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  • The Internet Journal of Pediatrics and Neonatology
  • Volume 8
  • Number 2

Original Article

Safety Comparative Study on Azithromycin Oral and IV Dosage Form in Pediatric Respiratory Infection Therapy

X Li, X Jielai

Keywords

adverse event, azithromycin, children, intravenous, oral

Citation

X Li, X Jielai. Safety Comparative Study on Azithromycin Oral and IV Dosage Form in Pediatric Respiratory Infection Therapy. The Internet Journal of Pediatrics and Neonatology. 2007 Volume 8 Number 2.

Abstract

Azithromycin is widely used for treatment in various of pediatric respiratory infections and there is no any strict requirement for selection of oral or intravenous (IV) dosage form. There is few comparative data in respective of safety between these two dosage forms. The purpose of this study was to review safety data between oral and IV for the treatment under 16-year-old children and intend to give pediatricians reference in the two dosage forms of azithromycin. This paper has reviewed adverse events ( AEs) data which include 3960 cases of children in 79 published paper for treatment in respiratory infection. There are 1628 cases in oral group,2302 cases in IV group and 30 AE individuals case reports (IV). The study result shows that the AE incidence is 14.12% in IV group and 9.28% in the oral group. It is significant different between the two groups (u=4.699, P<0.0005). In conclusion, Azithromycin oral dosage form resulted in better tolerance in children than that of IV, suggest pediatricians to prescribe oral dosage form as first line therapy.

 

Material and methods

All data came from the Wanfang Data-base and Weipu Data-base. The publishing date of literature used is from Jan.1 1997 to Dec. 1 2007. Meanwhile, we traced every reference literature. The index keyword included children, azithromycin, intravenous and oral administration.

Inclusion and exclusion criteria

Inclusion criteria

It is concomitantly demanded to meet next conditions:

  1. Patients under16 years old;

  2. Children are confirmed respiratory infection;

  3. IV group children are treated only by azithromycin IV administration and oral group children are treated only by azithromycin oral dosage form;

  4. Classified recording of AE in details.

Exclusion criteria

  1. If the case has any following AE before administration of azthiromycin should be excluded:

  2. Combination therapy with any other drug will be excluded.

Materials screening

There are 79 paper have been collected in this review which include 22 paper[1,2,3,4,5,6,7,8,9,10,11,12,13,14,15,16,17,18,19,20,21,22] for oral administration ,42 paper[2,23,24,25,26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52,53,54,55,56,57,58,59,60,61,62,63] for IV administration and 16 individual case report[64,65,66,67,68,69,70,71,72,73,74,75,76,77,78,79] for IV. Detailed see table 1.

Figure 1
Table 1: Materials screening

Refer to azithromycin oral and IV administration paper, the total number of children who have been used azithromycin oral and IV administration, the total number of children who have AE experience and total number for each kind of AE respectively were extracted from the qualified screening paper.

Data analysis

Calculate the incidence of AE. The difference between oral group and IV group in AE incidence is tested through U test. All data will be processed using SAS 8.2 statistics software.

Results

The total number of AE reported and incidence in azithromycin oral and IV group see table 2: the incidence of AE is 9.28% (151/1628) in oral group. The most common AE are gastrointestinal (GI) (122 cases), rash (20 cases), liver enzyme (ALT) increasing (5 cases) and headache (3 cases). The rate of AE is 14.12% (325/2302) in IV group which include rash (22 cases), wheal (3 cases), Injected site pain (16 cases), Phlebitis (4 cases), ALT elevated (13 cases). The incidence of AE between oral and IV groups were examined through u test (u=4.699, P<0.0005), it can be determined that it is different between the two groups in AE incidence, and AE incidence of IV group is higher than that of oral group.

