Cui Xin, Liang Long, Wang Lianxin, Wang Zhifei, Li Yuanyuan, Gao Yang, Zhang Cheng, Sun Menghua, Wang Shiheng, Liu Jiani, Zhang Yue, Wang Zhibo, Wei Xu, Xie Yanming
Institute of Basic Research in Clinical Medicine.
Wangjing Hospital.
Medicine (Baltimore). 2019 Aug;98(33):e16853. doi: 10.1097/MD.0000000000016853.
Low back pain is a common health problem worldwide, which also is a leading cause of long-term disability and has an important effect on the global economy and society. Usually, conservative therapies are used to treat low back pain. As a kind of Chinese patent medicine, Shujinjianyao pill (SJJYP) has a great curative effect on low back pain. However, its safety has not been studied yet. Therefore, we carried out this clinical trial to observe the safety of SJJYP in the real world.
First, participants need to meet the medication standards according to inclusion and exclusion criteria. Then, participants are conducted safety examination before taking SJJYP. After qualified screening, participants can be enrolled into the group. Second, all enrolled participants will receive SJJJYP for a period of 4 weeks. During the observation period, participants need to return to the hospital for a subsequent visit after 2 weeks of medication, and come to the hospital for safety check after 4 weeks of medication. Third, telephone follow-up is used to investigate any participants' physical discomfort after 6 to 8 weeks (2-4 weeks after medication withdrawal). After all these steps are completed, clinical observation is finished. If any adverse events occur during this process, we will record them in time. When serious adverse events occur, we will use nested case-control study to explore the causes and mechanisms.
This study will obtain the safety results of SJJYP in clinical real world, which will offer a scientific basis for clinicians in the treatment of low back pain, and also provide a methodological basis for the safety study of other medicines.
ClinicalTrial.gov registration number is NCT03598153. This study was approved by the ethics committee of Wangjing hospital, China Academy of Chinese Medical Sciences (WJEC-KT-2018-012-P002).
腰痛是全球常见的健康问题，也是导致长期残疾的主要原因，对全球经济和社会有重要影响。通常，保守疗法用于治疗腰痛。舒筋健腰丸（SJJYP）作为一种中成药，对腰痛有显著疗效。然而，其安全性尚未得到研究。因此，我们开展了这项临床试验，以观察舒筋健腰丸在现实世界中的安全性。
首先，参与者需根据纳入和排除标准符合用药标准。然后，参与者在服用舒筋健腰丸前进行安全性检查。经过合格筛选后，参与者可入组。其次，所有入组参与者将接受舒筋健腰丸治疗4周。在观察期内，参与者在用药2周后需返回医院进行复诊，并在用药4周后到医院进行安全性检查。第三，采用电话随访调查任何参与者在6至8周（停药后2 - 4周）后的身体不适情况。完成所有这些步骤后，临床观察结束。如果在此过程中发生任何不良事件，我们将及时记录。当发生严重不良事件时，我们将采用巢式病例对照研究来探讨其原因和机制。
本研究将获得舒筋健腰丸在临床现实世界中的安全性结果，这将为临床医生治疗腰痛提供科学依据，也为其他药物的安全性研究提供方法学依据。
ClinicalTrial.gov注册号为NCT03598153。本研究已获得中国中医科学院望京医院伦理委员会批准（WJEC - KT - 2018 - 012 - P002）。
