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| Evaluation on the efficacy and safety of Qizheng Xiaotong Plaster for the treatment of knee osteoarthritis: a randomized controlled,multicenter study |
| Hits 2234 Download times 1320 Received:October 16, 2018 |
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| DOI
10.11656/j.issn.1672-1519.2019.03.07 |
| Key Words
Qizheng Xiaotong Plaster;knee osteoarthritis;randomized controlled study |
| Author Name | Affiliation | E-mail | | ZHANG Hongmei | Wang Jing Hospital of CACMS, Beijing 100102, China | | | LIN Dingkun | Traditional Chinese Medicine Hospital of Guangdong Province, Guangzhou 510530, China | | | WANG Changxing | Xinhua Hospital of Zhejiang Province, Hangzhou 310005, China | | | ZHAO Zhongwen | The Second People's Hospital of Fujian Province, Fuzhou 350003, China | | | ZHU Yongliang | Nanjing Municipal Government Hospital, Nanjing 210008, China | | | CHEN Wenjun | Provincial Government Hospital of Jiangsu, Nanjing 210024, China | | | LI Xinxin | Tianjin Santan Hospital, Tianjin 300193, China | | | WU Xifa | Central Hospital of Zibo, Zibo 255036, China | | | WANG Zunlai | Tianjin Beichen North Gate Hospital, Tianjin 300400, China | | | WANG Rongzhou | Tianjin Paradise Hospital, Tianjin 300200, China | | | JIANG Ming | Traditional Chinese Medicine Hospital of Kunshan, Kunshan 215300, China | | | ZHU Liguo | Wang Jing Hospital of CACMS, Beijing 100102, China | zhlg95@aliyun.com |
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| Abstract
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| [Objective] To assess the efficacy and safety of Qizheng Xiaotong Plaster and the newtype Qizheng Xiaotong Plaster on the treatment of knee osteoarthritis in 8 hours and 24 hours conducted as a randomized controlled,multicenter study.[Methods] A multiple center,randomized controlled study was conducted and 455 knee osteoarthritis patients were involved in this research. The patients were randomly divided into A-D four groups. Group A received 8-hour external application of Qizheng Xiaotong Plaster every day. Group B received 8-hour external application of new type Qizheng Xiaotong Plaster every day. Group C received 24-hour external application of Qizheng Xiaotong Plaster every day;Group D received 24-hour external application of new type Qizheng Xiaotong Plaster every day. The course of treatment was two weeks. The joint pain VAS score,WOMAC questionnaire scores and knee osteoarthritis indications scale score were detected before and after treatment and 1 week after treatment respectively. The related safety evaluation indicators were also tested at the same time.[Results] The knee pain VAS score,WOMAC rating scale and knee osteoarthritis indications ratings in four groups after treatment and follow-up after 1 week were significantly improved than pre-treatment (P<0.01). There was no significant difference between the posttreatment and the follow-up results. And at the same time,no significant difference in efficacy was found between the four groups (P>0.05). In terms of safety indicators,there was no significant difference among the four groups (P>0.05),but the eight-hour group had a lower incidence of adverse events compared with the 24-hour group. The most adverse events were itching,burning sensation,which can disappear when the external application was stopped. There were no deaths during the whole treatment period.[Conclusion] The application the new/prototype Qizheng Xiaotong Plaster 8 hours or 24 hours a day,two weeks of treatment,can obviously improve the symptoms of patients with knee osteoarthritis,and less adverse reaction was found during the treatment. Besides,the application of 8 hours every day can reduce the adverse reaction,but did not reducing the treatment effect. There was no significant difference in the efficacy and safety between the newtype Qizheng Xiaotong Plaster and the Qizheng Xiaotong Plaster. |
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