Figure 2
Table 2: The total AE number and incidence of azithromycin oral and IV group

Figure 3
Table 3: Individual case AE reports of azithromycin IV in children

Discussion

Azithromycin is the most widely used macrolide antibiotics for treatment of pediatric respiratory infections caused by common pathogens such as Staph.aureus Streptococcus pneumoniae, Moraxella catarrhalis, Haemophilus influenzae, Mycoplasma pneumoniae and Chlamydophila pneumoniae. Because once daily administration pharmacokinetic feature of azithromycin, both oral and IV are prescribed widely by Chinese doctors. At present, the prescribing dosage forms of oral or IV and the treatment duration will depend on the habit of the doctors individually. The duration can be 3 to 4 weeks[65] by intermission administration for treatment of Mycoplasma and Chlamydophila infection. Now, there is no evidence based clinical study to compare these two dosage forms in safety and efficacy for treatment of children. However, two open comparative small sample China studies[4,7] indicated that the two dosage forms are equal in safety and efficacy for treatment of pediatric infections. From the theoretical point of view, oral administration should be safer than IV administration. It may be the sample is too small to show the difference between oral and IV administration in the previous local two studies. However, this 3930 cases review analysis shows that oral dosage form is safer than that of IV.

From the detailed individual AE reports of IV administration, we found that there are 1 dead case[70] of anaphylaxis and 3 allergic shock cases[71,72,73] happened. The results suggest that it should pay attention to allergic shock at the beginning of azithromycin IV administration. All 16 liver enzyme (ALT) elevated cases[64,65] have a long therapy experience from 4 to 12 continue days. The result suggest that it should be paid attention to the liver functions damage risk after 3 days duration therapy because azithromycin is eliminated through liver and an elimination half-life is 65.2 hours in 0.5 to 16 years old children[80] and children's liver functions are premature in necessary enzymes synthesis[81]. Contrast to IV dosage form, oral dosage form has not been found the report of dead of anaphylaxis or allergic shock yet. It is only found ALT minor reversible increasing, lower AE rate and safer than IV dosage form. So, we suggest pediatrician to prescribe azithromycin oral dosage form as priority choice in under-16-years-old children respiratory infection treatment.

Because we only reviewed the clinical observation data, it is possible that there are some shortages in this paper. First, the AE diagnosis criteria are different. Secondly, collected literatures sample can not represent the whole situation of China children. Last, lack of detailed information of every AE case and AE happened history and so on has hindered us to accurately analyze these data.

