128例口服卡马西平导致不良反应文献分析

doi:10.3877/cma.j.issn.1673-5250.2012.03.011

目的

探讨卡马西平(CMP)导致不良反应(ADR)的一般规律及特点，为临床合理用药提供参考。

方法

采用回顾性分析方法，选择2000年1月至2009年10月中国期刊全文数据库收载的国内医、药学期刊报道的128例口服CMP导致ADR患者纳入本研究，并对与ADR发生的相关数据进行统计学分析(本研究遵循的程序符合本院人体试验委员会所制定的伦理学标准，得到该委员会批准)。

结果

口服CMP导致ADR的临床表现复杂多样，皮肤及附件、中枢及外周神经系统和血液系统损害发生率分别为58.60%(75/128)，14.84%(19/128)和10.16%(13/128)。口服CMP导致的男、女个体ADR发生率比较，差异有统计学意义(P<0.05)，可发生于各年龄个体，但在11～40岁及>60岁个体的发生率较高。本组CMP联合用药导致的ADR较严重，包括大疱表皮坏死松解型药疹、全身性肌阵挛发作及白细胞计数降低等。128例患者中，治愈率为93.75%(120/128)，后遗症发生率为0.78%(1/128)，抢救无效死亡率为5.47%(7/128)。

结论

临床应重视口服CMP导致的ADR，尤其应警惕该药导致的重型药疹、再生障碍性贫血及急性肾衰竭等。另外，临床应特别重视CMP联合用药导致的大疱表皮坏死松解型药疹、全身性肌阵挛发作、白细胞计数降低等严重ADR。

关键词: 卡马西平, 不良反应, 文献分析

Objective

To explore the general characteristics of adverse drug reactions (ADR) caused by the carbamazepine (CMP), and provide some information for clinical medication.

Methods

The related reports about ADR caused by CMP were searched and retrospective analyzed in medical and academic journals from China Journal Full-Text Database between January 2000 and October 2009. At last, a total of 128 cases were include into this study. The study protocol was approved by the Ethical Review Board of Investigation in Human Being of Shanxi Medical University.

Results

Clinical manifestations of ADR caused by the CMP were complex and diverse. The top three incident rate of systemic injury were skin and its appendages injury (58.60%, 75/128), central and peripheral nervous system injury (14.84%, 19/128) and blood disorders (10.16%, 13/128). There had significant difference of incident rate between males and females (P<0.05). The ADR can occur in any age stages, and patients older than 60-year-old had the highest incident rate (11.72%, 5/128). The ADR caused by drug combination may have serious results, such as bullous epidermal necrolysis drug eruption, generalized myoclonic seizures and leukocyte reduction. In 128 patients, the cure rate was 93.75% (120/128), occurrence rate of sequelae was 0.78% (1/128) and rate of rescue invalid death was 5.47% (7/128).

Conclusions

Clinicians should pay attention to the ADR caused by CMP, especially guard against the occurrence of serious drug-induced rash, aplastic anemia and acute renal failure. And further knowledge about serious ADR, such as bullous epidermal necrolysis drug eruption, generalized myoclonic seizures and leukocyte reduction caused by drug combination, should be attention.

Key words: carbamazepine, adverse reaction, literature analysis

表1 128例发生不良反应患者的性别与年龄分布[n(%)]

Table 1 Distribution of ages and gender of adverse reactions caused by carbamazepine among 128 cases [n(%)]

年龄(岁)	男性	女性	构成比
<10	14(10.94)	2 (1.56)	16 (12.50)
11～20	7 (5.47)	13(10.16)	20 (15.63)
21～30	8 (6.25)	13(10.16)	21 (16.41)
31～40	8 (6.25)	14(10.94)	22 (17.18)
41～50	6 (4.69)	8 (6.25)	14 (10.94)
51～60	4 (3.13)	5 (3.91)	9 (7.03)
>60	15(11.72)	11 (8.59)	26 (20.31)
合计	62(48.44)	66(51.56)	128(100.00)

表1 128例发生不良反应患者的性别与年龄分布[n(%)]

Table 1 Distribution of ages and gender of adverse reactions caused by carbamazepine among 128 cases [n(%)]

