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精神药物临床研究常用量表:锥体外系不良反应评估

时间:2023-11-30 理论教育 版权反馈
【摘要】:锥体外系症状评定量表(续)(续表)锥体外系症状评定量表(续)(续表)*偶发:激发后出现或很少自发;**频繁:频繁自发并在激发后出现。

精神药物临床研究常用量表:锥体外系不良反应评估

第二节 锥体外系不良反应量表

一、药源性锥体外系症状评价标准(DIEPSS)

药源性锥体外系症状评价标准(The Drug-Induced Extrapyramidal Symp-toms Scale,DIEPSS)

要求DIEPSS评价人员仔细阅读手册中关于定位点的详细说明,按症状的严重程度选填①②③或④,如无该项症状则填“0”。0=无,正常1=极轻度,可疑2=轻度3=中等程度4=严重

1.步态              □

即走路碎步慢走姿势。评价走路速度的减慢,步伐的减少,上肢摆动幅度减少以及前屈姿势和前冲步态现象的程度。2.运动徐缓            □

即动作减慢和减少。动作开始或结束时表现为延迟或困难。评价面部表情变化的缺乏(面具脸)和单调,说话含糊不清。3.流涎              □唾液分泌过多。

4.肌硬直             □

即上肢屈伸运动的阻力。评价齿轮现象,蜡样屈曲现象,铅管样硬直和腕关节活动程度。

5.震颤              □

于口部、手指、四肢以及躯干可观察到反复、有规律(4~8Hz)的震颤,以及有规律的运动。

6.静坐不能                  □

即主观的、内在的不安感及由此引起的忧虑;感觉坐不住、腿动多,感觉不安,总想不停地动等。评价运动亢进症状(身体摇摆、双脚来回交替、原地踏步、反复交叉双腿和转来转去)。

7.肌张力障碍                 □

由于肌肉紧张异常亢进而引发的症状。评价在舌、颈部、四肢、躯干等部位可以观察到肌肉僵直、扭转等持续异常状态。评价舌外伸、斜颈、向后仰头、牙齿紧闭、眼球上翻、角弓反张综合征等。

8.运动功能障碍                □

异常运动亢进状态。于脸部、口部、舌部、颌、四肢、躯干等部位观察到不自觉、无目的、无规则、不随意的运动。包含舞蹈样运动和手足徐动症样运动,但不对震颤进行评价。9.严重程度概括                □锥体外系症状整体的严重程度。

二、锥体外系症状评定量表(ESRS)

锥体外系症状评定量表(The Extrapyramidal Symptom Rating Scale,ESRS)

锥体外系症状评定量表(ESRS)(续)

(续表)

*偶发:激发后出现或很少自发;**频繁:频繁自发并在激发后出现。

锥体外系症状评定量表(ESRS)(续)

(续表)

锥体外系症状评定量表(ESRS)(续)

(续表)

*偶发:激发后出现或很少自发;**频繁:频繁自发并在激发后出现。

锥体外系症状评定量表(ESRS)(续)

三、 Simpson-Angus量表(SAS)

Simpson-Angus量表(Simpson and Angus Scale,SAS)

Please check the appropriate box for each of the items mentioned below.请为以下每一项条目选择一个恰当的评分。

1. Gait步态

The subject is examined as he walks into the examining room. Gait, swing of his arms and general posture, all form the basis for overall score for this item. This is rated as follows:当受试者步入检查室时,检查受试者的步态、手臂摆动、一般姿势,所有这些构成了该项条目总体评分的依据。根据以下标准进行评分:

0: normal正常

1: diminution in swing while the subject is walking受试者行走时手臂摆动减少

2: marked diminution in swing with obvious rigidity in the arm双臂摆动明显减少,伴有明显的手臂僵直

3: stiff gait with arms held rigidly before the abdomen步态僵硬,双臂强直放在腹前

4: stooped shuffling gait with propulsion and retropulsion弯腰驼背拖足而行的步态,伴有前冲步态或后倾步态

2. Arm dropping手臂下垂

The subject and the examiner both raise their arms to shoulder height and let them fall to their sides. In a normal subject a stout slap is heard as the arms hit the sides. In the sub-ject with extreme Parkinson,s syndrome the arms fall very slowly:受试者和检查者都将手臂举到肩膀高度,然后让手臂向两侧落下。在正常受试者,手臂碰击身体两侧时可以听到响亮的拍击声。在患有严重帕金森综合征的患者,手臂落下非常缓慢:

