真实世界复方南星止痛膏治疗肢体部位慢性肌肉骨骼疼痛患者的临床疗效分析OA

Objective:To explore the clinical efficacy of Compound Nanxing Zhitong plaster in treating chronic musculo-skeletal pain in limb areas in the real world,and to provide a clinical reference for its standardized and rational application.Methods:A multicenter,prospective real-world study was conducted from November 2021 to December 2022 in 38 Chinese and Western hospitals across the country.A total of 3 029 patients with chronic musculoskeletal pain were collected,and 1 091 patients with chronic musculoskeletal pain in limb areas were included.Among them,666 patients used Compound Nanxing Zhitong plaster alone,and 425 patients used NSAIDs alone.Descriptive statistics were conducted on gender,age,and BMI.A 1∶1 propensity score matching(Caliper=0.05)was performed,and 380 patients using Com-pound Nanxing Zhitong plaster alone were assigned to the experimental group,and 380 patients using NSAIDs alone were assigned to the control group.The primary outcome measure was the visual analogue scale(VAS),and the secondary out-come measures were the global pain scale(GPS),the short form health survey(SF-12),and the traditional Chinese medi-cine(TCM)syndrome/symptom scale scores.Statistical analysis was conducted at 2,4,8,and 12 weeks after treat-ment.Data were analyzed using SPSS 27.0.Independent sample t-tests were used for normally distributed data,and Mann-Whitney U tests were used for non-normally distributed data.Results:In the full dataset before matching,the aver-age age of the experimental group(55.94±14.50)years old was higher than that of the control group(51.43±15.02)years old(P＜0.05);baseline VAS score of experimental group(5.74±0.95)points was higher than control group(5.60±0.93)points(P＜0.05).After propensity score matching,all baseline indicators were balanced between two groups(P＞0.05).At 2,4,and 8 weeks,the mean decrease in VAS scores in the experimental group was(1.67±1.13),(2.84±1.31),and(3.80±1.44)points,respectively,which was lower than that in the control group(2.09±1.26),(3.29±1.41),and(4.12±1.32)points(all P＜0.05).At 12 weeks,the VAS scores reduction of experimental group(4.72±1.52)points showed no significant difference with control group(4.76±1.34)points(P＞0.05).For GPS score,there was no intergroup difference at week 2(P＞0.05);at week 12,GPS score of experimental group 5.00(0.00,16.00)points was lower than control group 6.00(0.00,22.00)points(P＜0.05).In SF-12 PCS(physical component summary),experimental group score at week 2(48.79±8.14)points was lower than control group(50.11±9.11)points(P＜0.05),while no difference was found at week 12(P＞0.05).In MCS(mental component summary),experi-mental group score at week 2(57.34±7.71)points was higher than control group(56.25±7.00)points(P＜0.05),with no difference at week 12(P＞0.05).Total TCM syndrome score showed no difference at week 2(P＞0.05);at week 12,experimental group 3.00(2.00,7.00)points was superior to control group 5.00(2.00,7.00)points(P＜0.05).The improvement of aversion to wind and cold,local stiffness at all follow-up time points(week 2/4/8/12)in ex-perimental group were significantly better than control group(P＜0.05).The improvement of joint movement limitation was only superior in experimental group at week 8(P＜0.05),with no difference at week 2,4,12(P＞0.05).Conclusion:The single use of Compound Nanxing Zhitong plaster and the single use of NSAIDs drugs both have significant efficacy in treating chronic musculoskeletal pain in the limbs over short-term period of 2,4,and 8 weeks.Moreover,the analgesic effect of Compound Nanxing Zhitong plaster is comparable to NSAIDs at 12 weeks long-term follow-up.Compound Nanxing Zhitong plaster shows significant improvement in overall pain(GPS)and TCM cold syndrome symptoms compared with oral NSAIDs,especially for local aversion to wind and cold and stiffness caused by cold pathogen.