A Clinical Study on the Prolonged Administration of Pilocarpine Hydrochloride for Paient Suffered from Xerostomia Due to Sjögren's Syndrome

  • ISHIDA Takafumi
    Department of Oral and Maxillofacial Surgery, Kanagawa Dental University Department of Clinical Research, National Hospital Organization Tochigi Medical Center
  • IWABUCHI Hiroshi
    Department of Oral and Maxillofacial Surgery, Kanagawa Dental University Department of Dentistry and Oral Surgery, National Hospital Organization Tochigi Medical Center
  • IWABUCHI Emi
    Department of Dentistry and Oral Surgery, National Hospital Organization Tochigi Medical Center
  • UCHIYAMA Kimio
    Department of Dentistry and Oral Surgery, National Hospital Organization Tochigi Medical Center
  • KUBOTA Eiro
    Department of Oral and Maxillofacial Surgery, Kanagawa Dental University

Bibliographic Information

Other Title
  • シェーグレン症候群に伴う口腔乾燥症患者に対するピロカルピン塩酸塩の長期投与例の臨床的検討
  • シェーグレン症候群に伴う口腔乾燥症患者に対するピロカルピン塩酸塩の長期投与例の臨床的検討 : 長期投与に伴う副作用発現状況と唾液分泌量および自覚症状スコアの変化
  • シェーグレン ショウコウグン ニ トモナウ コウコウ カンソウショウ カンジャ ニ タイスル ピロカルピン エンサンエン ノ チョウキ トウヨレイ ノ リンショウテキ ケントウ : チョウキ トウヨ ニ トモナウ フクサヨウ ハツゲン ジョウキョウ ト ダエキ ブンピリョウ オヨビ ジカク ショウジョウ スコア ノ ヘンカ
  • A Clinical Study on the Prolonged Administration of Pilocarpine Hydrochloride for Paient Suffered from Xerostomia Due to Sjögren's Syndrome
  • ―長期投与に伴う副作用発現状況と唾液分泌量および自覚症状スコアの変化―
  • —Incidence of Adverse Reaction, Change of Salivary Secretion, and Subjective Symptom Due to the Prolonged Administration—

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Abstract

We evaluated the efficacy of pilocarpine hydrochloride and adverse drug reactions (ADRs) associated with administration of pilocarpine hydrochloride. A marketing approval has recently been granted to pilocarpine hydrochloride as a treatment for xerostomia associated with Sjögren's syndrome ("SS"). Among the patients treated with pilocarpine hydrochloride from October 2007 to March 2009, our study included 64 patients who had not previously been treated with cevimeline hydrochloride or anetholetrithione and were able to be followed for 4 weeks post-treatment. Salivary secretion and symptom scores were evaluated in 42 patients followed up for 52 weeks after starting the treatment. The results of salivary secretion (10-minute gum test) were significantly improved from baseline to 24 weeks after the initiation of treatment and thereafter. Subjective symptom scores were significantly improved from baseline to 12 weeks after the initiation of treatment and thereafter. No decrease in efficacy of pilocarpine hydrochloride due to the prolonged administration was observed in any subjects examined. ADRs occurred in 81.3% of patients. The most common ADR was heavy sweating followed by nausea and urinary frequency. Fifteen point six percent of the patient, discontinued the treatment because of adverse drug reactions such as nausea, urinary frequency or others. ADRs occurred within 4 weeks after the initiation of treatment 97.9% of patients. Nausea disappeared in 38.5% of patients by 12 weeks after the initiation of treatment. No increased incidence of ADRs due to the prolonged administration was observed in any subjects examined.

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