A Preliminary Clinical Study of Freshly Manufactured 35kDa Hyaluronan Fragment in the Treatment of Herpes Zoster Pain and Shoulder, Neck, Back and Temporal Pain

Bioactive Hyaluronan fragment HA35 of 35kDa was isolated from human colostrum. Literature studies have shown that female breast hyaluronidase and male testicular sperm acrosomal hyaluronidase PH20 come from the same gene. The investigators, recombinant human hyaluronidase PH20 and neutral hyaluronidase (PH20 or SPAM1) of bovine testicular sperm acrosome were used to cleave macromolecular Hyaluronan. Regardless of the cutting time, the Hyaluronan fragment HA35 with an average molecular weight 35kDa was produced(Registration number L20200708MP07707, Ministry of Health, Mongolia). Hyaluronidase injection is often used to improve the penetration and absorption of other injectable drugs. Hyaluronidase injection is also used to degrade excessive use of cosmetic injection or improper use of cross-linked macromolecular Hyaluronan fillers, which is an off-label drug use of hyaluronidase（https://www.realself.com/news/ hyaluronidase-dissolve-fillers）. In this study, Hyaluronan fragment HA35 of 35kDa was prepared by mixing hyaluronidase injection extracted from bovine testis (hyaluronidase for injection, H31022111) and Hyaluronan injection (sodium hyaluronate injection, H20174089) at room temperature for 20 minutes. Its analgesic effect on herpes zoster, shoulder, neck, back, and temporal pain was studied.

In this study, off-label drug use of hyaluronidase injection and Hyaluronan injection （https://www.realself.com/news/ hyaluronidase-dissolve-fillers）were used in the clinical study of shoulder, neck, back and temporal pain and herpes zoster pain, namely investigator initiated trails. In this clinical trial, 26 patients with shoulder, neck, back and temporal pain were studied in the Department of pain diagnosis and treatment of the affiliated Hospital of Qingdao University. Ten patients with herpes zoster were treated in the pain Department of the affiliated Hospital of Qingdao University. According to the ratio of 100mg high molecular Hyaluronan / 2000 unit hyaluronidase, the high molecular Hyaluronan injection (sodium hyaluronate injection, H20174089) and the hyaluronidase injection extracted from bovine testis (hyaluronidase for injection) were mixed at room temperature for 20 minutes. Each time according to the amount of high molecular Hyaluronan containing 100 mg Hyaluronan and hyaluronidase mixture, pain point area and pain point area of the nerve trunk innervation of the local multi-point injection. Then, pain scale was used to evaluate and record the pain relief of patients before and after treatment.