0: normal, free fall with loud slap and rebound正常,双臂自由落下时伴有响亮的拍击声和回弹

1: fall slowed slightly with less audible contact and little rebound落下稍缓慢,可听到较轻的接触声和小幅度的回弹

2: fall slowed, no rebound落下缓慢,无回弹

3: marked slowing, no slap at all落下明显缓慢,完全无拍击声

4: arms fall as though against resistance; as though through glue双臂落下犹如遇到阻力;像被胶水粘住一样

3. Shoulder shaking摇肩

The subject,s arms are bent at a right angle at the elbow and are taken one at a time by the examiner who grasps one hand and also clasps the other around the subject,s elbow. The subject,s upper arm is pushed to and fro and the humerus is externally rotated. The degree of resistance from normal to extreme rigidity is scored as follows:受试者手臂在肘关节弯成直角,检查者一次检查一只手,检查者握住一只手,并绕过受试者肘部抓住另一只手。将受试者的上臂来回推动,并将肱骨外旋。根据以下标准评价阻力程度,从正常到极度僵硬:

0: normal正常

1: slight stiffness and resistance轻度僵直和阻力

2: moderate stiffness and resistance中度僵直和阻力

3: marked rigidity with difficulty with passive movement明显僵直,伴有被动运动困难

4: extreme stiffness and rigidity with almost a frozen shoulder极度僵直和僵硬,几乎呈冻肩

4. Elbow rigidity肘部僵硬度

The elbow joints are separately bent at right angles and passively extended and flexed, with the subject,s biceps observed and simultaneously palpated. The resistance to this proce-dure is rated. (The presence of cog-wheel rigidity is noted separately.)分别将肘关节屈曲成直角,并被动屈伸,观察并同时触摸受试者的肱二头肌。评价对该动作的阻力(分别观察是否有齿轮样僵硬):

0: normal正常

1: slight stiffness and resistance轻微僵直和阻力

2: moderate stiffness and resistance中度僵直和阻力

3: marked rigidity with difficulty in passive movement明显僵硬,伴有被动运动困难

4: extreme stiffness and rigidity with almost a frozen elbow极端僵直和僵硬,几乎为冻肘

5. Wrist rigidity腕部僵硬度

The wrist is held in one hand and the fingers held by the examiner,s other hand,with the wrist moved to extension flexion and both ulnar and radial deviation.The resistance to this procedure is rated as follows:检查者一只手握住手腕,另一只手握住手指,让手腕屈伸,两者向尺骨和桡骨偏离。根据以下标准评价对该动作的阻力:

0: normal正常

1: slight stiffness and resistance轻微僵直和阻力

2: moderate stiffness and resistance中度僵直和阻力

3: marked rigidity with difficulty in passive movement明显僵硬,伴有被动运动困难

4: extreme stiffness and rigidity with almost a frozen wrist极度僵直和僵硬,几乎为冻腕

6. Leg pendulousness腿的摆动

The subject sits on a table with his legs hanging down and swinging free. The ankle is grasped by the examiner and raised until the knee is partially extended. It is then allowed to fall. The resistance to falling and the lack of swinging form the basis for the score on this item:让受试者坐在检查床上,双腿自然下垂并自由摆动。检查者握住踝部,并上抬直到膝关节部分伸展。然后落下。落下阻力以及缺少摆动,构成了该项条目评分的基础:

0: the legs swing freely双腿自由摆动

1: slight diminution in the swing of the legs双腿摆动稍微减少

2: moderate resistance to swing摆动有中度阻力

3: marked resistance and damping of swing明显有阻力,并且摆动减幅

4: complete absence of swing完全无摆动

7. Head rotation头部转动

The subject sits or stands and is told that you are going to move his head from side to side, that it will not hurt and that he should try and relax. (Questions about pain in the cer-vical area or difficulty in moving his head should be obtained to avoid causing any pain.)Clasp the patient,s head between the two hands with the fingers on the back of the neck. Gently rotate the head in a circular motion 3 times and evaluate the muscular resistance to this movement.受试者坐着或站着,被告知检查者要将他的头左右摆动,但不会受伤,他应该尝试一下并放松。 (应获知有颈部疼痛或头部移动困难的问题以避免引起疼痛。)在颈后用手指将受试者的头抱在两手之间。轻轻转动头部一圈共3次,评价肌肉对该动作的阻力:

0: loose, no resistance松弛,无抵抗

1: slight resistance to movement although the time to rotate may be normal运动时轻度抵抗,尽管转动时间可能正常