References

1. Wu Junrong, Tao Zhigang. Observation of Zithromycin in Treatment of Children Respiratory infection. THEORY AND PRACTICE OF CHINESE MEDICINE. August 2006; Vol.16, No.8:985
2. Yu Xiuqun, Tian Guiping. Clinical Observation of Azithromycin Cuspension and IV treatment in Childer Respiratory Infection. Clinical Focus. May 20, 2006; Vol.21, No.10:733
3. Cai Fenghua, Cai Liqin, Jiang Minfang. Clinical Observation of Azithromycin Oral Dosage Form Treatment in Children Respiratory Infection. Community Healthcare. 2006; Vol.5, No.6:68-70
4. Mo Chuxi, Cao Yan, Zhangweixing. Clinical Observation of Azithromycin Oral Dosage Form Treatment in Childen Mycoplasma Pneumoniae Infection. I MHGN. 2005; Vol.11, No.22: 57-58
5. Fan Shihui. 52 Cases Clinical Observation of Azithromycin Treatment in Children Acute Bronchitis. Modern medicine. 2005; Vol.21, No.1:74
6. Pangge Jiapu, Baha Tinu'er, Wu haiyan. Comparative Study of Azithromycin Oral and Erythromycin IV in Treatment of Children Mycoplasma Pneumonia. Hunan Medicine. 2007; Vol.17, No.1:78,25
7. Zeng Qiang, Guo Suixia.Clinical Observation of Azithromycin Oral Dosage Form Treatment in Children Mycoplasma Pneumoniae and Chlamydophila Pneumoniae. Practice Medicine Magazine. 2006; Vol.22, No.17:2045-2046
8. Jiang yun, Cui Xinhua.Clinical Efficacy Evaluation of Azithromycin Oral Dosage Form in Treatment of Children Up Respiratory Tract Infection. Hei Longjiang Medical and Pharmaceutical Science. June 2006; Vol.26, No.3:116
9. Yu Shuxiang.Clinical Observation of Azithromycin Oral Dosage Form Treatment in Children Up Respiratory Tract Infection. Sichuan Medical Journal. 2002; Vol.25, No.5:511
10. Chen Gang.Comparative Clinical Observation of Zithromycin Oral and Cefixime in Treatment of Children Acute Tonsillitis. Health Horizone.Medical Science. Sep. 2005; No.2:38
11. Liao Wei, Wen Enyi, Zhang Yuping, Li Weiming, Zhao Congmin, Jiang Xun. Clinical Observation of Zithromycin Treatment in Children Acute Respiratory Infection. ACTA ACADEMIAE MEDICINE MII JTARIS TERTIAE. Jan. 2001; Vol.23, No.6:673, 676
12. Cui Zhanju.Comparative Study of Azithromycin Treatment in Children Mycoplasma Up Respiratory Tract Infection. Journal of Medical Focus. Nov. 2007; Vol.28, No.21:71
13. Li Gang, Geng Aixia. Safety and Efficacy of Azithromycin Suspension in Treatment of Children Mycoplasma Pneumonia. World Clinical Drugs. 2006; Vol.27, No.4:246-248
14. Zhu Yu, Ruan Jieping. Comparative Study between Domestic and Imported Azithromycin in Treatment of Children Respiratory Infections. OCCUPATION AND HEALTH. May 2005; Vol.21, No.5:776-777
15. Zheng Qinyun. Azithromycin Treatment in Children Respiratory Infections. Chinese Comprehensive Journal 2004; Vol.6, No.2:25-26
16. Huang Chaoyang, Xie Huashan.Clinical Observation of Azithromycin in Treatment of Children Suppurative Tonsillitis. Youjiang Medicine. 2003; Vol.31, No.2:143-144
17. Yin Tao, Jiang Yuefei. Comparison of Azithromycin and Erythromycin in the Treatment of Pediatric Mycoplasmal Pneumonia. China Antibiotic Magazine. Apr. 2002; Vol.27, No.4:240-241
18. Ding Yufeng, Fang Shuxian, Qin Jiahui. Cost-effectiveness Analysis of Azithromycin and Erythromycin in Treatment of Mycoplasma Pheumonia in Children. Chinese Pharmacist. 2002, Vol.5, No.5:287-288
19. Xie Fayu, Yin Xiaojuan, Niu Yingxia. Efficacy Analysis of Domestic Azithromycin in Treatment of Children Mycoplasma. Henan Diagnosis and Therapedics Magazine. 2002; Vol.16. No.6:429-430
