Review article

Transcription

Review article
Global J Res. Med. Plants & Indigen. Med. | Volume 2, Issue 7 | July 2013 | 499–508
ISSN 2277-4289 | www.gjrmi.com | International, Peer reviewed, Open access, Monthly Online Journal
Review article
ANALYSIS OF TRADITIONAL CHINESE MEDICINE INJECTIONS USED
IN THE TREATMENT OF RESPIRATORY SYSTEM-RELATED DISEASES
BASED ON THE CHINESE MARKET
Zhi-Qiao Ma1, Jin-Jian Lu2, Wen-Shan Xu3, Xiu-Ping Chen4, Hao Hu5, Yi-Tao Wang6*
1, 2, 3, 4, 5, 6
State Key Laboratory of Quality Research in Chinese Medicine, Institute of Chinese Medical
Sciences, University of Macau, Macao, China
*Corresponding Author: Email: [email protected]
Received: 21/05/2013; Revised: 20/06/2013; Accepted: 27/06/2013
ABSTRACT
Traditional Chinese medicine (TCM) injections (TCMIs) comprise TCM formulations with vital
functions in the treatment of cancer, cardiovascular diseases, respiratory system-related diseases
(RSRDs) and so on. This article analyzes TCMIs used in the treatment of RSRDs in the Chinese
market with special emphasis on the Xiyanping, Tanreqing, Xuebijing, Yanhuning, Reduning,
Chuankezhi, Chuanhuning, and Shuanghuanglian (Chinese names of these TCMIs) injections, which
present excellent market performances. Analysis of the clinical applications, herbal and chemical
compositions, and pharmacological activities of these TCMIs were also conducted. TCMIs have vital
functions in the treatment of RSRDs. This article aims to explore the market prospects and
development of TCMIs used to treat RSRDs.
KEYWORDS: Traditional Chinese medicine injections (TCMIs),
related-diseases (RSRDs), Qingre, adverse reactions, Chinese market
Respiratory
Cite this article:
Zhi-Qiao Ma, Jin-Jian Lu, Wen-Shan Xu, Xiu-Ping Chen, Hao Hu, Yi-Tao Wang (2013), ANALYSIS
OF TRADITIONAL CHINESE MEDICINE INJECTIONS USED IN THE TREATMENT OF
RESPIRATORY SYSTEM-RELATED DISEASES BASED ON THE CHINESE MARKET, Global
J Res. Med. Plants & Indigen. Med., Volume 2(7): 499–508
Global Journal of Research on Medicinal Plants & Indigenous Medicine || GJRMI ||
system
Global J Res. Med. Plants & Indigen. Med. | Volume 2, Issue 7 | July 2013 | 499–508
INTRODUCTION
development of TCMIs used to treat RSRDs.
Many respiratory system-related diseases
(RSRDs), such as asthma, chronic obstructive
pulmonary disease and pneumonia are common
diseases. According to a data from the World
Health Organization (WHO), at least 3000
million people have died because of chronic
respiratory diseases and more than 90% of the
patients with such diseases come from low- or
middle-income countries (WHO, 2012a).
Lower respiratory tract infections are ranked
third in the top ten global death reasons and the
first in low-income countries. Almost 14
million children below five years old are killed
every year by pneumonia, a classic lower
respiratory tract infection (WHO, 2012b).
According to data from the 2010 Chinese
health statistical yearbook, the morbidity of
RSRDs in China is about 6.94%, totaling over
80 million people, and RSRDs rank as the
fourth leading cause of death in urban and rural
areas (Ministry of Health of the People’s
Republic of China, 2010).
MATERIAL AND METHODS
Besides chemical drugs used for standard
treatment of RSRDs, traditional Chinese
medicine (TCM) use is increasing in China
because of its excellent clinical effects (Wang
et al., 2006). TCMs have important functions in
preventing serious infections, such as SARS
and H1N1, as they have multiple functions,
which include relieving cough, diminishing
inflammation, eliminating phlegm, and
relieving asthma (Chang et al., 2011a).
TCM injections (TCMIs) are sterile
formulations (emulsion, powder, or thick liquid)
prepared for injecting into the body and are
made after extraction and purification (National
Pharmacopoeia Committee, 2005). TCMIs are
becoming increasingly valued in China due to
their positive clinical effects (Yao, 2007). This
article aims to explore the market prospects and
Data sources
Data on the sales of TCMIs in the whole
Chinese market were obtained from the
Chinese
Clinical
Medicine
Terminal
Competition Pattern Database of the State Food
and Drug Administration (SFDA), Southern
Medicine Economic Research Institute
(SMERI),
(China
Medicine
Economic
Information Network, 2012), which is
calculated by the TCM purchasing practices of
150 sample hospitals from nine cities (i.e.,
Beijing, Guangzhou, Nanjing, Chongqing,
Chengdu, Xian, Haerbin, Shenyang, and
Zhengzhou) in China. Thirteen large categories
and 75 small categories of drugs are listed
based on the WHO therapeutic classification,
Anatomical Therapeutic Chemical Code, and
national essential drugs list classification for
TCM. Data on clinical applications, herbal and
chemical compositions and pharmacological
activities were searched from China National
Knowledge Infrastructure (CNKI) database
and/or Pubmed database.
