再造生血胶囊治疗骨髓增生异常综合征临床疗效初步评价

目的探讨再造生血胶囊治疗骨髓增生异常综合征临床疗效。方法以符合骨髓增生异常综合征中西医诊断标准患者为研究对象,通过随机对照、多中心临床试验原则,共纳入139例患者。其中,治疗组103例给予再造生血胶囊每次5粒,每日3次;对照组36例给予复方皂矾丸每次8粒,每日3次。2组患者连续治疗3个月。比较2组患者治疗前后血液学改善(红细胞和血红蛋白、血小板、中性粒细胞),外周血象(HGB、RBC、MCV、PLT、WBC、NEUT)及亚组分析,中医证候与体征积分、出血程度、感染发生率、临床疗效以及安全性。结果治疗组与对照组红细胞和血红蛋白、血小板、中性粒细胞血液学改善总有效率分别为51.6%与38.5%、44.8%与40.0%、51.0%与68.2%,组间比较差异无统计学意义(P>0.05)。在总体及低危亚组患者中,治疗组治疗前后RBC及HGB比较,差异有统计学意义(P<0.05);在高危亚组患者中,治疗组治疗前后WBC比较,差异有统计学意义(P<0.05);在总体及低危亚组患者中,对照组治疗前后NEUT比较,差异有统计学意义(P<0.05);在低危亚组患者中,治疗组MCV治疗后较治疗前降低,差异有统计学意义(P<0.05)。治疗组与对照组中医证候显效与有效率分别为29.9%与30.3%、62.1%与57.6%,组间比较,差异无统计学意义(P>0.05);2组患者各单项症状与体征疗效组间比较,差异无统计学意义(P>0.05)。2组间止血疗效评价比较,差异无统计学意义(P>0.05)。2组间感染发生率比较,差异无统计学意义(P>0.05)。2组患者安全性指标治疗前后比较,差异无统计学意义(P>0.05)。结论再造生血胶囊、复方皂矾丸均能改善骨髓增生异常综合征患者骨髓病态造血,取得临床血液学缓解,并能够明显改善中医证候与单项症状与体征积分,且具有良好的临床用药安全性。

Preliminary evaluation of clinical efficacy of Zaizao Shengxue Capsule in treating myelodysplastic syndrome

Objective To investigate the clinical efficacy of Zaizao Shengxue(Blood-engendering Renewal)Capsule(ZZSXC)in the treatment of myelodysplastic syndrome.Methods A total of 139 patients who met the diagnostic criteria of Chinese and Western medicine for myelodysplastic syndrome were enrolled according to the principles of randomized multicenter controlled trials.The 103 patients in the treatment group were given 5 ZZSXCs each time,thrice daily.The 36 patients in the control group were given 8 Fufang Zaofan(Compound Zaofan)Pills(FFZFP)each time,thrice daily.The two groups were treated for 3 months.Then their hematological improvements in HI-E,HI-P and HI-N and peripheral blood parameters(HGB,RBC,MCV,PLT,WBC and NEUT)as well as subgroup analysis,TCM pattern and physical sign scores,bleeding,infection,clinical efficacy and safety were evaluated.Results In both the treatment group and the control group,the overall percentages of improvement in such hematological parameters as HI-E,HI-P and HI-N were 51.6%and 38.5%,44.8%and 40.0%,and 51.0%and 68.2%respectively without statistically significant difference between the two groups(P>0.05).The differences in RBC and HGB of all the patients and the subgroup of low-risk patients in the treatment group before and after treatment were statistically significant(P<0.05).The differences in WBC of the subgroup of high-risk patients in the treatment group before and after treatment were statistically significant(P<0.05).The differences in NEUT of all the patients and the subgroup of lowrisk patients in the control group before and after treatment were statistically significant(P<0.05).MCV was decreased of the subgroup of low-risk patients in the treatment group after treatment compared with that before treatment with statistical significance(P<0.05).The percentages of patients that enjoyed marked curative effects and curative effects in terms of TCM patterns in the treatment group and the control group were 29.9%and 30.3%,and 62.1%and 57.6%,respectively,with no statistically significant difference between the two groups(P>0.05).There was no statistically significant difference in curative effects for individual symptoms and signs between the two groups(P>0.05).There was no statistically significant difference in hemostasis,incidence of infection and safety parameters between the two groups(P>0.05).Conclusion Both ZZSXC and FFZFP can improve morbid hematopoiesis and hematological parameters in patients with MDS,and remarkably improve their TCM patterns and individual symptoms and signs with good clinical drug safety.