20. Liu Fuyin. The Effect of Azithromycin on the Treatment of Children with Pyogenic Tonsillitis. Journal of Pediatric Pharmacy. 2001; Vol.7, No.4:30-31
21. Zhang Ping.Clinical Observation of Azithromycin Treatment in 282 Cases of Children Suppurative Tonsillitis.New Medcine. Mar. 2000; Vol.31, No.3:160-161
22. Feng Xiaowei. Clinical Observation on Three-day Dosage Azithromycin Compared with Ten-day Dosage Roxithromycin in the Treatment of Mycoplasma Pneumonia. NATURAL SCIENCE JOURNAL OF HAINAN UNIVERSITY. September 1997; Vol.15, No.3:233-235
23. Chen Haisheng, Pu Zeqiong, Zhang Meihong. Controlled Study of Azithromycin and Erythromycin in the Treatment of Mycoplasma pneumonia in Children. Clinical Medical Journal of China. 2004; Vol.11, No.24:535-536
24. Huang Yihui, Deng Ying, Yu Li. 60 Cases of Azithromycin Treatment in Children Low Respiratory Tract Infection. Herald of Medicine. August 2004; Vol.23, No.8:560-561
25. Xiao Yin, Qiang Lieying, Liu Kai, Chen Jiang. Comparative Study between Azithromycin IV and Erythromycin in Treatment of Children Mycoplasma Pneumonia. China New Medicine. 2003; Vol.2, No.4:61
26. Qiu Suqing, Wan Shengming. Comparative Study between Azithromycin and Erythromycin in Treatment of Children Mycoplasma Pneumonia Clinical Medicine. Apr. 2004; Vol.24, No.4:32-33
27. Hu Jianguo.Comparative Study in Safety and Efficacy between Azithromycin and β-blactom Antibiotics in Treatment of Children Mycoplasma Pneumonia. Chinese Journal of Current Traditional and Western Medicine. 2005; Vol.3, No.5:416-417
28. Dai Xianguo, Fang Hongxing, Mo Cunjian. The Clinical Observation of Azithromycin in Treating 56 Children's Mycoplasma Pneumonia. Journal of Pediatric Pharmacy. 2006; Vol.12, No.2:42-43
29. Tan Yang. The Efficacy and Safety of Intravenous Azithromycin in Treating Children Bacterial Pneumonia. Chinese Journal of Microecology. Apr. 2005; Vol.17, No.2:144-146
30. Zhang Qihuang, Zheng Jingyang.Clinical Analysis of Azithromycin Treatment in 44 Cases of Children Mycoplasma Pneumonia. FJ Medical Journal. 2005; Vol.27, No.1:89-90
31. Wu Xun, Tan Yaoming.Clinical Analysis of Azithromycin Treatment in 131 Cases of Children Pneumonia. Lingnan Emergency Medical Journal. June 2005; Vol.10, No.2:143
32. Huang Zhigang, Jiang Peng.Clinical Safety and Efficacy Observation of Azithromycin Treatment in Community Acquired Pneumonia of Children. Base Medicine Forum. 2006; Vol.10, No.4, Version B:315
33. Chen Haiyan. Azithromycin to Treat Child Mycoplasma Pneumonia. Medicine Forum Journal. Apr. 2004; Vol.27, No.8:30-32
34. Liao Tongcheng. Observation and Analysis to the Effects of Azithromycin on Mycoplasma Pneumonia of Children. I MHGN. 2005; Vol.11, No.4:78-80
35. Wu Yanyong. Comparative Study between Aspartic Acid Azithromycin and Erythromycin in Treatment of Children Mycoplasma Pneumonia. Chin Pediatr Emerg Med. Apr. 2006; Vol.13, No.2:156-160
36. Luo Heping. Clinical Observation of Aspartic Acid Azithromycin in Treatment of Children Pneumonia. Applied Journal of General Practice. May 2006; Vol.4, No.3:304
37. Wang Daiming, Wang Xiaohong, Lu Quan, Hong Jianguo, Zhou Yunfang. Clinical Observation of Safety and Efficacy of Azithromycin in Treatment of Children Pneumonia. Chinese Practice Pediatric Journal. Dec. 2003. Vol.18, No.12:749- 750
38. Wang Xiaohong, Wang Daiming. Efficacy and Safety of Injectable Azithromycin in Treatment of Pneumonia in Children. Chinese Journal of New Drugs. 2001; Vol.10, No.9:695-696
39. Ma Yuzong. Analysis of Azhithromycin in Treatment of Children Mycoplasma Pneumonia. Chinese Remedics & Clinics. June 2005; Vol.5, No.6:452-453
