CAJ | 학술논문

目的：评价丹鹤生血颗粒治疗原发免疫性血小板减少症（阴虚血热证）的安全性和有效性。方法通过以维血宁颗粒为平行对照的随机、开放的临床试验，将2011年11月至2013年5月在南充市中心医院诊断为原发免疫性血小板减少症（阴虚血热型）的140例患者随机分为两组，对照组（A 组）给予维血宁颗粒，治疗组（B 组）给予丹鹤生血颗粒，1个月为1个疗程，随访3个月，观察紫斑、神疲乏力、五心烦热、口干、出血、血小板计数等各项指标变化。排除未按规定用药（A =3例，B=2例）、患者依从性差（A =2例，B =4例）、未按时随访（A =2例，B =4例）的病例，最后纳入统计病例治疗组63例，对照组60例。结果治疗组治疗后显效率为84.13%，总有效率为96.83%；对照组显效率为85.00%，有效率为95.00%，经统计学处理，差异无统计学意义。治疗组治疗后中医证候显效率为71.43%，总有效率为95.24%；对照组显效率为66.67%，总有效率为95.00%，经统计学处理，差异无统计学意义，说明两组间疗效相似。在试验过程中未发现明显的毒副作用与不良反应，仅个别患者出现恶心（治疗组1例，对照组1例）、腹泻（治疗组1例，对照组1例），但未影响继续用药，可能是个体差异所致。在试验过程中，未发现其他不良反应及毒副作用。结论丹鹤生血颗粒和维血宁颗粒治疗原发免疫性血小板减少症疗效相似，且不良反应少见。
목적：평개단학생혈과립치료원발면역성혈소판감소증（음허혈열증）적안전성화유효성。방법통과이유혈저과립위평행대조적수궤、개방적림상시험，장2011년11월지2013년5월재남충시중심의원진단위원발면역성혈소판감소증（음허혈열형）적140례환자수궤분위량조，대조조（A 조）급여유혈저과립，치료조（B 조）급여단학생혈과립，1개월위1개료정，수방3개월，관찰자반、신피핍력、오심번열、구간、출혈、혈소판계수등각항지표변화。배제미안규정용약（A =3례，B=2례）、환자의종성차（A =2례，B =4례）、미안시수방（A =2례，B =4례）적병례，최후납입통계병례치료조63례，대조조60례。결과치료조치료후현효솔위84.13%，총유효솔위96.83%；대조조현효솔위85.00%，유효솔위95.00%，경통계학처리，차이무통계학의의。치료조치료후중의증후현효솔위71.43%，총유효솔위95.24%；대조조현효솔위66.67%，총유효솔위95.00%，경통계학처리，차이무통계학의의，설명량조간료효상사。재시험과정중미발현명현적독부작용여불량반응，부개별환자출현악심（치료조1례，대조조1례）、복사（치료조1례，대조조1례），단미영향계속용약，가능시개체차이소치。재시험과정중，미발현기타불량반응급독부작용。결론단학생혈과립화유혈저과립치료원발면역성혈소판감소증료효상사，차불량반응소견。
Objective To evaluate the safety and effect of Danhe Shengxue granules in treating orig-inal immune thrombocytopenia(type of yin deficiency and blood heat). Methods A randomized,parallel, controlled clinical trial was conducted,and 140 patients with original immune thrombocytopenia(type of yin deficiency and blood heat)were randomly divided into control group(group A)and treatment group(group B). Patients in the control group were given Weixuening granules,and patients in the treatment group re-ceived Danhe Shengxue granules. The treatment course was one month,with 3 months of follow - up. The changes of purple macules,exhaustion,vexing heat in chest,palms and soles,dry mouth,bleeding and platelet level. Several cases were excluded for no regular drug administration(A = 3,B = 2),bad compliance(A = 2,B= 4),and not in - time follow - up(A = 3,B = 2). There were finally 63 cases in treatment group and 60 ca-ses in control group included into the analysis. Results The obvious effective rate of rate of treatment group was 84. 13% ,and its total effective rate was 96. 83% . The obvious effective rate of rate of control group was 85. 00% ,and its total effective rate was 95. 00% . There were no statistically significant differences between the groups in terms of effective rates. As for Chinese medicine syndromes,the obvious effective rate of treat-ment group was 71. 43% and its total effective rate was 95. 24% ;while in control group,the obvious effective rate was 66. 67% and its total effective rate was 95.00%. There was no statistically significant difference between the two groups. During the trial,there was no obvious toxin effect and side effect,and only few patients had nauseous(one case in treatment group,and one case in control group)and diarrhea(one case in treatment group,and one case in control group),which did not affect the administration and might be caused due to constitution differences. Conclusion Danhe Shengxue granules has similar therapeutic effect with Weixuen-ing granules in treating original immune thrombocytopenia(type of yin deficiency and blood heat)and there was few side effects.