背景:应用石杉碱甲、阿尼西坦、银杏叶制剂等治疗老年人记忆障碍的报导已很多,但实验过程中缺乏严格的双盲双模拟法的设计.目的:以认知功能、肝肾阴虚症状、记忆功能为观测指标,应用双盲双模拟法观察中药脑力宝治疗肝肾阴虚证老年人记忆障碍的疗效.设计:采用随机对照双盲双模拟法的前瞻性临床实验.单位:长春中医学院附属医院神经内科,吉林大学第二临床医院药剂科.对象:来源于2000-04/12长春中医学院附属医院神经内科门诊记忆障碍患者80例.年龄40～75岁;轻度不恒定健忘;中医辨证为肝肾阴虚证;根据临床痴呆评定表诊断为可疑痴呆,临床痴呆评定表评分为0或0.5;简易精神状态检查表积分>17(文盲)或>20(小学)或>23(初中以上)和<30.方法:将患者随机分为脑力宝组(n=43)及脑复康组(n=37).脑力宝组给予脑力宝丸,以地黄、菟丝子、地骨皮、远志、石菖蒲、茯苓组方,4丸/次,3次/d,脑复康空白片,2片/次,3次/d;脑复康组服用脑复康片400 mg/片,2片/次,3次/d,脑力宝空白丸,4丸/次,3次/d,疗程6周.选择基线点(治疗前)、终末点(治疗后)作为观察时点,分别记录症状、体征、神经心理学检查积分等指标.对显效病例进行随访.中医证候疗效判定依据<脑力宝丸治疗老年记忆障碍肝肾阴虚证临床方案>的疗效判定标准,治疗后症状积分下降与治疗前症状平均积分值比较,显效:≥2/3,有效1/3～2/3,无效≤1/3.认知及记忆功能疗效判定采用尼莫地平法计算公式[(治疗后积分-治疗前积分)÷治疗前积分]×100%,临床控制≥85%,显效≥50%,有效≥20%,无效≤20%.主要观察指标:①两组肝肾阴虚证治疗前后变化比较.②两组治疗前后肝肾阴虚证症状积分比较.③两组记忆功能各项指标评定结果比较.④显效病例随访结果.⑤不良事件和副反应.结果:脑力宝组43例和脑复康组37例纳入结果分析.①两组肝肾阴虚证治疗前后变化比较:脑力宝组辨证评分值的降低、改善患者肝肾阴虚证病情轻重、提高证候疗效方面优于脑复康组,差异有显著性意义(P<0.05～0.01).②两组治疗前后肝肾阴虚证症状积分比较:脑力宝组患者的多梦、耳鸣耳聋改善情况优于脑复康组,差异有显著性意义(P<0.05～0.01).③两组记忆功能各项指标评定结果比较:脑力宝组患者的即刻回忆、延迟回忆方面改善优于脑复康组,差异有显著性意义(P<0.05～0.01).④显效病例随访结果:3个月后,两组显效病例无病情加重情况.③不良事件和副反应:两组患者治疗后血常规、尿常规、便常规和肝功能、肾功能等安全性指标与治疗前比较,无异常改变,无不良反应发生.结论:脑力宝丸可以提高老年人记忆功能,改善即刻回忆功能、识别再认识功能及多梦、耳鸣耳聋等症状,疗效优于脑复康片,且安全性也较为可靠.
揹景:應用石杉堿甲、阿尼西坦、銀杏葉製劑等治療老年人記憶障礙的報導已很多,但實驗過程中缺乏嚴格的雙盲雙模擬法的設計.目的:以認知功能、肝腎陰虛癥狀、記憶功能為觀測指標,應用雙盲雙模擬法觀察中藥腦力寶治療肝腎陰虛證老年人記憶障礙的療效.設計:採用隨機對照雙盲雙模擬法的前瞻性臨床實驗.單位:長春中醫學院附屬醫院神經內科,吉林大學第二臨床醫院藥劑科.對象:來源于2000-04/12長春中醫學院附屬醫院神經內科門診記憶障礙患者80例.年齡40～75歲;輕度不恆定健忘;中醫辨證為肝腎陰虛證;根據臨床癡呆評定錶診斷為可疑癡呆,臨床癡呆評定錶評分為0或0.5;簡易精神狀態檢查錶積分>17(文盲)或>20(小學)或>23(初中以上)和<30.方法:將患者隨機分為腦力寶組(n=43)及腦複康組(n=37).腦力寶組給予腦力寶汍,以地黃、菟絲子、地骨皮、遠誌、石菖蒲、茯苓組方,4汍/次,3次/d,腦複康空白片,2片/次,3次/d;腦複康組服用腦複康片400 mg/片,2片/次,3次/d,腦力寶空白汍,4汍/次,3次/d,療程6週.選擇基線點(治療前)、終末點(治療後)作為觀察時點,分彆記錄癥狀、體徵、神經心理學檢查積分等指標.對顯效病例進行隨訪.中醫證候療效判定依據<腦力寶汍治療老年記憶障礙肝腎陰虛證臨床方案>的療效判定標準,治療後癥狀積分下降與治療前癥狀平均積分值比較,顯效:≥2/3,有效1/3～2/3,無效≤1/3.