2: resistance is apparent and time of rotation is shortened抵抗明显,转动时间减少

3: resistance is obvious and rotation is slowed抵抗明显,转动减慢

4: head appears stiff and rotation is difficult to carry out头部出现僵直,转动困难

8. Glabella tap轻叩眉间

The subject is told to open his eyes wide and not to blink. The glabella region is tapped at a steady, rapid speed. The number of times the subject blinks in succession is noted:告诉受试者睁开双眼,并且不要眨眼。然后以稳定的速度快速叩击眉间区域。记录受试者连续眨眼次数:

0: 0~5 blinks 0~5次眨眼

1: 6~10 blinks 6~10次眨眼

2: 11~15 blinks 11~15次眨眼

3: 16~20 blinks 16~20次眨眼

4: 21 or more blinks 21次以上眨眼

9. Tremor震颤

The subject is observed walking into examining room and then is re-examined for this item:受试者步入检查室时对其进行观察,然后再次检查该项:

0: normal正常

1: mild finger tremor, obvious to sight and touch手指轻度震颤,在观察和触摸时较为明显

2: tremor of hand or arm occurring spasmodically手或者手臂间歇性震颤

3: persistent tremor of one or more limbs一个或多个肢体持续性震颤

4: whole body tremor全身震颤

10. Salivation流涎

The subject is observed while talking and then asked to open his /her mouth and elevate the tongue. The following ratings are given:在患者讲话时对其进行观察,然后要求他(她)张嘴并抬起舌头。按以下标准进行评分:

0: normal正常

1: excess salivation to the extent that pooling takes place if the mouth is open and the tongue raised唾液分泌过多到一定程度,张嘴和抬起舌头时发生唾液汇集

2: excess salivation is present and might occasionally result in difficulty in speaking唾液分泌过多,并可能偶尔导致说话困难

3: speaking with difficulty because of excess salivation因唾液分泌过多而说话困难

4: frank drooling明显口涎外流

附录

SAS评定说明

1.主要用于评定抗精神病药物治疗中所引起的锥体外系不良反应。

2.项目3,4,5评分标准相同。

3.有些项目通过患者的动作和交谈观察评定,有些项目需直接检查评定。

四、 Barnes静坐不能量表(BARS)

Barnes静坐不能量表(Barnes Akathisia Rating Scale,BARS)

Answer questions by filling in the appropriate circle for each item.为每一项条目圈出一个恰当的回答。

INSTRUCTIONS FOR ASSESSMENT评分指导

Subjects should be observed while they are seated, and then standing while engaged in neutral conversation (for a minimum of two minutes in each position). Symptoms observed in other situations, for example, while engaged in routine activities, may also be rated, Subse-quently, the subjective phenomena should be elicited by direct questioning.应在患者取坐位时进行观察,然后一边与其自然交谈,一边让其站立(每个姿势保持至少2min)。在其他情况下,如进行日常活动时,观察到的症状也可以评定。随后,主观感觉应采用直接提问的方式获得。

OBJECTIVE客观

0: Normal, occasional fidgety movements of the limbs正常,偶尔有肢体不安的活动

1: Presence of characteristic restless movements; shuffling or tramping movements of the legs/feet, or swinging of one leg while sitting, and/or rocking from foot to foot or walking on the spot when standing, but movements present for less than half the time observed.存在特征性的坐立不安动作:在坐位时腿(脚)的曳行或做踏步运动,或一条腿摆动,和(或)在站立时两脚来回摆动或“原地踏步”,但这些动作存在的时间少于观察时间的一半。

2: Observed phenomena, as described in “1” above, which are present for at least half the observation period.观察到如上述“1”中描述的现象,且存在的时间占到观察时间的至少一半。

3: The subject is constantly engaged in characteristic restless movements, and/or is un-able to remain seated or standing without walking or pacing, during the time observed.在观察期间,患者不断出现特征性的坐立不安动作,和(或)患者不能保持坐位或站立而不走动或踏步。

SUBJECTIVE主观

Awareness of restlessness对坐立不安的知觉(www.xing528.com)

0: Absence of inner restlessness不存在内在的不安感

1: Non-specific sense of inner restlessness非特异性的内在不安感

2: The subject is aware of an inability to keep the legs still, or a desire to move the legs and/or complains of inner restlessness aggravated specifically by being required to stand or sit still.患者意识到不能保持腿不动,或感到对腿部活动的渴求,和(或)诉说尤其在被要求静立或静坐时内心不安感加重。

