一项评估AHPL/AYTAB/0313片剂对膝关节骨关节炎患者疗效和安全性的临床研究。

A clinical study to evaluate efficacy and safety of AHPL/AYTAB/0313 tablet in subjects suffering from osteoarthritis of knee(s).

作者信息

Nipanikar Sanjay U, Deshpande Shailesh, Bhosale Ashutosh H, Jadhav-Shinde Mayura V

机构信息

Medical Services Department, Head R and D, Ari Healthcare Pvt. Lt, Unit No.-401, International Biotech Park, BTS 2 Building, Chrysalis Enclave, 4th Floor, Plot No. 2A, MIDC, PhaseII, Hinjewadi, Maharashtra, India.

Department of Kayachikitsa, Pune District Education Association's, College of Ayurved and Research Centre and Hospital, Sector No. 25, Pradhikaran, Nigdi, Pune, Maharashtra, India.

出版信息

J Family Med Prim Care. 2020 Jan 28;9(1):61-68. doi: 10.4103/jfmpc.jfmpc_321_18. eCollection 2020 Jan.

DOI:10.4103/jfmpc.jfmpc_321_18

PMID:32110566

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7014886/

Abstract

BACKGROUND

Osteoarthritis (OA) is the most common form of arthritis with unsatisfactory treatment outcomes.

OBJECTIVES

To evaluate efficacy and safety of AHPL/AYTAB/0313 tablet in subjects with OA of knee joint.

STUDY DESIGN

Prospective, open-label, single-arm clinical study conducted in daily clinical practice setting.

METHOD

Subjects were advised to take 2 AHPL/AYTAB/0313 tablets twice daily orally after meals for 180 days. 48 subjects completed the study. The primary endpoints were changes in mean visual analogue scale (VAS) pain score and WOMAC score. Secondary endpoints were quality of life, time to walk 50 feet, knee joint swelling, use of analgesic drug as rescue medicine, and safety parameters.

RESULTS

At baseline visit, the mean index knee joint pain (VAS) score was 82.29 ± 15.19, which reduced significantly to 19.38 ± 13.75 on day 180. The mean WOMAC combined score at baseline was 39.94 ± 11.67, which reduced significantly to 09.58 ± 05.77 (76.0%) on day 180. The mean WOMAC pain score at baseline was 09.65 ± 02.91, which reduced significantly to 02.06 ± 01.46 on day 180. The mean WOMAC stiffness score at baseline was 03.48 ± 01.58, which reduced significantly to 00.63 ± 01.08 on day 180. The mean WOMAC difficulty score at baseline was 26.81 ± 09.63, which reduced significantly to 06.90 ± 04.78 on day 180. The mean walking time to walk 50 feet reduced significantly by 40% on day 180. Not a single subject was known to have knee joint swelling from 150 days onwards. Only 5 subjects were using analgesic as rescue medicine on day 180. Twenty-six subjects had adverse events (AEs). Most of the AEs were not associated with the study medication. Vitals and all the safety laboratory parameters were within normal limits both at baseline and on day 180.

CONCLUSION

"AHPL/AYTOP/0113" tablet is safe and significantly effective in reducing pain, swelling, and stiffness of knee joints and improving mobility of knee joints in patients with OA. CTRI registration No. is CTRI/2015/09/006177.

摘要

背景

骨关节炎（OA）是最常见的关节炎形式，治疗效果不尽人意。

目的

评估AHPL/AYTAB/0313片对膝关节骨关节炎患者的疗效和安全性。

研究设计

在日常临床实践环境中进行的前瞻性、开放标签、单臂临床研究。

方法

建议受试者每日餐后口服2片AHPL/AYTAB/0313片，持续180天。48名受试者完成了研究。主要终点是平均视觉模拟量表（VAS）疼痛评分和WOMAC评分的变化。次要终点是生活质量、行走50英尺的时间、膝关节肿胀、使用镇痛药作为急救药物以及安全性参数。

结果

在基线访视时，平均膝关节疼痛（VAS）评分为82.29±15.19，在第180天时显著降至19.38±13.75。基线时WOMAC综合平均评分为39.94±11.67，在第180天时显著降至09.58±05.77（降低了76.0%）。基线时WOMAC疼痛平均评分为09.65±02.91，在第180天时显著降至02.06±01.46。基线时WOMAC僵硬平均评分为03.48±01.58，在第180天时显著降至00.63±01.08。基线时WOMAC功能障碍平均评分为26.81±09.63，在第180天时显著降至06.90±04.78。在第180天时，行走50英尺的平均时间显著减少了40%。从第150天起，没有一名受试者出现膝关节肿胀。在第180天时，只有5名受试者使用镇痛药作为急救药物。26名受试者出现不良事件（AE）。大多数不良事件与研究药物无关。基线时和第180天时的生命体征和所有安全实验室参数均在正常范围内。