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Journal of Chinese Integrative Medicine ›› 2010, Vol. 8 ›› Issue (12): 1124-1132.doi: 10.3736/jcim20101204

• Systematic Review • Previous Articles     Next Articles

Adverse drug reactions or adverse events of Chaihu Injection: A systematic review

 Xiang-yu Konga, Yuan Haoa, Tai-xiang Wua, Yan-ming Xieb   

  1. a Chinese Evidence-Based Medicine Center, West China Hospital, Sichuan University, Chengdu 610041, Sichuan Province, China
    b Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China
  • Received:2010-07-16 Accepted:2010-09-17 Online:2010-12-20 Published:2010-12-15
  • Contact: Wu Tai-xiang E-mail:txwutx@hotmail.com

Background

Chaihu Injection (CI), which is widely used in treatment of febrile diseases, is an aqueous solution of Chaihu (Radix Bupleuri Chinensis) or Nanchaihu (Radix Bupleuri Scorzonerifolii) prepared by steam distillation.

Objective

This study aims at finding out the possible causes for adverse drug reaction or adverse event (ADR/AE) caused by CI and assessing its safety based on existing evidence.

Search strategy

 Manual search was not conducted. Electronic search was conducted by two authors in China National Knowledge Internet (CNKI) database and Chongqing VIP database (VIP). The search ended in June 30th, 2009.

Inclusion criteria

Studies of ADR/AE induced by CI were collected comprehensively without considering language of literature and outcome indicators. Search results were not limited by patient’s age, gender, race, primary disease, etc. Interventions were using CI alone or CI combined with other drugs (Chinese herbal medicine decoction or other drugs containing Chaihu were excluded).Data extraction and analysis: Two authors conducted data extraction independently. Microsoft Excel software was used to develop data extraction forms. Because of heterogeneity of the studies, only a descriptive analysis was conducted.

Results

Totally 83 studies with 203 cases were included in this review. Without the yield data and total amount of using, we cannot tell the incidence of ADR/AE induced by CI as well as assess the risk and safety of CI. The constituent ratio of severe cases was higher in children and old people than in other age groups. For most intramuscular cases, ADR/AE happened in 30 min after injection (constituent ratio of cumulative incidence in 30 min was 93.8%); for intravenously guttae patients, 4 cases of ADR/AE happened in the process of infusion; for first users, constituent ratio of cumulative incidence in 30 min and constituent ratio of cumulative incidence of severe cases in 30 min were higher than cases who had used CI before. Most ADRs/AEs were caused by incorrect use of CI, such as excessive doses (5 cases), intravenously guttae administration (6 cases), and violating incompatibility rules (7 cases). The incidence ratios of ADR and AE for severe and mild cases were 1.7︰1 and 1.1︰1, respectively; the ratios of the three relevant levels described as definitely related, most probably related and possibly related in the two types (severe and mild) of cases were 25︰14︰5 and 44︰9︰16, respectively.

Conclusion

Present evidence with low level shows that incorrect use is the main cause of ADR/AE of CI. Whether CI is proper for children and old people still needs further research. Training for correct use of CI is necessary for medical workers. Much improvement in reporting ADR/AE based on “Recommendations for Reporting Adverse Drug Reactions and Adverse Events of Traditional Chinese Medicine” is in need.

Key words: Bupleurum Chinense, Injection, Adverse drug reaction, Adverse event, Systematic review

Figure 1

Flow diagram of literature retrieval and selection"

Table 1

Clinical analysis of dead cases"

Table 2

Relationship between time of occurrence and severity of ADR/AE in first time intramuscular injection cases"

Table 3

Relationship between severity of ADR/AE caused by CI and drugs used simultaneously with CI (Case)"

Name of drugs - Cases of ADR/AE Total
Severe Mild
Antipyretic analgesic
Pyramidon veronal injection 8 63 71
Antibiotics
Cephalosporin (iv gtt) 1 0 1
Ciprofloxacin (iv gtt) 1 0 1
Benzyl penicillin sodium 0 1 1
Gentamycin 6 0 6
Virazole 1 0 1
Dexamethasone 2 0 2
Isatis root injection 2 0 2
Metoclopramide 1 0 1
Total 22* 64 86*