年龄(岁)	男性	女性	构成比
<10	14(10.94)	2 (1.56)	16 (12.50)
11～20	7 (5.47)	13(10.16)	20 (15.63)
21～30	8 (6.25)	13(10.16)	21 (16.41)
31～40	8 (6.25)	14(10.94)	22 (17.18)
41～50	6 (4.69)	8 (6.25)	14 (10.94)
51～60	4 (3.13)	5 (3.91)	9 (7.03)
>60	15(11.72)	11 (8.59)	26 (20.31)
合计	62(48.44)	66(51.56)	128(100.00)

表2 13例卡马西平联合用药导致不良反应发生率及其临床表现[n(%)]

Table 2 Rate of adverse reactions of carbamazepine in combination with other drugs among 13 cases and its clinical manifestations [n(%)]

联合药物	发生率	ADR临床表现
苯巴比妥	3(23.08)	皮疹、休克、四肢僵直、全身性肌阵挛
丙戊酸钠	2(15.38)	偏身抽搐、偏瘫综合征、重度变态反应性药疹
氯丙嗪	3(23.08)	大疱表皮坏死松解型药疹、牛皮癣复发
氯氮平	2(15.38)	急性肌张力障碍、剥脱性皮炎
舒必利	1 (7.69)	变态反应性皮疹及外周血白细胞计数降低
氟哌啶醇	1 (7.69)	腹痛
阿昔洛韦	1 (7.69)	药物性肝病

表2 13例卡马西平联合用药导致不良反应发生率及其临床表现[n(%)]

Table 2 Rate of adverse reactions of carbamazepine in combination with other drugs among 13 cases and its clinical manifestations [n(%)]

联合药物	发生率	ADR临床表现
苯巴比妥	3(23.08)	皮疹、休克、四肢僵直、全身性肌阵挛
丙戊酸钠	2(15.38)	偏身抽搐、偏瘫综合征、重度变态反应性药疹
氯丙嗪	3(23.08)	大疱表皮坏死松解型药疹、牛皮癣复发
氯氮平	2(15.38)	急性肌张力障碍、剥脱性皮炎
舒必利	1 (7.69)	变态反应性皮疹及外周血白细胞计数降低
氟哌啶醇	1 (7.69)	腹痛
阿昔洛韦	1 (7.69)	药物性肝病

表3 128例卡马西平导致不良反应涉及器官或系统[n(%)]

Table 3 Organs or systems involved in adverse reactions among 128 cases [n(%)]

涉及器官或系统	发生率	涉及器官或系统	发生率
皮肤及其附件	75(58.60)	消化系统	2(1.56)
中枢和外周神经系统	19(14.84)	呼吸系统	2(1.56)
血液系统	13(10.16)	泌尿系统	1(0.78)
肝胆系统	6 (4.69)	视觉系统	1(0.78)
心血管系统	5 (3.91)	其他	4(3.12)

表3 128例卡马西平导致不良反应涉及器官或系统[n(%)]

Table 3 Organs or systems involved in adverse reactions among 128 cases [n(%)]

涉及器官或系统	发生率	涉及器官或系统	发生率
皮肤及其附件	75(58.60)	消化系统	2(1.56)
中枢和外周神经系统	19(14.84)	呼吸系统	2(1.56)
血液系统	13(10.16)	泌尿系统	1(0.78)
肝胆系统	6 (4.69)	视觉系统	1(0.78)
心血管系统	5 (3.91)	其他	4(3.12)

表4 128例口服卡马西平后发生不良反应的时间分布[n(%)]

Table 4 Time distribution of adverse reactions caused by carbamazepine among 128 cases [n(%)]

发生时间(d)	发生率	发生时间(d)	发生率
<1	7 (5.48)	91～365	10(7.81)
1～30	99(77.34)	>365	3(2.34)
31～90	9 (7.03)	?	?

表4 128例口服卡马西平后发生不良反应的时间分布[n(%)]

Table 4 Time distribution of adverse reactions caused by carbamazepine among 128 cases [n(%)]

发生时间(d)	发生率	发生时间(d)	发生率
<1	7 (5.48)	91～365	10(7.81)
1～30	99(77.34)	>365	3(2.34)
31～90	9 (7.03)	?	?

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摘要

选择文件类型/文献管理软件名称

选择包含的内容

Literature Analysis of 128 Cases With Carbamazepine Induced Adverse Reactions

模态框（Modal）标题

选择文件类型/文献管理软件名称

选择包含的内容

Literature Analysis of 128 Cases With Carbamazepine Induced Adverse Reactions