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出典(authority):フリー百科事典『ウィキペディア（Wikipedia）』「2014/06/07 10:51:10」(JST)

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Serratiopeptidase (Serratia E-15 protease, also known as serralysin, serratiapeptase, serratia peptidase, serratio peptidase, or serrapeptidase) is a proteolytic enzyme (protease) produced by enterobacterium Serratia sp. E-15.^[1] This microorganism was originally isolated in the late 1960s from silkworm Bombyx mori L. (intestine),^[2] Serratiopeptidase is present in the silkworm intestine and allows the emerging moth to dissolve its cocoon. Serratiopeptase is produced by purification from culture of Serratia E-15 bacteria.

Claims of anti-inflammatory benefits

Some alternative medicine proponents claim that serratiopeptidase is beneficial for pain and inflammation^[3] but "existing trials [have been] small and generally of poor methodological quality."^[4] Online medical journal Bandolier (specializing in evidence-based thinking about healthcare)^[5] published an article (in about 2001) in response to a reader's enquiry about serratiopeptidase.^[6] After searching PubMed and the Cochrane Library "to see if there are any randomised, controlled trials", the article stated that the "evidence on serratiopeptidase being effective for anything is not based on a firm foundation of clinical trials."^[4]

The search found 34 publications in the medical databases covered, that addressed the efficacy of serratiopeptidase, of which several were found to be animal experiments, personal letters, uncontrolled trials or those with inadequate or nonexistent randomisation. The article warned against ignoring safety issues with use of biological agents.^[4] No studies were found to have been conducted on the efficacy of serratiopeptidase as treatment for back pain, heart attack, stroke, or asthma. Of the 10 medical conditions with randomized-evidence studies on file in connection with serratiopeptidase, the quality or construction of the trial studies was described as "generally poor".^[4]^[7]

In a news article published Feb 22, 2011, Kyodo News reports: "Takeda Pharmaceutical Co. said Monday it will voluntarily recall an anti-inflammatory drug touted effective for a variety of conditions ranging from chronic bronchitis to sprained ankles because recent tests have cast doubt on its efficacy even though it has been on the market for more than 40 years. Double-blind experiments comparing the effects of the drug Danzen, which debuted in 1968, and placebos showed no significant differences between the two, the major drugmaker said. Sales of the product, generically called serrapeptase, totaled ¥6.7 billion in fiscal 2009, but the impact of the recall will likely be limited because similar drugs are being sold on the market, it said." ^[8]^[9]

References

^ Nakahama K, Yoshimura K, Marumoto R, Kikuchi M, Lee IS, Hase T, Matsubara H (July 1986). "Cloning and sequencing of Serratia protease gene". Nucleic Acids Res. 14 (14): 5843–55. doi:10.1093/nar/14.14.5843. PMC 311595. PMID 3016665.
^ The preparation and some uses of the protease are described in US patent 3792160, Isono M, Kazutaka M, Kodama R, Tomoda K, Miyata K, "Method of treating inflammation and composition therefor", issued 1974-02-12, assigned to Takeda Chemical Industries Ltd. . The enzyme was also described by Miyata K, Maejima K, Tomoda K, Isono M (1970). "Serratia protease. Part I. Purification and general properties of the enzyme". Agricultural and Biological Chemistry 34 (2): 310–318. and the strain of bacteria producing serratiopeptidase has been deposited with the American Type Culture Collection as strain ATCC 21074. (For online information about ATCC 21074, enter 21074 on the ATCC/LGC search page)
^ Kokate CK, Purohit AP, Gokhale SB (2008). Pharmacognosy (14th ed.). Mumbai: Nirali Prakashan. p. 12.11. ISBN 81-85790-09-4.
^ ^a ^b ^c ^d "Serratiopeptidase: Finding the Evidence". Bandolier online edition. Retrieved 2008-03-20.
^ Bandolier online home-page
^ The Bandolier article is undated and unsigned but the text indicates that it was written in response to a letter sent by a reader of a newspaper article that was published in 2001. No references later than 2001 are cited.
^ According to Bandolier:

"Studies were small, outcomes were poorly defined, and in some, different medical conditions were mixed. Five studies were described as double blind: one was completely uninterpretable, three methodologically weak studies were positive, and one trial of apparent high quality was negative. This latter study compared serratiopeptidase, serraprose S or placebo in the treatment of chronic respiratory disease, with about 120 patients per group, and found no significant difference between groups for any outcome."

