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Serrapeptase

Serrapeptase-induced lung injury manifesting as acute eosiniphilic pneumonia.
An 84-year-old man was referred to our hospital because of fever, cough and hemoptysis. The patient had acute respiratory failure (PaO2 < 40 mmHg) on admission, with diffuse interstitial infiltration and bilateral pleural effusion. The bronchoalveolar lavage fluid was bloody, and contained a high percentage of eosinophils (32%). A diagnosis of acute eosinophilic pneumonia was established, and the patient made a rapid recovery after corticosteroids were administered. When the DLST (drug lymphocyte stimulation test) was performed after the corticosteroid therapy was stopped, it was positive for serrapeptase, which had been prescribed for chronic cystitis for three months before the onset of the pneumonia. This was a case of drug (serrapeptase)-induced pneumonitis manifesting as acute eosinophilic pneumonia.

Nihon Kokyuki Gakkai Zasshi. 2000 Jul;38(7):540-4.

The treatment of breast engorgement with Serrapeptase (Danzen): a randomised double-blind controlled trial.
We evaluated an anti-inflammatory enzyme drug Danzen (Serrapeptase: Takeda Chemical Industries, Ltd.) on 70 patients complaining of breast engorgement. These patients were randomly divided into two groups, a treatment group and a placebo group. A single observer, unaware of the group the patients were in, assessed the severity of each of the symptoms and signs of breast engorgement before treatment was commenced, and daily for three days, during which therapy was administered. Danzen was noted to be superior to placebo for improvement of breast pain, breast swelling and induration, and while 85.7% of the patients receiving Danzen had “Moderate to Marked” improvement, only 60.0% of the patients receiving placebo had a similar degree of improvement. “Marked” improvement was found in 22.9% of the treatment group and 2.9% of the placebo group. These differences were statistically significant (P less than 0.05). No adverse reactions were reported with the use of Danzen. Danzen is a safe and effective method for the treatment of breast engorgement.

Singapore Med J 1989 Feb;30(1):48-54.

A preliminary trial of serratiopeptidase in patients with carpal tunnel syndrome.
OBJECTIVES: This study was planned to assess the response of serratiopeptidase in patients with carpal tunnel syndrome (CTS). METHODS: Twenty patients with CTS were evaluated clinically. After baseline electrophysiological studies, these patients were given serratiopeptidase 10 mg twice daily with initial short course of nimesulide. Clinical and electrophysiological reassessment was done after six weeks. RESULTS: Mean age was 43.9 years with male to female ratio of 1:2.33. Sixty five percent cases showed significant clinical improvement which was supported by significant improvement in electrophysiological parameters. Recurrence was reported in four cases. No significant side effect was observed. CONCLUSIONS: Serratiopeptidase therapy may proved to be a useful alternative mode of conservative treatment. Larger study may be further helpful to establish the role of serratiopeptidase in CTS.

J Assoc Physicians India 1999 Dec;47(12):1170-2.

A multi-center, double-blind study of serrapeptase versus placebo in post-antrotomy buccal swelling.
A multi-center, double-blind, placebo-controlled trial was carried out to investigate the clinical efficacy of the anti-inflammatory enzyme serrapeptase in a total of 174 patients who underwent Caldwell-Luc antrotomy for chronic empyema. Eighty-eight patients received 10 mg serrapeptase three times on the day before operation, once on the night of the operation and three times daily for five days after operation; the other 86 received placebo. Changes in buccal swelling after operation were observed as a parameter of the response to treatment. The degree of swelling in the serrapeptase-treated patients was significantly less than that in the placebo-treated patients at every point of observation after operation up to the fifth day (p less than 0.01 to p less than 0.05). Maximal swelling throughout all the post-operative points of observation was also significantly smaller in size in the serrapeptase-treated group than in the placebo-treated group. No side effects were reported.

Pharmatherapeutica 1984;3(8):526-30

Evaluation of Serratia peptidase in acute or chronic inflammation of otorhinolaryngology pathology: a multicentre, double-blind, randomized trial versus placebo.
The efficacy and tolerability of Serratia peptidase were evaluated in a multicentre, double-blind, placebo-controlled study of 193 subjects suffering from acute or chronic ear, nose or throat disorders. Treatment lasted seven to eight days, with the drug or placebo being administered at a rate of two tablets three times a day. After three to four days’ treatment, significant symptom regression was observed in peptidase-treated patients. There was also a significant reduction in symptoms after seven to eight days for patients in both treatment groups but the response was more marked in those patients receiving the active drug. Statistical comparison between the two groups confirmed the greater efficacy and rapid action of the peptidase against all the symptoms examined at both stages. Tolerance was found to be very good and similar for both groups. It is concluded that Serratia peptidase has anti-inflammatory, anti-oedemic and fibrinolytic activity and acts rapidly on localized inflammation.

J Int Med Res 1990 Sep-Oct;18(5):379-88.

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