PLT,各组内治疗前后比较,差异均有统计学意义(P<0.01)。两组治疗后及治疗前后差值相比,差异有统计学意义(P<0.05)。说明试验组提高WBC、HB、PLT效果优于对照组。
     体温方面:两组治疗后0.5h、1.0h退热比较,差异无统计学意义(P>0.05)。治疗后2.0h、24.0h退热比较,差异有统计学意义(P<0.05)。由统计数值可知,两种治疗方法均可降低体温,试验组患者0.5h后开始显效,1-2h后体温恢复正常。表7显示,对照组体温下降缓慢,服药后1-2h体温才恢复正常。两组服药后发热到退热所需时间比较,差异无统计学意义,说明两组平均降热速度相当。两组治疗后复发热比例比较,差异有统计学意义(P<0.05),说明试验组比对照组较好控制发热的复发。
     主要临床症状及体征消失情况及不良反应情况:两组主要临床症状及体征(头痛、乏力、虚脱)消失率比较,均有统计学意义。试验组头痛、乏力、虚脱消失率均较对照组高,分别为84.4%、85.7%、97.1%。治疗后,试验组共有2例发生了胃肠道反应,仅占5.7%。而对照组有13例发生了皮下出血,29例患者发生了胃肠道反应,分别占37.1%、82.8%。两组不良反应率比较,均有统计学意义(P<0.01)。本研究显示试验组能较好的改善患者的临床症状和体征,降低患者的不良反应发生率。说明联合益气养阴中药治疗白血病,可以提高临床疗效,改善患者的生存质量。
     临床疗效方面:试验组35例,临床治愈16例,占45.7%;显效5例,占14.3%;有效11例,占31.4%,无效3例,占8.6%,总有效率91.4%。对照组35例,临床治愈12例,占34.3%;显效3例,占8.6%;有效9例,占25.7%,无效11例,占31.4%,总有效率68.6%。两组临床疗效经检验,差异无统计学意义。但总有效率比较,差异有统计学意义(P<0.05)。提示,联合益气养阴中药可以提高白血病患者的临床疗效。
     结论
     综合以上研究成果,采用益气养阴中药辅助治疗白血病,一方面清除血中“邪毒”,另一方面发挥中医特色,辨证论治,调整阴阳,提高机体免疫功能,使“正安邪去”,不仅退热,预防化疗后毒副作用,同时还可增强化疗的效果,提高临床疗效,值得临床推广。
Objective
     In order to making the supplementing qi and nourishing yin to treat the fever after chemotherapy of leukemia clinical research on a more rigorous scientific basis, the main topic of clinical epidemiology、clinical research methodology and statistics analysis were randomized controlled clinical study of the supplementing qi and nourishing yin to treat the fever after chemotherapy of leukemia clinical to make an objective of efficacy and safety, in order to further standardize the clinical efficacy, access to better social benefits.
     Methods
     Select from March 2008 to December 2009 during Chen Yu of any out-patient treatment,70 cases of leukemia patients that meet the screening criteria. Randomized 1:1 divided into the test group (conventional chemotherapy+ antibiotics Shengbai medicine+ supplementing qi and nourishing yin medicine) and the control group (conventional chemotherapy+ antibiotics Shengbai medicine) group,35 cases of each group. Chinese drug should be decocted in water for oral dose, one dose daily, for 4 weeks,4 weeks for a course of treatment, observation of a course of treatment. Before and after treatment recorded white blood cell count (WBC)、hemoglobin (Hb)、platelet values (PLT) and the rate of side effects such as infection、fever、nausea and bleeding incidence. All patients in two groups were tested the axillary temperature for 10min after treatment 0.5h,1. Oh,2.0 h,24h and were observed the clinical symptom.
     Database was set up with the software of Epi Data3. 1.The statistical analysis was used with the software of SPSS15.0. Measurement data was represented by mean±standard deviation (x±s), numeration data was represented by constituent ratio (%).The classification data was observed usingχ2 Test and the ranked data by Wilcoxon rank-sum Test. Independent T-test or Wilcoxon rank-sum Test was applied for group comparison. Matched t-test or Wilcoxon matched-rank-sum test was applied for self-AP:PA comparison. The software of Graph Pad Prism 4.03 was used for statistical figure.