40. Liu Ning, Li Suqin. Clinical Efficacy Comparative between Azithromycin and Erythromycin in Treatment of Respiratory Infection. Youjiang Ethnic Medical Colleague Journal.2004; No.4:547-548
41. Li Kaijun, Wang Xianfeng, Zhang Youwei.38 Cases Report on Azithromycin Treatment of Children Mycoplasma Pneumonia. Medicine Orientation Journal.Sep. 2004; Vol.23, No.9:663
42. Yang Yuandong. Efficacy Comparison of Azithromycin and Erythromycin on Mycoplasma Pneumonia of Children. J Henan Univ Sci Tech(Med Sci). Dec. 2003; Vol.21, No.4:300-301
43. Tang Debin. Clinical Comparative Study between Azithromycin and Erythromycin in Treatment of Children Mycoplasma Pneumonia. Clinical Lung Magazine. July 2006; Vol.11, No.4:545-546
44. Yan Yuping. Clinical Observation of Azithromycin Treatment of Mycoplasma pneumonia. Chinese Medicine of Factory and Mine. June 2005; Vol.18, No.3:232-233
45. Li Zhuling. Comparative Study between Azithromycin IV and Erythromycin IV in Treatment of Mycoplasma Pneumonia. Proceeding of Clinical Medicine J. Jun. 2005; Vol.14, No.6:437 -438
46. Han Zhiying. Clinical Observation of Azithromycin Treatment of Children Mycoplasma pneumonia. Shanxi Med J. June 2003; Vol.32, No.3:260-261
47. Huang Bo, Li Qing. Clinical Observation of Effects of Azithromycin on Children with Mycoplasma Pneumonia. Journal of Postgraduates of Medicine. May 2003; Vol.26, No.5:21-22
48. Sun Wenjuan, Li Ruiying, Liu Xiaohong. Clinical Observation of Azithromycin Treatment in Children Mycoplasma Pneumonia. Central Plains Medical Journal. May 2003; Vol.30, No.9:10-11
49. Gan Qinxiang. 34 Cases Clinical Analysis of Azithromycin in Treatment of Children Mycoplasma pneumonia. Chin Prim Med Pharma. Dec. 2004; Vol.11, No.12:1467
50. Zhu Hongbin, Zhang Fengxian. Clinical Observation of Azithromycin in Combination with Ceftriaxone in Treatment of Children Sever Community Acquired Pneumonia. Clinical Medicine, Capital Medicine. 25-26
51. Wu Xiaoyang, Zheng Liping. Comparative Study between Azithromycin and Erythromycin in Treatment of Children Respiratory Tract Mycoplasma Infection. Practical Clinical Medicine. 2006; Vol.7, No.1:95-96
52. Xie Cheng. Efficacy Analysis of Azithromycin Treatment in Children Mycoplasma Pneumonia. Practical Clinical Medicine. 2005; Vol.6, No.1:34-35
53. Xie Lanfang. Comparison of the Curative Effect of Azithromycin and Erythromycin on Child with Mycoplasma Pneumonia. Modern Hospital. Jan. 2004; Vol.4, No.6:29-30
54. Gu Li, Yang Rong, Lu Fengfeng. Azithromycin in Treating Mycoplasma Pneumonia:A Clinical Observation of 100 Cases. 2006; Vol.16, No.4:440-441
55. Zhang Jie, Song Xiaoting. Clinical Observation of Azithromycin Treatment of Children Mycoplasma Infection. Industry & Enterprise Medicine.2006; Vol.19, No.1:29
56. Li Shengli, Song Xiuru, Ma Cailing. Safety and Efficacy Inquiring of Azithromycin in Treatment of Mycomplasma Pneumonia. North-east Pharmacy Magazine. Feb. 2006; Vol.21, No.1:30
57. Feng Yue, Chen Jing. Observation to the Clinic Effects of Azithromycin in the Treatment of Mycoplasma Pneumonia in Children. J Huaihai Med, Jan. 2006, Vol.24, No.1:18-19
58. Yin Huiping, Shi Xiaoping. Clinical Observation of Azithromycin Treatment of Children Mycoplasma Pneumonia. Chin Hosp Pharm J. Aug. 2007; Vol.27, No.8:1121-1123
59. Wang Shirong. 25 Cases of Clinical Observation of Azithromycin Treatment in Children Mycoplasma Pneumonia. Journal of Clinical and Experimental Medicine. Aug. 2007; Vol.6, No.8:78