Table 4

Relationship between the dosage of CI and severity of ADR/AE (Case)"

Cases of ADR/AE 十 o 1
Dosage of Cl Severe Mild
0. 4 mL 1 0 i
0. 8 mL 1 0 i
1 mL 8 1 9
1. 5 mL 1 1 2
2 mL 24 79 103
3 mL 3 1 4
4 mL 19 13 32
8 mL 1 0 1
14 mL 3 0 3
20 mL 1 0 1
Total 62 95 157

Table 5

Relationship of route of administration and severity of ADR/AE caused by CI"

[1] Yuan Q, Wang L, Cheng L, Cui XH, Zhong DK, Li YY, Shang HC, Zhang BL , Li YP. Adverse drug reactions and adverse events of 33 varieties of traditional Chinese medicine injections on the National Essential Drugs List ( 2004 edition) of China: an overview on published literatures. Zhongguo Xun Zheng Yi Xue Za Zhi. 2010 ;10(2) : 132-139. Chinese with abstract in English.
袁强, 王莉, 成岚, 崔小花, 钟大可, 李媛媛, 商洪才, 张伯礼, 李幼平 . 国家基本药物目录( 2004年版)33种中药注射剂不良反应/不良事件文献分析.中国循证医学杂志. 2010; 10(2) : 132-139.
[2] Hou JY. Traditional Chinese pharmacology. 2nd ed. Beijing: China Press of Traditional Chinese Medicine. 2003: 31-33. Chinese.
侯家玉 . 中药药理学.第2版.北京: 中国中医药出版社. 2003: 31-33.
[3] Luo YP . Analysis of 6 apsychia cases induced by antondin and Chaihu injection. Zhongguo Xiao Yi. 2003; 17(5):429. Chinese.
罗燕萍 . 安痛定、柴胡注射液致晕厥6例分析.中国校医. 2003; 17(5):429.
[4] Li XH.Reaction and nursing after injecting Chaihu injection. Hang Kong Hang Tian Yi Yao. 1996; 7(2) : 118. Chinese.
李晓红 . 柴胡注射后的反应与护理. 航空航天医药. 1996; 7(2) : 118.
[5] Chen YX , Lin XL. Analysis of 14 apsychia cases in sitting position by intramuscular injection of Chaihu injection and prevention. Shenzhen Zhong Xi Yi Jie He Za Zhi. 2001; 11(2):128.
陈玉霞, 林小兰 . 14例坐位肌注柴胡注射液致晕厥的原因分析及预防.深圳中西医结合杂志. 2001; 11(2):128.
[6] State Food and Drug Administration . Recommendations for reporting adverse drug reactions and adverse events of traditional Chinese medicine, , 2004. Chinese.
国家食品药品监督管理局 . 药品不良反应报告和监测管理办法. , 2004.
[7] Zhao JH, Sun AJ , Liu X. One case of acute renal failure induced by Chaihu injection. Shi Yong Er Ke Lin Chuang Za Zhi. 2004; 19(11): 960, 998. Chinese.
赵军海, 孙爱军, 刘欣 .柴胡注射液致急性肾衰竭 1例 .实用儿科临床杂志. 2004; 19(11): 960, 998.
[8] Ma RH, Liu YP , Li HR. One dead case induced by overdose intravenous drip of Chaihu injection. Hebei Zhong Xi Yi Jie He Za Zhi. 1999; 8(5):802. Chinese.
马瑞荷, 刘岩平, 李会茹 . 大剂量柴胡注射液静点致死亡1例.河北中西医结合杂志. 1999; 8(5):802.
[9] Yin T. Allergic shock induced by mixed intramuscular injection of Chaihu injection and metoclopramide. Zhong Nan Yao Xue. 2003; 1(2):120. Chinese.
尹桃 . 混合肌内注射柴胡、甲氧氯普胺引起过敏性休克. 中南药学. 2003; 1(2):120.