3: Awareness of an intense compulsion to move most of the time and/or reports strong desire to walk or pace most of the time.感到在大部分时间有一种强烈地要求活动的冲动,和(或)报告在大部分时间有强烈的走动或踏步的意愿。

Reported distress related to restlessness诉说与坐立不安相关的痛苦

0: No distress无痛苦

1: Mild轻度

2: Moderate中度

3: Severe重度

Global clinical rating of akathisia对静坐不能的总体临床评价

0: Absent—No evidence or awareness of restlessness. Observation of characteristic movements of akathisia in the absence of a subjective report of inner restlessness or compul-sive desire to move the legs should be classified as pseudoakathisia.无——无感觉到坐立不安的证据或意识。观察到特征性的静坐不能动作,若没有内在不安感或活动腿部的冲动性渴求的主观报告,应当归入假性静坐不能一类。

1: Questionable—Non-specific inner tension and fidgety movements.可疑——非特异性的内在紧张感和不安动作

2: Mild Akathisia—Awareness of restlessness in the legs, and/or inner restlessness worse when required to stand still. Fidgety movements present, but characteristic restless move-ments of akathisia not necessarily observed. Condition causes little or no distress.轻度静坐不能——意识到腿部的不能静止,和(或)在被要求静止站立时内在不安感会加重。存在不安动作,但不一定能观察到特征性的静坐不能的坐立不安动作。这种情况引起轻微痛苦或不引起痛苦。

3: Moderate akathisia—Awareness of restlessness as described for mild akathisia above, combined with characteristic restless movements, such as rocking from foot to foot when standing. Subject finds the condition distressing.中度静坐不能——意识到有上述轻度静坐不能的坐立不安,同时有特征性的坐立不安动作,如在站立时两脚来回摆动。患者感到这种情况令人痛苦。

4: Marked akathisia—Subjective experience of restlessness includes a compulsive desire to walk or pace. However, the subject is able to remain seated for at least five minutes. The condition is obviously distressing.显著静坐不能——有主观的坐立不安经历,包括有走动或踏步的冲动性渴求。但患者能够保持坐姿至少5min。该情况明显令人痛苦。

5: Severe akathisia—The subject reports a strong compulsion to pace up and down most of the time.Unable to sit or lie down for more than a few minutes.Constant restlessness which is associated with intense distress and insomnia.严重静坐不能——患者诉说绝大多数时间存在强烈的想要上下踏步的冲动。不能坐下或躺下数分钟。持续性不能静止并伴有强烈的痛苦和失眠

五、异常不自主运动量表(AIMS)

异常不自主运动量表(Abnormal Involuntary Movement Scale,AIMS)

Please complete the examination procedure as detailed in the Trial Manual before mak-ing the ratings. Rate the highest severity observed and rate movements that occur on activa-tion one less than those observed spontaneously. Answer each item by filling in the appropri-ate circle.在进行评级之前请按试验手册要求详细完成检查程序。对观察到的最严重的情况进行评级,活动时发生的运动要比自发出现者低一个等级。为每一项条目圈出恰当的回答。

A) Facial and oral movements面部及口部运动

1. Muscles of facial expression面部表情肌肉

(e.g., movements of forehead, eyebrows, periorbital area, cheeks, including frowning, blinking, smiling, grimacing例如,前额、眉毛、眶周区域、脸颊的运动:包括皱眉、眨眼、微笑、扮鬼脸)

0: None无

1: Minimal, may be extreme normal轻微,可能很正常

2: Mild轻度

3: Moderate中度

4: Severe重度

2. Lips and perioral area唇部和口周区域

(e.g., puckering, pouting, smacking例如,蹙嘴、撅嘴、咂嘴)

0: None无

1: Minimal, may be extreme normal轻微,可能很正常

2: Mild轻度

3: Moderate中度

4: Severe重度

3. Jaw颌

(e.g., biting, clenching, chewing, mouth opening, lateral movement例如,咬合、磨牙、咀嚼、张口、侧向运动)

0: None无

1: Minimal, may be extreme normal轻微,可能很正常

2: Mild轻度

3: Moderate中度

4: Severe重度

4. Tongue舌头

(e.g., rate only increase in movement both in and out of mouth, not inability to sustain movement只对口腔内和口腔外运动的增多进行评级,不对无法维持的运动进行评级)