認知及記憶功能療效判定採用尼莫地平法計算公式[(治療後積分-治療前積分)÷治療前積分]×100%,臨床控製≥85%,顯效≥50%,有效≥20%,無效≤20%.主要觀察指標:①兩組肝腎陰虛證治療前後變化比較.②兩組治療前後肝腎陰虛證癥狀積分比較.③兩組記憶功能各項指標評定結果比較.④顯效病例隨訪結果.⑤不良事件和副反應.結果:腦力寶組43例和腦複康組37例納入結果分析.①兩組肝腎陰虛證治療前後變化比較:腦力寶組辨證評分值的降低、改善患者肝腎陰虛證病情輕重、提高證候療效方麵優于腦複康組,差異有顯著性意義(P<0.05～0.01).②兩組治療前後肝腎陰虛證癥狀積分比較:腦力寶組患者的多夢、耳鳴耳聾改善情況優于腦複康組,差異有顯著性意義(P<0.05～0.01).③兩組記憶功能各項指標評定結果比較:腦力寶組患者的即刻迴憶、延遲迴憶方麵改善優于腦複康組,差異有顯著性意義(P<0.05～0.01).④顯效病例隨訪結果:3箇月後,兩組顯效病例無病情加重情況.③不良事件和副反應:兩組患者治療後血常規、尿常規、便常規和肝功能、腎功能等安全性指標與治療前比較,無異常改變,無不良反應髮生.結論:腦力寶汍可以提高老年人記憶功能,改善即刻迴憶功能、識彆再認識功能及多夢、耳鳴耳聾等癥狀,療效優于腦複康片,且安全性也較為可靠.
배경:응용석삼감갑、아니서탄、은행협제제등치료노년인기억장애적보도이흔다,단실험과정중결핍엄격적쌍맹쌍모의법적설계.목적:이인지공능、간신음허증상、기억공능위관측지표,응용쌍맹쌍모의법관찰중약뇌력보치료간신음허증노년인기억장애적료효.설계:채용수궤대조쌍맹쌍모의법적전첨성림상실험.단위:장춘중의학원부속의원신경내과,길림대학제이림상의원약제과.대상:래원우2000-04/12장춘중의학원부속의원신경내과문진기억장애환자80례.년령40～75세;경도불항정건망;중의변증위간신음허증;근거림상치태평정표진단위가의치태,림상치태평정표평분위0혹0.5;간역정신상태검사표적분>17(문맹)혹>20(소학)혹>23(초중이상)화<30.방법:장환자수궤분위뇌력보조(n=43)급뇌복강조(n=37).뇌력보조급여뇌력보환,이지황、토사자、지골피、원지、석창포、복령조방,4환/차,3차/d,뇌복강공백편,2편/차,3차/d;뇌복강조복용뇌복강편400 mg/편,2편/차,3차/d,뇌력보공백환,4환/차,3차/d,료정6주.선택기선점(치료전)、종말점(치료후)작위관찰시점,분별기록증상、체정、신경심이학검사적분등지표.대현효병례진행수방.중의증후료효판정의거<뇌력보환치료노년기억장애간신음허증림상방안>적료효판정표준,치료후증상적분하강여치료전증상평균적분치비교,현효:≥2/3,유효1/3～2/3,무효≤1/3.인지급기억공능료효판정채용니막지평법계산공식[(치료후적분-치료전적분)÷치료전적분]×100%,림상공제≥85%,현효≥50%,유효≥20%,무효≤20%.주요관찰지표:①량조간신음허증치료전후변화비교.②량조치료전후간신음허증증상적분비교.③량조기억공능각항지표평정결과비교.④현효병례수방결과.⑤불량사건화부반응.결과:뇌력보조43례화뇌복강조37례납입결과분석.①량조간신음허증치료전후변화비교:뇌력보조변증평분치적강저、개선환자간신음허증병정경중、제고증후료효방면우우뇌복강조,차이유현저성의의(P<0.05～0.01).②량조치료전후간신음허증증상적분비교:뇌력보조환자적다몽、이명이롱개선정황우우뇌복강조,차이유현저성의의(P<0.05～0.01).③량조기억공능각항지표평정결과비교:뇌력보조환자적즉각회억、연지회억방면개선우우뇌복강조,차이유현저성의의(P<0.05～0.01).④현효병례수방결과:3개월후,량조현효병례무병정가중정황.③불량사건화부반응:량조환자치료후혈상규、뇨상규、편상규화간공능、신공능등안전성지표여치료전비교,무이상개변,무불량반응발생.결론:뇌력보환가이제고노년인기억공능,개선즉각회억공능、식별재인식공능급다몽、이명이롱등증상,료효우우뇌복강편,차안전성야교위가고.