[10] Yuan LN, Ding YF , Fang SX. One dead case of epider-molysis bullosa induced by intramuscular injection of Chaihu injection. Zhongguo Yao Shi. 2002; 5(6):361. Chinese.
苑丽娜, 丁玉峰, 方淑贤 . 肌注柴胡注射液致大疱性表皮松解型药疹死亡1例.中国药师. 2002; 5(6):361.
[11] Shi XZ. . On guard against allergy of Chaihu. Yao Wu Liu Xing Bing Xue Za Zhi. 2005; 14(1):38. Chinese.
石小庄 . 警惕柴胡过敏.药物流行病学杂志. 2005; 14(1):38.
[12] Teng J . One dead case of allergic shock induced by intravenous drip of Chaihu injection. Zhongguo Fa Yi Xue Za Zhi. 1998; 13(4):252. Chinese.
滕军 . 静脉滴注柴胡引起过敏性休克死亡1例.中国法医学杂志. 1998; 13(4):252.
[13] Wang SG . Two dead cases induced by mixed intramuscular injection of gentamycin and Chaihu injection. Hai Xia Yao Xue. 1999; 11(2) : 74. Chinese.
王顺国 . 庆大霉素与柴胡混合注射引起死亡2例.海峡药学. 1999; 11(2) : 74.
[14] Lou BC , Xu CL . One dead case induced by mixed intramuscular injection of gentamycin and Chaihu injection. Yao Wu Liu Xing Bing Xue Za Zhi. 2000; 9(3):150. Chinese.
娄必春, 徐春丽 . 庆大霉素与柴胡注射液混合注射致死 1例. 药物流行病学杂志. 2000; 9(3):150.
[15] Shi YH, Chen YL, Wang YX , Li YM . One dead case induced by intravenous drip of Chaihu injection. Hebei Zhong Xi Yi Jie He Za Zhi. 1999; 8(5):794. Chinese.
时彦红, 陈云丽, 王艳霞, 李英棉 . 静滴柴胡注射液致死亡1例.河北中西医结合杂志. 1999; 8(5):794.
[16] Xu RY , Yu XY . One case of allergic shock induced by intramuscular injection of Chaihu injection. Lin Chuang Yi Xue. 1993; 13(6):287. Chinese.
徐如意, 于秀云 . 肌注柴胡针致过敏性休克一例.临床医学. 1993; 13(6):287.
[17] Zhang CL . One case of allergic response induced by Chaihu injection. Heilongjiang Yi Yao Ke Xue. 2002 ; 25(1):117. Chinese.
张春莲 . 柴胡注射液引起过敏反应1例.黑龙江医药科学. 2002; 25(1):117.
[18] Wang JL. Clinical epidemiology. 3rd ed. Shanghai: Shanghai Scientific and Technical Publishers. 2009: 456-460. Chinese.
王家良 . 临床流行病学.第3版.上海: 上海科学技术出版社. 2009: 456-460.
[19] Zhou TS , Mi L. One case of allergic shock induced by mixed intramuscular injection of gentamycin and Chaihu injection. Zhongguo Yi Yuan Yao Xue Za Zhi. 1996 ; 16(7):331. Chinese.
周洮生, 米兰 . 庆大霉素与柴胡注射液混合注射引起过敏性休克1例.中国医院药学杂志. 1996; 16(7):331.
[20] Wu TX, Shang HC, Bian ZX, Zhang JH, Li YQ, Li YP , Zhang BL . Recommendations for reporting adverse drug reactions and adverse events of traditional Chinese medicine. Zhongguo Xun Zheng Yi Xue Za Zhi. 2010; 10(2):215-219. Chinese with abstract in English.
吴泰相, 商洪才, 卞兆祥, 张俊华, 李延谦, 李幼平, 张伯礼 . 中药不良反应/不良事件报告规范建议.中国循证医学杂志. 2010; 10(2):215-219.
[21] Center for Drug Re-evaluation of State Food and Drug Administration . National Center for ADR Monitoring of China. .
国家食品药品监督管理局药品评价中心, 国家药品不良反应监测中心 .药品不良反应报告流程. .
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