0: None无

1: Minimal, may be extreme normal轻微,可能很正常

2: Mild轻度

3: Moderate中度

4: Severe重度

B) Extremity movements四肢运动

5. Upper arm (arms, wrist, hands, fingers)上肢(手臂、腕部、手掌、手指)

Include choreic movements(rapid, objectively purposeless, irregular, spontaneous), athetoid movements (slow, irregular, complex, serpentine). Do not include tremor (repetitive, regular, rhythmic)包括舞蹈样动作(即快速、客观上无目的、不规则、自发运动),手足徐动症样运动(即慢速、不规则、复杂、扭动)。不包括震颤(即重复、规则、有节奏运动)

0: None无

1: Minimal, may be extreme normal轻微,可能很正常

2: Mild轻度

3: Moderate中度

4: Severe重度

6. Lower (legs, knees, ankles, toes)下肢(腿、膝关节、踝部、脚趾)

e.g., lateral knee movement, foot tapping, heel dropping, foot squirming, inversion or ev-ersion of foot例如,膝关节侧向运动、足部轻叩、脚跟下落、足部扭动、足内翻或外翻

0: None无

1: Minimal, may be extreme normal轻微,可能很正常

2: Mild轻度

3: Moderate中度

4: Severe重度

C) Trunk movements躯干运动

7. Neck, shoulders, hips颈部、肩关节、髋关节

(e.g., rocking, twisting, squirming, pelvic gyrations例如,摇动、扭动、摆动、髋部转动)

0: None无

1: Minimal, may be extreme normal轻微,可能很正常

2: Mild轻度

3: Moderate中度

4: Severe重度

D) Global judgements总体评定

8. Severity of abnormal movements异常运动的严重程度

0: None/normal无或正常

1: Minimal轻微

2: Mild轻度

3: Moderate中度

4: Severe重度

9. Incapacitation due to abnormal movements因异常运动而影响正常运动

0: None/normal无或正常

1: Minimal轻微

2: Mild轻度

3: Moderate中度

4: Severe重度

10. Subject,s awareness of abnormal movements (rate only subject,s report)患者对异常运动的觉察(仅根据患者的报告进行评级)

0: No awareness未觉察到

1: Aware no distress觉察到,无痛苦

2: Awareness mild distress觉察到,轻度痛苦

3: Aware moderate distress觉察到,中度痛苦

4: Aware severe distress觉察到,严重痛苦

E) Dental status牙齿状况

11. Current problems with teeth and/or dentures目前关于牙齿和(或)义齿问题

0: No否

1: Yes是

12. Does the subject usually wear dentures?患者是否经常佩戴义齿?

0: No否

1: Yes是

附录

AIMS评定说明

1.主要用于评定迟发性运动障碍的患者。

2.在完成检查之前或者之后,都应当在静息状态(例如,在等候室中)下谨慎观察患者。本检查中使用的椅子应当是硬座、稳固且不带扶手。

3.检查程序如下

(1)询问患者他(她)的口腔中是否有任何东西(例如,口香糖、糖果等),如果有,则将它们取出。

(2)询问患者他(她)牙齿目前的情况。询问患者他(她)是否佩戴义齿。牙齿或者义齿现在是否会给患者带来困扰?

(3)询问患者他(她)是否注意到口腔、面部、手或者足部有任何运动。如果是,则要求描述之,并询问目前对患者困扰的程度如何或者是否干扰了他(她)的活动。

(4)让患者坐在椅子上,手放在膝盖上、腿微分开、脚平放在地板上(在此坐姿时观察整个身体的运动)。

(5)要求患者坐下,手平举无支撑。如果是男性,手举在两腿之间,如果是女性且穿着女装,则举在膝盖上方(观察手以及身体其他部位)。

(6)要求患者张嘴(观察静息状态时舌头在口腔内的运动)。

(7)要求患者伸出舌头(观察异常的舌头运动)。重复1次。

(8)要求患者尽可能快地用各个手指轻扣大拇指,持续10~15min;右手单独做1次,然后左手(观察面部和腿运动)。

(9)屈伸患者的左手臂和右手臂(1次1只)[注意任何僵直,并根据剂量记录和治疗紧急症状量表(DOTES)评级]。

(10)要求患者起立(观察外形。再次观察所有身体部位,包括膝关节)。

(11)要求患者向前伸出双手臂,手掌朝下(观察躯干、腿和口部)。

(12)让患者走几步路,转身,走回到椅子边上来(观察手和步态)。重复1次。

4.项目(8),(11),(12)为主动运动。

5.评分时,按症状的最严重程度记分。

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