Data analysis
The annual sales and sales growth rate of
TCMIs were analyzed: For market share
calculations, the formula SN/Stotal × 100% was
used; for sales growth rate, the formula
(SN-SN-1)/SN × 100% was used, where SN is the
sales of one injection at the year N and Stotal are
the total sales of the drugs, including the
injections.
The top eight selling TCMIs used in the
treatment of RSRDs in the Chinese market
were chosen for analysis. The names of these
injections were used as key words to search for
Global Journal of Research on Medicinal Plants & Indigenous Medicine || GJRMI ||
Global J Res. Med. Plants & Indigen. Med. | Volume 2, Issue 7 | July 2013 | 499–508
their clinical applications, herbal and chemical
compositions, and pharmacological activities in
the CNKI database. The chemical names of the
injections were further used as key words to
perform searches in Pubmed database. All of
the studies included in this work were
published from 1994 to 2012.
RESULTS
TCM for RSRDs treatment in the Chinese
market
The sales of chemical drugs and TCMs
accounted for 82.6% and 17.4% of all drugs
sales in 2010, respectively, based on the data
from SFDA SMERI (China Medicine
Economic Information Network, 2012). The
sales of chemical drugs and TCMs for the
treatment of RSRDs accounted for 54.5% and
45.5% of all sales, respectively, in 2010
(excluding systemic anti-infective drugs, which
are mostly treated by antibiotics in China),
indicating the importance of TCMs in treating
RSRDs in China. The sales of TCMs for
RSRDs increased from 2006 to 2011, with an
average growth rate of 34% (Figure 1), the
annual growth rates from 2007 to 2011 are 24%,
17%, 29%, 16% and 25% respectively.
Figure 1. The sales of TCM for the treatment of RSRDs from 2006 to 2011
Global Journal of Research on Medicinal Plants & Indigenous Medicine || GJRMI ||
Global J Res. Med. Plants & Indigen. Med. | Volume 2, Issue 7 | July 2013 | 475–484
TCMIs for RSRDs treatment in the Chinese
market
At present, 1,269 TCMIs formulations are
registered in SFDA, including 524 species
(41.3%) for RSRDs treatment (China Medicine
Economic Information Network, 2012). Among
these injections, 365 species were listed in the
National Health Insurance Directory and 135
species were listed in the national essential
drugs list. These injections account for 70%
and 26% of the total number of TCMIs used in
the treatment of RSRDs, respectively.
The brand concentration of TCMIs for
RSRDs treatment is high. In 2011, five species
of injections were observed in the top ten sales
of TCMs for RSRDs treatment and their sales
accounted for 38% of the total sales of TCMs
for RSRDs. Among these injections, the sales
of three species added up to one billion (China
Medicine Economic Information Network,
2012). The top five selling TCMIs for RSRDs
treatment are Xiyanping, Tanreqing, Xuebijing,
Yanhuning, and Reduning injections (Chinese
names of some TCMIs) (see in Table 1). All of
the injections maintained a positive growth
trend, except for the Yanhuning injection, the
growth rate of which declined by 1% (Figure 2).
Xiyanping, Tanreqing, and Reduning injections
are all listed in the national health insurance
directory. The sales of Xiyanping injection
increased to 0.32 billion yuan (RMB) in 2011,
almost twice that of Bailing capsules, the best
seller of other TCM formulations for RSRDs
treatment
(China
Medicine
Economic
Information Network, 2012).
Figure 2. The change of TCMIs’ sales for the treatment of RSRDs from 2006 to 2011
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Global J Res. Med. Plants & Indigen. Med. | Volume 2, Issue 7 | July 2013 | 475–484
Table 1. The rank of TCMIs’ sales for the treatment of RSRDs in 2011
Rank
Injections
Chinese herbal
medicine
compositions
Main chemical
compositions
1
Xiyanping
injection
Tanreqing
injection
Herba
Andrographisis
Radix Scutellariae,
Bear bile powder,
Goat horn, Flos
Lonicerae
Japonicae, Fructus
Forsythiae
Flos Carthami,
Radix Paeoniae
Rubra, Rhizoma
Chuanxiong, Radix
Angelica Sinensis,
Radix Salviae
Miltiorrhizae
Herba
Andrographisis
Herba Artemisiae
Annuae, Flos
Lonicerae
Japonicae,
Fructus
Gardeniae
Herba Epimedii,
Radix Morinda
Officinalis
Andrographolide, etc.