- Bandolier, "Serratiopeptidase - Finding the Evidence"
^ http://search.japantimes.co.jp/cgi-bin/nb20110222a5.html?
^ "HSA Updates on the Phasing-Out of Serratiopeptidase-Containing Preparations as Medicinal Products". HSA Updates. Singapore: Health Sciences Authority. November 29, 2011. Retrieved July 25, 2012.

Mecikoglu M, Saygi B, Yildirim Y, Karadag-Saygi E, Ramadan SS, Esemenli T. The effect of proteolytic enzyme serratiopeptidase in the treatment of experimental implant-related infection. J Bone Joint Surg Am. 2006 Jun;88(6):1208-14.

External links

The MEROPS online database for peptidases and their inhibitors: M10.051

UpToDate Contents

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1. 小児および思春期における咽頭痛の症状緩和 symptomatic relief of sore throat in children and adolescents

English Journal

Serratiopeptidase loaded chitosan nanoparticles by polyelectrolyte complexation: in vitro and in vivo evaluation.

Mali N1, Wavikar P, Vavia P.
AAPS PharmSciTech.AAPS PharmSciTech.2015 Feb;16(1):59-66. doi: 10.1208/s12249-014-0201-0. Epub 2014 Aug 30.
The aim of the present study was to formulate serratiopeptidase (SER)-loaded chitosan (CS) nanoparticles for oral delivery. SER is a proteolytic enzyme which is very sensitive to change in temperature and pH. SER-loaded CS nanoparticles were fabricated by ionic gelation method using tripolyphosphate
PMID 25171974

Diclofenac-serratiopeptidase combination induced stevens - johnson syndrome - a rare case report with review of literature.

Moitra S1, Sen S2, Banerjee I2, Das P3, Tripathi SK4.
Journal of clinical and diagnostic research : JCDR.J Clin Diagn Res.2014 Jul;8(7):YD08-11. doi: 10.7860/JCDR/2014/9509.4610. Epub 2014 Jul 20.
Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) are severe cutaneous adverse reactions (SCAR) which are frequently caused by exposure to drugs and cause significant morbidity and mortality. A careful literature search revealed that only a few reports of diclofenac induced and one
PMID 25177625

The biotechnological potential of fibrinolytic enzymes in the dissolution of endogenous blood thrombi.

Kotb E1.
Biotechnology progress.Biotechnol Prog.2014 May-Jun;30(3):656-72. doi: 10.1002/btpr.1918. Epub 2014 May 7.
Formation of endogenous thrombi in blood vessels is one of the leading causes of death in our modern life. According to data provided by the World Health Organization (WHO) in 2000, heart diseases are responsible for 29% of the total mortality rate in the world. For this, a tremendous amount of rese
PMID 24799449

Japanese Journal

アンギオテンシンII受容体拮抗薬が誘因と推察された舌・口底部の血管性浮腫の1例

坂元亮一,上川善昭,永山知宏,杉原一正
歯科薬物療法 29(1), 21-24, 2010-04-01
… She visited an emergency hospital, and was prescribed serrapeptase, a complex of betamethasone and chlorpheniramine maleate, and epinastine hydrochloride. …
NAID 10026132690

イムノアッセイによるセラペプターゼの定量法開発とバリデーション

田中祥之,岡野由貴,吉田侑矢 [他]
生物試料分析 = Journal of analytical bio-science 33(3), 260-266, 2010
NAID 40019884460