60. Wang Liqin.Clinical Observation of Azithromycin Treatment in Children Yycoplasma Pneumonia. Modern Medicine & Health. 2006; Vol.22, No.23:3405
61. Chen Liping. Clinical Observation of Azithromycin Treatment in Children Respiratory Infection.Chinese Modern Medicine. Feb. 2006; Vol.4, No.2:41-42
62. Zhong Tianmei, Liu Hanchao. Clinical Observation Analysis of Lactose Acid Azithromycin Treatment in Children Bronchitis. Journal of Chinese Modern Pediatrics. 2005; Vol.2, No.10:905-906
63. Wang Jinfeng, Wu Shaoxia. Clinical Observation of Azithromycin Treatment of Mycoplasma Pneumonia. Chinese Community Doctor. 2006;No.1:15
64. Wu Qinghong.Two Cases of Liver Toxicity Reports Caused by Azithromycin. Herald of Medicine. September 2003; Vol.22, No.9:666
65. Bai Yan, Zhu Liping, Li Xianrong. 14 Pediatrics Analysis of Liver Impairment Caused by Long Term Infusion of Azithromycin. Chinese Journal of Current Clinical Medicine. 2005; Vol.3, No.23:2540-2541
66. Han Ping, Zhou Lihua, Zhang Dong. One Case Report of Hematuria Caused by Azithromycin IV. Chinese Clinical and health Journal. 2003; Vol.2, No.3:28
67. Wang Yingqiu. One Case Report of Medicinal Eruption Caused by Azithromycin IV. Central South Pharmacy. August 2005; Vol.3, No.4:254
68. Li Fenglan, Zhao Shuzhe. One Case Report of Medicinal Eruption Caused by Azithromycin IV. CHINESE JOURNAL OF CLINICAL PHARMACY. 2001; Vol.10, No.5:330
69. Zhou Juan, Tian Yuejie, Li Li. Adverse Events of Azithromycin. Qilu Pharmaceutical Affairs. 2004; Vol.23, No.4:58-59
70. Yang Yuanzhi. One Allergic Death Case Report Caused Azithromycin IV . Chin J Pediatr. December 2004; Vol.42, No.12:935
71. Liu Xiaoli. One Allergic Shock Case Report Caused by Azithromycin IV .Chinese Pediatric Practice Journal. April 2006; Vol.21, No.4:304
72. Sun Mingxiao, Dong Chonglin. One Allergic Shock Case Report Caused by Azithromycin IV. Sichuan Medical Journal. 2004; Vol.25, No.12:1293
73. Fang Huazhong. One Allergic Shock Case Report Caused by Azithromycin IV. Journal of Chinese Modern Pediatrics, 2005, Vol.2, No.12:1135
74. XuJjiagang. One Allergic Reaction Case Report Caused by Azithromycin IV. JPMT. March 2005; Vol.12, No.3B:809
75. Zhang Qingyou, Lu Liangjun, Zhou Dan. One Rreversible Supraventricular Tachycardia Case Report Caused by Azithromycin IV. Chinese Drug Epidemiological Journal. 2005; Vol.14, No.5:305
76. Deng Guifen, Wu Chen, Zhang Xiaole. Two Children Superficial Phlebitis Cases Reports Caused by Azithromycin IV. Clinical Mediation Journal. 2007; Vol.5, No.3:61
77. Wang Xuejie, Ou Wenhua, Wang Huirong. One Case of Ankles Joint Pain Report Caused by Azithromycin IV. Chin Hosp Pharm J. Jan 2006; Vol.26, No.1:115
78. Zhang Xinchun, Chen Fenglian, One Case of Extra-pyramid Reaction Report Caused by Azithromycin IV. Journal of Pediatric Pharmacy. 2005; Vol.11, No.3:64
79. Cao Hui, Cui Qing. One Case of Night Sweat on the Head and Neck Report Caused by Azithromycin IV. Clin J Med Offic. April 2006; Vol.34, No.2:199
80. Jacobs RF, Maples HD, Aranda JV, et al. Pharmacokinetics of Intravenously Administered Azithromycin in Pediatric Patients. Pediatr Infec Dis J. 2005; 24:34-9.
81. Luo Xin dong,Nie Qinghe. Clinical Features and Treatment in Special Population. World Chinese Digestive Journal. June 15 2003; Vol.11, No.6:768-772

Author Information

Xu Li
Dept of Health Statistics, The Fourth Military Medical University

Xia Jielai
Dept of Health Statistics, The Fourth Military Medical University

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