ResearchPad - original-articles-‐-clinical https://www.researchpad.co Default RSS Feed en-us © 2020 Newgen KnowledgeWorks <![CDATA[Phase I study of KRP‐116D, a 50% w/w dimethyl sulfoxide aqueous solution, on the systemic absorption from bladder by intravesical instillation in healthy Japanese subjects]]> https://www.researchpad.co/article/elastic_article_7004 This was a single‐institution, single‐dose, single‐arm phase 1 study in healthy adult males to evaluate the safety and absorption of dimethyl sulfoxide (DMSO) from the bladder into the body when KRP‐116D (a 50% w/w DMSO solution) was intravesically administered and allowed to remain in the bladder for 15 minutes.MethodsSix healthy adult males were enrolled in this study. KRP‐116D (50 mL) was instilled directly into the bladder via a catheter where it was allowed to remain for 15 minutes under lidocaine anesthesia in accordance with the usage of RIMSO‐50 (50% w/w DMSO solution) approved in the USA. The residual DMSO solution in the bladder was collected 15 minutes after instillation. The concentrations of DMSO in the plasma and the recovered solution were analyzed by a validated high‐performance liquid chromatography (HPLC) method. The concentration in the residual DMSO solution was multiplied by the solution volume and divided by the dosage to calculate the recovery rate of DMSO.ResultsPlasma DMSO was detected in one of six subjects, and in the remaining five subjects DMSO was not detected (<19.6 μg/mL). The recovery rate of DMSO from the bladder was 60.7% to 93.7%. The only drug‐related adverse event was breath odor (garlic‐like breath) observed in four of six subjects (66.7%).ConclusionAbsorption of DMSO from the bladder was low (16.3%), and the systemic exposure was limited. Most of the DMSO was recovered from the bladder. KRP‐116D 50 mL was well tolerated and safe. ]]> <![CDATA[Transurethral resection in women with symptomatic keratinizing squamous metaplasia of urinary bladder: A retrospective study of 92 cases]]> https://www.researchpad.co/article/elastic_article_6923 To investigate the efficacy of transurethral resection (TUR) on relieving urinary symptoms in patients with keratinizing squamous metaplasia (KSM) of the urinary bladder.MethodsData were analyzed from a retrospective study of patients receiving transurethral bipolar plasma resection (bi‐TUR) treatment for symptomatic KSM. Urinary symptoms were assessed by the International Prostate Symptom Score (IPSS) and a numeric rating scale pain score. Efficacy was assessed using the IPSS to determine changes from baseline in lower urinary tract symptoms (LUTS). Self‐reported quality of life (QoL) was assessed by the last question of the IPSS questionnaire.ResultsA total of 92 female patients were included in the analysis. The median age was 42 years. LUTS, pain, and hematuria were the most common symptoms that affected patients. The median follow‐up duration was 51 months. There were significant improvements in LUTS from baseline IPSS after TUR (P < .001). The percentage of the patients with moderate to severe LUTS went down from 52.2% to 18.5%. The median Numeric Rating Scale (NRS)‐11 pain score reduced from 3 at baseline to 0 at the last visit. Twenty‐one out of 40 patients reported that the pain symptoms disappeared completely. No patients reported hematuria symptoms at the final follow‐up. Improvement of self‐reported QoL was significant (P < .001). A total of 57.6% of patients reported an improvement, 26.1% of patients reported no improvement, and 16.3% reported deterioration.ConclusionsBi‐TUR therapy significantly relieved urinary symptoms in women with KSM. Improvement of QoL was acceptable with a success rate of 57.6%. Considering the very low complication rate, our study supported bi‐TUR as an alternative treatment for patients who are resistant to medical therapy. ]]> <![CDATA[Administration of Ratanhia-based herbal oral care products for the prophylaxis of oral mucositis in cancer chemotherapy patients: a clinical trial]]> https://www.researchpad.co/article/5b7d0b4a463d7e30fb54653b

Oral complications are a common side effect of cancer chemotherapy, as antineoplastic agents affect both the immune system and the oral mucosa. This study demonstrates preventive and therapeutic effects of dental treatment and regular use of Weleda Ratanhia-Mundwasser® (herbal mouthwash) and Weleda Pflanzen-Zahngel® (herbal toothgel) on oral mucositis during chemotherapy. Thirty-two female patients with breast cancer starting on chemotherapy were evaluated in this study. Plaque index, gingival index, degree of mucositis and 10 single symptoms were monitored once weekly for four consecutive weeks. After four weeks, plaque and gingival indexes were slightly decreased compared to baseline values. The degree of mucositis was increased by one grade in 15.6 % of the patients and over 70 % remained without symptoms. On the whole, single symptoms decreased from day 7 since beginning of chemotherapy to day 28. Mucositis symptoms were moderate in severity, and the results indicate a positive influence of using Weleda Ratanhia-Mundwasser and Weleda Pflanzen-Zahngel. Further studies might be promising.

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<![CDATA[Electro-Acupuncture in Relieving Labor Pain]]> https://www.researchpad.co/article/5b7c3cdb463d7e0f60fbbf64

To study the efficacy of electro-acupuncture for the relief of labor pain, and to build a better understanding of how electro-acupuncture might influence the neuroendocrine system, 36 primiparas were randomly divided into an electro-acupuncture group and a control group. Assessments of pain intensity and degree of relaxation during labor were analyzed. The differences between the electro-acupuncture group and the control group on the concentration of β-endorphin (β-EP) and 5-hydroxytryptamine (5-HT) in the peripheral blood were compared. The electro-acupuncture group was found to exhibit a lower pain intensity and a better degree of relaxation than the control group (p = 0.018; p = 0.031). There existed a significant difference in the concentration of β-EP and 5-HT in the peripheral blood between the two groups at the end of the first stage (p = 0.037; p = 0.030). Electro-acupuncture was found to be an effective alternative or complementary therapy in the relief of pain during labor. The benefit of electro-acupuncture for relieving labor pain may be based on the mechanism of producing a synergism of the central nervous system (CNS) with a direct impact on the uterus through increasing the release of β-EP and 5-HT into the peripheral blood.

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