急性好酸球性肺炎軽快後に, 「ニコラーゼ^【○!R】」による薬剤性好酸球性肺炎を発症した1例

甲斐直子,白井亮,平田範夫,岩田敦子,梅木健二,石井寛,岸建志,時松一成,平松和史,門田淳一
日本呼吸器学会雑誌 = The journal of the Japanese Respiratory Society 47(3), 254-258, 2009-03-10
NAID 10024823887

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リンク元

「セラペプターゼ」

Serralysin
Identifiers
Symbol	Spro_0210
Entrez	5605823
PDB	1SRP (RCSB PDB PDBe PDBj)
UniProt	P07268
Other data

Search
PMC	articles
PubMed	articles
NCBI	proteins

Serralysin
	Crystal structure of serralysin with co-ordinated zinc (grey) and calcium (white). Rendered from PDB 1SAT.
Identifiers
EC number	3.4.24.40
CAS number	70851-98-8
Databases
IntEnz	IntEnz view
BRENDA	BRENDA entry
ExPASy	NiceZyme view
KEGG	KEGG entry
MetaCyc	metabolic pathway
PRIAM	profile
PDB structures	RCSB PDB PDBe PDBsum
Search
PMC	articles
PubMed	articles
NCBI	proteins

　　[★]

英: serrapeptase
商: ダーゼン、セラピアーゼ、バザロイン

[pmid3016665-1] Nakahama K, Yoshimura K, Marumoto R, Kikuchi M, Lee IS, Hase T, Matsubara H (July 1986). "Cloning and sequencing of Serratia protease gene". Nucleic Acids Res. 14 (14): 5843–55. doi:10.1093/nar/14.14.5843. PMC 311595. PMID 3016665.

[serr1960s-2] The preparation and some uses of the protease are described in US patent 3792160, Isono M, Kazutaka M, Kodama R, Tomoda K, Miyata K, "Method of treating inflammation and composition therefor", issued 1974-02-12, assigned to Takeda Chemical Industries Ltd. . The enzyme was also described by Miyata K, Maejima K, Tomoda K, Isono M (1970). "Serratia protease. Part I. Purification and general properties of the enzyme". Agricultural and Biological Chemistry 34 (2): 310–318. and the strain of bacteria producing serratiopeptidase has been deposited with the American Type Culture Collection as strain ATCC 21074. (For online information about ATCC 21074, enter 21074 on the ATCC/LGC search page)

[isbn_8185790094-3] Kokate CK, Purohit AP, Gokhale SB (2008). Pharmacognosy (14th ed.). Mumbai: Nirali Prakashan. p. 12.11. ISBN 81-85790-09-4.

[Bandolier-4] "Serratiopeptidase: Finding the Evidence". Bandolier online edition. Retrieved 2008-03-20.

[5] Bandolier online home-page

[6] The Bandolier article is undated and unsigned but the text indicates that it was written in response to a letter sent by a reader of a newspaper article that was published in 2001. No references later than 2001 are cited.

[7] According to Bandolier:

"Studies were small, outcomes were poorly defined, and in some, different medical conditions were mixed. Five studies were described as double blind: one was completely uninterpretable, three methodologically weak studies were positive, and one trial of apparent high quality was negative. This latter study compared serratiopeptidase, serraprose S or placebo in the treatment of chronic respiratory disease, with about 120 patients per group, and found no significant difference between groups for any outcome."

- Bandolier, "Serratiopeptidase - Finding the Evidence"

[8] ttp://search.japantimes.co.jp/cgi-bin/nb20110222a5.html?

[9] "HSA Updates on the Phasing-Out of Serratiopeptidase-Containing Preparations as Medicinal Products". HSA Updates. Singapore: Health Sciences Authority. November 29, 2011. Retrieved July 25, 2012.

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serrapeptase