2
3
Xuebijing
injection
4
Yanhuning
injection
Reduning
injection
5
Market
share of
RSRDs
medicine
14.7%
Sales
(million,
RMB)
Growth
rate
(%)
323
73
Baicalin, Chlorogenic
acid,
Ursodeoxycholic acid
etc.
9.3%
204
22
Danshensu, Safflower
yellow pigment A,
Tetramethylpyrazine,
Ferulic acid,
Paeoniflorin,
Protocatechuic
aldehyde etc.
Andrographolide, etc.
6.5%
142
23
4.5%
98.2
-1
Chlorogenicacid,
Geniposide,
Artemisinin etc.
2.2%
47.5
11
0.4%
9.6
150
0.4%
8.1
-32
0.1%
2.6
-17
6
Chuankezhi
injection
7
Chuanhuning
injection
Herba
Andrographisis
Epimedium
polysaccharide,
Icariin,Epimedium
flavonoids etc.
Andrographolide ,
etc.
8
Shuanghuanglian
injection
Flos Lonicerae
Japonicae, Radix
Scutellariae,
Fructus Forsythiae
Caffeic acid,
Chlorogenic acid,
Baicalin, Forsythin
etc.
Global Journal of Research on Medicinal Plants & Indigenous Medicine || GJRMI ||
Global J Res. Med. Plants & Indigen. Med. | Volume 2, Issue 7 | July 2013 | 475–484
Clinical applications of TCMIs for RSRDs
Both Xiyanping and Reduning injections are
used to treat infectious diseases and mainly
focus on children (Liu et al., 2007; Zhang &
Yang, 2012). These injections are also used to
treat hand, foot, and mouth disease in babies,
infantile diarrhoea, acute icteric model hepatitis,
chronic prostatitis, and old herpes zoster,
among others, in addition to the treatment of
RSRDs (Liu et al., 2007; Zhang & Yang, 2012).
Tanreqing, Yanhuning, and Chuankezhi
injections are mostly used to treat bronchitis
and various types of pneumonia (Feng, 2007;
He, 2008; Liang, 2006). Besides treating
bronchitis and the upper respiratory tract
infections,
both
Chuanhuning
and
Shuanghuanglian injections are used to treat
gastrointestinal tract inflammation, urinary tract
infection, and myocarditis (Li, 2005; Liu & Xu,
2005). Xuebijing injection is significantly
different from the aforementioned injections, as
it is generally used for emergency and critical
care, such as systemic inflammatory response
syndrome caused by acute respiratory distress
syndrome and sepsis (Zhang, 2008). Therefore,
TCMIs have wide clinical applications and
excellent performance in the market for RSRDs
treatment.
Herbal compositions of TCMIs used for
RSRDs treatment
Among the TCMIs mentioned in Table 1,
most belong to the Qingre area (clearing heat)
in TCM. For example, the major compositions
of Xiyanping, Yanhuning, and Chuanhuning
injections are herbs of Andrographis (Ma &
Kuang, 2010; Zhong, Zeng, & Guo, 2010).
Both
Tanreqing
and
Shuanghuanglian
injections contain Flos Lonicerae Japonicae,
Radix Scutellariae and Fructus Forsythiae (Li
& Li, 2011; Tu & Huang, 2008). Reduning
injection contains Herba Artemisiae Annuae,
Flos Lonicerae Japonicae and Fructus
Gardeniae (Jiang, et al.,2008; Liang, Huang,
& Cai, 2008). The main herbs that compose
Xuebijing injection are Flos Carthami, Radix
Paeoniae Rubra, Rhizoma Chuanxiong, Radix
Angelica Sinensis and Radix Salviae
Miltiorrhizae, all of which have the effect of
Huoxue (promoting blood circulation) (Chang
et al., 2011b; Yu, 2011). The main herbs in
Chuankezhi injection are Herba Epimedii and
Radix Morinda Officinalis, which have the
effect of Buyi (tonic) (Li et al., 2009). No herb
belongs to the Huatan Zhike Pingchuan class
(preventing phlegm from forming, stopping
coughing and relieving asthma) of TCM, which
is the most-represented TCM for RSRDs
treatment among the top eight ranking
injections. The absence of an herbal component
is due to the dosage form, as syrup is the main
form for the Huatan Zhike Pingchuan class of
TCM.
Chemical compositions and pharmacological
activities of TCMIs used for RSRDs
treatment
We further analyzed the main chemical
compositions and pharmacological activities of
the top eight injections listed in Table 1. Three
injections contained andrographolide or its
derivatives. Andrographolide presents excellent
antibacterial, antiviral, anti-inflammatory, and
anticancer effects (Chen et al., 2009; Ji, 2011;
Lim et al., 2012). Chlorogenic acid and
baicalin have also emerged in numerous
injections.