     Results
     In this study,70 cases patients collected all were outpatients, aged 12 to 55 years old,55 cases were acute lymphoblastic leukemia with type of pathological,7 cases were acute myeloid leukemia,3 cases were acute leukemia of heterozygosity,5 cases were Granulocytic leukemia,2 cases were chronic lymphocytic leukemia. Both test group and control group was 35 cases, the experimental group were 20 males and 15 females, the average age was 25.83±5.85 years, with conventional chemotherapy drugs and antibiotics Shengbai and supplementing qi and nourishing yin Chinese medicine; the control group had 22 men and 13 females patients, the average age was 27.27±4.97 years, with the conventional chemotherapy drugs and antibiotics Shengbai medication.
     Comparability of baseline characteristics of patients in the two groups of gender, age, pathological type, treatment of blood WBC, HB, PLT count and adverse conditions, there was no statistical significance analysis which showed that the baseline data between the two groups were comparable.
     Blood test:After one course of treatment, the two treatment methods can improve leukemia WBC, HB, PLT, within each group before and after treatment, there was significant differences between two groups (P<0.01). There was significant difference between before and after treatment (P<0.05). It was showed that the effective of the test group was better than that the control group for increasing WBC, HB, PLT.
     Temperature aspect:There was not significant difference between two groups in the extent of pyretolysis after treatment,0.5h, 1.0h (P> 0.05). But there was significant difference between two groups after treatment 2. Oh, 24. Oh(P<0.05). Known by the statistical value of two treatment methods can reduce the body temperature. The experimental group markedly reduced the body temperature after 0.5h, and returned to normal after lh-2h. Table2.7 showed that the temperature was reduced slowly in the control group and returned to normal after 1~2h.
     The situation of the main clinical symptoms and signs disappeared and adverse reactions:The disappearance rates of two groups were statistically significant in reducing main clinical symptoms and signs (headache, weakness, exhaustion). The disappearance rate of headache, fatigue, exhaustion in test group was 84.4% and 85.7%,97.1% which higher than the control group. After treatment, the test group had two cases of gastrointestinal reaction, accounting for only 5.7%. The control group had 13 cases subcutaneous bleeding, 29 cases occurred in patients with gastrointestinal reactions, accounting for 37.1%,82.8%. Comparison of adverse reactions rate of the two groups, there had statistically significant (P<0.01). This study showed that the experimental group could better improve the clinical signs and symptoms, reduce the patient's adverse reaction incidence. The combined Yiqiyangyin medicine treatment of leukemia could improve the clinical efficacy and the quality of life of patients.
     Clinical curative effect:The experimental group had 35 cases,16 cases were clinically cured, accounting for 45.7percent; 5 cases had markedly effective, accounting for 14.3percent; 11 cases had effective curative effect, accounting for 31.4 percent; 3 cases had no effective, accounting for 8.6 percent, the total effective rate is 91.4 percent. The control group had 35 cases,12 cases were clinically cured, accounting for 34.3percent; 3 cases had excellence curative effect, accounting for 8.6 percent; 9 cases had effective curative effect, accounting for 25.7percent, ineffective 11 cases, accounting for 31.4percent, the total effective rate is 68.6percent. The difference was not statistically significant between two groups, However, there was significant difference in the total effective rate (P<0.05). It showed that combined supplementing qi and nourishing yin medicine could increase the clinical efficacy for patients with leukemia.
     Conclusion
     Concluded the above findings, using supplementing qi and nourishing yin medicine as adjuvant therapy for treated leukemia, on the one hand it could clear the blood "cult poison", on the other hand determination of treatment based in pathogenesis obtained through differentiation of symptoms and signs, regulated of yin and yang, enhance immune function, made "evil to being safe". it not only could prevent the chemotherapy side effects, but also enhance the effect of chemotherapy and improve clinical efficacy. It was worth for the further development.
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