BACKGROUND: There are many reports on treatment of senile memory impairment with huperzine A, aniracetam, ginkgobiloba, etc. But, a strict double-blind and double-dummy design is deficit during experiment.OBJECTIVE: With cognition, symptoms of yin deficiency of liver and kidney and memory taken as observed indexes, double-blind and doubledummy method was used to observe the therapeutic effects of Chinese drug naolibao on senile memory impairmentof yin deficiency of liver and kidney. DESIGN: Prospective clinical experiment with randomized controlled double-blind and double-dummy method was designed. SETTING: Department of Neurology of Affiliated Hospital with Changchun College of Chinese Medicine, Department of Medicament of 2nd Clinical Hospital Affiliated to Jilin University.PARTICIPANTS: Totally 80 cases of memory impairment were from the clinic of Department of Neurology of affiliated Hospital with Changchun College of Chinese Medicine from April to December 2000. They were aged varied from 40 to 75 years, with mild non-constant poor memory, differentiated as yin deficiency of liver and kidney and diagnosed as questionable dementia in Chinese medicine, scored as 0 or 0.5 according to Clinical Dementia Assessment Scale (CDAS) and their integrals were > 17 (illiteracy) or > 20 (elementary-school educated) or > 23 (juniorschool educated) and < 30 according to MMSE (mini mental status examination).METHODS:The patients were randomized into experimental group (n=43) and the control (n=37). In experimental group, naolibao wan was administrated, composed of dihuang (Radix Rehmanniae), tusizi (SemenCuscutae), digupi (Cortex Lycii), yuanzhi (Radix Polygalae), shichangpu (Rhizoma Acori Graminei) and fuling (Poria), 4 pills/times, 3 times/day,and piracetan blank tablet was given, 2 tablets/time, 3 times/d. In the control, piracetan tablet 400 mg/tablet was prescribed, two tablets/time,3 times/day and naolibao blank pill was administrated, 4 pills/time,3 times/day. The course of treatment was 6 weeks. On observed spot,named base-line spot (before treatment) and terminal spot (after treatment), the integrals were examined and recorded on symptoms, physical signs and neuropsychology successively. Follow-up visit was carried on for the cases with remarkable effects. Therapeutic effects of syndromes in Chinese medicine were based on the evaluating criteria of Clinical Plan of Treatment with Naolibao Wan for Senile Memory Disturbance of Yin Deficiency of Liver and Kidney. In comparison of decreased symptomatic integral after treatment with average symptomatic integral before treatment, remarkable effect: ≥ 2/3, effect: 1/3-2/3, no effect: ≤ 1/3. The therapeutic effects on cognition and memory were assessed by the formula [(integral after treatment-integral before treatment)÷integral before treatment] ×100%. Clinical control: ≥ 85%, remarkable effect:≥ 50%, effect: ≥ 20% and no effect: ≥ 20%.MAIN OUTCOME MEASURES: ① Comparison before and after treatment of yin deficiency of liver and kidney in two groups. ② Comparison of integrals before and after treatment for yin deficiency of liver and kidney of two groups. ③ Comparison of evaluation of every index for memory in two groups. ④ Results of follow-up visits for the cases with remarkable effects. ⑤ Harmful accident and side effects.RESULTS: Totally 43 cases in experimental group and 37 cases in the control were all employed in result analysis. ① Comparison before and after treatment of yin deficiency of liver and kidney in two groups: The reduced score in differentiation of symptoms, improvement of severity of yin deficiency of liver and kidney and promoted therapeutic effects on syndrome in experimental group were superior to those in the control, indicating significant difference (P < 0.05-0.01). ② Comparison of integrals before and after treatment for yin deficiency of liver and kidney of two groups: The improvement of dream-disturbed sleep, tinnitus and deafness in experimental group was superior to that in the control, indicating significant difference (P < 0.05-0.01). ③ Comparison of evaluation of every index for memory in two groups: The improvement of immediate recall and retarded recall in experimental group was superior to that in the contol,indicating significant difference (P < 0.05-0.01). ④ Results of follow-up visits for the cases with remarkable effects: Three months later, the disease was not aggravated among the cases with remarkable effects in two groups.⑤ Harmful accident and side effects: After treatment, there was no abnormal alternation and harmful reaction for safe indexes compared with those before treatment, such as blood routine, urine routine, feces routine, liver function, kidney function, etc.CONCLUSION: Naolibao wan improves memory, immediate recall, recog nition, dream-disturbed sleep, tinnitus and deafness for aged people, which is superior to piracetan tablet and it is safe and reliable in treatment.
