中医药学报
中醫藥學報
중의약학보
ACTA CHINESE MEDICINE AND PHARMACOLOGY
2015年
2期
72-75
,共4页
邹伟%于学平%滕伟%戴晓红%孙晓伟%于薇薇%马慧慧%王恒斌%李全
鄒偉%于學平%滕偉%戴曉紅%孫曉偉%于薇薇%馬慧慧%王恆斌%李全
추위%우학평%등위%대효홍%손효위%우미미%마혜혜%왕항빈%리전
健延龄胶囊%原发性失眠症%肾阴虚
健延齡膠囊%原髮性失眠癥%腎陰虛
건연령효낭%원발성실면증%신음허
Jian-yan-ling capsules%Primary insomnia%Kidney Yin deficiency
目的：观察健延龄胶囊治疗原发性失眠症（肾阴虚证）的有效性及安全性。方法：采用多中心随机对照试验的方法，分为试验组（ FAS集269例；PPS集266例）和对照组（ FAS集89例；PPS集87例），试验组口服健延龄胶囊，对照组口服乌灵胶囊，连续治疗28天，观察治疗前后PSQI指数及中医证候积分的变化，进行疗效评定；并且通过生命体征及实验室检查进行安全性评定。结果：FAS集试验组PSQI愈显率为44．98％（121／269），对照组42．70％（38／89），组间比较无显著性差异（P＞0．05）；试验组中医证候积分愈显率为18．22％（49／269），对照组的17．98％（16／89），组间比较无显著性差异（ P＞0.05）， FAS集结果与PPS集一致；两组间生命体征治疗前后无统计学差异（P＞0．05），实验室检查疗后均未见有意义的异常结果。结论：健延龄胶囊治疗原发性失眠症（肾阴虚证）疗效确定，并且其疗效及安全性与乌灵胶囊相当。
目的：觀察健延齡膠囊治療原髮性失眠癥（腎陰虛證）的有效性及安全性。方法：採用多中心隨機對照試驗的方法，分為試驗組（ FAS集269例；PPS集266例）和對照組（ FAS集89例；PPS集87例），試驗組口服健延齡膠囊，對照組口服烏靈膠囊，連續治療28天，觀察治療前後PSQI指數及中醫證候積分的變化，進行療效評定；併且通過生命體徵及實驗室檢查進行安全性評定。結果：FAS集試驗組PSQI愈顯率為44．98％（121／269），對照組42．70％（38／89），組間比較無顯著性差異（P＞0．05）；試驗組中醫證候積分愈顯率為18．22％（49／269），對照組的17．98％（16／89），組間比較無顯著性差異（ P＞0.05）， FAS集結果與PPS集一緻；兩組間生命體徵治療前後無統計學差異（P＞0．05），實驗室檢查療後均未見有意義的異常結果。結論：健延齡膠囊治療原髮性失眠癥（腎陰虛證）療效確定，併且其療效及安全性與烏靈膠囊相噹。
목적：관찰건연령효낭치료원발성실면증（신음허증）적유효성급안전성。방법：채용다중심수궤대조시험적방법，분위시험조（ FAS집269례；PPS집266례）화대조조（ FAS집89례；PPS집87례），시험조구복건연령효낭，대조조구복오령효낭，련속치료28천，관찰치료전후PSQI지수급중의증후적분적변화，진행료효평정；병차통과생명체정급실험실검사진행안전성평정。결과：FAS집시험조PSQI유현솔위44．98％（121／269），대조조42．70％（38／89），조간비교무현저성차이（P＞0．05）；시험조중의증후적분유현솔위18．22％（49／269），대조조적17．98％（16／89），조간비교무현저성차이（ P＞0.05）， FAS집결과여PPS집일치；량조간생명체정치료전후무통계학차이（P＞0．05），실험실검사료후균미견유의의적이상결과。결론：건연령효낭치료원발성실면증（신음허증）료효학정，병차기료효급안전성여오령효낭상당。
Objective:To observe the therapeutic effect and safe reliability of Jian-yan-ling capsules for the treatment of primary insomnia with kidney Yin deficiency.Methods:A multi-centered randomized controlled trial was conducted and the enrolled participants were divided into a treatment group( FAS 269 cases;PPS 266 cases) and a control group ( FAS 89 cases;PPS 87 cases) .The Jian-yan-ling capsules were applied in the treatment group and the Wu-ling capsules were used in the control group.The treatment session was 28 days.The therapeutic effects were systematically evaluated with the scores of PSQI and TCM syndrome, meanwhile we performed the safety assessment according to vital sign and laboratory examination.Results:In the FAS, the cure and markedly effective rates of PSQI in the treatment group and control group were 44.98%(121/269) and 42.70%(38/89);the cure and markedly effective rates of TCM syndrome in the treatment group and control group were 18.22%(49/269) and 17.98%(16/89),and the differences were no sta-tistically significant(P>0.05).PPS was in agreement with FAS.There was no significant difference in the vital sign be-tween two groups before and after the treatment(P>0.05)and there were no meaningful abnormal laboratory indices af-ter the treatment.Conclusion:The Jian-yan-ling capsules are an effective medicine for treating primary insomnia with kidney Yin deficiency and its security and effect are similar to the Wu-ling capsules.