Chlorogenic
acid
has
anti-inflammatory, antioxidative, antibacterial,
cardiovascular protective effects, and so on (Ji,
2011; Wang et al., 2011). Baicalin has
antibacterial,
antiviral,
antioxidative,
anti-inflammatory, sedation, and immune
system regulation effects (Ji, 2011; Srinivas,
2010; Zhu et al., 2012). Several injections
contain geniposide, danshensu, safflower
Global Journal of Research on Medicinal Plants & Indigenous Medicine || GJRMI ||
Global J Res. Med. Plants & Indigen. Med. | Volume 2, Issue 7 | July 2013 | 475–484
yellow A, phillyrin, and icariin, among others,
all of which have numerous pharmacological
activities (Ji, 2011).
DISCUSSION
Chemical drugs continue to enjoy several
advantages in the Chinese market. However,
the markets for TCM and chemical drugs are
similar in RSRDs treatment if the influence of
antibiotics is excluded. The TCM market in
RSRDs treatment has continuously grown in
recent years. If the Chinese government
continues to enforce numerous policies to
reduce antibiotic abuse, the advantages of TCM
will significantly increase.
TCMIs can enter human tissues, blood, or
organs directly, and can be absorbed faster than
other forms of TCM. Thus, TCMIs overcome
several disadvantages of TCM dosing, such as
dose inaccuracy, slow effect and low
bioavailability. Compared with anti-neoplastic
TCMIs, which are mostly used for adjuvant
therapy (Lai et al., 2012), TCMIs have more
important functions in RSRDs treatment. From
the herbal and chemical composition analysis,
most TCMIs for RSRDs treatment have Qingre
effects (clearing heat).
Classifying TCM against the standards of
Western medicine is difficult due to the
different theories behind Chinese and Western
medicine. For example, Xuebijing injection is
also used to treat cardiovascular diseases.
Clinical applications of cross treatments could
result in greater potential for TCMIs. With
more and more TCMIs used in the treatment of
RSRDs are into the national health insurance
directory, along with the new medical reform
policy is carried out constantly, the TCMIs
market will continue to expand in China.
Although the TCMIs market for RSRDs
treatment is increasing significantly, the entire
market scale remains small. The market
concentration is extremely high such that few
products occupy most of the market. The
increased market is mainly attributed to these
products, which are almost exclusively
manufactured or monopolized by a few
companies. Thus, the medicine market and
patients are cautious about the TCMIs used in
RSRDs treatment. Besides, the credibility of
TCMIs has decreased because numerous
patients have reported adverse reactions (Liang
& Shi, 2012; Ma & Kuang, 2010).
Chemical
compositions,
clinical
applications, and individual differences are the
three main reasons for the adverse reactions of
TCMIs. TCMIs have several features, such as
complex
compositions,
herb
quality
unsteadiness, and residual impurity, and these
factors are the main sources of adverse events
(Ma & Kuang, 2010; Wu et al., 2012).
Irrational clinical applications also result in
adverse reactions (Ma & Kuang, 2010; Wu et
al., 2012). For such adverse events, legal and
administrative regulations should be enhanced.
The SFDA carried out a series of specialized
policies for the quality of TCMIs and safety
evaluation from 2007 to 2009. These policies
have increased the threshold of TCMIs research
and development and advanced efforts for the
safety evaluation of TCMIs. Identifying and
controlling the effective and toxic compositions
of the injections are necessary. Technological
studies and clinical compatibility studies for
TCMIs should be given more attention.
CONCLUSION
TCMIs have highly important functions in
RSRDs treatment in China. From the market’s
perspective, TCMIs for RSRDs treatment show
a positive trend and great potential, with rapid
Global Journal of Research on Medicinal Plants & Indigenous Medicine || GJRMI ||
Global J Res. Med. Plants & Indigen. Med. | Volume 2, Issue 7 | July 2013 | 475–484
increasing sales and expanding market demand.
In clinical view, TCMIs show the predominant
and effective feature, by combining some
advantages between TCM and Western
medicine. Development of TCMIs is a
complicated issue with traditional theory and
advanced technology, so research and
development
institutes,
manufacturers,
hospitals, and regulation departments must
cooperate with one another to establish a
positive outlook for the development of
TCMIs.
ACKNOWLEDGMENTS:
This study is supported by the research
funding
of
University
of
Macau
(UL016/09Y4/CMS/WYT01/ICMS,
MYRG208(Y2-L4)-ICMS11-WYT,
and
MYRG160(Y2-L2)-ICMS11-HH).
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Conflict of Interest: None Declared
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